mteb/BIRCO-ClinicalTrial-Test huggingface dataset:
The main objective of this study is to verify whether a new clinical decision rule identifying patients diagnosed with unprovoked blood clots who have a low risk of recurrence can safely stop oral anticoagulant therapy after 5-7 months of treatment. Up to 50% of patients with a first episode of venous thromboembolism (VTE) have no identifiable cause (i.e. are unprovoked VTEs). The risk of recurrent VTE in this large group of patients with unprovoked VTE after 3-6 months of anticoagulant therapy is 5-10.8% in the year following discontinuation of oral anticoagulant therapy. One in six to one in twenty recurrences of a new VTE are fatal. Given the intermediate risks of recurrence in unselected unprovoked VTE patients, clinicians do not have clear guidance on whether to continue or discontinue anticoagulants in patients with unprovoked VTE. Recently attention has turned to the concept of risk stratification to identify subgroups of patients with unprovoked VTE who could safely discontinue oral anticoagulation therapy (OAT). In the REVERSE I study, a clinical decision rule derivation study conducted from 2001 to 2006, we developed and internally validated the clinical decision rule "Men continue and HER DOO2" that identifies patients with a first unprovoked VTE who likely have a low risk of recurrent VTE and could safely discontinue OAT subsequent to 5-7 months of OAT. The present study will evaluate if the "Men continue and HER DOO2" rule (comprised of gender, elevated D-dimer levels, post-thrombotic signs, obesity, and older age) is safe, clinically useful, and reproducible when prospectively implemented in multiple centers and a variety of settings.
You are admitted to hospital because of pulmonary embolism. You are treated with anticoagulants. The investigators know that, despite this treatment, pulmonary embolism can be a threat especially if heart function is compromized. The investigators investigate a well known study drug (epoprostenol) on top of regular treatment with anticoagulants, to see if heart function can be optimized Pulmonary thromboembolism (PE) with circulatory and/or respiratory symptoms is associated with high morbidity and mortality. Acute pulmonary hypertension is the hallmark of severe PE, and is to be held responsible for the full spectrum of clinical manifestations and complications. Although it is common belief that only mechanical obstruction by thrombus mass causes this pulmonary hypertension, there is strong evidence indicating that pulmonary vasoconstriction contributes significantly to the rise in pulmonary vascular resistance. Although all patients will receive anticoagulant treatment immediately after the diagnosis is established, morbidity and mortality are still disturbingly high when circulatory and/or respiratory symptoms accompany PE, or when hemodynamically stable PE patients have echocardiographic signs of acute right ventricle overload. There are no generally accepted guidelines for additional treatment options in these patients with moderate-to-severe PE. Thrombolytic therapy is recommended by many when hemodynamic symptoms are severe, but its effectiveness has never been proven in a controlled trial. In patients with moderate-to-large PE associated with echocardiographic signs of right ventricle overload, but who are still circulatory stable, mortality is increased, but thrombolytic therapy appears not to be beneficial.
Case control studies that randomly assign patients to either surgical or non-surgical treatment yield a relapse rate of approximately 14% at one year. It would be useful to know the relapse rate of patients who have, instead, been selected for a given treatment based on a thorough clinical evaluation, including physical examination and laboratory results (all characteristics forming the Alvarado Score) as well as radiological exams if needed or deemed helpful. If this clinical evaluation is useful,the investigators would expect patient selection to be better than chance, and relapse rate lower than 14%. Once the investigators have established the utility of this evaluation, the investigators can begin to identify those components that have predictive value (such as blood chemistry analysis, or CT findings). This is the first step toward developing an accurate diagnostic-therapeutic algorithm which will avoid the risks and costs of needless surgery. This will be a single-cohort prospective interventional study. It will not interfere with the usual procedures, consisting of clinical examination in the Emergency Department (ED) and execution of the following exams at the physician's discretion: complete blood count with differential, C reactive protein, abdominal ultrasound, abdominal CT. Patients admitted to Emergency Department with Lower Abdominal and suspicion of Acute Appendicitis not needing immediate surgery, are requested by informed consent to undergo observation and non operative treatment with antibiotic therapy (Amoxicillin and Clavulanic Acid).
