Kornimate/medical-research-clean huggingface dataset:
evaluation of the safety and efficacy of long-term use of omega-3 fatty acid ethyl esters

Conditions: Hyperlipidemia

Summary: the purpose of this study is to evaluate the safety and efficacy of long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (lotriga granular capsules) in patients with hyperlipidemia in daily medical practice

this special drug use surveillance on long-term use of granular capsule formulation of omega-3 fatty acid ethyl esters (lotriga granular capsules) was designed to investigate the frequency of adverse events in patients with hyperlipidemia the usual adult dosage is 2 g of omega-3 fatty acid ethyl esters administered orally once daily after meals. however, the dosage can be increased up to twice daily (at a dose of 2 g) depending on the participant's triglyceride level.

Eligibility criteria:
inclusion criteria: * patients with hyperlipidemia exclusion criteria: 1. patients with hemorrhage (e.g., hemophilia, capillary fragility, gastrointestinal ulcer, urinary tract hemorrhage, hemoptysis, or vitreous hemorrhage) 2. patients with a history of hypersensitivity to ingredients in granular capsule formulation of omega-3 fatty acid ethyl esters

Keywords: pharmacological therapy
grade 2 chondrosarcoma treated by intralesional curettage: follow-up vs resection

Conditions: Chondrosarcoma, Grade 2

Summary: the goal of this observational study is to assess the oncological outcomes in patients diagnosed with grade 2 chondrosarcoma, treated with intralesional curettage, stratified into two cohorts: those subjected to follow up monitoring and those who have undergone subsequent surgical intervention.

large resection of the tumor is considered the treatment of choice in patients affected by grade 2 chondrosarcoma. nonetheless, a preoperative diagnosis of a lower grade lesion (chs grade 1) is not infrequent, thus making these patients treated with intralesional curettage. intralesional curettage is a type of surgery in which the pathological component is removed from the affected bone and the resulting bone defects can be filled with bone substitutes or bone cement. bone cortexes are left in place like a shell. the results of this study could contribute to find the right therapeutic pathway in patients affected by grade 2 chondrosarcoma treated with intralesional curettage, in particular in patients who underwent further surgery (bone resection) or follow-up. since outcome data are scarce in the literature, the results of this study could be used to assess the feasibility of a randomized controlled trial with the correct sample size. it is an explorative, spontaneous, non-profit, retrospective, observational study. it involves the pseudonymous data collection of all patients matching inclusion criteria. the data recorded in this study are extracted from the medical records of patients who regularly seek care from the medical unit during their routine clinical visits. following a meticulous collection of patients' baseline data, the two therapeutic options (clinical monitoring or bone resection) in patients affected by grade 2 chondrosarcoma treated with intralesional curettage will be compared. data related to demographics, histologic and treatment data will be collected. oncologic follow-up data will be also collected. in particular, data related to local recurrences, distant metastasis and survival will be evaluated.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of grade 2 chondrosarcoma of the appendiceal skeleton in the definitive specimen; * patients treated with intralesional curettage surgery; * patients aged \>=18 years; * patients who were treated between 01/01/2008 and 31/12/2020. exclusion criteria: * patients diagnosed with grade 1 or 3 chondrosarcoma on the histological diagnosis of the operative specimen. * patients undergoing wide resection as the primary treatment. * patients with less than 12 months follow-up.

Keywords: intralesional curettage
mek162 and raf265 in adult patients with advanced solid tumors harboring ras or brafv600e mutations

Conditions: Advanced Solid Tumors

Summary: this is a multi- center, open-label, dose finding, phase ib study to be conducted in two stages: a dose escalation part to determine the maximum tolerated dose (mtd) safety and tolerability of concurrent administration of mek162 and raf265, followed by an expansion part to further assess the safety and preliminary anti-tumor efficacy of this oral combination within two separate patient populations: i) patients with advanced solid tumors harboring brafv600e mutations or ii) patients with advanced solid tumors harboring ras mutations.


