Kornimate/medical-research-clean huggingface dataset:
gastric ultrasound in pregnant women at term

Conditions: Respiratory Aspiration; Pregnancy

Summary: solid food or fluid residue in the stomach is always a major concern when patients need medical procedures under sedation or general anesthesia, due to the high risk of pulmonary aspiration of the stomach contents. this is especially important in emergency procedures, when a fasting period is not observed. the aspiration of the stomach contents into one's lungs can lead to serious complications (such as severe respiratory failure). information from a bedside ultrasound assessment of the stomach may be a very useful tool to decide whether or not it's safe to proceed, cancel or delay a surgical procedure.

food residue in the stomach of patients scheduled to have surgery is considered a major risk factor for pulmonary aspiration of gastric contents. the resulting respiratory compromise after aspiration is associated with significant morbidity and mortality. the risk of pulmonary aspiration is especially important in pregnant women, as they may often require surgery without having observed appropriate fasting. a bedside ultrasound assessment fo the status of the gastric content would be of great value for the clinician. this technique has recently been shown very promising in non-pregnant patients and it is important to study its feasibility in the pregnant population. in this study, patients fast overnight and are randomized to the following groups: empty, fluid (250 ml of apple juice before scanning) or solid (full breakfast). their gastric contents are then assessed by 3 different anesthesiologists, using ultrasound. at the end of the scanning, the true stomach contents are revealed. the ability of the assessors to accurately predict stomach contents, as well as the inter-observer agreement, will be examined.

Eligibility criteria:
inclusion criteria: * volunteer non-laboring pregnant women \>32 weeks gestation * 18 years or older * asa status i-iii * weigh between 50 and 120kg * height at least 150cm or taller * written informed consent exclusion criteria: * known pre-existing abnormal anatomy of the upper gi tract * protocol violation

Keywords: pregnancy respiratory aspiration gastric contents ultrasound
opsens prime class

Conditions: Aortic Stenosis

Summary: in this study it is aimed to determine the diagnostic value of physiological measurements in the presence of aortic stenosis, and whether these are more accurate than angiographic assessment. post-tavr ffr will be taken as the reference for predicting ischemic lesions, and angiography and physiology - ffr and diastolic pressure ratio (dpr) - will be performed immediately before and after tavr, in an all-comer multicentric observational study.

this is a post-marketing, prospective, observational, single arm, multi-center, single country study in subjects who have severe symptomatic aortic stenosis with a formal indication for tavr, and one or more intermediate coronary lesions in a relevant coronary artery (\>2mm). this study aims to assess if opsens non-hyperemic dpr (based on a proprietary algorithm) and/or opsens ffr are suitable methods for the physiological assessment and prediction of ischemic coronary lesions in subjects with aortic stenosis who are considered for tavr. this will be done by comparing pre-tavr measurements of angiography, dpr and ffr and placing them against the post-tavr ffr, which is considered as the gold standard. also the post tavr dpr will be compared with post-tavr ffr. a maximum of 137 subjects will be enrolled in 5 to 10 sites in spain to obtain the required minimum of 137 lesions (see section 11.2 sample size determination) the main hypothesis is that the specificity to predict ischemic lesions in tavr candidates based on a pre-tavr dpr ≤ 0.89 is superior compared to the specificity based on angiography alone (both qca and visual assessment of the stenosis \>50%), taking the post-tavr ffr value of ≤ 0.80 as a reference for positive lesions. the pressure guidewire used to measure dpr and ffr during diagnostic angiography is the commercially available (ce-marketed) optowire family of pressure guidewires from opsens inc.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years old * subject has a degenerative aortic stenosis with mean valvular gradient ≥40 mmhg * subject has a formal heart-team indication for tavr * subject has one or more stable coronary stenosis lesions 30-90% by visual estimation, in a vessel over 2 mm in diameter, and which is amenable for pressure-wire analysis * subject agrees to participate in the study and is able to sign the informed consent form exclusion criteria: * subject is unable to provide informed consent * subject has asthma or acute bronchospasm * subject has unstable angina or myocardial infarction * subject meets any contraindication in the applicable optowire ifu * subject is pregnant