This prospective randomized study aims to evaluate the effectiveness of periarticular multi-drug regimen injection on the relief of pain in patients undergoing partial hip replacement. Total 258 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation. Patients in group C will receive no medication intraoperatively, and patients in group I will receive oral oxycodone and celecoxib preoperatively and a periarticular injection of multi-drug regimen during operation. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 1, 4, 7 postoperative day. Patients in group I will receive oxycodone SR 10 mg, and celecoxib 200 mg with 10 ml of water 1 hour before surgery. And patients in group I will receive periarticular injection of 50 ml solution which contains ropivacaine 15 mg, epinephrine 0.3 mg, cefmetazole 1000mg, ketorolac 30 mg and morphine HCL 10mg before closure of surgical wound. Patients in group C will receive no medication.
This prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy. Total 60 patients will be randomized into one of two groups (groupC or groupI) based on Excel number generation. Patients in group C will receive no medication intraoperatively, and patients in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively. Patients in group I will receive 0.1% ropivacaine 10 ml before skin incision under guide of C-arm.
Primary Objective: - To obtain prospective, clinical practice-based data on how symptomatic VTE is managed with low molecular weight heparin (LMWH) enoxaparin in Canadian outpatient settings. Secondary Objective: - To describe the demographic and clinical characteristics of patients with symptomatic VTE including characteristics of VTE, VTE risk factors and bleeding risk factors. - To assess the frequency of patient characteristics that would necessitate adjustment in the dose or duration of enoxaparin therapy, e.g. high BMI, impaired creatinine clearance, advanced age, cancer-associated VTE. - To assess the degree of adherence in clinical practice to Consensus Guidelines (ACCP/American College of chest Physician 2008) for the management of acute VTE, vis a vis: - Appropriate dosing of enoxaparin - Recommended duration of initial LMWH therapy - Adequate overlap of LMWH with vitamin K antagonists (VKA) - Recommended duration of longterm VKA - Frequency of use of LMWH monotherapy to treat cancer-related VTE - To access safety outcomes (including bleeding and recurrent VTE) - To describe the utilization of resources due to bleeding and recurrent VTE during the treatment period.
The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of the investigators study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. The investigators expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD. Background: The most common cause of death in patients with NAFLD(Nonalcoholic Fatty Liver Disease) is CAD(Coronary Artery Disease). NAFLD patients have 65% more mortality than general population. The aim of our study is to diagnose early coronary artery disease in NAFLD patient by measuring of PLA2. Methods: 60 patients with chest pain and low to intermediate risk for coronary events will undergo Cardiac CT and blood test measurement of enzyme PLA2, markers of inflammation: CRP, MDA(Malondialdehide), Paraoxonase, FFA(Free Fatty Acids), TG(Triglycerids) will performed. CAD is defined as a stenosis of more than 50% in at least one major coronary artery, unstable plaque defined as low attenuated plaque <30HU and fatty liver defined as difference in liver and spleen attenuation value -10HU by using CT. Expected results : we expect that PLA2 will higher in patients with patients with combination of CAD, unstable plaque and NAFLD.
This study aims to investigate the analgesic effects offered by bupivacaine and Durolane (a hyaluronic acid supplement) administered immediately following the completion of knee arthroscopy. There is increasing evidence of the toxic effects of intraarticular administration of local anaesthetic. Hyaluronic acid supplementation given at the time of knee arthroscopy has not been fully evaluated as a possible alternative. We have studied the efficacy of a hyaluronic acid (HA) supplement (Durolane®) and a local anaesthetic (Bupivacaine) at providing early and short-term post-operative analgesic control following knee arthroscopy.Patients will be randomised to receive either 10mls of 0.5% Bupivacaine or 10mls of Durolane® into the joint immediately after completion of surgery. WOMAC and Tegner-Lysholm scores were obtained at baseline then at 1, 2, and 6-weeks post surgery. VAS pain scores were obtained at baseline; 1 and 24-hours; and 1, 2 and 6 weeks following surgery.
The purpose of this study is to determine whether supervised progressive resistance training is effective in the early phase after Total Hip Replacement. The investigators hypothesise that 10 weeks of supervised, progressive resistance training immediately after discharge will lead to increased functional performance, muscle strength and muscle power compared to standard rehabilitation consisting of home-based exercise. After total hip replacement (THR) surgery there is a documented deficit in muscle strength and functional performance. There is a lack of evidence concerning the effectiveness of postoperative physiotherapy and training, however a few small studies have shown promising effect of resistance training. The present study will provide new and important knowledge concerning the effect of different rehabilitation strategies after THR. This might lead to a change in the rehabilitation regimes and faster and better recovery after THR surgery.