Eligibility criteria:
inclusion criteria: patients with histologically or cytologically confirmed and non-resectable advanced solid tumors for which no further effective standard therapy exists. * the patients' tumors must contain documented activating somatic brafv600e\* , nras or kras mutations (except for pancreatic cancer) * all patients enrolled must provide fresh or archival tumor samples at baseline to enable central confirmation of braf or kras/nras mutations * measurable, or non-measurable but evaluable disease as determined by recist * adequate bone marrow function * adequate hepatic and renal function * adequate cardiovascular function * negative serum β hcg test (female patients of childbearing potential only) within 72 hrs prior to first dose exclusion criteria: * patients with a history of primary central nervous system tumors or brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases * current evidence of retinal disease; or ophthalmopathy as assessed by ophthalmologic examination at baseline that would be considered a risk factor for csr/rvo (e.g., optic disc cupping, visual field defects, iop \> 21 mm hg) * impaired cardio-/vascular function or clinically significant cardiovascular diseases, including any of the following: * history/evidence of acute coronary syndromes (including mi, unstable angina, cabg, coronary angioplasty, or stenting) ≤ 6 months prior to starting study drugs * thromboembolic event (dvt, cva, pe) ≤ 6 months prior to starting study * symptomatic chf, history or current evidence of clinically significant cardiac arrhythmia and/or conduction abnormality * uncontrolled arterial hypertension, defined as bp \> 140/100 mmhg (average of 3 consecutive readings) * history of melena, hematemesis or hemoptysis within the last 3 months * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\> 5 miu/ml) other protocol-defined inclusion/exclusion criteria may apply

Keywords: advanced solid tumors harboring ras harboring brafv600e
magnetic resonance imaging (mri) fat quantification of the liver

Conditions: Non-alcoholic Fatty Liver Disease; Obesity

Summary: fatty liver in the obese is a common finding; some cases develop steato-hepatosis which in the long-term can lead to liver cirrhosis. the effect of bariatric surgery on fat distribution in the liver has so far been studied with liver biopsies and single voxel mr techniques. with this trial investigators present a new, whole organ mr-quantification of liver fat and describe changes after bariatric surgery in visceral and subcutaneous fat.

currently, liver biopsy is still regarded as the gold-standard in the diagnosis of non-alcoholic fatty liver disease and monitoring of progression. however, accuracy of diagnosis is not perfect with a certain risk of sampling error depending on biopsy quality and a more or less homogeneous distribution of liver tissue alterations. complications are rare; however, the method is invasive and carries the risk of bleeding. therefore, non-invasive methods (such as serum biomarkers or imaging techniques) are sought for accurate diagnosis and safe monitoring of disease progression. unidimensional transient elastography (te; fibroscan®) is a non-invasive technique, which can be a helpful tool here: however, accuracy of diagnosis is depending on the stage of fibrosis and lower grades of fibrosis (stage 1 and 2) are difficult to assess. moreover, in obese patients this method cannot be applied. in recent years, the development of fat-water magnetic resonance imaging has enabled non-invasive assessment of fat and water content in tissues. in addition, modern mri devices allow brief breath holding, which reduces motion artifacts and provides us with excellent data and therefore mri has become an important tool for fat quantification. up to date only a few studies have focused on fat quantification before and after bariatric surgery: patients treated with laparoscopic gastric banding (a purely restrictive procedure) and patients undergoing metabolic surgery such as sleeve gastrectomy and gastric bypass have been examined pre- and postoperatively by means of mri fat quantification. however, in these studies single voxel spectroscopy was used. in contrast, in this current trial investigators aim to assess full organ volume, which hopefully will provide more accurate data.

