Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy and safety of diclofenac hpbcd 25, 50 mg/ml in the treatment of post-surgical pain following dental surgery

Conditions: Dental Pain

Summary: the present study is proposed to evaluate the efficacy and safety of single doses of diclofenac hpbcd subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.


Eligibility criteria:
inclusion criteria: * patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal. * patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery. * pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the investigator. exclusion criteria: * surgery performed under general anaesthesia, or sedation. * complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator. * acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation. * patients with clinical signs of gastritis, gastro-duodenal ulcer, gi bleeding. other gi disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of nsaids. * clinical signs or history of coagulation disorders that could be negatively affected by nsaids administration. * hepatic or renal impairment. * patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension. * hypersensitivity to diclofenac or other nsaids or to one of the study medication components. * patients under chronic treatment with topical or systemic analgesics/nsaids. * patients under treatment with any medication that may affect the treatment efficacy evaluation. * patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.
comparison of tramadol orally versus an optimized dose of intravenous tramadol for postoperative pain relief in ambulatory surgery

Conditions: Pain

Summary: the purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol iv given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. the first unit dose will be administered at arrival at the pacu when a visual analogue pain (vas) score of more than 3 is reached. the second and third unit dose will be administered after 1 and 2 hours, respectively, when a vas of more than 3 is observed.


Eligibility criteria:
inclusion criteria: * asa i and ii female or male patients undergoing wisdom teeth extraction * aged 18-70 years * scheduled for ambulatory surgery requiring postoperative pain medication exclusion criteria: * weight less than 70% or more than 130% of ideal body weight * neurological disorder * recent use of psycho-active medication, including alcohol * patients suffering from chronic pain receiving pre-operative pain medication including nsaid's * use of chronic anti-emetic medication * use of chronic corticoid therapy

Keywords: patients who will undergo a general anesthesia for a procedure in short stay
postoperative pain control in ais using liposomal bupivacaine vs. 0.25% bupivacaine with epinephrine

Conditions: Post Operative Pain; Spinal Fusion

Summary: a randomized controlled trial (rct) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (psf) for ais is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.


Eligibility criteria:
inclusion criteria: * ≥10 years old and ≤17 years old at assessment * diagnosis of adolescent idiopathic scoliosis * planned surgical treatment of progressive spinal deformity with posterior spinal fusion exclusion criteria: * diagnosis of neuromuscular, syndromic, or congenital scoliosis * history of known allergy to local anesthesia * chronic pre-operative opioid consumptions * any other analgesic treatment for chronic pain before surgery * psychiatric or neurological disorders * cannot fluently read or speak english
canadian health economics, outcome, and effectiveness comparison of treatment in patients with chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis

Summary: the economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of crs patients with frontal and other sinus disease in the canadian healthcare environment is not known at this time. this study will evaluate the impact of balloon sinuplasty and traditional fess treatment on crs patients.


Eligibility criteria:
inclusion criteria: * documented diagnosis of unilateral or bilateral chronic rhinosinusitis based on the european position paper on rhinosinusitis and nasal polyps (2) with at least frontal and maxillary sinus involvement * documented failed medical treatment of crs * eighteen (18) to sixty-five (65) years of age * employed in full time position or equivalent * planned fess for treatment of crs * must have an american society of anesthesiologists physical status of p3 classification or less * able to provide informed consent by signing the informed consent document at the screening visit prior to any study activities * able to read and understand english exclusion criteria: * previous sinonasal surgery * pregnant * cystic fibrosis * diagnosed immotile cilia syndrome * samter's triad * diagnosed immunodeficiency syndrome * diagnosed fungal sinusitis * concurrent septoplasty or turbinate surgery * diagnosed recurrent acute sinusitis * current smoker * presence of grade 2 or greater nasal polyps * sinonasal tumors or obstructive lesions * history of substance or alcohol abuse within the past 12 months * investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements * participation in a research study 30 days prior to surgery

Keywords: sinusitis chronic functional endoscopic sinus surgery balloon sinuplasty
study on the efficacy and timing of ecmo therapy in children with refractory septic shock

Conditions: Septic Shock; Extracorporeal Membrane Oxygenation Complication

Summary: severe sepsis and septic shock remain the leading causes of child mortality worldwide. sepsis is a complex process that ultimately leads to circulation disorders, organ perfusion abnormalities, capillary leakage, tissue hypoxia, and organ failure. the difficulty of clinical treatment is microcirculation and mitochondrial dysfunction in septic shock. once shock enters the stage of microcirculation failure, conventional treatment is ineffective. ecmo can effectively support the circulatory system and provide good oxygen delivery, but there are many controversies in clinical treatment. 1) whether ecmo can effectively improve the clinical prognosis of children with septic shock; 2) appropriate timing for ecmo intervention; 3) which key clinical factors affect the effect of ecmo treatment. this study intends to adopt a multi-center, prospective, non-randomized controlled trial design, and the main research hypothesis is whether ecmo treatment can improve the success of discharge survival of children with septic shock.