Fractures of the acetabulum are considered rare in the general community, but are quite common in major metropolitan areas and tertiary care centers. These fractures are some of the most complex and challenging injuries to successfully treat in the orthopaedic field. Extensile surgical exposures are required to access this unique structure that comprises the cup of the hip joint. Large skin incisions, significant soft tissue dissection, and elevation of periosteum and muscle from the intact and fractured fragments are often required for anatomic reductions of the acetabulum and good outcomes. Thus, there are many sources of intra-operative bleeding that can sum up to require strategies aimed at preventing bleeding or replacing blood loss. Cell-saver and transfusion of allogeneic blood products can replenish blood loss. The use of cell-saver is a good solution, but it is quite expensive. Trained perfusionists are required and cost over $400 per hour. Disposable products are also required for each patient. While blood loss can be great, often not enough blood is captured, processed, and available for return transfusion. Allogeneic blood transfusion is often routine. Appropriate blood is often on short supply. The cost of processing, testing, and transfusion is also high: minimum of $260 per standard unit of packed red blood cells. While risks of disease transmission are rare, they exist and can have serious consequences to patients.
This study intend to assess the pain intensity of newborns in neonatal intensive care unit (NICU) undergoing different techniques of respiratory therapy and compare these procedures. A randomized controlled clinical trial and blind trial with newborns admitted to NICU. The babies were categorized according to gestational age , age, weight, diagnosis, support and signs of respiratory distress. Then, they were allocated by lot to come from one of 3 groups: G1 - control, G2 - undergoing physical therapy; G3 - received the thoracoabdominal rebalancing. Each newborn received just one physical therapy session in that they were assessed before one of the three procedures (T1), immediately after (T2) and after 15 minutes (T3). This evaluation found cardiorespiratory parameters (oxygen saturation, heart and respiratory rate) and three specific scales for pain assessment (NIPS, NFCS and PIPP). The hypothesis is that newborns hospitalized in intensive care unit did not show pain when undergoing respiratory therapy.
In critically ill pediatric patients with Acute Respiratory Failure (ARF), Noninvasive Continuous Positive Airway Pressure (NCPAP) is applied to avoid intubation and all related complications such as tracheal injury and predisposition to nosocomial pulmonary infections. The choice of the interface is one of the crucial issues affecting treatment outcome in pediatric age and in particular in preschool children in whom intolerance frequently compromise noninvasive respiratory treatment. NCPAP is applied either through nasal or facial tight fitting masks and the most important principle in guiding the selection of an interface is that it should fit comfortably. However, while nasal mask can leak gas when the infant opens his/her mouth, facial mask can cause significant gastric distension and vomiting, with risk of aspirating gastric contents. Moreover, complications such as air leaks, skin irritation on the bridge of the nose, and discomfort reported with nasal or facial masks in children frequently lead to interruption of the respiratory treatment. Thus, improving the interface between the patient and the ventilator would be expected to facilitate longer and more effective application of NCPAP. A new small helmet specifically designed for young infants has been recently introduced to administer NCPAP. In a recent short term crossover physiological randomized controlled trial, the investigators found that NCPAP by helmet was associated with enhanced feasibility, less need of sedation and prolonged application time (see references below). The purpose of this prospective randomized multicenter study is to compare the efficacy and feasibility of NCPAP delivered either by helmet or by facial mask to treat acute respiratory failure in infants admitted to Pediatric Intensive Care Unit (PICU).
The purpose of this study is to determine if a 4 month resistance exercise program can reduce knee osteoarthritis pain functional impairment and cartilage turnover.
The aim of this study was to compare the oxygenation index (OI), dyspnea, and pain scale and evaluate the duration of thoracic drainage and pleural air leaks after lung resection in two groups of patients: chest physiotherapy (CP) patients and combined CP and Continuous Positive Airway Pressure (CPAP) patients. In pulmonary resection surgery complications that lead to significant functional losses of the lung parenchyma and alterations in the ventilatory function may trigger retention of secretions, atelectasis, pneumonia and respiratory failure, which prolong the duration of mechanical ventilation and hospitalisation and contribute to the increase in risk of mortality. In this study the oxygenation index (OI), Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection. Similar to Chest Physiotherapy, the preventive application of CPAP in the postoperative period after lung resection in our study also appeared to be a safe technique, which allowed improved oxygenation without increasing air leaks through the thoracic drains.