Eligibility criteria:
inclusion criteria: * morbidly obese patients with bmi over 35, scheduled for bariatric surgery (either sleeve gastrectomy or gastric bypass) exclusion criteria: * smoking * substance abuse * diabetes * history of gastrointestinal disorders * pace-maker * claustrophobia
sentinel lymph node biopsy versus lymphadenectomy in endometrial cancer

Conditions: Early Stage Endometrial Cancer; Sentinel Lymph Nodes; Lymphadenectomy

Summary: to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer.

this retrospective study aims to compare sentinel lymph nodes biopsy versus comprehensive lymphadenectomy in patients with early stage endometrial cancer by reviewing the medical records.

Eligibility criteria:
inclusion criteria: * ≧ 20 years * early stage endometrial cancer (figo stage i) exclusion criteria: * did not receive a complete course of treatment in this hospital, interrupted the treatment halfway (except if the disease continued to deteriorate or caused death during treatment), and did not follow up in this hospital after the course of treatment.
diaphragm ultrasound vs transpulmonary pressure to set peep in ards

Conditions: Acute Respiratory Distress Syndrome; Acute Respiratory Failure

Summary: this is a proof of concept study where the investigators aim to study the correlation between the use of a simple bedside ultrasound measurement of diaphragmatic muscle excursion with established (but time consuming) measurements made to optimize an important setting on the mechanical ventilator (positive end expiratory pressure or peep) in intubated adults with acute respiratory distress syndrome (ards) in the medical icu.

ventilator induced lung injury (vili) generates morbidity and mortality in mechanically ventilated patients. the awareness of respiratory mechanics is essential in the prevention of vili. currently, plateau pressures are widely used as a guide to assess alveolar pressure and minimize alveolar injury. however, patients with reduced chest wall compliance can have higher plateau pressures that may not reflect true alveolar pressure. the transpulmonary pressure has been cited as the true alveolar driving pressure because it takes into account pleural pressure that reflect chest wall mechanics; however, this requires measurement of esophageal pressure. the investigators have experienced a disproportionate degree of excursion between the posterior and anterior right hemidiaphragm on bedside ultrasound imaging in patients with ards, which may reflect the dependent atelectasis that occurs during low tidal volume ventilation, cardiac weight, weight of injured lung and accumulation of extravascular lung water in critically ill patients. the optimal peep can be guided by measurement of esophageal pressure (and subsequent calculation of transpulmonary distending pressure) with a balloon catheter placed into the esophagus much like a nasogastric tube for enteral access. the investigators believe that the normalization of the disproportionate degree of excursion between the anterior and posterior diaphragm can also be used to identify optimal peep, and may be correlated with changes in transpulmonary pressure (the current gold standard).

Eligibility criteria:
inclusion criteria: * adults older than 18 years old who develop ards, as defined by the berlin criteria, within 72 hours of icu admission. exclusion criteria: * any contraindication for nasogastric tube placement including recent injury or pathologic condition of the esophagus. * major bronchopleural fistula. * solid organ transplant recipient. * history or current diagnosis of diaphragmatic paralysis. * non-conventional mechanical ventilation strategy including high frequency oscillation, airway pressure release ventilation, prone ventilation and extra- corporeal membrane oxygenation. * hemodynamic instability defined as map\<65 with multiple vasopressors. * declining to sign consent form.

Keywords: ards peep critical care ultrasound
canalith repositioning procedure for bppv in primary care

Conditions: Benign Paroxysmal Positional Vertigo

Summary: the purpose of this study is to see whether family doctors can treat benign paroxysmal positional vertigo (bppv), or dizziness, using a procedure in the office. the study is looking at whether the treatment procedure cures the dizziness in more patients compared to patients that receive a "sham" or placebo procedure.

