Kornimate/medical-research-clean huggingface dataset:
comparison of the efficacy and safety of a new formulation of insulin glargine with lantus in patients with type 2 diabetes insufficiently controlled with non-insulin antidiabetic therapy

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare the efficacy of insulin glargine (u300) and lantus in terms of change of glycated hemoglobin a1c (hba1c) from baseline to endpoint (scheduled at month 6, week 26) in patients with type 2 diabetes mellitus. secondary objectives: * to compare insulin glargine (u300) and lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia. * to compare insulin glargine (u300) and lantus in terms of reaching target hba1c values (all and reaching target without hypoglycemia). * to compare insulin glargine (u300) and lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia). * to compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative). * to assess the safety and tolerability of insulin glargine (u300). * to assess the development of anti-insulin glargine antibodies (aia).

the total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety follow-up period.

Eligibility criteria:
inclusion criteria : * adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s). * signed written informed consent. exclusion criteria: * age \< legal age of adulthood. * hba1c \ 11% (\>97 mmol/mol) (at screening). * history of type 2 diabetes mellitus for less than 1 year before screening. * less than 6 months before screening with non-insulin antihyperglycemic treatment. * change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening. * initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(glp-1) receptor agonist in the last 6 months before screening visit. * patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization). * current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening. * severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. * unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
effect of active drain line clearance on catheter-associated bacteriuria

Conditions: Critical Illness; Burns; Surgery; Urinary Tract Infections; Bacteriuria

Summary: catheter-associated urinary tract infections (cauti) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs. the purpose of this study is to evaluate whether active drain line clearance by the accuryn monitoring system reduces the incidence of cauti in hospitalized patients requiring catheters.

urinary tract infection (uti) is the most common healthcare associated infection (hai) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the united states, of which 75% are associated with indwelling urinary catheters. it is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. the rate of catheter-associated uti (cauti) are highest in burn icus, followed by inpatient medical wards and neurosurgical icus. the purpose of this study is to evaluate whether active drain line clearance by the accuryn monitoring system reduces the incidence of bacteriuria and/or cauti in patients requiring catheters for more than 72 hours. this study will also evaluate the efficacy in reducing bacteriuria of the accuryn silver fabricated silicone catheters.

Eligibility criteria:
inclusion criteria: 1. adult (age ≥ 18) 2. patient or legally authorized representative (lar) possess the capacity to provide informed consent 3. indication for a urinary bladder catheter (or one currently in place) 4. expected urinary catheter requirement ≥ 72 hours 5. no current urinary tract infection 6. no current indication for prophylactic antibiotics. if a surgical patient, receive perioperative antibiotics for no greater than 24 hours exclusion criteria: 1. inability to receive a urinary bladder catheter 2. chronic suprapubic catheter in place 3. expected survival \< 72 hours 4. receipt of systemic antibiotics within 48 hours of enrollment, other than prophylactic antibiotics given at the time of surgery 5. surgery of the genitourinary tract in the past 6 months prior to admission 6. deemed unfit for the protocol by the investigator for any reason

Keywords: urinary catheter
follow-up strategies for fragile patients with decompensated heart failure

Conditions: Heart Failure; With Decompensation; Fragility

Summary: randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure.

randomized controlled clinical trial with intervention branch (management program cardiological-geriatric) and control branch (usual care) for fragile patients with decompensated heart failure. follow-up period 1 month. this protocol aims through a multidisciplinary vision, to carry out during hospitalization a comprehensive geriatric evaluation that allows to know the medical and socio-environmental needs of the patient to plan the required care at home and achieve an effective transition.

Eligibility criteria:
inclusion criteria: 1. age 65 years or older 2. decompensated heart failure 3. frail scale equal to 3 or more points 4. permanent residence in the metropolitan area of buenos aires exclusion criteria: 1. refusal to participate in the study 2. terminal oncology or cardiological disease 3. reversible or treatable etiology heart failure (e.g. takotsubo, acute cardiomyocarditis) 4. patients followed by geriatrics prior to admission 5. simultaneous participation in another research protocol
correlation between various inflammatory markers and vascular inflammation measured by 18fdg-pet

Conditions: Atherosclerosis

Summary: vascular inflammation is a key factor in both the pathogenesis and outcome of atherosclerosis. various inflammatory markers such as lppla2,mcp-2 and hscrp are well-known prognostic factors for the cardiovascular event. 18f-fluorodeoxyglucose (fdg) positron emission tomography (pet) is a promising tool for identifying and quantifying vascular inflammation within atherosclerotic plaques.therefore, the purpose of the study is to demonstrate the correlation between various inflammatory markers and vascular inflammation detected by 18fdg-pet.