This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing tonsillectomy. A total of 62 patients will be randomized into one of two groups (group C or group I) based on Excel number generation. Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.
This study will compare the Non Steroidal Anti-Inflammatory Drugs (NSAIDs) sparing effect of etanercept with that of placebo in adult subjects with axial Spondyloarthritis.
Preventing the formation of blood clots in the veins so they do not injure leg veins or travel to the lungs, also called venous thromboembolism prophylaxis (VTE-P) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including The investigators own. Two prior VTE-P improvement projects were completed at Mayo Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of the Department of Surgery. Both projects resulted in marked improvement in the percentage of patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from these two pilots along with known best practices for &quot;spreading&quot; to deploy methods that enhance VTE-P to the entire hospitalized population. The investigators seek appropriate VTE-P rates exceeding 95%. Venous thromboembolism prophylaxis (VTE-P) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including our own. Two prior VTE-P improvement projects were completed at Mayo Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of the Department of Surgery. Both projects resulted in marked improvement in the percentage of patients receiving appropriate VTE-P. This project seeks to utilize the lessons learned from these two pilots along with known best practices for &quot;spreading&quot; to deploy methods that enhance VTE-P to the entire hospitalized population.
Despite enormous progress insufficient postoperative pain management remains a frequent problem in the early postoperative phase after surgery. Furthermore, the pain that persists after healing of the surgical wound is a large, but often unrecognized, clinical problem and it is estimated that 5-10% of those undergoing surgery will develop severe persistent pain leading to chronic disability and psychosocial distress. Conditioned Pain Modulation (CPM), also known as the phenomenon "pain-inhibits-pain", is a reduction in pain somewhere on the body in response to the application of a second painful stimulus outside the painful area. In recent years, the CPM has been identified as a psycho-physical measure with clinical relevance in characterizing the individual's ability to modulate pain and consequently the individual's disposition to acquire painful conditions. The purpose of this study is primarily to assess the relationship between CPM efficacy and clinical postoperative pain (postoperative pain intensity, use of analgesics, the intensity of secondary hyperalgesia and allodynia, and the incidence of persistent postoperative pain) associated with minimally invasive repair of pectus excavatum. In addition, the study aims at identifying other patient- and/or surgery-related factors affecting the course of postoperative pain. Hypothesis: - The greater the positive difference between the experimental pressure pain threshold (kPa) measured before and after application of a second painful stimulus (Cold Pressor Test), the lower the risk of developing persistent postoperative pain.
Total hip replacement is a major surgical procedure usually associated with significant pain in the early postoperative period. In our hospital, total hip replacement is routinely performed under spinal anaesthesia with intrathecal bupivacaine local anaesthetic plus opioid in the form of preservative free morphine. The use of 'local infiltration analgesia' as an alternative postoperative analgesic technique has been investigated.In this technique the surgeon infiltrates the surgical site with a long-acting local anaesthetic and places a catheter under direct vision which remains in situ and is used to administer local anaesthetic in the postoperative period until such time as it is removed (when no longer deemed necessary for pain relief or at a pre-set time in the postoperative period e.g. 48 hours). We hypothesize that infiltration of the surgical site with peri- and intraarticular levobupivacaine local anaesthetic would be an efficacious pain management technique and would not be inferior to intrathecal morphine for postoperative pain management.
This is a phase-I clinical trial to determine the feasibility and safety of Cyclophosphamide/Fludarabine Lymphodepletion and an immunomodulatory combination of Interferon-alpha Bevacizumab and Aspirin followed by adoptive transfer of vaccine-primed ex vivo CD3/CD28-costimulated peripheral blood autologous T cells and vaccination with whole tumor vaccine administered intradermally in combination with Bevacizumab in patients with recurrent ovarian cancer fallopian tube or primary peritoneal cancer. (Funding Source - FDA OOPD) This is a phase-I clinical trial to determine the feasibility and safety of cyclophosphamide/fludarabine lymphodepletion and an immunomodulatory combination of Interferon-alpha (INF-a), Bevacizumab and Aspirin, followed by adoptive transfer of vaccine-primed, ex vivo CD3/CD28-costimulated peripheral blood autologous T-cells, and vaccination with whole tumor vaccine, administered intradermally in combination with Bevacizumab in patients with recurrent ovarian cancer, fallopian tube or primary peritoneal cancer who previously underwent induction vaccination with whole tumor vaccine. Subjects will receive T-lymphocytes infusion at a dose of 20 billion ± 20% cells for all patients. Subjects who cant meet target dose level can still enroll but will be analyzed separately. Before T-cell infusion, all subjects will undergo lymphodepletion with a single course of outpatient high-dose lymphodepleting chemotherapy with intravenous cyclophosphamide (300 mg/m2/d for 3 consecutive Days) and intravenous fludarabine (30 mg/m2/d for 3 consecutive Days on Days -5 to -3). Subjects enrolled in this study will receive an immunomodulatory cycle of (Bevacizumab and Aspirin) ~14 Days before apheresis (if they do not have a frozen apheresis product from a previous collection) and another cycle between apheresis and T-cell infusion (approx.