in this study, a variety of statistical analysis methods will be used to screen the clinical indicators and truncation values suitable for starting ecmo, and to construct a comprehensive prediction model, so as to determine the basis for the optimal timing of ecmo treatment in the future. the efficacy of scvo2, lactic acid, and vasoactive inotrope score (vis) on the ecmo treatment timing will also be evaluated. this study aims to evaluate and improve the clinical application of ecmo in the treatment of sepsis in children

Eligibility criteria:
inclusion criteria: • children with septic shock and refractory septic shock admitted to the picu of all the study centers exclusion criteria: * fatal chromosomal abnormalities (e.g., trisomy 13 or 18) * uncontrolled bleeding * irreversible brain damage * after allogeneic bone marrow transplantation * weight less than 2.5kg or severe malnutrition

Keywords: septic shock children ecmo timing
effectiveness of thrombus aspiration in plaque reduction for patients with acute coronary syndromes

Conditions: Acute Coronary Syndrome

Summary: although successful, percutaneous coronary interventions (pci) with stent implantation may be hampered by periprocedural myocardial necrosis. in acute st-elevation myocardial infarction (stemi), the reduction of thrombus burden through manual thrombus aspiration (ta) of an occluded coronary artery has been documented to produce an improved myocardial perfusion rate and significant survival advantage. to date, beyond feasibility and safety studies no clinical benefit has been yet documented with the use of ta before stent deployment in the setting of acute coronary syndromes (acs) outside acute stemi. the investigators hypothesize that ta before stent deployment reduces the thrombus/plaque burden - as assessed by intravascular imaging systems - in the setting of acute coronary syndromes (acs) outside acute stemi.

periprocedural myocardial infarction (mi) has an independent adverse prognostic relevance. several trials have documented a reduction in the occurrence of periprocedural mi through various pharmacological strategies, with enhanced inhibition of platelet aggregation or high dose statins. however, real-world registries still document an incidence of periprocedural mi in 30-40% of patients. currently available intravascular imaging techniques, intravascular ultrasound (ivus) and more recently available optical coherence tomography (oct) allow a precise evaluation of the coronary plaque and can be extremely useful for monitoring plaque modifications obtained with thrombus aspiration (ta). plaque burden will be assessed as plaque + media (p+m), commonly measured with ivus by subtracting lumen (l) to external elastic membrane (eem) cross sectional area (p+m= eem-l). expecting a mean plaque volume of 160±50 mm3 in a population of patients with acs undergoing pci, a sample size of at least 45 patients (52 lesions) with a recent (\<15 days, but after 24 hours) stemi or a non-st elevation (nste)-acs within 72 hours of symptoms would provide a 90% power to detect a 20% reduction in the plaque volume after ta with an alpha (probability value) of 0.05.

Eligibility criteria:
inclusion criteria: * age between 18-75 years old. * recent(\ 24 hrs)stemi or nste-acs within 72 hrs of symptoms. * presence at least one "culprit" high-grade (\>90%)lesion. exclusion criteria: * stemi within 24 hours. * cardiogenic shock, decompensated heart failure, lvef\<30%. * serum creatinine ≥ 2.5 mg/dl. * contraindication to aspirin, heparin, thienopyridines. * total occlusion of target vessel. * diseased vein graft or a restenosis.

Keywords: nste-acs pci thrombus aspiration ivus periprocedural myocardial infarction
creon for the treatment of post-rygb hypoglycemia

Conditions: Hypoglycemia

Summary: hypoglycemia is an increasingly recognized complication of roux-en-y gastric bypass (rygb) that is poorly understood and difficult to treat. investigators hypothesize that after rygb some patients have incomplete carbohydrate absorption in the small intestine which leads to inconsistent glucose levels and hypoglycemia during oral consumption of a meal. investigators further hypothesize that pancreatic enzyme supplementation with (creon) during meals and snacks will improve carbohydrate absorption and lead to more stable glucose levels in patients with post-rygb hypoglycemia.

primary objective: evaluate the feasibility and safety of creon in the treatment of post-rygb hypoglycemia as add-on therapy to a diet higher in protein and lower in carbohydrate. secondary objective: evaluate utility of continuous glucose monitoring (cgm) in monitoring hypoglycemia as an adjunct to standard venous blood testing using a glucometer in post-rygb hypoglycemia.