Eligibility criteria:
inclusion criteria: * healthy patients for visiting routine medical check in our clinic exclusion criteria: * history of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization) * diabetes * stage 2 hypertension (resting blood pressure, ≥160/100 mmhg) * malignancy * severe renal or hepatic disease * subjects taking medications that might affect inflammation such as nsiad and statin

Keywords: atherosclerosis vascular inflammation lppla2 hscrp mcp-1 18fdg-pet
element-mds: a study to compare the efficacy and safety of luspatercept in participants with myelodysplastic syndrome (mds) and anemia not receiving blood transfusions

Conditions: Myelodysplastic Syndromes

Summary: the purpose of the study is to compare the efficacy and safety of luspatercept vs epoetin alfa in the treatment of anemia in adults due to ipss-r very low, low, intermediate-risk mds in esa-naïve participants who are non-transfusion dependent (ntd).


Eligibility criteria:
inclusion criteria * participant has documented diagnosis of mds according to world health organization (who) 2016 that meet ipss-r classification of very low, low, or intermediate-risk disease, (intermediate-risk of ≤ 3.5 ipss-r score) confirmed via bone marrow aspirate and:. i) \< 5% blasts in bone marrow and \< 1% blasts in peripheral blood. * participant is not transfusion dependent (ntd) based on iwg2018 criteria. * participant is erythropoiesis-stimulating agent naive. participants may be randomized at the investigator's discretion if the participant received no more than 2 prior doses of epoetin alfa, epoetin alfa biosimilar, or darbepoetin alfa, with the last dose at least 8 weeks prior to randomization. * participant has a baseline endogenous serum erythropoietin (sepo) level of ≤ 500 u/l. * participant has symptoms of anemia:. i) participant records a severity score of "moderate" or greater on at least 1 pgi-s item of fatigue, weakness, shortness of breath, or dizziness performed during the screening period. * participant has a baseline hb concentration prior to randomization of ≤ 9.5 g/dl. the baseline hb will be calculated using the mean of the two lowest available hb measurements within 16 weeks prior to randomization and must include at least one central lab hb reading done within the screening period (no more than 35 days before randomization). the two hb measurements must have been performed at least seven days apart. hb levels less than 21 days following rbc transfusion should not be used. split samples for local assessments are not required. exclusion criteria * participant with secondary mds (that is, mds that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases). * participant with known history of diagnosis of aml. * participant with history of cerebrovascular accident (including ischemic, embolic, and hemorrhagic cerebrovascular accident), transient ischemic attack, deep venous thrombosis (including proximal and distal), pulmonary or arterial embolism, arterial thrombosis, or other venous thrombosis within 6 months prior to randomization. * participant with a history of pure red cell aplasia and/or antibody against erythropoietin. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: luspatercept bms-986346 ace-536 myelodysplastic syndrome epoetin alfa erythropoietin stimulating agent (esa) myelodysplastic syndromes (mds) anaemia
digital therapeutics (dtx) for pain: pilot study of a virtual reality software for chronic pain

Conditions: Chronic Low Back Pain

Summary: prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.

prospective, randomised, double-blind, 3-arm parallel group comparison of dtx for pain (treatment a), control (treatment b) and an open standard care arm, over 6-8 weeks. an optional adaptive, multi-objective, multi-purpose, extension is included. study devices will be delivered to the patient's home with instructions for use; patients will receive remote technical support.

Eligibility criteria:
inclusion criteria: * competent male or female adults (age ≥ 18 years). * chronic low back pain * written informed consent * finnish speaking * having a clear, flat surface of at least 2 x 2 m of size to interact with dtx for pain * can stoop without severe pain exclusion criteria: * history of epilepsy, migraine, vertigo or psychosis * confirmed diagnosis of cancer * prone to strong motion sickness requiring treatment * pregnancy * physiotherapy based interventions contraindicated * severe or acute structural pathologies (e.g. spondylitis, epidural abscess, spondylolisthesis, acute herniated or ruptured disc, traumatic injury, or severe spinal stenosis) that could be worsened by the intervention as assessed by the principal investigator * has received (in last 2 years) or is receiving formal psychotherapy from a psychologist for pain or allied health care professional at the screening stage * any other condition that would affect posture or balance, and * prior participation in dtx for pain feasibility study or in any part of the current study
intubation in coronavirus disease 19 with level 3 ppe