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease. Despite a potential link between the pathogenetic mechanisms involved in Chronic Obstructive Pulmonary Disease (COPD) and atherosclerotic cardiovascular disease, there are no currently approved therapies for patients with COPD that have clearly shown an additional beneficial effect in patients with cardiovascular comorbidities. The TOwards a Revolution in COPD Health (TORCH) study assessed the impact of the inhaled corticosteroid (ICS) fluticasone propionate (FP) in combination with the long-acting beta agonist (LABA), salmeterol (SAL), in reducing all-cause mortality. TORCH demonstrated a 17.5% reduction on all-cause mortality with salmeterol-fluticasone propionate combination (SFC) compared with placebo (HR=0.825, 95% CI (0.681, 1.002), p=0.052) in the entire COPD population with disease severity form moderate to very severe. A post hoc analysis of the data restricted to those subjects with an forced expiratory volume in 1 second (FEV1) >=50% predicted with an apparent history of cardiovascular co-morbidities (defined as use at baseline of beta-blockers, angiotensin converting enzyme inhibitors (ACEI)/angiotensin receptor blockers (ARB), HMG CoA reductase inhibitors (i.e. statins) or a prior MI recorded at baseline) demonstrated a 49% reduction in the risk of dying within 96 weeks for the comparison of SFC with placebo.
This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing 1-level posterior lumbar fusion. A total of 54 patients will be randomized into one of two groups (group C or group I) based on Excel number generation. Patients in group C will receive received normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 4, 12, 24, 48 hours postoperatively.
The patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. Echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. The primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-FABP (heart-type Fatty Acid-Binding Protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. As secondary outcomes, H-FABP results will be compared to other cardiac biomarkers (BNP, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.
To determine the safety and manufacturing feasibility of IV autologous chimeric immune receptor (CIR) T cells transfected with anti-mesothelin messenger RNA (mRNA) expressing a single chain antibody variable fragment linked to the intracellular CD 3 zeta T cell receptor domain and the 4-1BB costimulatory domain. The purpose of this study is to test the safety of infusing the study product CIR T cells. These T cells are made using T cells obtained through apheresis and introducing the T cells to a temporary gene which will cause them to start making a new type of antibody that will attach mesothelin (this antibody is found on the surface of the cancer cells). In theory, once the modified T cells attach to mesothelin, the cells will be activated to stimulate the subject's own immune system to attack the mesothelin cells. This type of modified cell is called a T cell transduced transfected with chimeric anti-mesothelin immunoreceptor. Subjects will be enrolled serially with all subjects receiving 1xe8 to 1x1e9 modified CIR T cells every other day for 3 infusions. Each patient will be observed for 9 days for toxicity assessment prior to receiving a second cycle of modified CIR T cells every other day for 3 infusions. The preceding subject must have completed the two-cycle regimen and been observed for toxicity through day 21 before the next subject can be enrolled.
In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive PE with right ventricular dysfunction(RVD). In acute pulmonary embolism (PE), normotensive patients with acute RV dysfunction on echocardiography or computed tomography and with myocardial troponin elevation may have an adverse outcome. Thrombolysis rapidly reverses RV pressure overload in PE, but it increases the possibility of bleeding and it remains unclear whether it may improve the early or long-term clinical outcome of these selected normotensive patients. In our previous study, we found that low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had less bleeding tendency than the 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus Low Molecular Weight Heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events. In this prospective, multicenter, randomized, control study, we compare low dose rt-PA plus LMWH vs. LMWH alone in acute normotensive pulmonary embolism patients with RV dysfunction.