Eligibility criteria:
inclusion criteria: * males and females 18 years and older * at least 6 months post-rygb surgery * clinical history of post-surgical hypoglycemia evident by subjective symptoms (i.e. tachycardia, sweating, hunger, confusion) and glucose monitoring demonstrating a venous blood sugars \< 70 mg/dl * women must be postmenopausal, surgically sterile, not heterosexually active or heterosexually active using highly effective method of birth control * women of childbearing potential must have negative pregnancy test * subjects must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and be willing to participate in the study * willing and able to adhere to restrictions and follow instructions specific to this study * adequate compliance in performing self-monitoring blood glucose (smbg) testing at least three or more times per week and taking assigned medication dose as instructed exclusion criteria: * current or past history of type 1 or type 2 diabetes * known hypersensitivity to creon * known hypersensitivity to pork-derived products * liver function studies 2 times the upper limit of normal (alt \& ast) and/or a gfr \< 90 * history of fibrosing colonic strictures * history of gastroparesis, dysphagia, chronic abdominal pain, gastric outlet obstruction, chronic pancreatitis * history of stomach, small intestine or colon surgery other than roux-en-y gastric bypass * an active cancer of any type requiring concurrent treatment * history of gout or hyperuricemia * current anemia requiring iron replacement * any clinically significant condition that in the opinion of the investigator would make participation not in the best interest or safety of the subject or could prevent limit or confound the specific endpoints assessments * not participating in any other research study * known history of drug or alcohol abuse within 6 months of screening visit * pregnancy or lactation (breastfeeding) * informed consent withdrawal by subject

Keywords: roux-en-y gastric bypass hypoglycemia creon
meniere disease and hearing aids

Conditions: Meniere Disease; Hearing Loss, Sensorineural

Summary: patients with unilateral meniere disease often a distortion that causes difficulties to provide hearing aids to these patients. those patients have two main problems: disorders in noise comprehension due to interaural threshold difference and increase in the distortion during dizziness crisis. due to these problems, some people cannot be fitting with hearing aids because the compression needed is too high or the discomfort in noise is not bearable for patients. our aim is to evaluate and to propose a way to adjust hearing aids to restore binaural hearing with comfort.


Eligibility criteria:
inclusion criteria: * age over 18 y.o * meniere disease as define by the barany society * unilateral deafness with a threshold over 50db * normal ear with a threshold above 30db * interaural threshold difference of at least 30db * patient who has already an hearing aids and satisfied with it exclusion criteria: * absence of consent of the patient or not able to give it * patient with hearing aids well fitted
clinical evaluation of cordio application in adult covid-19 virus positive patients

Conditions: Coronavirus Infection

Summary: study on adult patients positive to covid-19 virus. after signing informed consent and undergoing screening assessments, eligible patients will record few times a day several pre-defined sentences to the cordio app installed in a smartphone/tablet. the app will upload the vocal data to the sponsor's servers for analysis. the patient will record at hospital admittance (covid-19 positive) until patient defined as covid-19 negative and free of relevant clinical symptoms.


Eligibility criteria:
inclusion criteria: 1. 18+ years old 2. diagnosed with covid-19 positive patients according to medical center guidelines, with symptoms of cough and or dyspnea. patients that diagnosed with pneumonia, should be confirmed by x-ray and/or ct. 3. able to understand and provide written informed consent (manually or electronically or giving their consent via the telephone to the study investigator in case of isolated patients). exclusion criteria: 1. subjects, in the investigator's opinion, unable to comply with the daily use of the application including mental disorders (e.g., depression, dementia). 2. patients with severe alcohol or drug use. 3. women who are pregnant or lactating. 4. participating in another investigation therapy that may interfere with study results (according to investigator discretion)

Keywords: covid-19 positive
cns changes following sci

Conditions: Spinal Cord Injuries

Summary: the objective of this study is to better understand the structural and functional changes that the central nervous system (cns) undergoes following spinal cord injury and how these changes relate to clinical measures. both macroscopic and microscopic changes of the brain and the spinal cord will be examined in sci patients and compared to healthy controls. in terms of structural plasticity, we aim to identify mr biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. importantly, we aim to investigate which factors scale the patients' symptoms. in terms of functional plasticity, we will combine fmri with behavioural testing to understand which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. we will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.