Keywords: fractional flow reserve diastolic pressure ratio transcatheter aortic valve replacement
firefighters accessing care for trauma: a clinical case series of distance net for ptsd/i symptoms

Conditions: Post Traumatic Stress Disorder; Post Traumatic Stress Injury

Summary: repeated exposure to trauma is an unavoidable part of the job for firefighters. because of this, many canadian firefighters screen positive for posttraumatic stress disorder/injury (ptsd/i). unfortunately, like the general population, firefighters face many barriers to accessing mental health care. as a result, additional efforts are needed to increase timely access to effective ptsd/i services that are delivered in a way that reduces confidentiality and stigma risk. this research study will test the preliminary efficacy and feasibility of distance-delivered narrative exposure therapy (net) delivered by a paraprofessional for firefighters with ptsd/i. net is an evidence-based intervention approach developed specifically for ptsd/i resulting from repeated and continuous trauma. the intervention will be conducted via videoconference with a trained paraprofessional supervised by a clinical psychologist. the net intervention will consist of 12 weekly 90-minute videoconference sessions. approximately 25 firefighters will be recruited to participate in the study. to test the efficacy of the intervention, participants will complete self-report questionnaires about ptsd/i and other mental health symptoms pre- and post-intervention as well as two- and six-months following intervention completion. participants will also complete an open-ended interview at the end of the intervention to assess feasibility and participant satisfaction.


Eligibility criteria:
inclusion criteria: participants must meet the following criteria to be eligible to move on to consent 1. be at least 19 years of age 2. be able to understand spoken and written english at a grade 8 level 3. be employed, or have been employed, by the fire service or be current or past fire service volunteers. 4. fulfill the criteria of full or subclinical ptsd/i according to the pcl-5. 5. have access to a computer with internet. 6. live in atlantic canada or ontario. 7. consent to be audio- (for consent and interview) and video-recorded (for intervention sessions). exclusion criteria: 1. having a psychotropic medication change in the past three weeks. 2. are currently engaged in or have previously been engaged in exposure therapy for ptsd/i. 3. meet criteria for current mania or psychosis. 4. endorse suicidal ideation with plan or intent. 5. experience high levels of dissociation (as assessed by a score of \>18.5 on the shutdown dissociation scale).
prognostic analysis of different treatment options for cerebral hemorrhage

Conditions: Brain Hemorrhage

Summary: to analyze the influence of early hematoma morphology on hematoma expansion, optimize the treatment plan for cerebral hemorrhage, and guide the treatment of patients with cerebral hemorrhage in combination with clinical practice.

intracerebral hemorrhage refers to the hemorrhage caused by the rupture of blood vessels in the non-traumatic brain parenchyma, accounting for 20% to 30% of all strokes, with an acute mortality rate of 30% to 40%. different degrees of movement disorders, language disorders, etc. will be left behind. it is of great clinical significance to deeply explore the relevant factors and effective treatment plans for the evolution of cerebral hemorrhage. 30% of hematomas can still have active bleeding within 20 hours of onset. the interact test defines hematoma expansion as 24-48 hours of repeated non-enhanced ct. the increase in hematoma volume \>12.5ml or 33% of the original volume is the cause of neurological deterioration and abnormality. an important cause of poor prognosis, studies have confirmed that irregular hematoma morphology is a strong predictor of hematoma expansion. treatment of cerebral hemorrhage currently includes medical treatment and surgical treatment. surgical treatment has become an important method for the treatment of ich due to its advantages of rapid removal of hematoma, relief of high intracranial pressure, and release of mechanical compression. however, whether surgery can reduce the mortality of patients with cerebral hemorrhage and improve neurological damage is still controversial. surgical operations include dstereotactic intracranial hematoma puncture and drainage, decompressive craniectomy , neuroendoscopic. currently, there are large randomized controlled trials at home and abroad on minimally invasive hematoma evacuation. the treatment of spontaneous intracerebral hemorrhage is safe, but the effectiveness of minimally invasive surgery is unclear due to inconsistent bleeding volume, surgical trauma, and hematoma morphology.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years old; 2. intracerebral hemorrhage was diagnosed by head ct examination; exclusion criteria: 1. multiple intracranial hemorrhage; 2. intracranial hemorrhage caused by intracranial tumor, aneurysm, trauma, infarction or other lesions; 3. coagulation disorders or a history of taking anticoagulants; 4. infectious meningitis, systemic infection; 5. history of severe stroke, heart, kidney, liver and lung dysfunction in the past; 6. severe brain herniation (mydriasis, respiratory and circulatory failure); 7. incomplete or missing basic data or follow-up information in the hospital.
an open-label, fih study evaluating the safety and tolerability of vctx210a combination product in subjects with t1d

Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Disease; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Summary: this is an open-label, multicenter, phase 1 study evaluating the safety and tolerability of vctx210a combination product in patients with t1d

vctx210a combination product (unit) comprises 2 components: (1) allogeneic pancreatic endoderm cells (pec210a) genetically modified using clustered regularly interspaced short palindromic repeats/crispr-associated protein 9 (crispr/cas9) to promote immune evasiveness and survival, and (2) a durable, removable, perforated device designed to deliver and retain the pec210a cells.

Eligibility criteria:
inclusion criteria * diagnosis of t1d for a minimum of 5 years * stable, optimized diabetic regimen for at least 3 months prior to enrollment exclusion criteria * medical history of islet cell, kidney, and/or pancreas transplant * occurrence of 2 or more severe, unexplained hypoglycemic events within 6 months prior to enrollment * known causes of diabetes other than t1d * immunosuppressant therapy in the previous 30 days and/or requirements for chronic immunosuppressive therapy during the study * prior treatment with gene therapy or edited product

Keywords: type 1 diabetes t1d allogeneic combination device crispr-cas9 cell therapy t1dm diabetes vctx
cost effectiveness of omt for chronic low back pain

Conditions: Lumbar Radiculopathy; Lesion of Sciatic Nerve, Left Lower Limb; Lesion of Sciatic Nerve, Right Lower Limb; Lumbar Spinal Stenosis; Lumbar Spondylosis; Lumbago With Sciatica, Left Side; Lumbago With Sciatica, Right Side

Summary: the specific aim of this study is to conduct a prospective, multicenter cohort study over four months to compare the cost of standard of allopathic care (control group, n=90) versus standard of care plus osteopathic manipulative treatment (experimental group, n=90) in a cohort of 180 consecutive patients seeking treatment for chronic low back pain at three osteopathic clinics and three allopathic medical clinics (offering only standard care) located in three different regions of the united states.


Eligibility criteria:
inclusion criteria: * patients diagnosed with chronic low back pain (lasting more than 3 months) who are between 18 to 84 years old will be eligible for the study. inclusion criteria will be specified by the following the 2017/2018 international classification of diseases, tenth revision, clinical modification (icd-10-cm) codes associated with chronic low back pain: * m54.16 lumbar radiculopathy * g57.01 lesion of sciatic nerve, right lower limb * g57.02 lesion of sciatic nerve, left lower limb * m48.061 lumbar spinal stenosis, without neurogenic claudication * m48.062 lumbar spinal stenosis, with neurogenic claudication * m47.816 lumbar spondylosis * m48.07 lumbar spinal stenosis, lumbosacral * m54.41 lumbago with sciatica, right side * m54.42 lumbago with sciatica, left side exclusion criteria: * patients with diabetic neuropathy, congenital lumbar and sacral abnormalities, lumbar fracture, multiple myeloma, metastatic bone disease, history of spinal and/or pain lasting less than three months will be excluded from the study.