This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep. Recent studies have also supported the use of gabapentin as an adjuvant medication in postoperative pain management. Gabapentin decreased the pain associated with movement in post-mastectomy patients. Gilron et al showed a combination of gabapentin and rofecoxib superior to either medication alone in relieving pain after hysterectomy. Later, Gilron et al showed that adding meloxicam to gabapentin in patients undergoing outpatient laparoscopic surgery provided little additional benefit. Clarke et al demonstrated the decrease in the use of opioids in patients who received preoperative and postoperative gabapentin after total knee arthroplasty. They also noted that optimum timing and dosage of the gabapentin needed to be further elucidated. However, in the same year, Clarke et al also reported that gabapentin provided no benefit after total hip arthroplasty when a robust multimodal analgesic regimen was combined with spinal anesthesia.
The primary objective of this study is to investigate whether continuous PVB is equal in efficacy to epidural anesthesia in terms of analgesia in patients with INR lower than 1.2, or is continuous ICNB equal in efficacy to PCA in terms of analgesia, if patients have INRs equal to or greater than 1.2. Rib fractures are the most common injury sustained following blunt trauma. Ziegler and Agarwal noted that in a population of more than 7000 trauma patients, 10% had fractured ribs. These injuries are normally the hallmark of significant chest trauma; and as the number of fractured ribs increases, there is an exponential increase in morbidity and mortality. This injury therefore poses a challenging problem from both pulmonary and analgesia standpoints. Significant morbidity is often the result of hypoventilation leading to atelectasis, pneumonia, and respiratory failure. Pain management has been recognized as an important factor in preventing these complications. Good analgesia may help to improve a patient's respiratory mechanics, leading to a decreased need for mechanical ventilatory support, a shortened hospital stay, and can dramatically alter the course of recovery impacting both morbidity and mortality. For healthy patients with one to two fractured ribs, systemic analgesics may suffice. For more than three to four fractured ribs, studies and experience have reaffirmed the superior analgesia made possible with continuous thoracic epidural, continuous thoracic paravertebral, and continuous intercostal block, however, a comparative head to head trial comparing the relative merits and disadvantages of each technique has not been undertaken in multiple rib fracture patients.
This prospective randomized study aims to evaluate the effectiveness of intravenous lidocaine injection on the relief of pain in patients undergoing thyroidectomy. A total 56 patients will be randomized into one of two groups(group C or group I) based on Excel number generation. Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5mg/kg lidocaine followed by a continuous lidocaine infusion of 2mg/kg/hr. Visual analogue scale pain scores, fentanyl consumption, the frequency at which patients pushed the button(FPB) of a patient-controlled analgesia system, and presence or absence of nausea and vomiting will be recorded at 2,4,8,12,24,48 hours postoperatively.
This prospective randomized study aims to comparison the effectiveness of intravenous lidocaine injection and intraperitoneam lidocaine irrigation on the relief of pain in patients undergoing laparoscopic cholecystectomy. A total of 83 patients will be randomized into one of three groups (group C or group I or group P) based on Excel number generation. Patients in group C will receive normal saline intravenous injection, and patients in group I will receive an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr. Patients in group P will receive intraperitoneal lidocaine irrigation with 3.5 mg/kg lidocaine and normal saline 100cc. Visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (FPB) of a patient-controlled analgesia system will be recorded at 2, 4, 8, 12, 24, 48 hours postoperatively.
In patients with suspected APE (Acute Pulmonary Embolism) referred to the intensive care unit (ICU)after major surgery, serum NT-proBNP (N-terminal proBNP), Troponin-I and D-dimers were measured according to the standard hospital protocol. To definitively confirm or exclude APE, all patients underwent an angiographic CT-scan of the thorax. In patients with suspected APE referred to the intensive care unit after major surgery, serum NT-proBNP, Troponin-I and D-dimers were measured according to the standard hospital protocol. Blood samples were obtained within one hour after the onset of clinical symptoms. Definitive confirmation or exclusion of APE was performed with an angiographic CT-scan of the thorax.