Conditions: Intubation Complication

Summary: the world health organization (who) declared covid-19 as a pandemic in april 2020. covid-19 first discovered in wuhan, china in december 2019. as of may 4th, 2020, the total number of patients in china was 82,880, the number of deaths was 4,633, the death rate was 3.7%. in indonesia, until may 4th 2020, there were 11,192 confirmed cases of covid-19 with a total of 845 deaths. high transmission and death due to the severe acute respiratory syndrome coronavirus 2, patients with respiratory failure symptoms were suspected of having covid-19 until declared negative. a potential and continuing threatening complication is acute respiratory failure. patient with acute respiratory distress syndrome (ards) require both respiratory support and oxygen therapy. the choosing of endotracheal intubation is generally indicated in moderate to severe ards. apart from respiratory failure, endotracheal intubation is also commonly performed in patients undergoing surgical procedures under general anesthesia for the management of the patient's airway. to prevent transmission to medical personnel, intubation is carried out using ppe according to the guidelines. guidance for intubation in covid-19 patients is recommended to use a video laryngoscope because it offers several advantages such as assisting glottis visualization and making the intubation operator more distant from the patient's mouth when compared to direct laryngoscopes. this study aims to see the effect of using ppe and the type of laryngoscope on the intubation process carried out in the covid-19 pandemic. this study is a preliminary study aimed at seeing the effect size of the recommended ppe use on the process and success of intubation.


Eligibility criteria:
inclusion criteria: * age 18 to 59 years old * undergo elective or emergency surgery using general anesthesia with endotracheal tube * bmi below 30 kg/m2 exclusion criteria: * airway difficulty as assessed by preoperative assessment * critical patients with unstable hemodynamics * suspected or confirmed covid-19 with asa 3-5

Keywords: covid-19 intubation process personal protective equipment (ppe) laryngoscope
advm-022 intravitreal gene therapy for wet amd

Conditions: Wet Age-related Macular Degeneration; Neovascular Age-related Macular Degeneration

Summary: advm-022 (aav.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet amd). wet amd is a serious condition and the leading cause of blindness in the elderly. the available therapies for treating wet amd require life-long intravitreal (ivt) injections every 4-12 weeks to maintain efficacy. a one-time ivt administration of advm-022 has the potential to treat wet amd by providing durable expression of therapeutic levels of intraocular anti-vegf protein (aflibercept) and maintaining the vision of patients. advm-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet amd receiving anti-vegf therapy in clinical practice.

this open-label, multicenter, dose-ranging study will evaluate 2 dose levels in up to 30 subjects (15 per dose) with active choroidal neovascularization (cnv) secondary to amd. subjects who are under active anti-vegf treatment and have demonstrated a meaningful response to anti-vegf therapy will be considered for participation in this study. the primary endpoint for this study is safety and tolerability of advm-022. all subjects will continue to be assessed for 104 weeks following treatment with advm-022.

Eligibility criteria:
inclusion criteria: * age ≥ 50 * diagnosis of neovascular (wet) amd * bcva etdrs snellen equivalent between ≤20/32 and ≥20/320 for each cohort * subjects must be under active anti-vegf treatment for wamd and received a minimum of 2 injections within 4 months prior to screening * demonstrated a meaningful response to anti-vegf therapy * willing and able to provide consent exclusion criteria: * history of retinal disease in the study eye other than wet amd * fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement * history of retinal detachment (with or without repair) in the study eye * history of vitrectomy, trabeculectomy, or other filtration surgery in the study eye * uncontrolled glaucoma in the study eye * any prior treatment with photodynamic therapy or retinal laser for the treatment of wet amd and any previous therapeutic radiation in the region of the study eye * any previous intraocular or periocular surgery on the study eye within 6 months * acute coronary syndrome, myocardial infarction or coronary artery revascularization, cva, tia in the last 6 months * uncontrolled hypertension defined as average sbp ≥160 mmhg or an average dbp ≥100 mmhg

Keywords: choroidal neovascularizatio advm-022 cnv advm-022-01 aav.7m8 anti-vegf therapy blindness gene therapy aflibercept (eylea) age-related macular degeneration wet macular degeneration retinal degeneration retinal diseases eye diseases aav vector adverum wamd amd wet amd
conventional mechanical ventilation and high frequency percussive ventilation: comparison of their effects on alveolar recruitment and distension by ct-scan in early ards patients