Keywords: chronic low back pain osteopathic manipulative medicine
study of decitabine combined with haag regimen in newly diagnosed etp-all/lbl, t/m-mpal and all/lbl with myeloid or stem cell markers patients

Conditions: Induction Chemotherapy; Acute T-Lymphocytic Leukemia; T-cell Lymphoblastic Lymphoma Leukemia; T-cell/Myeloid Mixed Phenotype Acute Leukemia

Summary: the purpose of this study is to evaluate the efficacy and safety of decitabine combined with haag regimen in the treatment of newly diagnosed patients with etp-all/lbl, t/m-mpal and all/lbl with myeloid or stem cell markers.

this is a phase 3, open label, single arm, multi-center study in newly diagnosed etp-all/lbl, t/m-mpal and all/lbl patients who have myeloid or stem cell markers. the patients will receive decitabine combined with haag regimen in the induction treatment. the patients who respond to induction chemotherapy will undergo consolidation chemotherapy, and an optional allogeneic hematopoietic stem cell transplantation and post-transplantation maintenance treatment with decitabine according to patient's wishes.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed etp-all/lbl, t/m-mpal according to the 2016 revision to the who classification of myeloid neoplasms and acute leukemia, and t-all/lbl with one or more of the myeloid or stem cell markers (cd34, cd117, hladr, cd13, cd33, cd11b or cd65) on at least 25% of lymphoblasts. 2. age 15-60. 3. eastern cooperative oncology group (ecog) score: 0-2. 4. no history of previous chemotherapy or target therapy. 5. provide informed consent. exclusion criteria: 1. patients with another malignant disease. 2. patients has participated in or participating in other clinical trials. 3. patients with uncontrolled active infection. 4. patients with left ventricular ejection fraction \< 0.5 by echocardiography or grade iii/iv cardiovascular dysfunction according to the new york heart association classification. 5. patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dl. 6. patients with creatinine clearance rate \< 50ml/min. 7. patients with active hepatitis b or hepatitis c infection. 8. patients with hiv infection. 9. patients with active tuberculosis infection. 10. patients with uncontrolled active bleeding. 11. patients with a history of allergy to experimental drugs. 12. patients with other commodities that the investigators considered not suitable for the enrollment.

Keywords: t-all/lbl t/m-mpal decitabine combined with haag
evaluation of a spasticity management program for people with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study will examine the impacts of two different methods of managing ms-related spasticity of the lower limbs. both interventions will be presented via video teleconference in group classes consisting of exercises to reduce spasticity.

now online since covid-19

Eligibility criteria:
inclusion criteria: * a diagnosis of definite ms by 2010 updated mcdonald criteria * age 18 or older * able to walk 25 feet with any assistive devices (patient determined disease steps 0-6) * fluent in written and spoken english, as materials are not validated in languages other than english. * presence of self-reported lower extremity spasticity that is interfering with daily activities or sleep, using the this definition: have spasticity in your legs with unusual tightening of muscles that feels like leg stiffness, jumping of the legs, a repetitive bouncing of the foot, muscle cramping in the legs, or the legs going out tight and straight or drawing up. * all women that meet the above criteria * only veteran men that meet the above criteria exclusion criteria: * any uncontrolled medical or mental condition that would limit participation or completion of the study * any self-reported musculoskeletal or neurological condition other than ms that is known to cause spasticity

Keywords: muscle spasticity muscle stretching exercises
comparison of two oxygenation targets with two different oximeters - impact on oxygen flow rates and oxygenation

Conditions: Oxygen Toxicity; Respiratory Failure

Summary: the investigators recently evaluated 4 different oximeters among the most commonly used with arterial catheter in place and compared spo2 with sao2 obtained on arterial gas. correlations between sao2 and spo2 were poor for all oximeters, as previously known, and spo2-sao2 bias were different between oximeters. some oximeters (masimo, nellcor) had lower biases but they detected less well hypoxemia. some oximeters underestimated sao2 (nonin) but detected very well hypoxemia, and some overestimated sao2 (philips). the investigators concluded that oximeters provide different informations to clinicians, and oxygenation targets should take into account for these differences. the assumption is that the spo2 target and oximeter used will both have an impact on oxygen flows and that these effects will add up. with a high spo2 target, oxygen flows will be significantly greater and with the nonin oximeter, the required flows will be greater than with the philips oximeter. nb: the results obtained were in a population with light skin pigmentation (96% of the patients were fitzpatrick 1-2, reflecting the local hospitalized population).