many patients consult their family physicians because of dizziness. this is a disabling condition with serious consequences, especially in older people, as it may lead to falls and consequent fractures. one of the most common causes of dizziness is the so-called benign paroxysmal positional vertigo (bppv). patients with bppv typically have severe vertigo provoked by a change in head position. benign paroxysmal positional vertigo can now be accurately diagnosed, and distinguished form other dizziness producing conditions, in the physician's office and without any sophisticated diagnostics tools. furthermore, it can be treated in the office setting by specific head positioning maneuvers (canalith repositioning procedure) that are easy to learn and perform. the canalith repositioning procedure is currently almost exclusively performed in specialized settings by ear nose and throat (ent) and internal medicine specialists. its efficacy has been demonstrated in these settings. however, to-date no studies have been conducted in the primary care settings about the use and efficacy of the procedure, where the condition is first seen and assessed. this is a randomized controlled trial to determine whether the procedure performed by family doctors cures dizziness.

Eligibility criteria:
inclusion criteria: * confirmed bppv by positive dix-hallpike test exclusion criteria: * · positive results of the dix-hallpike maneuver in both right and left head-hanging position; * evidence of ongoing central nervous system disease (e.g., transient ischemic attack); * otitis media; * osteosclerosis; * inability to tolerate a diagnostic dix-hallpike head-hanging maneuver; * severe degenerative disc disease of cervical spine; * severe and uncontrolled angina or hypertension

Keywords: benign paroxysmal positional vertigo canalith repositioning maneuver dizziness primary care
assessment and management of post-stroke spasticity with botulinum toxin-a

Conditions: Stroke; Muscle Spasticity

Summary: within the first year after stroke, approximately 38% of stroke survivors experience an increased resistance to movement, also called spasticity. one type of treatment that is approved for stroke survivors in canada that could reduce spasticity is the injection of botulinum toxin (btx) into the affected muscle. while btx reduces spasticity, there is limited evidence to show that btx administration leads to functional improvements. this may occur because the outcomes aren't sensitive enough to detect change, some people may have better responses to btx, or because btx hasn't been paired with the right exercises to improve function. the aims of this research are: i) to determine if there is a way of improving the markers that measure change in response to treatment; and ii) to identify the ideal type of exercise that should be paired with btx to allow the drug to have it greatest effect. there are two primary research questions: a) what are the measures that will indicate whether a person with post-stroke spasticity will benefit from btx therapy? it is hypothesized that emg latency and amplitude, for those who best respond to btx, will differ from those who demonstrate a weaker response to btx; b)what is the ideal training approach for improving muscle function in stroke survivors receiving btx injections? it is hypothesized that a training protocol that focuses on optimizing specific muscle activation patterns will demonstrate better outcomes than a training program designed to improve function.


Eligibility criteria:
inclusion criteria: * \>120 days post first ischemic stroke * unilateral spasticity (mas ≥ 1) of the wrist or elbow * \>18 years of age * medical referral for focal bont-a injections * residual active control of the wrist or elbow exclusion criteria: * underlying neuromuscular disorders (i.e. als, neuropathies, myasthenia gravis) * inability to provide informed consent or communicate in english * bilateral paresis/spasticity * contractures * prescribed anti-spastic medication

Keywords: botulinum toxin rehabilitation electromyography electroencephalography transcranial magnetic stimulation
demineralized dentin allograft versus demineralized dentin autograft for socket preservation

Conditions: Alveolar Bone Loss

Summary: this study is designed to evaluate and compare clinically and radiographically the effectiveness of demineralized dentin allograft (dda) versus demineralized dentin autograft (auto-dd) for preservation of alveolar ridge dimensions after surgical extraction of the impacted mandibular third molar.


Eligibility criteria:
inclusion criteria: 1. patients aged between 25 to 35 years old. 2. patients scored as (asa i). 3. no adverse habits such as smoking, tobacco chewing, alcohol. 4. patients having bilaterally impacted mandibular third molar with similar degree of difficulty according to (kim jy, et al). 5. the recipient alveolar sockets are free of any pre-existing periapical pathology, based on x-ray. 6. alveolar sockets with a depth of 5 mm or more, using periodontal probe for assessment. 7. patients sign a consent for all procedures. exclusion criteria: * 1) pregnant or lactating patients. 2) relevant systemic diseases. 3) patients with history of chemotherapy or radiotherapy.