Eligibility criteria:
inclusion criteria - patients: * age 18-75 * traumatic or non-traumatic spinal cord injury (para- and tetraplegia) * acute (\ 6 months post sci) * signed informed consent exclusion criteria - patients: * contraindications to magnetic resonance imaging * neurological impairment of body function impairments not induced by spinal cord injury * bmi \> 40 * pregnancy * claustrophobia inclusion criteria - healthy subjects: * age 18-75 * signed informed consent exclusion criteria - healthy subjects: * contraindications to magnetic resonance imaging * pregnancy * neurological illness * impairment of body function induced by a spinal cord injury * claustrophobia * bmi \> 40
glp-1 receptor targeting in diabetic and healthy individuals

Conditions: Type 1 Diabetes

Summary: the purpose of the study is to determine whether there are differences in pancreatic uptake of the radiotracer between healthy individuals and patients with type 1 diabetes. if t1d patients have a markedly reduced uptake, the compound may be suitable for estimation of pancreatic beta cell mass, i.e. the cells in the pancreas that produce insulin.


Eligibility criteria:
inclusion criteria: * type 1 diabetes exclusion criteria: * breast feeding * pregnant

Keywords: diabetes
a placebo-controlled trial of daliresp on chronic obstructive pulmonary disease (copd)

Conditions: COPD

Summary: the purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe copd. the investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.


Eligibility criteria:
inclusion criteria: 1. male and female subjects, \> 40 years of age 2. clinical diagnosis of moderate to severe copd as defined by the gold criteria: post-bronchodilator fev1/fvc \< 70% post-bronchodilator fev1 \< 70% predicted 3. cigarette consumption of 10 pack-years or more. patients may be active smokers. 4. the presence of chronic cough and sputum production 5. willingness to make return visits and telephone availability for the study duration exclusion criteria: 1. a diagnosis of asthma as established by the study investigator on the basis of the recent american thoracic society/european respiratory society guidelines 2. clinically significant bronchiectasis 3. oxygen use \>12 hours/day 4. known sensitivity to roflumilast 5. use of other methylxanthines within 1 month (theophylline) 6. changes to current maintenance copd therapy within one month 7. pregnancy 8. an acute illness requiring antibiotics and/or corticosteroids within the month prior to enrolment. 9. immunosuppression 1. hiv 2. solid organ transplant 3. active malignancy 4. systemic corticosteroid use ≥ prednisone 20mg / day 5. other immunosuppressants 10. terminal illness defined as anticipated survival \<12 months 11. severe comorbidities including uncontrolled angina, congestive heart failure, end-stage renal disease, liver failure, or other conditions that would preclude the patient from safely completing the required tests or the study. -
mechanomyography for predictor of prognosis in cuts and pnd patients

Conditions: Cubital Tunnel Syndrome; Peroneal Nerve Entrapment

Summary: the study will be a non-blinded two cohort design consisting only of symptomatic patients with cuts or compressive peroneal neuropathy or in need of peroneal nerve decompression. the first cohort will be - patients with cuts. evaluation of each cuts patient will include assessment by the treating surgeon and a certified hand therapist. patients who have clinical examination and history consistent with a diagnosis of cuts based on subjective and functional assessment outlined below will be consented to this study. the second cohort will be patients in need pnd for compressive neuropathy of peroneal nerve. pnd patients will be evaluated by clinical exam and have imaging with high resolution ultrasound or mri negative for mass lesion.

visit 1 * exam and discussion with surgeon * exam and testing with occupational hand therapist (standard of care) as described above. (cuts cohort) * diagnostic studies (emg/nct) (standard of care) * questionnaires - promis and odi visit 2 * standard of care surgery * during surgery, the surgeon will perform an mmg immediately pre-decompression and immediately post-decompression of the nerve. this will entail placing a sensor and probe on the nerve that will be decompressed. visit 3 and 4 (6 week and 3 month post-op) * clinical exam by surgeon * exam and testing with occupational therapist (standard of care) as described above. (cuts cohort) * questionnaires - promis and odi visit 5 (6 months post-op) * clinical exam by surgeon * exam and testing with occupational therapist (standard of care) as described above. (cuts cohort) * questionnaires - promis and odi * evaluation of mmg parameters

Eligibility criteria:
inclusion criteria: * patients who have a diagnosis of cubital tunnel syndrome or compressive peroneal nerve neuropathy and will be undergoing a decompressive surgery. exclusion criteria: * patients under 18 years of age * patients who are unable to return for follow-up evaluation.

Keywords: cubital tunnel cubital peroneal nerve entrapment nerve compression nerve decompression cuts pnd mmg mechanomyography cubital tunnel syndrome peroneal nerve decompression