Patients with suspected Pulmonary Embolism (PE) and a high clinical probability or a high D-dimer level should undergo a second level diagnostic test such as Multidetector Computed Tomography Angiography (MCTPA). Unfortunately MCTPA involves radiation exposure, is expensive, is not feasible in unstable patients and has contraindications. UltraSound (US) is safe and rapidly available even in unstable patients. Many authors evaluated the diagnostic role of Compression Ultrasound Scan (CUS) for detecting limbs Deep Vein Thrombosis (DVT), TransThoracic Echocardiography (TTE) for detecting Right Ventricular Dysfunction (RVD) or Thoracic UltraSound (TUS) for detecting subpleural infarcts in patients with suspected PE. No previous studies have investigated the diagnostic accuracy of CUS, TTE and TUS combined (multiorgan US) for the diagnosis of PE. This study evaluates the diagnostic accuracy of multiorgan US. Methods. Consecutive patients that underwent MCTPA in the Emergency Department for clinical suspicion of PE and with a simplified Well's score>4 (PE likely) or with a D-dimer value ≥500ng/ml were enrolled in the study. MCTPA was considered the gold standard for PE diagnosis. A multiorgan US was performed by an emergency physician sonographer before MCTPA. PE was considered echographically present if CUS was positive for DVT or TTE was positive for RVD or at least one pulmonary subpleural infarct was detected with TUS. The accuracy of the single and multiorgan US was calculated.
Non-interventional, observational study of physicians' use of Dabigatran etexilate for stroke prevention in patients with atrial fibrillation and mild to moderate renal impairment
Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome. Glucose metabolism disorders (diabetes and pre-diabetes) and metabolic syndrome are common in joint replacement recipients. Improved physical activity following joint replacement could lead to better glucose control in diabetes and ameliorate impaired glucose and cholesterol levels. In this study patients previously recruited to "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study are being followed-up for one year in order to analyze if joint replacements have an effect on these metabolic abnormalities. In addition, the effect of glucose metabolism disorders on occurrence of persistent pain after surgery is analyzed.
The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.
This is a two year, multicentre, mixed methods feasibility study including a randomised controlled two-arm interventional trial, a nested qualitative study, focus groups and a United Kingdom (UK) wide survey exercise. Venous thromboembolism (VTE) is a term to describe blood clots in the legs known as a deep vein thrombus (DVT) or lung, known as a pulmonary embolus (PE). It is a common condition, which causes many symptoms including leg pain, swelling, chest pain and breathlessness. At its most serious, VTE may lead to sudden collapse and death. Treating VTE costs the UK National Health Service (NHS) £640 million every year, including the long-term complications experienced by nearly a third of patients. VTE treatment usually consists of three to six months blood thinning medicine known as an anticoagulant. For most patients, a tablet called warfarin is used, which requires regular blood tests to ensure the blood is adequately and safely thinned. We also know that VTE is particularly common in cancer. In the UK, over 250,000 people are diagnosed each year with cancer, of which nearly a fifth will develop VTE. Warfarin is a potentially risky treatment in cancer patients because it may increase the risk of bleeding. Also, VTE may come back in a fifth of patients who are treated with warfarin. Research has shown that a medicine known as low molecular weight heparin (LMWH) is better than warfarin at treating VTE in cancer patients and decreases the chance of VTE coming back by half.
The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart. The primary objective of this study is to estimate the rate of radiation-associated regional myocardial perfusion defects in patients 6 months after breast/chestwall radiation with DIBH for left-sided breast cancer. Cardiac perfusion will be assessed using SPECT cardiac perfusion scans pre- and 6 months post-radiation.
This study aims to evaluate the use of rivaroxaban and its short term safety when used by patients for the new indications of prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE. Any adult patient started by their care team on rivaroxaban or an alternative anticoagulant for the specified indications during the study period will be eligible to take part. A questionnaire will be completed by the care team of each patient at the start of treatment and again 12 weeks later. The care team will complete the questionnaires using information from the patient's medical notes, not by asking the patient directly. If a participant has an adverse event during the 12 week period, we may ask the patient's care team to fill out a further follow up questionnaire. No other examinations or tests will be performed. Patients will only be recruited to the study after the clinical decision to prescribe rivaroxaban or an alternative anticoagulant has been made, so that prescribing behaviour is not altered by the study. It is an observational, non-interventional study covering the whole of England and Wales.
The goal of this project is to determine if the change in oxygen saturation during deep inspiration ("augmented pulse oximetry") can be used as a method to rule out pulmonary embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who do not have a PE. Trained, blinded Respiratory Therapists or Study Coordinators will record each patient's oxygen saturation before, during, and after a 2-minute period of deep inspirations (vital capacity [the maximal amount of air that can be inhaled, measured in milliliters]) using an incentive spirometer. The investigators' central hypothesis is that persons with a PE will not respond to augmented pulse oximetry and will not significantly improve or normalize their oxygen saturation. Patients will be identified and enrolled by the Mayo Clinic St. Marys Emergency Department staff as they are undergoing medical care in the Emergency Department. The investigators will calculate the difference in oxygen saturation pre- and post-deep inspiration (ΔSpO2 at 1 minute, 2 minutes and 4 minutes), and then correlate these values with the CT result. In cases of PE, The investigators expect the SpO2 to remain unchanged, or to change less than 3-5%.