Keywords: socket preservation impacted mandibular third molar alveolar ridge augmentation
non-invasive central venous pressure estimation in pediatric patients

Conditions: Central Venous Pressure

Summary: central venous pressure (cvp) is a standard parameter for hemodynamic monitoring and is currently measured through the insertion of a catheter. the pediatric population is especially vulnerable to risks associated to this invasive procedure, including infection, thrombosis, and pneumothorax. the proposed pilot study will evaluate safety and preliminary efficacy of a new non-invasive ultrasound-based venous occlusion pressure (vop) monitoring device (cpmx2) in children equipped with an invasive catheter for cvp monitoring as part of standard of care.


Eligibility criteria:
inclusion criteria * provision of signed and dated informed consent form * male or female * age: birth to 21 years of age * equipped with a central venous catheter (cvc) for central venous pressure (cvp) monitoring indication as part of standard of care, or undergoing cardiac catheterization. exclusion criteria: * weight less than 2.5kg at the time of enrollment. * bilateral external jugular veins not accessible due to vascular access or dressing. * bilateral skin lesion contraindicating neck ultrasound * active bleeding * clinically unstable, per clinical assessment by attending physician and/or surgeon

Keywords: central venous pressure venous hypertension
fast titration in the treatment of schizophrenia, taiwan

Conditions: Schizophrenia

Summary: assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * signed informed consent, at least 18 years old, inpatients with relapse schizophrenia all subtypes, and with a cgi (clinical global impression) score \>=4. exclusion criteria: * pregnancy or breast-feeding, patients treated with clozapine within 28 days of randomization, patients with a known arrhythmia, any psychotic disorders not defined in the inclusion criteria.

Keywords: schizophrenia
complications of uti in patients on dapagliflozin

Conditions: Severe Complications of Urinary Tract Infections

Summary: the objective of this study is to compare, by insulin use at the index date, the sex-specific incidence of hospitalization or emergency department (ed) visit for severe complications of urinary tract infections (uti), defined as pyelonephritis and urosepsis, among patients with type 2 diabetes mellitus (t2dm) who are new users of dapagliflozin with those who are new users of antidiabetic drugs (ads) in classes other than sodium-glucose cotransporter 2 (sglt2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.

the overall goal of this research study is to estimate the sex-specific incidence of hospitalization or emergency department visit for severe complications of urinary tract infections, defined as pyelonephritis and urosepsis, in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations. the study will be implemented in three administrative health care data sources in two countries: in the united kingdom, the clinical practice research datalink (cprd); and in the united states, the centers for medicare and medicaid services (cms) medicare databases and the healthcore integrated research database (hirdsm). individuals in the databases will be included in the study if they meet the following age criteria; 18 years and older (cprd and hird), or 65 years or older (medicare); and if they did not have type 1 diabetes, are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. the study period starts july 1, 2013 in cprd, january 1, 2014 in pharmo and january 9, 2014 in the united states data sources, and will end at the latest available data at each database at the time of analysis

Eligibility criteria:
inclusion criteria: 1. 18 years and older (cprd and hird), or 65 years or older (medicare); 2. no diagnosisi of type 1 diabetes, 3. are new users of one of the study drugs and 4. have at least 180 days of electronic data before their first prescription of the study drug exclusion criteria: 1. the patient experienced chronic pyelonephritis at any time before the index date (i.e., during the available lookback time). 2. the patient was prescribed an sglt2 inhibitor other than dapagliflozin on or before the index date. 3. the patient initiated metformin or sulfonylurea as ad monotherapy at the index date. 4. the patient initiated insulin therapy at the index date. 5. the patient had evidence of type 1 diabetes before cohort entry or first recorded ad is insulin monotherapy