Conditions: ARDS

Summary: high frequency percussive ventilation (hfpv) is a high frequency ventilation mode in which high frequency pulses accumulate to generate a low frequency tidal volume at a controlled airway pressure. previous studies have suggested a protective effect of hfpv on lung injury. the goal of our study is to compare, in early ards patients, the effects of conventional mechanical ventilation and of high frequency percussive ventilation on alveolar recruitment and distension evaluated by ct-scan


Eligibility criteria:
inclusion criteria: * patient undergoing invasive ventilation for more than 24h * ards patient exclusion criteria: * pneumothorax drained or not * patient undergoing extracorporel mechanical oxygenation * patient who had a pneumonectomy partiel or total

Keywords: mechanical ventilation
mandibular movement test as a screening tool for polysomnography candidates

Conditions: Sleep Apnea Syndromes

Summary: the primary objective of this study is to determine the technical failure and inconclusive test rates when using the brizzy device for mandibular movement tracking.


Eligibility criteria:
inclusion criteria: * patient included in the brizzy register * mandibular movement test prescribed by practitioner * patient performed a mandibular movement test (ambulatory setting) using a magnetic sensor (brizzy, nomics, liege, belgium) exclusion criteria: * none

Keywords: mandibular movements
modified laparoendoscopic rendezvous for secondary choledocholithiasis: a nonrandomized controlled clinical study

Conditions: Choledocholithiasis

Summary: this study intends to explore the success rate and clinical efficacy of modified lerv in the treatment of patients with non-dilated common bile duct (internal diameter ≤10mm) through a non-randomized controlled clinical trial, and to clarify whether modified lerv can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

patients with cholecystolithiasis secondary to common bile duct stones requiring surgical treatment during a 3-year period from 2022-6-1 to 2025-3-31 were enrolled in this non-randomized controlled clinical trial. preoperative diameter of the middle common bile duct was determined by magnetic resonance cholangiography (mrcp) or b-ultrasound measurement. the actual treatment plan of the patients was recorded, including lerv treatment and ercp+lc treatment. the baseline data and the success rate of stone removal, operation time, postoperative stone residual rate, complication rate, length of hospital stay and hospitalization cost were recorded for observation and follow-up. to determine whether modified lerv can be used as the preferred routine treatment for choledocholithiasis secondary to gallbladder stones.

Eligibility criteria:
inclusion criteria: 1、18 years ≤ age \<85 years 2、clinical diagnosis of choledocholithiasis secondary to cholecystolithiasis and middle choledocholithiasis (mcbd) diameter ≤10mm; the diameter of mcbd was based on mrcp measurements. if mrcp could not be performed, ct images were used as reference, and b-ultrasound measurements were used as the standard. 3、 good cardiopulmonary function, anesthesia evaluation tolerance under general anesthesia laparoscopic + endoscopic surgery. - exclusion criteria: 1、 intrahepatic bile duct stones with indications for surgery, and need simultaneous surgery; 2、 patients with choledocholithiasis \>2 cm or a large number of stones were difficult to remove; 3、 patients with malignant hepatobiliary and pancreatic tumors or biliary tract malformations; 4、 severe patients with severe pancreatitis and septic shock before operation; 5、patients with previous gastric and duodenoscopic surgery history and interruption of gastroduodenal continuity; 6、 severe partial stenosis of the upper gastrointestinal tract (from the oral cavity to the second duodenum), which is expected to be inaccessible to the duodenoscope. -
hearing impairment as a risk factor for dementia in older adults

Conditions: Dementia; Hearing Loss

Summary: this doctor of philosophy (phd) project is part of a larger project on potentially modifiable risk factors for dementia in a life course perspective, with an overarching aim to improve prevention of dementia and thereby potentially relieve patient and caregiver distress and decrease societal load. the present phd project will concentrate on confirming knowledge of hi as an independent risk factor for dementia and exploring potentially causative factors to explain this relationship.

despite a huge increase in the knowledge about disease mechanisms in various types of dementia in recent years, no curative treatment exists at present. results from research on disease-modifying agents have been disappointing. this has led to an increased interest in other ways to reduce the prevalence of dementia. a recent report estimated that up to one third of dementia cases could be delayed or prevented by interventions directed at the most common risk factors. in the "lancet commission on dementia prevention, treatment, and care", hearing impairment (hi) was identified as the potentially most important modifiable risk factor. even though hi is considered an important modifiable risk factor, the evidence regarding the association between hi and dementia risk is still limited.

Eligibility criteria:
inclusion criteria: * living in designated area exclusion criteria: * none