the oximeters to be evaluated will be the nonin (plymouth, mn), and the philips (eindhoven, netherlands). the sensors used will be digital reusable sensors for all oximeters. because of the impact of the fingers used for spo2 measurement, each oximeter will be randomly assigned a different finger to each patient (digit 2 and 3 on the hand opposite to the arterial catheter). two spo2 targets will be assessed: 90% and 94%. a total of four 10-minute periods will be performed in randomized order: nonin 90, nonin 94, philips 90, and philips 94. at the end of each 10-minute period, arterial gas will be collected through the arterial catheter. the adjustment of the oxygen flow rates will be performed manually. the average oxygen flow of the last 2 minutes of the period will be considered.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * patients admitted to postoperative cardiac surgery intensive care unit * presence of an arterial catheter specific for the extubate patient * ongoing on conventional oxygen therapy at moderate flow (up to a maximum of 5l/min) with spo2 between 88 and 100% with the usual oximeter and nasal cannula. * spo2 \< 92% ambient air specific for the intubate patient fio2 \<= 0.60 with spo2 between 88 and 100% with usual oximeter spo2 \< 92% with fio2 0.21 exclusion criteria: * no spo2 signal with oximeter in use * false nails or nail polish * methemoglobinemia \>0.015 on last available arterial gas * patient in isolation (multi-resistant bacteria, c-difficile, sars-cov-2 ...) specific for the extubate patient * expected to use another respiratory support within one hour of inclusion (niv or nasal high flow oxygen) planned extubation within one hour of inclusion
µmri of therapeutic intervention in postmenopausal osteoporosis

Conditions: Osteoporosis, Osteopenia

Summary: the purpose of this study is to apply a novel advanced magnetic resonance imaging methodology to evaluate the response to drug intervention involving two treatment arms of postmenopausal participants with osteoporosis, randomized into either a teriparatide (forteo™) or zoledronic acid (reclast™) group.

the overall design is to determine and compare the effect of teriparatide and of zoledronic acid on trabecular architecture by magnetic resonance imaging of the midshaft tibia. post-menopausal women, aged 60 or older with osteoporosis and/or at increased risk of fracture, will be randomized to receive either teriparatide or zoledronic acid. trabecular microarchitecture, biomechanical parameters and bone mineral density will be examined at 0 and 12 months at 3t mri.

Eligibility criteria:
inclusion criteria: * women * age ≥ 60 years * bone mineral density t-score of either the spine (l1-l4), total hip or femoral neck of ≤ - 2.0, or has a history of an osteoporotic fracture exclusion criteria: * previous treatment with pamidronate, ibandronate, of more than 2 doses in 2 years and of zoledronic acid at any time * previous treatment with teriparatide, alendronate or risedronate of more than 2 months in the last 24 months * previous treatment with calcitonin within the previous year; previous treatment with an estrogen or selective estrogen modulator will not exclude a potential subject unless she has been taking it for \< 1 year (a woman who discontinued estrogen or a selective estrogen receptor within the previous year will also be excluded) * other diseases known to affect bone, such as paget's disease, cushing's disease, hyperthyroidism, hyperparathyroidism, bone cancer and metastases to bone, and vitamin d deficiency * medications known to affect bone, such as anticonvulsants, high dose glucocorticoids (20 mg/day or more \> 2 weeks within the previous 6 months) * current alcohol use \> 3 drinks/day * untreated or unstable cardiac, pulmonary, liver (sgot \> 2x upper limit of normal) or renal disease (creatinine \> 1.2 mg/dl) or uncontrolled diabetes (hemoglobin a1c \> 8.0) * prior radiation therapy to the skeleton * cardiac pacemakers, ferromagnetic implants or brain aneurysm clips * claustrophobia * subjects whose initial mri is of poor quality due to motion artifact will be asked to repeat the examination; if a repeat mri is of poor quality due to motion artifact, the subject will be excluded from the study * abnormalities of the which delay esophageal emptying such as stricture or achalasia * inability to stand or sit upright for at least 30 minutes * hypocalcemia * uric acid level \>7.5ml/dl * subjects with metallic objects in their bodies

Keywords: osteoporosis osteopenia fracture risk teriparatide or forteo zoledronic acid or reclast