Acute lung injury (ALI) and acute respiratory distress syndrome(ARDS) represent the most common and earliest organ dysfunction in acute pancreatitis, presenting as dyspnea and intractable hypoxemia, with secondary bilateral pulmonary infiltrates on radiograph. And mechanical ventilation (MV) is the essential intervention to improve oxygenation. When to initiate MV remains uncertain. In this study, we aim to compare the effect of early MV and conventional MV, and we hypothesize that early MV may be a better treatment option.
The investigators are presently using Exparel, a slow released local anesthestic, in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use. Title of Study: Evaluation of the Efficacy of EXPAREL Delivered Into the Thoracotomy and Chest Tube Sites After Minimally Invasive Cardiac Surgery Hypothesis: There is no difference in, the use of analgesics or the length of analgesia using Exparel infiltration when compared to regular bupivacaine. Objectives: The investigators are presently using Exparel in patients undergoing minimally invasive cardiac surgery. The primary objective of this study is to assess the efficacy of EXPAREL when delivered into the thoracotomy and chest tube sites to provide prolonged postoperative analgesia in patients undergoing minimally invasive cardiac surgery. Efficacy will be assessed by: the effectiveness of analgesia as measured by the subject's overall postoperative pain scores and postsurgical analgesic use. The safety of EXPAREL will be assessed by the occurrence of all postsurgical adverse events and serious adverse event through Day 30. Methodology: This is a prospective, open-label, non-randomized study evaluating the effectiveness of analgesia when using 266 mg EXPAREL delivered into the thoracotomy and chest tube sites by wide local infiltration.
The purpose of this study is to assess the pain-relieving effects of surgery for painful external snapping hip.
Pain is an expected part of surgical recovery but effective pain management remains challenging. The high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. Few studies have yet combined preoperative assessment of responses to experimental pain with measurements of cognitive and emotional processes in the prediction of postoperative pain. We hypothesize, that preoperative evoked brain potentials (using standard electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related catastrophic thinking are useful clinical predictors of postoperative pain and analgesic consumption. Preselected preoperative predictor variables/individual patient characteristics include the following: - Evoked brain potentials (using standard electroencephalographic brain imaging) - Capacity of descending pain inhibition induced by a cold pressor test (2C in 120 sec) - Pressure pain detection and tolerance thresholds in muscle (m.quadriceps) - Pressure pain tolerance thresholds in bone (sternum and tibia) - Heat pain tolerance threshold in skin (forearm) - Responses to the Situational and Dispositional Pain Catastrophizing Scale - Response to the State-Trait and Anxiety Inventory - Response to the Beck's Depression Inventory
The purpose of this study is to determine whether super-selective intra-arterial administration of verapamil immediately following successful intra-arterial thrombolysis is safe as a potential neuroprotective agent. Standard procedures are cerebral angiography and intra-arterial thrombolysis (intra-arterial administration of tPA and/or mechanical thrombectomy). Experimental procedure is superselective injection of verapamil intra-arterially. This trial represents the first time that verapamil will be evaluated in human subjects as a superselectively administered neuroprotective agent administered in an acute time frame as an adjunct to intra-arterial thrombolysis. The methods for administration, along with the routinized followup, will provide a paradigm for studying other potential neuroprotective agents. Subjects will undergo cerebral angiography with intra-arterial thrombolysis, which is standard of care. 'Intra-arterial thrombolysis will include possible intra-arterial administration of tPA, as well as possible mechanical thrombectomy with an accepted thrombectomy device. This includes the Mercí Retriever (Concentric Medical, Mountain View, CA), the Penumbra System (Penumbra, Alameda, CA), the Solitaire stent-triever (EV3, Covidien, Irvine, CA), and the Trevo stent-triever (Concentric Medical, Mountain View, CA). Immediately after the intra-arterial thrombolysis component of the angiographic procedure is completed, the microcatheter used during the procedure will be left in or guided into the vessel location of the clot. 10mg of verapamil in 20cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot.