Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

PubMed

Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

2016-03-01

Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P < 0.0001). No significant difference in striae width was observed between the treated or control quadrants. Global assessment by the physician who performed the treatment and by the patient both showed greater improved with the combination treatment compared to control areas (P = 0.004 and P = 0.01, respectively). A more homogeneous interlacing pattern and thicker collagen fibers with a decreased proportion of elastic fibers was observed after treatment. Fractional bipolar radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and

Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study.

PubMed

Vihervaara, Hanna; Grönroos, Juha M; Hurme, Saija; Gullichsen, Risto; Salminen, Paulina

2017-01-01

Endoscopic stents are used to relieve obstructive jaundice. The purpose of this prospective randomized study was to compare the patency of antireflux and conventional plastic biliary stent in relieving distal malignant biliary obstruction. All jaundiced patients admitted to hospital with suspected unresectable malignant distal biliary stricture between October 2009 and September 2010 were evaluated for the study. Eligible patients were randomized either to antireflux or conventional plastic stent arms. The primary endpoint was stent patency and the follow-up was continued either until the stent was occluded or until 6 months after the stent placement. At an interim analysis, antireflux stents (ARSs; n = 6) had a significantly shorter median patency of 34 (8-49) days compared with the conventional stent (n = 7) patency of 167 (38-214) days (P = .0003). Based on these results, the study was terminated due to ethical concerns. According to these results, the use of this ARS is not recommended.

The breast reconstruction evaluation of acellular dermal matrix as a sling trial (BREASTrial): design and methods of a prospective randomized trial.

PubMed

Agarwal, Jayant P; Mendenhall, Shaun D; Anderson, Layla A; Ying, Jian; Boucher, Kenneth M; Liu, Ting; Neumayer, Leigh A

2015-01-01

Recent literature has focused on the advantages and disadvantages of using acellular dermal matrix in breast reconstruction. Many of the reported data are from low level-of-evidence studies, leaving many questions incompletely answered. The present randomized trial provides high-level data on the incidence and severity of complications in acellular dermal matrix breast reconstruction between two commonly used types of acellular dermal matrix. A prospective randomized trial was conducted to compare outcomes of immediate staged tissue expander breast reconstruction using either AlloDerm or DermaMatrix. The impact of body mass index, smoking, diabetes, mastectomy type, radiation therapy, and chemotherapy on outcomes was analyzed. Acellular dermal matrix biointegration was analyzed clinically and histologically. Patient satisfaction was assessed by means of preoperative and postoperative surveys. Logistic regression models were used to identify predictors of complications. This article reports on the study design, surgical technique, patient characteristics, and preoperative survey results, with outcomes data in a separate report. After 2.5 years, we successfully enrolled and randomized 128 patients (199 breasts). The majority of patients were healthy nonsmokers, with 41 percent of patients receiving radiation therapy and 49 percent receiving chemotherapy. Half of the mastectomies were prophylactic, with nipple-sparing mastectomy common in both cancer and prophylactic cases. Preoperative survey results indicate that patients were satisfied with their premastectomy breast reconstruction education. Results from the Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial will assist plastic surgeons in making evidence-based decisions regarding acellular dermal matrix-assisted tissue expander breast reconstruction. Therapeutic, II.

A randomized prospective multicenter trial of a novel vascular sealant.

PubMed

Stone, William M; Cull, David L; Money, Samuel R

2012-11-01

Increasing use of anticoagulant medications, particularly antiplatelet therapies, can increase the difficulty in obtaining adequate suture line hemostasis. Multiple vascular sealants have been used as adjuncts to surgical procedures, but none of them have been universally successful. The aim of this study was to evaluate the safety and effectiveness of a new prophylactic vascular sealant in arterial surgery. A randomized prospective multi-institutional trial was undertaken comparing ArterX Vascular Sealant (AVS) with Gelfoam Plus during open arterial reconstruction. Three hundred thirty-one anastomotic sites in 217 patients were randomized. One hundred one of 167 (60.5%) anastomotic sites in the AVS group achieved immediate hemostasis compared with 65 of 164 (39.6%) in the control group (P = 0.001). In anastomoses with polytetrafluoroethylene grafts, 105 of 167 (62.5%) in the AVS group achieved immediate hemostasis compared with 56 of 164 (34.0%) in the control group (P < 0.001). No significant differences were noted in morbidity or mortality. Operative time was significantly less in the AVS group compared with the control group (3.2 vs. 3.8 hours, P < 0.01). Use of AVS results in superior hemostatic effectiveness compared with Gelfoam Plus, with no difference in safety. Although no cost analysis was performed, cost savings likely resulted from significantly decreased operative time. Copyright © 2012 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

PubMed

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial

PubMed Central

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction. PMID:11806769

Intrapleural chemo- and hyperthermotherapies for malignant pleural effusion: a randomized prospective study.

PubMed

Chen, Wen-Jun; Yuan, Shao-Fei; Yan, Qing-Yuan; Xiong, Jian-Ping; Wang, Sen-Ming; Zheng, Wei-E; Zhang, Wu; Sun, Hong-Yu; Chen, Hua; Wu, Li-Li

2012-02-01

The current prospective randomized study was designed to evaluate the safety and efficacy of combined intrapleural cisplatin and OK-432 (picibanil) plus hyperthermotherapy in patients with malignant pleural effusion (MPE). A total of 358 patients with MPE due to end-stage malignancies were enrolled and randomly divided into two groups, A and B: the intrapleural combination of cisplatin and OK-432 with hyperthermotherapy (n = 179) or without hyperthermotherapy (n = 179), respectively. Mild toxicities such as nausea, vomiting or anorexia, bone marrow depression, and pyrexia were similar in both groups. Patients in Group A (with hyperthermotherapy) showed a significantly higher overall response (93.4%) compared to those in Group B (79.8%, χ(2) = 43.11, p < .05). The median survival time for patients in Group A and Group B were 8.9 and 6.2 months, respectively (p > .05). After treatment, the quality of life scores were significantly increased in both groups as compared to prior treatment (p < .05). In conclusion, our study suggests that combined intrapleural cisplatin and OK-432 followed by hyperthermotherapy are more effective in the control of MPE and improve patients' quality of life.

Evaluating the Effectiveness of Developmental Mathematics by Embedding a Randomized Experiment within a Regression Discontinuity Design

ERIC Educational Resources Information Center

Moss, Brian G.; Yeaton, William H.; Lloyd, Jane E.

2014-01-01

Using a novel design approach, a randomized experiment (RE) was embedded within a regression discontinuity (RD) design (R-RE-D) to evaluate the impact of developmental mathematics at a large midwestern college ("n" = 2,122). Within a region of uncertainty near the cut-score, estimates of benefit from a prospective RE were closely…

Prospective randomized study of chevron osteotomy versus Mitchell's osteotomy in hallux valgus.

PubMed

Buciuto, Robert

2014-12-01

We conducted a prospective randomized trial to compare the most popular osteotomy types of operative treatment of hallux valgus (HV) used in Norway, Mitchell's osteotomy (MO) and chevron osteotomy (CO). One hundred twenty adult female patients were prospectively randomized to treatment with either MO or CO. All operative procedures were performed with ankle block and with tourniquet applied. None of the patients received any antibiotic or antithrombotic prophylaxis. The follow-up period was 3 years. Clinical results were rated according to the American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System (CRS). HV in the MO group was reduced from 30 (range, 20 to 44) to 15 (range, 8 to 24) degrees and IM angle from 11 (range, 6 to 14) to 7 (range, 4 to 11) degrees. HV in the CO group was reduced from 31 (range, 22 to 42) to 16 (range, 6 to 24) degrees and IM angle from 14 (range, 8 to 20) to 6 (range, 2 to 10) degrees. Transfer metatarsalgia occurred in 36 (60%) patients and hammertoe in 6 (10%) patients in the MO group. In the CO group, metatarsalgia occurred in 5 patients. The median loss of postoperative HV correction was 4 (range, 2 to 10) degrees in mild deformity and 6 (6 to 10) degrees in moderate deformity. Patients treated with CO had significantly better results for AOFAS CRS, number of postoperative complications, patient satisfaction, and length of sick leave for the employed patients. Based on our results, we consider that in female patients CO should be regarded as the first-line procedure for treatment of mild and moderate HV. Level I, prospective randomized study. © The Author(s) 2014.

Fibrin Sealant Improves Hemostasis in Peripheral Vascular Surgery: A Randomized Prospective Trial

PubMed Central

Schenk, Worthington G.; Burks, Sandra G.; Gagne, Paul J.; Kagan, Steven A.; Lawson, Jeffrey H.; Spotnitz, William D.

2003-01-01

Objective To evaluate the efficacy and safety of an investigational fibrin sealant (FS) in a randomized prospective, partially blinded, controlled, multicenter trial. Summary Background Data Upper extremity vascular access surgery using polytetrafluorethylene (PTFE) graft placement for dialysis was chosen as a reproducible, clinically relevant model for evaluating the usefulness of FS. The FS consisted of pooled human fibrinogen (60 mg/mL) and thrombin (500 NIH U/mL). Time to hemostasis was measured, and adverse events were monitored. Methods Consenting adult patients (n = 48) undergoing placement of a standard PTFE graft were randomized in a 2:1:1 ratio to the treatment group using FS (ZLB Bioplasma AG, Bern, Switzerland), oxidized regenerated cellulose (Surgicel, Johnson & Johnson, New Brunswick, NJ), or pressure. Patients received heparin (3,000 IU IVP) before placement of vascular clamps. If the treatment was FS, clamps were left in place for 120 seconds after the application of study material to permit polymerization. If treatment was Surgicel, clamps were left in place until the agent had been applied according to manufacturer’s instructions. If the treatment was pressure, clamps were released as soon as the investigator was ready to apply compression. Immediately after release of the last clamp, the arterial and venous suture lines were evaluated for bleeding. The time to hemostasis at both the venous and arterial sites was recorded. Results Significant (P ≤ .005) reduction in time to hemostasis was achieved in the FS group. Thirteen (54.2%) patients randomized to FS experienced immediate hemostasis at both suture lines following clamp removal compared to no patients using Surgicel or pressure. Only one patient (7.1%) in the Surgicel group and no patients in the pressure group experienced hemostasis at 120 seconds from clamp removal, compared to 13 (54.2%) patients for FS. Adverse events were comparable in all groups. There were no seroconversions

Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization

PubMed Central

Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J.; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K.; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M.; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J.; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E.; Nordestgaard, Børge G.; Nielsen, Sune F.; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K.; Rookus, Matti A.; van den Hurk, Katja; de Kort, Wim L. A. M.; Couch, Fergus J.; Olson, Janet E.; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M. Pilar; Perez, Jose I. A.; Cox, Angela; Cross, Simon S.; Reed, Malcolm W. R.; Andrulis, Irene L.; Knight, Julia A.; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J.; Tomlinson, Ian; Kerin, Michael J.; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A.; Henderson, Brian E.; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J.; Martens, John W. M.; Tilanus-Linthorst, Madeleine M. A.; Collée, J. Margriet; Hopper, John L.; Southey, Melissa C.; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E.; Ambrosone, Christine B.; Yannoukakos, Drakoulis; Giles, Graham G.; Milne, Roger L.; McLean, Catriona; Fasching, Peter A.; Haeberle, Lothar; Ekici, Arif B.; Beckmann, Matthias W.; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J.; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M.; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J.; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K.; Neuhausen, Susan L.; Anton-Culver, Hoda; Kristensen, Vessela N.; Grenaker Alnæs, Grethe I.; Pierce, Brandon L.; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S.; John, Esther M.; Gammon, Marilie D.; Malone, Kathleen E.; Tessier, Daniel C.; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S.; González-Neira, Anna; Pita, Guillermo; Alonso, M. Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D. P.; Simard, Jacques; Hall, Per; Hunter, David J.; Easton, Douglas F.

2015-01-01

Background: Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. Methods: We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control subjects, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control subjects. Results: The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor–positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P < 5×10–8. Conclusions: Our study provides strong evidence that adult height is a risk factor for breast cancer in women and certain genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. PMID:26296642

Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Sasso, Willa R; Smucker, Joseph D; Sasso, Maria P; Sasso, Rick C

2017-02-15

Prospective, randomized, single-center, clinical trial. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055). At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy. 1.

Evaluation of intralesional injection of hyaluronic acid compared with verapamil in Peyronie's disease: preliminary results from a prospective, double-blinded, randomized study.

PubMed

Favilla, V; Russo, G I; Zucchi, A; Siracusa, G; Privitera, S; Cimino, S; Madonia, M; Cai, T; Cavallini, G; Liguori, G; D'Achille, G; Silvani, M; Franco, G; Verze, P; Palmieri, A; Torrisi, B; Mirone, V; Morgia, G

2017-07-01

Several intralesional therapeutic protocols have been proposed for the treatment of Peyronie's disease. Among all, hyaluronic acid (HA) and verapamil have been differently tested. We aimed to evaluate the efficacy of intralesional verapamil (ILVI) compared with intralesional HA in patients with early onset of Peyronie's disease (PD). This is a multi-centre prospective double-arm, randomized, double-blinded study comparing ILVI vs. intralesional HA after 12-weeks. Sexually active men, older than 18 years and affected by the acute phase of PD were eligible for this study. Patients have been double-blinded randomly divided into two groups (1 : 1 ratio): Group A received intralesional treatment with Verapamil (10 mg in 5 mL of normal saline water) weekly for 12 weeks, while group B received intralesional treatment with HA (0.8% highly purified sodium salt HA 16 mg/2 mL) weekly for 12 weeks. The primary efficacy outcome was the change from the baseline to the endpoint (12 weeks after therapy) for the penile curvature (degree). The secondary outcome was the change in the plaque size and in the International Index of erectile Function (IIEF-5) score. The difference between post- and pre-treatment plaque size was -1.36 mm (SD ± 1.27) for Group A and -1.80 mm (SD ± 2.47) for Group B (p-value = NS). IIEF-5 increased of 1.46 points (SD ± 2.18) in Group A and 1.78 (SD ± 2.48) in Group B (p-value ± NS). No difference in penile curvature was observed in Group A, while in Group B the penile curvature decreased of 4.60° (SD ± 5.63) from the baseline (p < 0.001) and vs. Group A. According to PGI-I results, we found significant difference as concerning patient global impression of improvement (PGI-I) (4.0 vs. 2.0; p < 0.05). This prospective, double-arm, randomized, double-blinded study comparing ILVI vs. HA as intralesional therapy showed greater efficacy of HA in terms of penile curvature and PGI-I. © 2017 American Society of Andrology and

Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study.

PubMed

Anastasiadis, Kyriakos; Asteriou, Christos; Antonitsis, Polychronis; Argiriadou, Helena; Grosomanidis, Vassilios; Kyparissa, Magdalena; Deliopoulos, Apostolos; Konstantinou, Dimitrios; Tossios, Paschalis

2013-10-01

A minimal extracorporeal circulation (MECC) circuit integrates the advances in cardiopulmonary bypass (CPB) technology into a single circuit and is associated with improved short-term outcome. The aim of this study was to prospectively evaluate MECC compared with conventional CPB in facilitating fast-track recovery after elective coronary revascularization procedures. Prospective randomized study. All patients scheduled for elective coronary artery surgery were evaluated, excluding those considered particularly high risk for fast-track failure. The fast-track protocol included careful preoperative patient selection, a fast-track anesthetic technique based on minimal administration of fentanyl, surgery at normothermia, early postoperative extubation in the cardiac recovery unit, and admission to the cardiothoracic ward within the first 24 hours postoperatively. One hundred twenty patients were assigned randomly into 2 groups (60 in each group). Group A included patients who were operated on using the MECC circuit, whereas patients in Group B underwent surgery on conventional CPB. Incidence of fast-track recovery was significantly higher in patients undergoing MECC (25% v 6.7%, p = 0.006). MECC also was recognized as a strong independent predictor of early recovery, with an odds ratio of 3.8 (p = 0.011). Duration of mechanical ventilation and cardiac recovery unit stay were significantly lower in patients undergoing MECC together with the need for blood transfusion, duration of inotropic support, need for an intra-aortic balloon pump, and development of postoperative atrial fibrillation and renal failure. MECC promotes successful early recovery after elective coronary revascularization procedures, even in a nondedicated cardiac intensive care unit setting. Copyright © 2013 Elsevier Inc. All rights reserved.

Prospective, randomized, controlled trial using best-selling smoking-cessation book.

PubMed

Foshee, James P; Oh, Anita; Luginbuhl, Adam; Curry, Joseph; Keane, William; Cognetti, David

2017-07-01

Our prospective, randomized, controlled trial aimed to evaluate the efficacy of the self-help book, The Easy Way to Stop Smoking, by Allen Carr, in promoting smoking cessation in patients with head and neck cancer. We assessed active smokers for their willingness to read a smoking cessation book. Participants were randomized to either receive the book from our department or recommended to purchase the book. All patients received smoking cessation counseling at recruitment. Phone surveys were conducted at short- and long-term intervals to determine if the patients had purchased and/or read the book and whether they were still smoking. One hundred twelve patients were recruited, 52 of whom completed follow-up surveys. Those who received the book for free were more likely to read the book (p = 0.05). Reading the book did not correlate with successful smoking cessation (p = 0.81). Some 26% of the 27 patients who received the book quit smoking compared with 32% of the 25 patients who were recommended the book (p = 0.76). Patients who indicated motivation to quit smoking were more likely to succeed. In our study, smoking cessation did not appear to be influenced by reading The Easy Way to Stop Smoking. Despite 80.8% of the cohort indicating at least a readiness to quit smoking at recruitment, only 28.8% of patients managed to achieve successful smoking cessation at long-term follow-up. Patient motivation remains an important factor in achieving long-term smoking abstinence. Quitting smoking remains a daunting challenge for patients, with multiple interventions likely needed to achieve cessation.

The effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment: a prospective, randomized, and controlled study.

PubMed

Fekaj, Enver; Gjata, Arben; Maxhuni, Mehmet

2013-09-22

In patients with obstructive jaundice, multi-organ dysfunction may develop. This trial is a prospective, open-label, randomized, and controlled study with the objective to evaluate the effect of ursodeoxycholic acid in liver functional restoration in patients with obstructive jaundice after endoscopic treatment. The aim of this study is to evaluate the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice after endoscopic treatment. The hypothesis of this trial is that patients with obstructive jaundice, in which will be administered UDCA, in the early phase after endoscopic intervention will have better and faster functional restoration of the liver than patients in the control group.Patients with obstructive jaundice, randomly, will be divided into two groups: (A) test group in which will be administered ursodeoxycholic acid twenty-four hours after endoscopic procedure and will last fourteen days, and (B) control group.Serum-testing will include determination of bilirubin, alanine transaminase, aspartate transaminase, gama-glutamil transpeptidase, alkaline phosphatase, albumin, and cholesterol levels. These parameters will be determined one day prior endoscopic procedure, and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic intervention. This trial is a prospective, open-label, randomized, and controlled study to asses the effect of ursodeoxycholic acid in liver functional restoration of patients with obstructive jaundice in the early phase after endoscopic treatment.

Clinical Efficacy of Intravenous Lidocaine for Thyroidectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial.

PubMed

Choi, Geun Joo; Kang, Hyun; Ahn, Eun Jin; Oh, Jong In; Baek, Chong Wha; Jung, Yong Hun; Kim, Jin Yun

2016-12-01

Systemic lidocaine has analgesic and anti-inflammatory effects. The purpose of this prospective, randomized, double-blind study was to evaluate the effects of intravenous lidocaine on pain following thyroidectomy. Fifty-eight adult patients scheduled for total thyroidectomy were randomly allocated to receive a 1.5 mg/kg lidocaine bolus followed by a 2 mg/kg/h infusion during surgery, or the same volume of normal saline (control). After thyroidectomy, we evaluated postoperative pain, nausea, fentanyl consumption, frequency of pushing the button (FPB) for patient-controlled analgesia (PCA), High-sensitivity C-reactive protein (hs-CRP) in serum, and patient satisfaction scores regarding the recovery process. Postoperative pain and nausea scores were significantly lower in the lidocaine group for the first 4 h following thyroidectomy, compared to the control group. Fentanyl consumption and FPB for the PCA were also significantly reduced in the lidocaine group for 4 h following thyroidectomy, and hs-CRP was significantly less in the lidocaine group at postoperative days 1 and 3. Furthermore, satisfaction scores were significantly higher in the lidocaine group compared to the control group. Intravenous lidocaine effectively reduced postoperative pain and nausea following thyroidectomy as well as improved the quality of recovery. Clinicaltrials.gov NCT01608360.

Endoscopic versus traditional saphenous vein harvesting: a prospective, randomized trial.

PubMed

Allen, K B; Griffith, G L; Heimansohn, D A; Robison, R J; Matheny, R G; Schier, J J; Fitzgerald, E B; Shaar, C J

1998-07-01

Saphenous vein harvested with a traditional longitudinal technique often results in leg wound complications. An alternative endoscopic harvest technique may decrease these complications. One hundred twelve patients scheduled for elective coronary artery bypass grafting were prospectively randomized to have vein harvested using either an endoscopic (group A, n = 54) or traditional technique (group B, n = 58). Groups A and B, respectively, were similar with regard to length of vein harvested (41 +/- 8 cm versus 40 +/- 14 cm), bypasses done (4.1 +/- 1.1 versus 4.2 +/- 1.4), age, preoperative risk stratification, and risks for wound complication (diabetes, sex, obesity, preoperative anemia, hypoalbuminemia, and peripheral vascular disease). Leg wound complications were significantly (p < or = 0.02) reduced in group A (4% [2 of 51] versus 19% [11 of 58]). Univariate analysis identified traditional incision (p < or = 0.02) and diabetes (p < or = 0.05) as wound complication risk factors. Multiple logistic regression analysis identified only the traditional harvest technique as a risk factor for leg wound complications with no significant interaction between harvest technique and any preoperative risk factor (p < or = 0.03). Harvest rate (0.9 +/- 0.4 cm/min versus 1.2 +/- 0.5 cm/min) was slower for group A (p < or = 0.02) and conversion from endoscopic to a traditional harvest occurred in 5.6% (3 of 54) of patients. In a prospective, randomized trial, saphenous vein harvested endoscopically was associated with fewer wound complications than the traditional longitudinal method.

Accelerated rehabilitation after arthroscopic Bankart repair for selected cases: a prospective randomized clinical study.

PubMed

Kim, Seung-Ho; Ha, Kwon-Ick; Jung, Min-Wook; Lim, Moon-Sup; Kim, Young-Min; Park, Jong-Hyuk

2003-09-01

Increased stress within a certain limit enhances ligament healing and improves joint function. In this prospective randomized clinical trial, we compared the clinical results of early motion versus conventional immobilization after arthroscopic Bankart repair in a selected patient population. Prospective randomized clinical trial. We performed an arthroscopic Bankart repair using suture anchors in 62 patients with traumatic recurrent anterior instability of the shoulder. Patients were randomized into 2 groups; group 1 (28 patients; mean age, 28 years) was managed with 3 weeks of immobilization using an abduction sling and conventional rehabilitation program, and group 2 (34 patients; mean age, 29 years) was managed with an accelerated rehabilitation program that consisted of staged range of motion and strengthening exercises from the immediate postoperative day. Selection criteria were nonathletes with recurrent anterior shoulder dislocation and a classic Bankart lesion with a robust labrum limited to 1 cm from the midglenoid notch. The patients were followed up for a mean of 31 months (range, 27 to 45 months; standard deviation, 9 months). Analysis of outcome included pain scores at 6 weeks and at final follow-up evaluation, range of motion, return to activity, recurrence rate, patient satisfaction with each rehabilitation program, and shoulder scores assessed by the American Shoulder and Elbow Surgeons Shoulder Index, the rating system of the University of California at Los Angeles, and another scoring system. The recurrence rate was not different between the 2 groups (P =.842). None of the groups developed recurrent dislocation. Two patients from each group were positive for anterior apprehension signs. Patients who underwent accelerated rehabilitation resumed functional range of motion faster (P <.001) and returned earlier to the functional level of activity (P <.001). Accelerated rehabilitation decreased postoperative pain (P =.013), and more patients were

The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial.

PubMed

Chu, Edward W; Chernoguz, Artur; Divino, Celia M

2016-06-01

The perioperative safety profile of clopidogrel, a potent antiplatelet agent used in the management of cardiovascular disease, is unknown, and there are no evidence-based guidelines recommending for either its interruption or continuation at this time. The aim of this study was to determine whether patients who are maintained on clopidogrel before general surgical procedures are at increased risk of perioperative bleeding complications. Patients receiving clopidogrel at the time of elective general surgery were randomized to either discontinue clopidogrel 1 week before surgery (group A) or continue clopidogrel into surgery (group B). All other antiplatelet and anticoagulant agents were discontinued before surgery. The primary end points were perioperative bleeding requiring intraoperative or postoperative transfusion of blood or blood components and bleeding-related readmission, reoperation, or mortality within 90 days of surgery. The secondary end points were perioperative myocardial infarction or cerebrovascular accidents within 90 days of surgery. Thirty-nine patients were enrolled and underwent 43 general surgical operations. Twenty-one procedures were randomized to group A and 22 to group B. The most commonly performed individual procedures were open inguinal hernia repair (23%), laparoscopic cholecystectomy (21%), open ventral hernia repair (15%), laparoscopic ventral hernia repair (11%), and laparoscopic inguinal hernia repair (9%). No perioperative mortalities, bleeding events requiring blood transfusion, or reoperations occurred. One readmission for intra-abdominal hematoma requiring percutaneous drainage occurred in each group (group A: 4.8% vs group B: 4.5%; P = 1.0). No myocardial infarctions or cerebrovascular accidents were observed or reported. The outcomes from this prospective study suggest that, patients undergoing commonly performed elective general surgical procedures can be safely maintained on clopidogrel without increased perioperative

Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization.

PubMed

Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E; Nordestgaard, Børge G; Nielsen, Sune F; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K; Rookus, Matti A; van den Hurk, Katja; de Kort, Wim L A M; Couch, Fergus J; Olson, Janet E; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; Dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M Pilar; Perez, Jose I A; Cox, Angela; Cross, Simon S; Reed, Malcolm W R; Andrulis, Irene L; Knight, Julia A; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J; Tomlinson, Ian; Kerin, Michael J; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A; Henderson, Brian E; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J; Martens, John W M; Tilanus-Linthorst, Madeleine M A; Collée, J Margriet; Hopper, John L; Southey, Melissa C; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E; Ambrosone, Christine B; Yannoukakos, Drakoulis; Giles, Graham G; Milne, Roger L; McLean, Catriona; Fasching, Peter A; Haeberle, Lothar; Ekici, Arif B; Beckmann, Matthias W; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K; Neuhausen, Susan L; Anton-Culver, Hoda; Kristensen, Vessela N; Grenaker Alnæs, Grethe I; Pierce, Brandon L; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S; John, Esther M; Gammon, Marilie D; Malone, Kathleen E; Tessier, Daniel C; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S; González-Neira, Anna; Pita, Guillermo; Alonso, M Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D P; Simard, Jacques; Hall, Per; Hunter, David J; Easton, Douglas F; Zheng, Wei

2015-11-01

Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control patients, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control patients. The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor-positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P < 5×10(-8). Our study provides strong evidence that adult height is a risk factor for breast cancer in women and certain genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

The Effect of Listening to Music During Percutaneous Nephrostomy Tube Placement on Pain, Anxiety, and Success Rate of Procedure: A Randomized Prospective Study.

PubMed

Hamidi, Nurullah; Ozturk, Erdem

2017-05-01

To evaluate the effect of listening to music on pain, anxiety, and success of procedure during office-based percutaneous nephrostomy tube placement (PNTP). One hundred consecutive patients (age >18 years) with hydronephrosis were prospectively enrolled in this study. All patients were prospectively randomized to undergo office-based PNTP with (Group I, n = 50) or without music (Group II, n = 50). Anxiety levels were evaluated with State Trait Anxiety Inventory. A visual analog scale was used to evaluate pain levels, patient's satisfaction, and willingness to undergo the procedure. We also compared success rates of procedures. The mean age, duration of procedure, and gender distribution were statistically similar between the two groups. The mean postprocedural heart rates and systolic blood pressures in Group I patients were significantly lower than Group II patients (p = 0.01 and p = 0.028, respectively), whereas preprocedural pulse rate and systolic blood pressure were similar. The mean anxiety level and mean pain score of Group I were significantly lower than those of Group II (p = 0.008 and p < 0.001, respectively). Group I also carried a significant greater mean satisfaction score and willingness to undergo repeat procedure compared with Group II (p < 0.001 for both). Success rate of nephrostomy tube placement in Group I was significantly higher compared with Group II (92% vs 66%, p = 0.04). The present randomized prospective study demonstrates that listening to music during office-based PNTP decreases anxiety or pain and increases success rate of procedure. As an alternative to sedation or general anesthesia, music is easily accessible without side effect and cost.

Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

PubMed

Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

2016-01-01

Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p < 0.05), resulting in a 10 % lower plasma removal rate of the mTPE treatment. Both treatments were comparable in terms of decrease in median (IQR) IgG [pre-mTPE 5.34 (3.48-8.37), post-mTPE 1.96 (1.43-2.84) g/L; pre-cTPE 5.88 (3.42-8.84), post-cTPE 1.89 (1.21-3.52) g/L]. Also the median (IQR) amount of IgG removed in mTPE [13.14 (7.42-16.10) g] was not different from the cTPE treatment [9.30 (6.26-15.69) g]. This was also true for IgM removal. Platelet loss during mTPE was nearly twice as much as with cTPE (15 ± 9 versus 7 ± 9 %, p < 0.05). Although the centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite

Patient’s self-evaluation of two education programs for age-related skin changes in the face: a prospective, randomized, controlled study

PubMed Central

Williams, Linda M; Alderman, Jane E; Cussell, Garry; Goldston, John; Hamilton, Neal; Lim, Adrian C; Goodman, Greg J; Halstead, Michael B; Rogers, John D

2011-01-01

Background: An interactive software program (HOYS) has been developed utilizing a database of digital images depicting various aspects and degrees of aging of exposed skin across seven geographic regions, representing a total of 35 facial and extrafacial subregions. A five-point photonumeric rating scale, which portrays age-related skin changes across five decades for each of these subregions, underpins this patient-based interactive self-assessment program. Based on the resulting outputs from this program, an individualized treatment prioritization list is generated for each region where significant differences between the patient’s chronological and esthetic ages exist. This provides guidance for the patient and the treating physician on treatment options. Methods: To evaluate the utility of HOYS in the clinic, relative to education programs currently used in Australian private esthetic clinics, a total of 95 esthetically-orientated patients were enrolled in a prospective, randomized, controlled, multicenter study. Results: Compared with a prospective cohort of patients completing a standard education program commonly utilized in Australian esthetic clinics, patients receiving the HOYS education program reported greater empowerment through improved knowledge of specific age-related skin changes. This was associated with a clearer understanding of treatment options available to them, and a perceived ability to participate in the selection of the treatments potentially administered to improve their appearance. These differences between the two education groups were highly significant. Conclusion: Patients completing the HOYS patient education program have an improved understanding of age-related changes to exposed skin of their face, neck, décolletage, and hands. Due to the patient-specific nature of the program, these patients perceive a greater role in the deciding which esthetic treatments should be subsequently administered to enhance their appearance

Prospective, randomized comparison of transperitoneal versus retroperitoneal laparoscopic adrenalectomy.

PubMed

Rubinstein, Mauricio; Gill, Inderbir S; Aron, Monish; Kilciler, Mete; Meraney, Anoop M; Finelli, Antonio; Moinzadeh, Ali; Ukimura, Osamu; Desai, Mihir M; Kaouk, Jihad; Bravo, Emmanuel

2005-08-01

We report a prospective, randomized comparison of transperitoneal laparoscopic adrenalectomy (TLA) vs retroperitoneal laparoscopic adrenalectomy (RLA) for adrenal lesions with long-term followup. Between December 1997 and November 1999, 57 consecutive eligible patients with surgical adrenal disease were prospectively randomized to undergo TLA (25) or RLA (32). Study exclusion criteria were patient age greater than 80 years, body mass index greater than 40, bilateral adrenalectomy and significant prior abdominal surgery in the quadrant of interest. Mean followup was 5.96 years in the 2 groups. The groups were matched in regard to patient age (p = 0.84), body mass index (p = 0.43), American Society of Anesthesiologists class (p = 0.81) and laterality (p = 0.12). Median adrenal mass size was 2.7 cm (range 1 to 9) in the TLA group and 2.6 cm (range 0.5 to 6) in the RLA group (p = 0.83). TLA was comparable to RLA in terms of operative time (130 vs 126.5 minutes, p = 0.64), estimated blood loss (p = 0.92), specimen weight (p = 0.81), analgesic requirements (p = 0.25), hospital stay (p = 0.56) and the complication rate (p = 0.58). One case per group was electively converted to open surgery. Pathology data on the intact extracted specimens were similar between the groups. Averaged convalescence was 4.7 weeks in the TLA group and 2.3 weeks in the RLA group (p = 0.02). During a mean followup of 6 years 2 patients in the TLA group had a late complication (port site hernia). Mortality occurred in 5 patients, including 1 with TLA and 4 with RLA, during the 6-year followup. For most benign adrenal lesions requiring surgery laparoscopic adrenalectomy can be performed safely and effectively by the transperitoneal or the retroperitoneal approach.

Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

PubMed

Raunest, J; Löhnert, J

1990-01-01

A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

A prospective randomized study of use of drain versus no drain after burr-hole evacuation of chronic subdural hematoma.

PubMed

Singh, Amit Kumar; Suryanarayanan, Bhaskar; Choudhary, Ajay; Prasad, Akhila; Singh, Sachin; Gupta, Laxmi Narayan

2014-01-01

Chronic subdural hematoma (CSDH) recurs after surgical evacuation in 5-30% of patients. Inserting subdural drain might reduce the recurrence rate, but is not commonly practiced. There are few prospective studies to evaluate the effect of subdural drains. A prospective randomized study to investigate the effect of subdural drains in the on recurrence rates and clinical outcome following burr-hole drainage (BHD) of CSDH was undertaken. During the study period, 246 patients with CSDH were assessed for eligibility. Among 200 patients fulfilling the eligibility criteria, 100 each were assigned to "drain group" (drain inserted into the subdural space following BHD) and "without drain group" (subdural drain was not inserted following BHD) using random allocation software. The primary end point was recurrence needing re-drainage up to a period of 6 months from surgery. Recurrence occurred in 9 of 100 patients with a drain, and 26 of 100 patients in without drain group (P = 0.002). The mortality was 5% in patients with drain and 4% in patients without drain group (P = 0.744). The medical and surgical complications were comparable between the two study groups. Use of a subdural drain after burr-hole evacuation of a CSDH reduces the recurrence rate and is not associated with increased complications.

Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

PubMed

Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

2017-11-01

The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

PubMed

Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T; Farah, Bruno; Dubois, Christophe L; Feldman, Robert L; Dens, Joseph; Hagiwara, Nobuhisa; Allocco, Dominic J; Dawkins, Keith D

2011-04-19

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. Copyright © 2011 American College of Cardiology Foundation. Published by

Myocardial revascularization with miniaturized extracorporeal circulation versus off pump: Evaluation of systemic and myocardial inflammatory response in a prospective randomized study.

PubMed

Formica, Francesco; Broccolo, Francesco; Martino, Antonello; Sciucchetti, Jennifer; Giordano, Vincenzo; Avalli, Leonello; Radaelli, Gianluigi; Ferro, Orazio; Corti, Fabrizio; Cocuzza, Clementina; Paolini, Giovanni

2009-05-01

This prospective randomized study sought to verify the systemic inflammatory response, inflammatory myocardial damage, and early clinical outcome in coronary surgery with the miniaturized extracorporeal circulation system or on the beating heart. Sixty consecutive patients were randomized to miniaturized extracorporeal circulation (n = 30) or off-pump coronary revascularization (off-pump coronary artery bypass grafting, n = 30). Intraoperative and postoperative data were recorded. Plasma levels of interleukin-6 and tumor necrosis factor-alpha were measured from systemic blood intraoperatively, at the end of operation, and 24 and 48 hours thereafter. Levels of the same markers and blood lactate were measured from coronary sinus blood intraoperatively to evaluate myocardial inflammation. Markers of myocardial damage were also analyzed. One patient died in the off-pump coronary artery bypass grafting group. There was no statistical difference in early clinical outcome in both groups. Release of interleukin-6 was higher in the off-pump coronary artery bypass grafting group 24 hours after the operation (P = .03), whereas levels of tumor necrosis factor-alpha were not different in both groups. Cardiac release of interleukin-6, tumor necrosis factor-alpha, and blood lactate were not different in both groups. Release of troponin T was not significantly different in both groups. Levels of creatine kinase mass were statistically higher in the miniaturized extracorporeal circulation group than in the off-pump coronary artery bypass grafting group, but only at the end of the operation (P < .0001). Hemoglobin levels were significantly higher in the miniaturized extracorporeal circulation group than in the off-pump coronary artery bypass grafting group after 24 hours (P = .01). Miniaturized extracorporeal circulation can be considered similar to off-pump surgery in terms of systemic inflammatory response, myocardial inflammation and damage, and early outcome.

Evaluation of an educational "toolbox" for improving nursing staff competence and psychosocial work environment in elderly care: results of a prospective, non-randomized controlled intervention.

PubMed

Arnetz, J E; Hasson, H

2007-07-01

Lack of professional development opportunities among nursing staff is a major concern in elderly care and has been associated with work dissatisfaction and staff turnover. There is a lack of prospective, controlled studies evaluating the effects of educational interventions on nursing competence and work satisfaction. The aim of this study was to evaluate the possible effects of an educational "toolbox" intervention on nursing staff ratings of their competence, psychosocial work environment and overall work satisfaction. The study was a prospective, non-randomized, controlled intervention. Nursing staff in two municipal elderly care organizations in western Sweden. In an initial questionnaire survey, nursing staff in the intervention municipality described several areas in which they felt a need for competence development. Measurement instruments and educational materials for improving staff knowledge and work practices were then collated by researchers and managers in a "toolbox." Nursing staff ratings of their competence and work were measured pre and post-intervention by questionnaire. Staff ratings in the intervention municipality were compared to staff ratings in the reference municipality, where no toolbox was introduced. Nursing staff ratings of their competence and psychosocial work environment, including overall work satisfaction, improved significantly over time in the intervention municipality, compared to the reference group. Both competence and work environment ratings were largely unchanged among reference municipality staff. Multivariate analysis revealed a significant interaction effect between municipalities over time for nursing staff ratings of participation, leadership, performance feedback and skills' development. Staff ratings for these four scales improved significantly in the intervention municipality as compared to the reference municipality. Compared to a reference municipality, nursing staff ratings of their competence and the

Prospective randomized clinical trial: single and weekly viscosupplementation

PubMed Central

Zóboli, Alejandro Agustin Carri; de Rezende, Márcia Uchôa; de Campos, Gustavo Constantino; Pasqualin, Thiago; Frucchi, Renato; de Camargo, Olavo Pires

2013-01-01

OBJECTIVE: To compare two different dosages of an intermediate molecular weight sodium hyaluronate (HA) (Osteonil®-TRB Pharma) assessing whether a single 6 ml application of this HA has the same effectiveness as the classical three-weekly 2 ml dose. METHODS: 108 patients with knee osteoarthritis were randomized into two groups of 54 patients each. The groups were designated "single" (S) and "weekly" (W). Patients in group S underwent a viscosupplementation procedure by application of only 6 ml of sodium hyaluronate and 1 ml triamcinolone hexacetonide. Patients in group W underwent the procedure of viscosupplementation through three applications with 2 ml sodium hyaluronate with a week interval between them, and the first application was also performed with the infiltration of 1 ml (20 mg) of Triamcinolone Hexacetonide. Both groups were assessed before, at one month and three months after application, by responding to the WOMAC, Lequesne, IKDC and VAS questionnaires. RESULTS: There was no statistical difference between the single application of 6 ml of sodium hyaluronate and classic application with three weekly injections. However, only the classical regime showed statistically significant improvement in baseline pain (WOMAC pain and VAS). CONCLUSION: Our results suggest that both application schemes improve application function, but the three-weekly regimen of 2 ml was more effective in reducing pain. Level of Evidence I, Prospective Randomized, Clinical Trial. PMID:24453681

Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial.

PubMed

Palacio, Evandro Pereira; Schiavetti, Rafael Ramos; Kanematsu, Maiara; Ikeda, Tiago Moreno; Mizobuchi, Roberto Ryuiti; Galbiatti, José Antônio

2016-01-01

To evaluate the effects of platelet-rich plasma (PRP) infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH) and Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaires. Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62). There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires.

One-year results of a prospective randomized, evaluator-blinded, multicenter study comparing TVT and TVT Secur.

PubMed

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Bergqvist, Christina Eten; Persson, Jan

2013-02-01

The aim of this prospective randomized multicenter study was to compare retropubic tension-free vaginal tape (TVT) with TVT Secur in terms of efficacy and safety. We set out to enrol 280 stress urinary incontinent (SUI) women with a half-time interim analysis of short-term cure and adverse events. The short-term results have previously been published. Of the 133 randomized women, 125 underwent surgery, and 121 (TVT n = 61, TVT Secur n = 60) were available for follow-up 1 year postsurgery. No significant differences were found between groups regarding demographics or incontinence grade. One year after surgery, both subjective and objective cure rates were significantly lower for TVT Secur than for TVT (subjective cure: TVT 98 %, TVT Secur 80 %, p = 0.03; objective cure: TVT 94 %, TVT Secur 71 % for cough test, p = 0.01; TVT 76 %, TVT Secur 58 % for pad test, p = 0.05 ). Three major complications occurred in the TVT Secur group: one tape erosion into the urethra, one tape inadvertently placed into the bladder, and one immediate postoperative bleeding due to injury to the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding peroperative bleeding, hospital stay, urge symptoms, residual urinary volume, subjective bladder emptying problems, postoperative urinary tract infections, and minor complications. The TVT Secur group used more antimuscarine medication after surgery than the TVT group (p = 0.03). Median time for surgery was 13 and 22 min for TVT Secur and TVT, respectively (p < 0.0001). The TVT Secur procedure had significantly inferior subjective and objective cure rates compared with the retropubic TVT procedure. Three serious adverse events occurred in the TVT Secur group. We therefore discourage further use of TVT Secur.

A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

PubMed

Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

2011-01-01

A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

Magnesium Sulfate Reduced Opioid Consumption in Obese Patients Undergoing Sleeve Gastrectomy: a Prospective, Randomized Clinical Trial.

PubMed

Kizilcik, Nurcan; Koner, Ozge

2018-05-12

The purpose of the study was to investigate the effect of magnesium sulfate on pain management for pain after sleeve gastrectomy operation. A prospective, randomized, placebo-controlled clinical study. University hospital. Eighty patients undergoing sleeve gastrectomy. Visual analog scale for the evaluation of pain, sedation score, mean arterial pressure, heart rate, and total analgesic consumption was recorded. Serum magnesium levels were determined before the operation, at the end of the operation, and at 24 h. There were no significant differences between the groups with respect to demographics, and sedation scores. Cumulative morphine consumption and pain scores were found to be higher in the control group than the magnesium group. Perioperative use of magnesium sulfate reduced postoperative pain and opioid consumption in obese patients undergoing sleeve gastrectomy operations.

The efficacy of surgical drainage in cervicofacial rhytidectomy: a prospective, randomized, controlled trial.

PubMed

Jones, Barry M; Grover, Rajiv; Hamilton, Stephen

2007-07-01

Postoperative drainage is often used instinctively in face lifting on the assumption that it may reduce the likelihood of complications. This potential benefit should be balanced against cost, discomfort, and the possibility of provoking bleeding and hematoma on removal. Evidence-based decisions on drainage are problematic, since no prospective studies have examined its role. This study was designed to address this issue directly. Fifty consecutive patients undergoing face lift over a 3-month period were randomized to drainage of one side of the face only, with the contralateral side serving as a paired control. Bruising, swelling, and hematoma or seroma were assessed objectively, independently of the operating surgeon and subjectively by the patients. Postoperative hematoma and edema were not influenced by the use of drains (p > 0.5). Patients reported no difference between the two sides with respect to swelling (p = 0.6) or discomfort (p = 0.5). However, drains produced a statistically significant reduction in postoperative bruising both on clinical assessment (p = 0.005) and patient assessment (p = 0.002). This article represents the first prospective, randomized, controlled trial assessing the use of postoperative drainage in facial rejuvenation surgery. Surgical drains do not influence postoperative complications, but they do significantly reduce bruising and so may facilitate the patient's return to normal activity.

A random urine test can identify patients at risk of mesalamine non-adherence: a prospective study.

PubMed

Gifford, Anne E; Berg, Anders H; Lahiff, Conor; Cheifetz, Adam S; Horowitz, Gary; Moss, Alan C

2013-02-01

Mesalamine non-adherence is common among patients with ulcerative colitis (UC), and can be difficult to identify in practice. We sought to determine whether a random urine test for salicylates could be used as a marker of 5-aminosalicylic acid (5-ASA) ingestion and identify patients at risk of non-adherence. Our aim is to determine whether measurement of salicylates in a random urine sample correlates with 5-ASA levels, and predicts an individual's risk of mesalamine non-adherence. Prospective observational study. Urinary salicylates (by colorimetry) and 5-ASA (by liquid chromatography and tandem-mass spectrometry) were measured in a random urine sample at baseline in patients and controls. Mesalamine adherence was quantified by patient self-reports at enrollment and pharmacy refills of mesalamine over 6 months. A total of 93 patients with UC taking mesalamine maintenance therapy were prospectively enrolled from the clinic. Random urine salicylate levels (by colorimetry) were highly correlated with urine 5-ASA metabolite levels (by mass spectrometry; R2=0.9). A random urine salicylate level above 15 mg/dl distinguished patients who had recently taken mesalamine from controls (area under the curve value 0.9, sensitivity 95%, specificity 77%). A significant proportion of patients (27%) who self-identified as "high adherers" by an adherence questionnaire (Morisky Medication Adherence Scale-8) had random levels of urine salicylate below this threshold. These patients were at higher risk of objectively measured non-adherence to mesalamine over the subsequent 6 months (RR: 2.7, 95% CI: 1.1-7.0). A random urine salicylate level measured in the clinic can identify patients who have not recently taken mesalamine, and who are at higher risk of longitudinal non-adherence. This test could be used to screen patients who may warrant interventions to improve adherence and prevent disease relapse.

Cardiac effects of granisetron in a prospective crossover randomized dose comparison trial.

PubMed

Cakir, F B; Yapar, O; Canpolat, C; Akalin, F; Berrak, S G

2012-10-01

Cardiac side effects of granisetron have been studied mostly in adult patients that are using cardiotoxic chemotherapeutics. There is limited evidence in pediatric age group and no information in pediatric oncology patients with non-cardiotoxic chemotherapeutics. In this prospective, crossover randomized study, the cardiac side effects of granisetron are compared in pediatric oncology patients who had carboplatin based chemotherapy. They were randomized to receive either 10 or 40 μg kg(-1) dose(-1) of granisetron before each cycle of chemotherapy. We drew blood for creatine phosphokinase (CPK), CPK-muscle band (MB) and Troponin-T before and 24 h after administering granisetron. Electrocardiography (ECG) tracings were taken at 0, 1, 2, 3, 6 and 24 h of granisetron. Twenty-four hours Holter ECG monitorisation was performed after each granisetron infusion. A total of 16 patients (median 8.7 years of age) were treated with weekly consecutive courses of carboplatin. There was bradycardia (p = 0.000) in patients that had granisetron at 40 μg/kg and PR interval was shortened in patients that had granisetron at 10 μg/kg dose (p = 0.021). At both doses of granisetron, QTc interval and dispersion were found to be similar. CPK, CK-MB and Troponin-T values were found to be normal before and 24 h after granisetron infusion. As the first study that has studied cardiac side effects of granisetron in patients that are not using cardiotoxic chemotherapeutics, we conclude that granisetron at 40 μg kg(-1) dose(-1) causes bradycardia only. We have also demonstrated that granisetron does not cause any clinically cardiac side effects either at 10 or 40 μg kg(-1) dose(-1). However, our results should be supported by prospective randomized studies with larger samples of patient groups.

A comparison of septal stapler to suture closure in septoplasty: a prospective, randomized trial evaluating the effect on operative time.

PubMed

Sowerby, Leigh J; Wright, Erin D

2013-11-01

Septoplasty requires coaptation of the mucosal flaps at the conclusion of the procedure; classically this is done with nasal packing. Quilting sutures provide a welcome alternative to packing, but can be time-consuming to place. A septal stapler has recently been developed that provides a rapid alternative to quilting sutures but the timesaving has not been quantified. This study was a prospective, randomized trial comparing a septal stapler to quilting suture for coaptation of mucosal flaps in septoplasty. After meeting inclusion criteria, patients underwent septoplasty and inferior turbinoplasty. The total operative time, surgical segment times, including time for closure was recorded. Preoperative and postoperative Nasal Obstruction Symptom Evaluation (NOSE) scores were recorded. A sample size of 16 was determined to detect a difference of 5 minutes in closure time. A total of 16 patients were enrolled in the study. The mean time for closure with septal stapler was 35 ± 22 seconds vs 7 minutes ± 1 minute 10 seconds for suture closure (p < 0.0001). The mean total operative time using the septal stapler was 28 minutes ± 6 minutes whereas 43 minutes ± 13 minutes was required for suture (p = 0.014). No difference in postoperative complications or mucosal healing was seen; preoperative and postoperative improvement in NOSE scores was comparable. Coaptation of the mucosal flaps in septoplasty with a septal stapler affords a timesaving in the operating room with no difference in operative outcome. © 2013 ARS-AAOA, LLC.

Open versus percutaneous repair in the treatment of acute Achilles tendon rupture: a randomized prospective study.

PubMed

Gigante, A; Moschini, A; Verdenelli, A; Del Torto, M; Ulisse, S; de Palma, L

2008-02-01

There is no agreement on the ideal type of surgical management for Achilles tendon rupture. The present randomized prospective study was performed to compare outcome data of open and percutaneous repair in the treatment of Achilles tendon rupture. Forty consecutive patients with acute rupture of Achilles tendon were recruited. Patients were randomized to receive open (group A) or percutaneous repair with Tenolig (group B). All patients followed the same rehabilitation protocol except for slight differences in the duration of immobilization. Follow-up included objective evaluation (at 4 and 12 months), subjective evaluation using the SF-12 questionnaire (at 24 months), and bilateral ultrasound scanning and isokinetic testing (at 12 months). The differences in the parameters evaluated clinically were not significant except for ankle circumference, which was significantly greater in group B. There were two minor complications in the open repair group and one case of failed repair in the percutaneous group. SF-12 questionnaire, ultrasound and isokinetic test data did not show significant differences between the groups. The present study demonstrates that the open and the percutaneous technique are both safe and effective in repairing the ruptured Achilles tendon and that both afford the same degree of restoration of clinical, ultrasound and isokinetic patterns. Medium-term results were substantially comparable. Percutaneous repair is performed on a day-surgery basis, it reduces cutaneous complications and operation times, and enables faster recovery, enhancing overall patient compliance. To us, these characteristics make it preferable to open repair in managing subcutaneous ruptures of Achilles tendon in non-professional sports practicing adults.

Physical therapy after prophylactic mastectomy with breast reconstruction: a prospective randomized study.

PubMed

Unukovych, Dmytro; Johansson, Hemming; Johansson, Elizabeth; Arver, Brita; Liljegren, Annelie; Brandberg, Yvonne

2014-08-01

The rate of prophylactic mastectomies (PM) is increasing. Patients generally report high levels of health related quality of life and satisfaction after the procedure, whereas body image perception and sexuality may be negatively affected. The aim of the study was to evaluate the interest in physical therapy as a means of improving body image and sexuality in women after PM. Patients undergoing PM at Karolinska University Hospital between 2006 and 2010 were eligible. The following patient-reported outcome measures were used at study baseline and 2 years postoperatively: the body image scale (BIS), the sexual activity questionnaire (SAQ), the short-form health survey (SF-36), the hospital anxiety and depression scale (HAD), and a study specific "pain/motion/sensation scale". Out of 125 patients invited to participate in this prospective randomized study, 43 (34%) consented and were randomized into the intervention (n = 24, 56%) or control (n = 19, 44%) groups. There were no statistically significant between-group differences found with respect to BIS, SAQ, SF-36, HAD, and "pain/motion/sensation". Two years postoperatively, more than half of the patients in both groups reported problems like feeling less attractive, less sexually attractive, their body feeling less whole, and being dissatisfied with their body. A majority marked a decreased sensation in breast area. The interest in a physiotherapy intervention was limited among women who had undergone PM. The intervention did not show any substantial effects. A large proportion of patients reported specific body image related and pain/motion/sensation problems postoperatively. Copyright © 2014 Elsevier Ltd. All rights reserved.

A comparative, prospective, and randomized study of two conservative treatment protocols for first-episode lateral ankle ligament injuries.

PubMed

Prado, Marcelo Pires; Mendes, Alberto Abussamra Moreira; Amodio, Daniel Tasseto; Camanho, Gilberto Luis; Smyth, Niall A; Fernandes, Tulio Diniz

2014-03-01

The objective of this study was to investigate functional results, the amount of time that patients missed from regular working activities, and the incidence of residual mechanical ankle instability following conservative treatment of a first episode of severe lateral ankle ligament sprain (with articular instability). This prospective and randomized study included 186 patients with severe lateral ankle ligament injuries, who were randomly assigned into 2 conservative treatment groups. In group A, participants were treated with a walking boot with weight-bearing allowed, pain management, ice, and elevation with restricted joint mobilization for 3 weeks. In group B, patients were treated with a functional brace for 3 weeks. After this period, patients from both groups were placed in a short, functional brace for an additional 3 weeks, during which they also started a rehabilitation program. No statistically significant difference was found in pain intensity score between the 2 groups; however, functional evaluations based on the AOFAS ankle and hindfoot score system showed a statistically significant improvement in the group treated with the functional brace. In addition, the average recovery period necessary for patients of group B to resume their duties was shorter than that for patients in group A. No significant difference was detected in residual mechanical ankle instability between the 2 groups. Patients with severe lateral ankle ligament lesions treated with a functional brace were shown to exhibit somewhat better results than those treated with a walking boot, and both methods presented a very low incidence of residual chronic instability. We found adequate conservative treatment was sufficient to reestablish ankle stability and that functional treatment had a marginally better clinical short-term outcome with a shorter average recovery period. Level I, prospective randomized study.

A prospective randomized cohort study evaluating 3 weeks vs 6 weeks of oral antibiotic treatment in the setting of "maximal medical therapy" for chronic rhinosinusitis.

PubMed

Sreenath, Satyan B; Taylor, Robert J; Miller, Justin D; Ambrose, Emily C; Rawal, Rounak B; Ebert, Charles S; Senior, Brent A; Zanation, Adam M

2015-09-01

Surprisingly, little literature exists evaluating the optimal duration of antibiotic treatment in "maximal medical therapy" for chronic rhinosinusitis (CRS). As such, we investigated whether 3 weeks vs 6 weeks of antibiotic therapy resulted in significant differences in clinical response. A prospective, randomized cohort study was performed with patients assigned to 3-week or 6-week cohorts. Our primary outcome was failure of "maximal medical therapy" and surgical recommendation. Secondary outcomes included changes in pretherapy and posttherapy scores for the Rhinosinusitis Disability Index (RSDI), Chronic Sinusitis Survey (CSS), and computed tomography (CT)-based Lund-Mackay (LM) evaluation. Analyses were substratified based on presence of nasal polyps. Forty patients were randomized to the 3-week or 6-week treatment cohorts, with near-complete clinical follow-up achieved. No significant difference was found between the proportion of patients who failed medical therapy and were deemed surgical candidates between the 2 cohorts (71% vs 68%, p = 1.000). No significant difference was found in the change of RSDI or CSS scores in the 3 vs 6 weeks of treatment groups (mean ± standard error of the mean [SEM]; RSDI: 9.62 ± 4.14 vs 1.53 ± 4.01, p = 0.868; CSS: 5.75 ± 4.36 vs 9.65 ± 5.34, p = 0.573). Last, no significant difference was found in the change of LM scores (3.35 ± 1.11 vs 1.53 ± 0.81, p = 0.829). Based on this data, there is little difference in clinical outcomes between 3 weeks vs 6 weeks of antibiotic treatment as part of "maximal medical therapy" for CRS. Increased duration of antibiotic treatment theoretically may increase risk from side effects and creates higher healthcare costs. © 2015 ARS-AAOA, LLC.

Drain placement can safely be omitted for open partial nephrectomy: Results from a prospective randomized trial.

PubMed

Kriegmair, Maximilian C; Mandel, Philipp; Krombach, Patrick; Dönmez, Hasan; John, Axel; Häcker, Axel; Michel, Maurice S

2016-05-01

To examine the benefit of drain placement during open partial nephrectomy. Overall, 106 patients treated with open partial nephrectomy were enrolled in a prospective randomized trial. Based on the randomization, a drain was placed or omitted. Complications were assessed according to the Clavien classification. Pain level and requirement for analgesics was evaluated according to a customized pattern. There was no significant difference in the two groups regarding age, body mass index, American Society of Anesthesiologists score, tumor size and nephrometry (preoperative aspects and dimensions used for an anatomical classification). In terms of overall and drain-related complications, no advantage of placing a drain could be proven (P = 0.249). Patients with a drain suffered from a significantly higher pain level (P = 0.01) and showed prolonged mobilization (P < 0.001). There was no difference in bowel movements and requirement of additional analgesics (P = 0.347 and 0.11). The results of the study suggest that drain placement during open partial nephrectomy can safely be omitted, even in cases with violation of the collecting system. © 2016 The Japanese Urological Association.

Prevention of sternal wound complications after sternotomy: results of a large prospective randomized multicentre trial†

PubMed Central

Gorlitzer, Michael; Wagner, Florian; Pfeiffer, Steffen; Folkmann, Sandra; Meinhart, Johann; Fischlein, Theodor; Reichenspurner, Hermann; Grabenwoeger, Martin

2013-01-01

OBJECTIVES A prospective randomized multicentre trial was performed to analyse the efficacy of a vest (Posthorax support vest®) to prevent sternal wound infection after cardiac surgery, and to identify risk factors. METHODS From September 2007 to March 2010, 2539 patients undergoing cardiac surgery via median sternotomy were prospectively randomized into those who received a Posthorax® vest and those who did not. Patients were instructed to wear the vest postoperatively for 24 h a day for at least 6 weeks; the duration of follow-up was 90 days. Patients who did not use the vest within a period of 72 h postoperatively were regarded as study dropouts. Statistical calculations were based on an intention-to-treat (ITT) analysis. Further evaluations comprised all subgroups of patients. RESULTS Complete data were available for 2539 patients (age 67 ± 11years, 45% female). Of these, 1351 were randomized to receive a vest, while 1188 received no vest. No significant differences were observed between groups regarding age, gender, diabetes, body mass index, chronic obstructive pulmonary disease (COPD), renal failure, the logistic EuroSCORE and the indication for surgery. The frequency of deep wound complications (dWC: mediastinitis and sternal dehiscence) was significantly lower in vest (n = 14; 1.04%) vs non-vest (n = 27; 2.27%) patients (ITT, P < 0.01), but superficial complications did not differ between groups. Subanalysis of vest patients revealed that only 933 (Group A) wore the vest according to the protocol, while 202 (Group BR) refused to wear the vest (non-compliance) and 216 (Group BN) did not use the vest for other reasons. All dWC occurred in Groups BR (n = 7) and BN (n = 7), although these groups had the same preoperative risk profile as Group A. Postoperatively, Group BN had a prolonged intubation time, a longer stay in the intensive care unit, greater use of intra-aortic balloon pump, higher frequency of COPD and a larger percentage of patients who

Effects of specific alpha-1A/1D blocker on lower urinary tract symptoms due to double-J stent: a prospectively randomized study.

PubMed

Wang, Chung-Jing; Huang, Shi-Wei; Chang, Chien-Hsing

2009-06-01

The aim of our study was to evaluate the effect of tamsulosin in improving symptoms in patients with indwelling double-J ureteral stents. This prospective study lasted from April 2006 to March 2008. All the patients with symptomatic lower ureteral stones with <15 mm diameter were enrolled, and were prospectively randomized (random numbers table) into two groups. A total of 154 patients, with insertion of a double-J ureteral stent after ureteroscopic stone removal. In group 1, 75 patients were enrolled and received placebo for 2 weeks. Group 2 included 79 patients who received 0.4 mg of tamsulosin, once daily for 2 weeks. All patients completed the validated ureteral stent symptom questionnaire (USSQ) and quality of life of international prostate symptom scale (IPSS) for evaluating the symptoms of double-J stents and quality of life after double-J stent insertion and removal, respectively. The analysis of the questionnaire at W1 revealed a significant difference in the main score index of urinary symptoms, body pain and general health between groups 1 and 2. When comparing W1 evaluation with that of W4 after double-J removal, both groups showed significant worsening of urinary symptoms, body pain, general health and work performance, except sexual performance. The mean score of quality of life in IPSS was 4.21 in group 1 and 1.6 in group 2. Tamsulosin can improve a subset of stent-related urinary symptoms and quality of life effectively and may be applied in routine clinical practice.

Parecoxib sodium pretreatment reduces myoclonus after etomidate: A prospective, double-blind, randomized clinical trial
.

PubMed

Li, Xiuze; Liu, Jun; Zhou, Mengjun; Zhou, Chaojing

2017-07-01

Myoclonus induced by etomidate during induction of general anesthesia is a common phenomenon. This prospective, randomized, saline-controlled clinical study was performed to evaluate the effect of parecoxib sodium pretreatment on the incidence and severity of etomidate-induced myoclonus. 60 patients, American Society of Anesthesiologists (ASA) physical status I or II, aged 20 to 60 years, who were scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia, were allocated randomly into one of two groups to receive parecoxib sodium 40 mg intravenous (group P, n = 30) or the same volume of saline (group S, n = 30) 30 minutes before administration of etomidate (0.3 mg/kg). Myoclonus was assessed on a scale of 0 - 3. Postoperative side effects were recorded. The two groups were comparable with regard to baseline characteristics. The incidence of myoclonus was significantly lower in the parecoxib sodium group (11/30; 37%) than in the saline group (21/30; 70%) (p < 0.05). The severity of myoclonic movements was also significantly reduced by parecoxib sodium (p < 0.05). There were no significant differences between the two groups with respect to postoperative side effects. Pretreatment with intravenous injection of parecoxib sodium 40 mg significantly reduced the incidence and severity of etomidate-induced myoclonus without significant side effects.
.

Comparison of Suction Versus Nonsuction Drainage After Lung Resections: A Prospective Randomized Trial.

PubMed

Gocyk, Wojciech; Kużdżał, Jarosław; Włodarczyk, Janusz; Grochowski, Zbigniew; Gil, Tomasz; Warmus, Janusz; Kocoń, Piotr; Talar, Piotr; Obarski, Piotr; Trybalski, Łukasz

2016-10-01

Sufficiently large, prospective randomized trials comparing suction drainage and nonsuction drainage are lacking. The aim of the present study was to compare the effects of suction drainage and nonsuction drainage on the postoperative course in patients who have undergone lung resection. This prospective, randomized trial included patients undergoing different types of lung resections. On the day of surgery, suction drainage at -20 cm H2O was used. On the morning of the first postoperative day, patients, in whom the pulmonary parenchyma was fully reexpanded, were randomized in the ratio of 1:1. Patients assigned to group A continued with suction drainage, while those assigned to group B underwent nonsuction drainage. The study included 254 patients, with 127 patients in each group. The drainage volumes were 1098.8 mL and 814.4 mL in groups A and B, respectively (p = 0.0014). The times to chest tube removal were 5.61 days and 4.49 days in groups A and B, respectively (p = 0.0014). Prolonged air leakage occurred in 5.55% of patients in group A and in 0.7% of patients in group B (p = 0.032), and asymptomatic residual air spaces were noted in 0.8% of patients in group A and 9.4% of patients in group B (p = 0.0018). Nonsuction drainage is more effective than suction drainage with regard to drainage volume, drainage duration, and incidence of persistent air leakage. However, it is associated with a higher incidence of asymptomatic residual air spaces. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Unilateral versus bilateral neck exploration for primary hyperparathyroidism: a prospective randomized controlled trial.

PubMed

Bergenfelz, Anders; Lindblom, Pia; Tibblin, Sten; Westerdahl, Johan

2002-11-01

To compare unilateral and bilateral neck exploration for primary hyperparathyroidism in a prospective randomized controlled trial. Based on the assumption that unilateral neck exploration for a solitary parathyroid adenoma should reduce operating time and morbidity, a variety of minimally invasive procedures have challenged the idea that bilateral neck exploration is the gold standard for the surgical treatment of primary hyperparathyroidism. However, to date, no open prospective randomized trial has been published comparing unilateral and bilateral neck exploration. Ninety-one patients with the preoperative diagnosis of primary hyperparathyroidism were randomized to unilateral or bilateral neck exploration. Preoperative scintigraphy and intraoperative parathyroid hormone measurement guided the unilateral exploration. Gross morphology and frozen section determined the extent of parathyroid tissue resection in the bilateral group. The primary end-point was the use of postoperative medication for hypocalcemic symptoms. Eighty-eight patients (97%) were cured. Histology and cure rate did not differ between the two groups. Patients in the bilateral group consumed more oral calcium, had lower serum calcium values on postoperative days 1 to 4, and had a higher incidence of early severe symptomatic hypocalcemia compared with patients in the unilateral group. In addition, for patients undergoing surgery for a solitary parathyroid adenoma, unilateral exploration was associated with a shorter operative time. The cost for the two procedures did not differ. Patients undergoing a unilateral procedure had a lower incidence of biochemical and severe symptomatic hypocalcemia in the early postoperative period compared with patients undergoing bilateral exploration. Unilateral neck exploration with intraoperative parathyroid hormone assessment is a valid surgical strategy in patients with primary hyperparathyroidism with distinct advantages, especially for patients with solitary

[Non-randomized evaluation studies (TREND)].

PubMed

Vallvé, Carles; Artés, Maite; Cobo, Erik

2005-12-01

Nonrandomized intervention trials are needed when randomized clinical trials cannot be performed. To report the results from nonrandomized intervention studies transparently, the TREND (Transparent Reporting of Evaluations with Nonrandomized Designs) checklist should be used. This implies that nonrandomized studies should follow the remaining methodological tools usually employed in randomized trials and that the uncertainty introduced by the allocation mechanism should be explicitly reported and, if possible, quantified.

Immediate mobilization following fixation of mandible fractures: a prospective, randomized study.

PubMed

Kaplan, B A; Hoard, M A; Park, S S

2001-09-01

To compare outcomes of open reduction and internal fixation of displaced mandible fractures followed by either immediate mobilization or 2 weeks of mandibular-maxillary fixation. A prospective, randomized, single-blinded study was performed. The study was performed between January 1, 1997, and March 30, 2000. Inclusion criteria were displaced fractures between the mandibular angles, age greater than 16 years, and no involvement of the alveolus, ramus, condyles, or maxilla. All fractures were repaired by means of open reduction and internal fixation using 2.0-mm titanium plates secured either in transoral fashion or percutaneously. Data were collected at 6-week and 3- and 6-month postoperative examinations. Variables were assessed by a surgeon blinded to the history of immobilization and included pain, malunion or nonunion, occlusion, trismus, wound status, infection rates, dental hygiene, and weight loss. Twenty-nine consecutive patients were enrolled, 16 patients to immediate function and 13 patients to 2 weeks of mandibular-maxillary fixation. No statistically significant differences were found between groups for any of the variables. Immediate release and temporary immobilization showed mean weight loss of 10 and 8 pounds and trismus of 4.2 and 4.6 cm, respectively. One wound separation and one infection were seen in the immobilization population, and no wound separation or infection was seen in the immediate-release group. Dental hygiene was similar between the groups. No malunion or nonunion was noted in either group. In this prospective and randomized study, no significant differences were noted between the groups receiving either immediate release or 2 weeks of mandibular-maxillary fixation. The findings support the treatment of selective mandible fractures with 2.0-mm miniplates and immediate mobilization.

Evaluation of the Efficacy of Tranexamic Acid on the Surgical Field in Primary Cleft Palate Surgery on Children-A Prospective, Randomized Clinical Study.

PubMed

Durga, Padmaja; Raavula, Parvathi; Gurajala, Indira; Gunnam, Poojita; Veerabathula, Prardhana; Reddy, Mukund; Upputuri, Omkar; Ramachandran, Gopinath

2015-09-01

To assess the effect of tranexamic acid on the quality of the surgical field. Prospective, randomized, double-blind study. Institutional, tertiary referral hospital. American Society of Anesthesiologists physical status class I patients, aged 8 to 60 months with Group II or III (Balakrishnan's classification) clefts scheduled for cleft palate repair. Children were randomized into two groups. The control group received saline, and the tranexamic acid group received tranexamic acid 10 mg/kg as a bolus, 15 minutes before incision. Grade of surgical field on a 10-point scale, surgeon satisfaction, and primary hemorrhage. Significant improvements were noted in surgeon satisfaction and median grade of assessment of the surgical field (4 [interquartile range, 4 to 6] in the control group vs. 3 [interquartile range, 2 to 4] in the test group; P = .003) in the tranexamic acid group compared to the control group. Preincision administration of 10 mg/kg of tranexamic acid significantly improved the surgical field during cleft palate repair.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses.

PubMed

Khankari, Nikhil K; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I; Easton, Douglas; Eeles, Rosalind A; Gruber, Stephen B; Haiman, Christopher A; Hunter, David J; Chanock, Stephen J; Pierce, Brandon L; Zheng, Wei

2016-09-01

Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the risk of these cancers.

Association between Adult Height and Risk of Colorectal, Lung, and Prostate Cancer: Results from Meta-analyses of Prospective Studies and Mendelian Randomization Analyses

PubMed Central

Khankari, Nikhil K.; Shu, Xiao-Ou; Wen, Wanqing; Kraft, Peter; Lindström, Sara; Peters, Ulrike; Schildkraut, Joellen; Schumacher, Fredrick; Bofetta, Paolo; Risch, Angela; Bickeböller, Heike; Amos, Christopher I.; Easton, Douglas; Gruber, Stephen B.; Haiman, Christopher A.; Hunter, David J.; Chanock, Stephen J.; Pierce, Brandon L.; Zheng, Wei

2016-01-01

Background Observational studies examining associations between adult height and risk of colorectal, prostate, and lung cancers have generated mixed results. We conducted meta-analyses using data from prospective cohort studies and further carried out Mendelian randomization analyses, using height-associated genetic variants identified in a genome-wide association study (GWAS), to evaluate the association of adult height with these cancers. Methods and Findings A systematic review of prospective studies was conducted using the PubMed, Embase, and Web of Science databases. Using meta-analyses, results obtained from 62 studies were summarized for the association of a 10-cm increase in height with cancer risk. Mendelian randomization analyses were conducted using summary statistics obtained for 423 genetic variants identified from a recent GWAS of adult height and from a cancer genetics consortium study of multiple cancers that included 47,800 cases and 81,353 controls. For a 10-cm increase in height, the summary relative risks derived from the meta-analyses of prospective studies were 1.12 (95% CI 1.10, 1.15), 1.07 (95% CI 1.05, 1.10), and 1.06 (95% CI 1.02, 1.11) for colorectal, prostate, and lung cancers, respectively. Mendelian randomization analyses showed increased risks of colorectal (odds ratio [OR] = 1.58, 95% CI 1.14, 2.18) and lung cancer (OR = 1.10, 95% CI 1.00, 1.22) associated with each 10-cm increase in genetically predicted height. No association was observed for prostate cancer (OR = 1.03, 95% CI 0.92, 1.15). Our meta-analysis was limited to published studies. The sample size for the Mendelian randomization analysis of colorectal cancer was relatively small, thus affecting the precision of the point estimate. Conclusions Our study provides evidence for a potential causal association of adult height with the risk of colorectal and lung cancers and suggests that certain genetic factors and biological pathways affecting adult height may also affect the

Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study.

PubMed

Postgate, Aymer; Tekkis, Paris; Patterson, Neil; Fitzpatrick, Aine; Bassett, Paul; Fraser, Chris

2009-05-01

Capsule endoscopy (CE) is limited by incomplete small-bowel transit and poor view quality in the distal bowel. Currently, there is no consensus regarding the use of bowel purgatives or prokinetics in CE. To evaluate the usefulness of bowel purgatives and prokinetics in small-bowel CE. Prospective single-blind randomized controlled study. Academic endoscopy unit. A total of 150 patients prospectively recruited. Patients were randomized to 1 of 4 preparations: "standard" (fluid restriction then nothing by mouth 12 hours before the procedure, water and simethicone at capsule ingestion [S]); "standard" + 10 mg oral metoclopramide before the procedure (M); Citramag + senna bowel-purgative regimen the evening before CE (CS); Citramag + senna + 10 mg metoclopramide before the procedure (CSM). Gastric transit time (GTT) and small-bowel transit time (SBTT), completion rates (CR), view quality, and patient acceptability. positive findings, diagnostic yield. No significant difference was noted among groups for GTT (median [minutes] M, CS, and CSM vs S: 17.3, 24.7, and 15.1 minutes vs 16.8 minutes, respectively; P = .62, .18, and .30, respectively), SBTT (median [minutes] M, CS, and CSM vs S: 260, 241, and 201 vs 278, respectively; P = .91, .81, and .32, respectively), or CRs (85%, 85%, and 88% vs 89% for M, CS, and CSM vs S, respectively; P = .74, .74, and 1.00, respectively). There was no significant difference in view quality among groups (of 44: 38, 37, and 40 vs 37 for M, CS, and CSM, vs S, respectively; P = .18, .62, and .12, respectively). Diagnostic yield was similar among the groups. CS and CSM regimens were significantly less convenient (P < .001), and CS was significantly less comfortable (P = .001) than standard preparation. Bowel purgatives and prokinetics do not improve CRs or view quality at CE, and bowel purgatives reduce patient acceptability.

Evaluation of intradermal absorbable and mattress sutures to close pilonidal sinus wounds with Limberg flap: a prospective randomized comparative study.

PubMed

Çetin, Kenan; Sikar, Hasan Ediz; Kocaoğlu, Aytaç Emre; Kündeş, Muhammet Fikri; Karahan, Mehmet; Kaptanoğlu, Levent

2018-02-01

We aimed to compare skin closure techniques, standard (intermittent mattress) and continuous subcuticular sutures, following Limberg flap procedure. From July 2013 to July 2015, 92 patients with sacrococcygeal pilonidal disease were prospectively randomized into 2 groups consisting of 46 patients for both. Patients underwent sinus excision and closure with Limberg flap; continuous subcuticular suture was used in subcuticular group (SG) and intermittent mattress sutures were used in mattress group (MG) for skin closure. Characteristics of patients, features of pilonidal disease, macerations, infections, wound dehiscence, flap necrosis, operation time, time of drain removal, wound complications, early recurrences, and time till return to work were compared between the 2 groups. There was no statistical difference between groups per sex, age, body mass index, smoking, number of sinuses, depth of intergluteal sulcus, distance of incision to anus, volume of extracted tissue, number of hair follicles per cm 2 , recurrence, operation, and mean follow-up time. Two patients showed signs of wound complications (4.4%) in SG, whereas 8 cases (17.4%) showed signs in MG (P < 0.05). One patient in SG had surgical site infection and required antibiotics (2.2%), where as there were 6 cases treated in MG (13.0%) (P < 0.05). Removal of drain tube, and time till return to work rates are lower for SG than MG (P < 0.05). In conclusion, surgical procedures which include Limberg flap method and subcuticular closure may reduce infection and maceration rates. Future studies are needed to achieve greater detailed evaluation.

Hyperbaric Oxygen Therapy Can Improve Post Concussion Syndrome Years after Mild Traumatic Brain Injury - Randomized Prospective Trial

PubMed Central

Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Background Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. Methods and Findings The trial population included 56 mTBI patients 1–5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. “Mindstreams” was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. Conclusions HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. Trial Registration ClinicalTrials.gov NCT00715052 PMID:24260334

Hyperbaric oxygen therapy can improve post concussion syndrome years after mild traumatic brain injury - randomized prospective trial.

PubMed

Boussi-Gross, Rahav; Golan, Haim; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

2013-01-01

Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. The trial population included 56 mTBI patients 1-5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. "Mindstreams" was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. ClinicalTrials.gov NCT00715052.

Hospital cost analysis of a prospective, randomized trial of early vs interval appendectomy for perforated appendicitis in children.

PubMed

Myers, Adrianne L; Williams, Regan F; Giles, Kim; Waters, Teresa M; Eubanks, James W; Hixson, S Douglas; Huang, Eunice Y; Langham, Max R; Blakely, Martin L

2012-04-01

The methods of surgical care for children with perforated appendicitis are controversial. Some surgeons prefer early appendectomy; others prefer initial nonoperative management followed by interval appendectomy. Determining which of these two therapies is most cost-effective was the goal of this study. We conducted a prospective, randomized trial in children with a preoperative diagnosis of perforated appendicitis. Patients were randomized to early or interval appendectomy. Overall hospital costs were extracted from the hospital's internal cost accounting system and the two treatment groups were compared using an intention-to-treat analysis. Nonparametric data were reported as median ± standard deviation (or range) and compared using a Wilcoxon rank sum test. One hundred thirty-one patients were randomized to either early (n = 64) or interval (n = 67) appendectomy. Hospital charges and costs were significantly lower in patients randomized to early appendectomy. Total median hospital costs were $17,450 (range $7,020 to $55,993) for patients treated with early appendectomy vs $22,518 (range $4,722 to $135,338) for those in the interval appendectomy group. Median hospital costs more than doubled in patients who experienced an adverse event ($15,245 vs $35,391, p < 0.0001). Unplanned readmissions also increased costs significantly and were more frequent in patients randomized to interval appendectomy. In a prospective randomized trial, hospital charges and costs were significantly lower for early appendectomy when compared with interval appendectomy. The increased costs were related primarily to the significant increase in adverse events, including unplanned readmissions, seen in the interval appendectomy group. Copyright © 2012. Published by Elsevier Inc.

Effect of warming bupivacaine 0.5% on ultrasound-guided axillary plexus block. Randomized prospective double-blind study.

PubMed

Trabelsi, W; Ben Gabsia, A; Lebbi, A; Sammoud, W; Labbène, I; Kchelfi, S; Ferjani, M

2017-02-01

To evaluate the effect of warming bupivacaine 0.5% on ultrasound-guided axillary brachial plexus block. Prospective, randomized, double-blind. Eighty patients undergoing elective or emergency surgery beyond the distal third of the upper limb were divided into two groups of 40 patients: the warm group received 15mL bupivacaine 0.5% heated to 37°C; the cold group received 15mL 0.5% bupivacaine stored for at least 24hours in the lower compartment of a refrigerator at 13-15°C. Onset and duration of sensory and motor blocks were evaluated every 5minutes for 40minutes. Postoperative pain was evaluated at 1, 3, 6, 12 and 24hours. Effective analgesia time was recorded as the interval between anesthetic injection and the first analgesia requirement (VAS>30mm). Time to onset of sensory and motor block was significantly shorter in the warm group, and mean duration of sensory and motor block and of postoperative analgesia significantly longer. Warming bupivacaine 0.5% to 37°C accelerated onset of sensory and motor block and extended action duration. Copyright © 2016 Elsevier Masson SAS. All rights reserved.

A prospective, randomized study on the efficacy of tongue protector in patients with burning mouth syndrome.

PubMed

López-Jornet, P; Camacho-Alonso, F; Andujar-Mateos, P

2011-04-01

To apply a tongue protector with habit-modifying therapy through self-control, in the patients with burning mouth syndrome (BMS). A prospective, randomized study was made of 65 consecutive patients with BMS. Fifty subjects were randomized to two groups: group A (informed) and group B (informed and the application of a tongue protector). The symptoms were evaluated by VAS, whereas the psychological profile was assessed using the HAD, with application of the quality of life questionnaires SF-36 and OHIP-49. The duration of treatment was 2 months. Fifty patients (46 females and 4 males) completed the study. The VAS scores in group B were 8.2 at baseline and 4.5 after 2 months. The respective scores in group A were 7.1 and 5.6 - the differences between the two groups being significant (P < 0.001). In group B the OHIP-49 yielded lower scores for most of the scales, with significant differences vs group A. In group B the SF 36 yielded significant differences vs group A in physical role, bodily pain, general health and emotional role. Parafunctional traumatism of the tongue should be taken into account in the pathogenesis of BMS with a view to exploring new therapeutic options. © 2010 John Wiley & Sons A/S.

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

PubMed

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with

Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

PubMed Central

Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

1989-01-01

In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies. PMID:2529814

Randomized prospective study comparing vancomycin with teicoplanin in the treatment of infections associated with Hickman catheters.

PubMed

Smith, S R; Cheesbrough, J; Spearing, R; Davies, J M

1989-08-01

In 72 episodes of suspected or proven Hickman-catheter-associated infection occurring in 59 patients with various hematological disorders, patients were assigned to treatment with either vancomycin or teicoplanin in a randomized nonblinded prospective study. Of 60 episodes evaluable for response, 28 were treated with vancomycin and 32 were treated with teicoplanin. Sixteen infective episodes were microbiologically documented in the vancomycin group, and twenty-one were microbiologically documented in the teicoplanin group. Microbiologically and clinically documented infections treated with vancomycin had an 80% response rate, compared with a 69% response rate for those treated with teicoplanin (P = 0.316). Adverse events occurred in nine (25%) of the episodes in the vancomycin group, compared with three (8%) in the teicoplanin group (P = 0.044). Teicoplanin may provide an effective alternative to vancomycin in the treatment of Hickman-catheter-associated infection in patients with hematological malignancies.

Evaluating the Flipped Classroom: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Wozny, Nathan; Balser, Cary; Ives, Drew

2018-01-01

Despite recent interest in flipped classrooms, rigorous research evaluating their effectiveness is sparse. In this study, the authors implement a randomized controlled trial to evaluate the effect of a flipped classroom technique relative to a traditional lecture in an introductory undergraduate econometrics course. Random assignment enables the…

Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

PubMed

Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

2013-09-01

We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P < 0.05. One hundred comparative evaluations of pulmonary auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P < 0.0001). Compared with Littmann Cardiology III, auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

Prospective randomized trial: outcomes of SF₆ versus C₃F₈ in macular hole surgery.

PubMed

Briand, Sophie; Chalifoux, Emmanuelle; Tourville, Eric; Bourgault, Serge; Caissie, Mathieu; Tardif, Yvon; Giasson, Marcelle; Boivin, Jocelyne; Blanchette, Caty; Cinq-Mars, Benoit

2015-04-01

To compare macular hole (MH) closure and visual acuity improvement after vitrectomy using SF6 versus C3F8 gas tamponade. The secondary purposes were to report the cumulative incidence of cataract development at 1 year after MH surgery and the proportion of complications. Prospective, randomized study. Thirty-one patients were prospectively randomized to the SF6 group and 28 patients to the C3F8 group. Preoperative data included MH minimum diameter, Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA), cataract staging, and intraocular pressure (IOP) measurement. Postoperative data included optical coherence tomography confirmation of the closure at 6 weeks and 1 year, and ETDRS BCVA and cataract development/extraction, both 1 year after the MH surgery. Primary MH closure was achieved in 93.3% in the SF6 group and 92.9% in the C3F8 group. Mean ETDRS BCVA improved by 17.7 letters in the SF6 and 16.9 letters in the C3F8 group. The difference in cumulative incidence of cataract development and extraction between both groups was not statistically significant. Regardless of the dye used, similar results were achieved. Finally, the proportion of adverse events was similar in both groups. MH surgery with SF6 gas achieves results similar to C3F8 in terms of visual acuity improvement, MH closure, cataract development/extraction, and adverse events. Copyright © 2015 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Video on Diet Before Outpatient Colonoscopy Does Not Improve Quality of Bowel Preparation: A Prospective, Randomized, Controlled Trial.

PubMed

Rice, Sean C; Higginbotham, Tina; Dean, Melanie J; Slaughter, James C; Yachimski, Patrick S; Obstein, Keith L

2016-11-01

Successful outpatient colonoscopy (CLS) depends on many factors including the quality of a patient's bowel preparation. Although education on consumption of the pre-CLS purgative can improve bowel preparation quality, no study has evaluated dietary education alone. We have created an educational video on pre-CLS dietary instructions to determine whether dietary education would improve outpatient bowel preparation quality. A prospective randomized, blinded, controlled study of patients undergoing outpatient CLS was performed. All patients received a 4 l polyethylene glycol-based split-dose bowel preparation and standard institutional pre-procedure instructions. Patients were then randomly assigned to an intervention arm or to a no intervention arm. A 4-min educational video detailing clear liquid diet restriction was made available to patients in the intervention arm, whereas those randomized to no intervention did not have access to the video. Patients randomized to the video were provided with the YouTube video link 48-72 h before CLS. An attending endoscopist blinded to randomization performed the CLS. Bowel preparation quality was scored using the Boston Bowel Preparation Scale (BBPS). Adequate preparation was defined as a BBPS total score of ≥6 with all segment scores ≥2. Wilcoxon rank-sum and Pearson's χ 2 -tests were performed to assess differences between groups. Ninety-two patients were randomized (video: n=42; control: n=50) with 47 total video views being tallied. There were no demographic differences between groups. There was no statistically significant difference in adequate preparation between groups (video=74%; control=68%; P=0.54). The availability of a supplementary patient educational video on clear liquid diet alone was insufficient to improve bowel preparation quality when compared with standard pre-procedure instruction at our institution.

Proof Construction and Evaluation Practices of Prospective Mathematics Educators

ERIC Educational Resources Information Center

Imamoglu, Yesim; Togrol, Aysenur Yontar

2015-01-01

This study was conducted with 93 freshmen and 82 senior prospective mathematicians and mathematics teachers in order to investigate how they construct and evaluate proofs and whether there are any significant differences in their proof construction (with respect to department and grade) and proof evaluation (with respect to department)…

Design and application of nickel-titanium olecranon memory connector in treatment of olecranon fractures: a prospective randomized controlled trial.

PubMed

Chen, Xiao; Liu, Peng; Zhu, Xiaofei; Cao, Liehu; Zhang, Chuncai; Su, Jiacan

2013-06-01

We carried out this study to test the efficacy of the olecranon memory connector (OMC) in olecranon fractures. We designed a prospective randomised controlled trial involving 40 cases of olecranon fractures. From May 2004 to December 2009, 40 patients with olecranon fractures were randomly assigned into two groups. Twenty patients were treated with OMC, while another 20 patients were fixed with locking plates in our hospital. The DASH score, MEP score, range of motion and radiographs were used to evaluate the postoperative elbow function and complications. For MEP score, OMC was better than the locking plate; for DASH score, complication rate, and range of elbow motion, the two methods presented no significant difference. The study showed that OMC could be an effective alternative to treat olecranon fractures.

Arthroscopic versus mini-open rotator cuff repair: a prospective, randomized study with 24-month follow-up.

PubMed

Zhang, Zhenxiang; Gu, Beibei; Zhu, Wei; Zhu, Lixian; Li, Qingsong

2014-08-01

This prospective, randomized study was performed to evaluate the results of mini-open and arthroscopic rotator cuff repair in a comparative case series of patients followed for 24 months. A total of 125 patients were randomized to mini-open (Group I) or arthroscopic (Group II) rotator cuff repair at the time of surgical intervention. The University of California Los Angeles (UCLA) score, the American Shoulder and Elbow Surgeons (ASES) index, and muscle strength were measured to evaluate the clinical results, while magnetic resonance arthrography was used at 24-month follow-up to investigate the postoperative rotator cuff integrity. Fifty-three patients in Group I and 55 patients in Group II were available for evaluation at 24-month follow-up. At 24-month follow-up, the UCLA score, the ASES index, and muscle strength were statistically significantly increased in both groups postoperatively, while no significant difference was detected between the 2 groups. Intact rotator cuffs were investigated in 42 patients in Group I and 35 in Group II, and there was a significant difference in postoperative structural integrity between the two groups (P < 0.05). When analysis was limited to the patients with full-thickness tear, the muscle strength of the shoulder was significantly better in Group II, and the retearing rate was significantly higher in Group II. Based on the results obtained from this study, it can be indicated that arthroscopic and mini-open rotator cuff repair displayed substantially equal outcomes, except for higher retearing rate in the arthroscopic repair group. While for patients with full-thickness tear, arthroscopic rotator cuff repair displayed better shoulder strength and significantly higher retearing rate as compared to mini-open rotator cuff repair at 24-month follow-up.

Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research.

PubMed

Burbach, J P M; Kurk, S A; Coebergh van den Braak, R R J; Dik, V K; May, A M; Meijer, G A; Punt, C J A; Vink, G R; Los, M; Hoogerbrugge, N; Huijgens, P C; Ijzermans, J N M; Kuipers, E J; de Noo, M E; Pennings, J P; van der Velden, A M T; Verhoef, C; Siersema, P D; van Oijen, M G H; Verkooijen, H M; Koopman, M

2016-11-01

Systematic evaluation and validation of new prognostic and predictive markers, technologies and interventions for colorectal cancer (CRC) is crucial for optimizing patients' outcomes. With only 5-15% of patients participating in clinical trials, generalizability of results is poor. Moreover, current trials often lack the capacity for post-hoc subgroup analyses. For this purpose, a large observational cohort study, serving as a multiple trial and biobanking facility, was set up by the Dutch Colorectal Cancer Group (DCCG). The Prospective Dutch ColoRectal Cancer cohort is a prospective multidisciplinary nationwide observational cohort study in the Netherlands (yearly CRC incidence of 15 500). All CRC patients (stage I-IV) are eligible for inclusion, and longitudinal clinical data are registered. Patients give separate consent for the collection of blood and tumor tissue, filling out questionnaires, and broad randomization for studies according to the innovative cohort multiple randomized controlled trial design (cmRCT), serving as an alternative study design for the classic RCT. Objectives of the study include: 1) systematically collected long-term clinical data, patient-reported outcomes and biomaterials from daily CRC practice; and 2) to facilitate future basic, translational and clinical research including interventional and cost-effectiveness studies for both national and international research groups with short inclusion periods, even for studies with stringent inclusion criteria. Seven months after initiation 650 patients have been enrolled, eight centers participate, 15 centers await IRB approval and nine embedded cohort- or cmRCT-designed studies are currently recruiting patients. This cohort provides a unique multidisciplinary data, biobank, and patient-reported outcomes collection initiative, serving as an infrastructure for various kinds of research aiming to improve treatment outcomes in CRC patients. This comprehensive design may serve as an example for

The Frank Stinchfield Award: the impact of socioeconomic factors on outcome after THA: a prospective, randomized study.

PubMed

Allen Butler, R; Rosenzweig, Seth; Myers, Leann; Barrack, Robert L

2011-02-01

Most studies of total hip arthroplasty (THA) focus on the effect of the type of implant on the clinical result. Relatively little data are available on the impact of the patient's preoperative status and socioeconomic factors on the clinical results following THA. We determined the relative importance of patient preoperative and socioeconomic status compared to implant and technique factors in predicting patient outcome as reflected by scores on commonly utilized rating scales (eg, Harris Hip Score, WOMAC, SF-12, degree of patient satisfaction, or presence or severity of thigh pain) following cementless THA. All patients during the study period were offered enrollment in a prospective, randomized study to receive either a titanium, tapered, proximally coated stem; or a Co-Cr, cylindrical, extensively coated stem; 102 patients were enrolled. We collected detailed patient data preoperatively including diagnosis, age, gender, insurance status, medical comorbidities, tobacco and alcohol use, household income, educational level, and history of treatment for lumbar spine pathology. Clinical evaluation included Harris Hip Score, SF-12, WOMAC, pain drawing, and UCLA activity rating and satisfaction questionnaire. Implant factors included stem type, stem size, fit in the canal, and stem-bone stiffness ratios. Minimum 2 year followup was obtained in 95% of the enrolled patients (102 patients). Patient demographics and preoperative status were more important than implant factors in predicting the presence of thigh pain, dissatisfaction, and a low hip score. The most predictive factors were ethnicity, educational level, poverty level, income, and a low preoperative WOMAC score or preoperative SF-12 mental component score. No implant parameter correlated with outcome or satisfaction. Socioeconomic factors and preoperative status have more impact on the clinical outcome of cementless THA than implant related factors. Level I, prospective, randomized clinical trial. See the

Evaluation of the efficacy and safety of Tribulus terrestris in male sexual dysfunction-A prospective, randomized, double-blind, placebo-controlled clinical trial.

PubMed

Kamenov, Zdravko; Fileva, Svetlana; Kalinov, Krassimir; Jannini, Emmanuele A

2017-05-01

The primary objectives were to compare the efficacy of extracts of the plant Tribulus terrestris (TT; marketed as Tribestan), in comparison with placebo, for the treatment of men with erectile dysfunction (ED) and with or without hypoactive sexual desire disorder (HSDD), as well as to monitor the safety profile of the drug. The secondary objective was to evaluate the level of lipids in blood during treatment. Phase IV, prospective, randomized, double-blind, placebo-controlled clinical trial in parallel groups. This study included 180 males aged between 18 and 65 years with mild or moderate ED and with or without HSDD: 90 were randomized to TT and 90 to placebo. Patients with ED and hypertension, diabetes mellitus, and metabolic syndrome were included in the study. In the trial, an herbal medicine intervention of Bulgarian origin was used (Tribestan ® , Sopharma AD). Each Tribestan film-coated tablet contains the active substance Tribulus terrestris, herba extractum siccum (35-45:1) 250mg which is standardized to furostanol saponins (not less than 112.5mg). Each patient received orally 3×2 film-coated tablets daily after meals, during the 12-week treatment period. At the end of each month, participants' sexual function, including ED, was assessed by International Index of Erectile Function (IIEF) Questionnaire and Global Efficacy Question (GEQ). Several biochemical parameters were also determined. The primary outcome measure was the change in IIEF score after 12 weeks of treatment. Complete randomization (random sorting using maximum allowable% deviation) with an equal number of patients in each sequence was used. This randomization algorithm has the restriction that unequal treatment allocation is not allowed; that is, all groups must have the same target sample size. Patients, investigational staff, and data collectors were blinded to treatment. All outcome assessors were also blinded to group allocation. 86 patients in each group completed the study. The IIEF

Testing the prospective evaluation of a new healthcare system

PubMed Central

Planitz, Birgit; Sanderson, Penelope; Freeman, Clinton; Xiao, Tania; Botea, Adi; Orihuela, Cristina Beltran

2012-01-01

Research into health ICT adoption suggests that the failure to understand the clinical workplace has been a major contributing factor to the failure of many computer-based clinical systems. We suggest that clinicians and administrators need methods for envisioning future use when adopting new ICT. This paper presents and evaluates a six-stage “prospective evaluation” model that clinicians can use when assessing the impact of a new electronic patient information system on a Specialist Outpatients Department (SOPD). The prospective evaluation model encompasses normative, descriptive, formative and projective approaches. We show that this combination helped health informaticians to make reasonably accurate predictions for technology adoption at the SOPD. We suggest some refinements, however, to improve the scope and accuracy of predictions. PMID:23304347

Social Media and Peer-Reviewed Medical Journal Readership: A Randomized Prospective Controlled Trial.

PubMed

Hawkins, C Matthew; Hunter, Makeba; Kolenic, Giselle E; Carlos, Ruth C

2017-05-01

To prospectively evaluate the impact of increasing levels of social media engagement on page visits and web-link clicks for content published in the Journal of the American College of Radiology. A three-arm prospective trial was designed using a control group, a basic Twitter intervention group (using only the Journal's @JACRJournal Twitter account), and an enhanced Twitter intervention group (using the personal Twitter accounts of editorial board members and trainees). Overall, 428 articles published between June 2013 and July 2015 were randomly assigned to the three groups. Article-specific tweets for both intervention arms were sent between September 14, 2015, and October 28, 2015. Primary end points included article-specific weekly and monthly page visits on the journal's Elsevier website (Amsterdam, Netherlands). For the two intervention groups, additional end points included 7-day and 30-day Twitter link clicks. Weekly page visits for the enhanced Twitter arm (mean 18.2; 95% confidence interval [CI] 15.6-20.7) were significantly higher when compared with the weekly page visits for the control arm (mean 7.6; 95% CI 1.7-13.6). However, there was no demonstrable increase in weekly page visits (mean 9.4; 95% CI 7.4-11.5) for the basic Twitter arm compared with the control arm. No intervention effects over control, regardless of Twitter arm assignment, were demonstrated for monthly page visits. The enhanced Twitter intervention resulted in a statistically significant increase in both 7-day and 30-day Twitter link clicks compared with the basic Twitter intervention group. An organized social media strategy, with focused social media activity from editorial board members, increased engagement with content published in a peer-reviewed radiology journal. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Comparative Evaluations of Randomly Selected Four Point-of-Care Glucometer Devices in Addis Ababa, Ethiopia.

PubMed

Wolde, Mistire; Tarekegn, Getahun; Kebede, Tedla

2018-05-01

Point-of-care glucometer (PoCG) devices play a significant role in self-monitoring of the blood sugar level, particularly in the follow-up of high blood sugar therapeutic response. The aim of this study was to evaluate blood glucose test results performed with four randomly selected glucometers on diabetes and control subjects versus standard wet chemistry (hexokinase) methods in Addis Ababa, Ethiopia. A prospective cross-sectional study was conducted on randomly selected 200 study participants (100 participants with diabetes and 100 healthy controls). Four randomly selected PoCG devices (CareSens N, DIAVUE Prudential, On Call Extra, i-QARE DS-W) were evaluated against hexokinase method and ISO 15197:2003 and ISO 15197:2013 standards. The minimum and maximum blood sugar values were recorded by CareSens N (21 mg/dl) and hexokinase method (498.8 mg/dl), respectively. The mean sugar values of all PoCG devices except On Call Extra showed significant differences compared with the reference hexokinase method. Meanwhile, all four PoCG devices had strong positive relationship (>80%) with the reference method (hexokinase). On the other hand, none of the four PoCG devices fulfilled the minimum accuracy measurement set by ISO 15197:2003 and ISO 15197:2013 standards. In addition, the linear regression analysis revealed that all four selected PoCG overestimated the glucose concentrations. The overall evaluation of the selected four PoCG measurements were poorly correlated with standard reference method. Therefore, before introducing PoCG devices to the market, there should be a standardized evaluation platform for validation. Further similar large-scale studies on other PoCG devices also need to be undertaken.

Postoperative therapy with infliximab for Crohn's disease: a 2-year prospective randomized multicenter study in Japan.

PubMed

Fukushima, Kouhei; Sugita, Akira; Futami, Kitaro; Takahashi, Ken-Ichi; Motoya, Satoshi; Kimura, Hideaki; Yoshikawa, Shusaku; Kinouchi, Yoshitaka; Iijima, Hideki; Endo, Katsuya; Hibi, Toshihumi; Watanabe, Mamoru; Sasaki, Iwao; Suzuki, Yasuo

2018-06-01

The prevention of postoperative recurrence is a critical issue in surgery for Crohn's disease. Prospective randomized trials in Western countries have shown that the postoperative use of anti-tumor necrosis factor α-antibodies was effective in reducing the recurrence rate. We investigated the efficacy of infliximab (IFX) for the prevention of postoperative Crohn's disease recurrence. We performed a prospective randomized multicenter study. Patients who underwent intestinal resection were assigned to groups treated with or without IFX. Immediately after surgery, patients in the IFX group received IFX at 5 mg/kg at 0, 2, and 6 weeks, followed by every 8 weeks for 2 years. The primary study outcome was the proportion of patients with endoscopic and/or clinical recurrence at 2 years after surgery. Thirty-eight eligible patients participated in this study: 19 in the IFX group and 19 in the non-IFX group. The disease recurrence rate in the IFX group was 52.6% (10/19), which was significantly lower than that in the non-IFX group (94.7% [18/19]). The postoperative use of IFX is effective in preventing Crohn's disease recurrence for 2 years.

The Effect of Cartilage Fragments on Femoral Tunnel Widening After Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Study.

PubMed

Zhang, Chi; Pan, Jun; Chen, Jian-De; Zhang, Yi-Jun; Gu, Peng-Cheng; Lin, Xiang-Jin; Cai, You-Zhi

2018-05-03

To analyze the effect of cartilage fragments on tunnel widening and tendon-bone integration at 2 years' follow-up after anterior cruciate ligament reconstruction (ACLR). A prospective randomized controlled study was performed in 116 patients who underwent ACLR with autologous hamstring tendons augmented with cartilage fragments (study group, n = 56) or without any augmentation (control group, n = 60). All patients were followed up for 25.6 months (range, 24-28 months), and the International Knee Documentation Committee score, Lysholm score, and visual analog scale score were determined. Computed tomography scans of all patients were obtained 2 years after surgery to evaluate the diameter of the femoral tunnel and thereby assess the amount of tunnel widening. Magnetic resonance imaging evaluation was performed 2 years postoperatively to evaluate the status of the graft in the femoral tunnel. In addition, 5 patients underwent biopsy of the tendon-bone interface at 24 months postoperatively with histologic assessment and transmission electron microscopy. A total of 107 patients completed the follow-up. There were no significant differences between the 2 groups in terms of International Knee Documentation Committee score (P = .07), Lysholm score (P = .10), and visual analog scale score (P = .57) at 24 months' follow-up. The femoral tunnel diameter and the tunnel widening percentage in the study group were significantly smaller than those in the control group (P < .001). The signal-noise quotient value of the graft in the femoral tunnel was 10.4 ± 7.0 in the study group, which was significantly lower than that in the control group (19.5 ± 9.2, P < .001). Histologic studies of the tendon-bone interface showed that there were more bone formations containing chondroid cells with aligned connective tissue in the study group compared with the control group; in addition, the diameter of the collagen fibrils in the study group was considerably thicker than that

A randomized prospective trial of radical (Halsted) mastectomy versus modified radical mastectomy in 311 breast cancer patients.

PubMed Central

Maddox, W A; Carpenter, J T; Laws, H L; Soong, S J; Cloud, G; Urist, M M; Balch, C M

1983-01-01

This study reports the results of a prospectively randomized trial for treatment of carcinoma of the breast comparing standard (Halsted) radical mastectomy to a modified radical mastectomy. Three hundred eleven patients with primary operable carcinoma of the breast were entered in a surgical and adjunctive chemotherapy trial in Alabama between 1975 and 1978. A total of 91 surgeons participated (all Diplomats of the American Board of Surgery and Members of the American College of Surgeons). All operative reports, pathology and therapy were reviewed by referees. Histologically node positive patients were randomized after operation to receive melphalan or C.M.F.(cytoxan, methotrexate, and 5-FU) for 1 year. After a median follow-up of 5.5 years, there was no significant difference in disease-free survival or in overall survival between the two groups. There was a trend toward improved 5-year survival rates in the radical mastectomy group compared to the modified radical mastectomy group (84% vs. 76%, p = 0.14). There was also an increased incidence of local wound recurrence in those patients receiving modified radical mastectomy, but the differences were not statistically significant (p = 0.09). Longer follow-up will be necessary to evaluate these results more fully. PMID:6870379

Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

PubMed

Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

2014-05-01

To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total

Randomized Sequential Individual Assignment in Social Experiments: Evaluating the Design Options Prospectively

ERIC Educational Resources Information Center

Lohr, Sharon L.; Zhu, Xiaoshu

2017-01-01

Many randomized experiments in the social sciences allocate subjects to treatment arms at the time the subjects enroll. Desirable features of the mechanism used to assign subjects to treatment arms are often (1) equal numbers of subjects in intervention and control arms, (2) balanced allocation for population subgroups and across covariates, (3)…

TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial.

PubMed

Krofta, Ladislav; Feyereisl, Jaroslav; Otcenásek, Michal; Velebil, Petr; Kasíková, Eva; Krcmár, Michal

2010-02-01

A study was conducted to compare the efficacy and complications of TVT and TVT-O. This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated with TVT-O. At the 1 year follow-up, 141 TVT patients and 147 TVT-O patients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. The mean operating time was shorter in the TVT-O group (p < 0.001). Urinary retention was not significantly different (p > 0.05). Inner thigh discomfort was reported by 5.4% of TVT-O patients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-O patients (p = 0.015). The groups showed comparable objective and subjective cure rates.

Comparison of Rifaximin and Lactulose for the Treatment of Hepatic Encephalopathy: A Prospective Randomized Study

PubMed Central

Paik, Yong-Han; Han, Kwang-Hyub; Song, Kun Hoon; Kim, Myoung Hwan; Moon, Byung Soo; Ahn, Sang Hoon; Lee, Se Joon; Park, Hyo Jin; Lee, Dong Ki; Chon, Chae Yoon; Lee, Sang In; Moon, Young Myoung

2005-01-01

Rifaximin has been reported to be effective for the treatment of hepatic encephalopathy (HE) in Europe. However, it is unknown whether Rifaximin is effective for the treatment of HE in Koreans, therefore we conducted a open-label prospective randomized study to evaluate the efficacy of rifaximin versus lactulose in Korean patients. Fifty-four patients with liver cirrhosis and hepatic encephalopathy were enrolled. Thirty-two patients were randomized to receive rifaximin and 22 to receive lactulose both over a 7-day periods. Before and at the end of treatment, gradation of blood ammonia, flapping tremor, mental status, number connection test (NCT) were performed and estimation of HE indexes determined. Both rifaximin and lactulose were effective in the majority of patients (84.4% and 95.4%, respectively, p=0.315). Blood NH3, flapping tremor, mental status, and NCT was significantly improved by rifaximin and lactulose, and the posttreatment levels of these measures were similar for the rifaximin and lactulose-treated groups, as was the HE index (rifaximin group (10.0→4.2, p=0.000); lactulose group (11.3→5.0, p=0.000)). One patient treated with rifaximin complained of abdominal pain, which was easily controlled. There was no episode of renal function impairment in either treatment group. Rifaximin proved to be as safe and as effective as lactulose for the treatment of Korean patients with hepatic encephalopathy. PMID:15988813

High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial.

PubMed

Kudo, Taiki; Kawakami, Hiroshi; Hayashi, Tsuyoshi; Yasuda, Ichiro; Mukai, Tsuyoshi; Inoue, Hiroyuki; Katanuma, Akio; Kawakubo, Kazumichi; Ishiwatari, Hirotoshi; Doi, Shinpei; Yamada, Reiko; Maguchi, Hiroyuki; Isayama, Hiroyuki; Mitsuhashi, Tomoko; Sakamoto, Naoya

2014-12-01

EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial. To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles. Prospective, single-blind, randomized, controlled crossover trial. Seven tertiary referral centers. Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist. EUS-FNA by using NNP and HNP. The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP. We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy. This was a single-blinded, crossover study. Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. ( UMIN000005939.). Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Standard donor lung procurement with normothermic ex vivo lung perfusion: A prospective randomized clinical trial.

PubMed

Slama, Alexis; Schillab, Lukas; Barta, Maximilian; Benedek, Aris; Mitterbauer, Andreas; Hoetzenecker, Konrad; Taghavi, Shahrokh; Lang, Gyoergy; Matilla, Jose; Ankersmit, Hendrik; Hager, Helmut; Roth, Georg; Klepetko, Walter; Aigner, Clemens

2017-07-01

Ex vivo lung perfusion (EVLP) was primarily developed for evaluation of impaired donor lungs. The good clinical results raise the question for its possible impact on lungs meeting standard criteria. Before application of EVLP on such lungs enters routine clinical practice, it must be demonstrated whether EVLP would affect or improve outcome when used in standard donor lungs. We performed a prospective randomized trial to investigate the role of EVLP in standard lung transplantation (Tx). This prospective randomized clinical trial compared patients who underwent Tx with ex vivo evaluated donor lungs with an equivalent patient population without previous EVLP. From October 2013 to May 2015, 193 lung Tx were performed at the Medical University of Vienna. During this period, 80 recipient/donor pairs that met the inclusion criteria were included in this trial, 41 pairs in the control group, and 39 in the EVLP group. In the EVLP group, 4 lungs (10.2%) ultimately did not qualify for Tx and were rejected for lung Tx owing to technical reasons (n = 2) and quality criteria (n = 2). Donor and recipient characteristics were comparable in both groups. Total cold ischemic time in the EVLP group was significantly longer for both implanted lungs (first side, 372 minutes vs 291 minutes, p < 0.001; second side, 437 minutes vs 370 minutes, p = 0.001); median duration of surgery showed no differences (277 minutes vs 275 minutes). Median oxygen partial pressure/fraction of inspired oxygen ratio at 24 hours after Tx was 516 (range, 280-557) in the EVLP group and 491 (range, 352-575) in the control group (p = 0.63). Incidence of primary graft dysfunction >1 was lower in the EVLP group at all time points compared with the control group (24 hours, 5.7% vs 19.5%, p = 0.10), and need for post-operative prolonged extracorporeal membrane oxygenation was lower in the EVLP group (5.7% vs 12.2%, p = 0.44). Short-term clinical outcomes did not differ between recipients in the 2 groups. Patients

Treatment of benign esophageal stricture by Eder-Puestow or balloon dilators: a comparison between randomized and prospective nonrandomized trials.

PubMed

Yamamoto, H; Hughes, R W; Schroeder, K W; Viggiano, T R; DiMagno, E P

1992-03-01

To determine whether the natural history of strictures is affected by the type of dilator used to treat newly diagnosed peptic strictures, we designed a prospective randomized trial to compare the results after Eder-Puestow or Medi-Tech balloon dilation. We entered 31 patients into the trial. We also prospectively followed up all 92 nonrandomized patients who underwent their first dilation for a benign stricture during the same period as the prospective randomized trial. The nonrandomized patients also underwent dilation with either the Eder-Puestow or the balloon technique at the discretion of the gastroenterologist performing the endoscopy. We found no statistically significant differences in the immediate or long-term results of the two methods among the randomized, nonrandomized, and overall combined groups. All but 1 of the 123 patients had immediate relief of dysphagia. Within each group of patients, the probability of remaining free of dysphagia 1 year after the initial dilation was approximately 20%, and the probability of not requiring a second dilation was approximately 65% with either technique. Major (esophageal rupture) and minor (bleeding or chest pain) complications occurred in 1% and 5% of the patients and 0.4% and 3% of the total dilation procedures, respectively. The esophageal rupture and four of six minor complications occurred after repeated dilations. Five of the six minor complications occurred with use of the Eder-Puestow dilators. We conclude that Eder-Puestow and balloon dilations of benign esophageal strictures are associated with similar outcomes, but repeated dilations and the Eder-Puestow technique may be associated with an increased risk of complications.

Is The Convergence Insufficiency Symptom Survey Specific for Convergence Insufficiency? A Prospective, Randomized Study.

PubMed

Horan, Lindsay A; Ticho, Benjamin H; Khammar, Alexander J; Allen, Megan S; Shah, Birva A

2015-01-01

The Convergence Insufficiency Symptom Survey (CISS) is a questionnaire used as an outcome measure in treatment of convergence insufficiency. The current prospective randomized trial evaluates the diagnostic specificity of the CISS. Surveys were completed by 118 adolescent patients who presented for routine eye examinations. Scores were compared between patients who could be classified as having convergence insufficiency (CI) or normal binocular vision (NBV). In addition, a comparison was done between self-and practitioner-administered CISS scores within these groups. The mean CISS score did not differ significantly between NBV patients (14.1±11.3, range of 0 to 43) and CI patients (12.3±6.7, range of 3 to 28); P=0.32. Mean CISS scores were lower when physician-administered (11.4±7.9) than when self-administered (16.3±11.4); P=0.007. CISS scores tend to be higher when self-vs. practitioner-administered. This study suggests that the CISS questionnaire is not specific for convergence insufficiency. © 2015 Board of regents of the University of Wisconsin System, American Orthoptic Journal, Volume 65, 2015, ISSN 0065-955X, E-ISSN 1553-4448.

Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial.

PubMed

Buchweitz, Olaf; Frye, Christian; Moeller, Claus Peter; Nugent, Wolfgang; Krueger, Eckart; Nugent, Andreas; Biel, Peter; Juergens, Sven

2016-06-01

In an elective laparoscopic surgery, the cosmetic outcome becomes increasingly important. We conducted a study to evaluate the cosmetic outcome 3 months after a laparoscopic procedure and compared skin adhesive (SA) versus transcutaneous suture (TS). A randomized, controlled, prospective study was conducted at a single study centre in Hamburg, Germany. Seventy-seven patients undergoing laparoscopic surgery with two lower abdominal port sites met the study requirements. It was decided randomly which port site would be closed with SA. The opposite site was closed with TS. Wounds were assessed after 7-12 days and after 3 months. Cosmetic outcome was measured by a visual analogue scale (VAS) completed by the patient, by the Hollander wound evaluation scale (HWES) and by the judgement of blinded investigators. Seventy-seven subjects were randomized. Complete data from the 3-month follow-up visit were available from 56 patients (72.7 %). The VAS scale ranged from 0 to 100 mm with "0" representing the best possible cosmetic outcome. Median satisfaction was 2 mm in the TS group and 3 mm in the SA group. The mean was high in both groups 4.6 (s = 13.1) versus 3.8 mm (s = 4.6). The outcome was neither clinically nor statistically significant. Cosmetic outcome was assessed by an investigator, and the HWES showed no difference. In regard to complications, no difference was found between SA and TS, either. In conclusion this study demonstrated that closure of laparoscopic port-site wounds leads to equivalent outcomes whether SAs or TSs are used. Complications are rare in both methods. Thus, SAs seem to be a valid alternative to sutures in laparoscopic surgery. Registration site: www.clinicaltrials.gov . NCT02179723.

Removal of diminutive colorectal polyps: A prospective randomized clinical trial between cold snare polypectomy and hot forceps biopsy

PubMed Central

Komeda, Yoriaki; Kashida, Hiroshi; Sakurai, Toshiharu; Tribonias, George; Okamoto, Kazuki; Kono, Masashi; Yamada, Mitsunari; Adachi, Teppei; Mine, Hiromasa; Nagai, Tomoyuki; Asakuma, Yutaka; Hagiwara, Satoru; Matsui, Shigenaga; Watanabe, Tomohiro; Kitano, Masayuki; Chikugo, Takaaki; Chiba, Yasutaka; Kudo, Masatoshi

2017-01-01

AIM To compare the efficacy and safety of cold snare polypectomy (CSP) and hot forceps biopsy (HFB) for diminutive colorectal polyps. METHODS This prospective, randomized single-center clinical trial included consecutive patients ≥ 20 years of age with diminutive colorectal polyps 3-5 mm from December 2014 to October 2015. The primary outcome measures were en-bloc resection (endoscopic evaluation) and complete resection rates (pathological evaluation). The secondary outcome measures were the immediate bleeding or immediate perforation rate after polypectomy, delayed bleeding or delayed perforation rate after polypectomy, use of clipping for bleeding or perforation, and polyp retrieval rate. Prophylactic clipping after polyp removal wasn’t routinely performed. RESULTS Two hundred eight patients were randomized into the CSP (102), HFB (106) and 283 polyps were evaluated (CSP: 148, HFB: 135). The en-bloc resection rate was significantly higher with CSP than with HFB [99.3% (147/148) vs 80.0% (108/135), P < 0.0001]. The complete resection rate was significantly higher with CSP than with HFB [80.4% (119/148) vs 47.4% (64/135), P < 0.0001]. The immediate bleeding rate was similar between the groups [8.6% (13/148) vs 8.1% (11/135), P = 1.000], and endoscopic hemostasis with hemoclips was successful in all cases. No cases of perforation or delayed bleeding occurred. The rate of severe tissue injury to the pathological specimen was higher HFB than CSP [52.6% (71/135) vs 1.3% (2/148), P < 0.0001]. Polyp retrieval failure was encountered CSP (7), HFB (2). CONCLUSION CSP is more effective than HFB for resecting diminutive polyps. Further long-term follow-up study is required. PMID:28127206

Removal of diminutive colorectal polyps: A prospective randomized clinical trial between cold snare polypectomy and hot forceps biopsy.

PubMed

Komeda, Yoriaki; Kashida, Hiroshi; Sakurai, Toshiharu; Tribonias, George; Okamoto, Kazuki; Kono, Masashi; Yamada, Mitsunari; Adachi, Teppei; Mine, Hiromasa; Nagai, Tomoyuki; Asakuma, Yutaka; Hagiwara, Satoru; Matsui, Shigenaga; Watanabe, Tomohiro; Kitano, Masayuki; Chikugo, Takaaki; Chiba, Yasutaka; Kudo, Masatoshi

2017-01-14

To compare the efficacy and safety of cold snare polypectomy (CSP) and hot forceps biopsy (HFB) for diminutive colorectal polyps. This prospective, randomized single-center clinical trial included consecutive patients ≥ 20 years of age with diminutive colorectal polyps 3-5 mm from December 2014 to October 2015. The primary outcome measures were en-bloc resection (endoscopic evaluation) and complete resection rates (pathological evaluation). The secondary outcome measures were the immediate bleeding or immediate perforation rate after polypectomy, delayed bleeding or delayed perforation rate after polypectomy, use of clipping for bleeding or perforation, and polyp retrieval rate. Prophylactic clipping after polyp removal wasn't routinely performed. Two hundred eight patients were randomized into the CSP (102), HFB (106) and 283 polyps were evaluated (CSP: 148, HFB: 135). The en-bloc resection rate was significantly higher with CSP than with HFB [99.3% (147/148) vs 80.0% (108/135), P < 0.0001]. The complete resection rate was significantly higher with CSP than with HFB [80.4% (119/148) vs 47.4% (64/135), P < 0.0001]. The immediate bleeding rate was similar between the groups [8.6% (13/148) vs 8.1% (11/135), P = 1.000], and endoscopic hemostasis with hemoclips was successful in all cases. No cases of perforation or delayed bleeding occurred. The rate of severe tissue injury to the pathological specimen was higher HFB than CSP [52.6% (71/135) vs 1.3% (2/148), P < 0.0001]. Polyp retrieval failure was encountered CSP (7), HFB (2). CSP is more effective than HFB for resecting diminutive polyps. Further long-term follow-up study is required.

Involved-Field Radiotherapy versus Elective Nodal Irradiation in Combination with Concurrent Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer: A Prospective Randomized Study

PubMed Central

Chen, Ming; Bao, Yong; Ma, Hong-Lian; Wang, Jin; Wang, Yan; Peng, Fang; Zhou, Qi-Chao; Xie, Cong-Hua

2013-01-01

This prospective randomized study is to evaluate the locoregional failure and its impact on survival by comparing involved field radiotherapy (IFRT) with elective nodal irradiation (ENI) in combination with concurrent chemotherapy for locally advanced non-small cell lung cancer. It appears that higher dose could be delivered in IFRT arm than that in ENI arm, and IFRT did not increase the risk of initially uninvolved or isolated nodal failures. Both a tendency of improved locoregional progression-free survival and a significant increased overall survival rate are in favor of IFRT arm in this study. PMID:23762840

Does press-fit technique reduce tunnel volume enlargement after anterior cruciate ligament reconstruction with autologous hamstring tendons? A prospective randomized computed tomography study.

PubMed

Hwang, Dae-Hee; Shetty, Gautam M; Kim, Jong In; Kwon, Jae Ho; Song, Jae-Kwang; Muñoz, Michael; Lee, Jun Seop; Nha, Kyung-Wook

2013-01-01

The purpose of this prospective, randomized, computed tomography-based study was to investigate whether the press-fit technique reduces tunnel volume enlargement (TVE) and improves the clinical outcome after anterior cruciate ligament reconstruction at a minimum follow-up of 1 year compared with conventional technique. Sixty-nine patients undergoing primary ACL reconstruction using hamstring autografts were randomly allocated to either the press-fit technique group (group A) or conventional technique group (group B). All patients were evaluated for TVE and tunnel widening using computed tomography scanning, for functional outcome using International Knee Documentation Committee and Lysholm scores, for rotational stability using the pivot-shift test, and for anterior laxity using the KT-2000 arthrometer at a minimum of 1-year follow-up. There were no significant differences in TVE between the 2 groups. In group A, in which the press-fit technique was used, mean volume enlargement in the femoral tunnel was 65% compared with 71.5% in group B (P = .84). In group A, 57% (20 of 35) of patients developed femoral TVE compared with 67% (23 of 34) of patients in group B (P = .27). Both groups showed no significant difference for functional outcome (mean Lysholm score P = .73, International Knee Documentation Committee score P = .15), or knee laxity (anterior P = .78, rotational P = .22) at a minimum follow-up of 1 year. In a comparison of press-fit and conventional techniques, there were no significant differences in TVE and clinical outcome at short-term follow-up. Level II, therapeutic study, prospective randomized clinical trial. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Transfusion Requirement in Burn Care Evaluation (TRIBE): A Multicenter Randomized Prospective Trial of Blood Transfusion in Major Burn Injury.

PubMed

Palmieri, Tina L; Holmes, James H; Arnoldo, Brett; Peck, Michael; Potenza, Bruce; Cochran, Amalia; King, Booker T; Dominic, William; Cartotto, Robert; Bhavsar, Dhaval; Kemalyan, Nathan; Tredget, Edward; Stapelberg, Francois; Mozingo, David; Friedman, Bruce; Greenhalgh, David G; Taylor, Sandra L; Pollock, Brad H

2017-10-01

Our objective was to compare outcomes of a restrictive to a liberal red cell transfusion strategy in 20% or more total body surface area (TBSA) burn patients. We hypothesized that the restrictive group would have less blood stream infection (BSI), organ dysfunction, and mortality. Patients with major burns have major (>1 blood volume) transfusion requirements. Studies suggest that a restrictive blood transfusion strategy is equivalent to a liberal strategy. However, major burn injury is precluded from these studies. The optimal transfusion strategy in major burn injury is thus needed but remains unknown. This prospective randomized multicenter trial block randomized patients to a restrictive (hemoglobin 7-8 g/dL) or liberal (hemoglobin 10-11 g/dL) transfusion strategy throughout hospitalization. Data collected included demographics, infections, transfusions, and outcomes. Eighteen burn centers enrolled 345 patients with 20% or more TBSA burn similar in age, TBSA burn, and inhalation injury. A total of 7054 units blood were transfused. The restrictive group received fewer blood transfusions: mean 20.3 ± 32.7 units, median = 8 (interquartile range: 3, 24) versus mean 31.8 ± 44.3 units, median = 16 (interquartile range: 7, 40) in the liberal group (P < 0.0001, Wilcoxon rank sum). BSI incidence, organ dysfunction, ventilator days, and time to wound healing (P > 0.05) were similar. In addition, there was no 30-day mortality difference: 9.5% restrictive versus 8.5% liberal (P = 0.892, χ test). A restrictive transfusion strategy halved blood product utilization. Although the restrictive strategy did not decrease BSI, mortality, or organ dysfunction in major burn injury, these outcomes were no worse than the liberal strategy (Clinicaltrials.gov identifier NCT01079247).

Effect of local anesthetic dilution on the onset time and duration of double-injection sciatic nerve block: a prospective, randomized, blinded evaluation.

PubMed

Cappelleri, Gianluca; Ambrosoli, Andrea Luigi; Turconi, Stefania; Gemma, Marco; Ricci, Erika Basso; Cornaggia, Gabriele

2014-08-01

Among the various factors influencing the success rate, onset time, and duration of peripheral nerve blocks, the role of local anesthetics concentration remains uncertain. In this prospective, randomized, single-blinded study, we evaluated whether varying the dilution of a fixed dose of mepivacaine solution influenced onset time and duration of sciatic nerve block. Ninety ASA physical status I to II patients scheduled for foot surgery were randomly allocated to receive a double-injection Labat sciatic nerve block with 12 mL mepivacaine 2% (group concentration I = 45 patients) or 24 mL of mepivacaine 1% (group volume II = 45 patients). The nerve stimulator was initially set at 2 Hz, 0.1 millisecond, 1 mA. The total amount of local anesthetic (240 mg) was kept constant and equally divided between the peroneal and tibial nerves. All patients also received an ultrasound-guided popliteal sciatic nerve catheter for postoperative analgesia. Times to readiness for surgery, performance, and offset of local anesthetic were recorded. Our primary end point was to determine a possible difference in offset time between groups. Continuous variables were expressed as median (IQR) and compared with the Wilcoxon-Mann-Whitney U test; WMWodds are reported together with their 95% confidence interval. The overall success rate of sciatic nerve block was 99%. Time of performance was shorter in group I, 120 seconds (90-150 seconds), than that in group II, 150 seconds (120-180 seconds) (P = 0.0048; WMWodds 2.26 [1.35-4.34]). The onset time of sensory and motor sciatic nerve block was 4 minutes (2-9 minutes) in group I and 6 minutes (4-10 minutes) in group II (P = 0.41; WMWodds 1.21 [0.77-1.95]), while the duration of sensory block was 235 minutes (203-250 minutes) in group I, and 240 minutes (218-247 minutes) in group II respectively (P = 0.51; WMWodds 1.20 [0.69-2.16]). We found no evidence that varying volume and concentration while maintaining a fixed total dose of mepivacaine alters the

A Randomized Prospective Trial Comparing Paravertebral Block and General Anesthesia for Operative Treatment of Breast Cancer

DTIC Science & Technology

2001-10-01

block the anesthetic of choice for operative treatment of breast cancer. To test this hypothesis we proposed a prospective randomized clinical trial ...coordinators. Months 4-6. Status: Complete The study’s existing part-time Clinical Trial Coordinator, Mr. John Arbo, was enlisted full-time in June...of full-time Clinical Trial Coordinator for Mount Sinai. ■ Poster presentation by Mount Sinai staff of study goals and methods at a Department of

Differences in highly cross-linked polyethylene wear between zirconia and cobalt-chromium femoral heads in Japanese patients: a prospective, randomized study.

PubMed

Kawate, Kenji; Ohmura, Tetsuji; Kawahara, Ikuo; Tamai, Katsuya; Ueha, Tomoyuki; Takemura, Kazuo

2009-12-01

The purpose of this study was to compare highly cross-linked polyethylene wear between the zirconia head and the cobalt-chromium head in Japanese patients. A prospective, randomized study was performed to evaluate the outcomes in 32 hips that had zirconia heads and in 30 hips that had cobalt-chromium heads. The mean follow-up periods of both groups were same (5 years). There were no significant differences between the zirconia head and the cobalt-chromium head in the mean polyethylene linear wear per year and the mean volumetric polyethylene wear per year in the steady phase. This study indicates that zirconia head offers no benefits over metal head in terms of wear reduction at 5 years in Japanese patients who have lightweight and thin polyethylene liners.

Bispectral Index Monitoring during Anesthesiologist-Directed Propofol and Remifentanil Sedation for Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial

PubMed Central

Park, Woo Young; Shin, Yang-Sik; Lee, Sang Kil; Kim, So Yeon; Lee, Tai Kyung

2014-01-01

Purpose Endoscopic submucosal dissection (ESD) is a technically difficult and lengthy procedure requiring optimal depth of sedation. The bispectral index (BIS) monitor is a non-invasive tool that objectively evaluates the depth of sedation. The purpose of this prospective randomized controlled trial was to evaluate whether BIS guided sedation with propofol and remifentanil could reduce the number of patients requiring rescue propofol, and thus reduce the incidence of sedation- and/or procedure-related complications. Materials and Methods A total of 180 patients who underwent the ESD procedure for gastric adenoma or early gastric cancer were randomized to two groups. The control group (n=90) was monitored by the Modified Observer's Assessment of Alertness and Sedation scale and the BIS group (n=90) was monitored using BIS. The total doses of propofol and remifentanil, the need for rescue propofol, and the rates of complications were recorded. Results The number of patients who needed rescue propofol during the procedure was significantly higher in the control group than the BIS group (47.8% vs. 30.0%, p=0.014). There were no significant differences in the incidence of sedation- and/or procedure-related complications. Conclusion BIS-guided propofol infusion combined with remifentanil reduced the number of patients requiring rescue propofol in ESD procedures. However, this finding did not lead to clinical benefits and thus BIS monitoring is of limited use during anesthesiologist-directed sedation. PMID:25048506

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

Prospective double blind randomized placebo-controlled clinical trial of the pectoral nerves (Pecs) block type II.

PubMed

Versyck, Barbara; van Geffen, Geert-Jan; Van Houwe, Patrick

2017-08-01

The aim of this clinical trial was to test the hypothesis whether adding the pectoral nerves (Pecs) block type II to the anesthetic procedure reduces opioid consumption during and after breast surgery. A prospective randomized double blind placebo-controlled study. A secondary hospital. 140 breast cancer stage 1-3 patients undergoing mastectomy or tumorectomy with sentinel node or axillary node dissection. Patients were randomized to receive either a Pecs block with levobupivacaine 0.25% (n=70) or placebo block with saline (n=70). The pain levels were evaluated by Numeric Rating Scale (NRS) pain scores at 15-minute intervals during the post anesthesia care unit stay time (PACU), at 2-hour intervals for the first 24h on the ward and at 4-hour intervals for the next 24h. Intraoperative and postoperative opioid consumption were recorded during the full stay. Patient satisfaction was evaluated upon discharge using a 10-point scale. Intraoperative sufentanil requirements were comparable for the Pecs and placebo group (8.0±3.5μg and 7.8±3.0μg, P=0.730). Patients in the Pecs group experienced significantly less pain than patients in the control group (P=0.048) during their PACU stay. Furthermore, patients in the Pecs group required significant less postoperative opioids (9.16±10.15mg and 14.97±14.38mg morphine equivalent, P=0.037) and required significant fewer postsurgical opioid administration interventions than patients in the control group (P=0.045). Both patient-groups were very satisfied about their management (9.6±0.6 and 9.1±1.8 on a 10-point scale, P=0.211). The Pecs block reduces postsurgical opioid consumption during the PACU stay time for patients undergoing breast surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial.

PubMed

Ott, O J; Hertel, S; Gaipl, U S; Frey, B; Schmidt, M; Fietkau, R

2012-10-01

The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 ± 20.2 and 55.7 ± 18.0 (p = 0.463), 32.1 ± 24.5 and 34.4 ± 22.5 (p = 0.256), and 27.0 ± 27.7 and 23.5 ± 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 ± 2.9 and 8.1 ± 3.1 (p = 0.207), 4.5 ± 3.2 and 5.0 ± 3.4 (p = 0.507), 3.9 ± 3.6 and 2.8 ± 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy.

Intravenous levetiracetam vs phenytoin for status epilepticus and cluster seizures: A prospective, randomized study.

PubMed

Gujjar, Arunodaya R; Nandhagopal, Ramachandiran; Jacob, Poovathoor C; Al-Hashim, Abdulhakeem; Al-Amrani, Khalfan; Ganguly, Shyam S; Al-Asmi, Abdullah

2017-07-01

Status Epilepticus (SE) is a common medical emergency carrying a high morbidity and mortality. Levetiracetam (LEV) is a novel anticonvulsant effective against varied seizures. Few prospective studies have addressed its use in SE. We aimed to examine the efficacy of intravenous LEV in controlling SE and cluster attacks of seizures (CS), in comparison with IV phenytoin (DPH), using a prospective, randomized study design. Adult patients with SE or CS, following an initial dose of IV benzodiazepine to control ongoing seizure, were randomized to receive either medication. Rates of seizure control over 24h, adverse effects and outcomes were compared. A logistic regression model was used to identify outcome predictors. 52 patients with SE and 63 with CS received either LEV or DPH. In the SE group, LEV was effective in18/22(82%) and DPH in 22/30(73.3%) patients in controlling seizures. Among patients with CS, LEV was effective in 31/38(81.6%) and DPH in 20/25(80%). With the use of LEV, DPH or both, SE and CS were controlled among 92% and 96% of patients respectively. Adverse events included hypotension (in 2 on DPH) and transient agitation (2 on LEV). IV Levetiracetam controls status epilepticus or cluster seizures with an efficacy comparable to that of phenytoin. Use of these two agents consecutively may control >90% of all such conditions without resort to anaesthetic agents. Further studies should explore its efficacy in larger cohorts of epileptic emergencies. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Biodegradable implants versus standard metal fixation for displaced radial head fractures. A prospective, randomized, multicenter study.

PubMed

Helling, Hanns-Joachim; Prokop, Axel; Schmid, Hans Ulrich; Nagel, Michael; Lilienthal, Jürgen; Rehm, Klaus Emil

2006-01-01

This multicenter, prospective, randomized study compares the use of biodegradable polylactide pins with standard metal mini-fragment implants for the treatment of displaced radial head fractures. It compares complication rates and clinical outcomes of both treatment methods. At 2 years, 135 (82%) of 164 patients were available for evaluation. Equivalence of treatment method was defined as a difference of 10% or less in the number of complication-free patients. Functional status was assessed by using the Broberg and Morrey Elbow Score and compared by an unpaired t test. Good or excellent clinical results were achieved by 92% (56/61) of the control patients and 96% (71/74) of the polylactide patients. The incidence of complication-free patients was 3.7% less in the polylactide group than in the control group. The 1-sided 95% confidence interval for the treatment difference between the 2 groups was more than -6.1%. Biodegradable polylactide pins have at least comparable outcomes as standard metal implants for the internal fixation of reconstructable displaced radial head fractures.

A Prospective, Randomized, Masked, Placebo-Controlled Clinical Study of Capromorelin in Dogs with Reduced Appetite.

PubMed

Zollers, B; Wofford, J A; Heinen, E; Huebner, M; Rhodes, L

2016-11-01

Reduced appetite is a common clinical sign in dogs. This study evaluated the effectiveness and safety of capromorelin oral solution, (ENTYCE ® , Aratana Therapeutics, Leawood, KS) a new drug that is a ghrelin receptor agonist, for stimulation of appetite in dogs with reduced appetite. Capromorelin will increase appetite, as measured by the owner's evaluation, over 4 days. An additional objective was to evaluate the safety of capromorelin at the labeled dose. A total of 244 client-owned dogs reported by owners to be inappetent for at least 2 days were enrolled, with 177 cases in the effectiveness analysis. In this prospective, randomized, masked, placebo-controlled study, dogs were treated daily with capromorelin (3 mg/kg) oral solution (n = 121) or placebo oral solution (n = 56). Owners completed an evaluation of appetite at days 0 and 3 ± 1. Success was defined as improvement in appetite at day 3. Safety was evaluated by physical examination, clinical pathology, and monitoring adverse events and owner observations. Capromorelin treatment improved appetite compared to placebo (68.6% and 44.6% treatment successes with 95% CI 59.7, 76.3 and 32.2, 57.8, respectively, P = .008). Mean body weight in capromorelin-treated dogs increased compared to placebo-treated dogs (1.8% with 95% CI 1.3, 2.3, and 0.1% with 95% CI 0.9, 1.1, respectively, P < .001). Adverse reactions occurring in >5% of either group were diarrhea and vomiting. Capromorelin oral solution is an effective treatment for stimulation of appetite in dogs and represents the first ghrelin receptor agonist shown to be effective for this indication. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

PubMed

Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

2010-01-01

To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

The effect of tourniquet use on fixation quality in cemented total knee arthroplasty a prospective randomized clinical controlled RSA trial.

PubMed

Molt, Mats; Harsten, Andreas; Toksvig-Larsen, Sören

2014-03-01

A concern that arises with any change in technique is whether it affects the long-term implant stability. The objective of this study was to evaluate the early migration, measured by radiostereometric analysis (RSA), and the functional outcome of the Triathlon™ cemented knee prosthesis, operated on with or without a tourniquet. During the last decades RSA has emerged as a way to assess prosthetic fixation and long time prognosis. The method has been used extensively in both hip and knee arthroplasty. This was a single centre prospective study including 60 patients randomized into two groups operated on either with or without tourniquet. RSA investigation was done within 2-3 days postoperatively after full weight bearing, and then at 3 months, 1 year and 2 years postoperatively. There were no differences between the groups regarding the translation along or rotation around the three coordinal axes, or in maximum total point motion (MTPM). At 2 years the mean MTPM (SD) was 0.71 mm (0.64) for the tourniquet-group and 0.53 mm (0.21) for the non-tourniquet-group. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability whether operated on with or without tourniquet. Level I. Article focus: A safety study for total knee replacement operated on with or without perioperative tourniquet regarding the prosthetic fixation. Strengths and limitations: Strength of this study is that it is a randomized prospective trial using an objective measuring tool. The sample size of 25-30 patients is reportedly sufficient for the screening of implants using RSA (1-3). Clinical trials NCT01604382, Ethics Committee approval D-nr: 144/20085. © 2013.

Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

PubMed

Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

2016-11-20

High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

PubMed

Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

2018-02-01

There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Prospect evaluation of shallow I-35 reservoir of NE Malay Basin offshore, Terengganu, Malaysia

DOE Office of Scientific and Technical Information (OSTI.GOV)

Janjua, Osama Akhtar, E-mail: janjua945@hotmail.com; Wahid, Ali, E-mail: ali.wahid@live.com; Salim, Ahmed Mohamed Ahmed, E-mail: mohamed.salim@petronas.com.my

2016-02-01

A potential accumulation of hydrocarbon that describes significant and conceivable drilling target is related to prospect. Possibility of success estimation, assuming discovery of hydrocarbons and the potential recoverable quantities range under a commercial development program are the basis of Prospect evaluation activities. The objective was to find the new shallow prospects in reservoir sandstone of I –Formation in Malay basin. The prospects in the study area are mostly consisting of faulted structures and stratigraphic channels. The methodology follows seismic interpretation and mapping, attribute analysis, evaluation of nearby well data i.e., based on well – log correlation. The petrophysical parameters analoguemore » to nearby wells was used as an input parameter for volumetric assessment. Based on analysis of presence and effectiveness, the prospect has a complete petroleum system. Two wells have been proposed to be drilled near the major fault and stratigraphic channel in I-35 reservoir that is O-1 and O-2 prospects respectively. The probability of geological success of prospect O-1 is at 35% while for O-2 is 24%. Finally, for hydrocarbon in place volumes were calculated which concluded the best estimate volume for oil in O-1 prospect is 4.99 MMSTB and O-2 prospect is 28.70 MMSTB while for gas is 29.27 BSCF and 25.59 BSCF respectively.« less

Thymoglobulin induction in liver transplant recipients with a tacrolimus, mycophenolate mofetil, and steroid immunosuppressive regimen: a five-year randomized prospective study.

PubMed

Boillot, Olivier; Seket, Belhassen; Dumortier, Jérôme; Pittau, Gabriella; Boucaud, Catherine; Bouffard, Yves; Scoazec, Jean-Yves

2009-11-01

This randomized, comparative study assessed the long-term efficacy and tolerability of thymoglobulin (TMG) induction in 93 liver transplant patients with an initial regimen of tacrolimus (Tac), mycophenolate mofetil (MMF), and steroids. Forty-four patients were randomly allocated to the TMG+ group, and 49 patients were randomly allocated to the TMG- group. In both groups, Tac was given orally at the initial daily dose of 0.075 mg/kg twice daily, and MMF was given at the initial daily dose of 2 g/day. Steroid withdrawal was planned at 3 months after liver transplantation. The results were evaluated with respect to acute rejection incidence, patient and graft survival, graft function, and medical complications until 5 years or death for all patients. No significant differences were found between groups for the incidence of acute rejection at 5 years (11.4% versus 14.3%), 5-year patient survival (77.3% versus 87.8%), graft function, or postoperative renal function. One patient in the TMG- group underwent retransplantation. There was no difference between groups with respect to the incidence of medical complications, excepted for a higher rate of leukopenia in the TMG+ group, during the 5-year follow-up. In conclusion, the results of this prospective randomized study suggest that the addition of TMG to a triple immunosuppressive regimen (Tac, MMF, and steroids) did not modify the incidence of acute rejection episodes or long-term survival and was responsible for increased leukopenia rates.

Acute Adverse Reactions to Nonionic Iodinated Contrast Media for CT: Prospective Randomized Evaluation of the Effects of Dehydration, Oral Rehydration, and Patient Risk Factors.

PubMed

Motosugi, Utaroh; Ichikawa, Tomoaki; Sano, Katsuhiro; Onishi, Hiroshi

2016-11-01

The objective of our study was to determine the effects of dehydration and oral rehydration on the incidence of acute adverse reactions to iodinated contrast media administered during abdominal and pelvic CT in outpatients. For our prospective randomized study performed at a single institution, adult outpatients undergoing contrast-enhanced abdominal CT were randomly divided into a rehydration group (n = 2244 patients [1379 men and 865 women]; mean age, 65.2 years; age range, 18-90 years) and a control group (n = 3715 [2112 male patients and 1603 female patients]; mean age, 65.8 years; age range, 17-96 years), which included an age- and sex-matched subgroup (adjusted control group, n = 2244). The rehydration group received an oral rehydration solution (500 mL of liquid in which osmotic pressure is adjusted to enhance gastrointestinal absorption) before abdominal and pelvic CT. Patients were also divided into subclinically dehydrated (n = 997) and hydrated (n = 4962) groups according to their answers to a questionnaire that they completed before the CT examination. The patients were interviewed about contrast-induced adverse reactions before they left the CT room, and the reactions were categorized as allergiclike or physiologic. The incidence of reactions was compared between the rehydration and control groups and between the subclinical dehydration and hydrated groups. The rehydration and control groups were compared with an unpaired t test or a chi-square or Fisher test. The overall incidence of an acute adverse reaction was 4.3% (254/5959); the acute adverse reactions included 136 allergiclike and 118 physiologic reactions. Fourteen allergiclike and nine physiologic reactions were moderate grade, and none was severe. There was no significant difference between the rehydration group and adjusted control group in the overall incidence of adverse reactions (99/2244 [4.4%] vs 100/2244 [4.5%], respectively; p = 0.9422) or between the subclinically dehydrated group

Comparison of palonosetron, granisetron, and ramosetron for the prevention of postoperative nausea and vomiting after laparoscopic gynecologic surgery: a prospective randomized trial.

PubMed

Lee, Won-Suk; Lee, Kwang-Beom; Lim, Soyi; Chang, Young Gin

2015-09-03

Selective 5-hydroxytryptamine type 3 (5-HT3) receptor antagonists are reported to have potent antiemetic effects for postoperative nausea and vomiting (PONV). The purpose of this study was to prospectively evaluate the efficacy of palonosetron, granisetron, and ramosetron for the prevention of PONV in patients undergoing laparoscopic gynecologic surgery. In this prospective, randomized observational study, 105 healthy female patients who were undergoing laparocopic hystectomy under general anaesthesia were enrolled (clinical trial number: NCT01752374, www.clinicaltrials.gov ). Patients were divided into three groups: the palonostron (0.075 mg i.v.; n = 35), the granisetron group (3 mg i.v.; n = 35), and the ramosetron group (0.3 mg i.v.; n = 35). The treatments were given before the end of surgery. The incidence of PONV, severity of nausea/vomiting, and the use of rescue antiemetic requirements during the first 48 h after surgery were evaluated. The overall incidence of PONV was 33.3 % for this series. The number of complete responders at 48 h after the surgery was 21 (60.0 %) for palonosetron, 24 (68.6 %) for granisetron, and 26 (71.4 %) for ramosetron, representing no statistical difference (P = 0.086). There were no significant differences in the overall incidence of postoperative nausea and vomiting and complete responders for palonosetron, granisetron and ramosetron group. NCT01752374 , www.clinicaltrials.gov .

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

PubMed

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

Impact of Targeted Preoperative Optimization on Clinical Outcome in Emergency Abdominal Surgeries: A Prospective Randomized Trial.

PubMed

Sethi, Ashish; Debbarma, Miltan; Narang, Neeraj; Saxena, Anudeep; Mahobia, Mamta; Tomar, Gaurav Singh

2018-01-01

Perforation peritonitis continues to be one of the most common surgical emergencies that need a surgical intervention most of the times. Anesthesiologists are invariably involved in managing such cases efficiently in perioperative period. The assessment and evaluation of Acute Physiology and Chronic Health Evaluation II (APACHE II) score at presentation and 24 h after goal-directed optimization, administration of empirical broad-spectrum antibiotics, and definitive source control postoperatively. Outcome assessment in terms of duration of hospital stay and mortality in with or without optimization was also measured. It is a prospective, randomized, double-blind controlled study in hospital setting. One hundred and one patients aged ≥18 years, of the American Society of Anesthesiologists physical Status I and II (E) with clinical diagnosis of perforation peritonitis posted for surgery were enrolled. Enrolled patients were randomly divided into two groups. Group A is optimized by goal-directed optimization protocol in the preoperative holding room by anesthesiology residents whereas in Group S, managed by surgery residents in the surgical wards without any fixed algorithm. The assessment of APACHE II score was done as a first step on admission and 24 h postoperatively. Duration of hospital stay and mortality in both the groups were also measured and compared. Categorical data are presented as frequency counts (percent) and compared using the Chi-square or Fisher's exact test. The statistical significance for categorical variables was determined by Chi-square analysis. For continuous variables, a two-sample t -test was applied. The mean APACHE II score on admission in case and control groups was comparable. Significant lowering of serial scores in case group was observed as compared to control group ( P = 0.02). There was a significant lowering of mean duration of hospital stay seen in case group (9.8 ± 1.7 days) as compared to control group ( P = 0

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

PubMed

Coric, Domagoj; Guyer, Richard D; Nunley, Pierce D; Musante, David; Carmody, Cameron; Gordon, Charles; Lauryssen, Carl; Boltes, Margaret O; Ohnmeiss, Donna D

2018-03-01

OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but

[Prospective economic evaluation of image-guided radiation therapy for prostate cancer in the framework of the national programme for innovative and costly therapies assessment].

PubMed

Pommier, P; Morelle, M; Perrier, L; de Crevoisier, R; Laplanche, A; Dudouet, P; Mahé, M-A; Chauvet, B; Nguyen, T-D; Créhange, G; Zawadi, A; Chapet, O; Latorzeff, I; Bossi, A; Beckendorf, V; Touboul, E; Muracciole, X; Bachaud, J-M; Supiot, S; Lagrange, J-L

2012-09-01

The main objective of the economical study was to prospectively and randomly assess the additional costs of daily versus weekly patient positioning quality control in image-guided radiotherapy (IGRT), taking into account the modalities of the 3D-imaging: tomography (CBCT) or gold seeds implants. A secondary objective was to prospectively assess the additional costs of 3D versus 2D imaging with portal imaging for patient positioning controls. Economics data are issued from a multicenter randomized medico-economics trial comparing the two frequencies of patient positioning control during prostate IGRT. A prospective cohort with patient positioning control with PI (control group) was constituted for the cost comparison between 3D (IGRT) versus 2D imaging. The economical evaluation was focused to the radiotherapy direct costs, adopting the hospital's point of view and using a microcosting method applied to the parameters that may lead to cost differences between evaluated strategies. The economical analysis included a total of 241 patients enrolled between 2007 and 2011 in seven centres, 183 in the randomized study (128 with CBCT and 55 with fiducial markers) and 58 in the control group. Compared to weekly controls, the average additional cost per patient of daily controls was €847 (CBCT) and €179 (markers). Compared to PI, the average additional cost per patient was €1392 (CBCT) and €997 (fiducial markers) for daily controls; €545 (CBCT) and €818 (markers) in case of weekly controls. A daily frequency for image control in IGRT and 3D images patient positioning control (IGRT) for prostate cancer lead to significant additional cost compared to weekly control and 2D imaging (PI). Long-term clinical assessment will permit to assess the medico-economical ratio of these innovative radiotherapy modalities. Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

Carvedilol prospective randomized cumulative survival (COPERNICUS) trial: carvedilol in severe heart failure.

PubMed

Fowler, Michael B

2004-05-06

The impact of carvedilol on the survival of patients with severe heart failure was examined in the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial. The trial recruited 2,289 patients with symptoms at rest or on minimal exertion despite therapy with angiotensin-converting enzyme inhibitors and a left ventricular ejection fraction of < or = 0.25. After an average follow-up period of 10.4 months, mortality was reduced by 34% in the carvedilol group. Carvedilol also reduced the number of days spent in the hospital for any cause by 27% and the number of days spent in the hospital for heart failure by 40%. Patients in the carvedilol group felt better and were less likely to have a serious adverse event. The benefits of carvedilol appeared early and were detected during the up-titration period.

Checklists for the Evaluation of Educational Software: Critical Review and Prospects.

ERIC Educational Resources Information Center

Tergan, Sigmar-Olaf

1998-01-01

Reviews strengths and weaknesses of check lists for the evaluation of computer software and outlines consequences for their practical application. Suggests an approach based on an instructional design model and a comprehensive framework to cope with problems of validity and predictive power of software evaluation. Discusses prospects of the…

Prophylactic amnioinfusion in preganancies complicated by chorioamnionitis: a prospective randomized trial.

PubMed

Parilla, B V; McDermott, T M

1998-01-01

The objective of this article is to prospectively investigate the efficacy of amnioinfusion as a means to reduce febrile morbidity in pregnancies complicated by chorioamnionitis. All laboring patients with a temperature > or =100.1 degrees F were approached for study participation. Exclusion criteria included amnionitis diagnosed at greater than 8 cm dilation, multiple gestation, placental abruption, or a nonreassuring fetal heart rate tracing. Consenting patients were randomized to receive antibiotics (ampicillin or penicillin with gentamicin) and acetaminophen with or without amnioinfusion. All patients received intrauterine pressure catheter placement. For study patients, normal saline at room temperature was infused at 10 mL/min for 60 min, then 3 mL/min until delivery. Postpartum endometritis was defined as a temperature = 100.4 degrees F accompanied by uterine tenderness more than 12 hr after delivery. Statistical analysis was performed using the Student's t-test for continuous data and Chi-square for discrete variables. Thirty-six patients were enrolled, and complete data were available for 34 patients (17 in each group). There were no differences between groups with respect to maternal age, gravidity, race, or gestational age. There were also no differences between groups in duration of rupture of membranes, temperature at randomization, interval from randomization to delivery, cesarean section rate, or umbilical cord arterial pH. The mean temperature at the time of delivery was 99.8+/-0.9 degrees F for the amnioinfusion group versus 100.5+/-1.0 degrees F for the control group (p=0.046). Three of 17 amnioinfusion patients and 3 of 17 control patients had postpartum endometritis. There was 1 neonatal infection in the treatment group and no neonatal infections among the control patients. Prophylactic amnioinfusion was associated with a decline in temperature at the time of delivery. No untoward effects from the amnioinfusion were identified.

Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial.

PubMed

Wu, Xiuwen; Ren, Jianan; Wang, Gefei; Wang, Jianzhong; Wang, Feng; Fan, Yueping; Li, Yuanxin; Han, Gang; Zhou, Yanbing; Song, Xiaofei; Quan, Bin; Yao, Min; Li, Jieshou

2015-10-07

The management of an enterocutaneous fistula poses a significant challenge to surgeons and is often associated with a costly hospital stay and long-term discomfort. The use of fibrin glue in the fistula tract has been shown to promote closure of low output enterocutaneous fistulas. Our previous nonrandomized study demonstrated that autologous platelet-rich fibrin glue treatment significantly decreased time to fistula closure and promoted closure rates. However, there are several limitations in the study, which may lead to bias in our conclusion. Thus, a multicenter, randomized, controlled clinical trial is required. The study is designed as a randomized, open-label, three-arm, multicenter study in nine Chinese academic hospitals for evaluating the efficacy and safety of fibrin glue for sealing low-output fistulas. An established number of 171 fistula patients will undergo prospective random assignment to autologous fibrin glue, commercial porcine fibrin sealants or drainage cessation (1:1:1). The primary endpoint is fistula closure time (defined as the interval between the day of enrollment and day of fistula closure) during the 14-day treatment period. To our knowledge, this is the first study to evaluate the safety and efficacy of both autologous and commercial fibrin glue sealing for patients with low-output volume fistulas. NCT01828892 . Registration date: April 2013.

Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

PubMed Central

Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

2017-01-01

An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies. PMID:28584874

Prospective evaluation of oral gastrografin(®) in the management of postoperative adhesive small bowel obstruction.

PubMed

Rahmani, Nasrin; Mohammadpour, Reza Ali; Khoshnood, Peyman; Ahmadi, Amirhossein; Assadpour, Sara

2013-06-01

Oral Gastrografin®, a hyperosmolar water-soluble contrast medium, may have a therapeutic effect in adhesive small bowel obstruction. However, findings are still conflicting, as some authors did not find a therapeutic advantage. So, this prospective, randomized, and clinical trial study was designed to determine the value of Gastrografin in adhesive small bowel obstruction. The primary end points were the evaluation of the operative rate reduction and shortening the hospital stay after the use of Gastrografin. A total of 84 patients were randomized into two groups: the control group received conventional treatment, whereas the study group received in addition of 100 mL Gastrografin meal. Patients were followed up within 4 days after admission, and clinical and radiological (if needed) improvements were evaluated. Although the results showed that Gastrografin can decrease the need for surgical management by 14.5 %, no statistically significant differences were observed between the two groups (P = 0.07). Nevertheless, the length of hospital stay revealed a significant reduction from 4.67 ± 1.18 days to 2.69 ± 1.02 days (P = 0.00). The use of Gastrografin in adhesive small bowel obstruction is safe and reduces the length of hospital stay. As a result, the cost of hospital bed occupancy is reduced. Hence, if there was no indication of emergency surgery, administration of oral Gastrografin as a nonoperative treatment in adhesive small bowel obstruction is also recommended.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces

PubMed Central

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

Purpose To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Setting Assil Eye Institute, Beverly Hills, CA, USA. Design Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients and methods Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Results Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. Conclusion The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

PubMed

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

PubMed

Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

2016-05-01

Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were

Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial.

PubMed

Lee, Dong Gyu; Ahn, Sang-Ho; Lee, Jungwon

2016-08-01

Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid.

Clinical comparison between open plating and minimally invasive plate osteosynthesis for displaced proximal humeral fractures: A prospective randomized controlled trial.

PubMed

Sohn, Hoon-Sang; Jeon, Yoon Sang; Lee, JuHan; Shin, Sang-Jin

2017-06-01

Recently, minimally invasive plate osteosynthesis (MIPO) has been widely used for the treatment of proximal humeral fractures. However, there is concern about whether the MIPO in comminuted proximal humeral fractures is also comparable to open plating. The purpose of this study was to compare the clinical and radiographic outcomes of open plating and MIPO for acute displaced proximal humeral fractures. In this prospective, randomized controlled study, 107 patients who had an acute proximal humeral fracture were randomized to either the open plating or MIPO techniques. Forty-five patients treated with open plating and 45 with the MIPO technique who were followed up at least 1year were evaluated. Shoulder functional assessment, operating time, several radiographic parameters, and complications were evaluated at final follow-up. The mean follow-up period was 15.0 months in the open plating and 14.3 months in the MIPO technique. There were no statistically significant differences in functional assessment scores and radiographic parameters between the two groups. High complications rates were found in 4-part fracture in both surgical methods The average operation time in the MIPO group were significantly lower compared to the open plating group (p<0.05). This study showed MIPO in proximal humerus fractures had similar clinical and radiographic outcomes compared to the open plating. However, the MIPO technique in proximal humerus fracture provided significantly shorter operation time than the open plating. Copyright © 2017 Elsevier Ltd. All rights reserved.

Double-blind prospective randomized study comparing polyethylene glycol to lactulose for bowel preparation in colonoscopy.

PubMed

Menacho, Aline Moraes; Reimann, Adriano; Hirata, Lie Mara; Ganzerella, Caroline; Ivano, Flavio Heuta; Sugisawa, Ricardo

2014-01-01

Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation.

DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY COMPARING POLYETHYLENE GLYCOL TO LACTULOSE FOR BOWEL PREPARATION IN COLONOSCOPY

PubMed Central

MENACHO, Aline Moraes; REIMANN, Adriano; HIRATA, Lie Mara; GANZERELLA, Caroline; IVANO, Flavio Heuta; SUGISAWA, Ricardo

2014-01-01

Background Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. Aim To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. Methods A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Results Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Conclusion Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation. PMID:24676290

Measuring change in quality of life: bias in prospective and retrospective evaluation.

PubMed

Blome, Christine; Augustin, Matthias

2015-01-01

Treatment effects on health-related quality of life (QOL) often differ depending on whether they are measured prospectively (before and after treatment) or retrospectively (after treatment only). These two approaches can be subject to different sorts of bias: Prospective evaluations may be biased by scale recalibration (a changed understanding of the response scale), and retrospective evaluations may be biased by recall bias (a wrong assessment of former QOL). On the basis of an analysis of the literature, we present an overview on possible biases in prospective and retrospective measurement of QOL and how these biases are named and defined in the literature. The definitions of different biases are inconsistent. Many authors do not clearly distinguish measurement bias from true change. Furthermore, some consider only scale recalibration or only recall bias. Much of the current discussion on bias in prospective and retrospective QOL measurement suffers from unclear definitions, especially of "response shift" and "recall bias," or from neglecting one of the possible biases. We suggest more elaborate definitions for different types of bias and recommend taking both kinds of bias into consideration when measuring change in QOL. The relevance of the different biases depends on the type of study, and so either prospective or retrospective assessment may be more appropriate. Copyright © 2015. Published by Elsevier Inc.

Topical silver sulfadiazine vs collagenase ointment for the treatment of partial thickness burns in children: a prospective randomized trial.

PubMed

Ostlie, Daniel J; Juang, David; Aguayo, Pablo; Pettiford-Cunningham, Janine P; Erkmann, Erin A; Rash, Diane E; Sharp, Susan W; Sharp, Ronald J; St Peter, Shawn D

2012-06-01

The 2 most commonly used topical agents for partial thickness burns are silver sulfadiazine (SSD) and collagenase ointment (CO). Silver sulfadiazine holds antibacterial properties, and eschar separation occurs naturally. Collagenase ointment is an enzyme that cleaves denatured collagen facilitating separation but has no antibacterial properties. Currently, there are no prospective comparative data in children for these 2 agents. Therefore, we conducted a prospective randomized trial. After institutional review board approval, patients were randomized to daily debridement with SSD or CO. Primary outcome was the need for skin grafting. Patients were treated for 2 days with SSD with subsequent randomization. Polymyxin was mixed with CO for antibacterial coverage. Debridements were performed daily for 10 days or until the burn healed. Grafting was performed after 10 days if not healed. From January 2008 to January 2011, 100 patients were enrolled, with no differences in patient characteristics. There were no differences in clinical course, outcome, or need for skin grafting. Wound infections occurred in 7 patients treated with CO and 1 patient treated with SSD (P = .06). Collagenase ointment was more expensive than SSD (P < .001). However, total hospital charges did not differ. There are no differences in outcomes between topical SSD or CO in the management of childhood burns results. Copyright © 2012 Elsevier Inc. All rights reserved.

Preparation of nose for nasal endoscopy: cotton pledget packing versus topical spray. A prospective randomized blinded study.

PubMed

Mishra, Prasun; Kaushik, Maitri; Dehadaray, Arun; Qadri, Haris; Raichurkar, Annapurna; Seth, Tanvi

2013-01-01

During nasal endoscopy it is essential to have proper visualization of structures with minimal discomfort to patient and surgeon. For this it is essential that the nose is well prepared before the procedure. The main objective of the study is to compare and evaluate the efficacy of cotton pledget packing versus topical sprays in preparation of nose for nasal endoscopy. The method includes prospective randomized blinded study on 100 patients. Patients were randomly divided in two groups. In first group the nose was packed with 4% lignocaine with xylometazoline nasal drops and in the other group it was prepared with 10% lignocaine topical spray and xylometazoline nose drops. Following the procedure, patient and the surgeon were asked a pre-formed questionnaire to know their experience during endoscopy. It was observed the packing group required more preparatory time as compared to the spray group. The group which was packed had less discomfort, less pain while endoscopy. The visualization of structures was significantly better in the packed group. Eight patients in the packed group did have some mucosal bleed during the process of packing which was not seen in the spray group. Both methods of preparation have merits and demerits but in terms of discomfort, pain during procedure and visualization of structure, packing of nasal cavity with 4% lignocaine and xylometazoline drops is better than spraying of nose with 10% lignocaine and xylometazoline drops.

Cardiac catheterization laboratory inpatient forecast tool: a prospective evaluation

PubMed Central

Flanagan, Eleni; Siddiqui, Sauleh; Appelbaum, Jeff; Kasper, Edward K; Levin, Scott

2016-01-01

Objective To develop and prospectively evaluate a web-based tool that forecasts the daily bed need for admissions from the cardiac catheterization laboratory using routinely available clinical data within electronic medical records (EMRs). Methods The forecast model was derived using a 13-month retrospective cohort of 6384 catheterization patients. Predictor variables such as demographics, scheduled procedures, and clinical indicators mined from free-text notes were input to a multivariable logistic regression model that predicted the probability of inpatient admission. The model was embedded into a web-based application connected to the local EMR system and used to support bed management decisions. After implementation, the tool was prospectively evaluated for accuracy on a 13-month test cohort of 7029 catheterization patients. Results The forecast model predicted admission with an area under the receiver operating characteristic curve of 0.722. Daily aggregate forecasts were accurate to within one bed for 70.3% of days and within three beds for 97.5% of days during the prospective evaluation period. The web-based application housing the forecast model was used by cardiology providers in practice to estimate daily admissions from the catheterization laboratory. Discussion The forecast model identified older age, male gender, invasive procedures, coronary artery bypass grafts, and a history of congestive heart failure as qualities indicating a patient was at increased risk for admission. Diagnostic procedures and less acute clinical indicators decreased patients’ risk of admission. Despite the site-specific limitations of the model, these findings were supported by the literature. Conclusion Data-driven predictive analytics may be used to accurately forecast daily demand for inpatient beds for cardiac catheterization patients. Connecting these analytics to EMR data sources has the potential to provide advanced operational decision support. PMID:26342217

A Prospective Evaluation of Helical Tomotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bauman, Glenn; Yartsev, Slav; Rodrigues, George

2007-06-01

Purpose: To report results from two clinical trials evaluating helical tomotherapy (HT). Methods and Materials: Patients were enrolled in one of two prospective trials of HT (one for palliative and one for radical treatment). Both an HT plan and a companion three-dimensional conformal radiotherapy (3D-CRT) plan were generated. Pretreatment megavoltage computed tomography was used for daily image guidance. Results: From September 2004 to January 2006, a total of 61 sites in 60 patients were treated. In all but one case, a clinically acceptable tomotherapy plan for treatment was generated. Helical tomotherapy plans were subjectively equivalent or superior to 3D-CRT inmore » 95% of plans. Helical tomotherapy was deemed equivalent or superior in two thirds of dose-volume point comparisons. In cases of inferiority, differences were either clinically insignificant and/or reflected deliberate tradeoffs to optimize the HT plan. Overall imaging and treatment time (median) was 27 min (range, 16-91 min). According to a patient questionnaire, 78% of patients were satisfied to very satisfied with the treatment process. Conclusions: Helical tomotherapy demonstrated clear advantages over conventional 3D-CRT in this diverse patient group. The prospective trials were helpful in deploying this technology in a busy clinical setting.« less

Feasibility of quasi-random band model in evaluating atmospheric radiance

NASA Technical Reports Server (NTRS)

Tiwari, S. N.; Mirakhur, N.

1980-01-01

The use of the quasi-random band model in evaluating upwelling atmospheric radiation is investigated. The spectral transmittance and total band adsorptance are evaluated for selected molecular bands by using the line by line model, quasi-random band model, exponential sum fit method, and empirical correlations, and these are compared with the available experimental results. The atmospheric transmittance and upwelling radiance were calculated by using the line by line and quasi random band models and were compared with the results of an existing program called LOWTRAN. The results obtained by the exponential sum fit and empirical relations were not in good agreement with experimental results and their use cannot be justified for atmospheric studies. The line by line model was found to be the best model for atmospheric applications, but it is not practical because of high computational costs. The results of the quasi random band model compare well with the line by line and experimental results. The use of the quasi random band model is recommended for evaluation of the atmospheric radiation.

Suprapatellar Versus Infrapatellar Tibial Nail Insertion: A Prospective Randomized Control Pilot Study.

PubMed

Chan, Daniel S; Serrano-Riera, Rafael; Griffing, Rebecca; Steverson, Barbara; Infante, Anthony; Watson, David; Sagi, H Claude; Sanders, Roy W

2016-03-01

The purpose of this OTA-approved pilot study was to compare the clinical and functional outcomes of the knee joint after infrapatellar (IP) versus suprapatellar (SP) tibial nail insertion. Prospective, randomized. Level I trauma center. After institutional review board approval, skeletally mature patients with OTA 42 tibial shaft fractures were randomized into either an IP or SP nail insertion group after informed consent was obtained. The SP also underwent prenail and postnail insertion patella-femoral (PF) joint arthroscopy. Patients underwent follow-up (6 weeks, 3, 6, and 12 months) with standard radiographs, as well as visual analog score and pain diagram documentation. At the 6-month and 12-month visits, knee function questionnaires (Lysholm knee scale and SF-36) were completed. Magnetic resonance imaging/image (MRI) of the affected knee was obtained at 12 months. Ten patients in each group were required for a power analysis for the anticipated larger randomized control trial, but enrollment in each arm was not limited because of known problems with patient follow-up over a 12-month period. A total of 41 patients/fractures were enrolled in this study. Of those, only 25 patients/fractures (14 IP, 11 SP) fully complied with and completed 12 months of follow-up. Six of 11 SP presented with articular changes (chondromalacia) in the PF joint during the preinsertion arthroscopy. Three patients displayed a change in the articular cartilage based on postnail insertion arthroscopy. At 12 months, all fractures in both groups had proceeded to union. There were no differences between the affected and unaffected knee with respect to range of motion. Functional visual analog score and Lysholm knee scores showed no significant differences between groups (P > 0.05). The SF-36v2 comparison also revealed no significant differences in the overall score, all 4 mental components, and 3/4 physical components (P > 0.05). The bodily pain component score was superior in the SP group

A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation.

PubMed

Haidinger, Michael; Werzowa, Johannes; Voigt, Hans-Christian; Pleiner, Johannes; Stemer, Gunar; Hecking, Manfred; Döller, Dominik; Hörl, Walter H; Weichhart, Thomas; Säemann, Marcus D

2010-10-06

New-onset diabetes mellitus after transplantation (NODAT), a frequent and serious complication after transplantation, is associated with decreased graft and patient survival. Currently, it is diagnosed and treated primarily according to existing guidelines for type II diabetes. To date, only a few trials have studied antidiabetic drugs in patients with NODAT. Vildagliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor that improves pancreatic islet function by enhancing both α- and β-cell responsiveness to increased blood glucose. Experimental data show potential protective effects of DPP-4 inhibitors on islet function after exogenous stress stimuli including immunosuppressants. Therefore, the therapy of NODAT with this class of compounds seems attractive. At present, vildagliptin is used to treat type II diabetes as monotherapy or in combination with other antidiabetic drugs, since that it efficiently decreases glycated hemoglobin (HbA1c) values. Additionally, vildagliptin has been shown to be safe in patients with moderately impaired kidney function. This study will evaluate the safety and efficacy of vildagliptin monotherapy in renal transplant recipients with recently diagnosed NODAT. This study is a randomized, placebo-controlled, double-blind, prospective phase II trial. Using the results of routinely performed oral glucose tolerance tests (OGTT) in stable renal transplant patients at our center, we will recruit patients without a history of diabetes and a 2 h glucose value surpassing 200 mg/dl (11.1 mmol/l). They are randomized to receive either 50 mg vildagliptin or placebo once daily. A total of 32 patients with newly diagnosed NODAT will be included. The primary endpoint is the difference in the 2 h glucose value between baseline and the repeated OGTT performed 3 months after treatment start, compared between the vildagliptin- and the placebo-group. Secondary endpoints include changes in HbA1c and fasting plasma glucose (FPG). The safety of

[Nitroglycerin patch for tocolysis--a prospective randomized comparison with fenoterol by infusion].

PubMed

Schleussner, E; Richter, S; Gross, W; Kähler, C; Möller, A; Möller, U; Seewald, H J

2001-01-01

To evaluate tocolytic efficacy of transdermal glyceryl trinitrate (GTN) in comparison to fenoterol per infusionem in a prospective randomized multicenter study. 50 pregnant women between 27 and 35 weeks of gestation with preterm labour were treated with either GTN patches (0.4-0.8 mg/h) or fenoterol per infusionem (60-120 micrograms/h) up to stop of contractions or 35 weeks in maximum. The primary outcomes were the prolongation of gestation by 48 h, 7 days or up to 37 weeks of gestation as well as the neonatal outcome. The progression of cervical ripening and maternal side effects during tocolysis were assessed as secondary outcome criteria. There was no difference in successful tocolysis for 48 h and 7 days in both groups, whereas significantly more women passed 37 weeks after GTN therapy. So mean duration of pregnancy, birth weight and height were greater, whereas transfer into neonatal care unit was significantly rare after GTN. There were no differences in neonatal outcome and progression of cervical ripening during tocolysis. Maternal side effects during GTN were fewer and weaker compared with fenoterol. Circa 70% of GTN treated women had a headache temporary, whereas more than 90% of the patients with fenoterol suffered from tachycardia and tremor. Tocolytic efficacy of transdermal GTN was at least equivalent to the established beta-mimetic therapy with fenoterol. Because of the lower preterm delivery rate transfer into neonatal care for control was significantly rarer after GTN with equally good neonatal outcome in both groups. Beside the headache transdermal GTN therapy had lower maternal side effects in comparison to fenoterol.

Is instillation of anesthetic gel necessary in flexible cystoscopic examination? A prospective randomized study.

PubMed

Kobayashi, Takashi; Nishizawa, Koji; Ogura, Keiji

2003-01-01

To determine whether urethral injection of anesthetic and lubricating agent before outpatient flexible cystoscopic examination is worthwhile regarding patient tolerance of pain. A randomized prospective study was conducted. A total of 133 consecutive men scheduled to undergo flexible cystoscopy were randomized to receive 11 mL of 0.2% oxybuprocaine hydrochloride gel (group 1), 11 mL of plain lubricating gel (group 2), or no gel injection (group 3). In every group, 2% lidocaine gel was applied to the fiberscope. Patients recorded the level of pain during gel instillation, scope insertion, and intravesical observation separately on a 100-mm visual analog self-assessment scale. Pain scores for gel instillation were approximately two thirds those for scope insertion and intravesical observation in groups 1 and 2. No significant difference was noted in the pain score of each group during either scope insertion or intravesical observation. Pain during intraurethral gel instillation is significant. Anesthetic gel instillation has no advantage compared with no-gel injection in men when lubricating gel is applied to a flexible fiberscope.

Prone position as prevention of lung injury in comatose patients: a prospective, randomized, controlled study.

PubMed

Beuret, Pascal; Carton, Marie-Jose; Nourdine, Karim; Kaaki, Mahmoud; Tramoni, Gerard; Ducreux, Jean-Claude

2002-05-01

Comatose patients frequently exhibit pulmonary function worsening, especially in cases of pulmonary infection. It appears to have a deleterious effect on neurologic outcome. We therefore conducted a randomized trial to determine whether daily prone positioning would prevent lung worsening in these patients. Prospective, randomized, controlled study. Sixteen-bed intensive care unit. Fifty-one patients who required invasive mechanical ventilation because of coma with Glascow coma scores of 9 or less. In the prone position (PP) group: prone positioning for 4 h once daily until the patients could get up to sit in an armchair; in the supine position (SP) group: supine positioning. The primary end point was the incidence of lung worsening defined by an increase in the Lung Injury Score of at least 1 point since the time of randomization. The secondary end point was the incidence of ventilator-associated pneumonia (VAP). A total of 25 patients were randomly assigned to the PP group and 26 patients to the SP group. The characteristics of the patients from the two groups were similar at randomization. The incidence of lung worsening was lower in the PP group (12%) than in the SP group (50%) ( p=0.003). The incidence of VAP was 20% in the PP group and 38.4% in the SP group ( p=0.14). There was no serious complication attributable to prone positioning, however, there was a significant increase of intracranial pressure in the PP. In a selected population of comatose ventilated patients, daily prone positioning reduced the incidence of lung worsening.

The WOMEN study: what is the optimal method for ischemia evaluation in women? A multi-center, prospective, randomized study to establish the optimal method for detection of coronary artery disease (CAD) risk in women at an intermediate-high pretest likelihood of CAD: study design.

PubMed

Mieres, Jennifer H; Shaw, Leslee J; Hendel, Robert C; Heller, Gary V

2009-01-01

Coronary artery disease remains the leading cause of morbidity and mortality in women. The optimal non-invasive test for evaluation of ischemic heart disease in women is unknown. Although current guidelines support the choice of the exercise tolerance test (ETT) as a first line test for women with a normal baseline ECG and adequate exercise capabilities, supportive data for this recommendation are controversial. The what is the optimal method for ischemia evaluation in women? (WOMEN) study was designed to determine the optimal non-invasive strategy for CAD risk detection of intermediate and high risk women presenting with chest pain or equivalent symptoms suggestive of ischemic heart disease. The study will prospectively compare the 2-year event rates in women capable of performing exercise treadmill testing or Tc-99 m tetrofosmin SPECT myocardial perfusion imaging (MPI). The study will enroll women presenting for the evaluation of chest pain or anginal equivalent symptoms who are capable of performing >5 METs of exercise while at intermediate-high pretest risk for ischemic heart disease who will be randomized to either ETT testing alone or with Tc-99 m tetrofosmin SPECT MPI. The null hypothesis for this project is that the exercise ECG has the same negative predictive value for risk detection as gated myocardial perfusion SPECT in women. The primary aim is to compare 2-year cardiac event rates in women randomized to SPECT MPI to those randomized to ETT. The WOMEN study seeks to provide objective information for guidelines for the evaluation of symptomatic women with an intermediate-high likelihood for CAD.

A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

PubMed

Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

2014-09-01

To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

Recommendations and illustrations for the evaluation of photonic random number generators

NASA Astrophysics Data System (ADS)

Hart, Joseph D.; Terashima, Yuta; Uchida, Atsushi; Baumgartner, Gerald B.; Murphy, Thomas E.; Roy, Rajarshi

2017-09-01

The never-ending quest to improve the security of digital information combined with recent improvements in hardware technology has caused the field of random number generation to undergo a fundamental shift from relying solely on pseudo-random algorithms to employing optical entropy sources. Despite these significant advances on the hardware side, commonly used statistical measures and evaluation practices remain ill-suited to understand or quantify the optical entropy that underlies physical random number generation. We review the state of the art in the evaluation of optical random number generation and recommend a new paradigm: quantifying entropy generation and understanding the physical limits of the optical sources of randomness. In order to do this, we advocate for the separation of the physical entropy source from deterministic post-processing in the evaluation of random number generators and for the explicit consideration of the impact of the measurement and digitization process on the rate of entropy production. We present the Cohen-Procaccia estimate of the entropy rate h (𝜖 ,τ ) as one way to do this. In order to provide an illustration of our recommendations, we apply the Cohen-Procaccia estimate as well as the entropy estimates from the new NIST draft standards for physical random number generators to evaluate and compare three common optical entropy sources: single photon time-of-arrival detection, chaotic lasers, and amplified spontaneous emission.

Physical function outcome in cervical radiculopathy patients after physiotherapy alone compared with anterior surgery followed by physiotherapy: a prospective randomized study with a 2-year follow-up.

PubMed

Peolsson, Anneli; Söderlund, Anne; Engquist, Markus; Lind, Bengt; Löfgren, Håkan; Vavruch, Ludek; Holtz, Anders; Winström-Christersson, Annelie; Isaksson, Ingrid; Öberg, Birgitta

2013-02-15

Prospective randomized study. To investigate differences in physical functional outcome in patients with radiculopathy due to cervical disc disease, after structured physiotherapy alone (consisting of neck-specific exercises with a cognitive-behavioral approach) versus after anterior cervical decompression and fusion (ACDF) followed by the same structured physiotherapy program. No earlier studies have evaluated the effectiveness of a structured physiotherapy program or postoperative physical rehabilitation after ACDF for patients with magnetic resonance imaging-verified nerve compression due to cervical disc disease. Our prospective randomized study included 63 patients with radiculopathy and magnetic resonance imaging-verified nerve root compression, who were randomized to receive either ACDF in combination with physiotherapy or physiotherapy alone. For 49 of these patients, an independent examiner measured functional outcomes, including active range of neck motion, neck muscle endurance, and hand-related functioning before treatment and at 3-, 6-, 12-, and 24-month follow-ups. There were no significant differences between the 2 treatment alternatives in any of the measurements performed (P = 0.17-0.91). Both groups showed improvements over time in neck muscle endurance (P ≤ 0.01), manual dexterity (P ≤ 0.03), and right-handgrip strength (P = 0.01). Compared with a structured physiotherapy program alone, ACDF followed by physiotherapy did not result in additional improvements in neck active range of motion, neck muscle endurance, or hand-related function in patients with radiculopathy. We suggest that a structured physiotherapy program should precede a decision for ACDF intervention in patients with radiculopathy, to reduce the need for surgery. 2.

Low-pressure pneumoperitoneum versus standard pneumoperitoneum in laparoscopic cholecystectomy, a prospective randomized clinical trial.

PubMed

Sandhu, Trichak; Yamada, Sirikan; Ariyakachon, Veeravorn; Chakrabandhu, Thiraphat; Chongruksut, Wilaiwan; Ko-iam, Wasana

2009-05-01

Post-laparoscopic pain syndrome is well recognized and characterized by abdominal and particularly shoulder tip pain; it occurs frequently following laparoscopic cholecystectomy. The etiology of post-laparoscopic pain can be classified into three aspects: visceral, incision, and shoulder. The origin of shoulder pain is only partly understood, but it is commonly assumed that the cause is overstretching of the diaphragmatic muscle fibers owing to a high rate of insufflations. This study aimed to compare the frequency and intensity of shoulder tip pain between low-pressure (7 mmHg) and standard-pressure (14 mmHg) in a prospective randomized clinical trial. One hundred and forty consecutive patients undergoing elective laparoscopic cholecystectomy were randomized prospectively to either high- or low-pressure pneumoperitoneum and blinded by research nurses who assessed the patients during the postoperative period. The statistical analysis included sex, mean age, weight, American Society of Anesthesiologists (ASA) grade, operative time, complication rate, duration of surgery, conversion rate, postoperative pain by using visual analogue scale, number of analgesic injections, incidence and severity of shoulder tip pain, and postoperative hospital stay. p < 0.05 was considered indicative of significance. The characteristics of the patients were similar in the two groups except for the predominance of males in the standard-pressure group (controls). The procedure was successful in 68 of 70 patients in the low-pressure group compared with in 70 patients in the standard group. Operative time, number of analgesic injections, visual analogue score, and length of postoperative days were similar in both groups. Incidence of shoulder tip pain was higher in the standard-pressure group, but not statistically significantly so (27.9% versus 44.3%) (p = 0.100). Low-pressure pneumoperitoneum tended to be better than standard-pressure pneumoperitoneum in terms of lower incidence of

MicroSaw and Piezosurgery in Harvesting Mandibular Bone Blocks from the Retromolar Region: A Randomized Split-Mouth Prospective Clinical Trial.

PubMed

Hanser, Thomas; Doliveux, Romain

The aim of this randomized prospective split-mouth clinical trial was to evaluate the outcome of bone block harvesting from the retromolar region using the MicroSaw and Piezosurgery. Fifty-three patients for extensive bilateral bone grafting procedures with or without concomitant implant placement in the maxilla and/or mandible were scheduled. In each patient, bone blocks were harvested in the retromolar area within the external oblique ridge of the mandible. Using a randomized protocol, bone blocks were harvested with the MicroSaw and Piezosurgery either from the right or the left side. Clinical outcome parameters were the comparison of osteotomy time; volume of block graft; and clinical determination of intraoperative complications such as hemorrhage, nerve injury, pain, swelling, and healing of the donor site. The mean osteotomy time for harvesting including luxating a bone block was 5.63 (± 1.37) minutes using the MicroSaw and 16.47 (± 2.74) minutes using Piezosurgery (P < .05). A mean graft volume of 1.62 (± 0.27) cm 3 was measured with the MicroSaw and 1.26 (± 0.27) cm 3 with the piezoelectric surgical device (P < .05). No heavy bleeding at the donor site occurred in any of the cases. Complications due to injury of adjacent teeth or nerve lesion of the mandibular nerve were not observed in any cases. According to a scale, there was little postoperative pain with both instruments, and it decreased within 14 days postoperatively (P > .05). Swelling did not appear significantly different either (P > .05), and none of the donor sites showed primary healing complications. The data described in this randomized prospective split-mouth clinical trial indicate that the MicroSaw and Piezosurgery allowed efficient and safe bone block harvesting from the external oblique ridge. Clinically, concerning harvesting time and volume of the grafts, the MicroSaw performed significantly better, whereas pain, swelling, and healing did not appear to be considerably different

Treatment of Non-neurogenic Overactive Bladder with OnabotulinumtoxinA: Systematic Review and Meta-analysis of Prospective, Randomized, Placebo-controlled Clinical Trials.

PubMed

Arruda, Raquel Martins; Takano, Claudia Cristina; Girão, Manoel João Batista Castelo; Haddad, Jorge Milhem; Aleixo, Gabriel Francisco; Castro, Rodrigo Aquino

2018-04-01

We performed a systematic review and meta-analysis of randomized placebo-controlled trials that studied non-neurogenic overactive bladder patients who were treated with 100 units of onabotulinumtoxinA or placebo. The primary purpose of our study was to evaluate the clinical effectiveness with regard to urinary urgency, urinary frequency, nocturia, and incontinence episodes. Our secondary purpose consisted of evaluating the adverse effects. Our initial search yielded 532 entries. Of these, seven studies met all the inclusion criteria (prospective, randomized, placebo-controlled studies, ≥ 3 points on the Jadad scale) and were selected for analysis. For all primary endpoints, the toxin was more effective than placebo ( p  < 0.0001; 95% confidence interval [95CI]), namely: urgency (mean difference = -2.07; 95CI = [-2.55-1.58]), voiding frequency (mean difference = -1.64; 95CI = [-2.10-1.18]), nocturia (mean difference = -0.25; 95CI = [-0.39-0.11]) and incontinence episodes (mean difference = -2.06; 95CI= [-2.60-1.52]). The need for intermittent catheterization and the occurrence of urinary tract infection (UTI) were more frequent in patients treated with onabotulinumtoxinA than in patients treated with placebo ( p  < 0.0001). Compared with placebo, onabotulinumtoxinA had significantly and clinically relevant reductions in overactive bladder symptoms and is associated with higher incidence of intermittent catheterization and UTI. Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil.

Fluvastatin in the prevention of renal transplant vasculopathy: results of a prospective, randomized, double-blind, placebo-controlled trial.

PubMed

Serón, Daniel; Oppenheimer, Federico; Pallardó, Luis M; Lauzurica, Ricardo; Errasti, Pedro; Gomez-Huertas, Ernesto; Bosmans, Jean Louis; Sanchez-Plumed, Jaime; Romero, Rafael; Marques, María; Fulladosa, Xavier; Moreso, Francesc

2008-07-15

Statins prevent the progression of transplant vasculopathy in heart transplants, but its beneficial effect on the transplanted kidney is controversial. The aim is to evaluate the utility of fluvastatin 80 mg/day to reduce the progression of 6-month renal transplant vasculopathy in a multicenter, prospective, randomized, placebo-controlled trial stratified according to donor age. All patients received cyclosporine, mycophenolate mofetil, and prednisone. The progression of transplant vasculopathy was evaluated in paired donor and 6-month protocol biopsies. The primary efficacy variable was the progression of mean arterial intimal volume fraction (deltaVvintima/artery) evaluated with histomorphometry. The minimum sample size to detect a 50% reduction in the progression of deltaVvintima/artery was 62 patients per group. The secondary efficacy variable included the incidence of transplant vasculopathy evaluated according to Banff criteria. A total of 89 patients were included, 74 completed the 6-month study and 57 have paired biopsies with sufficient tissue for histological evaluation. The deltaVvintima/artery was not different between treatment and placebo groups (6.9+/-8.2% vs. 6.9+/-7.4%, P=ns), whereas the incidence of transplant vasculopathy was lower in the fluvastatin group (7% vs. 33%; P=0.02). Because there was a discrepancy between the primary and secondary efficacy variables, post hoc analysis was performed to evaluate the reproducibility of both variables in a subset of 50 biopsies. The reproducibility of transplant vasculopathy was higher than the reproducibility of Vvintima/artery (kappa 0.86 vs. 0.33). In summary, there were no differences in deltaVvintima/artery between groups, but fluvastatin treatment was associated with a reduced incidence of transplant vasculopathy.

Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study.

PubMed

Heikkilä, Jouni T; Kukkonen, Juha; Aho, Allan J; Moisander, Susanna; Kyyrönen, Timo; Mattila, Kimmo

2011-04-01

Purpose of this study was to compare bioactive glass and autogenous bone as a bone substitute material in tibial plateau fractures. We designed a prospective, randomized study consisting of 25 consecutive operatively treated patients with depressed unilateral tibial comminuted plateau fracture (AO classification 41 B2 and B3).14 patients (7 females, 7 males, mean age 57 years, range 25-82) were randomized in the bioglass group (BG) and 11 patients (6 females, 5 males, mean age 50 years, range 31-82) served as autogenous bone control group (AB). Clinical examination of the patients was performed at 3 and 12 months, patients' subjective and functional results were evaluated at 12 months. Radiological analysis was performed preoperatively, immediately postoperatively and at 3 and 12 months. The postoperative redepression for both studied groups was 1 mm until 3 months and remained unchanged at 12 months. No differences were identified in the subjective evaluation, functional tests and clinical examination between the two groups during 1 year follow-up. We conclude that bioactive glass granules can be clinically used as filler material instead of autogenous bone in the lateral tibial plateau compression fractures.

Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): A prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease

PubMed Central

Ripley, David P.; Brown, Julia M.; Everett, Colin C.; Bijsterveld, Petra; Walker, Simon; Sculpher, Mark; McCann, Gerry P.; Berry, Colin; Plein, Sven; Greenwood, John P.

2015-01-01

Background A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of noninvasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance. Trial Design CE-MARC 2 is a prospective, multicenter, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pretest likelihood 10%-90%) requiring further investigation. A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance–guided care, single-photon emission computed tomography–guided care (according to American College of Cardiology/American Heart Association appropriate-use criteria), or National Institute for Health and Care Excellence guidelines–based management. The primary (efficacy) end point is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost-effectiveness and health-related quality-of-life measures will be performed. Conclusions The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD, with the intension of reducing unnecessary invasive angiography rates. Evaluation of these management strategies has the potential to improve patient care, health-related quality of life, and the cost-effectiveness of CHD investigation. PMID:25497243

Is It Necessary to Repair Stable Ramp Lesions of the Medial Meniscus During Anterior Cruciate Ligament Reconstruction? A Prospective Randomized Controlled Trial.

PubMed

Liu, Xin; Zhang, Hui; Feng, Hua; Hong, Lei; Wang, Xue-Song; Song, Guan-Yang

2017-04-01

A special type of meniscal lesion involving the peripheral attachment of the posterior horn of the medial meniscus (PHMM), termed a "ramp lesion," is commonly associated with an anterior cruciate ligament (ACL) injury. However, its treatment is still controversial. Recently, stable ramp lesions treated with abrasion and trephination alone have been shown to have good clinical outcomes after ACL reconstruction. Stable ramp lesions treated with abrasion and trephination alone during ACL reconstruction will result in similar clinical outcomes compared with those treated with surgical repair. Randomized controlled trial; Level of evidence, 2. A prospective randomized controlled study was performed in 91 consecutive patients who had complete ACL injuries and concomitant stable ramp lesions of the medial meniscus. All patients were randomly allocated to 1 of 2 groups based on whether the stable ramp lesions were surgically repaired (study group; n = 50) or only abraded and trephined (control group; n = 41) during ACL reconstruction. All surgical procedures were performed by a single surgeon who was blinded to the functional assessment findings of the patients. The Lysholm score, subjective International Knee Documentation Committee (IKDC) score, and stability assessments (pivot-shift test, Lachman test, KT-1000 arthrometer side-to-side difference, and KT-1000 arthrometer differences of <3, 3-5, and >5 mm) were evaluated preoperatively and at the last follow-up. Moreover, magnetic resonance imaging (MRI) was used to evaluate the healing status of the ramp lesions. All consecutive patients who were screened for eligibility from August 2008 to April 2012 were enrolled and observed clinically. There were 40 patients in the study group and 33 patients in the control group who were observed for at least 2 years. At the final follow-up, there were no significant differences between the study group and the control group in terms of the mean Lysholm score (88.7 ± 4.8 vs 90.4 �

Comparison of two picosecond lasers to a nanosecond laser for treating tattoos: a prospective randomized study on 49 patients.

PubMed

Lorgeou, A; Perrillat, Y; Gral, N; Lagrange, S; Lacour, J-P; Passeron, T

2018-02-01

Q-switched nanosecond lasers demonstrated their efficacy in treating most types of tattoos, but complete disappearance is not always achieved even after performing numerous laser sessions. Picosecond lasers are supposed to be more efficient in clearing tattoos than nanosecond lasers, but prospective comparative data remain limited. To compare on different types of tattoos the efficacy of a nanosecond laser with two types of picosecond lasers. We conducted a prospective randomized study performed from December 2014 to June 2016 on adult patients with all types of tattoos. The tattoos were divided into two halves of equal size. After randomization, half of the tattoo was treated with a picosecond laser and the other half with a nanosecond laser. The evaluation was performed on standardized pictures performed before treatment and 2 months after the last session, by two physicians, not involved in the treatment, blinded on the type of treatments received. The main end point was a clearance above 75% of the tattoos. A total of 49 patients were included. Professional tattoos represented 85.7%, permanent make-up 8.2% and non-professional tattoo 6.1%. The majority were black or blue and 10.2% were polychromatic. No patient was lost during follow-up. A reduction of 75% or more of the colour intensity was obtained for 33% of the tattoos treated with the picosecond lasers compared to 14% with the nanosecond laser (P = 0.008). An improvement superior to 75% was obtained in 34% monochromic black or blue tattoos with the picosecond lasers compared to 9% for the nanosecond laser. Only one of the five polychromic tattoos achieved more than 75% of improvement with the two types of laser. Our results show a statistically significant superiority of the picosecond lasers compared to the nanosecond laser for tattoo clearance. However, they do not show better efficacy for polychromic tattoos and the difference in terms of side-effects was also minimal with a tendency of picosecond

Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

PubMed

Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

2013-12-15

Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

Evaluation of the Program Effectiveness of Research Competence Development in Prospective Elementary School Teachers

ERIC Educational Resources Information Center

Khan, Natalya N.; Kolumbayeva, Sholpan Zh.; Karsybayeva, Raissa K.; Nabuova, Roza A.; Kurmanbekova, Manshuk B.; Syzdykbayeva, Aigul Dzh.

2016-01-01

To develop research competence in prospective teachers, a system of methods for diagnostics and formation of this competence in prospective elementary school teachers in the training process is designed. To diagnose the research competence, a series of techniques were used that allow subtle evaluation of each competence research component:…

Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

PubMed

Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

2013-03-01

Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study.

PubMed

Zelen, Charles M; Poka, Attila; Andrews, James

2013-10-01

Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results of a randomized clinical trial examining the efficacy of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis. An institutional review board-approved, prospective, randomized, single-center clinical trial was performed. Forty-five patients were randomized to receive injection of 2 cc 0.5% Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being. Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period. At 1 week, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (P < .001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (P < .001). By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both P < .001). No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM. In patients with refractory plantar fasciitis, mDHACM is a viable treatment option. Larger studies are needed to confirm our findings. Level I, prospective randomized study.

A Meta-Analysis of Randomized Controlled Trials and Prospective Cohort Studies of Eicosapentaenoic and Docosahexaenoic Long-Chain Omega-3 Fatty Acids and Coronary Heart Disease Risk.

PubMed

Alexander, Dominik D; Miller, Paige E; Van Elswyk, Mary E; Kuratko, Connye N; Bylsma, Lauren C

2017-01-01

To conduct meta-analyses of randomized controlled trials (RCTs) to estimate the effect of eicosapentaenoic and docosahexaenoic acid (EPA+DHA) on coronary heart disease (CHD), and to conduct meta-analyses of prospective cohort studies to estimate the association between EPA+DHA intake and CHD risk. A systematic literature search of Ovid/Medline, PubMed, Embase, and the Cochrane Library from January 1, 1947, to November 2, 2015, was conducted; 18 RCTs and 16 prospective cohort studies examining EPA+DHA from foods or supplements and CHD, including myocardial infarction, sudden cardiac death, coronary death, and angina, were identified. Random-effects meta-analysis models were used to generate summary relative risk estimates (SRREs) and 95% CIs. Heterogeneity was examined in subgroup and sensitivity analyses and by meta-regression. Dose-response was evaluated in stratified dose or intake analyses. Publication bias assessments were performed. Among RCTs, there was a nonstatistically significant reduction in CHD risk with EPA+DHA provision (SRRE=0.94; 95% CI, 0.85-1.05). Subgroup analyses of data from RCTs indicated a statistically significant CHD risk reduction with EPA+DHA provision among higher-risk populations, including participants with elevated triglyceride levels (SRRE=0.84; 95% CI, 0.72-0.98) and elevated low-density lipoprotein cholesterol (SRRE=0.86; 95% CI, 0.76-0.98). Meta-analysis of data from prospective cohort studies resulted in a statistically significant SRRE of 0.82 (95% CI, 0.74-0.92) for higher intakes of EPA+DHA and risk of any CHD event. Results indicate that EPA+DHA may be associated with reducing CHD risk, with a greater benefit observed among higher-risk populations in RCTs. Copyright © 2016 Mayo Foundation for Medical Education and Research. Published by Elsevier Inc. All rights reserved.

Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

2017-02-01

Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

Synergistic effects of intravenous and intra-articular tranexamic acid on reducing hemoglobin loss in revision total knee arthroplasty: a prospective, randomized, controlled study.

PubMed

Yuan, Xiangwei; Wang, Jiaxing; Wang, Qiaojie; Zhang, Xianlong

2018-04-01

Tranexamic acid decreases blood loss in primary total knee arthroplasty, and no related prospective randomized clinical trials have been conducted to evaluate the effectiveness and safety of tranexamic acid in revision total knee arthroplasty. Thus, we conducted this work to evaluate the synergistic effects of intravenous plus intra-articular tranexamic acid on reducing hemoglobin loss compared with intra-articular tranexamic acid alone in revision total knee arthroplasty. This prospective, controlled study randomized 96 patients undergoing revision total knee arthroplasty into two groups: an intravenous plus intra-articular tranexamic acid group (48 patients who received 20 mg/kg intravenous tranexamic acid and 3.0 g intra-articular tranexamic acid); and an intra-articular tranexamic acid alone group (48 patients who received the same intravenous volume of normal saline and 3.0 g intra-articular tranexamic acid). The primary outcome was hemoglobin loss. Secondary outcomes included the volume of drain output, the percentage of patients who received transfusions, the number of units transfused, and thromboembolic events. The baseline data, preoperative hemoglobin, and tourniquet time were similar in both groups. There was significantly less hemoglobin loss in the intravenous plus intra-articular tranexamic acid group compared with the intra-articular tranexamic acid alone group (2.7 ± 0.6 g/dL and 3.7 ± 0.7 g/dL; p < 0.001). Compared with the intra-articular tranexamic acid alone group, the intravenous plus intra-articular tranexamic acid group also had significantly less drain output, fewer patients who received transfusions, and fewer units transfused (all p < 0.05). There were no significant differences in thromboembolic events in the two groups during the 3-month follow-up. Compared with intra-articular tranexamic acid alone, combined intravenous plus intra-articular tranexamic acid significantly reduced hemoglobin loss and the need for

Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

PubMed

Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

2016-11-03

The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

Randomized prospective study of olecranon fracture fixation: cable pin system versus tension band wiring.

PubMed

Liu, Q-H; Fu, Z-G; Zhou, J-L; Lu, T; Liu, T; Shan, L; Liu, Y; Bai, L

2012-01-01

This prospective, randomized study compared the effectiveness of the cable pin system (CPS) versus tension band wiring (TBW) for olecranon fracture fixation. Patients with acute transverse or slight oblique olecranon fractures were randomly divided into two groups: one fixed by CPS and the other by TBW. Clinical outcome data were collected and analysed following a mean duration of 21 months. The mean ± SD fracture healing time was significantly shorter in the CPS group (n = 30; 9.73 ± 2.02 weeks) compared with the TBW group (n = 32; 11.13 ± 2.21 weeks). One patient in the CPS group and seven patients in the TBW group experienced postoperative complications; this difference was statistically significant. The mean ± SD Mayo Elbow Performance Score in the CPS group was significantly higher (88.67 ± 6.42) than that in the TBW group (80.78 ± 11.99). Logistic regression analysis showed an association between fixation method and fracture healing time, complications and elbow function. Internal fixation by CPS is an effective method for olecranon fracture and is associated with a shorter healing time, fewer complications and better function than TBW.

Quality control of colonoscopy procedures: a prospective validated method for the evaluation of professional practices applicable to all endoscopic units.

PubMed

Coriat, R; Pommaret, E; Chryssostalis, A; Viennot, S; Gaudric, M; Brezault, C; Lamarque, D; Roche, H; Verdier, D; Parlier, D; Prat, F; Chaussade, S

2009-02-01

To produce valid information, an evaluation of professional practices has to assess the quality of all practices before, during and after the procedure under study. Several auditing techniques have been proposed for colonoscopy. The purpose of this work is to describe a straightforward original validated method for the prospective evaluation of professional practices in the field of colonoscopy applicable in all endoscopy units without increasing the staff work load. Pertinent quality-control criteria (14 items) were identified by the endoscopists at the Cochin Hospital and were compatible with: findings in the available literature; guidelines proposed by the Superior Health Authority; and application in any endoscopy unit. Prospective routine data were collected and the methodology validated by evaluating 50 colonoscopies every quarter for one year. The relevance of the criteria was assessed using data collected during four separate periods. The standard checklist was complete for 57% of the colonoscopy procedures. The colonoscopy procedure was appropriate according to national guidelines in 94% of cases. These observations were particularly noteworthy: the quality of the colonic preparation was insufficient for 9% of the procedures; complete colonoscopy was achieved for 93% of patients; and 0.38 adenomas and 0.045 carcinomas were identified per colonoscopy. This simple and reproducible method can be used for valid quality-control audits in all endoscopy units. In France, unit-wide application of this method enables endoscopists to validate 100 of the 250 points required for continuous medical training. This is a quality-control tool that can be applied annually, using a random month to evaluate any changes in routine practices.

Randomized, Prospective Comparison of Ursodeoxycholic Acid for the Prevention of Gallstones after Sleeve Gastrectomy.

PubMed

Adams, Lindsay B; Chang, Craig; Pope, Janet; Kim, Yeonsoo; Liu, Pei; Yates, Amy

2016-05-01

Several studies have examined the role of ursodeoxycholic acid (UDCA) for the prevention of cholelithiasis (gallstones) following rapid weight loss from restrictive diets, vertical band gastroplasty, and Roux-en-Y gastric bypass. However, to date, there have been no prospective, controlled studies examining the role of UDCA for the prevention of gallstones following sleeve gastrectomy (SG). This study was conducted to identify the effectiveness of UDCA for prevention of gallstones after SG. Following SG, eligible patients were randomized to a control group who did not receive UDCA treatment or to a group who were prescribed 300 mg UDCA twice daily for 6 months. Gallbladder ultrasounds were performed preoperatively and at 6 and 12 months postoperatively. Patients with positive findings preoperatively were excluded from the study. Compliance with UDCA was assessed. Between December 2011 and April 2013, 37 patients were randomized to the UDCA treatment arm and 38 patients were randomized to no treatment. At baseline, the two groups were similar. At 6 months, the UDCA group had a statistically significant lower incidence of gallstones (p = 0.032). Analysis revealed no significant difference in gallstones between the two groups at 1 year (p = 0.553 and p = 0.962, respectively). The overall gallstone formation rate was 29.8%. The incidence of gallstones is higher than previously estimated in SG patients. UDCA significantly lowers the gallstone formation rate at 6 months postoperatively.

A prospective, randomized controlled preclinical trial to evaluate different formulations of biphasic calcium phosphate in combination with a hydroxyapatite collagen membrane to reconstruct deficient alveolar ridges.

PubMed

Nevins, Myron; Nevins, Marc L; Schupbach, Peter; Kim, Soo-Woo; Lin, Zhao; Kim, David M

2013-04-01

Many patients and clinicians would prefer a synthetic particulate bone replacement graft, but most available alloplastic biomaterials have limited osteogenic potential. An alloplast with increased regenerative capacity would be advantageous for the treatment of localized alveolar ridge defects. This prospective, randomized controlled preclinical trial utilized 6 female foxhounds to analyze the osteogenic impact of different formulations of biphasic calcium phosphate (BCP) in combination with an hydroxyapatite-collagen membrane and their ability to reconstruct deficient alveolar ridges for future implant placement. The grafted sites were allowed to heal 3 months, and then trephine biopsies were obtained to perform light microscopic and histomorphometric analyses. All treated sites healed well with no early membrane exposure or adverse soft tissue responses during the healing period. The grafted sites exhibited greater radiopacity than the surrounding native bone with BCP particles seen as radiopaque granules. The graft particles appeared to be well-integrated and no areas of loose particles were observed. Histologic evaluation demonstrated BCP particles embedded in woven bone with dense connective tissue/marrow space. New bone growth was observed around the graft particles as well as within the structure of the graft particulate. There was intimate contact between the graft particles and newly formed bone, and graft particles were bridged by the newly formed bone in all biopsies from the tested groups. The present study results support the potential of these BCP graft particulates to stimulate new bone formation. Clinical studies are recommended to confirm these preclinical findings.

A Multi-centric, Double-blind, Placebo-controlled, Randomized, Prospective Study to Evaluate the Efficacy and Safety of Carica papaya Leaf Extract, as Empirical Therapy for Thrombocytopenia associated with Dengue Fever.

PubMed

Kasture, Prabhu Nagnathappa; Nagabhushan, K H; Kumar, Arun

2016-06-01

Dengue is a rapidly expanding global health problem. Approximately 2.5 billion people live in dengue-risk regions with about 100 million new cases each year worldwide. The cumulative dengue diseases burden has attained an unprecedented proportion in recent times with sharp increase in the size of human population at risk. The management of dengue virus infection is essentially supportive and symptomatic and no specific treatment is available for increasing the fallen platelets, which have a significant role in causing the mortality of dengue patient.This study was conducted to evaluate the platelet increasing efficacy of Carica papaya leaf extract (CPLE) in patients with dengue fever (DF). The administration of Carica papaya leaf extract should significantly increase the platelet count in cases of thrombocytopenia associated with dengue, preventing the patient to go in DHF or DSS conditions. A Multi-centric, Double blind, Placebo controlled, Randomized, prospective study was conducted in 300 patients across 5 centres', to evaluate the Efficacy and Safety of Carica Papaya Leaf Extract, as empirical therapy for thrombocytopenia associated with dengue fever. The subjects were randomized into two groups, as control and intervention group. Both the groups were managed by the standard management guidelines for dengue except steroid administration. In addition to this, the intervention group received CPLE tablet three times daily for five days. All of them were followed daily with platelet monitoring. This study has been registered in the clinical trial registry-India (CTRI Registration number: CTRI/2015/05/005806). The results indicate that CPLE had significant increase(p< 0.01) in the platelet count over the therapy duration, in dengue fever patients, confirming CPLE accelerates the increase in platelet count compared to the control group. There were few adverse events related to GI disturbance like nausea and vomiting which were similar in both groups. Thus this study

Algorithms for detecting and predicting influenza outbreaks: metanarrative review of prospective evaluations

PubMed Central

Spreco, A; Timpka, T

2016-01-01

Objectives Reliable monitoring of influenza seasons and pandemic outbreaks is essential for response planning, but compilations of reports on detection and prediction algorithm performance in influenza control practice are largely missing. The aim of this study is to perform a metanarrative review of prospective evaluations of influenza outbreak detection and prediction algorithms restricted settings where authentic surveillance data have been used. Design The study was performed as a metanarrative review. An electronic literature search was performed, papers selected and qualitative and semiquantitative content analyses were conducted. For data extraction and interpretations, researcher triangulation was used for quality assurance. Results Eight prospective evaluations were found that used authentic surveillance data: three studies evaluating detection and five studies evaluating prediction. The methodological perspectives and experiences from the evaluations were found to have been reported in narrative formats representing biodefence informatics and health policy research, respectively. The biodefence informatics narrative having an emphasis on verification of technically and mathematically sound algorithms constituted a large part of the reporting. Four evaluations were reported as health policy research narratives, thus formulated in a manner that allows the results to qualify as policy evidence. Conclusions Awareness of the narrative format in which results are reported is essential when interpreting algorithm evaluations from an infectious disease control practice perspective. PMID:27154479

Stand-alone anchored cage versus cage with plating for single-level anterior cervical discectomy and fusion: a prospective, randomized, controlled study with a 2-year follow-up.

PubMed

Nemoto, Osamu; Kitada, Akira; Naitou, Satoko; Tachibana, Atsuko; Ito, Yuya; Fujikawa, Akira

2015-07-01

To avoid complications associated with plating in anterior cervical discectomy and fusion (ACDF), stand-alone anchored PEEK cage was developed and favourable outcomes with a low rate of dysphasia have been described. The objective of this study was to compare the clinical and radiological outcomes of ACDF using a standalone anchored PEEK cage (PREVAIL; Medtronic Sofamor Danek, Memphis, TN) with those of a PEEK cage with plating in a prospective randomized manner. Fifty patients with single-level cervical radiculopathy were randomly assigned to a PREVAIL or a PEEK cage with plating. Following 3, 6, 12, and 24 months, clinical and radiological outcomes were assessed. The mean surgical time for the patients with a PREVAIL was significantly shorter than that for those with a PEEK cage with plating. The clinical outcomes evaluated by visual analogue scale for pain and the Odom's criteria were comparable between both the groups. Both the groups demonstrated the high fusion rate (92% in PREVAIL; 96% in PEEK cage with plating). The subsidence rate and the improvement of cervical alignment were comparable between both the groups. The incidence of adjacent-level ossification was significantly lower for patients with a PREVAIL than that for those with a PEEK cage with plating. The rate of dysphasia graded by the method of Bazaz and measurement of prevertebral soft tissue swelling indicated no significant differences between both the groups. Our prospective randomized study confirmed that stand-alone anchored PEEK cage is a valid alternative to plating in ACDF with a low rate of adjacent-level ossification. However, the potential to reduce the incidence of dysphasia was not confirmed.

Prospective histopathologic evaluation of lifestyle modification in nonalcoholic fatty liver disease: a randomized trial

PubMed Central

Eckard, Carly; Cole, Renee; Lockwood, Joshua; Torres, Dawn M.; Williams, Christopher D.; Shaw, Janet C.

2013-01-01

Background and aims: Nonalcoholic fatty liver disease (NAFLD) is now recognized as part of the metabolic syndrome, and is specifically related to obesity and insulin resistance. Lifestyle modification is advocated for the treatment of NAFLD, but few studies have evaluated its impact on liver histology. The purpose of this study was to investigate which, if any, specific diet and exercise recommendations are associated with histopathologic changes. Methods: A total of 56 participants were randomly assigned to 1 of 4 lifestyle modification subgroups for 6 months: standard care, low-fat diet and moderate exercise, moderate-fat/low-processed-carbohydrate diet and moderate exercise, or moderate exercise only. All subjects had biopsy-proven NAFLD, to include nonalcoholic steatohepatitis (NASH), and received a repeat 6-month biopsy to detect histopathologic changes. Other measures included blood assay of liver enzymes (aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase), fasting glucose, serum insulin, lipid panel, body weight, dietary intake, fat mass, and fitness level. Results: Among the 41 participants who completed the study (88% with NASH), a significant change was found in pre- to post-NAFLD activity score in the group as a whole (p < 0.001) with no difference detected between subgroups (p = 0.31). Our results confirm that lifestyle modification is effective in improving NAFLD and NASH. Conclusions: Regardless of intervention group, lifestyle modification improved liver histology, as verified by repeat biopsy, after a 6-month intervention. This study reinforces the importance of lifestyle modification as the primary treatment strategy for patients with NAFLD. PMID:23814606

Comparison of Tension-Band Wiring With the Cable Pin System in Patella Fractures: A Randomized Prospective Study.

PubMed

Tian, Qing-xian; Hai, Yong; Du, Xin-ru; Xu, Zi-yu; Lu, Tie; Shan, Lei; Liu, Yang; Zhou, Jun-lin

2015-12-01

To compare the outcome of tension-band wiring (TBW) with the cable pin system (CPS) for transverse fractures of the patella. Randomized prospective study. Academic Level I trauma center. From February 2008 to December 2011, 73 consecutive patients with transverse fractures of the patella were prospectively enrolled in this study. The patients were randomly divided into 2 groups: one group was treated using the CPS, and the other group was treated using the modified TBW. The clinical outcome assessment included analyses of the radiographic images, the modified Hospital for Special Surgery scoring system, and complications. The follow-up time ranged from 12 to 29 months. All fractures healed, with a union rate of 100%. The fracture healing time was significantly shorter in the CPS group (8.51 ± 2.59 weeks, n = 34) compared with the TBW group (11.79 ± 3.04 weeks, n = 39). Postoperative complications in the CPS and TBW groups were observed in 1 and 9 patients, respectively, a difference that was statistically significant. The mean Hospital for Special Surgery score for the CPS group (90.53 ± 5.19 points) was significantly higher than that for the TBW group (81.36 ± 12.71 points). The CPS is a viable option for transverse fractures of the patella and is associated with a shorter healing time, fewer complications, and better function than TBW. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Prospective Evaluation of Self-Reported Aggression in Transgender Persons.

PubMed

Defreyne, Justine; T'Sjoen, Guy; Bouman, Walter Pierre; Brewin, Nicola; Arcelus, Jon

2018-05-01

from friends in transgender women. Hormone-prescribing physicians can be reassured that the long-term administration of testosterone in transgender men does not increase aggressive behavior. This is the 1st prospective study to assess the effect of gender-affirming hormonal care on aggression. Limitations included the use of different laboratories, the use of a patient-reported outcome measure, and the lack of aggression subtypes. Testosterone therapy was not associated with an increase in levels of aggression in transgender men or a decrease in aggressive behavior in transgender women on antiandrogen and estrogen therapy, but other psychological and/or social factors, such as anxiety levels, appear to contribute to self-reported aggression in transgender people. Defreyne J, T'Sjoen G, Bouman WP, et al. Prospective Evaluation of Self-Reported Aggression in Transgender Persons. J Sex Med 2018;15:768-776. Copyright © 2018 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Enalapril/amlodipine combination in cyclosporine-treated renal transplant recipients: a prospective randomized trial.

PubMed

Halimi, Jean-Michel; Giraudeau, Bruno; Buchler, Matthias; Al-Najjar, Azmi; Etienne, Isabelle; Laouad, Inass; Bruyère, Franck; Lebranchu, Yvon

2007-01-01

Most hypertensive renal transplant recipients require two or more antihypertensive medications to achieve blood pressure control. However, which medications must be combined is still a matter of debate. A prospective randomized open-label blinded evaluation trial comparing the six-month effects of the amlodipine-enalapril combination (n = 32) vs. enalapril alone (n = 33) and vs. amlodipine alone (n = 34) on arterial pressure, renal function, albuminuria and tolerability. At six months, diastolic arterial pressure was more adequately controlled (i.e., <90 mmHg) in the combination group than in the amlodipine and enalapril groups (100% vs. 82.4% and 84.8%, respectively, p = 0.038). The same trend was observed for systolic arterial pressure (65.6% vs. 58.8% and 51.5%, NS). The six-month change in albuminuria was similar in the combination group and in the enalapril group (-64.7% vs. -59.5%); however, patients in the combination group exhibited a greater reduction in albuminuria than in the amlodipine group (-64.7% vs. -29.0%, p = 0.002). As compared with baseline values, serum creatinine and potassium remained unchanged in the combination group, whereas they increased by 9 +/- 12 micromol/L (p = 0.01) and by 0.2 +/- 0.4 mmol/L (p < 0.01), respectively, in the enalapril group. The cyclosporine trough levels remained unchanged in the combination group, but increased in the amlodipine group. Angiotensin-converting enzyme inhibitor (ACEI)-calcium-channel blocker (CCB) combination controls arterial pressure more adequately than ACEI alone or CCB alone, reduces albuminuria and may prevent the ACEI-induced initial rise in serum creatinine.

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias.

PubMed

Ielpo, Benedetto; Duran, Hipolito; Diaz, Eduardo; Fabra, Isabel; Caruso, Riccardo; Malavé, Luis; Ferri, Valentina; Lazzaro, Sara; Kalivaci, Denis; Quijano, Yolanda; Vicente, Emilio

2017-07-19

In literature, only a few studies have prospectively compared the results of laparoscopic with open inguinal hernia repair yet none have compared bilateral inguinal hernia repair. The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic trans-abdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia. Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters included hospital stay, operation time, postoperative complications, immediate postoperative pain and chronic pain, recurrence and quality of life. Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-operative pain up to 7 days from surgery (p = 0.003), a shorter length of hospital stay (p = 0.001), less postoperative complications (p = 0.012) and less chronic pain (0.04) when compared with the OLR approach. TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay and postoperative complications. Copyright © 2017 Elsevier Inc. All rights reserved.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

Evaluation of Cyavanaprāśa on Health and Immunity related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study.

PubMed

Gupta, Arun; Kumar, Sunil; Dole, Sanjeeva; Deshpande, Shailesh; Deshpande, Vaishali; Singh, Sudha; Sasibhushan, V

2017-01-01

Cyavanaprāśa (CP) is an Ayurvedic immune booster formulation that confers vigor and vitality while delaying the ageing process. Benefits of CP have been studied widely in adult population. Current study assessed beneficial effects of CP on health and immunity related parameters in healthy children. This study was a 6 month long two armed, randomized, open labeled, prospective clinical study. School going healthy children between ages of 5-12 years were randomized to receive orally daily either CP (approx. 6 g) followed by a cup of milk (100 - 200 ml) or cup of milk only twice a day while continuing with their normal/routine diet. Results were analyzed based on number of episodes, severity, duration of illness (infections and allergies) and number of absent days due to illness during the study duration and changes in levels of energy, physical fitness, strength, stamina and quality of life in children which were recorded in subject diary by their parents/Legally Acceptable Representative (LAR). 702 participants were randomized, out of which 627 completed the study (CP n = 313; Control n = 314). Results of immunity (episodes of infections or allergy related conditions) showed more than 2 times protection from immunity related illness in CP Group as compared to the control. CP also showed better percentage improvement in energy levels, physical fitness, strength, stamina and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children. Regular consumption of CP for a period of six months could significantly improve immunity, energy levels, physical fitness, strength, stamina and quality of life in school going healthy children. Clinical Trail Registry of India vide CTRI/2015/02/005574, Dated 24 February 2015.

Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study.

PubMed

Karaman, Tugba; Karaman, Serkan; Dogru, Serkan; Tapar, Hakan; Sahin, Aynur; Suren, Mustafa; Arici, Semih; Kaya, Ziya

2016-05-01

This study was designed to evaluate the effectiveness of lavender aromatherapy on pain, anxiety, and level of satisfaction associated with the peripheral venous cannulation (PVC) in patients undergoing surgery. One hundred and six patients undergoing surgery were randomized to receive aromatherapy with lavender essential oil (the lavender group) or a placebo (the control group) during PVC. The patients' pain, anxiety, and satisfaction scores were measured. There was no statistically significantly difference between the groups in terms of demographic data. After cannulation, the pain and anxiety scores (anxiety 2) of the patients in the lavender group were significantly lower than the control group (for p = 0.01 for pain scores; p < 0.001 for anxiety 2 scores). In addition, patient satisfaction was significantly higher in the lavender group than in the control group (p = 0.003). Lavender aromatherapy had beneficial effects on PVC pain, anxiety, and satisfaction level of patients undergoing surgery. Copyright © 2016 Elsevier Ltd. All rights reserved.

Intrathecal pressure monitoring and cerebrospinal fluid drainage in acute spinal cord injury: a prospective randomized trial.

PubMed

Kwon, Brian K; Curt, Armin; Belanger, Lise M; Bernardo, Arlene; Chan, Donna; Markez, John A; Gorelik, Stephen; Slobogean, Gerard P; Umedaly, Hamed; Giffin, Mitch; Nikolakis, Michael A; Street, John; Boyd, Michael C; Paquette, Scott; Fisher, Charles G; Dvorak, Marcel F

2009-03-01

Ischemia is an important factor in the pathophysiology of secondary damage after traumatic spinal cord injury (SCI) and, in the setting of thoracoabdominal aortic aneurysm repair, can be the primary cause of paralysis. Lowering the intrathecal pressure (ITP) by draining CSF is routinely done in thoracoabdominal aortic aneurysm surgery but has not been evaluated in the setting of acute traumatic SCI. Additionally, while much attention is directed toward maintaining an adequate mean arterial blood pressure (MABP) in the acute postinjury phase, little is known about what is happening to the ITP during this period when spinal cord perfusion pressure (MABP - ITP) is important. The objectives of this study were to: 1) evaluate the safety and feasibility of draining CSF to lower ITP after acute traumatic SCI; 2) evaluate changes in ITP before and after surgical decompression; and 3) measure neurological recovery in relation to the drainage of CSF. Twenty-two patients seen within 48 hours of injury were prospectively randomized to a drainage or no-drainage treatment group. In all cases a lumbar intrathecal catheter was inserted for 72 hours. Acute complications of headache/nausea/vomiting, meningitis, or neurological deterioration were carefully monitored. Acute Spinal Cord Injury motor scores were documented at baseline and at 6 months postinjury. On insertion of the catheter, mean ITP was 13.8 +/- 1.3 mm Hg (+/- SD), and it increased to a mean peak of 21.7 +/- 1.5 mm Hg intraoperatively. The difference between the starting ITP on catheter insertion and the observed peak intrathecal pressure after decompression was, on average, an increase of 7.9 +/- 1.6 mm Hg (p < 0.0001, paired t-test). During the postoperative period, the peak recorded ITP in the patients randomized to the no-drainage group was 30.6 +/- 2.3 mm Hg, which was significantly higher than the peak intraoperative ITP (p = 0.0098). During the same period, the peak recorded ITP in patients randomized to receive

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

PubMed

Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

2013-02-08

Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting

Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus in Adults: A Prospective Randomized Controlled Trial in China.

PubMed

Su, Yingying; Liu, Gang; Tian, Fei; Ren, Guoping; Jiang, Mengdi; Chun, Brian; Zhang, Yunzhou; Zhang, Yan; Ye, Hong; Gao, Daiquan; Chen, Weibi

2016-12-01

Although generalized convulsive status epilepticus (GCSE) is a life-threatening emergency, evidence-based data to guide initial drug treatment choices are lacking in the Chinese population. We conducted this prospective, randomized, controlled trial to evaluate the relative efficacy and safety of intravenous phenobarbital and valproate in patients with GCSE. After the failure of first-line diazepam treatment, Chinese adult patients with GCSE were randomized to receive either intravenous phenobarbital (standard doses, low rate) or valproate (standard). Successful treatment was considered when clinical and electroencephalographic seizure activity ceased. Adverse events following treatment, as well as the neurological outcomes at discharge and 3 months later, were also evaluated. Overall, 73 cases were enrolled in the study. Intravenous phenobarbital was successful in 81.1% of patients, and intravenous valproate was successful in 44.4% of patients (p < 0.05). The relapse rate of status epilepticus within 24 h of receiving phenobarbital (6.7%) was significantly lower than that in patients receiving valproate (31.3%), and the total number of adverse events did not differ significantly between the two groups (p > 0.05). In the phenobarbital group, two patients (5.4%) required ventilation and two patients (5.4%) developed serious hypotension. The neurological outcomes of the phenobarbital group were generally better than those of the valproate group; however, no significant differences were observed between phenobarbital and valproate with respect to mortality (8.1 vs. 16.6%) at discharge, or mortality (16.2 vs. 30.5%) and post-symptomatic epilepsy (26.3 vs. 42.8%) at 3-month follow-up. Intravenous phenobarbital appears to be more effective than intravenous valproate for Chinese adult patients with GCSE. The occurrence of serious respiratory depression and hypotension caused by phenobarbital was reduced by decreasing the intravenous infusion rate; however, even at a

Quantitative framework for prospective motion correction evaluation.

PubMed

Pannetier, Nicolas A; Stavrinos, Theano; Ng, Peter; Herbst, Michael; Zaitsev, Maxim; Young, Karl; Matson, Gerald; Schuff, Norbert

2016-02-01

Establishing a framework to evaluate performances of prospective motion correction (PMC) MRI considering motion variability between MRI scans. A framework was developed to obtain quantitative comparisons between different motion correction setups, considering that varying intrinsic motion patterns between acquisitions can induce bias. Intrinsic motion was considered by replaying in a phantom experiment the recorded motion trajectories from subjects. T1-weighted MRI on five volunteers and two different marker fixations (mouth guard and nose bridge fixations) were used to test the framework. Two metrics were investigated to quantify the improvement of the image quality with PMC. Motion patterns vary between subjects as well as between repeated scans within a subject. This variability can be approximated by replaying the motion in a distinct phantom experiment and used as a covariate in models comparing motion corrections. We show that considering the intrinsic motion alters the statistical significance in comparing marker fixations. As an example, two marker fixations, a mouth guard and a nose bridge, were evaluated in terms of their effectiveness for PMC. A mouth guard achieved better PMC performance. Intrinsic motion patterns can bias comparisons between PMC configurations and must be considered for robust evaluations. A framework for evaluating intrinsic motion patterns in PMC is presented. © 2015 Wiley Periodicals, Inc.

Effect of surgical closing in total knee arthroplasty at flexion or extension: a prospective, randomized study.

PubMed

Kömürcü, Erkam; Yüksel, Halil Yalçın; Ersöz, Murat; Aktekin, Cem Nuri; Hapa, Onur; Çelebi, Levent; Akbal, Ayla; Biçimoğlu, Ali

2014-12-01

The aim of this study was to evaluate the effect of knee position during wound closure (flexed vs. extended) in total knee arthroplasty on knee strength and function, as determined by knee society scores and isokinetic testing of extensor and flexor muscle groups. In a prospective, randomized, double-blind trial, 29 patients were divided in two groups: for Group 1 patients, surgical closing was performed with the knee extended, and for Group 2 patients, the knee flexed at 90°. All the patients were treated with the same anaesthesia method, surgical team, surgical technique, prosthesis type, and rehabilitation process. American Knee Society Score values and knee flexion degrees were recorded. Isokinetic muscle strength measurements of both knees in flexion and extension were taken using 60° and 180°/s angular velocity. The peak torque and total work values, isokinetic muscle strength differences, and total work difference values were calculated for surgically repaired and healthy knees. No significant difference in the mean American Knee Society Score values and knee flexion degrees was observed between the two groups. However, using isokinetic evaluation, a significant difference was found in the isokinetic muscle strength differences and total work difference of the flexor muscle between the two groups when patients were tested at 180°/s. Less loss of strength was detected in the isokinetic muscle strength differences of the flexor muscle in Group 2 (-4.2%) than in Group 1 (-23.1%). For patients undergoing total knee arthroplasty, post-operative flexor muscle strength is improved if the knee is flexed during wound closure. II.

Prospective randomized comparison of human oocyte cryopreservation with slow-rate freezing or vitrification.

PubMed

Smith, Gary D; Serafini, Paulo C; Fioravanti, Joyce; Yadid, Isaac; Coslovsky, Marcio; Hassun, Pericles; Alegretti, José Roberto; Motta, Eduardo L

2010-11-01

To compare cryopreservation of mature human oocytes with slow-rate freezing and vitrification and determine which is most efficient at establishing a pregnancy. Prospective randomized. Academically affiliated, private fertility center. Consenting patients with concerns about embryo cryopreservation and more than nine mature oocytes at retrieval were randomized to slow-rate freezing or vitrification of supernumerary (more than nine) oocytes. Oocytes were frozen or vitrified, and upon request oocytes were thawed or warmed, respectively. Oocyte survival, fertilization, embryo development, and clinical pregnancy. Patient use has resulted in 30 thaws and 48 warmings. Women's age at time of cryopreservation was similar. Oocyte survival was significantly higher following vitrification/warming (81%) compared with freezing/thawing (67%). Fertilization was more successful in oocytes vitrified/warmed compared with frozen/thawed. Fertilized oocytes from vitrification/warming had significantly better cleavage rates (84%) compared with freezing/thawing (71%) and resulted in embryos with significantly better morphology. Although similar numbers of embryos were transferred, embryos resulting from vitrified oocytes had significantly enhanced clinical (38%) pregnancy rates compared with embryos resulting from frozen oocyte (13%). Miscarriage and/or spontaneous abortion rates were similar. Our results suggest that vitrification/warming is currently the most efficient means of oocyte cryopreservation in relation to subsequent success in establishing pregnancy. Copyright © 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Prospective randomized comparison of dacarbazine (DTIC) versus DTIC plus interferon-alpha (IFN-alpha) in metastatic melanoma.

PubMed

Young, A M; Marsden, J; Goodman, A; Burton, A; Dunn, J A

2001-01-01

Dacarbazine (DTIC) has been the mainstay of chemotherapy for metastatic melanoma for over two decades, but only 15%-20% of patients respond and benefit is usually transient. Randomized studies combining DTIC with interferon-alpha (IFN-alpha) in advanced disease have so far been inconclusive in terms of response and survival. We report a randomized prospective pilot Phase III trial of DTIC +IFN-alpha in patients with metastatic melanoma. The primary endpoint was death. A total of 61 patients were randomized between April 1995 and April 1998. Differences in survival between groups were assessed using log-rank analysis. Quality of life was measured using the European Organization for Research on Treatment of Cancer QLQ C30 (+3) questionnaire. Fifty-seven patients died during the study. The median survival for patients receiving DTIC was 7.2 months (95% confidence interval (CI) 4.4-9.0); it was 4.8 months for DTIC + IFN-alpha (95% CI 2.0-8.0). There was no significant difference in survival between the two treatment arms (chi2 unadjusted = 0.15, P = 0.70; chi2 adjusted = 0.01, P = 0.91). The 6-month survival of those patients randomized to DTIC alone was 58% compared with 40% for those patients randomized to DTIC + IFN-alpha. There were no differences in quality of life between treatment groups. This study failed to demonstrate a survival benefit for patients receiving IFN-alpha in combination with DTIC. These results are inconclusive primarily owing to the small size of the trial. A meta-analysis is required to determine whether there is a role for the addition of IFN-alpha to DTIC in the treatment of this disease.

Rotator cuff healing after needling of a calcific deposit using platelet-rich plasma augmentation: a randomized, prospective clinical trial.

PubMed

Verhaegen, Filip; Brys, Peter; Debeer, Philippe

2016-02-01

Arthroscopic needling of a rotator cuff calcification is a highly reliable operation in terms of pain relief and return of function. However, during the needling process, a cuff defect is created. Little is known about the evolution of this defect. We conducted a prospective, randomized controlled clinical trial to investigate the evolution of the aforementioned defect and the role of platelet-rich plasma (PRP) augmentation in this healing process. Patients were randomized to either group 1 (PRP, n = 20) or group 2 (no PRP [control group], n = 20). Patients in group 1 received a perioperative PRP infiltration at the rotator cuff defect, whereas the control group did not. Patients were assessed clinically preoperatively and postoperatively at 6 weeks, 3 and 6 months, and 1 year. The Constant score, Simple Shoulder Test, and QuickDASH (short version of Disabilities of the Arm, Shoulder and Hand questionnaire) were used as outcome measures. The evolution of the cuff defect was evaluated on sonography at 3 and 6 months and with magnetic resonance imaging after 1 year. All patients improved significantly after surgery (P < .05). There was no difference in clinical outcome or rotator cuff healing between groups. We observed a high rate of persistent rotator cuff defects after 1 year in both groups. The presence of residual cuff defects did not influence the clinical outcome. Arthroscopic needling is an operation with a predictive, good clinical outcome. We found a high rate of persistent rotator cuff defects after 1 year. This study could not identify any beneficial effect of the addition of PRP on rotator cuff healing. Level II; Randomized Controlled Trial; Treatment Study. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Comparison of Early Total Thyroidectomy with Antithyroid Treatment in Patients with Moderate-Severe Graves' Orbitopathy: A Randomized Prospective Trial

PubMed Central

Erdoğan, Murat Faik; Demir, Özgür; Ersoy, Reyhan Ünlü; Gül, Kamile; Aydoğan, Berna İmge; Üç, Ziynet Alphan; Mete, Türkan; Ertek, Sibel; Ünlütürk, Uğur; Çakır, Bekir; Aral, Yalçın; Güler, Serdar; Güllü, Sevim; Çorapçıoğlu, Demet; Dağdelen, Selçuk; Erdoğan, Gürbüz

2016-01-01

Background The optimal therapeutic choice for Graves' hyperthyroidism in the presence of moderate-severe Graves' orbitopathy (GO) remains controversial. Objectives We aimed to compare GO course in patients with moderate-severe GO treated with early total thyroidectomy (TTx) versus antithyroid drug (ATD) regimens, in a prospective, randomized manner. Methods Forty-two patients with moderate-severe GO were enrolled. A total of 4.5 g of pulse corticosteroids were given intravenously to all patients before randomization. Patients in the first group were given TTx, whereas patients in the second group were treated with ATDs. TSH was kept between 0.4 and 1 mIU/l. The clinical course of GO was evaluated with proptosis, lid aperture, clinical activity score (CAS), and diplopia. Results Eighteen and 24 patients were randomized to the TTx and ATD groups, respectively. Thyroid autoantibodies decreased significantly, and there were significant improvements in proptosis, lid aperture, and CAS in the TTx group. While in the ATD group the decrement in thyroid autoantibodies was not significant, there were significant improvements in proptosis and CAS. When the TTx group was compared with the ATD group, anti-TPO, anti-Tg, and TSH-receptor antibodies were significantly decreased in the TTx group (p < 0.01), but there was no significant difference with respect to proptosis, lid aperture, CAS, and diplopia between the two groups during a median (min.-max.) follow-up period of 60 months (36-72). Conclusion Although no definitive conclusions could be drawn from the study, mainly due to limited power, early TTx and the ATD treatment regimens, followed by intravenous pulse corticosteroid therapy, seemed to be equally effective on the course of GO in this relatively small group of patients with moderate-severe GO during a median (min.-max.) follow-up period of 60 months (36-72). PMID:27493884

Comparison of Early Total Thyroidectomy with Antithyroid Treatment in Patients with Moderate-Severe Graves' Orbitopathy: A Randomized Prospective Trial.

PubMed

Erdoğan, Murat Faik; Demir, Özgür; Ersoy, Reyhan Ünlü; Gül, Kamile; Aydoğan, Berna İmge; Üç, Ziynet Alphan; Mete, Türkan; Ertek, Sibel; Ünlütürk, Uğur; Çakır, Bekir; Aral, Yalçın; Güler, Serdar; Güllü, Sevim; Çorapçıoğlu, Demet; Dağdelen, Selçuk; Erdoğan, Gürbüz

2016-07-01

The optimal therapeutic choice for Graves' hyperthyroidism in the presence of moderate-severe Graves' orbitopathy (GO) remains controversial. We aimed to compare GO course in patients with moderate-severe GO treated with early total thyroidectomy (TTx) versus antithyroid drug (ATD) regimens, in a prospective, randomized manner. Forty-two patients with moderate-severe GO were enrolled. A total of 4.5 g of pulse corticosteroids were given intravenously to all patients before randomization. Patients in the first group were given TTx, whereas patients in the second group were treated with ATDs. TSH was kept between 0.4 and 1 mIU/l. The clinical course of GO was evaluated with proptosis, lid aperture, clinical activity score (CAS), and diplopia. Eighteen and 24 patients were randomized to the TTx and ATD groups, respectively. Thyroid autoantibodies decreased significantly, and there were significant improvements in proptosis, lid aperture, and CAS in the TTx group. While in the ATD group the decrement in thyroid autoantibodies was not significant, there were significant improvements in proptosis and CAS. When the TTx group was compared with the ATD group, anti-TPO, anti-Tg, and TSH-receptor antibodies were significantly decreased in the TTx group (p < 0.01), but there was no significant difference with respect to proptosis, lid aperture, CAS, and diplopia between the two groups during a median (min.-max.) follow-up period of 60 months (36-72). Although no definitive conclusions could be drawn from the study, mainly due to limited power, early TTx and the ATD treatment regimens, followed by intravenous pulse corticosteroid therapy, seemed to be equally effective on the course of GO in this relatively small group of patients with moderate-severe GO during a median (min.-max.) follow-up period of 60 months (36-72).

Treatment of chronic antibody mediated rejection with intravenous immunoglobulins and rituximab: A multicenter, prospective, randomized, double-blind clinical trial.

PubMed

Moreso, Francesc; Crespo, Marta; Ruiz, Juan C; Torres, Armando; Gutierrez-Dalmau, Alex; Osuna, Antonio; Perelló, Manel; Pascual, Julio; Torres, Irina B; Redondo-Pachón, Dolores; Rodrigo, Emilio; Lopez-Hoyos, Marcos; Seron, Daniel

2018-04-01

There are no approved treatments for chronic antibody mediated rejection (ABMR). We conducted a multicenter, prospective, randomized, placebo-controlled, double-blind clinical trial to evaluate efficacy and safety of intravenous immunoglobulins (IVIG) combined with rituximab (RTX) (EudraCT 2010-023746-67). Patients with transplant glomerulopathy and anti-HLA donor-specific antibodies (DSA) were eligible. Patients with estimated glomerular filtration rate (eGFR) <20 mL/min per 1.73m 2 and/or severe interstitial fibrosis/tubular atrophy were excluded. Patients were randomized to receive IVIG (4 doses of 0.5 g/kg) and RTX (375 mg/m 2 ) or a wrapped isovolumetric saline infusion. Primary efficacy variable was the decline of eGFR at one year. Secondary efficacy variables included evolution of proteinuria, renal lesions, and DSA at 1 year. The planned sample size was 25 patients per group. During 2012-2015, 25 patients were randomized (13 to the treatment and 12 to the placebo group). The planned patient enrollment was not achieved because of budgetary constraints and slow patient recruitment. There were no differences between the treatment and placebo groups in eGFR decline (-4.2 ± 14.4 vs. -6.6 ± 12.0 mL/min per 1.73 m 2 , P-value = .475), increase of proteinuria (+0.9 ± 2.1 vs. +0.9 ± 2.1 g/day, P-value = .378), Banff scores at one year and MFI of the immunodominant DSA. Safety was similar between groups. These data suggest that the combination of IVIG and RTX is not useful in patients displaying transplant glomerulopathy and DSA. © 2017 The American Society of Transplantation and the American Society of Transplant Surgeons.

The Evaluation of the Opinions of Prospective Teachers about the Objectives of Human Rights Education

ERIC Educational Resources Information Center

Özbek, Ramazan

2017-01-01

The aim of this study is to evaluate opinions of prospective teachers attending Social Sciences Teaching Department Primary Education Section on the objectives of Human Rights Education in the scope of Citizenship and Democracy Education Curriculum. This study is vital for learning of democratic life. 25 prospective teachers studying in the 8th…

Prospective Randomized Controlled Trial of Hindfoot and Ankle Fusions Treated With rhPDGF-BB in Combination With a β-TCP-Collagen Matrix.

PubMed

Daniels, Timothy R; Younger, Alastair S E; Penner, Murray J; Wing, Kevin J; Le, Ian L D; Russell, Iain S; Lalonde, Karl-André; Evangelista, Peter T; Quiton, Jovelyn D; Glazebrook, Mark; DiGiovanni, Christopher W

2015-07-01

Ankle and hindfoot arthrodesis is often supplemented with autograft to promote bony union. Autograft harvest can lead to increased perioperative morbidity. Purified recombinant human platelet-derived growth factor BB homodimer (rhPDGF-BB) has stimulated bone formation in mandibular defects and hindfoot fusion. This randomized controlled trial evaluated the efficacy and safety of rhPDGF-BB combined with an injectable, osteoconductive beta-tricalcium phosphate (β-TCP)-collagen matrix versus autograft in ankle and hindfoot fusions. Seventy-five patients requiring ankle or hindfoot fusion were randomized 5:1 for rhPDGF-BB/β-TCP-collagen (treatment, n = 63) or autograft (control, n = 12). Prospective analysis included 142 autograft control subjects from another clinical trial with identical study protocols. Standardized operative and postoperative protocols were used. Patients underwent standard internal fixation augmented with autograft or 0.3 mg/mL rhPDGF-BB/β-TCP-collagen. Radiologic, clinical, and quality-of-life outcomes were assessed over 52 weeks. Primary outcome was joint fusion (50% or more osseous bridging on computed tomography) at 24 weeks. Secondary outcomes included radiographs, clinical healing status, visual analog scale pain score, American Orthopaedic Foot & Ankle Society Ankle-Hindfoot Scale score, Foot Function Index score, and Short Form-12 score. Noninferiority P values were calculated. Complete fusion of all involved joints at 24 weeks as indicated by computed tomography was achieved in 53 of 63 (84%) rhPDGF-BB/β-TCP-collagen-treated patients and 100 of 154 (65%) autograft-treated patients (P < .001). Mean time to fusion was 14.3 ± 8.9 weeks for rhPDGF-BB/β-TCP-collagen patients versus 19.7 ± 11.5 weeks for autograft patients (P < .01). Clinical success at 52 weeks was achieved in 57 of 63 (91%) rhPDGF-BB/β-TCP-collagen patients and 120 of 154 (78%) autograft patients (P < .001). Safety-related outcomes were equivalent. Autograft controls

Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

PubMed

Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

2013-10-01

Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

A prospective randomized comparison between pylorus- and subtotal stomach-preserving pancreatoduodenectomy on postoperative delayed gastric emptying occurrence and long-term nutritional status.

PubMed

Matsumoto, Ippei; Shinzeki, Makoto; Asari, Sadaki; Goto, Tadahiro; Shirakawa, Sachiyo; Ajiki, Tetsuo; Fukumoto, Takumi; Suzuki, Yasuyuki; Ku, Yonson

2014-06-01

Pylorus-preserving pancreatoduodenectomy (PPPD) has been associated with a high incidence of delayed gastric emptying (DGE). There are few studies comparing DGE associated with PPPD and subtotal stomach-preserving pancreatoduodenectomy (SSPPD). Moreover, differences between the procedures with respect to long-term results have not been reported. A prospective randomized study was conducted to compare perioperative complications and long-term nutritional status with PPPD and SSPPD. One hundred patients with periampullary lesions were randomized to receive either PPPD (n = 50) or SSPPD (n = 50). All patients were followed up for 3 years after surgery or to the time of recurrence to evaluate nutritional status for the study. The effects of the procedure, age, and malignancy on changes in nutritional indicators were estimated with linear mixed models. This study was registered at UMIN Clinical Trials Registry (UMIN 000012337). The incidence of DGE assessed by the International Study Group of Pancreatic Surgery was 20% with PPPD and 12% with SSPPD (P = 0.414). There were no significant differences between the two procedures on postoperative serum albumin levels, serum total cholesterol levels, and body mass index during the 3-year follow-up period. SSPPD is equally effective in DGE occurrence rate and long-term nutritional status comparing to PPPD. © 2014 Wiley Periodicals, Inc.

Does transfusion of residual cardiopulmonary bypass circuit blood increase postoperative bleeding? A prospective randomized study in patients undergoing on pump cardiopulmonary bypass

PubMed Central

Duara, Rajnish; Misra, Manoranjan; Bhuyan, Ritwick Raj; Sarma, P. Sankara; Jayakumar, Karunakaran

2008-01-01

Objective: Homologous blood transfusion after open heart surgery puts a tremendous load on the blood banks. This prospective randomized study evaluates the efficacy of infusing back residual cardiopulmonary bypass (CPB) circuit i.e., pump blood as a means to reduce homologous transfusion after coronary artery bypass surgery (CABG) and whether its use increases postoperative drainage. Materials and Methods: Sixty-seven consecutive patients who underwent elective CABGs under CPB were randomized into 2 groups: (1) cases where residual pump blood was used and (2) controls where residual pump blood was not used. Patients were monitored for hourly drainage on the day of surgery and the 1st postoperative day and the requirements of homologous blood and its products. Data were matched regarding change in Hemoglobin, Packed Cell Volume and coagulation parameters till 1st postoperative day. All cases were followed up for three years. Results: There was a marginal reduction in bleeding pattern in the early postoperative period in the cases compared to controls. The requirement of homologous blood and its products were also reduced in the cases. Conclusions: The use of CPB circuit blood is safe in the immediate postoperative period. The requirement of homologous blood transfusion can come down if strict transfusion criteria are maintained. PMID:20041077

Randomized Controlled Trial Evaluating a Standardized Strategy for Uveitis Etiologic Diagnosis (ULISSE).

PubMed

de Parisot, Audrey; Kodjikian, Laurent; Errera, Marie-Hélène; Sedira, Neila; Heron, Emmanuel; Pérard, Laurent; Cornut, Pierre-Loïc; Schneider, Christelle; Rivière, Sophie; Ollé, Priscille; Pugnet, Grégory; Cathébras, Pascal; Manoli, Pierre; Bodaghi, Bahram; Saadoun, David; Baillif, Stéphanie; Tieulie, Nathalie; Andre, Marc; Chiambaretta, Frédéric; Bonin, Nicolas; Bielefeld, Philip; Bron, Alain; Mouriaux, Frédéric; Bienvenu, Boris; Vicente, Stéphanie; Bin, Sylvie; Broussolle, Christiane; Decullier, Evelyne; Sève, Pascal

2017-06-01

To prospectively assess the efficiency of a standardized diagnostic approach, compared to an open strategy, for the etiologic diagnosis of uveitis. Noninferiority, prospective, multicenter, clustered randomized controlled trial. Consecutive patients with uveitis, who visited 1 of the participating departments of ophthalmology, were included. In the standardized group, all patients had a minimal evaluation regardless of the type of uveitis (complete blood count, erythrocyte sedimentation rate, C-reactive protein, tuberculin skin test, syphilis serology, and chest radiograph) followed by more complex investigations according to ophthalmologic findings. In the open group, the ophthalmologist could order any type of investigation. Main outcome was the percentage of etiologic diagnoses at 6 months. Nine hundred and three patients with uveitis were included from January 2010 to May 2013 and the per-protocol population comprised 676 patients (open 373; standardized 303). Mean age at diagnosis was 46 years. Anatomic distribution of uveitis was as follows: anterior (60.8% and 72.3%, P = .0017), intermediate (11.7% and 12.3%, P = .8028), posterior (17.8% and 8.2%, P = .0004), and panuveitis (15.3% and 15.2%, P = .9596). An etiologic diagnosis was established in 54.4% of cases in the open group and 49.5% in the standardized group (P = .2029). The difference between both strategies (standardized minus open) was -4.9% (95% CI [-12.5%; 2.6%]). There were more investigations in the open group than in the standardized group (5371 vs 3759, P < .0001). The standardized strategy appears to be an efficient diagnostic approach for the etiologic diagnosis of uveitis, although its noninferiority cannot be proved. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of Cyavanaprāśa on Health and Immunity related Parameters in Healthy Children: A Two Arm, Randomized, Open Labeled, Prospective, Multicenter, Clinical Study

PubMed Central

Gupta, Arun; Kumar, Sunil; Dole, Sanjeeva; Deshpande, Shailesh; Deshpande, Vaishali; Singh, Sudha; Sasibhushan, V.

2017-01-01

Context: Cyavanaprāśa (CP) is an Ayurvedic immune booster formulation that confers vigor and vitality while delaying the ageing process. Benefits of CP have been studied widely in adult population. Objectives: Current study assessed beneficial effects of CP on health and immunity related parameters in healthy children. Methods: This study was a 6 month long two armed, randomized, open labeled, prospective clinical study. School going healthy children between ages of 5-12 years were randomized to receive orally daily either CP (approx. 6 g) followed by a cup of milk (100 – 200 ml) or cup of milk only twice a day while continuing with their normal/routine diet. Results were analyzed based on number of episodes, severity, duration of illness (infections and allergies) and number of absent days due to illness during the study duration and changes in levels of energy, physical fitness, strength, stamina and quality of life in children which were recorded in subject diary by their parents/Legally Acceptable Representative (LAR). Results: 702 participants were randomized, out of which 627 completed the study (CP n = 313; Control n = 314). Results of immunity (episodes of infections or allergy related conditions) showed more than 2 times protection from immunity related illness in CP Group as compared to the control. CP also showed better percentage improvement in energy levels, physical fitness, strength, stamina and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children. Conclusion: Regular consumption of CP for a period of six months could significantly improve immunity, energy levels, physical fitness, strength, stamina and quality of life in school going healthy children. Study Registration: Clinical Trail Registry of India vide CTRI/2015/02/005574, Dated 24 February 2015. PMID:28867858

Prospective evaluation of the clinical utility of laryngeal electromyography.

PubMed

Ingle, John W; Young, VyVy N; Smith, Libby J; Munin, Micheal C; Rosen, Clark A

2014-12-01

To prospectively evaluate the clinical utility of laryngeal electromyography (LEMG) STUDY DESIGN: Prospective observational study. The study involved 50 consecutive patients referred for LEMG. Laryngologists initially indicated diagnoses and treatment plans under the assumption of no access to LEMG. Patients then underwent LEMG by blinded examiners. LEMG results were reviewed by each patient's laryngologist. Diagnoses and treatment plans were either maintained or altered based on the LEMG results. The diagnosis changed 10% (5/50) of the time and treatment plans were altered 36% (18/50) of the time based on information provided by LEMG. Observational periods were eliminated in 13/50 patients based on LEMG, moving them to permanent treatment. LEMG allowed the differentiation between joint fixation and bilateral paralysis in three patients. Previously unrecognized superior laryngeal neuropathies were identified in three patients. Laryngeal electromyography often provides clinically useful information that typically leads to a more accurate diagnosis and a more appropriate, expedited treatment plan. 2b. © 2014 The American Laryngological, Rhinological and Otological Society, Inc.

Early Rehabilitation of Distal Radius Fractures Stabilized by Volar Locking Plate: A Prospective Randomized Pilot Study

PubMed Central

Quadlbauer, Stefan; Pezzei, Christoph; Jurkowitsch, Josef; Kolmayr, Brigitta; Keuchel, Tina; Simon, Daniel; Hausner, Thomas; Leixnering, Martin

2016-01-01

Background Distal radius fractures are very common and an increased incidence of 50% is estimated by 2030. Therefore, both operative and postsurgical treatment remains pertinent. Main aim in treating intra-articular fractures is to restore the articular surface by internal fixation and early mobilization (EM). Questions/Purposes The purpose of this study was to compare functional results between EM immediately after surgery and 5 weeks of immobilization (IM). Patients and Methods In a randomized prospective study, 30 patients with an isolated distal radius fracture were treated by open reduction and internal fixation using a single volar locking plate excluding bone graft. Fifteen patients were randomized in the EM group and 15 in the IM group. At 6 weeks, 9 weeks, 3 months, 6 months, and 1 year postsurgery, range of motion, grip strength and X-rays were evaluated. Additionally, Quick Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire, Patient-Rated Wrist Evaluation (PRWE), modified Green O'Brien (Mayo) score, and pain according to the Visual Analog Scale score were analyzed. Results Patients in the EM group had a significantly better range of motion in the sagittal plane, in grip strength up to 6 months, in the frontal plane up to 9 weeks, and in forearm rotation up to 6 weeks. Also QuickDASH and PRWE scores were better up to 6 weeks postsurgery. The Green O'Brien score differed significantly up to 1 year. At 1 year, 93% “excellent” and “good” results in the Green O'Brien score with a mean QuickDASH of 5.98 ± 10.94 and PRWE score of 4.27 ± 9.23 were observed in the EM group. No differences regarding loss of reduction, pain, duration of physiotherapy, and sick leave were noted. Conclusion EM of surgically treated distal radius fractures (without bone graft) is a safe method for postoperative aftercare and leads to an improved range of motion and grip strength at 6 months postsurgery compared with an IM of 5 weeks

Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

PubMed

Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

2011-12-01

This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

PubMed Central

2011-01-01

Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning). Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation, radiological consolidation

The Effect of Botulinum Toxin A Injections in the Spine Muscles for Cerebral Palsy Scoliosis, Examined in a Prospective, Randomized Triple-blinded Study.

PubMed

Wong, Christian; Pedersen, Søren Anker; Kristensen, Billy B; Gosvig, Kasper; Sonne-Holm, Stig

2015-12-01

A prospective, randomized triple-blinded cross-over design treating with either botulinum toxin A (BXT) or saline (NaCl). To examine the efficacy of BTX treatment in cerebral palsy scoliosis (CPS). Intramuscular injections with BTX have been used off label in treating CPS. 1 prospective study has been conducted, demonstrating in both radiological and clinical improvement, whereas showing no side effects or complications. Subjects (brace-treated CPS between 2 and 18 yr) were injected using ultrasonic-guidance with either NaCl or BTX in selected spine muscles with 6 mo intervals (block randomization, sealed envelope). Radiographs of the spine and clinical follow-up were captured before and 6 weeks after each injection. Primary outcome parameter was radiological change in Cobb angle, where a 7° change was regarded as an effect (1 SD). Radiological parameters were measured before and 6 weeks after treatment by 3 experienced doctors separately. Moreover, clinical results were evaluated by the pediatric quality of life score and systematic open questioning of the parents about the child's wellbeing. Subjects, researchers, and monitors were blinded during the trial. Appropriate permissions (2008-004584-19) and no funding were obtained. 16 cerebral palsy patients (GFMCS III-V) with CPS were consecutively included, whereas 6 patients were excluded. There were no drop-outs to follow-up, but 1 possible serious adverse event of pneumonia resulting in death was recorded and the study was terminated. No significant radiological or clinical changes were detected when compared with NaCl injections using Wilcoxon matched pair signed-rank test. No positive radiological or clinical effects were demonstrated by this treatment, except for the parent's initial subjective but positive appraisal of the effect. However, the study was terminated due to 1 possible severe adverse event and scheduled numbers needed to treat (hence power) were not reached. 1.

Neurostimulation in ultrasound-guided infraclavicular block: a prospective randomized trial.

PubMed

Dingemans, Emmanuel; Williams, Stephan R; Arcand, Geneviève; Chouinard, Philippe; Harris, Patrick; Ruel, Monique; Girard, François

2007-05-01

Ultrasound guidance (USG) for infraclavicular blocks provides real time visualization of the advancing needle and local anesthetic distribution. Whether visualization of local anesthetic spread can supplant neurostimulation as the end point for local anesthetic injection during USG block has never been formally evaluated. Therefore, for this prospective randomized study, we recruited 72 patients scheduled for hand or forearm surgery and compared the speed of execution and quality of USG infraclavicular block with either USG alone (Group U) or USG combined with neurostimulation (Group S). In Group U, local anesthetic was deposited in a U-shaped distribution posterior and to each side of the axillary artery using as few injections as possible (1, 2, and 3 injections in 29, 6, and 3 patients, respectively). In Group S, a single injection was made after obtaining a distal motor response with a stimulating current between 0.3 and 0.6 mA. The anesthetic solution consisted of 0.5 mL/kg of lidocaine 1.5%, bupivacaine 0.125%, and epinephrine 1:200 000 (final concentrations). Procedure times were significantly shorter in Group U compared with Group S (3.1 +/- 1.6 min and 5.2 +/- 4.7 min, respectively; P = 0.006). In Group S, anesthetic spread was mainly anterior to the axillary artery in 37% of patients and mainly posterior in 63% of patients. Thirty minutes after the injection, 86% of patients in Group U had complete sensory block in the musculocutaneous, median, radial, and ulnar nerve territories compared with 57% in Group S (P = 0.007). Patients blocked in Group U with a single injection had the same rate of complete block (86%) as those blocked with more than one injection (86%). Block supplementation rates were 8% in Group U versus 26% in Group S (P = 0.049). Block failure occurred in one patient in Group S because of an inability to obtain a distal stimulation after 20 min. We conclude that USG infraclavicular block is more rapidly performed and yields a higher

Papillary vs Nonpapillary Puncture in Percutaneous Nephrolithotomy: A Prospective Randomized Trial.

PubMed

Kallidonis, Panagiotis; Kyriazis, Iason; Kotsiris, Dimitrios; Koutava, Adamantia; Kamal, Wissam; Liatsikos, Evangelos

2017-04-01

Literature suggests that the percutaneous punctures for percutaneous nephrolithotomy (PCNL) must be performed at the papilla of the renal calix and a puncture at the infundibulum or the direction of the pelvis is not advisable because of increased hemorrhagic risk. A prospective randomized study was conducted to investigate the safety in terms of blood loss of the infundibular approach for PCNL. Patients with renal stones with an accumulative size of at least 2 cm were randomly assigned to one of two parallel groups to undergo PCNL with either papillary (Group 1) or infundibular (Group 2) renal access. The primary outcome measures were the reduction in hemoglobin on first postoperative day and the need for transfusion during the first postoperative month. Secondary endpoints included the operative and fluoroscopy time, number of accesses performed, overall complication rate, hospitalization time, and complications up to 3 months. In total, 27 and 28 patients were enrolled in Groups 1 and 2, respectively. Patient age, body mass index, and stone size were similar among the groups (p = 0.672, 0.256, and 0.889, respectively). Reduction in hemoglobin and transfusion rate did not differ among Groups 1 and 2 (p = 0.916, p = 1.0, respectively). Operative time was higher in the case of Group 1 (p = 0.027). The overall complications rate was 7.4% for Group 1 and 7.14% for Group 2. Hospitalization time was not significantly different in the study groups (p = 0.724). The infundibular approach for PCNL to the posterior middle renal calices is not associated with higher blood loss or transfusion rate in comparison with the respective approach to the fornix of the papilla when the currently described technique is performed.

[Prospective evaluation of pain associated with indwelling JJ stents following ureterorenoscopic lithotripsy].

PubMed

Dudek, Przemysław; Gołabek, Tomasz; Jaskulski, Jarosław; Orłowski, Paweł; Bukowczan, Jakub; Szopiński, Tomasz; Chłosta, Piotr

2013-01-01

Routine placement of JJ ure teric stents, following uncomplicated endoscopic removal of a ureteral stone, still remains debatable. Indwelling JJ stents are not without any risks. They often can cause marked discomfort, or even pain. The aim of this study was to prospectively evaluate patient's perceived pain due to renal colic and indwelling JJ stent left following ure terorenoscopic lithotripsy (URSL). 54 patients with colicky pain due to distal ureteric stone, and who underwent uncompli cated ureterorenoscopic lithotripsy, were included in the study. Follow ing URSL, patients were randomly selected to have either JJ stent left in situ (Group I), or remain without a stent (Group II). Among all study par ticipants levels of pain prior, as well as 14 days after the procedure were evalu ated with the use of a visual analogue pain scale. Pain perception at the time of colic did not vary between men and women (6.30 +/- 1.33 and 6.38 +/- 1.11, respectively, p=0.293). Similarly, no differences in perceived pain were noted 14 days following URSL. Mean pain score in patients with indwelling JJ stent was 2.12 +/- 1.23 as compared to 2.15 +/- 0.67 in those without it (p=0.148). No increase in pain levels due to indwelling JJ stent could be observed. Further research to allow for better assessment of discomfort and pain caused by an indwelling JJ stent on a larger cohort, and which could also discriminate patients' psy chosomatic symptoms, is needed.

Effects of low-intensity pulsed ultrasound on radiographic healing of tibial plateau leveling osteotomies in dogs: a prospective, randomized, double-blinded study.

PubMed

Kieves, Nina R; Canapp, Sherman O; Lotsikas, Peter J; Christopher, Scott A; Leasure, Christopher S; Canapp, Debra; Gavin, Patrick R

2018-05-20

To determine the influence of low-intensity pulsed ultrasound (LIPUS) on radiographic healing and limb function after uncomplicated, stable osteotomies in dogs. In vivo, prospective, randomized, double-blinded, placebo-control study. Fifty client-owned dogs. Fifty client-owned dogs with naturally occurring unilateral cranial cruciate ligament rupture were enrolled prior to tibial plateau leveling osteotomy. Dogs were assigned to an active (LIPUS) treatment group or a placebo control (SHAM) treatment group via block randomization on the basis of age, weight, and affected limb. Dogs in the LIPUS treatment group underwent LIPUS treatments for 20 minutes daily: 1.5-MHZ ultrasound wave pulsed at 1 kHZ with a 20% duty cycle at an intensity of 30 mW/cm 2 for the duration of the study (12 weeks). Radiographic evaluation was performed at 4, 8, 10, and 12 weeks postoperatively to evaluate bone healing. Limb function was assessed with temporal-spatial gait analysis preoperatively and at 4, 8, and 12 weeks postoperatively by using a pressure-sensitive walkway system. Both groups had significant improvement in radiographic score and limb use over time. However, there was no significant difference in radiographic bone healing, or limb use as measured by objective gait analysis detected between the LIPUS treatment group and SHAM treatment group at any point in the study. LIPUS treatment did not improve healing in this stable osteotomy model. This study does not provide evidence to support the clinical application of LIPUS to stimulate the healing of stable, uncomplicated osteotomies to accelerate bone healing. © 2018 The American College of Veterinary Surgeons.

Prospective randomized controlled trial: fibrin sealant reduces split skin graft donor-site pain.

PubMed

Healy, Ciaran; Greig, Aina V H; Murphy, Adrian D; Powell, Christopher; Pinder, Richard J; Saour, Samer; Abela, Christopher; Knight, William; Geh, Jenny L C

2013-07-01

Pain at split skin graft donor sites is common. Fibrin sealant has been demonstrated to reduce time to hemostasis at wound sites, and patients receiving this treatment were incidentally noted to report less pain. This study aimed to evaluate pain and incapacity in split skin graft donor sites treated with and without fibrin sealant. Fifty patients requiring thigh donor-site split skin grafts were prospectively randomized to receive either a self-adhesive fabric dressing alone or fibrin sealant plus the self-adhesive fabric dressing as primary donor-site dressings. External secondary dressings were the same. Patients were blinded with regard to treatment group. Using visual analogue scales (scored 0 to 5), patients rated their donor-site pain and incapacity for 14 days postoperatively. Secondary endpoints were length of hospital stay and duration of requirement for dressings. Forty patients were included in the study analysis and completed self-reported pain and incapacity scores. Twenty received the fibrin sealant plus self-adhesive fabric dressing and 20 received the fabric dressing only (controls). Patients using the fibrin sealant plus the dressing reported significantly less pain (mean score, 0.42 versus 1.60, p < 0.001) and significantly less incapacity (mean score, 0.48 versus 1.71, p < 0.001). Patients allocated to the fibrin sealant group recorded shorter lengths of stay and faster time to discontinuation of dressing, though statistical significance was not achieved. Patients whose split skin graft donor sites were dressed with fibrin sealant plus self-adhesive fabric dressing experienced significantly less pain and incapacity than patients with self-adhesive fabric dressings alone, allowing a more rapid return to normal activity. Therapeutic, II.

Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial.

PubMed

Soltani, Rasool; Soheilipour, Saeed; Hajhashemi, Valiollah; Asghari, Gholamreza; Bagheri, Mahdi; Molavi, Mahdi

2013-09-01

To evaluate the effect of aromatherapy with Lavandula angustifolia essential oil on post-tonsillectomy pain in pediatric patients. This was a randomized controlled prospective clinical trial. In this study, 48 post-tonsillectomy patients aged 6-12 years were randomly assigned to two groups (24 patients in each group). After tonsillectomy surgery, all patients received acetaminophen (10-15 mg/kg/dose, PO) every 6h as necessary to relieve pain. The patients of the case group also inhaled lavender essential oil. The frequencies of daily use of acetaminophen and nocturnal awakening due to pain, and pain intensity (evaluated using visual analog scale [VAS]) were recorded for each patient for 3 days after surgery. Finally, the mean values of variables were compared between two groups separately for each post-operative day. The use of lavender essential oil caused statistically significant reduction in daily use of acetaminophen in all three post-operative days but had not significant effects on pain intensity and frequency of nocturnal awakening. Aromatherapy with lavender essential oil decreases the number of required analgesics following tonsillectomy in pediatric patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

DTIC Science & Technology

2014-10-01

SCI. In this prospective randomized controlled trial, we will objectively measure sleep disordered breathing ( SDB ) in chronic SCI patients using...portable sleep studies, and systematically evaluate the association between SDB , cognitive performance, mood, pain, and CV measures. We will randomize...randomized shortly. 15. SUBJECT TERMS SDB , SCI, PAP, CV 16. SECURITY CLASSIFICATION OF: 17. LIMITATION OF ABSTRACT 18. NUMBER OF PAGES 19a

Effects of simvastatin and oral contraceptive agent on polycystic ovary syndrome: prospective, randomized, crossover trial.

PubMed

Banaszewska, Beata; Pawelczyk, Leszek; Spaczynski, Robert Z; Dziura, James; Duleba, Antoni J

2007-02-01

Polycystic ovary syndrome (PCOS) is associated with hyperandrogenism and cardiovascular risks including dyslipidemia and systemic inflammation. In vitro, statins decrease proliferation and steroidogenesis of ovarian theca-interstitial cells. The study objective was to compare effects of two treatments of PCOS: simvastatin plus oral contraceptive pill (OCP) vs. OCP alone. In a prospective, crossover trial, 48 women with PCOS were randomized to either simvastatin plus OCP for 12 wk followed by OCP alone for an additional 12 wk, or to OCP alone for 12 wk and, subsequently, simvastatin plus OCP for an additional 12 wk. Evaluations were performed at baseline, after 12 wk (crossover), and after 24 wk. Data were analyzed using a random effects model. The study was conducted in an academic medical center. Serum total testosterone was the primary outcome measure. Total testosterone decreased by 38% after Statin + OCP, whereas OCP alone led to a 26% decrease; the statin-attributable effect was significant (P < 0.004). Free testosterone declined by 58% after Statin + OCP, significantly more than the 35% decline after OCP alone (P = 0.006). Hirsutism decreased by 8.1% after Statin + OCP, a greater effect than the 4.7% decrease after OCP alone (P = 0.02). Statin decreased LH, but not FSH or prolactin. Statin + OCP decreased total and low-density lipoprotein cholesterol by 7.5% and 20%, respectively. OCP alone led to a 5% increase of total cholesterol without effect on low-density lipoprotein cholesterol. Statin prevented OCP induced increase of triglycerides. C-reactive protein decreased by 45% after Statin + OCP, a significantly different effect (P = 0.006) than a 6% increase after OCP alone. Soluble vascular cell adhesion molecule 1 decreased by 18% after Statin + OCP, a greater decline than the 10% decrease after OCP alone (P = 0.01). Simvastatin improved endocrine/clinical aspects of PCOS and had beneficial effects on lipid profile and markers of systemic inflammation.

Glycemic Control Reduces Infections in Post-Liver Transplant Patients: Results of a Prospective, Randomized Study.

PubMed

Wallia, Amisha; Schmidt, Kathleen; Oakes, Diana Johnson; Pollack, Teresa; Welsh, Nicholas; Kling-Colson, Susan; Gupta, Suruchi; Fulkerson, Candice; Aleppo, Grazia; Parikh, Neehar; Levitsky, Josh; Norvell, J P; Rademaker, Alfred; Molitch, Mark E

2017-02-01

Previous studies have shown a relationship between glycemic control and posttransplant morbidity. We conducted a prospective randomized controlled trial in postliver transplant patients to evaluate intensive inpatient glycemic control and effects on outcomes to 1 year. A total of 164 patients [blood glucose (BG) >180 mg/dL] were randomized into 2 target groups: 82 with a BG of 140 mg/dL and 82 with a BG of 180 mg/dL. Continuous insulin infusions were initiated and then converted to subcutaneous basal bolus insulin therapy by our glucose management service. The inpatient mean BG level was significantly different (140 group, 151.4 ± 19.5 mg/dL vs 180 group, 172.6 ± 27.9 mg/dL; P < 0.001). Any infection within 1 year occurred in 35 of the 82 patients (42.7%) in the 140 group and 54 of 82 (65.9%) in the 180 group (P = 0.0046). In a time-to-first infection analysis, being in the 140 group resulted in a hazard ratio of 0.54 (95% confidence interval, 0.35 to 0.83; P = 0.004); the difference between the 2 groups was statistically significant at 1 month (P = 0.008). The number with adjudicated transplant rejection was similar between the 2 groups [17 of 82 (20.7%) and 20 of 82 (24.3%) in the 140 and 180 groups, respectively; P = not significant]. Severe hypoglycemia (BG ≤40 mg/dL) occurred in 3 patients (2 in the 140 group and 1 in the 180 group). However, more patients had moderate hypoglycemia (BG, 41 to 70 mg/dL) in the 140 group [27 of 82 (32.9%) vs 10 of 82 (12.2%) in the 180 group; P = 0.003]. Insulin-related hypoglycemia was not associated with the incidence of severe adverse outcomes. Glycemic control of 140 mg/dL safely resulted in a reduced incidence of infection after transplantation compared with 180 mg/dL, but with an increase in moderate hypoglycemia. Copyright © 2017 by the Endocrine Society

Double-layer versus single-layer bone-patellar tendon-bone anterior cruciate ligament reconstruction: a prospective randomized study with 3-year follow-up.

PubMed

Mei, Xiaoliang; Zhang, Zhenxiang; Yang, Jingwen

2016-12-01

To evaluate the clinical results of a randomized controlled trial of single-layer versus double-layer bone-patellar tendon-bone (BPTB) anterior cruciate ligament (ACL) reconstruction. Fifty-eight subjects who underwent primary ACL reconstruction with a BPTB allograft were prospectively randomized into two groups: single-layer reconstruction (n = 31) and double-layer reconstruction (n = 27). The following evaluation methods were used: clinical examination, KT-1000 arthrometer measurement, muscle strength, Tegner activity score, Lysholm score, subjective rating scale regarding patient satisfaction and sports performance level, graft retear, contralateral ACL tear, and additional meniscus surgery. Forty-eight subjects (24 in single-layer group and 24 in double-layer group) who were followed up for 3 years were evaluated. Preoperatively, there were no differences between the groups. At 3-year follow-up, the Lachman and pivot-shift test results were better in the double-layer group (P = 0.019 and P < 0.0001, respectively). KT measurements were better in the double-layer group (mean 2.9 versus 1.5 mm; P = 0.0025). The Tegner score was also better in the double-layer group (P = 0.024). There were no significant differences in range of motion, muscle strength, Lysholm score, subjective rating scale, graft retear, and secondary meniscal tear. In ACL reconstruction, double-layer BPTB reconstruction was significantly better than single-layer reconstruction regarding anterior and rotational stability at 3-year follow-up. The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the double-layer group, whereas there was no difference in the anterior drawer test results. The Tegner score was also better in the double-layer group; however, there were no differences in the other subjective findings.

Reduction of shunt obstructions by using a peel-away sheath technique? A multicenter prospective randomized trial.

PubMed

Kehler, Uwe; Langer, Niels; Gliemroth, Jan; Meier, Ullrich; Lemcke, Johannes; Sprung, Christian; Schlosser, Hans-Georg; Kiefer, Michael; Eymann, Regina; Heese, Oliver

2012-05-01

Shunt obstructions may partly be caused by brain debris, which intrude into the ventricular catheter during ventricle puncture. Avoiding contact between the catheter and brain tissue, by using a peel-away sheath, should reduce the number of shunt failures caused by obstruction. To test this hypothesis, we conducted a randomized, prospective multicenter study. 201 patients from 6 different neurosurgical centers in Germany receiving a ventriculo-peritoneal shunt were included in this study. Of these, 177 patients completed a 1-year follow-up period. Surgery was randomized in a 1 to 1 fashion, such that out of 177 procedures, 91 were performed using a peel-away sheath and 86 were performed without. The rate of surgical re-interventions and shunt obstructions within a 12-month period was recorded. Within 1 year post-surgery, 17 shunt obstructions (9.6%) leading to shunt revisions were recorded. However, no difference was found between surgeries performed using a peel-away sheath (9.9%) or not (9.3%). The overall shunt infection rate was 2.8% and the shunt revision rate for overdrainage was 3.9%. The theoretical advantages attributed to the use of a peel-away sheath to introduce a ventricular catheter could not be confirmed in this randomized study, suggesting that the proposed role of brain debris in shunt obstructions may be overestimated. Copyright © 2011 Elsevier B.V. All rights reserved.

In-line filtration minimizes organ dysfunction: new aspects from a prospective, randomized, controlled trial.

PubMed

Boehne, Martin; Jack, Thomas; Köditz, Harald; Seidemann, Kathrin; Schmidt, Florian; Abura, Michaela; Bertram, Harald; Sasse, Michael

2013-02-06

Infused particles induce thrombogenesis, impair microcirculation and modulate immune response. We have previously shown in critically ill children, that particle-retentive in-line filtration reduced the overall complication rate of severe events, length of stay and duration of mechanical ventilation. We now evaluated the influence of in-line filtration on different organ function and thereby elucidated the potential underlying pathophysiological effects of particle infusion. In this single-centre, prospective, randomized controlled trial 807 critically ill children were assigned to either control (n = 406) or filter group (n = 401), the latter receiving in-line filtration for complete infusion therapy. Both groups were compared regarding the differences of incidence rates and its 95% confidence interval (CI) of different organ dysfunction as defined by the International Pediatric Sepsis Consensus Conference 2005. The incidence rates of respiratory (-5.06%; 95% CI, -9.52 to -0.59%), renal (-3.87%; 95% CI, -7.58 to -0.15%) and hematologic (-3.89%; 95% CI, -7.26 to -0.51%) dysfunction were decreased in the filter group. No difference was demonstrated for the occurrence rates of cardiovascular, hepatic, or neurologic dysfunction between both groups. In-line filtration has beneficial effects on the preservation of hematologic, renal and respiratory function in critically ill patients. The presented clinical data further support our hypothesis regarding potential harmful effects of particles. In critically ill patients infused particles may lead to further deterioration of the microcirculation, induce a systemic hypercoagulability and inflammation with consecutive negative effects on organ function. ClinicalTrials.gov number; NCT00209768.

Lumbar spinous process splitting decompression provides equivalent outcomes to conventional midline decompression in degenerative lumbar canal stenosis: a prospective, randomized controlled study of 51 patients.

PubMed

Rajasekaran, S; Thomas, Ashok; Kanna, Rishi M; Prasad Shetty, Ajoy

2013-09-15

Prospective, randomized controlled study. To compare the functional outcomes and extent of paraspinal muscle damage between 2 decompressive techniques for lumbar canal stenosis. Lumbar spinous process splitting decompression (LSPSD) preserves the muscular and liga-mentous attachments of the posterior elements of the spine. It can potentially avoid problems such as paraspinal muscle atrophy and trunk extensor weakness that can occur after conventional midline decompression. However, large series prospective randomized controlled studies are lacking. Patients with lumbar canal stenosis were randomly allocated into 2 groups: LSPSD (28 patients) and conventional midline decompression (23 patients). The differences in operative time, blood loss, time to comfortable mobilization, and hospital stay were studied. Paraspinal muscle damage was assessed by postoperative rise in creatine phosphokinase and C-reactive protein levels. Functional outcome was evaluated at 1 year by Japanese Orthopaedic Association score, neurogenic claudication outcome score, and visual analogue scale for back pain and neurogenic claudication. Fifty-one patients of mean age 56 years were followed-up for a mean 14.2 ± 2.9 months. There were no significant differences in the operative time, blood loss, and hospital stay. Both the groups showed significant improvement in the functional outcome scores at 1 year. Between the 2 groups, the Japanese Orthopaedic Association score, neurogenic claudication outcome score improvement, visual analogue scale for back pain, neurogenic claudication visual analogue scale, and the postoperative changes in serum C-reactive protein and creatine phosphokinase levels did not show any statistically significant difference. On the basis of the Japanese Orthopaedic Association recovery rate, it was found that 73.9% of conventional midline decompression group had good outcomes compared with only 60.7% after LSPSD. The functional outcome scores, back pain, and claudication

Evaluation of the Alexon-Trend ProSpecT Campylobacter Microplate Assay

PubMed Central

Tolcin, Rita; LaSalvia, Margaret M.; Kirkley, Barbara A.; Vetter, Emily A.; Cockerill, Franklin R.; Procop, Gary W.

2000-01-01

We evaluated stool specimens known to contain or be free of Campylobacter by traditional culture, using the ProSpecT Campylobacter microplate assay (Alexon-Trend, Ramsey, Minn.). This rapid enzyme immunoassay for the detection of Campylobacter-specific antigens demonstrated 96% sensitivity and 99% specificity and is an acceptable alternative method of Campylobacter detection. PMID:11015419

Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

ERIC Educational Resources Information Center

Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

2011-01-01

We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

A randomized, prospective cross-over trial comparing methylene blue-directed biopsy and conventional random biopsy for detecting intestinal metaplasia and dysplasia in Barrett's esophagus.

PubMed

Ragunath, K; Krasner, N; Raman, V S; Haqqani, M T; Cheung, W Y

2003-12-01

The value of methylene blue-directed biopsies (MBDB) in detecting specialized intestinal metaplasia and dysplasia in Barrett's esophagus remains unclear. The aim of this study was to compare the accuracy of MBDB with random biopsy in detecting intestinal metaplasia and dysplasia in patients with Barrett's esophagus. A prospective, randomized, cross-over trial was undertaken to compare MBDB with random biopsy in patients with Barrett's esophagus segments 3 cm or more in length without macroscopic evidence of dysplasia or cancer. Dysplasia was graded as: indefinite for dysplasia, low-grade dysplasia, high-grade dysplasia, or carcinoma, and was reported in a blinded fashion. Fifty-seven patients were recruited, 44 of whom were male. A total of 1,269 biopsies were taken (MBDB-651, random biopsie-618). Analysis of the results by per-biopsy protocol showed that the MBDB technique diagnosed significantly more specialized intestinal metaplasia (75 %) compared to the random biopsy technique (68 %; P = 0.032). The sensitivity and specificity rates of MBDB for diagnosing specialized intestinal metaplasia were 91 % (95 % CI, 88 - 93 %) and 43 % (95 % CI, 36 - 51 %), respectively. The sensitivity and specificity rates of MBDB for diagnosing dysplasia or carcinoma were 49 % (95 % CI, 38 - 61 %) and 85 % (95 % CI, 82 - 88 %), respectively. There were no significant differences in the diagnosis of dysplasia and carcinoma - MBDB 12 %, random biopsy 10 %. The methylene blue staining pattern appeared to have an influence on the detection of specialized intestinal metaplasia and dysplasia/carcinoma. Dark blue staining was associated with increased detection of specialized intestinal metaplasia (P < 0.0001), and heterogeneous staining (P = 0.137) or no staining (P = 0.005) were associated with dysplasia and/or carcinoma detection. The MBDB technique prolonged the endoscopy examination by an average of 6 min. The diagnostic accuracy of the MBDB technique was superior to that of the

SMERFS: Stochastic Markov Evaluation of Random Fields on the Sphere

NASA Astrophysics Data System (ADS)

Creasey, Peter; Lang, Annika

2018-04-01

SMERFS (Stochastic Markov Evaluation of Random Fields on the Sphere) creates large realizations of random fields on the sphere. It uses a fast algorithm based on Markov properties and fast Fourier Transforms in 1d that generates samples on an n X n grid in O(n2 log n) and efficiently derives the necessary conditional covariance matrices.

Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

DOE Office of Scientific and Technical Information (OSTI.GOV)

Abbott, Andrea M.; Portschy, Pamela R.; Lee, Chung

2013-11-01

Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatmentmore » in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.« less

Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach.

PubMed

Sarli, L; Iusco, D R; Sansebastiano, G; Costi, R

2001-08-01

No randomized trial exists that specifically addresses the issue of laparoscopic bilateral inguinal hernia repair. The purpose of the present prospective, randomized, controlled, clinical study was to assess short- and long-term results when comparing simultaneous bilateral hernia repair by an open, tension-free anterior approach with laparoscopic "bikini mesh" posterior repair. Forty-three low-risk male patients with bilateral primary inguinal hernia were randomly assigned to undergo either laparoscopic preperitoneal "bikini mesh" hernia repair (TAPP) or open Lichtenstein hernioplasty. There was no difference in operating time between the two groups. The mean cost of laparoscopic hernioplasty was higher (P < 0.001). The intensity of postoperative pain was greater in the open hernia repair group at 24 hours, 48 hours, and 7 days after surgery (P < 0.001), with a greater consumption of pain medication among these patients (P < 0.05). The median time to return to work was 30 days for the open hernia repair group and 16 days for the laparoscopic "bikini mesh" repair group (P < 0.05). Only 1 asymptomatic recurrence (4.3%) was discovered in the open group. The laparoscopic approach to bilateral hernia with "bikini mesh" appears to be preferable to the open Lichtenstein tension-free hernioplasty in terms of the postoperative quality of life and interruption of occupational activity.

A Randomized, Prospective, Parallel Group Study of Laparoscopic vs. Laparoendoscopic Single Site Donor Nephrectomy for Kidney Donation

PubMed Central

Aull, Meredith J.; Afaneh, Cheguevara; Charlton, Marian; Serur, David; Douglas, Melissa; Christos, Paul J.; Kapur, Sandip; Del Pizzo, Joseph J.

2014-01-01

Few prospective, randomized studies have assessed benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN vs. LDN from surgery through 5 years post-donation. Subjects complete recovery/satisfaction questionnaires at 2, 6, and 12 months post-donation; transplant recipient outcomes are also recorded. 100 subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) vs. 2 LDN (3.9%; P=0.67). Questionnaires revealed 97.2% of LESS-DN vs. 79.5% of LDN (P=0.03) were 100% recovered by two months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation. PMID:24934732

Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period.

PubMed

de la Barrera-Núñez, M-C; Yáñez-Vico, R-M; Batista-Cruzado, A; Heurtebise-Saavedra, J-M; Castillo-de Oyagüe, R; Torres-Lagares, D

2014-03-01

To evaluate the anti-inflammatory and analgesic effect of Bromelain (pineapple extract) administered orally in the postoperative after extraction of impacted lower molars. This is a prospective, placebo-controlled, unicentric, double-blind study; the sample size was 34 patients. The pre and postoperative outcomes, evaluated on the third (D3) and eighth day (D8), included inflamtion, pain and oral aperture, as well as the need for analgesics. One group received Bromelain 150mg per day for three days and 100mg on days 4 to 7. The other group received placebo in the same dosage. All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples. Although there were no statistically significant differences between the treatment groups, a trend towards less inflammation and improved oral aperture was observed in the group that received Bromelain, compared to the group that received placebo. This trend can be attributed completely to random reasons, since there is no statistical difference in the results. Further studies are necessary to analyze different administration patterns and doses of Bromelain for the use in the postoperative of impacted third molars.

Evaluation of homeopathic Arnica montana for ecchymosis after upper blepharoplasty: a placebo-controlled, randomized, double-blind study.

PubMed

Kotlus, Brett S; Heringer, Dustin M; Dryden, Robert M

2010-01-01

Ecchymosis is commonly encountered after upper eyelid blepharoplasty. The use of homeopathic preparations of Arnica montana, a flowering herb, has been advocated by physicians, patients, and manufacturers for reduction of postsurgical ecchymosis. The authors evaluate its efficacy after upper eyelid blepharoplasty. A prospective, placebo-controlled, double-blind study was performed in which patients were randomly assigned to the administration of homeopathic A. montana or placebo concurrent with unilateral upper eyelid blepharoplasty followed by contralateral treatment at least 1 month later. Ecchymosis was evaluated at days 3 and 7 by rank order of severity and measurement of surface area of observable ecchymosis. There was no statistically significant difference in area of ecchymosis or rank order of ecchymosis severity for days 3 and 7 after treatment with A. montana versus placebo. Additionally, there was no difference in ease of recovery per patient report, and there was no difference in the rate of ecchymosis resolution. The authors find no evidence that homeopathic A. montana, as used in this study, is beneficial in the reduction or the resolution of ecchymosis after upper eyelid blepharoplasty.

Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

PubMed

Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

2014-07-01

The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop: Prospective double-blind randomized study.

PubMed

Moscovici, Bernardo Kaplan; Holzchuh, Ricardo; Sakassegawa-Naves, Fernando Eiji; Hoshino-Ruiz, Diego Ricardo; Albers, Marcos Bottene Villa; Santo, Ruth Miyuki; Hida, Richard Yudi

2015-10-01

To describe the clinical efficacy of the treatment of Sjögren's syndrome dry eye using 0.03% tacrolimus eye drop. Prospective double-blind randomized study. Institutional outpatient clinic. Forty-eight eyes of twenty-four patients with dry eye related to Sjögren syndrome were enrolled in this study. The patients were randomized in 2 groups: tacrolimus (n=14) and vehicle (n=10) group. The tacrolimus group received a vial containing tacrolimus 0.03% (almond oil as vehicle) and the other group received the almond oil vehicle. All patients were instructed to use the eye drops every 12h in the lower conjunctival sac. Schirmer I test, break-up-time (BUT), corneal fluorescein and Rose Bengal staining scores were evaluated in all patients one day before the treatment (baseline), 7, 14, 28 and 90 days after treatment with the eye drops. The average fluorescein and Rose Bengal scores improved statistically after 7 days of treatment and even more after 90 days. The average Schirmer I and BUT values were unchanged after 7, 14 and 21 days but did show an improvement relative to baseline after 28 days of treatment. Schirmer I, BUT, fluorescein and Rose Bengal did not show any statistical significance in the vehicle group. Topical 0.03% tacrolimus eye drop improved tear stability and ocular surface status in cases of inflammatory or SS-related dry eye. ClinicalTrials.gov Identifier: NCT01850979. Copyright © 2015 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials

DOE Office of Scientific and Technical Information (OSTI.GOV)

Logan, Jennifer K.; Tang, Chad; Liao, Zhongxing

Purpose: Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. Methods and Materials: From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials inmore » NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results: A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Conclusion: Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design.« less

Early hospital discharge versus continued hospitalization in febrile pediatric cancer patients with prolonged neutropenia: A randomized, prospective study.

PubMed

Ahmed, Nabil; El-Mahallawy, Hadir A; Ahmed, Ibrahim A; Nassif, Shimaa; El-Beshlawy, Aamal; El-Haddad, Alaa

2007-11-01

Hospitalization with single or multi-agent antibiotic therapy has been the standard of care for treatment of febrile neutropenia in cancer patients. We hypothesized that an empiric antibiotic regimen that is effective and that can be administered once-daily will allow for improved hospital utilization by early transition to outpatient care. Febrile pediatric cancer patients with anticipated prolonged neutropenia were randomized between a regimen of once-daily ceftriaxone plus amikacin (C + A) and imipenem monotherapy (control). Afebrile patients on C + A satisfying "Early Discharge Criteria" at 72 hr continued treatment as outpatients. We compared the outcome, adverse events, duration of hospitalization, and cost between both groups. A prospective randomized controlled clinical trial was conducted on 129 febrile episodes in pediatric cancer patients with prolonged neutropenia. No adverse events were seen in 32 children (84% of study arm) treated on an outpatient basis. We found a statistically significant difference between the duration of hospitalization of the C + A group [median 5 days] and control [median 9 days](P < 0.001), per episode antibiotic cost (P < 0.001) and total episode cost (P < 0.001). There was no statistically significant difference in the response to treatment at 72 hr or after necessary antimicrobial modifications. We conclude that pediatric febrile cancer patients initially considered at risk for sepsis due to prolonged neutropenia can be re-evaluated at 72 hr for outpatient therapy. The convenience, low incidence of adverse effects, and cost benefit of the once-daily regimen of C + A may be particularly useful to reduce the overall treatment costs and duration of hospitalization. (c) 2007 Wiley-Liss, Inc.

Scissor-type knife significantly improves self-completion rate of colorectal endoscopic submucosal dissection: Single-center prospective randomized trial.

PubMed

Yamashina, Takeshi; Takeuchi, Yoji; Nagai, Kengo; Matsuura, Noriko; Ito, Takashi; Fujii, Mototsugu; Hanaoka, Noboru; Higashino, Koji; Uedo, Noriya; Ishihara, Ryu; Iishi, Hiroyasu

2017-05-01

Colorectal endoscopic submucosal dissection (C-ESD) is recognized as a difficult procedure. Recently, scissors-type knives were launched to reduce the difficulty of C-ESD. The aim of this study was to evaluate the efficacy and safety of the combined use of a scissors-type knife and a needle-type knife with a water-jet function (WJ needle-knife) for C-ESD compared with using the WJ needle-knife alone. This was a prospective randomized controlled trial in a referral center. Eighty-five patients with superficial colorectal neoplasms were enrolled and randomly assigned to undergo C-ESD using a WJ needle-knife alone (Flush group) or a scissor-type knife-supported WJ needle-knife (SB Jr group). Procedures were conducted by two supervised residents. Primary endpoint was self-completion rate by the residents. Self-completion rate was 67% in the SB Jr group, which was significantly higher than that in the Flush group (39%, P = 0.01). Even after exclusion of four patients in the SB Jr group in whom C-ESD was completed using the WJ needle-knife alone, the self-completion rate was significantly higher (63% vs 39%; P = 0.03). Median procedure time among the self-completion cases did not differ significantly between the two groups (59 vs 51 min; P = 0.14). No fatal adverse events were observed in either group. In this single-center phase II trial, scissor-type knife significantly improved residents' self-completion rate for C-ESD, with no increase in procedure time or adverse events. A multicenter trial would be warranted to confirm the validity of the present study. © 2016 Japan Gastroenterological Endoscopy Society.

Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

PubMed

De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

2017-11-15

Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P < .05 was used to reject the null hypothesis for the primary outcome. Seventy subjects were randomized and sixty-five completed the study. Patients' baseline characteristics and surgical factors were similar between the study groups. There was a clinically significant difference in the global QoR-40 scores between the acetaminophen and the saline groups, median (IQR) of 189 (183 to 194) and 183 (175 to 190), respectively, P = .01. In addition, there was an inverse relationship (Spearman's rho= -0.33) between oral opioid consumption at home (oral morphine equivalents) and 24 hour postoperative quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory

Pre-Service Teachers' Retrospective and Prospective Evaluations: Program, Self, and Teaching Profession

ERIC Educational Resources Information Center

Ulusoy, Mustafa

2015-01-01

This study aimed to investigate teacher candidates' retrospective and prospective evaluations about the classroom teacher education program, self, and the teaching profession. Observations, interviews, focus group interviews, and surveys were used to collect data from the 240 subjects. Teacher candidates believed that the teaching profession is…

Prospective Evaluation of Few Homeopathic Rubrics of Kent's Repertory From Bayesian Perspective.

PubMed

Koley, Munmun; Saha, Subhranil; Das, Kaushik Deb; Roy, Sushabhan; Goenka, Rachna; Chowdhury, Pulak Roy; Hait, Himangsu; Bhattacharyya, Chapal Kanti; Sadhukhan, Sanjoy Kumar

2016-10-01

Absolute grading system of homeopathic repertories poses substantial threat to reliability; however, it may be resolved by evaluating rubrics prospectively using likelihood ratio (LR). The authors evaluated few "physical general" rubrics from Kent's repertory-"chilly," "hot," "ambithermal," "preference for hot/cold food," "desire/aversion for fish/egg/meat/sour/pungent/salt/sweet/bitter"-prospectively in West Bengal, India, for 1.5 years using the Outcome Related to Impact on Daily Living scale. Per symptom/rubric, LRs < 1.5 were discarded. A total of 2039 encounters were analyzed for thermal relations and 4715 for desires/aversions for specific food items. Comparison with Kent's repertory revealed discrepancies. One new rubric with corresponding medicines was suggested to be introduced, new entries of medicines were recommended, and some seemed to maintain their ascribed importance. The authors refrained from converting LRs into typefaces prematurely; still they propose introducing LR to repertories for a structural update, changing its use, and enabling homeopaths to make more reliable predictions. © The Author(s) 2015.

A prospective, randomized, double blind, placebo-controlled evaluation of the effects of eicosapentaenoic acid and docosahexaenoic acid on the clinical signs and erythrocyte membrane polyunsaturated fatty acid concentrations in dogs with osteoarthritis.

PubMed

Mehler, Stephen J; May, Lauren R; King, Crystal; Harris, William S; Shah, Zubin

2016-06-01

Osteoarthritis (OA) in dogs is a prevalent and serious condition. The most common treatment for the clinical signs of OA in dogs is the administration of nonsteroidal antiiflammatory pharmaceuticals. Omega-3 (n-3) fatty acids have been shown to reduce the clinical signs of osteoarthritis in dogs. The primary goals of this study were 1) to determine the effects of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on the clinical signs of OA in dogs, 2) to evaluate the effects of supplementation on the arachadonic acid (ARA)/ (EPA+DHA) algorithm and 3) to correlate alterations in the ARA/(EPA+DHA) with changes in the clinical signs of canine OA. Seventy-eight client owned dogs were enrolled in a prospective, randomized, double-blind, placebo controlled clinical trial. Dogs were randomized to placebo oil or triglyceride n-3 oil (providing an average dose of 69mg EPA+DHA/kg/day). Orthopedic examinations and blood analyses were performed at baseline, day 42, and day 84. A single investigator confirmed a diagnosis of OA of the coxofemoral joints and/or stifle joints in all dogs. Seventy-four dogs completed the trial. All clinical outcomes for measuring discomfort, lameness, and joint severity at day 84 and all blood metrics at day 42 and day 84 significantly (p<0.05) improved compared with placebo. No major side effects were observed. This study demonstrated that the daily supplementation of a dogs diet with EPA and DHA shifts the blood fatty acid concentrations correlating to relief of clinical signs associated with OA in dogs. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Prospect evaluation as a function of numeracy and probability denominator.

PubMed

Millroth, Philip; Juslin, Peter

2015-05-01

This study examines how numeracy and probability denominator (a direct-ratio probability, a relative frequency with denominator 100, a relative frequency with denominator 10,000) affect the evaluation of prospects in an expected-value based pricing task. We expected that numeracy would affect the results due to differences in the linearity of number perception and the susceptibility to denominator neglect with different probability formats. An analysis with functional measurement verified that participants integrated value and probability into an expected value. However, a significant interaction between numeracy and probability format and subsequent analyses of the parameters of cumulative prospect theory showed that the manipulation of probability denominator changed participants' psychophysical response to probability and value. Standard methods in decision research may thus confound people's genuine risk attitude with their numerical capacities and the probability format used. Copyright © 2015 Elsevier B.V. All rights reserved.

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey.

PubMed

Hunter, Kylie Elizabeth; Seidler, Anna Lene; Askie, Lisa M

2018-03-01

To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100-500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Despite some progress, compliance with prospective registration remains suboptimal. Linking

Prospective registration trends, reasons for retrospective registration and mechanisms to increase prospective registration compliance: descriptive analysis and survey

PubMed Central

Seidler, Anna Lene; Askie, Lisa M

2018-01-01

Objectives To analyse prospective versus retrospective trial registration trends on the Australian New Zealand Clinical Trials Registry (ANZCTR) and to evaluate the reasons for non-compliance with prospective registration. Design Part 1: Descriptive analysis of trial registration trends from 2006 to 2015. Part 2: Online registrant survey. Participants Part 1: All interventional trials registered on ANZCTR from 2006 to 2015. Part 2: Random sample of those who had retrospectively registered a trial on ANZCTR between 2010 and 2015. Main outcome measures Part 1: Proportion of prospective versus retrospective clinical trial registrations (ie, registration before versus after enrolment of the first participant) on the ANZCTR overall and by various key metrics, such as sponsor, funder, recruitment country and sample size. Part 2: Reasons for non-compliance with prospective registration and perceived usefulness of various proposed mechanisms to improve prospective registration compliance. Results Part 1: Analysis of the complete dataset of 9450 trials revealed that compliance with prospective registration increased from 48% (216 out of 446 trials) in 2006 to 63% (723/1148) in 2012 and has since plateaued at around 64%. Patterns of compliance were relatively consistent across sponsor and funder types (industry vs non-industry), type of intervention (drug vs non-drug) and size of trial (n<100, 100–500, >500). However, primary sponsors from Australia/New Zealand were almost twice as likely to register prospectively (62%; 4613/7452) compared with sponsors from other countries with a WHO Network Registry (35%; 377/1084) or sponsors from countries without a WHO Registry (29%; 230/781). Part 2: The majority (56%; 84/149) of survey respondents cited lack of awareness as a reason for not registering their study prospectively. Seventy-four per cent (111/149) stated that linking registration to ethics approval would facilitate prospective registration. Conclusions Despite some

Efficacy of an activated charcoal-simethicone combination in dyspeptic syndrome: results of a randomized prospective study in general practice.

PubMed

Lecuyer, M; Cousin, T; Monnot, M-N; Coffin, B

2009-01-01

The aim of this prospective, multicenter, randomized, placebo-controlled trial was to evaluate the efficacy of a commercial combination of simethicone and activated charcoal (Carbosylane) on dyspeptic symptoms in patients consulting a general practitioner. A total of 132 patients were studied. Treatment duration was 3 months, followed by a 2 months follow-up period. At the end of the treatment period, the percentage of patients with a reduction of at least two points on the symptom intensity scale was significantly higher with Carbosylane than with a placebo (P=0.043). Compared with placebo, the intensity of three symptoms (abdominal fullness, bloating and the sensation of slow digestion) was significantly decreased after 90 days of Carbosylane (P<0.05). At the end of the post-treatment follow-up, the percentages of patients with moderate or severe global complaints were 6.78% and 21.43% in the Carbosylane and placebo groups, respectively (P<0.03). Among patients consulting a general practitioner for dyspeptic syndrome, 3 months of treatment with Carbosylane resulted in significant symptomatic improvement. The improvement was still evident 2 months after the end of treatment.

Regression Discontinuity in Prospective Evaluations: The Case of the FFVP Evaluation

ERIC Educational Resources Information Center

Klerman, Jacob Alex; Olsho, Lauren E. W.; Bartlett, Susan

2015-01-01

While regression discontinuity has usually been applied retrospectively to secondary data, it is even more attractive when applied prospectively. In a prospective design, data collection can be focused on cases near the discontinuity, thereby improving internal validity and substantially increasing precision. Furthermore, such prospective…

Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

NASA Astrophysics Data System (ADS)

Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

2012-11-01

Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

PubMed

Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

2018-06-01

There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

Prospective nailfold capillaroscopy evaluation of Raynaud's phenomenon in children and adolescents.

PubMed

Piotto, Daniela G P; Hilário, Maria O E; Carvalho, Natalia S; Len, Cláudio A; Andrade, Luis E C; Terreri, Maria T R A

2013-01-01

To evaluate prospectively the clinical features and nailfold capillaroscopy findings of a cohort of children and adolescents who presented Raynaud's phenomenon (RP) without criteria for autoimmune rheumatic diseases. 40 children and adolescents with isolated RP were included. Evidence of systemic autoimmune rheumatic diseases (SARD) was ruled out by thorough clinical and laboratory examination. Concomitantly we also performed wide-field nailfold capillaroscopy evaluation using an optical microscope with magnifications of 10 and 16X. All patients were prospectively re-evaluated within a mean interval time between evaluations of 1.6 years. Thirty (75%) out of 40 patients were female with a mean age of 14.6 years and mean follow-up time of 4.2 years. The mean age of disease onset was 10.4 years and the mean time until diagnosis was 1.4 years. Fourteen out of 40 patients (35%) presented antinuclear antibodies (ANA). Five (12.5%) patients had altered nailfold capillaroscopy at first examination: four presented non-specific microangiopathy and one presented scleroderma pattern. At the re-evaluation three patients (7.5%) presented nailfold capillaroscopy alterations (two SD pattern and one non-specific microangiopathy). The two patients who showed scleroderma pattern at the nailfold capillaroscopy presented along the follow-up a diagnosis of mixed connective tissue disease and hypothyroidism, respectively. One 10 year-old girl with normal nailfold capillaroscopy and presence of autoantibodies (ANA 1/640, nuclear homogeneous pattern, anti-native DNA 1/80) was diagnosed with systemic lupus erythematosus after 1 year of initial evaluation. None of the other children presented diagnosis of SARD along the follow-up. Primary Raynaud´s phenomenon remained the diagnosis in most cases in this series of children and adolescents presenting with initial RP complaint. Nailfold capillaroscopy and determination of autoantibodies were useful ancillary tools in the investigation of

Pressure Ulcer Prevention Program Study: a randomized, controlled prospective comparative value evaluation of 2 pressure ulcer prevention strategies in nursing and rehabilitation centers.

PubMed

Shannon, Ronald J; Brown, Lynne; Chakravarthy, Debashish

2012-10-01

This article assesses the comparative prevention-effectiveness and economic implications of a Pressure Ulcer Prevention Program (PUPP) against standard practice of prevention using Agency for Health Care Policy and Research (now the Agency for Healthcare Research and Quality [AHRQ]) guidelines and a mixture of commercial products. The study is a randomized, controlled, prospective cohort study with an accompanying economic evaluation. The economic evaluation is performed from the perspective of the nursing and rehabilitation centers. Two nursing and rehabilitation centers under the same quality and safety support organization. Both institutions are experiencing high nursing staff turnover and incidence of pressure ulcers (PrUs). 133 residents at risk of developing PrUs (EQUIP-for-Quality Risk Score Moderate to Very High [MVH]). All are Medicare-eligible residents with Minimum Data Set (MDS) 2.0 evaluations. The PUPP includes a strategic product bundle and decision algorithms driven by MDS 2.0 Resident Assessment Scores to assist in reducing or preventing PrUs and incontinence-associated skin conditions. The control group utilizes a different brand and assortment of commercial skin care products, briefs, pads, and mattresses, but without use of the decision algorithms driven by MDS 2.0 Resident Assessment Scores. Pressure ulcer prevention education was done for all nurses by a nurse certified in the PUPP program at the beginning and ad libitum by trained senior nursing staff at the end of the study. Comparative reduction in the incidence of nosocomial PrUs and average 6-month net cost savings per MVH-risk resident. Residents were assessed for PrU risk using EQUIP-for-Quality risk assessment algorithm based on data from their Minimum Data Set (MDS 2.0), then assigned to either the PUPP program or control group (standard practice following AHRQ guidelines). Residents were followed until discharge, death, development of PrU, or a maximum time period of 6 months. Direct

Non-invasive high-intensity focused ultrasound for UV-induced hyperpigmentation in Fitzpatrick skin types III and IV: a prospective, randomized, controlled, evaluator-blinded trial.

PubMed

Vachiramon, Vasanop; Jurairattanaporn, Natthachat; Harnchoowong, Sarawin; Chayavichitsilp, Pamela

2018-02-01

Skin hyperpigmentation is a frequently encountered problem, particularly in darker skin types. Unfortunately, standard treatments for this condition have shown disappointing results. High-intensity focused ultrasound (HIFU) is commonly indicated for skin laxity, but recently was used to treat UV-induced hyperpigmentation in animal models. This study is aimed to evaluate the efficacy and safety of high-intensity focused ultrasound for UVB-induced hyperpigmentation in human subjects. A randomized, evaluator-blinded pilot study was conducted on 20 subjects. Each subject was induced three hyperpigmentary spots by local broadband UVB. After 2 weeks, each spot was randomly allocated to control, low-energy, and high-energy HIFU. Subjects were instructed to follow up weekly for a duration of 1 month. Lightness index measurements, mean improvement scores, subjects' satisfaction, pain scores, and side effects were evaluated. All 20 subjects completed the study. Fourteen subjects had Fitzpatrick (FPT) skin type III and six subjects had FPT skin type IV. Twelve subjects showed greater improvement at control sites while eight subjects showed greater improvement at HIFU-treated sites. In FPT skin type III, HIFU appeared to be inferior to control in both lightness index and mean improvement scores, but in FPT skin type IV, HIFU had greater lightness index improvement and higher improvement scores than control. Side effects were more frequent in high-energy-treated areas. Focused ultrasound may be offered in some patients with hyperpigmentary conditions. More research is needed to determine proper energy settings for optimal outcome.

Quantized Step-up Model for Evaluation of Internship in Teaching of Prospective Science Teachers.

ERIC Educational Resources Information Center

Sindhu, R. S.

2002-01-01

Describes the quantized step-up model developed for the evaluation purposes of internship in teaching which is an analogous model of the atomic structure. Assesses prospective teachers' abilities in lesson delivery. (YDS)

Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

ERIC Educational Resources Information Center

Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

2016-01-01

Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

Long-term outcomes and recurrence patterns of standard versus extended pancreatectomy for pancreatic head cancer: a multicenter prospective randomized controlled study.

PubMed

Jang, Jin-Young; Kang, Jae Seung; Han, Youngmin; Heo, Jin Seok; Choi, Seong Ho; Choi, Dong Wook; Park, Sang Jae; Han, Sung-Sik; Yoon, Dong Sup; Park, Joon Seong; Yu, Hee Chul; Kang, Koo Jeong; Kim, Sang Geol; Lee, Hongeun; Kwon, Wooil; Yoon, Yoo-Seok; Han, Ho-Seong; Kim, Sun-Whe

2017-07-01

Our previous randomized controlled trial revealed no difference in 2-year overall survival (OS) between extended and standard resection for pancreatic adenocarcinoma. The present study evaluated the 5-year OS and recurrence patterns according to the extent of pancreatectomy. Between 2006 and 2009, 169 consecutive patients were prospectively enrolled and randomized to standard (n = 83) or extended resection (n = 86) groups to compare 5-year OS rate, long-term recurrence patterns and factors associated with long-term survival. The surgical R0 rate was similar between the standard and extended groups (85.5 vs. 90.7%, P = 0.300). Five-year OS (18.4 vs. 14.4%, P = 0.388), 5-year disease-free survival (14.8 vs. 14.0%, P = 0.531), and overall recurrence rates (74.7 vs. 69.9%, P = 0.497) were not significantly different between the two groups, although the incidence of peritoneal seeding was higher in the extended group (25 vs. 8.1%, P = 0.014). Extended pancreatectomy does not have better short-term and long-term survival outcomes, and shows similar R0 rates and overall recurrence rates compared with standard pancreatectomy. Extended pancreatectomy does not have to be performed routinely for all cases of resectable pancreatic adenocarcinoma, especially considering its associated increased morbidity shown in our previous study. © 2017 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

Effect of perioperative parecoxib sodium on postoperative pain control for transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma: a prospective randomized trial.

PubMed

Lv, Ning; Kong, Yanan; Mu, Luwen; Pan, Tao; Xie, Qiankun; Zhao, Ming

2016-10-01

Pain is one of the most common side effects of transcatheter arterial chemoembolization (TACE) treatment. This study aimed to assess the analgesic effect of parecoxib sodium for postoperative pain control in patients with inoperable hepatocellular carcinoma (HCC) undergoing TACE. This randomized placebo-controlled prospective clinical study was conducted at a single cancer centre. Patients were randomly assigned to receive parecoxib sodium (experimental group; n = 60) or 0.9 % sodium chloride (control group; n = 60) 1 h before TACE and once every 12 h for 2 days after TACE. Pain level, morphine consumption, adverse events, and quality of life were evaluated and compared between the two groups. Pain scores, percentage distribution of pain categories, and morphine consumption were significantly lower in the experimental group than in the control group (P < 0.05). Fever score comparisons revealed significantly better body temperature balance in the experimental group than in the control group (P = 0.024). Quality-of-life scores in the experimental group were significantly better than those in the control group (P < 0.05). Our results demonstrate that the perioperative administration of parecoxib significantly improved its effectiveness in the control of postoperative pain after TACE. • Perioperative administration of parecoxib is effective for control of pain after TACE. • COX-2 inhibitors provide effective and safe pain control. • Parecoxib helps improve quality-of-life after TACE for patients with inoperable hepatocellular carcinoma.

Tadalafil once daily and extracorporeal shock wave therapy in the management of patients with Peyronie's disease and erectile dysfunction: results from a prospective randomized trial.

PubMed

Palmieri, A; Imbimbo, C; Creta, M; Verze, P; Fusco, F; Mirone, V

2012-04-01

Extracorporeal shock wave therapy improves erectile function in patients with Peyronie's disease. However, erectile dysfunction still persists in many cases. We aimed to investigate the effects of extracorporeal shock wave therapy plus tadalafil 5 mg once daily in the management of patients with Peyronie's disease and erectile dysfunction not previously treated. One hundred patients were enrolled in a prospective, randomized, controlled study. Patients were randomly allocated to receive either extracorporeal shock wave therapy alone for 4 weeks (n = 50) or extracorporeal shock wave therapy plus tadalafil 5 mg once daily for 4 weeks (n = 50). Main outcome measures were: erectile function (evaluated through the shortened version of the International Index of Erectile Function), pain during erection (evaluated through a Visual Analog Scale), plaque size, penile curvature and quality of life (evaluated through an internal questionnaire). Follow-up evaluations were performed after 12 and 24 weeks. In both groups, at 12 weeks follow-up, mean Visual Analog Scale score, mean International Index of Erectile Function score and mean quality of life score ameliorated significantly while mean plaque size and mean curvature degree were unchanged. Intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and quality of life score in patients receiving the combination. After 24 weeks, intergroup analysis revealed a significantly higher mean International Index of Erectile Function score and mean quality of life score in patients that received extracorporeal shock wave therapy plus tadalafil. In conclusion extracorporeal shock wave therapy plus tadalafil 5 mg once daily may represent a valid conservative strategy for the management of patients with Peyronie's disease and erectile dysfunction. © 2011 The Authors. International Journal of Andrology © 2011 European Academy of Andrology.

Prospective evaluation of a bivalirudin to warfarin transition nomogram.

PubMed

Hohlfelder, Benjamin; Sylvester, Katelyn W; Rimsans, Jessica; DeiCicchi, David; Connors, Jean M

2017-05-01

Bivalirudin may cause a falsely prolonged international normalized ratio (INR) that complicates the discontinuation of bivalirudin when used as a bridge to warfarin. To prospectively validate our novel bivalirudin to warfarin transition nomogram, adult patients who received bivalirudin as a bridge to warfarin between July 2015 and June 2016 were prospectively evaluated, utilizing our predictive nomogram. The major outcome of our analysis was the correlation between the predicted change in INR upon bivalirudin discontinuation based on the nomogram, and the actual change in INR upon bivalirudin discontinuation. The major outcome was analyzed using the Pearson's correlation test. A Pearson's correlation coefficient >0.6 was considered to be a strong correlation. Bivalirudin was used as a bridge to warfarin in 29 patients. The majority of patients (86%) included in the analysis had a ventricular assist device. The median initial bivalirudin rate was 0.07 mg/kg/h and the mean increase in INR when starting bivalirudin was 0.6. The mean final weight-based bivalirudin rate was 0.08 mg/kg/h and the mean change in INR after stopping bivalirudin was 0.7. The Pearson correlation coefficient between the predicted change in INR upon bivalirudin discontinuation and the actual change in INR upon bivalirudin discontinuation was 0.86 (p < 0.001). After bivalirudin discontinuation, 68% of patients had a therapeutic INR. The results of this prospective analysis successfully validated our novel bivalirudin to warfarin transition nomogram. There was a very strong correlation between the predicted change and actual change in INR upon bivalirudin discontinuation.

The long-term efficacy of hydrocele treatment with aspiration and sclerotherapy with polidocanol compared to placebo: a prospective, double-blind, randomized study.

PubMed

Lund, L; Kloster, A; Cao, T

2014-05-01

We evaluate whether aspiration and sclerosing of hydrocele testis is an effective treatment. Men with symptomatic hydrocele testis were included in this prospective, double-blind, randomized study with polidocanol and placebo. Patients were randomized to active treatment or placebo at the first treatment. Depending on hydrocele testis size (less than 100, 100 to 200 and greater than 200 ml), the patients were treated with 1, 3 or 4 ml polidocanol after aspiration. Patients with recurrence at the 5-week followup received active treatment. A total of 77 patients were included in the study. In group 1 (active treatment) there were 36 patients with a median age of 63 years (range 34 to 92). In group 2, comprised of 41 patients, the median age was 59 years (range 26 to 82). Median followup was 72 months. A significant difference between the groups was observed after the first and second treatments. Recurrence after the first treatment was seen in 16 (44%) patients from group 1 and in 32 (78%) from group 2 (p <0.05). Recurrence after re-treatment with the active drug in both groups was seen in 4 (25%) patients in group 1 and in 14 (44%) in the former placebo group (p <0.05). The overall success rate of treatment in the active group was 89%. There was no difference between the 2 groups in terms of volume of fluid aspirated, symptoms or complications. This long-term efficacy randomized study with placebo showed that polidocanol is effective for the treatment of hydrocele testis with a low recurrence rate. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Inspiratory muscle training in bronchiectasis patients: a prospective randomized controlled study.

PubMed

Liaw, Mei-Yun; Wang, Yi-Hsi; Tsai, Yu-Chin; Huang, Kuo-Tung; Chang, Pei-Wen; Chen, Yung-Che; Lin, Meng-Chih

2011-06-01

To investigate the efficacy and feasibility of home-based inspiratory muscle training in patients with bronchiectasis. A prospective, single-blind, randomized, controlled study. Outpatient clinic of a tertiary care medical centre. Twenty-six patients with bronchiectasis were randomly divided into inspiratory muscle training and control groups. In the inspiratory muscle training group (n = 13), the training programme started with an intensity of 30% maximal inspiratory pressure (MIP), which was increased by 2 cmH(2)O each week, for 30 minutes daily, 5 days a week for eight weeks. The control group (n = 13) did not receive inspiratory muscle training. Main outcome measures included spirometry, resting oxyhaemoglobin saturation by pulse oximetry (SpO(2)), lowest SpO(2) and Borg Scale during 6-minute walking tests, 6-minute walking distance (6MWD), 6-minute walking work (6M(work)), MIP, maximal expiratory pressure (MEP) and St George's Respiratory Questionnaire. There were significant differences in change from baseline in 6MWD (411.9 (133.5) vs. 473.2 (117.2) m, P = 0.021), 6M(work) (21 051.0 (8286.7) vs. 23 915.5 (8343.0) kg-m, P = 0.022), MIP (60.8 (21.8) vs. 84.6 (29.0) cmH(2)O, P = 0.004), and MEP (72.3 (31.1) vs. 104.2 (35.7) cmH(2)O, P = 0.004) in the inspiratory muscle training group. Significant improvements in both MIP (23.8 (25.3) vs. 2.3 (16.4) cmH(2)O, adjusted P-value = 0.005) and MEP (31.9 (30.8) vs. 11.5 (20.8) cmH(2)O, adjusted P-value = 0.038) levels after adjusting for age by linear regression analysis were observed between groups. An eight-week home-based inspiratory muscle training is feasible and effective in improving both inspiratory and expiratory muscle strength, but has no effect on respiratory function and quality of life in patients with bronchiectasis.

Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

PubMed

Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

2011-05-06

The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional

Levofloxacin compared with imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia: a multicenter, prospective, randomized, open-label study.

PubMed

West, Mike; Boulanger, Bernard R; Fogarty, Charles; Tennenberg, Alan; Wiesinger, Barbara; Oross, Margaret; Wu, Shu-Chen; Fowler, Cynthia; Morgan, Nancy; Kahn, James B

2003-02-01

Therapy of nosocomial pneumonia is usually empiric and includes > or = 1 broad-spectrum antimicrobial agent. When considering the use of fluoroquinolones in these difficult-to-treat infections--in which drug delivery to the site of infection may be impaired or organisms with higher minimum inhibitory concentrations may be present--an agent should be chosen whose pharmacodynamics ensure maximal drug exposure. Use of the 750-mg dose of levofloxacin should enhance therapeutic benefit in patients with nosocomial pneumonia. The goal of this study was to compare the efficacy and safety of levofloxacin 750 mg and imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia. This was a multicenter, prospective, randomized, open-label trial conducted in North America. Patients were randomly assigned to 1 of 2 treatment arms: levofloxacin 750 mg QD given i.v. and then orally for 7 to 15 days or imipenem/cilastatin 500 mg to 1 g i.v. every 6 to 8 hours, followed by oral ciprofloxacin 750 mg every 12 hours for 7 to 15 days. Adjunctive antibacterial therapy was mandatory in patients with documented or suspected Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus infection. The primary predefined outcome measure was the clinical response (cure, improvement, failure, or unable to evaluate) in microbiologically evaluable patients 3 to 15 days after the end of therapy. The study enrolled 438 adult patients (315 men, 123 women; mean [SD] age, 55.7 [20.04] years). Two hundred twenty patients received levofloxacin, and 218 received the comparator regimen. Demographic and baseline clinical characteristics were similar in the intent-to-treat and clinically evaluable populations. In patients evaluable for microbiologic efficacy, clinical success (cure or improvement) was achieved in 58.1% (54/93) of patients who received levofloxacin, compared with 60.6% (57/94) of patients who received the comparator regimen (95% CI, -12.0 to 17.2). Similar

Small bowel preparations for capsule endoscopy with mannitol and simethicone: a prospective, randomized, clinical trial.

PubMed

Chen, Hong-bin; Huang, Yue; Chen, Su-yu; Song, Hui-wen; Li, Xiao-lin; Dai, Dong-lin; Xie, Jia-tia; He, Song; Zhao, Yuan-yuan; Huang, Chun; Zhang, Sheng-jun; Yang, Lin-na

2011-04-01

There is no consensus concerning small bowel preparation before capsule endoscopy (CE). This study evaluated the effects of 4 regimens on small bowel cleansing and diagnostic yield. Patients were randomly divided into 4 groups. Group A consumed a clear liquid diet after lunch on the day before CE, followed by overnight fasting. Group B took 250 mL 20% mannitol and 1 L 0.9% saline orally at 05:00 hours on the day of the procedure. In group C, the same regimen was taken at 20:00 hours on the day before and at 05:00 hours on the day of CE. In group D, in addition to the group C regimen, 20 mL oral simethicone was taken 30 minutes before CE. Two hundred patients were prospectively enrolled, and 7 were excluded from the final analysis because of incomplete small bowel transit. No significant difference was noted among the 4 groups for small bowel transit time. Bowel preparation in group D was significantly better than for the other regimens for overall cleansing of the proximal small bowel, and showed improved overall cleansing of the distal small bowel when compared with 10-hours overnight fasting. Pathological lesions of the proximal and distal small bowel were, respectively, achieved in 82 and 74 patients, mostly distributed in group D. Small bowel preparation that involves split-dose oral mannitol plus single-dose simethicone for CE can improve mucosal visualization and subsequent diagnostic yield when compared with 10-hours overnight fasting.

Comparison of digital and traditional thoracic drainage systems for postoperative chest tube management after pulmonary resection: A prospective randomized trial.

PubMed

Takamochi, Kazuya; Nojiri, Shuko; Oh, Shiaki; Matsunaga, Takeshi; Imashimizu, Kota; Fukui, Mariko; Suzuki, Kenji

2018-04-01

The objective of this study was to evaluate whether a digital thoracic drainage system (group D) is clinically useful compared with a traditional thoracic drainage system (group T) in chest tube management following anatomic lung resection. Patients scheduled to undergo segmentectomy or lobectomy were prospectively randomized before surgery to group D or T. A stratification randomization was performed according to the following air leak risk factors: age, sex, smoking status, and presence of emphysema and/or chronic obstructive pulmonary disease. The primary end point was the duration of chest tube placement. No statistically significant differences were found between groups D (n = 135) and T (n = 164) with regard to the duration of chest tube placement (median, 2.0 vs 3.0 days; P = .149), duration of hospitalization (median, 6.0 vs 7.0 days; P = .548), or frequency of postoperative adverse events (25.1% vs 20.7%; P = .361). In subgroup analyses of the 64 patients with postoperative air leak (20 in group D and 44 in group T), the duration of chest tube placement (median, 4.5 vs 4.0 days; P = .225) and duration of postoperative air leak (median, 3.0 vs 3.0 days; P = .226) were not significantly different between subgroups. The use of a digital thoracic drainage system did not shorten the duration of chest tube placement in comparison to a traditional thoracic drainage system after anatomic lung resection. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Prospective evaluation of the utility of routine postoperative cystogram after traumatic bladder injury.

PubMed

Inaba, Kenji; Okoye, Obi T; Browder, Timothy; Best, Charles; Branco, Bernardino C; Teixeira, Pedro G; Barmparas, Galinos; Reddy, Sravanthi; Demetriades, Demetrios

2013-12-01

The value of routinely testing bladder repair integrity with a cystogram before urinary catheter removal is unclear. The purpose of this study was to prospectively evaluate the utility of routine postoperative cystogram after traumatic bladder injury. All patients sustaining a bladder injury requiring operative repair at two Level I trauma centers were prospectively enrolled during a 62-month study period ending on January 2011. Injury demographics, imaging data, and outcomes were extracted. All patients were evaluated with either a plain or a computed tomography cystogram. A total of 127 patients were enrolled (mean [SD] age, 30.4 [13.5] years; blunt trauma, 63.8%, mean [SD] Injury Severity Score [ISS], 17.7 [10.6]). A total of 75 patients (59.1%) had an intraperitoneal (IP) bladder injury, 44 (34.6%) had an extraperitoneal (EP) bladder injury, and 8 had a (6.3%) combined IP/EP bladder injury. All patients with IP and IP/EP injuries (n = 83) underwent operative repair and a postoperative cystogram at 8.6 (1.8) days (range, 5-13 days). Sixty-nine IP injuries (83.1%) were simple (dome or body disruption/penetrating injury), while 14 (16.9%) were complex (trigone/requiring ureter implantation). There were no deaths during the follow-up period. With the exception of one patient (1.2%) with a complex injury requiring ureteric implantation, there were no leaks demonstrated on postoperative cystogram, and the urinary catheters were successfully removed. In this prospective evaluation of the role of bladder evaluation after operative repair, routine use of follow-up cystograms for simple injuries did not impact clinical management. For complex repairs to the trigone or those requiring ureter implantation, a follow-up cystogram should be obtained before catheter removal. Diagnostic study, level II.

[Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

PubMed

Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

2016-02-01

Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

A prospective, randomized, controlled study of a suspension positioning system used with elderly bedridden patients with neurogenic fecal incontinence.

PubMed

Su, Mei-Yin; Lin, Shi-Quan; zhou, Ye-Wen; Zhou, Ye-Wen; Liu, Si-Ya; Lin, Ai; Lin, Xi-Rong

2015-01-01

Elderly patients with acute neurological impairment are prone to severe disability, fecal incontinence (FI), and resultant complications. A suspension positioning system (SPS), based on the orthopedic suspension traction system commonly used for conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture, was developed to facilitate FI management in patients immobilized secondary to an acute neurological condition. To evaluate the effectiveness and safety of the system, a prospective, randomized, controlled study was conducted between October 2009 and July 2012. Two hundred (200) elderly, bedridden, hospitalized patients with acute, nonchronic neurological impairment were randomly assigned to receive routine FI nursing care (ie, individualized dietary modification, psychological support, health education, and social support for caregivers and family members [control group]) or routine incontinence care plus the SPS (experimental group) during the day. Rates of perianal fecal contamination, skin breakdown, incontinence associated dermatitis, pressure ulcer development, and lower urinary tract infection (LUTI) were significantly lower in the SPS than in the control group (P <0.05). Length of hospitalization and costs of care were also lower in the SPS group (P <0.05). Patient quality-of-life (QoL) and FI QoL scores were similar at baseline but significantly higher (better) at the 6-month follow-up interview in the SPS than in the control group (P <0.05). In this study, the rate of FI-associated morbidities was lower and 6-month patient QoL scores were higher in the SPS than in the control group. No adverse events were observed, and all patients completed the study. Further clinical studies are needed to examine the long-term effects of SPS use among neurologically impaired FI patients.

Effect of increased exercise in school children on physical fitness and endothelial progenitor cells: a prospective randomized trial.

PubMed

Walther, Claudia; Gaede, Luise; Adams, Volker; Gelbrich, Götz; Leichtle, Alexander; Erbs, Sandra; Sonnabend, Melanie; Fikenzer, Kati; Körner, Antje; Kiess, Wieland; Bruegel, Mathias; Thiery, Joachim; Schuler, Gerhard

2009-12-01

The aim of this prospective, randomized study was to examine whether additional school exercise lessons would result in improved peak oxygen uptake (primary end point) and body mass index-standard deviation score, motor and coordinative abilities, circulating progenitor cells, and high-density lipoprotein cholesterol (major secondary end points). Seven sixth-grade classes (182 children, aged 11.1+/-0.7 years) were randomized to an intervention group (4 classes with 109 students) with daily school exercise lessons for 1 year and a control group (3 classes with 73 students) with regular school sports twice weekly. The significant effects of intervention estimated from ANCOVA adjusted for intraclass correlation were the following: increase of peak o(2) (3.7 mL/kg per minute; 95% confidence interval, 0.3 to 7.2) and increase of circulating progenitor cells evaluated by flow cytometry (97 cells per 1 x 10(6) leukocytes; 95% confidence interval, 13 to 181). No significant difference was seen for body mass index-standard deviation score (-0.08; 95% confidence interval, -0.28 to 0.13); however, there was a trend to reduction of the prevalence of overweight and obese children in the intervention group (from 12.8% to 7.3%). No treatment effect was seen for motor and coordinative abilities (4; 95% confidence interval, -1 to 8) and high-density lipoprotein cholesterol (0.03 mmol/L; 95% confidence interval, -0.08 to 0.14). Regular physical activity by means of daily school exercise lessons has a significant positive effect on physical fitness (o(2)max). Furthermore, the number of circulating progenitor cells can be increased, and there is a positive trend in body mass index-standard deviation score reduction and motor ability improvement. Therefore, we conclude that primary prevention by means of increasing physical activity should start in childhood. URL: http://www.clinicaltrials.gov. Identifier: NCT00176371.

Custom vs conventional PRK: a prospective, randomized, contralateral eye comparison of postoperative visual function.

PubMed

Mifflin, Mark D; Hatch, Bryndon B; Sikder, Shameema; Bell, James; Kurz, Christopher J; Moshirfar, Majid

2012-02-01

To determine whether VISX S4 (VISX Inc) custom photorefractive keratectomy (PRK) results in better visual outcomes than VISX S4 conventional PRK. Photorefractive keratectomy was performed on 80 eyes from 40 patients in this randomized, prospective, contralateral eye study. Dominant eyes were randomized to one group with the fellow eye receiving the alternate treatment. Primary outcome measures included uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and root-mean-square (RMS) higher order aberrations. Mean UDVA was -0.023±0.099 (20/19) in the custom group and -0.044±0.080 (20/18) in the conventional group 6 months after surgery (P=.293). Mean CDVA was -0.073±0.067 (20/17) in the custom group and -0.079±0.071 (20/17) in the conventional group 6 months after surgery (P=.659). Total higher order aberration RMS and spherical aberration increased in both groups compared to preoperative values (P<.05). Coma increased in the conventional group (P<.05) whereas it was similar to preoperative values in the custom group. No significant differences were noted in induction of trefoil. Custom and conventional PRK were shown to be safe and effective with excellent visual acuity and contrast sensitivity performance at 6 and 12 months. Conventional PRK induced more coma than custom PRK; however, this did not seem to correlate with clinical outcomes. Copyright 2012, SLACK Incorporated.

A Prospective Randomized Trial of Apixaban Dosing During Atrial Fibrillation Ablation: The AEIOU Trial.

PubMed

Reynolds, Matthew R; Allison, J Scott; Natale, Andrea; Weisberg, Ian L; Ellenbogen, Kenneth A; Richards, Mark; Hsieh, Wen-Hua; Sutherland, Julie; Cannon, Christopher P

2018-05-01

This study sought to determine whether uninterrupted apixaban would have similar rates of bleeding and thromboembolic events as does minimally interrupted apixaban at the time of atrial fibrillation (AF) ablation and to compare those results with rates in historical patients treated with uninterrupted warfarin. The safety, efficacy, and optimal dosing regimen for apixaban at the time of AF ablation are uncertain. This prospective, multicenter clinical trial enrolled 306 patients undergoing catheter ablation for nonvalvular AF and randomized 300 to uninterrupted versus minimally interrupted (holding 1 dose) periprocedural apixaban. A retrospective cohort of patients treated with uninterrupted warfarin at the same centers was matched to the apixaban-treated subjects for comparison. Endpoints included clinically significant bleeding, major bleeding, and nonhemorrhagic stroke or systemic embolism (SE) from the time of ablation through 30 days. There were no stroke or SE events. Clinically significant bleeding occurred in 11.3% of 150 evaluable patients on uninterrupted apixaban and 9.7% of 145 evaluable patients on interrupted apixaban (risk difference: 1.7% [95% confidence interval: -5.5% to 8.8%]; p = NS). Rates of major bleeding were 1.3% with uninterrupted apixaban, and 2.1% with interrupted (risk difference: -0.7%; p = NS). The rates of clinically significant and major bleeding were similar for all apixaban patients combined (10.5% and 1.7%), compared with the matched warfarin group (9.8% and 1.4%). Both uninterrupted and minimally interrupted apixaban at the time of AF ablation were associated with a very low rate of thromboembolic events, and rates of both major (<2%) and clinically significant bleeding were similar to uninterrupted warfarin. (Apixaban Evaluation of Interrupted Or Uninterrupted Anticoagulation for Ablation of Atrial Fibrillation [AEIOU]; NCT02608099). Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc

Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study.

PubMed

Wu, Yan-Guang; Lazzaroni-Tealdi, Emanuela; Wang, Qi; Zhang, Lin; Barad, David H; Kushnir, Vitaly A; Darmon, Sarah K; Albertini, David F; Gleicher, Norbert

2016-08-24

Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated. We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology. We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology. We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo. Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time (P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation. Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled

Influence of an apical negative pressure irrigation system on bacterial elimination during endodontic therapy: a prospective randomized clinical study.

PubMed

Pawar, Rekha; Alqaied, Abdullah; Safavi, Kamran; Boyko, Jennifer; Kaufman, Blythe

2012-09-01

Recent in vitro studies that use an apical negative pressure irrigation system, EndoVac, have demonstrated promising results in the production of debris-free root canals, while also preventing potential extrusion of irrigants into the periapical region. We conducted a randomized, controlled, prospective clinical study to determine whether the use of EndoVac irrigation (EndoVac group) was more efficient compared with standard needle irrigation (control group) in obtaining canals from which microbes could not be cultivated. Routine endodontic therapy was performed in 48 patients with necrotic, single-rooted, single-canal teeth. The patients were randomly assigned to either the EndoVac group (n = 25) or control group (n = 23). Irrigation with either method was carried out with 0.5% sodium hypochlorite. After surface disinfection, before instrumentation and on completion of chemomechanical preparation, intracanal microbial samples were obtained and cultured under anaerobic conditions. The frequency of microbial cultivability by using either irrigation system was analyzed. The frequency of obtaining culture-negative root canals was 90.9% and 82.6% for the control group and EndoVac group, respectively. There was no significant difference in the antimicrobial efficacy of either control group or EndoVac group (Fisher exact test, P = .665). Furthermore, no significant association between study variables and the irrigation systems' antimicrobial efficacy was found (P > .05). The results of this prospective in vivo study demonstrate that the antimicrobial efficacy of EndoVac irrigation is comparable to that of standard irrigation. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Economic evaluation of the prophylaxis for thromboembolism in critical care trial (E-PROTECT): study protocol for a randomized controlled trial.

PubMed

Fowler, Robert A; Mittmann, Nicole; Geerts, William H; Heels-Ansdell, Diane; Gould, Michael K; Guyatt, Gordon; Krahn, Murray; Finfer, Simon; Pinto, Ruxandra; Chan, Brian; Ormanidhi, Orges; Arabi, Yaseen; Qushmaq, Ismael; Rocha, Marcelo G; Dodek, Peter; McIntyre, Lauralyn; Hall, Richard; Ferguson, Niall D; Mehta, Sangeeta; Marshall, John C; Doig, Christopher James; Muscedere, John; Jacka, Michael J; Klinger, James R; Vlahakis, Nicholas; Orford, Neil; Seppelt, Ian; Skrobik, Yoanna K; Sud, Sachin; Cade, John F; Cooper, Jamie; Cook, Deborah

2014-12-20

Venous thromboembolism (VTE) is a common complication of critical illness with important clinical consequences. The Prophylaxis for ThromboEmbolism in Critical Care Trial (PROTECT) is a multicenter, blinded, randomized controlled trial comparing the effectiveness of the two most common pharmocoprevention strategies, unfractionated heparin (UFH) and low molecular weight heparin (LMWH) dalteparin, in medical-surgical patients in the intensive care unit (ICU). E-PROTECT is a prospective and concurrent economic evaluation of the PROTECT trial. The primary objective of E-PROTECT is to identify and quantify the total (direct and indirect, variable and fixed) costs associated with the management of critically ill patients participating in the PROTECT trial, and, to combine costs and outcome results to determine the incremental cost-effectiveness of LMWH versus UFH, from the acute healthcare system perspective, over a data-rich time horizon of ICU admission and hospital admission. We derive baseline characteristics and probabilities of in-ICU and in-hospital events from all enrolled patients. Total costs are derived from centers, proportional to the numbers of patients enrolled in each country. Direct costs include medication, physician and other personnel costs, diagnostic radiology and laboratory testing, operative and non-operative procedures, costs associated with bleeding, transfusions and treatment-related complications. Indirect costs include ICU and hospital ward overhead costs. Outcomes are the ratio of incremental costs per incremental effects of LMWH versus UFH during hospitalization; incremental cost to prevent a thrombosis at any site (primary outcome); incremental cost to prevent a pulmonary embolism, deep vein thrombosis, major bleeding event or episode of heparin-induced thrombocytopenia (secondary outcomes) and incremental cost per life-year gained (tertiary outcome). Pre-specified subgroups and sensitivity analyses will be performed and confidence

Online self-administered training for post-traumatic stress disorder treatment providers: design and methods for a randomized, prospective intervention study

PubMed Central

2012-01-01

This paper presents the rationale and methods for a randomized controlled evaluation of web-based training in motivational interviewing, goal setting, and behavioral task assignment. Web-based training may be a practical and cost-effective way to address the need for large-scale mental health training in evidence-based practice; however, there is a dearth of well-controlled outcome studies of these approaches. For the current trial, 168 mental health providers treating post-traumatic stress disorder (PTSD) were assigned to web-based training plus supervision, web-based training, or training-as-usual (control). A novel standardized patient (SP) assessment was developed and implemented for objective measurement of changes in clinical skills, while on-line self-report measures were used for assessing changes in knowledge, perceived self-efficacy, and practice related to cognitive behavioral therapy (CBT) techniques. Eligible participants were all actively involved in mental health treatment of veterans with PTSD. Study methodology illustrates ways of developing training content, recruiting participants, and assessing knowledge, perceived self-efficacy, and competency-based outcomes, and demonstrates the feasibility of conducting prospective studies of training efficacy or effectiveness in large healthcare systems. PMID:22583520

Prospective double-blind clinical trial evaluating the effectiveness of Bromelain in the third molar extraction postoperative period

PubMed Central

de la Barrera-Núñez, María C.; Yáñez-Vico, Rosa M.; Batista-Cruzado, Antonio; Heurtebise-Saavedra, Jean M.; Castillo-de Oyagüe, Raquel

2014-01-01

Objectives: To evaluate the anti-inflammatory and analgesic effect of Bromelain (pineapple extract) administered orally in the postoperative after extraction of impacted lower molars. Study Design: This is a prospective, placebo-controlled, unicentric, double-blind study; the sample size was 34 patients. The pre and postoperative outcomes, evaluated on the third (D3) and eighth day (D8), included inflamtion, pain and oral aperture, as well as the need for analgesics. One group received bromelain 150mg per day for three days and 100mg on days 4 to 7. The other group received placebo in the same dosage. All outcomes werrecorded quantitatively and analyzed with the Mann-Whitney U test for independent samples. Results: Although there were no statistically significant differences between the treatment groups, a trend towards less inflammation and improved oral aperture was observed in the group that received bromelain, compared to the group that received placebo. This trend can be attributed completely to random reasons, since there is no statistical difference in the results. Conclusions: Further studies are necessary to analyze different administration patterns and doses of bromelain for the use in the postoperative of impacted third molars. Key words:Tooth extraction, third molar, postoperative period, bromeline, clinical study. PMID:24316697

[The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study].

PubMed

Rafal'skiĭ, V V; Dovgan', E V; Kozyrev, Iu V; Gustovarova, T A; Khlybova, S V; Novoselova, A V; Filippenko, N G; Likhikh, D G

2013-01-01

The study was aimed to the evaluation of efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women. A prospective, multicenter, randomized study that included 112 pregnant women with asymptomatic bacteriuria was performed. 58 women were randomized in group 1 (cefixime [suprax solutab] 400 mg 1 time a day, 7 days), 54 women were included in group 2 (amoxicillin/clavulanate [amoksiklav] 625 mg 3 times a day, 7 days). The average age of the patients in group 1 was 25.2 +/- 6.6; in group 2--26.6 +/- 5.8 years. Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2). Comparable effectiveness of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women was found. Eradication of the pathogen and sustained bacteriological response were observed in 94.8 and 92.7% of women treated with cefixime, and in 98.2 and 92.5% of women treated with amoxicillin/clavulanate, respectively (P > 0.05). At the same time, the use of amoxicillin/clavulanate compared with cefixime significantly higher was followed by the development of adverse reactions (13% and 1.7; respectively; P = 0.02). Seven-day courses of cefixime at a dose 400 mg 1 time a day and amoxicillin/clavulanate at a dose of 625 mg 3 times a day are high-effective treatment regimens for asymptomatic bacteriuria in pregnant women in Russia. The use of amoxicillin/clavulanate is significantly more often accompanied by the development of adverse reactions compared with cefixime.

Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

PubMed

Kortekangas, Tero H J; Pakarinen, Harri J; Savola, Olli; Niinimäki, Jaakko; Lepojärvi, Sannamari; Ohtonen, Pasi; Flinkkilä, Tapio; Ristiniemi, Jukka

2014-10-01

This study compared mid-term functional and radiologic results of syndesmotic transfixation with no fixation in supination external rotation (SER) ankle fractures with intraoperatively confirmed syndesmosis disruption. Our hypothesis was that early-stage good functional results would remain and unfixed syndesmosis disruption in SER IV ankle fractures would not lead to an increased incidence of osteoarthritis. A prospective study of 140 operatively treated patients with Lauge-Hansen SER IV (Weber B) ankle fractures was performed. After bony fixation, the 7.5-Nm standardized external rotation stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. The patients were randomized to either syndesmotic screw fixation (13 patients) or no syndesmotic fixation (11 patients). After a minimum of 4 years of follow-up (mean, 58 months), ankle function and pain (Olerud-Molander, a 100-mm visual analogue scale [VAS] for ankle function and pain) and quality of life (RAND-36) of all 24 patients were assessed. Ankle joint congruity and osteoarthritis were assessed using mortise and lateral projection plain weight-bearing radiographs and magnetic resonance imaging (MRI; 3T) scans. Improvement in Olerud-Molander score, VAS, and RAND-36 showed no significant difference between groups during the follow-up. In the syndesmotic transfixation group, improvements in all functional parameters and pain measurements were not significant, whereas in the group without syndesmotic fixation, the Olerud-Molander score improved from 84 to 93 (P = .007) and the pain (VAS) score improved from 11 to 4 (P = .038) from 1 year to last follow-up. X-ray or MRI imaging showed no difference between groups at the last follow-up visit. With the numbers available, no significant difference in functional outcome or radiologic findings could be detected

Transcutaneous electrical nerve stimulation for postoperative pain relief after arthroscopic rotator cuff repair: a prospective double-blinded randomized trial.

PubMed

Mahure, Siddharth A; Rokito, Andrew S; Kwon, Young W

2017-09-01

Arthroscopic rotator cuff repair (ARCR) can be associated with significant postoperative pain. Concern for opioid abuse has led surgeons to identify alternative, efficacious methods of postoperative analgesia. To determine whether transcutaneous electrical nerve stimulation (TENS) can have a similarly beneficial effect after shoulder procedures, we conducted a prospective double-blinded randomized trial in patients undergoing outpatient ARCR. All patients undergoing ARCR of a full-thickness rotator cuff tear by the senior authors were identified. Patients with a history of recent narcotic use or prior narcotic abuse and those under management of a pain control specialist were excluded. Patients were randomized into 2 groups, active or placebo TENS, and used the device for 4 sessions/day for 45 minutes/session for the first postoperative week. All patients received Percocet 5/325 mg (oxycodone/acetaminophen) for use as rescue pain pills. One-week narcotic consumption and visual analog scale pain scores were compared between groups. The final analysis included 37 patients (21 active,16 placebo). Baseline and procedural differences were not different between groups. At 1 week postoperatively, patients in the active group had significantly lower pain scores (3.6 ± 2.1 vs. 5.8 ± 1.2; P= .008). Postoperative Percocet consumption during the initial 48 hours (12.8 ± 4.7 vs. 17.2 ± 6.3; P = .020) and during the first week (25.2 ± 9.9 vs. 33.8 ± 14.3; P = .037) was also significantly lower in the active group. Results from this prospective double-blinded randomized trial demonstrate that compared with placebo TENS, active TENS can result in significantly less pain and reduced opioid use in the immediate postoperative period after ARCR, suggesting that TENS may be potentially useful in a multimodal approach to managing postoperative pain. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier

China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China

PubMed Central

Gao, Peng; Zhao, Zhenwei; Wang, Daming; Wu, Jian; Cai, Yiling; Li, Tianxiao; Wu, Wei; Shi, Huaizhang; He, Weiwen; Zhu, Fengshui; Ling, Feng

2015-01-01

Background Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria. Methods The China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. It recruits patients with recent TIA or stroke caused by 70%–99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. Conclusion In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention.

PubMed

Yousefi, Hadi; Chopra, Arvind; Farrokhseresht, Reza; Sarmukaddam, Sanjeev; Noghabi, Fariba Asadi; Bedekar, Nilima; Madani, Abdolhosain

2015-01-01

Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities.

Resistant metatarsus adductus: prospective randomized trial of casting versus orthosis.

PubMed

Herzenberg, John E; Burghardt, Rolf D

2014-03-01

Metatarsus adductus is a common pediatric foot deformity related to intrauterine molding. It is usually a mild deformity that responds well to simple observation or minimal treatment with a home program of stretching. Resistant cases may need a more aggressive approach such as serial casting or special bracing to avoid the need for surgical intervention. We compared clinical outcomes using serial casting with orthoses for resistant metatarsus adductus. We prospectively treated 27 infants (43 feet) between the ages 3 and 9 months who failed home stretching treatment. Patients were randomized to either serial plaster casting or Bebax orthoses. Footprints and simulated weight-bearing anteroposterior and lateral view radiographs were made at entry and follow-up. There was no statistical difference between casting and Bebax for the following parameters: age at study entry, length of treatment, number of clinic visits, follow-up, and follow-up maintenance treatments. Both groups showed improvement in footprint and radiographic measurements post-treatment, without worsening of heel valgus. The Bebax group had greater improvement in the footprint heel bisector measurement than the casting group. The Bebax treatment requires more active parental cooperation. A simulated cost analysis of materials and office visit charges, however, revealed that Bebax treatment was significantly less expensive, about half the cost of casting. Because of the cost savings and virtually identical clinical results, we recommend the Bebax orthosis for resistant metatarsus in pre-walking infants with parents who are compliant. Other considerations include specific insurance plans, which may pay for casts but not orthoses.

Voice Disorders in Teacher Students-A Prospective Study and a Randomized Controlled Trial.

PubMed

Ohlsson, Ann-Christine; Andersson, Eva M; Södersten, Maria; Simberg, Susanna; Claesson, Silwa; Barregård, Lars

2016-11-01

Teachers are at risk of developing voice disorders, but longitudinal studies on voice problems among teachers are lacking. The aim of this randomized trial was to investigate long-term effects of voice education for teacher students with mild voice problems. In addition, vocal health was examined prospectively in a group of students without voice problems. First-semester students answered three questionnaires: one about background factors, one about voice symptoms (Screen6), and the Voice Handicap Index. Students with voice problems according to the questionnaire results were randomized to a voice training group or a control group. At follow-up in the sixth semester, all students answered Screen6 again together with four questions about factors that could have affected vocal health during their teacher education. The training group and the control group also answered the Voice Handicap Index a second time. At follow-up, 400 students remained in the study: 27 in the training group, 54 in the control group, and 319 without voice problems at baseline. Voice problems had decreased somewhat more in the training group than in the control group, but the difference was not statistically significant (P = 0.1). However, subgroup analyses showed significantly larger improvement among the students in the group with complete participation in the training program compared with the group with incomplete participation. Of the 319 students without voice problems at baseline, 14% had developed voice problems. Voice problems often develop in teacher students. Despite extensive dropout, our results support the hypothesis that voice education for teacher students has a preventive effect. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Intravitreal injection anesthesia--comparison of different topical agents: a prospective randomized controlled trial.

PubMed

Yau, Gary L; Jackman, Christopher S; Hooper, Philip L; Sheidow, Tom G

2011-02-01

To compare the anesthetic effectiveness of 3 topical agents used for intravitreal injections. Randomized, triple-armed, double-blinded, prospective, single-centered trial in patients receiving intravitreal ranibizumab for neovascular age-related macular degeneration. Patients were randomized 1:1:1 to receive 0.5% tetracaine hydrochloride drops and a 4% lidocaine pledget (n = 31), 0.5% tetracaine hydrochloride drops alone (n = 31), or 4% cocaine (+ epinephrine 1/100,000) drops alone (n = 31). Patients were asked to score their pain experience using a visual analogue scale (VAS) immediately following and 15 minutes after their injection. The average of these scores was used as the primary outcome. The physician performing the procedure separately scored his perception of the patients' pain using the Wong-Baker FACES scale. Means of the averaged VAS pain score for Groups 1, 2, and 3 were: 19 (95% confidence interval [CI] 12-26), 21 (95% CI 13-29), and 21 (95% CI 16-27) respectively. Mean Wong-Baker pain scores for Groups 1, 2, and 3 were 1.9 (95% CI 1.3-2.6), 2.1 (95% CI 1.4-2.7), and 2.3 (95% CI 1.6-3.1) respectively. There was no significant difference (P = .549) between groups for average VAS pain score. Similarly, there was no significant difference (P = .790) for the physician-perceived pain score between groups. There was no clinical difference in patient pain experience between the 3 anesthetic options tested. The addition of a 4% lidocaine pledget offered no clinical advantage in pain relief compared to 0.5% tetracaine or 4% cocaine (+ epinephrine 1/100,000) drops alone. Copyright © 2011 Elsevier Inc. All rights reserved.

Vapocoolant Anesthesia for Cosmetic Facial Rejuvenation Injections: A Randomized, Prospective, Split-Face Trial.

PubMed

Zeiderman, Matthew R; Kelishadi, Shahrooz Sean; Tutela, John Paul; Rao, Arun; Chowdhry, Saeed; Brooks, Ronald M; Wilhelmi, Bradon J

2018-01-01

Background: Minimally invasive cosmetic procedures are the most commonly performed aesthetic techniques by plastic surgeons. Patients are interested in a pain-free experience. Surgeons desire patient satisfaction and time-efficient utilization of office staff and resources. Clinical evidence exists for use of vapocoolant technology to reduce pain associated with intravenous cannulation in the pediatric population and in hemodialysis patients. Applying vapocoolant technology to facial rejuvenation is a novel approach to decrease pain associated with neurotoxin or filler injection. Methods: A randomized, prospective study was conducted, testing 15 subjects receiving filler injections and another 15 patients receiving neurotoxin injections using a split-face model. The vapocoolant spray used was composed of a 95:5 ratio of 1,1,1,3,3-pentafluoropropane and 1,1,1,2-tetrafluoroethane. Within each group, individual patients randomly received injection (filler or neurotoxin) alone versus injection (filler or neurotoxin) plus vapocoolant on an equivalent half of his or her face. An independent examiner recorded from each patient on a scale of 1 to 10 perceived pain for injection alone versus injection plus vapocoolant spray. Results were calculated as a percentage change of pain scores experienced after injection for each person between the control (nonvapocoolant) and treatment (vapocoolant) sides of the face. Results: Vapocoolant spray at the time of cosmetic facial injections leads to a 59% decrease in perceived pain score with neurotoxin injections (range, 0%-100% change) and 64% decrease in perceived pain score with filler injections (range, 0%-100% change). These results were statistically significant with P < .05. Conclusion: Vapocoolant spray reduces pain associated with facial rejuvenation procedures.

Conceptual Paradigms and Empirical Investigations for Evaluating INTELSAT's Past Performance and Future Prospects.

ERIC Educational Resources Information Center

Snow, Marcellus S.

This paper summarizes the results of a recent study of the past performance and future prospects of the International Telecommunications Satellite (INTELSAT) Organization. First, an overview of INTELSAT's history is provided and major policy issues are detailed. Five alternative paradigms are then presented through which to evaluate INTELSAT's…

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model.

PubMed

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20-60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Our results suggest that RJ improves tear volume in patients with dry eye. Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446).

Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal.

PubMed

Yayla Abide, Cigdem; Ozkaya, Enis; Sanverdi, Ilhan; Bostancı Ergen, Evrim; Kurek Eken, Meryem; Devranoglu, Belgin; Bilgiç, Bulent Emre; Kilicci, Cetin; Kayatas Eser, Semra

2018-05-14

To compare embryo transfer (ET) technique based on catheter rotation during its withdrawal in cases with unexplained infertility in a prospective, randomized trial (NCT03097042). Two hundred intracytoplasmic sperm injection (ICSI) patients undergoing ET with cleaving or blastocyst-stage fresh embryos were randomized into 2 groups: cases with (n = 100), and without (n = 100) catheter rotation during its withdrawal. Groups were matched for age and some clinical parameters. A soft catheter was used to transfer a single embryo with catheter rotation during its withdrawal in the study group and without rotation in the control. The use of a stiff catheter or tenaculum was not needed in any case. Groups were compared in terms of cycle characteristics and clinical pregnancy rates. Pregnancy rate was significantly higher in the study group (41 vs. 26%, p = 0.04). Clinical pregnancy rate was also significantly higher in the study group (39 vs. 25%, OR 1.9 [1.1-3.5], p = 0.05). On the other hand, the ongoing pregnancy rate was similar between the 2 groups (33 vs. 23%, p = 0.2). Catheter rotation during its withdrawal may be associated with increased pregnancy and clinical pregnancy rates; however, the difference in ongoing pregnancy rates did not reach statistical significance. © 2018 S. Karger AG, Basel.

A Prospective, Randomized, Masked, Placebo-Controlled Multisite Clinical Study of Grapiprant, an EP4 Prostaglandin Receptor Antagonist (PRA), in Dogs with Osteoarthritis.

PubMed

Rausch-Derra, L; Huebner, M; Wofford, J; Rhodes, L

2016-05-01

This study evaluated the effectiveness and safety of grapiprant for treatment of pain in dogs with osteoarthritis (OA). Grapiprant will relieve pain as measured by the owner's and veterinarian's evaluation of pain in dogs with OA. Another objective was evaluation of the safety of grapiprant. Two hundred and eighty-five client-owned dogs with OA were enrolled and treated with grapiprant or placebo with 262 cases (N = 131 in each group) evaluable for the effectiveness analysis. In this prospective, randomized, masked, placebo-controlled study dogs were treated daily with grapiprant (2 mg/kg) per OS or placebo. Owners completed an evaluation using the Canine Brief Pain Inventory (CBPI) on days 0, 7, 14, 21, and 28. Success was defined as improvement in the CBPI. Veterinary assessments were made on screening and days 14 and 28. Safety was evaluated by physical examination, evaluation of clinical pathology results, and owner observations. Grapiprant treatment improved pain compared to placebo on day 28 (48.1 and 31.3% treatment successes respectively; P = .0315). The pain interference score (PIS) and pain severity score (PSS) improved in the grapiprant group compared to placebo (P = .0029 and 0.0022, respectively). Veterinary assessments were significantly better in the grapiprant-treated dogs (P = .0086). Grapiprant generally was well tolerated, but a higher percentage of treated dogs (17.02%) had occasional vomiting as compared to the placebo group (6.25%). Grapiprant is an effective treatment for alleviation of pain in dogs with OA, and represents a modality of treatment that may be better tolerated than current options. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Improving Diabetes Care and Health Measures among Hispanics Using Community Health Workers: Results from a Randomized Controlled Trial

ERIC Educational Resources Information Center

Babamoto, Kenneth S.; Sey, Kwa A.; Camilleri, Angela J.; Karlan, Vicki J.; Catalasan, Joana; Morisky, Donald E.

2009-01-01

The increasing prevalence of diabetes and obesity, growing health disparities, and shortage of bilingual and culturally trained health care professionals underscore the role of trained community health workers (CHWs) to provide economically sustainable and culturally relevant services. This prospective randomized design evaluated the relative…

A Study on Chocolate Consumption in Prospective Teachers

ERIC Educational Resources Information Center

Ozgen, Leyla

2016-01-01

This study was planned and conducted to determine the chocolate consumption habits of prospective teachers. The study population was comprised of students attending the Faculty of Education at Gazi University in Ankara and the sample consisted of 251 prospective teachers selected with simple random sampling. 96.4% and 3.6% of the prospective…

Benefits of maltodextrin intake 2 hours before cholecystectomy by laparotomy in respiratory function and functional capacity: a prospective randomized clinical trial

PubMed Central

Zani, Fabiana Vieira Breijão; Aguilar-Nascimento, José Eduardo; Nascimento, Diana Borges Dock; da Silva, Ageo Mário Cândido; Caporossi, Fernanda Stephan; Caporossi, Cervantes

2015-01-01

ABSTRACT Objective: To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting. Methods: Randomized prospective clinical trial, with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting. The variables measured were the peak expiratory flow, forced expiratory volume in the first second, forced vital capacity, dominant handgrip strength, and non-dominant handgrip strength. Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation. Results: The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics, as well as for all variables. However, postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow (128.7±62.5 versus 115.7±59.9; p=0.040), forced expiratory volume in the first second (1.5±0.6 versus 1.2±0.5; p=0.040), forced vital capacity (2.3±1.1 versus 1.8±0.9; p=0.021), and for muscle function tests dominant handgrip strength (24.9±6.8 versus 18.4±7.7; p=0.001) and non-dominant handgrip strength (22.9±6.3 versus 17.0±7.8; p=0.0002). In the intragroup evaluation, there was a decrease in preoperative compared with postoperative values, except for dominant handgrip strength (25.2±6.7 versus 24.9±6.8; p=0.692), in the shortened fasting group. Conclusion: Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength. PMID:26154547

Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass.

PubMed

Remadi, Jean Paul; Rakotoarivelo, Zava; Marticho, Paul; Benamar, Amar

2006-01-01

To assess the potential benefits of a new concept of cardiopulmonary bypass (CPB), the mini-extracorporeal circulation (MECC) Jostra System, we conducted a prospective randomized study among patients who underwent coronary artery bypass grafting (CABG) with a MECC Jostra System or with a standard CPB. In a prospective randomized study, 400 patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients). The patients were randomly assigned to have preoperative data similar for both groups. The operative mortality rate (< 30 days) was 1.5% for the MECC group and 2.5% for the CPB group (P = NS). Low-cardiac-output syndrome occurred in 0.66% and 4% for the CPB group (P < .001.). The inflammatory response was significantly reduced with the MECC. Likewise, C-reactive protein release was significantly higher in group B at 24 hours (69.6 +/- 38.5 vs 40.8 +/- 21.8 mg/L for the group A, P < .01) and at 48 hours (116.7 +/- 47.0 vs 65.4 +/- 39.5 mg/L, P < .05) postoperatively. In the CPB group, there was a significantly higher decrease of hematocrit and hemoglobin rate. So, the intraoperative transfusion rate amounted to 6% for the MECC group and 12.8% for the CPB group (P < .001). Patients in the CPB group had significantly higher levels of postoperative blood creatinine and urea. The MECC system is a new concept of CPB that seems to be reliable and safe. To perform CABG, the MECC provides an excellent surgical exposure like a standard CPB and a better biologic profile like CABG without CPB.

An Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective Randomized Control Trials

PubMed Central

Logan, Jennifer K; Tang, Chad; Liao, Zhongxing; Lee, J. Jack; Heymach, John V.; Swisher, Stephen G.; Welsh, James W.; Zhang, Jianjun; Lin, Steven H.; Gomez, Daniel R.

2018-01-01

Purpose Effective clinical trial enrollment can be difficult in a protocol designs that contain one treatment arm that is perceived as being more “aggressive” or “favorable.” There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to enrollment, particularly the influence of timing, in context of three prospective randomized oncology trials where one arm was considered more aggressive. Methods and materials From June 2011 to March 2015, patients who were enrolled on three prospective institutional protocols (an oligometastatic non-small cell lung cancer (NSCLC) trial, and two proton vs. intensity-modulated radiation therapy (IMRT) trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher’s exact test, Student’s t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. Results 309 eligible patients were approached about trial enrollment. The enrollment success rate (ESR) during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligomet protocol: 5 vs. 3 appointments (P<0.001), NSCLC protocol: 4 vs. 3 appointments (P = 0.0018), esophageal protocol: 3 vs. 2 appointments (P = 0.0086No other factors or patient characteristics significantly affected ESR. Conclusion Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success, and may help overcome accrual barriers without compromising trial design. PMID:28244413

Pain and recovery after total knee arthroplasty: a 12-month follow-up after a prospective randomized study evaluating Nefopam and Ketamine for early rehabilitation.

PubMed

Aveline, Christophe; Roux, Alain Le; Hetet, Hubert Le; Gautier, Jean F; Vautier, Pierre; Cognet, Fabrice; Bonnet, Francis

2014-09-01

Ketamine and nefopam has been documented to decrease pain intensity and improve rehabilitation after total knee arthroplasty (TKA). We conducted a follow-up study of a previously randomized clinical trial to determine the prevalence and risk factors of chronic pain 1 year after TKA and to assess the role of perioperative administration of ketamine and nefopam. The original randomized, double-blind trial evaluated postoperative pain in 75 patients scheduled for TKA who received either a 48-hour infusion of ketamine or nefopam compared with placebo. The current study has evaluated patients at 6 and 12 months for the presence of chronic pain defined as a visual analogue scale ≥40 mm during a stair-climbing test. Other outcomes were incidence of neuropathic pain evaluated (DN4 score), active flexion of the knee, and functional outcome (KOOS-PS score). A total of 69 patients completed the trial. The prevalence of chronic pain at 12 months was 17.4% (95% confidence interval [CI], 10.2%-27.9%) without difference between the ketamine (12.5%), nefopam (13.7%), and placebo groups (26.1%). Prevalence of neuropathic pain was 10.2% (95% CI, 3%-17.3%). Ketamine reduced DN4 scores (P=0.02), increased knee flexion (P=0.0007), and KOOS-PS scores (P<0.0001) compared with placebo. A visual analogue scale score ≥60 mm in the postoperative period was the only risk factor associated with the occurrence of chronic pain (odds ratio 4.54; 95% CI, 1.17-17.67). After TKA, the intensity of postoperative pain is a risk factor of chronic pain on movement. Intraoperative ketamine seems to improve long-term results of rehabilitation in this setting.

[Postpartum pelvic floor rehabilitation on prevention of female pelvic floor dysfunction: a multicenter prospective randomized controlled study].

PubMed

Sun, Zhijing; Zhu, Lan; Lang, Jinghe; Zhang, Yewu; Liu, Guizhi; Chen, Xiaochun; Feng, Songzhi; Zhang, Juxin; Yao, Yuhong; Zhang, Jie; Su, Yuanyuan; Fang, Guiying; Yang, Mei; Liu, Juan; Ma, Zhimin

2015-06-01

To study the postpartum pelvic floor rehabilitation on the improvement of pelvic floor electrical physiological indexes and the prevention of female pelvic floor dysfunction in China. A multicenter prospective randomized controlled study was carried out. From October 2011, postpartum women in five provinces were randomly assigned into treatment group and control group. The women in treatment group received electrical stimulation and biofeedback treatment. The women in control group performed pelvic floor muscle exercise at home. When 6 months and 12 months after delivery, comparing two groups of patients with pelvic floor electrical physiological indexes and pelvic organ prolapse quantitation measurements (POP-Q), to evaluate the effect of postpartum pelvic floor rehabilitation on the prevention of pelvic floor dysfunction. Pelvic floor impact questionnaire short form (PFIQ-7) and pelvic organ prolapse/incontinence sexual questionnaire-12 (PISQ-12) were used to evaluate the influence on quality of life and sexual life. Until June 2013, 324 women were participated, 124 in control group, 200 in treatment group. According to the baseline results, there was statistical significance in the results of pelvic floor electrical physiological indexes between the treatment and control groups in postpartum 6 months and 12 months; the proportion above level III of type I and type II muscle fibers strength in the treatment group, it was from 41.5% (83/200) and 40.5% (81/200) to 76.3% (145/190) and 79.5% (151/190) in postpartum 6 weeks and postpartum 6 months, increased to 80.6% (58/72) and 80.6% (58/72) in postpartum 12 months, improved significantly comparing with the control group (P < 0.01). According to Point Aa, treatment group and control group in the postpartum 6 weeks was (-2.2 ± 0.7) versus (-2.4 ± 0.6) cm, in postpartum 12 months (- 2.5 ± 1.1) versus (- 2.7 ± 0.6) cm, the improvement in treatment group was statistically significant (P < 0.01). And the other points

Effect of Aloe vera topical gel combined with tretinoin in treatment of mild and moderate acne vulgaris: a randomized, double-blind, prospective trial.

PubMed

Hajheydari, Zohreh; Saeedi, Majid; Morteza-Semnani, Katayoun; Soltani, Aida

2014-04-01

Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritations. Combination therapy with natural preparations could be effective in treatment and decreasing adverse events. The aim of this study was to compare the efficacy and safety of the combination of tretinoin (TR) cream (0.05%) and Aloe vera topical gel (50%) with TR and vehicle. The randomized, double-blind, prospective 8-week trial evaluated inflammatory and non-inflammatory lesion scores and tolerability in 60 subjects with mild to moderate acne vulgaris (global acne grading system scale). Several formulations of A. vera leaf gel were prepared and the most stable one was selected for clinical study based on physicochemical evaluations. The combination therapy showed superior efficacy to TR and placebo. TR/Aloe vera gel (AVG) was significantly more effective in reducing non-inflammatory (p = 0.001), inflammatory (p = 0.011) and total (p = 0.003) lesion scores than control group. The highest percentage of adverse cutaneous effect was reported for scaling. At the end of study, erythema in the TR/AVG-treated group was significantly less severe (p = 0.046). The combination TR/AVG was well tolerated and significantly more effective than TR and vehicle for the treatment of mild to moderate acne vulgaris.

A prospective randomized comparison of continuous hemihepatic with intermittent total hepatic inflow occlusion in hepatectomy for liver tumors.

PubMed

Liang, Guanlin; Wen, Tianfu; Yan, Lunan; Li, B O; Wu, Guochang; Yang, Jian; Lu, Bo; Chen, Zheyu; Liao, Zhixue; Ran, Shun; Yu, Zhang

2009-01-01

To evaluate whether continuous hemihepatic inflow occlusion (HHO) during hepatectomy can be safer than and be as effective as intermittent total hepatic inflow occlusion (THO) in reducing blood loss. Eighty patients undergoing liver resections were included in a prospective randomized study comparing the intra- and postoperative course under THO (n=40) or HHO (n=40). THO was performed with periods of 20 minutes of occlusion and 5 minutes of releasing, while HHO was performed with continuous occlusion. The surface area of liver transection, amount of blood loss, measurements of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and postoperative evolution were recorded. The two groups were similar at entry in terms of preoperative liver function and in the proportion of patients experiencing major hepatectomy. The total ischemic time of the two groups was similar (p=0.37), but the operative time in the THO group was longer than in the HHO group (p=0.02). No significant difference was found between the HHO and THO group in blood loss during liver parenchyma transection (p=0.14), the elevations of ALT and AST on the first postoperative day (ALT: p=0.12; AST: p=0.66) and postoperative morbidity (p=0.35). On the basis of our findings, if it is feasible, continuous HHO is recommended for complex liver resection.

Effect of number and position of intraocular lens haptics on anterior capsule contraction: a randomized, prospective trial.

PubMed

Choi, Mihyun; Lazo, Marjorie Z; Kang, Minji; Lee, Jeehye; Joo, Choun-Ki

2018-03-20

The present study aimed to evaluate the degree of anterior capsule contraction (capsulorhexis contraction) with three different single-piece, hydrophilic acrylic intraocular lenses (IOLs). Patients were prospectively randomized to be implanted with one of three types of IOLs during cataract surgery: the Ophtec Precizon (IOL A), the Lucid Korea Microflex (IOL B), and the Carl Zeiss Asphina (IOL C). One week, 2 weeks, and 6 months after surgery, the area of the anterior capsule opening was measured using digital retro-illumination images after dilation of the pupil. The data were then evaluated using POCOman software. The study included 236 eyes of 202 patients. The area of the anterior capsule opening reduced by 3.53 ± 3.31 mm (17.06% ± 15.99%) between 1 week and 2 months post-operatively in the IOL A group, by 0.62 ± 1.32 mm (2.87% ± 6.03%) in the IOL B group, and by 1.09 ± 1.53 mm (4.72% ± 6.10%) in the IOL C group. The IOL B group showed minimal anterior capsule contraction 2 months after surgery (p < 0.001). IOLs with a four-plate haptic design (IOL B) showed more anterior capsular stability than those with a two-loop plate haptic (IOL A) or two-plate haptic (IOL C) design. The number and position of haptics in a capsular bag may affect anterior capsule contraction. We assume that supporting the zonules evenly may play a role in anterior capsular stability. Current Controlled Trials ISRCTN76566080 , Retrospectively registered (Date of registration: 14 Feb 2018).

Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial.

PubMed

Ahmed, Magdy R; Sayed Ahmed, Waleed A; Atwa, Khaled A; Metwally, Lobna

2014-05-01

To assess whether immediate (0h), intermediate (after 6h) or delayed (after 24h) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention, rate of urinary tract infection, ambulation time and length of hospital stay. Prospective randomized controlled trial conducted at Suez Canal University Hospital, Egypt. Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups. Women in group A (73 patients) had their urinary catheter removed immediately after surgery. Group B (81 patients) had the catheter removed 6h post-operatively while in group C (67 patients) the catheter was removed after 24h. The main outcome measures were the frequency of urinary retention, urinary tract infections, ambulation time and length of hospital stay. There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups (16.4% versus 2.5% and 0% respectively). Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections (15%), delayed ambulation time (10.3h) and longer hospital stay (5.6 days) compared to the early (1.4%, 4.1h and 3.2 days respectively) and intermediate (3.7%, 6.8h and 3.4 days respectively) removal groups. Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Random Forests for Evaluating Pedagogy and Informing Personalized Learning

ERIC Educational Resources Information Center

Spoon, Kelly; Beemer, Joshua; Whitmer, John C.; Fan, Juanjuan; Frazee, James P.; Stronach, Jeanne; Bohonak, Andrew J.; Levine, Richard A.

2016-01-01

Random forests are presented as an analytics foundation for educational data mining tasks. The focus is on course- and program-level analytics including evaluating pedagogical approaches and interventions and identifying and characterizing at-risk students. As part of this development, the concept of individualized treatment effects (ITE) is…

A Prospective Randomized Peri- and Post-Operative Comparison of the Minimally Invasive Anterolateral Approach Versus the Lateral Approach

PubMed Central

Landgraeber, Stefan; Quitmann, Henning; Güth, Sebastian; Haversath, Marcel; Kowalczyk, Wojciech; Kecskeméthy, Andrés; Heep, Hansjörg; Jäger, Marcus

2013-01-01

There is still controversy as to whether minimally invasive total hip arthroplasty enhances the postoperative outcome. The aim of this study was to compare the outcome of patients who underwent total hip replacement through an anterolateral minimally invasive (MIS) or a conventional lateral approach (CON). We performed a randomized, prospective study of 75 patients with primary hip arthritis, who underwent hip replacement through the MIS (n=36) or CON (n=39) approach. The Western Ontario and McMaster Universities Osteoarthritis Index and Harris Hip score (HHS) were evaluated at frequent intervals during the early postoperative follow-up period and then after 3.5 years. Pain sensations were recorded. Serological and radiological analyses were performed. In the MIS group the patients had smaller skin incisions and there was a significantly lower rate of patients with a positive Trendelenburg sign after six weeks postoperatively. After six weeks the HHS was 6.85 points higher in the MIS group (P=0.045). But calculating the mean difference between the baseline and the six weeks HHS we evaluated no significant differences. Blood loss was greater and the duration of surgery was longer in the MIS group. The other parameters, especially after the twelfth week, did not differ significantly. Radiographs showed the inclination of the acetabular component to be significantly higher in the MIS group, but on average it was within the same permitted tolerance range as in the CON group. Both approaches are adequate for hip replacement. Given the data, there appears to be no significant long term advantage to the MIS approach, as described in this study. PMID:24191179

Twelve-Year Follow-Up of Navigated Computer-Assisted Versus Conventional Total Knee Arthroplasty: A Prospective Randomized Comparative Trial.

PubMed

Cip, Johannes; Obwegeser, Florian; Benesch, Thomas; Bach, Christian; Ruckenstuhl, Paul; Martin, Arno

2018-05-01

Navigated computer-assisted total knee arthroplasty (TKA) was introduced to expedite long-term survival based on improved postoperative implantation accuracy. However, long-term outcome data after 10 years or more are rare, even available meta-analyses show controversial study results. In a prospective randomized trial, 100 conventional TKAs (group CONV) were compared with 100 computer-assisted TKAs (group NAV) after a mean follow-up of 12 years postoperatively. A long-leg weight-bearing X-ray was performed for measuring mechanical axis of the limb, lateral distal femoral angle, and medial proximal tibial angle. Tibial slope, patella alpha angle, and radiolucent lines were also observed. Clinical investigation included evaluation of 4 different scores: Insall Knee Score, Western Ontario and MacMaster University Index score, Hospital for Special Surgery Knee Score, and visual analog scale. Based on a follow-up rate of at least 75%, no difference in TKA survival was found 12 years postoperatively: 91.5% in group CONV vs 98.2% in group NAV (P = .181). Since 5-year follow-up, no additional TKA revision had been performed in both groups. Group CONV showed a nonsignificant higher inaccuracy of neutral lower limb axis (1.8° ± 1.4°) compared to group NAV (1.6° ± 1.7°, P = .700). All X-ray assessments were not significant different within both study groups (P ≥ .068). Clinical examination showed no differences in evaluations (P ≥ .204). All collected outcome score results were similar (P ≥ .222). Twelve years postoperatively, no differences were found in terms of long-term survival, implantation accuracy, clinical outcome or score results. Copyright © 2017 Elsevier Inc. All rights reserved.

Comparison of treatment outcomes according to output voltage during shockwave lithotripsy for ureteral calculi: a prospective randomized multicenter study.

PubMed

Park, Jinsung; Kim, Hong-Wook; Hong, Sungwoo; Yang, Hee Jo; Chung, Hong

2015-05-01

To investigate the effect of fixed versus escalating voltage during SWL on treatment outcomes in patients with ureteral calculi (UC). A prospective, randomized, multicenter trial was conducted on 120 patients who were diagnosed with a single radiopaque UC. The patients were randomized into group C (n = 60, constant 13 kV, 3,000 shock wave, 2 Hz) or group E (n = 60, 11.4-12.0-13 kV per 1,000 shock waves, 2 Hz). They were evaluated by plain abdominal radiography and urinalysis at 1 week after a single session of SWL, and repeat SWL was performed if needed. The primary endpoint was stone-free rate at 1 week (SFR1) after SWL. Secondary endpoints were post-SWL visual pain score (VPS), oral analgesic requirements during 1 week, and cumulative SFRs after the second and third sessions of SWL. Groups C and E were well balanced in terms of baseline patients and stone characteristics, including pre-SWL VPS, stone location, and stone size (6.24 ± 1.92 vs. 6.30 ± 2.13 mm). SFR1s were not significantly different between groups C and E (60.0 vs. 68.3%, p = 0.447). Analyses stratified by stone size (<6 vs. ≥6 mm) showed no difference in SFR1 (p = 0.148 vs. 0.808). In the analyses stratified by stone location, group E tended to be more effective in distal UC (81.0 vs. 50.0%, p = 0.052), whereas no difference was seen in proximal UC (p = 0.487). Secondary endpoints were also similar between the two groups. Our results suggest that voltage escalation during SWL in UC may not provide superior stone fragmentation compared to fixed voltage.

Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

PubMed

Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

2016-09-01

Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon

Impact of selected magnetic fields on the therapeutic effect in patients with lumbar discopathy: A prospective, randomized, single-blinded, and placebo-controlled clinical trial.

PubMed

Taradaj, Jakub; Ozon, Marcin; Dymarek, Robert; Bolach, Bartosz; Walewicz, Karolina; Rosińczuk, Joanna

2018-03-23

Interdisciplinary physical therapy together with pharmacological treatment constitute conservative treatment strategies related to low back pain (LBP). There is still a lack of high quality studies aimed at an objective evaluation of physiotherapeutic procedures according to their effectiveness in LBP. The aim of this study is to carry out a prospective, randomized, single-blinded, and placebocontrolled clinical trial to evaluate the effectiveness of magnetic fields in discopathy-related LBP. A group of 177 patients was assessed for eligibility based on inclusion and exclusion criteria. In the end, 106 patients were randomly assigned into 5 comparative groups: A (n = 23; magnetic therapy: 10 mT, 50 Hz); B (n = 23; magnetic therapy: 5 mT, 50 Hz); C (n = 20; placebo magnetic therapy); D (n = 20; magnetic stimulation: 49.2 μT, 195 Hz); and E (n = 20; placebo magnetic stimulation). All patients were assessed using tests for pain intensity, degree of disability and range of motion. Also, postural stability was assessed using a stabilographic platform. In this study, positive changes in all clinical outcomes were demonstrated in group A (p < 0.05). The most effective clinical effect was observed for pain reduction (p < 0.05), improvement of the range of motion (p < 0.05) and functional ability of the spine (p <0.05). It is also worth noting that the effects in the majority of the measured indicators were mostly short-term (p > 0.05). It was determined that the application of magnetic therapy (10 mT, 50 Hz, 20 min) significantly reduces pain symptoms and leads to an improvement of functional ability in patients with LBP.

Use of axillary deodorant and effect on acute skin toxicity during radiotherapy for breast cancer: a prospective randomized noninferiority trial.

PubMed

Théberge, Valérie; Harel, François; Dagnault, Anne

2009-11-15

To prospectively determine the effect of deodorant use on acute skin toxicity and quality of life during breast radiotherapy (RT). Before breast RT, 84 patients were randomly assigned to the deodorant group (n = 40) or the no-deodorant group (n = 44). The patients were stratified by axillary RT and previous chemotherapy. Toxicity evaluations were always performed by the principal investigator, who was unaware of the group assignment, at the end of RT and 2 weeks after completion using the Radiation Therapy Oncology Group acute skin toxicity criteria. Symptoms of acute skin toxicity (i.e., discomfort, pain, pruritus, sweating) and quality of life were self-evaluated. For each criterion, the point estimate of rate difference with the 95% one-sided upper confidence limit was computed. To claim noninferiority owing to deodorant use, the 95% one-sided upper confidence limit had to be lower than the noninferiority margin, fixed to 12.8%. In the deodorant vs. no-deodorant groups, Grade 2 axillary radiodermatitis occurred in 23% vs. 30%, respectively, satisfying the statistical criteria for noninferiority (p = .019). Grade 2 breast radiodermatitis occurred in 30% vs. 34% of the deodorant vs. no-deodorant groups, respectively, also satisfying the statistical criteria for noninferiority (p = .049). Similar results were observed for the self-reported evaluations. The deodorant group reported less sweating (18% vs. 39%, p = .032). No Grade 3 or 4 radiodermatitis was observed. According to our noninferiority margin definition, the occurrence of skin toxicity and its related symptoms were statistically equivalent in both groups. No evidence was found to prohibit deodorant use (notwithstanding the use of an antiperspirant with aluminum) during RT for breast cancer.

A randomized, prospective, comparison study of a mixture of acacia fiber, psyllium fiber, and fructose vs polyethylene glycol 3350 with electrolytes for the treatment of chronic functional constipation in childhood.

PubMed

Quitadamo, Paolo; Coccorullo, Paola; Giannetti, Eleonora; Romano, Claudio; Chiaro, Andrea; Campanozzi, Angelo; Poli, Emanuela; Cucchiara, Salvatore; Di Nardo, Giovanni; Staiano, Annamaria

2012-10-01

To compare the effectiveness of a mixture of acacia fiber, psyllium fiber, and fructose (AFPFF) with polyethylene glycol 3350 combined with electrolytes (PEG+E) in the treatment of children with chronic functional constipation (CFC); and to evaluate the safety and effectiveness of AFPFF in the treatment of children with CFC. This was a randomized, open label, prospective, controlled, parallel-group study involving 100 children (M/F: 38/62; mean age ± SD: 6.5 ± 2.7 years) who were diagnosed with CFC according to the Rome III Criteria. Children were randomly divided into 2 groups: 50 children received AFPFF (16.8 g daily) and 50 children received PEG+E (0.5 g/kg daily) for 8 weeks. Primary outcome measures were frequency of bowel movements, stool consistency, fecal incontinence, and improvement of other associated gastrointestinal symptoms. Safety was assessed with evaluation of clinical adverse effects and growth measurements. Compliance rates were 72% for AFPFF and 96% for PEG+E. A significant improvement of constipation was seen in both groups. After 8 weeks, 77.8% of children treated with AFPFF and 83% of children treated with PEG+E had improved (P = .788). Neither PEG+E nor AFPFF caused any clinically significant side effects during the entire course of the study period. In this randomized study, we did not find any significant difference between the efficacy of AFPFF and PEG+E in the treatment of children with CFC. Both medications were proved to be safe for CFC treatment, but PEG+E was better accepted by children. Copyright © 2012 Mosby, Inc. All rights reserved.

Efficacy and safety of two different n-butyl-2-cyanoacrylates for the embolization of varicoceles: a prospective, randomized, blinded study.

PubMed

Vanlangenhove, Peter; De Keukeleire, Katrien; Everaert, Karel; Van Maele, Georges; Defreyne, Luc

2012-06-01

This was a prospective, randomized, blinded comparative study of the efficacy and safety of two different n-butyl-2-cyanoacrylates (NBCAs) for embolization of varicoceles. A total of 112 insufficient spermatic veins (left-sided, n=84; right-sided, n=28) that were diagnosed in 83 adult males were prospectively randomized for blinded embolization with NBCA (n=54; Histoacryl, Braun, Germany) or NBCA-MS (n=58; Glubran2, General Enterprise Marketing, Viareggio, Lucca, Italy). Handling, embolic efficacy, and safety of both NBCAs were compared according the fulfillment of a standardized embolization plan, the occlusive effect on the spermatic vein, and the sticking to the microcatheter. Statistical analysis was performed with the Mann-Whitney U test and the Fisher's exact test. Patients of both study arms were comparable for age and clinical indication. Spermatic vein characteristics were comparable for varicocele classification and embolization side. Both NBCAs were equally efficient in occluding the spermatic vein and blocking reflux (NBCA, n=54/54, 100% vs. NBCA-MS, n=54/57, 94.7%; P=0.244). The embolization plan could be accomplished in an equal number of veins for both groups (NBCA, n=45/54, 83.3% vs. NBCA-MS, n=41/58, 70.7%; P=0.124). Adhesiveness of the glue to the microcatheter was the same in both NBCA groups (NBCA, n=25/54, 46.3% vs. NBCA-MS, n=29/58, 50%; P=0.71). No glue-related complications were noted. NBCA and NBCA-MS are equally efficient and safe glues for embolization of varicoceles.

Effect of prospective reimbursement on nursing home costs.

PubMed

Coburn, A F; Fortinsky, R; McGuire, C; McDonald, T P

1993-04-01

This study evaluates the effect of Maine's Medicaid nursing home prospective payment system on nursing home costs and access to care for public patients. The implementation of a facility-specific prospective payment system for nursing homes provided the opportunity for longitudinal study of the effect of that system. Data sources included audited Medicaid nursing home cost reports, quality-of-care data from state facility survey and licensure files, and facility case-mix information from random, stratified samples of homes and residents. Data were obtained for six years (1979-1985) covering the three-year period before and after implementation of the prospective payment system. This study used a pre-post, longitudinal analytical design in which interrupted, time-series regression models were estimated to test the effects of prospective payment and other factors, e.g., facility characteristics, nursing home market factors, facility case mix, and quality of care, on nursing home costs. Prospective payment contributed to an estimated $3.03 decrease in total variable costs in the third year from what would have been expected under the previous retrospective cost-based payment system. Responsiveness to payment system efficiency incentives declined over the study period, however, indicating a growing problem in achieving further cost reductions. Some evidence suggested that cost reductions might have reduced access for public patients. Study findings are consistent with the results of other studies that have demonstrated the effectiveness of prospective payment systems in restraining nursing home costs. Potential policy trade-offs among cost containment, access, and quality assurance deserve further consideration, particularly by researchers and policymakers designing the new generation of case mix-based and other nursing home payment systems.

A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

ClinicalTrials.gov

2016-07-03

Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

Comparison of intravenous versus topical tranexamic acid in total knee arthroplasty: a prospective randomized study.

PubMed

Patel, Jay N; Spanyer, Jonathon M; Smith, Langan S; Huang, Jiapeng; Yakkanti, Madhusudhan R; Malkani, Arthur L

2014-08-01

The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0g TXA, versus IV administration of 10mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients. Copyright © 2014 Elsevier Inc. All rights reserved.

[Sugammadex versus neostigmine in pediatric patients: a prospective randomized study].

PubMed

Kara, Turhan; Ozbagriacik, Ozgur; Turk, Hacer Sebnem; Isil, Canan Tulay; Gokuc, Ozan; Unsal, Oya; Seyhan, Emrah; Oba, Sibel

2014-01-01

Acetylcholinesterase inhibitors may cause postoperative residual curarization when they are used for reversal of neuromuscular blockade. Sugammadex reverses neuromuscular blockade by chemical encapsulation and is not associated with the side effects that may occur with the use of anticholinesterase agents. Because of increased outpatient surgical procedures postoperative residual curarization and rapid postoperative recovery have a greater importance in the pediatric patient population. The aim of this study was to compare the efficacy of sugammadex and neostigmine on reversing neuromuscular blockade in pediatric patients undergoing outpatient surgical procedures. 80 patients, aged 2-12 years, scheduled for outpatient surgery were enrolled in this randomized prospective study. Neuromuscular blockade was achieved with 0.6mgkg(-1) rocuronium and monitorized with train-of-four. Group RN (n=40) received 0.03mgkg(-1) neostigmine, Group RS (n=40) received 2mgkg(-1) sugammadex for reversal of rocuronium. Extubation time (time from the reversal of neuromuscular blockade to extubation), train-of-four ratio during this time, time to reach train-of-four>0.9, and probable complications were recorded. There was no significant difference between the patients' characteristics. Extubation time and time to reach train-of-four>0.9 were significantly higher in Group RN (p=0.001, p=0.002). Train-of-four at the time of neostigmine/sugammadex injection in Group RN were significantly higher than in the RS group (p=0.020). Extubation train-of-four ratio was significantly lower in Group RN (p=0.002). Sugammadex provides safer extubation with a shorter recovery time than neostigmine in pediatric patients undergoing outpatient surgical procedures. Copyright © 2014 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Prospective randomized trial to assess effects of continuing hormone therapy on cerebral function in postmenopausal women at risk for dementia.

PubMed

Rasgon, Natalie L; Geist, Cheri L; Kenna, Heather A; Wroolie, Tonita E; Williams, Katherine E; Silverman, Daniel H S

2014-01-01

The objective of this study was to examine the effects of estrogen-based hormone therapy (HT) on regional cerebral metabolism in postmenopausal women (mean age = 58, SD = 5) at risk for development of dementia. The prospective clinical trial design included pre- and post-intervention neuroimaging of women randomized to continue (HT+) or discontinue (HT-) therapy following an average of 10 years of use. The primary outcome measure was change in brain metabolism during the subsequent two years, as assessed with fluorodeoxyglucose-18 positron emission tomography (FDG-PET). Longitudinal FDG-PET data were available for 45 study completers. Results showed that women randomized to continue HT experienced relative preservation of frontal and parietal cortical metabolism, compared with women randomized to discontinue HT. Women who discontinued 17-β estradiol (17βE)-based HT, as well as women who continued conjugated equine estrogen (CEE)-based HT, exhibited significant decline in metabolism of the precuneus/posterior cingulate cortical (PCC) area. Significant decline in PCC metabolism was additionally seen in women taking concurrent progestins (with either 17βE or CEE). Together, these findings suggest that among postmenopausal subjects at risk for developing dementia, regional cerebral cortical metabolism is relatively preserved for at least two years in women randomized to continue HT, compared with women randomized to discontinue HT. In addition, continuing unopposed 17βE therapy is associated specifically with preservation of metabolism in PCC, known to undergo the most significant decline in the earliest stages of Alzheimer's disease. ClinicalTrials.gov NCT00097058.

PRK and butterfly LASEK: prospective, randomized, contralateral eye comparison of epithelial healing and ocular discomfort.

PubMed

Ghanem, Vinícius C; Souza, Giselle C; Souza, Denise C; Viese, Juliana M Z; Weber, Sarah L P; Kara-José, Newton

2008-06-01

To compare corneal reepithelialization, pain scores, ocular discomfort, and tear production after photorefractive keratectomy (PRK) and butterfly laser epithelial keratomileusis (LASEK). This prospective, randomized, double-masked study comprised 102 eyes of 51 patients who underwent laser refractive surgery. Each patient was randomized to have one eye operated on with PRK and the other with butterfly LASEK. Patients were followed for 1 year. The mean reepithelialization time in the PRK group was 4.35+/-0.48 days (range: 4 to 5 days) and 4.75+/-0.72 days (range: 4 to 6 days) in the butterfly LASEK group (P<.002). Pain scores and ocular discomfort were not statistically different between groups, although a trend towards a lower pain level with PRK was noted (3.31+/-4.09 vs 4.43+/-4.27; P=.18). Schirmer test values were significantly reduced from preoperative levels through 12 months with both PRK (23.6+/-8.1 vs 19.4+/-10.1; P<.002) and butterfly LASEK (22.4+/-8.7 vs 18.9+/-9.7; P=.01); however, no difference between groups was noted at any time. Photorefractive keratectomy showed a modest but statistically significant shorter reepithelialization time and a tendency towards lower pain scores than butterfly LASEK. The reepithelialization time was strongly associated with the duration of surgery in both techniques. A similar reduction of Schirmer test values was observed up to 1 year postoperatively in both groups.

Single-Level Degenerative Cervical Disc Disease and Driving Disability: Results from a Prospective, Randomized Trial

PubMed Central

Kelly, Michael P.; Mitchell, M. David; Hacker, Robert J.; Riew, K. Daniel; Sasso, Rick C.

2013-01-01

Study Design Post hoc analysis of prospective, randomized trial. Objective To investigate the disability associated with driving and single-level degenerative, cervical disc disease and to investigate the effect of surgery on driving disability. Methods Post hoc analysis of data obtained from three sites participating in a multicenter, randomized, controlled trial comparing cervical disc arthroplasty (TDA) with anterior cervical discectomy and fusion (ACDF). The driving subscale of the Neck Disability Index (NDI) was analyzed for all patients. A dichotomous severity score was created from the NDI. Statistical comparisons were made within and between groups. Results Two-year follow-up was available for 118/135 (87%) patients. One half of the study population (49.6%) reported moderate or severe preoperative driving difficulty. This disability associated with driving was similar among the two groups (ACDF: 2.5 ± 1.1, TDA: 2.6 ± 1.0, p = 0.646). The majority of patients showed improvement, with no or little driving disability, at the sixth postoperative week (ACDF: 75%, TDA: 90%, p = 0.073). At no follow-up point did a difference exist between groups according to the severity index. Conclusions Many patients suffering from radiculopathy or myelopathy from cervical disc disease are limited in their ability to operate an automobile. Following anterior cervical spine surgery, most patients are able to return to comfortable driving at 6 weeks. PMID:24436875

Phase II prospective randomized trial of weight loss prior to radical prostatectomy.

PubMed

Henning, Susanne M; Galet, Colette; Gollapudi, Kiran; Byrd, Joshua B; Liang, Pei; Li, Zhaoping; Grogan, Tristan; Elashoff, David; Magyar, Clara E; Said, Jonathan; Cohen, Pinchas; Aronson, William J

2017-12-04

Obesity is associated with poorly differentiated and advanced prostate cancer and increased mortality. In preclinical models, caloric restriction delays prostate cancer progression and prolongs survival. We sought to determine if weight loss (WL) in men with prostate cancer prior to radical prostatectomy affects tumor apoptosis and proliferation, and if WL effects other metabolic biomarkers. In this Phase II prospective trial, overweight and obese men scheduled for radical prostatectomy were randomized to a 5-8 week WL program consisting of standard structured energy-restricted meal plans (1200-1500 Kcal/day) and physical activity or to a control group. The primary endpoint was apoptotic index in the radical prostatectomy malignant epithelium. Secondary endpoints were proliferation (Ki67) in the radical prostatectomy tissue, body weight, body mass index (BMI), waist to hip ratio, body composition, and serum PSA, insulin, triglyceride, cholesterol, testosterone, estradiol, leptin, adiponectin, interleukin 6, interleukin 8, insulin-like growth factor 1, and IGF binding protein 1. In total 23 patients were randomized to the WL intervention and 21 patients to the control group. Subjects in the intervention group had significantly more weight loss (WL:-3.7 ± 0.5 kg; Control:-1.6 ± 0.5 kg; p = 0.007) than the control group and total fat mass was significantly reduced (WL:-2.1 ± 0.4; Control: 0.1 ± 0.3; p = 0.015). There was no significant difference in apoptotic or proliferation index between the groups. Among the other biomarkers, triglyceride, and insulin levels were significantly decreased in the WL compared with the control group. In summary, this short-term WL program prior to radical prostatectomy resulted in significantly more WL in the intervention vs. the control group and was accompanied by significant reductions in body fat mass, circulating triglycerides, and insulin. However, no significant changes were observed in malignant

Comparison of anastomotic leakage and stricture formation following layered and stapler oesophagogastric anastomosis for cancer: a prospective randomized controlled trial.

PubMed

Zhang, Y S; Gao, B R; Wang, H J; Su, Y F; Yang, Y Z; Zhang, J H; Wang, C

2010-01-01

The objective of this prospective, randomized, controlled trial, conducted from May 2002 to December 2007, was to compare post-operative anastomotic leakage and stricture formation following layered manual versus stapler oesophagogastric anastomosis in patients who underwent resection of oesophageal or gastric cardia carcinoma. Patients (n = 516) were randomized to receive either layered manual or circular stapled oesophagogastric anastomosis. Mean follow-up time was > 12 months. Anastomotic leakage occurred in one (0.4%) patient in the layered group and six (2.2%) in the stapler group; no statistically significant between-group difference. After operation, two (0.8%) patients in the layered group and 13 (5.0%) in the stapler group developed a benign oesophageal stricture; the difference between the groups was statistically significant. Compared with stapler anastomosis, layered manual anastomosis may significantly reduce the incidence of anastomotic strictures. This method is easy to apply and could be used as an alternative procedure for oesophagogastric anastomosis after resection for oesophageal or cardia carcinoma.

Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model

PubMed Central

Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

2017-01-01

Background Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. Methods and Findings We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20–60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Conclusion Our results suggest that RJ improves tear volume in patients with dry eye. Trial Registration Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446) PMID:28060936

Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

PubMed Central

2015-01-01

OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

Evaluation of the path integral for flow through random porous media

NASA Astrophysics Data System (ADS)

Westbroek, Marise J. E.; Coche, Gil-Arnaud; King, Peter R.; Vvedensky, Dimitri D.

2018-04-01

We present a path integral formulation of Darcy's equation in one dimension with random permeability described by a correlated multivariate lognormal distribution. This path integral is evaluated with the Markov chain Monte Carlo method to obtain pressure distributions, which are shown to agree with the solutions of the corresponding stochastic differential equation for Dirichlet and Neumann boundary conditions. The extension of our approach to flow through random media in two and three dimensions is discussed.

Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial.

PubMed

Aggarwal, Vivek; Singla, Mamta; Kabi, Debipada

2010-03-01

Anesthetic efficacy of inferior alveolar nerve block decreases in patients with irreversible pulpitis. It was hypothesized that premedication with nonsteroidal anti-inflammatory drugs might improve the success rates in patients with inflamed pulps. Sixty-nine adult volunteers who were actively experiencing pain participated in this prospective, randomized, double-blind study. The patients were divided into 3 groups on a random basis and were randomly given 1 of the 3 drugs including ibuprofen, ketorolac, and placebo 1 hour before anesthesia. All patients received standard inferior alveolar nerve block of 2% lidocaine with 1:200,000 epinephrine. Endodontic access preparation was initiated after 15 minutes of initial inferior alveolar nerve block. Pain during treatment was recorded by using a Heft Parker visual analog scale. Success was recorded as none or mild pain. Statistical analysis with nonparametric chi2 tests showed that placebo gave 29% success rate. Premedication with ibuprofen gave 27%, and premedication with ketorolac gave 39% success rate. There was no significant difference between the 3 groups. Preoperative administration of ibuprofen or ketorolac has no significant effect on success rate of inferior alveolar nerve block in patients with irreversible pulpitis. Copyright (c) 2010 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Arthroscopic Debridement Versus Platelet-Rich Plasma Injection: A Prospective, Randomized, Comparative Study of Chronic Lateral Epicondylitis With a Nearly 2-Year Follow-Up.

PubMed

Merolla, Giovanni; Dellabiancia, Fabio; Ricci, Annamaria; Mussoni, Maria Pia; Nucci, Simonetta; Zanoli, Gustavo; Paladini, Paolo; Porcellini, Giuseppe

2017-07-01

The purpose of this prospective, randomized study was to compare the efficacy of autologous platelet-rich plasma (PRP) injections and arthroscopic lateral release in treating chronic lateral epicondylitis (LE). Patients who had a clinical diagnosis of LE confirmed by ultrasound (US) were included in this study. A total of 101 patients received arthroscopic release (n = 50) or US-guided PRP injections (n = 51). Outcomes were assessed using a visual analog scale for pain, the Patient-Rated Tennis Elbow Evaluation (PRTEE), and a calibrated hand dynamometer for grip strength. Both patient groups experienced significant improvement in all measures. Between-group comparisons showed a significantly higher value in the PRP group only for grip strength at week 8 (P = .0073); all other significant differences were in favor of arthroscopy: overall pain (P = .0021), night pain (P = .0013), and PRTEE score (P = .0013) at week 104 and grip strength at weeks 24, 52, and 104 (all P < .0001). Consumption of rescue pain medication was not significantly different between the groups. The present findings suggest that (1) PRP injections and arthroscopic extensor carpi radialis brevis release are both effective in the short and medium term; (2) PRP patients experienced a significant worsening of pain at 2 years; (3) arthroscopic release ensured better long-term outcomes in terms of pain relief and grip strength recovery; and (4) both procedures were safe and well accepted by patients. LEVEL OF EVIDENCE: Level II, prospective comparative study. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

PubMed Central

Zigler, Jack E.; Jackson, Robert; Nunley, Pierce D.; Bae, Hyun W.; Kim, Kee D.; Ohnmeiss, Donna D.

2016-01-01

Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and

Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

PubMed

Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

2015-12-01

There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

Cardioprotective Effects of Intracoronary Morphine in ST-Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention: A Prospective, Randomized Trial.

PubMed

Gwag, Hye Bin; Kim, Eun Kyoung; Park, Taek Kyu; Lee, Joo Myung; Yang, Jeong Hoon; Song, Young Bin; Choi, Jin-Ho; Choi, Seung-Hyuk; Lee, Sang Hoon; Chang, Sung-A; Park, Sung-Ji; Lee, Sang-Chol; Park, Seung Woo; Jang, Woo Jin; Lee, Mirae; Chun, Woo Jung; Oh, Ju Hyeon; Park, Yong Hwan; Choe, Yeon Hyeon; Gwon, Hyeon-Cheol; Hahn, Joo-Yong

2017-04-03

A cardioprotective role of morphine acting via opioid receptors has been demonstrated, and previous preclinical studies have reported that morphine could reduce reperfusion injury and myocardial infarct size in a way similar to that of ischemic periconditioning. This study aimed to evaluate the effect of intracoronary morphine on myocardial infarct size in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. This study was designed as a 2-center, prospective, randomized, open-label, blinded end point trial. A total of 91 ST-elevation myocardial infarction patients with thrombolysis in myocardial infarction flow grade of 0 to 1 undergoing primary percutaneous coronary intervention were randomly assigned to a morphine or control group at a 1:1 ratio. The morphine group received 3 mg of morphine sulfate diluted with 3 mL of normal saline, and the control group received 3 mL of normal saline into a coronary artery immediately after restoration of coronary flow. The primary end point was myocardial infarct size assessed by cardiac magnetic resonance imaging The cardiac magnetic resonance images were evaluated for 42 and 38 patients in the morphine and control groups, respectively. Myocardial infarct size was not different between the 2 groups (25.6±11.2% versus 24.6±10.5%, P =0.77), nor was the extent of microvascular obstruction or myocardial salvage index (6.0±6.3% versus 5.1±4.6%, P =0.91; 31.1±15.2% versus 30.3±10.9%, P =0.75, respectively). There was no difference in peak creatine kinase-MB level, final thrombolysis in myocardial infarction flow, myocardial brush grade, or complete resolution of ST-segment. Intracoronary morphine administration could not reduce myocardial infarct size in ST-elevation myocardial infarction patients undergoing primary percutaneous coronary intervention. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01738100. © 2017 The Authors. Published on behalf of the

Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

PubMed

Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

2017-10-01

This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p < 0.001) and higher IgA (p < 0.001) levels immediately after aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p < 0.001) weeks gestational age (GA) were significantly higher than the pretest IgA at 16 weeks GA (baseline). This study presented evidence that aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial-PROSPECT: protocol for a feasibility randomized pilot trial.

PubMed

Johnstone, Jennie; Meade, Maureen; Marshall, John; Heyland, Daren K; Surette, Michael G; Bowdish, Dawn Me; Lauzier, Francois; Thebane, Lehana; Cook, Deborah J

2015-01-01

Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 10 10 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and

Effects of moderate red wine consumption on liver fat and blood lipids: a prospective randomized study.

PubMed

Kechagias, Stergios; Zanjani, Sepehr; Gjellan, Solveig; Leinhard, Olof Dahlqvist; Kihlberg, Johan; Smedby, Orjan; Johansson, Lars; Kullberg, Joel; Ahlström, Håkan; Lindström, Torbjörn; Nystrom, Fredrik H

2011-11-01

There have been no human prospective randomized studies of the amount of alcohol that can induce hepatic steatosis. Thirty-two healthy women and twelve healthy men (34 ± 9 years of age) were randomized to consume 150 ml of red wine/day for women (16 g ethanol/day) or double that amount for men (33 g ethanol/day), or to alcohol abstention for 90 days. Participants underwent proton-nuclear magnetic-resonance spectroscopy for measurement of hepatic triglyceride content (HTGC). Blood samples for assessment of cardiovascular risk were drawn before and after the intervention. After exclusion of three subjects with steatosis at baseline a trend towards increased HTGC was apparent for red wine (before median: 1.1%, range 0.2-3.9%, after median: 1.1%, range 0.5-5.2 %, P = 0.059) a difference that was statistically significant compared with abstainers (p = 0.02). However, no subject developed hepatic steatosis. Low-density lipoprotein (LDL)-cholesterol was lowered by red wine (-0.3 mmol/l, SE -0.1, 95% CI -0.6 to -0.04). Moderate consumption of red wine during three months increased HTGC in subjects without steatosis at baseline. However, since not a single participant developed steatosis we suggest that the threshold of alcohol consumption to define nonalcoholic fatty liver disease should not be lower than the amount in our study.

Efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy: A prospective, randomized study

PubMed Central

Akaraviputh, Thawatchai; Leelouhapong, Charay; Lohsiriwat, Varut; Aroonpruksakul, Somkiat

2009-01-01

AIM: To determine the efficacy of perioperative parecoxib injection on postoperative pain relief after laparoscopic cholecystectomy. METHODS: A prospective, double-blind, randomized, placebo-controlled study was conducted on 70 patients who underwent elective laparoscopic cholecystectomy under general anesthesia at Siriraj Hospital, Bangkok, from January 2006 to December 2007. Patients were randomized to receive either 20 mg parecoxib infusion 30 min before induction of anesthesia and at 12 h after the first dose (treatment group), or normal saline infusion, in the same schedule, as a placebo (control group). The degree of the postoperative pain was assessed every 3 h in the first 24 h after surgery, and then every 12 h the following day, using a visual analog scale. The consumption of analgesics was also recorded. RESULTS: There were 40 patients in the treatment group, and 30 patients in the control group. The pain scores at each time point, and analgesic consumption did not differ between the two groups. However, there were fewer patients in the treatment group than placebo group who required opioid infusion within the first 24 h (60% vs 37%, P = 0.053). CONCLUSION: Perioperative administration of parecoxib provided no significant effect on postoperative pain relief after laparoscopic cholecystectomy. However, preoperative infusion 20 mg parecoxib could significantly reduce the postoperative opioid consumption. PMID:19399934

Is quadriceps tendon a better graft choice than patellar tendon? a prospective randomized study.

PubMed

Lund, Bent; Nielsen, Torsten; Faunø, Peter; Christiansen, Svend Erik; Lind, Martin

2014-05-01

The purpose of this randomized controlled study was to compare knee stability, kneeling pain, harvest site pain, sensitivity loss, and subjective clinical outcome after primary anterior cruciate ligament (ACL) reconstruction with either bone-patellar tendon-bone (BPTB) or quadriceps tendon-bone (QTB) autografts in a noninferiority study design. From 2005 to 2009, a total of 51 patients were included in the present study. Inclusion criteria were isolated ACL injuries in adults. Twenty-five patients were randomized to BPTB grafts and 26 to QTB grafts. An independent examiner performed follow-up evaluations 1 and 2 years postoperatively. Anteroposterior knee laxity was measured with a KT-1000 arthrometer (MEDmetric, San Diego, CA). Anterior knee pain was assessed clinically and by knee-walking ability. Knee Injury and Osteoarthritis Outcome Score (KOOS) and subjective International Knee Documentation Committee (IKDC) score were used for patient-evaluated outcome. Anterior knee laxity was equal between the 2 groups with KT-1000 values of 1.1 ± 1.4 mm and 0.8 ± 1.7 mm standard deviation (SD) at follow-up in QTB and BPTB groups, respectively (P = .65), whereas positive pivot shift test results were seen less frequently (14% compared with 38%, respectively; P = .03). Anterior kneeling pain, evaluated by the knee walking ability test, was significantly less in the QTB group, with only 7% of patients grading knee walking as difficult or impossible compared with 34% in the BPTB group. At 1 and 2 years' follow-up, there was no difference between the 2 groups in subjective patient-evaluated outcome. The IKDC score was 75 ± 13 patients and 76 ± 16 SD at 1-year follow-up in QTB and BPTB groups, respectively (P = .78). At 2 years, 12 patients were lost to follow-up, resulting in 18 in the BPTB group and 21 in the QTB group. The use of the QTB graft results in less kneeling pain, graft site pain, and sensitivity loss than seen with BPTB grafts; however, similar anterior knee

[Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].

PubMed

Xiao, Songshu; Wan, Yajun; Zou, Fangjun; Ye, Mingzhu; Deng, Henan; Ma, Jiezhi; Wei, Yingying; Tan, Chen; Xue, Min

2015-01-01

To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study.

PubMed

Luo, Fang; Wang, Tao; Shen, Ying; Meng, Lan; Lu, Jingjing; Ji, Nan

2017-05-01

A recent study showed that 50% of patients who suffered from refractory neuralgia of the infraorbital nerve obtained satisfactory efficacy after pulsed radiofrequency (PRF) treatment. A pilot study showed that increasing the output voltage of PRF significantly improved the efficacy for trigeminal neuralgia; however, whether increasing the output voltage of PRF can improve the treatment outcomes for neuralgia of the infraorbital nerve is unknown. To evaluate the efficacy and safety of high voltage PRF treatment in comparison with standard voltage PRF for neuralgia of the infraorbital nerve. Prospective, single-center, double-blinded, randomized, controlled trial. Beijing Tiantan Hospital, Capital Medical University. A total of 60 patients with refractory neuralgia of the infraorbital nerve were randomly divided into the high voltage PRF group and the standard voltage PRF group to treat their infraorbital nerves. Neither the patients, pain physicians, nor the follow-up evaluators knew the patient group assignments. The primary outcome measure was the one-year response rate. The secondary outcome measures included the time to take effect after PRF, the one-month, 3-month, and 6-month response rates, the relapse rate, and adverse reactions. The intent-to-treat analysis showed that the one-month, 3-month, 6-month, and one-year response rates were all 90% in the high voltage group, which were significantly higher than the rates in the standard voltage group (67% [P < 0.05], 67% [P < 0.05], 63% [P < 0.05], and 60% [P <0.01], respectively). Furthermore, 27% of the patients in the high-voltage group and 13% of the patients in the standard voltage group experienced minor transient (10 - 30 days) numbness in the innervation area after PRF; no other serious adverse reactions were observed in the 2 groups (P > 0.05). We did not investigate the dose-effect relationship between the output voltage and efficacy or the effect of a higher pulse dose on efficacy. This study was a

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

PubMed

Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

2014-04-01

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

Intrapartum amnioinfusion for meconium-stained fluid: meta-analysis of prospective clinical trials.

PubMed

Pierce, J; Gaudier, F L; Sanchez-Ramos, L

2000-06-01

To evaluate the effectiveness of intrapartum prophylactic amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid. We identified prospective clinical trials of amnioinfusion in pregnancies complicated by meconium-stained amniotic fluid (AF) published in English by using computerized databases, references in published studies, and index reviews. We analyzed prospective studies of intrapartum amnioinfusion for meconium-stained AF. In every case, group allocation was based exclusively on meconium in AF. Only published studies with clearly documented outcome data were included. The trials were evaluated for meconium below the vocal cords, meconium aspiration syndrome, fetal acidemia, cesarean delivery, and postpartum endometritis. Each trial was evaluated for the quality of its methodology, inclusion and exclusion criteria, adequacy of randomization, amnioinfusion protocols, definition of outcomes, and statistical analyses. Thirteen studies met inclusion criteria for our systematic review. Odds ratios (ORs) with their 95% confidence intervals (CIs) were calculated for each outcome. Estimates of ORs and risk differences for dichotomous outcomes were calculated using random and fixed-effects models. We tested for homogeneity across the studies. We found that intrapartum amnioinfusion significantly reduced the frequency of meconium aspiration syndrome (OR 0.30; 95% CI 0.19, 0. 46), of meconium below the vocal cords, and neonatal acidemia. Subjects allocated to receive amnioinfusion also had a significantly lower overall cesarean rate (OR 0.74, 95% CI 0.59, 0.93) without increased postpartum endometritis. Amnioinfusion in cases of meconium-stained fluid significantly improves neonatal outcome, lowers the cesarean delivery rate, and does not increase the postpartum endometritis rate.

A prospective randomized blister prevention trial assessing paper tape in endurance distances (Pre-TAPED).

PubMed

Lipman, Grant S; Ellis, Mark A; Lewis, Erica J; Waite, Brandee L; Lissoway, John; Chan, Garrett K; Krabak, Brian J

2014-12-01

Friction foot blisters are a common injury occurring in up to 39% of marathoners, the most common injury in adventure racing, and represent more than 70% of medical visits in multi-stage ultramarathons. The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners. This prospective randomized trial was undertaken during RacingThePlanet 155-mile (250-km), 7-day self-supported ultramarathons in China, Australia, Egypt, Chile, and Nepal in 2010 and 2011. Paper tape was applied prerace to one randomly selected foot, with the untreated foot acting as the own control. The study end point was development of a hot spot or blister on any location of either foot. One hundred thirty-six participants were enrolled with 90 (66%) having completed data for analysis. There were 36% women, with a mean age of 40 ± 9.4 years (range, 25-40 years) and pack weight of 11 ± 1.8 kg (range, 8-16 kg). All participants developed blisters, with 89% occurring by day 2 and 59% located on the toes. No protective effect was observed by the intervention (47 versus 35; 52% versus 39%; P = .22), with fewer blisters occurring around the tape on the experimental foot than under the tape (23 vs 31; 25.6% versus 34.4%), yet 84% of study participants when queried would choose paper tape for blister prevention in the future. Although paper tape was not found to be significantly protective against blisters, the intervention was well tolerated with high user satisfaction. Copyright © 2014 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

Randomized Trial of Smartphone-Based Evaluation for an Obstetrics and Gynecology Clerkship.

PubMed

Sobhani, Nasim C; Fay, Emily E; Schiff, Melissa A; Stephenson-Famy, Alyssa; Debiec, Katherine E

2017-12-19

We hypothesized that compared to paper evaluations, a smartphone-based quick response (QR) evaluation tool would improve timeliness of feedback, enhance efficacy of giving and receiving feedback, and be as easy to use. We performed a randomized controlled trial of student and instructor experience with two evaluation tools in the OB/GYN clerkship at University of Washington School of Medicine (UWSOM). Sites were randomized to the QR or paper tool; students at QR sites received individualized QR codes at the beginning of the clerkship. Instructors and students completed postintervention surveys regarding the evaluation tool and associated feedback. We compared responses between groups using chi-squared tests. Participating clerkship sites included primary, tertiary, private practice and institutional settings affiliated with the University of Washington in the Washington, Wyoming, Alaska, Montana and Idaho region. Of the 29 OB/GYN UWSOM clerkship sites, 18 agreed to participate and were randomized. Of 29 eligible instructors, 25 (86%) completed the survey, with n = 18 using QR and n = 7 using paper. Of 161 eligible students, 102 (63%) completed the survey, with n = 54 using QR and n = 48 using paper. Compared to those using paper evaluations, instructors using QR evaluations were significantly more likely to agree that the evaluation tool was easy to understand (100% QR vs 43% paper, p = 0.002), the tool was effective in providing feedback (78% QR vs 29% paper, p = 0.002), and they felt comfortable approaching students with the tool (89% QR vs 43% paper, p = 0.002). Compared to those using paper evaluations, students using QR evaluations were less likely to agree the tool was effective in eliciting feedback (QR 43% vs paper 55%, p = 0.042). Instructors found QR evaluations superior to paper evaluations for providing feedback to medical students, whereas students found QR evaluations less effective for feedback. Copyright © 2017 Association of Program Directors in

Thulium laser enucleation (ThuLEP) versus transurethral resection of the prostate in saline (TURis): A randomized prospective trial to compare intra and early postoperative outcomes.

PubMed

Bozzini, G; Seveso, M; Melegari, S; de Francesco, O; Buffi, N M; Guazzoni, G; Provenzano, M; Mandressi, A; Taverna, G

2017-06-01

To compare clinical intra and early postoperative outcomes between thulium laser transurethral enucleation of the prostate (ThuLEP) and transurethral bipolar resection of the prostate (TURis) for treating benign prostatic hyperplasia (BPH) in a prospective randomized trial. The study randomized 208 consecutive patients with BPH to ThuLEP (n=102) or TURis (n=106). For all patients were evaluated preoperatively with regards to blood loss, catheterization time, irrigation volume, hospital stay and operative time. At 3 months after surgery they were also evaluated by International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), and postvoid residual urine volume (PVR). The patients in each study arm each showed no significant difference in preoperative parameters. Compared with TURIS, ThuLEP had same operative time (53.69±31.44 vs 61.66±18.70minutes, P=.123) but resulted in less hemoglobin decrease (0.45 vs 2.83g/dL, P=.005). ThuLEP also needed less catheterization time (1.3 vs 4.8 days, P=.011), irrigation volume (29.4 vs 69.2 L, P=.002), and hospital stay (1.7 vs 5.2 days, P=.016). During the 3 months of follow-up, the procedures did not demonstrate a significant difference in Qmax, IPSS, PVR, and QOLS. ThuLEP and TURis both relieve lower urinary tract symptoms equally, with high efficacy and safety. ThuLEP was statistically superior to TURis in blood loss, catheterization time, irrigation volume, and hospital stay. However, procedures did not differ significantly in Qmax, IPSS, PVR, and QOLS through 3 months of follow-up. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

A Prospective Randomized Study of Pfannenstiel Versus Expanded Port Site Incision for Intact Specimen Extraction in Laparoscopic Radical Nephrectomy.

PubMed

Binsaleh, Saleh; Madbouly, Khaled; Matsumoto, Edward D; Kapoor, Anil

2015-08-01

To compare intra- and postoperative outcome of patients undergoing laparoscopic radical nephrectomy with intact specimen extraction through a Pfannenstiel (PFN) transverse suprapubic or expanded port site (EPS) incision in a prospective randomized fashion. Patients undergoing laparoscopic transperitoneal radical nephrectomies for suspected renal tumors were randomized for intact renal specimen extraction via a PFN or EPS incision. Operative, perioperative, 1 week, 6 weeks, and 6 months postoperative parameters were prospectively recorded and analyzed including specimen weight, size in maximum diameter, incision length, total operative time, extraction time, estimated blood loss, length of hospital stay, pain score in the postoperative holding area and on the first post operative day, narcotic consumption, time to fluid intake/full diet intake, unassisted ambulation, cosmesis, and wound-related complications. A postoperative quality-of-life questionnaire was also filled out by all the patients. Our series included 51 patients: 26 in the PFN group and 25 in the EPS group. The two groups were similar in demographic characteristics and intraoperative and postoperative parameters apart from a longer PFN incision (P<0.00). First postoperative day pain score was significantly less in the PFN group than in the EPS group (P=0.023). Complication rate was less in the PFN group, although not statistically significant. Hospital stay was significantly shorter in the PFN than in the EPS group (P=0.01). Mean cosmesis and operative satisfaction scores at week 1, week 6, and 6 month visits were not significantly different between both groups. Compared with the EPS group, PFN group patients significantly will choose the same operation if they would do it again (P=0.004). PFN incision has less morbidity, pain score, and hospital stay compared with EPS incision for intact specimen extraction after transperitoneal laparoscopic radical nephrectomy. Both incisions are associated with high

Prospective randomized double-blinded trial comparing 2 anti-MRSA agents with supplemental coverage of cefazolin before lower extremity revascularization.

PubMed

Stone, Patrick A; AbuRahma, Ali F; Campbell, James R; Hass, Stephen M; Mousa, Albeir Y; Nanjundappa, Aravinda; Srivastiva, Mohit; Modak, Asmita; Emmett, Mary

2015-09-01

To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion. Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin. No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections. Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections? Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014. One hundred seventy-eight (178) patients were evaluated at 90 days for surgical site infection. Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days. Early vascular surgical site infection occurred in 7(8.24%) of patients in the Vancomycin arm, and 11 (11.83%) in the Daptomycin arm (P = 0.43). Gram-positive related infections and MRSA infections occurred in 1(1.18%)/0(0%) of Vancomycin patients and 9 (9.68%)/1 (1.08%) of Daptomycin patients, respectively (P < 0.02 and P = 1.00). Readmissions related to surgical site infections occurred in 4(4.71%) in the Vancomycin group and 11 (11.8%) in the Daptomycin group (P = 0.11). Patients undergoing operative exploration occurred in 5 (5.88%) in the Vancomycin group and 10 (10.75%) of the Daptomycin group (P = 0.17). Late infections were reported in 3 patients, 2 of which were in the combined Daptomycin group. Median hospital charges related to readmissions due to a surgical site infection was $50,823 in the combination Vancomycin arm and $110,920 in the combination Daptomycin group; however, no statistical significance was appreciated (P = 0.11). Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis. The Incidence of MRSA-related surgical site infections is low with the addition of either anti

Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies.

PubMed

Azad, Meghan B; Abou-Setta, Ahmed M; Chauhan, Bhupendrasinh F; Rabbani, Rasheda; Lys, Justin; Copstein, Leslie; Mann, Amrinder; Jeyaraman, Maya M; Reid, Ashleigh E; Fiander, Michelle; MacKay, Dylan S; McGavock, Jon; Wicklow, Brandy; Zarychanski, Ryan

2017-07-17

Nonnutritive sweeteners, such as aspartame, sucralose and stevioside, are widely consumed, yet their long-term health impact is uncertain. We synthesized evidence from prospective studies to determine whether routine consumption of non-nutritive sweeteners was associated with long-term adverse cardiometabolic effects. We searched MEDLINE, Embase and Cochrane Library (inception to January 2016) for randomized controlled trials (RCTs) that evaluated interventions for nonnutritive sweeteners and prospective cohort studies that reported on consumption of non-nutritive sweeteners among adults and adolescents. The primary outcome was body mass index (BMI). Secondary outcomes included weight, obesity and other cardiometabolic end points. From 11 774 citations, we included 7 trials (1003 participants; median follow-up 6 mo) and 30 cohort studies (405 907 participants; median follow-up 10 yr). In the included RCTs, nonnutritive sweeteners had no significant effect on BMI (mean difference -0.37 kg/m 2 ; 95% confidence interval [CI] -1.10 to 0.36; I 2 9%; 242 participants). In the included cohort studies, consumption of nonnutritive sweeteners was associated with a modest increase in BMI (mean correlation 0.05, 95% CI 0.03 to 0.06; I 2 0%; 21 256 participants). Data from RCTs showed no consistent effects of nonnutritive sweeteners on other measures of body composition and reported no further secondary outcomes. In the cohort studies, consumption of nonnutritive sweeteners was associated with increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events. Publication bias was indicated for studies with diabetes as an outcome. Evidence from RCTs does not clearly support the intended benefits of nonnutritive sweeteners for weight management, and observational data suggest that routine intake of nonnutritive sweeteners may be associated with increased BMI and cardiometabolic risk. Further

Prospective Randomized Double-blinded Trial Comparing 2 Anti-MRSA Agents With Supplemental Coverage of Cefazolin Before Lower Extremity Revascularization

PubMed Central

Stone, Patrick A.; AbuRahma, Ali F.; Campbell, James R.; Hass, Stephen M.; Mousa, Albeir Y.; Nanjundappa, Aravinda; Srivastiva, Mohit; Modak, Asmita; Emmett, Mary

2015-01-01

Objective To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion. Background Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin. No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections. Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections? Methods Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014. One hundred seventy-eight (178) patients were evaluated at 90 days for surgical site infection. Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days. Results Early vascular surgical site infection occurred in 7(8.24%) of patients in the Vancomycin arm, and 11 (11.83%) in the Daptomycin arm (P = 0.43). Gram-positive related infections and MRSA infections occurred in 1(1.18%)/0(0%) of Vancomycin patients and 9 (9.68%)/1 (1.08%) of Daptomycin patients, respectively (P < 0.02 and P = 1.00). Readmissions related to surgical site infections occurred in 4(4.71%) in the Vancomycin group and 11 (11.8%) in the Daptomycin group (P = 0.11). Patients undergoing operative exploration occurred in 5 (5.88%) in the Vancomycin group and 10 (10.75%) of the Daptomycin group (P = 0.17). Late infections were reported in 3 patients, 2 of which were in the combined Daptomycin group. Median hospital charges related to readmissions due to a surgical site infection was $50,823 in the combination Vancomycin arm and $110,920 in the combination Daptomycin group; however, no statistical significance was appreciated (P = 0.11). Conclusions Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis. The Incidence of MRSA-related surgical site infections

Laparoscopic Complete Mesocolic Excision versus Open Complete Mesocolic Excision for Transverse Colon Cancer: Long-Term Survival Results of a Prospective Single Centre Non-Randomized Study.

PubMed

Storli, Kristian Eeg; Eide, Geir Egil

2016-01-01

Laparoscopic complete mesocolic excision (CME) used in the treatment of transverse colon cancer has been questioned on the basis of the technical challenges. The aim of this study was to evaluate the medium- and long-term clinical and survival outcomes after laparoscopic and open CME for transverse colon cancer and to compare the 2 approaches. This study was a retrospective non-randomized study of patients with prospectively registered data on open and laparoscopic CME for transverse colon cancer tumour-node-metastasis stages I-III operated on between 2007 and 2014. This was a single-centre study in a community teaching hospital. A total of 56 patients with transverse colon cancer were included, excluding those with tumours in the colonic flexures. The outcome aims were 4-year time to recurrence (TTR) and cancer-specific survival (CSS). Morbidity was also measured. The 4-year TTR was 93.9% in the laparoscopic group and 91.3% in the open group (p = 0.71). The 4-year CSS was 97.0% in the laparoscopic group and 91.3% in the open group (p = 0.42). This was a prospective single-institution study with a small sample size. Results of the study suggest that the laparoscopic CME approach might be the preferred approach for transverse colon cancer, especially regarding its benefits in terms of short-term morbidity, length of stay and oncological outcome. © 2016 S. Karger AG, Basel.

A Prospective Randomized Comparison Between Laparoscopic Ureterolithotomy and Semirigid Ureteroscopy for Upper Ureteral Stones >2 cm: A Single-Center Experience.

PubMed

Kumar, Anup; Vasudeva, Pawan; Nanda, Biswajit; Kumar, Niraj; Jha, Sanjeev Kumar; Singh, Harbinder

2015-11-01

The optimal management method of upper ureteral stones >2 cm is still a challenge. We performed a prospective randomized comparison between laparoscopic ureterolithotomy (LU) and ureteroscopic lithotripsy for upper ureteral calculus >2 cm to evaluate safety and efficacy of both procedures. Between January 2010 and May 2012, 110 patients with a single radiopaque upper ureteral calculus >2 cm were included in the present study. Randomization was done in two groups-group A: LU was performed and group B: Ureteroscopy (URS) was performed using a 6/7.5F semirigid ureteroscope (Richard Wolf) with holmium laser intracorporeal lithotripsy. Statistical analysis was performed regarding demographic profile, success, retreatment, auxiliary procedure rates, and also complications. Out of the total 110 patients, 54 patients were enrolled in group A and 56 patients were enrolled in group B. Mean stone size was 2.3±0.2 cm in group A versus 2.2±0.1 cm in group B (p=0.52). The overall 3-month stone-free rate was (50/50) 100% for group A versus (38/50) 76% for group B (p=0.02). The retreatment rate was significantly greater in group B than group A (8% vs. 0%, respectively; (p=0.01). Auxiliary procedure rate was higher in group B than in group A (26% vs. 0% respectively; p=0.001). The complication rate was 12% in group A versus 26% in group B (p=0.001). For upper ureteral stones of size greater than 2 cm, LU has a greater stone clearance rate, comparable operating time, lesser need for auxiliary procedure, and complication rate as compared to URS.

Prospective, Randomized Comparison of Cervical Total Disk Replacement Versus Anterior Cervical Fusion: Results at 48 Months Follow-up.

PubMed

Hisey, Michael S; Bae, Hyun W; Davis, Reginald J; Gaede, Steven; Hoffman, Greg; Kim, Kee D; Nunley, Pierce D; Peterson, Daniel; Rashbaum, Ralph F; Stokes, John; Ohnmeiss, Donna D

2015-05-01

This was a prospective, randomized, controlled multicenter trial. The purpose of this study was to compare clinical outcomes at 4-year follow-up of patients receiving cervical total disk replacement (TDR) with those receiving anterior cervical discectomy and fusion (ACDF). ACDF has been the traditional treatment for symptomatic disk degeneration. Several studies found single-level TDR to be as safe and effective as ACDF at ≥2 years follow-up. Patients from 23 centers were randomized in a 2:1 ratio with 164 receiving the investigational device (Mobi-C Cervical Disc Prosthesis) and 81 receiving ACDF using an anterior plate and allograft. Patients were evaluated preoperatively and 6 weeks, 3, 6, 12, 18, 24, 36, and 48 months postoperatively. Outcome assessments included a composite success score, Neck Disability Index, visual analog scales assessing neck and arm pain, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent-segment degeneration. The composite success rate was similar in the 2 groups at 48-month follow-up. Mean Neck Disability Index, visual analog scale, and SF-12 scores were significantly improved in early follow-up in both groups with improvements maintained throughout 48 months. On some measures, TDR had significantly greater improvement during early follow-up. At no follow-up were TDR scores significantly worse than ACDF scores. Subsequent surgery rate was significantly higher for ACDF compared with TDR (9.9% vs. 3.0%, P<0.05). Range of motion was maintained with TDR having a mean baseline value of 8 degrees compared with 10 degrees at 48 months. The incidence of adjacent-segment degeneration was significantly higher with ACDF at inferior and superior segments compared with TDR (inferior: 50% vs. 30%, P<0.025; superior: 53% vs. 34%, P<0.025). Significant improvements were observed in pain and function. TDR patients maintained motion and had significantly lower rates of reoperation and adjacent

Effective and safe mannitol administration in patients undergoing supratentorial tumor surgery: A prospective, randomized and double blind study.

PubMed

Akcil, Eren Fatma; Dilmen, Ozlem Korkmaz; Karabulut, Esra Sultan; Koksal, Serdar Selcuk; Altindas, Fatis; Tunali, Yusuf

2017-08-01

Although osmotic diuresis with mannitol is commonly used to provide brain relaxation, there is no consensus regarding its optimal dose and combination with loop diuretics. The aim of the present study is to evaluate the effects of mannitol and combination of furosemide with different doses of mannitol on brain relaxation and on blood electrolytes, lactate level, urine output, fluid balance and blood osmolarity in patients undergoing supratentorial tumor surgery. This prospective, randomized, double blind, placebo-controlled study included 51 patients (ASA I-III) scheduled for elective supratentorial craniotomy. Different doses and combinations of diuretics were administered after the bone flap removal. The Group 1 received mannitol at 0.5gkg -1 and furosemide at 0.5mgkg -1 , the Group 2 received mannitol at 1gkg -1 and furosemide at 0.5mgkg -1 , and the Group 3 received mannitol at 0.5gkg -1 and placebo. The primary end-point of the present study is to evaluate the effects of mannitol and combination of furosemide with different doses of mannitol on brain relaxation and the secondary end-points are to evaluate their effects on blood electrolytes, lactate level, urine output, fluid balance and blood osmolarity. This study shows that mannitol alone (0.5gkg -1 ), and the combinations of furosemide (0.5mgkg -1 ) with different doses of mannitol (0.5gkg -1 -1gkg -1 ) provides adequate brain relaxation. However, administration of furosemide with low or high doses of mannitol may cause reduction in the sodium and chloride levels as well as rise in the lactate level. Moreover it may cause high urine output and negative intra-operative fluid balance. Administration of 0.5gkg -1 mannitol provides adequate brain relaxation without causing systemic side effects in patients undergoing supratentorial tumor surgery. This study is registered to clinical trials (Clinical Trials.gov identifier NCT02712476). Copyright © 2017 Elsevier B.V. All rights reserved.

Randomized, Prospective Study of the Impact of a Sleep Health Program on Firefighter Injury and Disability.

PubMed

Sullivan, Jason P; O'Brien, Conor S; Barger, Laura K; Rajaratnam, Shantha M W; Czeisler, Charles A; Lockley, Steven W

2017-01-01

Firefighters' schedules include extended shifts and long work weeks which cause sleep deficiency and circadian rhythm disruption. Many firefighters also suffer from undiagnosed sleep disorders, exacerbating fatigue. We tested the hypothesis that a workplace-based Sleep Health Program (SHP) incorporating sleep health education and sleep disorders screening would improve firefighter health and safety compared to standard practice. Prospective station-level randomized, field-based intervention. US fire department. 1189 firefighters. Sleep health education, questionnaire-based sleep disorders screening, and sleep clinic referrals for respondents who screened positive for a sleep disorder. Firefighters were randomized by station. Using departmental records, in an intention-to-treat analysis, firefighters assigned to intervention stations which participated in education sessions and had the opportunity to complete sleep disorders screening reported 46% fewer disability days than those assigned to control stations (1.4 ± 5.9 vs. 2.6 ± 8.5 days/firefighter, respectively; p = .003). There were no significant differences in departmental injury or motor vehicle crash rates between the groups. In post hoc analysis accounting for intervention exposure, firefighters who attended education sessions were 24% less likely to file at least one injury report during the study than those who did not attend, regardless of randomization (OR [95% CI] 0.76 [0.60, 0.98]; χ2 = 4.56; p = .033). There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. A firefighter workplace-based SHP providing sleep health education and sleep disorders screening opportunity can reduce injuries and work loss due to disability in firefighters. © Sleep Research Society 2016. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

An open, prospective, randomized pilot investigation evaluating pain with the use of a soft silicone wound contact layer vs bridal veil and staples on split thickness skin grafts as a primary dressing.

PubMed

Patton, Mary Lou; Mullins, Robert Fred; Smith, David; Korentager, Richard

2013-01-01

An open, prospective, randomized, pilot investigation was implemented to evaluate the pain, cost-effectiveness, ease of use, tolerance, efficacy, and safety of a soft silicone wound contact layer (Mepitel One) vs Bridal Veil and staples used on split thickness skin grafts in the treatment of deep partial or full-thickness thermal burns. Individuals aged between 18 and 70 years with deep partial or full-thickness thermal burns (1-25% TBSA) were randomized into two groups and treated for 14 days or until greater than 95% graft take was achieved, whichever occurred first. Data were obtained and analyzed on pain experienced before, during, and after dressing removal. Secondary considerations included the overall cost (direct), graft take and healing, the ease of product use, overall experience of the dressing, and adverse events. A total of 43 subjects were recruited. There were no significant differences in burn area profiles within the groups. The pain level during dressing removal was significant between the groups (P = .0118) with the removal of Mepitel One being less painful. The staff costs were lower in the group of patients treated with Mepitel One (P = .0064) as reflected in the shorter time required for dressing removal (P = .0005), with Mepitel One taking on average less than a quarter of the time to remove. There was no significant difference in healing between the two groups, with 99.0% of the Mepitel One group and 93.1% of the Bridal Veil and staples group showing greater than 95% graft take at post-op day 7 (+/-1) (P = .2373). Clinicians reported that the soft silicone dressing was easier to use, more conformable, and demonstrated better ability to stay in place, compared with the Bridal Veil and staples regime. Both treatments were well tolerated, with no serious adverse events in either treatment group. Mepitel One was at least as effective in the treatment of patients as the standard care (Bridal Veil and staples). In addition, the group of patients

Comparison of topical versus intravenous tranexamic acid in primary total knee arthroplasty: a meta-analysis of randomized controlled and prospective cohort trials.

PubMed

Wang, Hao; Shen, Bin; Zeng, Yi

2014-12-01

There has been much debate and controversy about the optimal regimen of tranexamic acid in primary total knee arthroplasty. The purpose of this study was to undertake a meta-analysis to compare the efficacy of topical and intravenous regimen of tranexamic acid in primary total knee arthroplasty. A systematic review of the electronic databases PubMed, CENTRAL, Web of Science, and Embase was undertaken. All randomized controlled trials and prospective cohort studies evaluating the effectiveness of topical and intravenous tranexamic acid during primary total knee arthroplasty were included. The focus of the analysis was on the outcomes of blood loss, transfusion rate, and thromboembolic complications. Subgroup analysis was performed when possible. Of 328 papers identified, six trials were eligible for data extraction and meta-analysis comprising 679 patients (739 knees). We found no statistically significant difference between topical and intravenous administration of tranexamic acid in terms of blood loss, transfusion requirements and thromboembolic complications. Topical tranexamic acid has a similar efficacy to intravenous tranexamic acid in reducing both blood loss and transfusion rate without sacrificing safety in primary total knee arthroplasty. II. Copyright © 2014 Elsevier B.V. All rights reserved.

Effect of prospective reimbursement on nursing home costs.

PubMed Central

Coburn, A F; Fortinsky, R; McGuire, C; McDonald, T P

1993-01-01

OBJECTIVE. This study evaluates the effect of Maine's Medicaid nursing home prospective payment system on nursing home costs and access to care for public patients. DATA SOURCES/STUDY SETTING. The implementation of a facility-specific prospective payment system for nursing homes provided the opportunity for longitudinal study of the effect of that system. Data sources included audited Medicaid nursing home cost reports, quality-of-care data from state facility survey and licensure files, and facility case-mix information from random, stratified samples of homes and residents. Data were obtained for six years (1979-1985) covering the three-year period before and after implementation of the prospective payment system. STUDY DESIGN. This study used a pre-post, longitudinal analytical design in which interrupted, time-series regression models were estimated to test the effects of prospective payment and other factors, e.g., facility characteristics, nursing home market factors, facility case mix, and quality of care, on nursing home costs. PRINCIPAL FINDINGS. Prospective payment contributed to an estimated $3.03 decrease in total variable costs in the third year from what would have been expected under the previous retrospective cost-based payment system. Responsiveness to payment system efficiency incentives declined over the study period, however, indicating a growing problem in achieving further cost reductions. Some evidence suggested that cost reductions might have reduced access for public patients. CONCLUSIONS. Study findings are consistent with the results of other studies that have demonstrated the effectiveness of prospective payment systems in restraining nursing home costs. Potential policy trade-offs among cost containment, access, and quality assurance deserve further consideration, particularly by researchers and policymakers designing the new generation of case mix-based and other nursing home payment systems. PMID:8463109

Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

PubMed

Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

2016-12-01

The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

The china patient‐centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design

PubMed Central

Du, Xue; Pi, Yi; Dreyer, Rachel P.; Li, Jing; Li, Xi; Downing, Nicholas S.; Li, Li; Feng, Fang; Zhan, Lijuan; Zhang, Haibo; Guan, Wenchi; Xu, Xiao; Li, Shu‐Xia; Lin, Zhenqiu; Masoudi, Frederick A.; Spertus, John A.; Krumholz, Harlan M.

2016-01-01

Background The number of percutaneous coronary interventions (PCI) in China has increased more than 20‐fold over the last decade. Consequently, there is a need for national‐level information to characterize PCI indications and long‐term patient outcomes, including health status, to understand and improve evolving practice patterns. Objectives: This nationwide prospective study of patients receiving PCI is to: (1) measure long‐term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient‐reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient‐ and hospital‐level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. Methods: The China Patient‐centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012–2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in‐hospital outcomes from medical charts, and conducted baseline, 1‐, 6‐, and 12‐month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12‐month follow‐up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. Conclusion: China PEACE Prospective Study of PCI will

The china patient-centered evaluative assessment of cardiac events (PEACE) prospective study of percutaneous coronary intervention: Study design.

PubMed

Du, Xue; Pi, Yi; Dreyer, Rachel P; Li, Jing; Li, Xi; Downing, Nicholas S; Li, Li; Feng, Fang; Zhan, Lijuan; Zhang, Haibo; Guan, Wenchi; Xu, Xiao; Li, Shu-Xia; Lin, Zhenqiu; Masoudi, Frederick A; Spertus, John A; Krumholz, Harlan M; Jiang, Lixin

2016-12-01

The number of percutaneous coronary interventions (PCI) in China has increased more than 20-fold over the last decade. Consequently, there is a need for national-level information to characterize PCI indications and long-term patient outcomes, including health status, to understand and improve evolving practice patterns. This nationwide prospective study of patients receiving PCI is to: (1) measure long-term clinical outcomes (including death, acute myocardial infarction [AMI], and/or revascularization), patient-reported outcomes (PROs), cardiovascular risk factor control and adherence to medications for secondary prevention; (2) determine patient- and hospital-level factors associated with care process and outcomes; and (3) assess the appropriateness of PCI procedures. The China Patient-centered Evaluative Assessment of Cardiac Events (PEACE) Prospective Study of PCI has enrolled 5,000 consecutive patients during 2012-2014 from 34 diverse hospitals across China undergoing PCI for any indication. We abstracted details of patient's medical history, treatments, and in-hospital outcomes from medical charts, and conducted baseline, 1-, 6-, and 12-month interviews to characterize patient demographics, risk factors, clinical presentation, healthcare utilization, and health status using validated PRO measures. The primary outcome, a composite measure of death, AMI and/or revascularization, as well as PROs, medication adherence and cardiovascular risk factor control, was assessed throughout the 12-month follow-up. Blood and urine samples were collected at baseline and 12 months and stored for future analyses. To validate reports of coronary anatomy, 2,000 angiograms are randomly selected and read by two independent core laboratories. Hospital characteristics regarding their facilities, processes and organizational characteristics are assessed by site surveys. China PEACE Prospective Study of PCI will be the first study to generate novel, high-quality, comprehensive

Nasogastric tube versus gastrostomy tube for gastric decompression in abdominal surgery: a prospective, randomized trial comparing patients' tube-related inconvenience.

PubMed

Hoffmann, S; Koller, M; Plaul, U; Stinner, B; Gerdes, B; Lorenz, W; Rothmund, M

2001-11-01

Perioperative decompression of the stomach is still a common procedure and can be achieved using either nasogastric tubes (NTs) or gastrostomy tubes (GTs). While both procedures appear to be equally effective, some authors believe that NTs are less convenient for patients than GTs. However, to date, no reliable prospective data are available on this issue. We conducted a prospective, randomized trial comparing NTs versus GTs with a total of 110 patients undergoing elective colon surgery. The primary outcome measure was the patient's tube-related inconvenience and pain, assessed in a standardized interview on day 2 after surgery and quantified by means of a visual-analog scale (VAS). A questionnaire including the EORTC QLQ-C30 and additional items regarding retrospective tube-related judgements was administered on the day of discharge and 4 weeks after discharge. Secondary endpoints were the therapy-related morbidity and general complications. When patients were asked which of their drainage tubes (all patients had three or four drainage tubes, such as decompression drains, urinary drains, central venous line) was most inconvenient, 43% (CI 33-53%) in the NT group reported that the NT was most inconvenient, while only 4% (CI 1-10%) of the GT patients judged the GT most inconvenient ( P<0.001, Chi(2) test). This effect was also found in VAS ratings of inconvenience and discomfort ( P<0.01). Also postoperatively (p.o.), NT patients evidenced less preference for their tube system (day 2 p.o.: 71%, CI 61-80%; 4 weeks p.o.: 66%, CI 56-75%) than did GT patients (day 2 p.o.: 94%, CI 88-98%; 4 weeks p.o.: 91% CI 84-96%); again, these differences were statistically significant ( P<0.02; Chi(2) test). No differences between groups emerged regarding global quality of life or conventional clinical outcomes. This prospective randomized trial supports the clinical observation that NT causes more subjective inconvenience than GT. In cases when a prolonged postoperative ileus is

Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial.

PubMed

Aigner, F; Kronberger, I; Oberwalder, M; Loizides, A; Ulmer, H; Gruber, L; Pratschke, J; Peer, S; Gruber, H

2016-07-01

Novel minimally invasive techniques aimed to reposition the haemorrhoidal zone have been established for prolapsing haemorrhoids. We present a prospective randomized controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries (DG-HAL) in patients with symptomatic Grade III haemorrhoids. The trial was registered as ClinicalTrials.gov identifier NCT02372981. All consecutive patients with symptomatic Grade III haemorrhoids were randomly allocated to one of the two study arms: (i) Group A, DG-HAL with mucopexy or (ii) Group B, mucopexy alone. End-points were postoperative pain, faecal incontinence, bleeding, residual prolapse and alterations of the vascularization of the anorectal vascular plexus. Vascularization of the anorectal vascular plexus was assessed by transperineal contrast enhanced ultrasound. Patients recorded their symptoms in a diary maintained for a month. Forty patients were recruited and randomized to the two study groups. Patients in Group A had less pain in the first two postoperative weeks. At the 12-month follow-up, two patients in Group A (10%) and one in Group B (5%) showed recurrent Grade III haemorrhoids (P = 0.274). No significant morphological changes were observed in the transperineal ultrasound findings between the preoperative assessment and the assessment at 1 and 6 months in either group (P > 0.05). Mucopexy techniques for treating prolapsing haemorrhoids are effective, but DG-HAL does not add significantly to the results achieved by mucopexy. Repositioning the haemorrhoidal zone is the key to success, and mucopexy should be placed at the sites of the largest visible prolapse. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

Conformable covered versus uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction: a randomized prospective study.

PubMed

Lim, Sun Gyo; Kim, Jin Hong; Lee, Kee Myung; Shin, Sung Jae; Kim, Chan Gyoo; Kim, Kyung Ho; Kim, Ho Gak; Yang, Chang Heon

2014-07-01

A conformable self-expandable metallic stent was developed to overcome the limitation of previous self-expandable metallic stents. The aim of this study was to evaluate outcomes after placement of conformable covered and uncovered self-expandable metallic stents for palliation of malignant gastroduodenal obstruction. A single-blind, randomized, parallel-group, prospective study were conducted in 4 medical centres between March 2009 and July 2012. 134 patients with unresectable malignant gastroduodenal obstruction were assigned to a covered double-layered (n=66) or uncovered unfixed-cell braided (n=68) stent placement group. Primary analysis was performed to compare re-intervention rates between two groups. 120 patients were analysed (59 in the covered group and 61 in the uncovered group). Overall rates of re-intervention were not significantly different between the two groups: 13/59 (22.0%) in the covered group vs. 13/61 (21.3%) in the uncovered group, p=0.999. Stent migration was more frequent in the covered group than in the uncovered group (p=0.003). The tumour ingrowth rate was higher in the uncovered group than in the covered group (p=0.016). The rates of re-intervention did not significantly differ between the two stents. Conformable covered double-layered and uncovered unfixed-cell braided stents were associated with different patterns of stent malfunction. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

A randomized prospective study of oral levofloxacin vs intravenous flomoxef prophylaxis in postoperative infection after endoscopic sinus surgery.

PubMed

Inoshita, Ayako; Yokoi, Hidenori; Matsumoto, Fumihiko; Yao, Toru; Kawano, Kenji; Furukawa, Masayuki; Ikeda, Katsuhisa

2010-01-01

The clinical efficacy and cost effectiveness of oral antimicrobial prophylaxis with levofloxacin (LVFX) on endoscopic sinus surgery (ESS) was evaluated. Ninety-three patients undergoing ESS were prospectively enrolled in the present study. The patients were randomly divided into 2 groups, LVFX and flomoxef (FMOX). Two hundred milligrams of LVFX was orally given 2 hours before the start of surgery and 6 hours after the end of surgery, which was followed by the administration of 200 mg every 12 hours for 2 days. One gram of FMOX was dissolved in 100 ml of physiological saline and given intravenously at the induction of anesthesia and 6 hours after the end of surgery, followed by infusion twice daily for 2 days. There were no statistically significant differences between 2 groups in terms of age, sex, systemic complications, surgical procedures, the duration of the operation, the length of hospitalization, the amount of blood loss, body temperature, or the number of white blood cells or C-reactive protein. Although no statistical significance was observed in the bacterial resistance between the two antibiotics, LVFX seems to show a low rate of resistance pattern change as compared to FMOX. The present study demonstrated that no patients treated with LVFX or FMOX were afflicted with postsurgical infection. Oral administration of LVFX is a simple, cost-effective and safe alternative to intravenous prophylaxis in ESS based on clinical efficacy and bacteriological study. Copyright 2010 Elsevier Inc. All rights reserved.

The effect of adding active flexion to modified Kleinert regime on outcomes for zone 1 to 3 flexor tendon repairs. A prospective randomized trial.

PubMed

Rigó, István Zoltán; Haugstvedt, Jan-Ragnar; Røkkum, Magne

2017-11-01

In a prospective randomized study, we studied whether adding active flexion to a modified Kleinert regime changed outcomes of flexor tendon repairs in zone 1, 2 and 3 in 73 fingers (53 patients). Evaluation included active range of finger motion, grip and pinch strengths. Twelve months after surgery, the increase in range of active finger motion after adding active flexion was insignificant compared with that with the modified Kleinert regime. According to the Strickland criteria, 20 out of 29 fingers had excellent or good recovery after adding active flexion, as did 28 out of 34 fingers with the modified Kleinert regime; we could not detect significant improvement of the good and excellent rate. At 6 months, the pinch strength was significantly higher with the addition of active flexion. We failed to find that adding active finger flexion to the modified Kleinert regime improves the overall long-term results of repairs in zone 1 to 3, though recovery appeared faster, and the good and excellent recovery of zone 2 repairs was 17% greater with the active flexion protocol. I.

Role of patient information handouts following operative treatment of ankle fractures: a prospective randomized study.

PubMed

Mayich, D Joshua; Tieszer, Christina; Lawendy, Abdel; McCormick, William; Sanders, David

2013-01-01

Widespread evidence exists for directed patient information interventions (eg, pamphlets) in the setting of several orthopaedic conditions and interventions. Up until now, no study had assessed the role of these interventions in the management of patients following ankle fractures. Between 2005 and 2007, 40 patients who suffered an operative ankle fracture were randomized to either a standard treatment group for an ankle fracture or an enhanced information group who received an American Academy of Orthopaedic Surgeons ankle fracture information pamphlet that explained postoperative routine at our institution and a physiotherapy handout depicting a standard protocol. Study participants were followed for 3 months clinically and radiographically. At the 6-week and 3-month intervals, study participants completed the Olerud-Molander Questionnaire and 2 questions regarding their level of satisfaction. The primary outcome measure was the Likert-scale-based survey question determining the level of satisfaction with the treating staff. Participants in the enhanced information group were more satisfied with treatment at 3 months (9.2 vs 6.3; P < .001). There were significant improvements in work/activity ability at 6 weeks (P = .01), but this advantage disappeared at 3 months (P = .24). No differences in postoperative complication rates were noted. Information enhancement in the form of pamphlets can be helpful in providing patients with accessible information in the postoperative period. While they do not seem to have a sustained impact on postoperative outcomes, handouts may enhance the interaction between staff and patient at postoperative visits, improving patient satisfaction. Level I, appropriately powered randomized prospective cohort study.

Beneficial role of green plantain [Musa paradisiaca] in the management of persistent diarrhea: a prospective randomized trial.

PubMed

Alvarez-Acosta, Thais; León, Cira; Acosta-González, Salvador; Parra-Soto, Haydeé; Cluet-Rodriguez, Isabel; Rossell, Maria Rosario; Colina-Chourio, José A

2009-04-01

To evaluate the beneficial effects of green plantain-based diet on stool volume, frequency and weight gain as compared with a traditional yogurt-based diet in children with persistent diarrhea. In a prospective, in-hospital controlled trial, two different treatments were administered to a sample of 80 children of both sexes, with ages ranging from 1 to 28 months, who had experienced >or= 14 days of persistent diarrhea. The sample was divided into two groups of isocaloric (100 kcal/kg/d) diets: experimental and control, of 40 patients each. The experimental group was randomly given a-week treatment consisting of a 50 g/L of cooked green plantain-based diet. The control group was fed on a yogurt-based diet. Both groups were not statistically different at admission. Pathogens were isolated from stools in 21.2% and 25% of patients in the experimental and control groups respectively; Aeromonas hydrophilia and Shigela flexneri were the most frequently found bacteria. The experimental group fed on a green plantain diet had a significantly better response in: diminishing stool output and consistency (p < 0.002), stool weight, diarrhea duration (p < 0.001), and increasing daily body weight gain (p < 0.001) than the yogurt-based diet group. The average duration of diarrhea in the plantain-based diet group was 18 hours shorter (p < 0.005) and it also had lower cost (p < 0.005). Our results support the benefits of green plantain in the dietary management of persistent diarrhea in hospitalized children, in relation to diarrheal duration, weight gain and costs.

Evaluating the Collaborative Strategic Reading Intervention: An Overview of Randomized Controlled Trial Options

ERIC Educational Resources Information Center

Hitchcock, John H.; Kurki, Anja; Wilkins, Chuck; Dimino, Joseph; Gersten, Russell

2009-01-01

When attempting to determine if an intervention has a causal impact, the "gold standard" of program evaluation is the randomized controlled trial (RCT). In education studies random assignment is rarely feasible at the student level, making RCTs harder to conduct. School-level assignment is more common but this often requires considerable resources…

Prospective safety performance evaluation on construction sites.

PubMed

Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

2015-05-01

This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

Platelet-rich plasma in rotator cuff repair: a prospective randomized study.

PubMed

Malavolta, Eduardo Angeli; Gracitelli, Mauro Emilio Conforto; Ferreira Neto, Arnaldo Amado; Assunção, Jorge Henrique; Bordalo-Rodrigues, Marcelo; de Camargo, Olavo Pires

2014-10-01

Although platelet-rich plasma (PRP) has been used in rotator cuff repair, most authors have been unable to report the advantages of this method in clinical trials. The use of PRP promotes better functional and structural results in arthroscopic rotator cuff repair. Randomized controlled trial; Level of evidence, 1. This was a prospective, randomized, double-blind study with 2 groups of 27 patients each (PRP group and control group). Complete supraspinatus tears with retraction of less than 3 cm were subjected to arthroscopic single-row repair; at the end of the surgical procedure, liquid PRP prepared by apheresis was given to the patients in the PRP group with autologous thrombin. The outcomes were assessed by the University of California at Los Angeles (UCLA) and Constant scales, visual analog scale (VAS) for pain, and magnetic resonance imaging (MRI) before and 3, 6, 12, and 24 months after surgery. The significance level was 5%. The 2 groups of patients exhibited significant clinical improvement (P < .001). Between the preoperative assessment and 24-month follow-up, the mean UCLA score increased from 13.63 ± 3.639 to 32.70 ± 3.635 and from 13.93 ± 4.649 to 32.44 ± 4.318 in the control and PRP groups, respectively (P = .916). The mean Constant score increased from 47.37 ± 11.088 to 85.15 ± 9.879 in the control group and from 46.96 ± 11.937 to 84.78 ± 14.048 in the PRP group (P = .498). The mean VAS score varied from 7.00 ± 1.939 and 6.67 ± 1.617 before surgery to 1.15 ± 1.916 and 0.96 ± 2.244 at the 24-month assessment in the control and PRP groups, respectively (P = .418). The only difference was in the mean UCLA score at 12 months, with 30.04 ± 4.528 in the control group and 32.30 ± 3.506 in the PRP group (P = .046). The control group exhibited 1 case of a complete retear and 4 partial retears, and the PRP group exhibited 2 cases of partial retears (P = .42). Platelet-rich plasma prepared by apheresis and applied in the liquid state with thrombin

Prospective Randomized Trial of Use of In-House Prepared Low-Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer.

PubMed

Agarwal, Gaurav; Rajan, Sendhil; Mayilvaganan, Sabaretnam; Mishra, Anjali; Krishnani, Narendra; Gambhir, Sanjay

2018-05-01

The current standard-of-care for surgical staging of the axilla in clinically node-negative (N0) early breast cancers is sentinel lymph node biopsy (SLNB), which requires expensive radiopharmaceuticals for efficacious results. In-house produced low-cost radiopharmaceuticals may be the solution and have shown efficacy in earlier observational/pilot studies. We compared SLNB using in-house prepared radiopharmaceutical ( 99m Tc-Antimony-colloid) versus commercially marketed radiopharmaceutical ( 99m Tc-Sulphur-colloid) in this prospective randomized study. 78 clinically N0 early breast cancer patients (T1/2, N0 stages), undergoing primary surgery were prospectively randomized 1:1 into two groups; to receive SLNB using methylene blue, and either 99m Tc-Antimony colloid (Group-1) or   99m Tc-Sulphur colloid (Group-2). Completion axillary dissection was done in all (validation SLNB). SLNB indices were compared between the groups. The groups were comparable with regard to age, stage, tumour size, hormone receptors and HER2neu status. Cost of the in-house prepared 99m Tc-antimony colloid was 16-times lesser compared to 99m Tc-sulphur colloid. SLN identification rates (IR) in Groups 1 and 2 were 100 and 97.4% respectively, (p > 0.05). False negative rates (FNR) in Group 1 and 2 were 6.3% (1/16 patients) and 7.7% (1/13 patients), respectively, (p > 0.05). There were no major allergic reactions in either group. In this prospective randomized trial on early breast cancer patients, accuracy of SLNB was comparable using in-house prepared, 99m Tc-antimony colloid and commercially marketed 99m Tc-sulphur colloid as radiopharmaceutical, while 99m Tc-antimony colloid was much cheaper than 99m Tc-sulphur colloid.

Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

PubMed

Rawlings, Arthur; Soper, Nathaniel J; Oelschlager, Brant; Swanstrom, Lee; Matthews, Brent D; Pellegrini, Carlos; Pierce, Richard A; Pryor, Aurora; Martin, Valeria; Frisella, Margaret M; Cassera, Maria; Brunt, L Michael

2012-01-01

The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH < 4 were not significant between the two groups. Abnormal acid reflux was present in 10 of 24 Dor group patients (41.7%) and in 4 of 19 Toupet patients (21.0%) (p = 0.152). Dysphagia and regurgitation symptom scores improved significantly in both groups compared to preoperative scores. No significant differences in any esophageal symptoms were noted between the two groups preoperatively or at follow-up. SF-36 quality-of-life measures changed significantly from pre- to postoperative for five of ten domains in the Dor group and seven of ten in the Toupet patients (not significant between groups). Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet

To evaluate the effectiveness of health care ethics consultation based on the goals of health care ethics consultation: a prospective cohort study with randomization.

PubMed

Chen, Yen-Yuan; Chu, Tzong-Shinn; Kao, Yu-Hui; Tsai, Pi-Ru; Huang, Tien-Shang; Ko, Wen-Je

2014-01-03

The growing prevalence of health care ethics consultation (HCEC) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance, and for the debates surrounding why and how HCEC is evaluated. The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters. Patients with medical uncertainty or conflict regarding value-laden issues, and requests made by the attending physicians or nurses for HCEC from December 1, 2009 to April 30, 2012 were randomly assigned to the usual care group (UC group) and the intervention group (HCEC group). The patients in the HCEC group received HCEC conducted by an individual ethics consultant. Data analysis was based on the intention-to-treat principle. Mann-Whitney test and Chi-squared test were used depending on the scale of measurement. Thirty-three patients (53.23%) were randomly assigned to the HCEC group and 29 patients were randomly assigned to the UC group. Among the 33 patients in the HCEC group, two (6.06%) of them ultimately did not receive a HCEC service. Among the 29 patients in the UC group, four (13.79%) of them received a HCEC service. The survival rate at hospital discharge did not differ between the two groups. Patients in the HCEC group showed significant reductions in the entire ICU stay and entire hospital stay. HCEC significantly facilitated achieving the goal of medical care (p < .01). Furthermore, patients in the HCEC group had a shorter ICU stay and shorter hospital stay after the occurrence of medical uncertainty or conflict regarding value-laden issues than those in the UC group. Our findings demonstrated that HCEC were associated with reduced consumption of medical resources as indicated by shorter entire ICU stay, entire hospital stay, and shorter ICU and hospital stay after the occurrence of the medical uncertainty or conflict regarding value-laden issues. This study also

Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial.

PubMed

Lee, Ju-Hee; Kim, Sang-Hyun; Choi, Dong-Ju; Tahk, Seung-Jea; Yoon, Jung-Han; Choi, Si Wan; Hong, Taek-Jong; Kim, Hyo-Soo

2017-01-01

This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva ® ) and the reference formulation (Lipitor ® ) of atorvastatin, both at a dosage of 20 mg once daily. This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (-43.9%±15.3% in the generic group, -43.3%±17.0% in the reference group, P =0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P =0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P =0.804). The generic formulation

Efficacy and tolerability of two different formulations of atorvastatin in Korean patients with hypercholesterolemia: a multicenter, prospective, randomized clinical trial

PubMed Central

Lee, Ju-Hee; Kim, Sang-Hyun; Choi, Dong-Ju; Tahk, Seung-Jea; Yoon, Jung-Han; Choi, Si Wan; Hong, Taek-Jong; Kim, Hyo-Soo

2017-01-01

Purpose This study was designed to compare the efficacy and tolerability of the generic formulation (Atorva®) and the reference formulation (Lipitor®) of atorvastatin, both at a dosage of 20 mg once daily. Methods This study was a prospective open-label, randomized controlled study. Hypercholesterolemic patients who had not achieved low-density lipoprotein (LDL) cholesterol goals according to the National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) guideline were randomized to generic formulation or reference formulation of atorvastatin. The primary end point was the percent change of blood LDL cholesterol at 8 weeks from the baseline. The secondary end points included the percent changes of total cholesterol, high-density lipoprotein (HDL) cholesterol, triglyceride (TG), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) levels, the percent changes of ApoB/ApoA1 and total cholesterol/HDL cholesterol ratios, and the change in high-sensitivity C-reactive protein (hsCRP) levels. The LDL cholesterol goal achievement rate according to the NCEP-ATP III guideline was also evaluated. Results Three hundred and seventy-six patients were randomized, and 346 patients (176 in the generic group and 170 in the reference group) completed the study. After the 8 weeks of treatment, LDL cholesterol level was significantly decreased in both the groups, and the decrement was comparable between the two groups (−43.9%±15.3% in the generic group, −43.3%±17.0% in the reference group, P=0.705). The percent changes of total cholesterol, HDL cholesterol, TG, ApoB, ApoA1, ApoB/ApoA1 ratio, total cholesterol/HDL cholesterol ratio, and hsCRP showed insignificant difference between the two groups. However, LDL cholesterol goal achievement rate was significantly higher in the generic group compared to the reference group (90.6% vs 83.0%, P=0.039) in per-protocol analysis. Adverse event rate was comparable between the two groups (12.0% vs 13.7%, P=0

Levetiracetam for the treatment of alcohol withdrawal syndrome: a multicenter, prospective, randomized, placebo-controlled trial.

PubMed

Richter, Christoph; Hinzpeter, Axel; Schmidt, Folkhard; Kienast, Thorsten; Preuss, Ulrich W; Plenge, Thomas; Heinz, Andreas; Schaefer, Martin

2010-12-01

Treatment of alcohol withdrawal syndrome (AWS) with benzodiazepines is limited by risk of abuse, intoxication, respiratory problems, and liver toxicity. Alternatives such as carbamazepine and valproate may also have safety problems, such as hepatotoxicity or central nervous adverse effects. We therefore investigated the safety and efficacy of levetiracetam (LV), a newer antiepileptic with a potentially favorable adverse-effect profile, for the treatment of AWS. One hundred six patients were enrolled in a prospective, randomized, double-blind, multicenter, placebo-controlled trial. Levetiracetam was administered in a fixed dose schedule over 6 days. Diazepam was added when symptom triggered as rescue medication. Severity of the AWS was measured with the AWS and Clinical Institute Withdrawal Assessment Scale. Although tolerability and safety data were similar in the LV group when compared with placebo, the total daily and weekly dose of diazepam as rescue medication and the severity of alcohol withdrawal symptoms did not differ significantly between groups. Our data so far do not support an additional effect of LV on the reduction of alcohol withdrawal symptoms.

Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study.

PubMed

Goldstein, Rachel Y; Montero, Nicole; Jain, Sudheer K; Egol, Kenneth A; Tejwani, Nirmal C

2012-10-01

To compare postoperative pain control in patients treated surgically for ankle fractures who receive popliteal blocks with those who received general anesthesia alone. Institutional Review Board approved prospective randomized study. Metropolitan tertiary-care referral center. All patients being treated with open reduction internal fixation for ankle fractures who met inclusion criteria and consented to participate were enrolled. Patients were randomized to receive either general anesthesia (GETA) or intravenous sedation and popliteal block. Patients were assessed for duration of procedure, total time in the operating room, and postoperative pain at 2, 4, 8, 12, 24, and 48 hours after surgery using a visual analog scale. Fifty-one patients agreed to participate in the study. Twenty-five patients received popliteal block, while 26 patients received GETA. There were no anesthesia-related complications. At 2, 4, and 8 hours postoperatively, patients who underwent GETA demonstrated significantly higher pain. At 12 hours, there was no significant difference between the 2 groups with regard to pain control. However, by 24 hours, those who had received popliteal blocks had significantly higher pain with no difference by 48 hours. Popliteal block provides equivalent postoperative pain control to general anesthesia alone in patients undergoing operative fixation of ankle fractures. However, patients who receive popliteal blocks do experience a significant increase in pain between 12 and 24 hours. Recognition of this "rebound pain" with early narcotic administration may allow patients to have more effective postoperative pain control.

Optimal wrist angulation shortens time needed for radial artery catheterization: a prospective, randomized, and blinded study.

PubMed

Pandey, R; Ashraf, H; Bhalla, A P; Garg, R

2012-01-01

Optimal wrist position is essential for successful catheterization of the radial artery. We planned to study the success rate of radial artery catheterization at various degrees of wrist extension angulations. This prospective, randomized study was performed in 60 consenting patients aged between 18-65 years and undergoing variable surgeries where the anesthetic management required an arterial catheterization. All patients were randomized into three groups of 20 patients each, according to wrist angulation during radial artery catheterization : either 30 degrees (Group 30), 45 degrees (Group 45), or 60 degrees (Group 60). Three metallic angulated wrist boards with angles of 30 degrees, 45 degrees, and 60 degrees (angle measured with calipers) were prepared, on which patient's wrist was kept at the above-mentioned angles of extension. Radial artery catheterization success rate, catheterization time, and numbers of attempts were recorded. The catheterization time was minimal in group 45 (30.50 +/- 16.82 sec) as compared to 36.00 +/- 14.19 sec and 43.50 +/- 13.80 sec in group 30 and 60, respectively. Radial artery was catheterized at first attempt in 60% of Group 45 and Group 60 patients, and in 50% of Group 30 patients. The arterial catheterization was successful in 14/20 patients in Group 30, 19/20 patients in group 45, and 16/20 patients in group 60. We conclude that a wrist extension of 450 appears to be the optimal wrist joint extension for a successful radial artery cannula insertion.

Prospective, randomized, controlled comparison of SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops for the treatment of moderate dry eye.

PubMed

Jacobi, Christina; Kruse, Friedrich E; Cursiefen, Claus

2012-12-01

The aim of this prospective, randomized, clinical, single-center study was to compare the safety and efficacy of 2 ocular surface lubricant eye drops: preservative-free hydroxypropyl (HP)-Guar (SYSTANE UD(®)) eye drops versus preservative-free Tamarindus indica seed polysaccharide (TSP) 1% (VISINE INTENSIV 1% EDO(®)) eye drops. Fifty-six eyes of 28 patients with moderate keratoconjunctivitis sicca (DEWS severity level 2) were enrolled in the trial. Patients were randomized for 2 treatment groups (SYSTANE UD eye drops vs. VISINE INTENSIV 1% EDO eye drops). The eye drops in both groups were applied 5 times per day for 3 months. Statistical analyses were performed using Statistica™ software (Mann-Whitney U-test and Wilcoxon test). P-Values<0.05 were considered significant. After 3 months of treatment the patients of both groups had subjective benefit in the relief of symptoms of dry eye disease evaluated by the Ocular Surface Disease Index (OSDI) questionnaire score. Patients treated with HP-Guar and TSP showed improvements in tear film stability measured by tear break-up time (TBUT), which are statistically significant in the HP-Guar group (P=0.02). The results of this clinical trial show improvements of symptoms and signs in patients with moderate dry eye after the consistent use of preservative-free HP-Guar and TSP lubricant eye drops. Both artificial tear formulations produce amelioration in tear film stability improving eye conditions and patient quality of life. HP-Guar seems to be slightly more effective in improving ocular surface protection by decreasing tear film evaporation.

Autologous transplantation in CLL patients with B and C Binet stages: final results of the prospective randomized GOELAMS LLC 98 trial.

PubMed

Brion, A; Mahé, B; Kolb, B; Audhuy, B; Colombat, P; Maisonneuve, H; Foussard, C; Bureau, A; Ferrand, C; Lesesve, J F; Béné, M C; Feugier, P

2012-04-01

The relevance of high-dose chemotherapy followed by auto-SCT in CLL remains to be defined. The aim of the prospective, randomized, GOELAMS LLC 98 trial was to compare two strategies in previously untreated CLL patients aged <60 years. Conventional chemotherapy (Arm A) consisted of six monthly courses of CHOP followed by six CHOP courses in every 3 months in those achieving a complete or PR. Arm A was compared with high-dose therapy with auto-SCT (Arm B), used as consolidation after three CHOP courses in case of CR or very good PR. A total of 86 patients were enrolled, of which 39 and 43 patients were evaluable in arm A and arm B, respectively. The primary endpoint was PFS. On an intent-to-treat basis and with a median follow-up time of 77.1 (range 1-135.5) months, the median PFS was 22 months in Arm A and 53 months in Arm B (P<0.0001). Median survival time was 104.7 months in arm A and 107.4 months in arm B. This trial demonstrates that frontline high-dose therapy with auto-SCT prolongs PFS but does not translate into a survival advantage in advanced CLL patients in the pre-rituximab era.

Isotope-dilution assay for urinary methylmalonic acid in the diagnosis of vitamin B12 deficiency. A prospective clinical evaluation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Matchar, D.B.; Feussner, J.R.; Millington, D.S.

1987-05-01

Vitamin B12 deficiency is a frequently considered diagnosis for which there is no single, commonly available and accurate test. A urinary methylmalonic acid assay using gas chromatography-mass spectrometry has been proposed as the preferred test. We reviewed vitamin B12 assays on 1599 consecutive patients and prospectively studied all patients with low serum B12 levels (n = 75) and a random sample of patients with normal levels (n = 68). Of 96 evaluable patients, 7 had clinical deficiency. All 7 deficient patients had urinary methylmalonic acid levels greater than 5 micrograms/mg creatine (sensitivity, 100%; confidence interval, 65% to 100%). Of themore » 89 patients who were not clinically deficient, 88 had urinary methylmalonic acid levels less than or equal to 5 micrograms/mg creatinine (specificity, 99%). The overall test accuracy in this population was 99%. If the high sensitivity and specificity of the gas chromatography-mass spectrometry assay for urinary methylmalonic acid is supported by other clinical studies, the methylmalonic acid assay may become the reference standard for the diagnosis of vitamin B12 deficiency.« less

YAG laser peripheral iridotomy for the prevention of pigment dispersion glaucoma a prospective, randomized, controlled trial.

PubMed

Scott, Andrew; Kotecha, Aachal; Bunce, Catey; Balidis, Miltos; Garway-Heath, David F; Miller, Michael H; Wormald, Richard

2011-03-01

To test the hypothesis that neodymium:yttrium-aluminum-garnet (Nd:YAG) laser peripheral iridotomy (LPI) significantly reduces the incidence of conversion from pigment dispersion syndrome (PDS) with ocular hypertension (OHT) to pigmentary glaucoma (PG). Prospective, randomized, controlled 3-year trial. One hundred sixteen eyes of 116 patients with PDS and OHT. Patients were assigned randomly either to Nd:YAG LPI or to a control group (no laser). The primary outcome measure was conversion to PG within 3 years, based on full-threshold visual field (VF) analysis using the Ocular Hypertension Treatment Study criteria. Secondary outcome measures were whether eyes required topical antiglaucoma medications during the study period and the time to conversion or medication. Fifty-seven patients were randomized to undergo laser treatment and 59 were randomized to no laser (controls). Age, gender, spherical equivalent refraction, and intraocular pressure at baseline were similar between groups. Outcome data were available for 105 (90%) of recruited subjects, 52 in the laser treatment group and 53 in the no laser treatment group. Patients were followed up for a median of 35.9 months (range, 10-36 months) in the laser arm and 35.9 months (range, 1-36 months) in the control arm. Eight eyes (15%) in the laser group and 3 eyes (6%) in the control group converted to glaucoma in the study period. The proportion of eyes started on medical treatment was similar in the 2 groups: 8 eyes (15%) in the laser group and 9 eyes (17%) in the control group. Survival analyses showed no evidence of any difference in time to VF progression or commencement of topical therapy between the 2 groups. Cataract extraction was performed on 1 patient in the laser group and in 1 patient in the control group during the study period (laser eye at 18 months; control eye at 34 months). This study suggests that there was no benefit of Nd:YAG LPI in preventing progression from PDS with OHT to PG within 3 years of

Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

PubMed Central

2012-01-01

Background The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. Methods/Design Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. Discussion The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor

Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

PubMed

Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

2012-06-01

To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blind study.

PubMed

Roje, Zeljka; Racić, Goran; Dogas, Zoran; Pisac, Valdi Pesutić; Timms, Michael

2009-03-01

The aim of this prospective randomized single blind study was to determine the depth of thermal damage to tonsillar tissue due to coblation, and to compare it with thermal damage to tonsillar tissue following conventional tonsillectomy; to correlate the depth of thermal damage to tonsillar tissue with the parameters of postoperative morbidity, to compare intraoperative blood loss, postoperative pain severity, time to resuming normal physical activity, and incidence of postoperative bleeding between two groups of tonsillectomized children aged up to 16 years. 72 children aged 3-16 years scheduled for tonsillectomy randomly assigned into two groups submitted either to conventional tonsillectomy with bipolar diathermy coagulation or to coblation tonsillectomy, with a 14-day follow up. Statistically significant differences were observed in the depth of thermal damage to tonsillar tissue (p < 0.001), intraoperative blood loss (p < 0.004), in postoperative pain severity (p < 0.05) and in time to resuming normal physical activity between the two groups (p < 0.001). There was no case of reactionary or secondary bleeding in either group. In this paper for the first time we have correlated postoperative morbidity and thermal tissue damage: less thermal damage is associated with less postoperative morbidity.

Epilutein for Early-Stage Age-Related Macular Degeneration: A Randomized and Prospective Study.

PubMed

Forte, Raimondo; Panzella, Lucia; Cesarano, Ida; Cennamo, Gilda; Eidenberger, Thomas; Napolitano, Alessandra

2017-01-01

The hypothesis that oral supplementation of the epilutein/lutein combination could augment the macular pigment optical density (MPOD) in patients with age-related macular degeneration (AMD) was tested. In a prospective randomized interventional study, 40 consecutive patients with early-stage AMD were recruited. After a 2-week run-in period, patients were randomly treated with a daily oral administration of 8 mg epilutein and 2 mg lutein (group 1) or 10 mg lutein (group 2) for 2 months. At baseline (BL) and 1-month (M1) and 2-month visits (M2), all patients underwent a complete ophthalmological examination, including measurement of MPOD in a 7° area (Visucam 200; Carl Zeiss Meditec, Milan, Italy). Xanthophylls were quantified in plasma, as well as the HDL, non-HDL, and erythrocyte fractions at each study visit. Twenty-one patients (mean age 69.4 ± 6.7 years, 35 eyes) were included in group 1. Mean MPOD was 0.203 ± 0.02 optical density units (ODU) at BL, and increased to 0.214 ± 0.04 ODU at M1 (p = 0.008) and 0.206 ± 0.03 ODU at M2 (p = 0.04). Sixteen patients (mean age 72.0 ± 6.3 years, 29 eyes) were included in group 2. Mean MPOD was 0.215 ± 0.03 at BL, which reduced to 0.202 ± 0.03 ODU at M1 (p = 0.003) and 0.207 ± 0.02 ODU at M2 (p < 0.001). A rise in the systemic level of total xanthophylls was observed at M1 for both groups. At M2, total xanthophylls were significantly increased only in group 1 and decreased in group 2. In patients with early-stage AMD, the administration of lutein in combination with epilutein was associated with an increased MPOD compared to the administration of lutein alone. © 2017 S. Karger AG, Basel.

Intraoperative Sedation With Dexmedetomidine is Superior to Propofol for Elderly Patients Undergoing Hip Arthroplasty: A Prospective Randomized Controlled Study.

PubMed

Mei, Bin; Meng, Gaige; Xu, Guanghong; Cheng, Xinqi; Chen, Shishou; Zhang, Ye; Zhang, Ming; Liu, Xuesheng; Gu, Erwei

2018-03-09

Peripheral nerve block is a preferable method for elderly patients receiving hip arthroplasty. Sedation with dexmedetomidine may reduce postoperative delirium. The aim of this study was to investigate whether intraoperative sedation with dexmedetomidine, as a supplementary to peripheral nerve block for elderly patients receiving total hip arthroplasty, can decrease the prevalence of postoperative delirium. A prospective, randomized controlled study was conducted with patients 65 years of age or older who underwent total hip arthroplasty between June 2016 and June 2017. The patients were randomly assigned to receive a lumbosacral plexus plus T12 paravertebral block supplemented with propofol or dexmedetomidine for sedation. Incidence of postoperative delirium was the primary endpoint and was determined with the Confusion Assessment Method, and incidence of postoperative cognitive dysfunction was assessed with the Mini-Mental State Examination. The time of ambulation, discharge time, and complications over a 30-day post-surgery period were also recorded. 296 patients were randomly assigned to two groups. The patients sedated with dexmedetomidine had lower incidences of postoperative delirium and postoperative cognitive dysfunction and were out of bed and discharged sooner than the patients sedated with propofol. There was no difference in complications between the two groups. As a supplementary to peripheral nerve block, intraoperative sedation with dexmedetomidine could be associated with a lower incidence of POD, which may have benefits on reducing the incidence of early postoperative cognitive dysfunction and offering a better short-term recovery for elderly patients receiving hip arthroplasty.

A prospective randomized single blind trial of Fleet phosphate enema versus glycerin suppositories as preparation for flexible sigmoidoscopy.

PubMed

Underwood, D; Makar, R R; Gidwani, A L; Najfi, S M; Neilly, P; Gilliland, R

2010-03-01

This study compared the efficacy and patient acceptability of two methods of bowel preparation for flexible sigmoidoscopy. Patients attending for outpatient flexible sigmoidoscopy were prospectively randomized to receive one Fleet ready-to-use enema or 2 x 4 g glycerin suppositories, 2 h preprocedure. Patient and endoscopist questionnaires were used to compare the outcomes. From November 2000 to August 2001, 203 (male = 95; female = 108) patients were randomized. Patient data available for 163 patients (enema = 93; suppository = 70) revealed: ease of use (enema = 52; suppository = 25; P < 0.02, Fisher's exact); assistance required (enema = 19; suppository = 3; P < 0.005, Fisher's exact); grade of effectiveness (enema = 83; suppository = 44; P < 0.0001, Fisher's exact), and whether patients wished to try another preparation in future (enema = 16; suppository = 24; P = 0.016, Fisher's exact). Endoscopist data available for 151 patients (enema = 76; suppository = 75) revealed: average depth of insertion (enema = 53.6 +/- 11.6 cm; suppository 46.3 +/- 13.7 cm; P < 0.001, Student's t test); acceptable (excellent + good) quality of preparation [enema = 60 (78.9%); suppository = 34 (45.3%); P < 0.0001, Fisher's exact]. Bowel preparation for flexible sigmoidoscopy using a single Fleet enema is acceptable to patients and more effective than glycerin suppositories.

Hypoparathyroidism after total thyroidectomy: prospective evaluation and relation with early hypocalcemia.

PubMed

D'Alessandro, Nicola; Tramutola, Giuseppe; Fasano, Giovanni Michele; Gilio, Francesco; Iside, Giovanni; Izzo, Maria Lucia; Loffredo, Andrea; Pici, Mariano; Pinto, Margherita; Tramontano, Salvatore; Citro, Giuseppe

2016-01-01

Definitive hypoparathyrodism (hypo-PTH) represents one of the most dangerous complication after total thyroidectomy. Partial or total lesion or accidental removal of parathyroid glands is an unpredictable adverse event, although real incidence is not well defined, such as management of this deficit. We started a prospective evaluation of patients treated with total thyroidectomy in our centre, to identify incidence of hypo-PTH, symptomatic or not, in relation to incidence of early postoperative hypocalcemia in our experience. We prospectively evaluated 177 patients treated for benign and malign pathology, measuring calcium before surgery and calcium and PTH at least three months after surgery. Postoperative hypocalcemia was observed in 37.3% of cases. Eight patients (4.5% of cohort) presented low level of PTH, at mean follow-up of 9.1 months. Positive predictive value for postoperative hypocalcemia was 12.1%, while negative predictive was 95.4%; confirming high sensitivity (100%) and low specificity (65.4%) for detecting hypo-PTH. All patients with late hypo-PTH presented hypocalcemia on early analysis, while no case with normal postoperative calcemia accounted with hypo-PTH: this may indicate calcemia as valid prognostic factor of good gland production, when is in the range. Moreover, isolated analysis is too limited to determine real predictability. Technical standardization represents the best method for prevention of hypo-PTH. Early hypocalcemia is a prognostic factor, even with a low specificity, of deficit of PTH-production. This observation must be related to other known prognostic factors. Postoperative normal calcemia should be a positive prognostic factor of an acceptable PTHfunction, supported by large cohorts. Hypocalcemia, Parathormone, Thyroidectomy.

A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

PubMed

Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

2018-05-01

Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

MR imaging of silicone breast implants: evaluation of prospective and retrospective interpretations and interobserver agreement.

PubMed

Quinn, S F; Neubauer, N M; Sheley, R C; Demlow, T A; Szumowski, J

1996-01-01

MR imaging was used to evaluate the integrity of silicone breast implants in 54 women with 108 implants. MR images were interpreted by relatively inexperienced readers who tried to reproduce the experiences reported in the literature. The study examines the interobserver agreement using different diagnostic signs and the influence of experience on interpretation errors. Prospective and retrospective interpretations were compared with surgical findings at the time of explanation. Diagnostic indicators, including the linguine sign, the inverted tear drop sign, the C sign, water droplets mixed with silicone, and extracapsular globules of silicone, were evaluated for diagnostic efficacy and interobserver agreement. The prospective sensitivity and specificity were 87% and 78%, respectively. With the retrospective interpretations, the sensitivity and specificity increased to 93% and 92%, respectively. Most of the prospective false-positive interpretations were due to misinterpreting radial folds as signs of implant rupture. Six implants interpreted retrospectively as false positives had gross amounts of silicone around the implants at surgery but there were no obvious rents in the implant shells. There was fair to excellent interobserver agreement with the individual diagnostic signs except for extracapsular globules of silicone. All of the signs had specificities of greater than 90%. The sensitivities of the individual signs were less than the overall retrospective sensitivity. With experience, the sensitivity improved from 87% to 93% and the specificity improved from 78% to 92%. This study helps substantiate the use of diagnostic signs used by other authors to detect silicone loss from breast implants by MR imaging; however, questions remain as to the clinical role of MR imaging in evaluating implants for silicone loss.

Use of Play Therapy in Nursing Process: A Prospective Randomized Controlled Study.

PubMed

Sezici, Emel; Ocakci, Ayse Ferda; Kadioglu, Hasibe

2017-03-01

Play therapy is a nursing intervention employed in multidisciplinary approaches to develop the social, emotional, and behavioral skills of children. In this study, we aim to determine the effects of play therapy on the social, emotional, and behavioral skills of pre-school children through the nursing process. A single-blind, prospective, randomized controlled study was undertaken. The design, conduct, and reporting of this study adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The participants included 4- to 5-year-old kindergarten children with no oral or aural disabilities and parents who agreed to participate in the study. The Pre-school Child and Family Identification Form and Social Competence and the Behavior Evaluation Scale were used to gather data. Games in the play therapy literature about nursing diagnoses (fear, social disturbance, impaired social interactions, ineffective coping, anxiety), which were determined after the preliminary test, constituted the application of the study. There was no difference in the average scores of the children in the experimental and control groups in their Anger-Aggression (AA), Social Competence (SC), and Anxiety-Withdrawal (AW) scores beforehand (t = 0.015, p = .988; t = 0.084, p = .933; t = 0.214, p = .831, respectively). The difference between the average AA and SC scores in the post-test (t = 2.041, p = .045; t = 2.692, p = .009, respectively), and the retests were statistically significant in AA and SC average scores in the experimental and control groups (t = 4.538, p = .000; t = 4.693; p = .000, respectively). In AW average scores, no statistical difference was found in the post-test (t = 0.700, p = .486), whereas in the retest, a significant difference was identified (t = 5.839, p = .000). Play therapy helped pre-school children to improve their social, emotional, and behavioral skills. It also provided benefits for the children to decrease their fear and anxiety levels, to improve

Comparison of EUS-guided tissue acquisition using two different 19-gauge core biopsy needles: a multicenter, prospective, randomized, and blinded study

PubMed Central

DeWitt, John; Cho, Chang-Min; Lin, Jingmei; Al-Haddad, Mohammad; Canto, Marcia Irene; Salamone, Ashley; Hruban, Ralph H.; Messallam, Ahmed A.; Khashab, Mouen A.

2015-01-01

Background and study aims: The optimal core biopsy needle for endoscopic ultrasound (EUS) is unknown. The principle aim of this study is to compare outcomes of EUS-fine-needle biopsy (EUS-FNB) with a new 19-gauge EUS histology needle (ProCore, Cook Medical Inc., Winston-Salem, North Carolina, United States) to a conventional 19-gauge Tru-Cut biopsy (EUS-TCB) needle (19G, Quick-Core, Cook Medical Inc.). Patients and methods: Patients referred for EUS who require possible histologic biopsy were prospectively randomized to EUS-FNB or EUS-TCB. With the initial needle, ≤ 3 biopsies were obtained until either technical failure or an adequate core was obtained. Patients with suspected inadequate biopsies were crossed over to the other needle and similarly ≤ 3 passes were obtained until adequate cores or technical failure occurred. Technical success, diagnostic histology, accuracy and complication rates were evaluated. Results: Eighty-five patients (mean 58 years; 43 male) were randomized to FNB (n = 44) and TCB (n = 41) with seven patients excluded. Procedure indication, biopsy site, mass size, number of passes, puncture site, overall technical success and adverse events were similar between the two groups. FNB specimens had a higher prevalence of diagnostic histology (85 % vs. 57 %; P = 0.006), accuracy (88 % vs. 62 %; P = 0.02), mean total length (19.4 vs. 4.3 mm; P = 0.001), mean complete portal triads from liver biopsies (10.4 vs. 1.3; P = 0.0004) and required fewer crossover biopsies compared to those of TCB (2 % vs. 65 %; P = 0.0001). Overall technical success and complication rates were comparable. Conclusion: EUS-FNB using a 19-gauge FNB needle is superior to 19-gauge EUS-TCB needle. PMID:26528504

Fludarabine and cytarabine versus high-dose cytarabine in consolidation treatment of t(8; 21) acute myeloid leukemia: A prospective, randomized study.

PubMed

Li, Ruiqi; Hu, Xiaoxia; Wang, Libing; Cheng, Hui; Lv, Shuqing; Zhang, Weiping; Wang, Jianmin; Yang, Jianmin; Song, Xianmin

2017-01-01

Acute myeloid leukemia (AML) patients with t(8;21) aberration often have favorable outcomes, however, relapse still occurs in 30-40% patients, with only 50-60% of patients with t(8;21) AML cured with regimens containing high-dose cytarabine (HD-Ara-C). To evaluate the effects of fludarabine and cytarabine (FA) consolidation therapy for t(8;21) AML patients, a prospective randomized study was performed. A total of 45 patients with t(8;21) AML after achieving complete remission (CR) were randomly assigned to receive four course consolidation with FA (n = 23) or HD-Ara-C (n = 22). Our study showed that at 36-months, relapse-free survival (RFS) was 81.73% in the FA arm and 50.73% in the HD-Ara-C arm (P = 0.04), overall survival (OS) was 91.1% and 48.4% (P = 0.01) in the FA arm and in the HD-Ara-C arm respectively; whereas cumulative incidence of relapse (CIR) was 18.27% and 47.39%, in the FA arm and in the HD-Ara-C arm respectively (P = 0.05). In our study, treatment with FA, MRD2 status (reduction ≥ 3-log) and absence of c-kit mutations were identified as independent prognostic factors for lower risk of relapse, improved RFS and OS. We also found RFS for patients without c-kit mutations was 100% in FA arm, and 57.8% in HD-Ara-C arm at 36 months (P = 0.005); OS of both groups at 36 months was 100% and 51.4%, respectively (P = 0.004), suggesting a benefit of consolidation therapy with FA for t(8;21) AML patients, especially, those without c-kit mutations (Clinicaltrials.org ID NCT# 02024308). Am. J. Hematol. 92:12-17, 2017. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Limited shock wave therapy vs sham treatment in men with Peyronie's disease: results of a prospective randomized controlled double-blind trial.

PubMed

Chitale, Sudhanshu; Morsey, Mohammed; Swift, Louise; Sethia, Krishna

2010-11-01

To assess the role of extracorporeal shock wave therapy (SWT), in a prospective randomized controlled trial, comparing limited SWT vs sham therapy in men with Peyronie's disease. In all, 36 men were randomized to six sessions of SWT or sham treatment. Geometrical measurements of penile length and deformity, and the abridged International Index of Erectile Function (IIEF) score and visual analogue score (VAS) were recorded and re-evaluated at 6 months. The patient and assessor were unaware of the treatment type. Standard nonparametric tests were used for the statistical analysis. A full set of outcome data was obtained for 16 patients in the intervention group and 20 in the sham/control group (mean age 58 and 60 years, respectively, mean duration of symptoms 15 and 33 months). There was no significant difference in the mean change between the control and intervention groups on any outcome measure. There were improvements in the mean (sd) dorsal and lateral angle, of 5.3 (11.66)° and 3.5 (17.38)° in the control group, and a deterioration of 0.9 (16.01)° and 0.9 (15.56)° in SWT group. Mean improvements in curved and straight lengths were 0.2 (0.58) and 0.1 (0.8) cm in the control and mean reductions of 0.1 (0.9) and 0.1 (1.49) cm in the SWT group. The mean changes in the IIEF and VAS scores were 0.1 (3.32) and -0.8 (1.77) for control and 0.56 (2.6) and -1.05 (1.79) for SWT group. There were no significant differences in changes of variables in Peyronie's disease treated with short-term SWT. © 2010 THE AUTHORS. JOURNAL COMPILATION © 2010 BJU INTERNATIONAL.

Virtue male sling for post-prostatectomy stress incontinence: a prospective evaluation and mid-term outcomes.

PubMed

Ferro, Matteo; Bottero, Danilo; D'Elia, Carolina; Matei, Deliu Victor; Cioffi, Antonio; Cozzi, Gabriele; Serino, Alessandro; Cordima, Giovanni; Bianchi, Roberto; Incarbone, Piero Giacomo; Brescia, Antonio; Musi, Gennaro; Fusco, Ferdinando; Detti, Serena; Mirone, Vincenzo; de Cobelli, Ottavio

2017-03-01

To evaluate the efficacy and safety of the Virtue ® male sling (Coloplast, Humlebaek, Denmark) in a cohort of patients affected by post-prostatectomy stress urinary incontinence (SUI). All 29 consecutive patients treated with a Virtue male sling at our Institution between July 2012 and October 2013 were included in the present prospective, non-randomized study. Patients were evaluated preoperatively and at 1, 3, 6, 12, 24 and 36 months after surgery using a 24-h pad weight test, the International Consultation on Incontinence short-form questionnaire (ICIQ-SF), Urinary Symptom Profile (USP) questionnaire, a bladder diary, uroflowmetry and the Patient Global Impression of Improvement (PGI-I) and Patient Global Impression of Severity questionnaires. The mean patient age was 65.5 years. A total of 72.4% of patients had preoperative mild incontinence (1-2 pads/day), while nine patients used 3-5 pads/day. There were a total of 17 complications, which occurred in 29 patients (58.6%); all were Clavien-Dindo grade I. At 12-month follow-up patients showed a significant improvement in 24-h pad test (128.6 vs 2.5 g), number of pads per day (2 vs 0), ICIQ-SF score (14.3 vs 0.9) and USP score for SUI (4 vs 0), and outcomes remained stable at 36 months. At last follow-up, the median score on the PGI-I questionnaire was 1 (very much better). The Virtue male sling is an effective treatment option for low to moderate post-prostatectomy incontinence. © 2016 The Authors BJU International © 2016 BJU International Published by John Wiley & Sons Ltd.

Isoflavones, calcium, vitamin D and inulin improve quality of life, sexual function, body composition and metabolic parameters in menopausal women: result from a prospective, randomized, placebo-controlled, parallel-group study.

PubMed

Vitale, Salvatore Giovanni; Caruso, Salvatore; Rapisarda, Agnese Maria Chiara; Cianci, Stefano; Cianci, Antonio

2018-03-01

Menopause results in metabolic changes that contribute to increase risk of cardiovascular diseases: increase in low density lipoprotein (LDL) and triglycerides and decrease in high density lipoprotein (HDL), weight gain are associated with a correspondent increase in incidence of hypertension and diabetes. The aim of this study was to evaluate the effect of a preparation of isoflavones, calcium vitamin D and inulin in menopausal women. We performed a prospective, randomized, placebo-controlled, parallel-group study. A total of 50 patients were randomized to receive either oral preparations of isoflavones (40 mg), calcium (500 mg) vitamin D (300 UI) and inulin (3 g) or placebo (control group). Pre- and post-treatment assessment of quality of life and sexual function were performed through Menopause-Specific Quality of Life Questionnaire (MENQOL) and Female Sexual Function Index (FSFI); evaluations of anthropometric indicators, body composition through bioelectrical impedance analyser, lumbar spine and proximal femur T-score and lipid profile were performed. After 12 months, a significant reduction in MENQOL vasomotor, physical and sexual domain scores ( p < 0.05) and a significant increase in all FSFI domain scores ( p < 0.05) were observed in treatment group. Laboratory tests showed significant increase in serum levels of HDL ( p < 0.05). No significant changes of lumbar spine and femur neck T-score ( p > 0.05) were found in the same group. According to our data analysis, isoflavones, calcium, vitamin D and inulin may exert favourable effects on menopausal symptoms and signs.

Between-individual comparisons in performance evaluation: a perspective from prospect theory.

PubMed

Wong, Kin Fai Ellick; Kwong, Jessica Y Y

2005-03-01

This article examines how between-individual comparisons influence performance evaluations in rating tasks. The authors demonstrated a systematic change in the perceived difference across ratees as a result of changing the way performance information is expressed. Study 1 found that perceived performance difference between 2 individuals was greater when their objective performance levels were presented with small numbers (e.g., absence rates of 2% vs. 5%) than when they were presented with large numbers (e.g., attendance rates of 98% vs. 95%). Extending this finding to situations involving trade-offs between multiple performance attributes across ratees, Study 2 showed that the relative preference for 1 ratee over another actually reversed when the presentation format of the performance information changed. The authors draw upon prospect theory to offer a theoretical framework describing the between-individual comparison aspect of performance evaluation.

Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage: a prospective, randomized, controlled trial (LUMAS).

PubMed

Al-Tamimi, Yahia Z; Bhargava, Deepti; Feltbower, Richard G; Hall, Gregory; Goddard, Anthony J P; Quinn, Audrey C; Ross, Stuart A

2012-03-01

A single-center prospective randomized controlled trial has been conducted to determine if lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage reduces the prevalence of delayed ischemic neurological deficit and improves clinical outcome. Patients with World Federation of Neurological Surgeons Grade 1 to 3 aneurysmal subarachnoid hemorrhage and modified Fisher Grades 2, 3, 4, and 3+4 were randomized to either the study group of standard therapy plus insertion of a lumbar drain or the control group of standard therapy alone. The primary outcome measure was the prevalence of delayed ischemic neurological deficit. Two hundred ten patients with aneurysmal subarachnoid hemorrhage (166 female, 44 male; median age, 54 years; interquartile range, 45-62 years) were recruited into the control (n=105) and study (n=105) groups of the trial. World Federation of Neurological Surgeons grade was: 1 (n=139), 2 (n=60), and 3 (n=11); Fisher grade was: 2 (n=87), 3 (n=85), and 4 (n=38). The prevalence of delayed ischemic neurological deficit was 35.2% and 21.0% in the control and study groups, respectively (P=0.021). The prevalence of a modified Rankin Scale score of 4, 5, or 6 at Day 10 and 6 months, respectively, was 62.5% and 18.6% in the control group and 44.8% and 19.8% in the study group (P=0.009 and 0.83, respectively). Lumbar drainage of cerebrospinal fluid after aneurysmal subarachnoid hemorrhage has been shown to reduce the prevalence of delayed ischemic neurological deficit and improve early clinical outcome but failed to improve outcome at 6 months after aneurysmal subarachnoid hemorrhage. URL: www.clinicaltrials.gov. Unique identifier: NCT00842049.

Questionnaire-based evaluation of sexual life after laparoscopic surgery for endometriosis: a systematic review of prospective studies.

PubMed

Franck, Cecilie; Poulsen, Marlene H; Karampas, Grigorios; Giraldi, Annamaria; Rudnicki, Martin

2018-05-12

Endometriosis is a benign disease that affects women of reproductive age. Laparoscopic excision of endometriotic implants is considered one of the most effective therapeutic options. The disease and its treatment can have a major impact on psychosexual well-being but this is often overlooked as most studies focus on pain instead of sexuality in a holistic approach. The aim of this study was to review the current literature regarding the effect of laparoscopic surgery for endometriosis on quality of sexual life (QoSL). Following the "Preferred Reporting Items for Systematic Reviews and Meta-Analyses" guidelines we conducted a systematic review that involved searching PubMed and Embase databases for prospective studies evaluating the effect of laparoscopic surgery for endometriosis on QoSL, using validated questionnaires. Of 357 papers, 17 were selected for full text evaluation. Twelve studies using seven different questionnaires fulfilled the inclusion criteria. All studies reported improvements in QoSL following laparoscopic surgery for endometriosis. A meta-analysis could not be performed due to substantial heterogeneity among the included studies arising from differences in questionnaires, follow-up duration, stages of endometriosis, use of hormonal treatment, and missing data. Laparoscopic excision of endometriosis can improve QoSL. However, there is a need for randomized controlled trials based on a new validated questionnaire regarding specifically QoSL in association with endometriosis. As sexual functioning is a complex phenomenon driven by multiple physical, psychological and social factors, QoSL should be holistically evaluated by a team of different healthcare providers, implementing treatment programs that are individualized to each woman. © 2018 Nordic Federation of Societies of Obstetrics and Gynecology.

Relapse of Graves' disease after successful outcome of antithyroid drug therapy: results of a prospective randomized study on the use of levothyroxine.

PubMed

Hoermann, Rudolf; Quadbeck, Beate; Roggenbuck, Ulla; Szabolcs, István; Pfeilschifter, Johannes; Meng, Wieland; Reschke, Kirsten; Hackenberg, Klaus; Dettmann, Juergen; Prehn, Brigitte; Hirche, Herbert; Mann, Klaus

2002-12-01

Antithyroid drugs are effective in restoring euthyroidism in Graves' disease, but many patients experience relapse after withdrawal. Prevention of recurrence would therefore be a desirable goal. In a prospective study, patients with successful outcome of 12 to 15 months antithyroid drug therapy were stratified for risk factors and randomly assigned to receive levothyroxine in a variable thyrotropin (TSH)-suppressive dose for 2 years or no treatment. The levothyroxine group was randomized to continue or discontinue levothyroxine after 1 year. End points included relapse of overt hyperthyroidism. Of 346 patients with Graves' disease enrolled 225 were euthyroid 4 weeks after antithyroid drug withdrawal and were randomly assigned to receive levothyroxine (114 patients) or no treatment (controls, 111 patients). Of those not randomized, 39 patients showed early relapse within 4 weeks, 61 endogenous TSH suppression, 7 TSH elevation, and 14 had to be excluded. Dropout rate during the study were 13.3%. Kaplan-Meier analyses showed relapse rates to be similar in the levothyroxine group (20% after 1 year, 32% after 2 years) and the randomized controls (18%, 24%), whereas relapses were significantly more frequent in the follow-up group of patients with endogenously suppressed TSH (33%, 49%). Levothyroxine therapy did not influence TSH-receptor antibody, nor did it reduce goiter size. The best prognostic marker available was basal TSH determined 4 weeks after withdrawal of antithyroid drugs (posttreatment TSH). The study demonstrates that levothyroxine does not prevent relapse of hyperthyroidism after successful restoration of euthyroid function by antithyroid drugs and characterizes posttreatment TSH as a main prognostic marker.

Randomized trial of harp therapy during in vitro fertilization-embryo transfer.

PubMed

Murphy, Erin M; Nichols, Jennifer; Somkuti, Steve G; Sobel, Michael; Braverman, Andrea; Barmat, Larry I

2014-04-01

This study evaluated whether harp therapy reduces levels of stress and improves clinical outcomes in patients undergoing embryo transfer. This prospective randomized trial enrolled 181 women undergoing embryo transfer, who were randomized to harp therapy during embryo transfer or standard treatment. Patients underwent standardized psychological testing and physiologic assessment of stress. The study was conducted in a reproductive medicine practice. No statistically significant differences were found in the heart and respiratory rates, nor was there a significant difference in event-based anxiety at baseline. Harp therapy had a significantly larger decrease in state anxiety from pre- to post-embryo transfer. Clinical pregnancy was 53% versus 48% for the harp therapy and standard treatment groups, respectively. Harp therapy decreases state, or event-based, anxiety, significantly lowering state scores posttransfer and having a positive effect on acute levels of stress. There was an increased pregnancy rate, but larger sample sizes are needed to evaluate whether harp therapy has an effect on clinical outcomes.

78 FR 34664 - Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-06-10

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-up Exclusive Evaluation License: Portable Device and Method for Detecting Hematomas AGENCY: National... device and method for detecting hematomas based on near infrared light emitted perpendicularly into a...

A Walnut-Enriched Diet Reduces Lipids in Healthy Caucasian Subjects, Independent of Recommended Macronutrient Replacement and Time Point of Consumption: a Prospective, Randomized, Controlled Trial.

PubMed

Bamberger, Charlotte; Rossmeier, Andreas; Lechner, Katharina; Wu, Liya; Waldmann, Elisa; Stark, Renée G; Altenhofer, Julia; Henze, Kerstin; Parhofer, Klaus G

2017-10-06

Studies indicate a positive association between walnut intake and improvements in plasma lipids. We evaluated the effect of an isocaloric replacement of macronutrients with walnuts and the time point of consumption on plasma lipids. We included 194 healthy subjects (134 females, age 63 ± 7 years, BMI 25.1 ± 4.0 kg/m²) in a randomized, controlled, prospective, cross-over study. Following a nut-free run-in period, subjects were randomized to two diet phases (8 weeks each). Ninety-six subjects first followed a walnut-enriched diet (43 g walnuts/day) and then switched to a nut-free diet. Ninety-eight subjects followed the diets in reverse order. Subjects were also randomized to either reduce carbohydrates ( n = 62), fat ( n = 65), or both ( n = 67) during the walnut diet, and instructed to consume walnuts either as a meal or as a snack. The walnut diet resulted in a significant reduction in fasting cholesterol (walnut vs. -8.5 ± 37.2 vs. -1.1 ± 35.4 mg/dL; p = 0.002), non-HDL cholesterol (-10.3 ± 35.5 vs. -1.4 ± 33.1 mg/dL; p ≤ 0.001), LDL-cholesterol (-7.4 ± 32.4 vs. -1.7 ± 29.7 mg/dL; p = 0.029), triglycerides (-5.0 ± 47.5 vs. 3.7 ± 48.5 mg/dL; p = 0.015) and apoB (-6.7 ± 22.4 vs. -0.5 ± 37.7; p ≤ 0.001), while HDL-cholesterol and lipoprotein (a) did not change significantly. Neither macronutrient replacement nor time point of consumption significantly affected the effect of walnuts on lipids. Thus, 43 g walnuts/d improved the lipid profile independent of the recommended macronutrient replacement and the time point of consumption.

Epidemiology of RBC Transfusions in Patients With Severe Acute Kidney Injury: Analysis From the Randomized Evaluation of Normal Versus Augmented Level Study.

PubMed

Bellomo, Rinaldo; Mårtensson, Johan; Kaukonen, Kirsi-Maija; Lo, Serigne; Gallagher, Martin; Cass, Alan; Myburgh, John; Finfer, Simon

2016-05-01

To assess the epidemiology and outcomes associated with RBC transfusion in patients with severe acute kidney injury requiring continuous renal replacement therapy. Post hoc analysis of data from a multicenter, randomized, controlled trial. Thirty-five ICUs in Australia and New Zealand. Cohort of 1,465 patients enrolled in the Randomized Evaluation of Normal versus Augmented Level replacement therapy study. Daily information on morning hemoglobin level and amount of RBC transfused were prospectively collected in the Randomized Evaluation of Normal versus Augmented Level study. We analyzed the epidemiology of such transfusions and their association with clinical outcomes. Overall, 977 patients(66.7%) received a total of 1,192 RBC units. By day 5, 785 of 977 transfused patients (80.4%) had received at least one RBC transfusion. Hemoglobin at randomization was lower in transfused than in nontransfused patients (94 vs 111 g/L; p < 0.001). Mean daily hemoglobin was 88 ± 7 and 99 ± 12 g/L in transfused and nontransfused patients. Among transfused patients, 228 (46.7%) had died by day 90 when compared with 426 (43.6%) of nontransfused patients (p = 0.27). Survivors received on average 316 ± 261 mL of RBC, whereas nonsurvivors received 302 ± 362 mL (p = 0.42). On multivariate Cox regression analysis, RBC transfusion was independently associated with lower 90-day mortality (hazard ratio, 0.55; 95% CI, 0.38-0.79). However, we found no independent association between RBC transfusions and mortality when the analyses were restricted to patients surviving at least 5 days (hazard ratio, 1.29; 95% CI, 0.90-1.85). We found no independent association between RBC transfusion and renal replacement therapy-free days, mechanical ventilator-free days, or length of stay in ICU or hospital. In patients with severe acute kidney injury treated with continuous renal replacement therapy, we found no association of RBC transfusion with 90-day mortality or other

Short-term effects of highly-bioavailable curcumin for treating knee osteoarthritis: a randomized, double-blind, placebo-controlled prospective study.

PubMed

Nakagawa, Yasuaki; Mukai, Shogo; Yamada, Shigeru; Matsuoka, Masayuki; Tarumi, Eri; Hashimoto, Tadashi; Tamura, Chieko; Imaizumi, Atsushi; Nishihira, Jun; Nakamura, Takashi

2014-11-01

We previously developed a surface-controlled water-dispersible form of curcumin and named it Theracurmin(®) (Theracurmin; Theravalues, Tokyo, Japan). The area under the blood concentration-time curve of Theracurmin in humans was 27-fold higher than that of curcumin powder. We determined the clinical effects of orally administered Theracurmin in patients with knee osteoarthritis during 8 weeks of treatment. Fifty patients with knee osteoarthritis of Kellgren-Lawrence grade II or III and who were aged more than 40 years were enrolled in this randomized, double-blind, placebo-controlled, prospective clinical study. Placebo or Theracurmin containing 180 mg/day of curcumin was administered orally every day for 8 weeks. To monitor adverse events, blood biochemistry analyses were performed before and after 8 weeks of each intervention. The patients' knee symptoms were evaluated at 0, 2, 4, 6, and 8 weeks by the Japanese Knee Osteoarthritis Measure, the knee pain visual analog scale (VAS), the knee scoring system of the Japanese Orthopedic Association, and the need for nonsteroidal anti-inflammatory drugs. At 8 weeks after treatment initiation, knee pain VAS scores were significantly lower in the Theracurmin group than in the placebo group, except in the patients with initial VAS scores of 0.15 or less. Theracurmin lowered the celecoxib dependence significantly more than placebo. No major side effects were observed with Theracurmin treatment. Theracurmin shows modest potential for the treatment of human knee osteoarthritis.

Parecoxib Possesses Anxiolytic Properties in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Clinical Study.

PubMed

Sarridou, Despoina G; Chalmouki, Georgia; Braoudaki, Maria; Siafaka, Ioanna; Asmatzi, Chrisi; Vadalouka, Athina

2016-06-01

Intravenous administration of parecoxib could provide significant pain relief in surgical operations that require additional forms of analgesia. However, very little is known about its effects on the anxiety levels of patients before a surgical procedure. The aim of this prospective study was to investigate whether intravenous parecoxib, pre-emptively administered, has an effect on anxiety levels experienced post-surgically after total knee arthroplasty (TKA) and if it influences the reported pain of the procedure itself. A total of 90 patients who underwent TKA under spinal anesthesia were included in the study. Prior to TKA, all patients received continuous femoral nerve block (CFNB) and were randomized into two groups: Group D consisted of 45 patients who received the drug parecoxib intravenously in addition to CFNB, whereas Group P consisted of 45 patients who received a placebo drug (N/S 0.9 %) intravenously instead of parecoxib. All patients were asked to fill in the questionnaires STAI1 and STAI2 in order to evaluate anxiety levels pre- and post-surgically, respectively. One of the main aims was to distinguish personality-trait anxiety from state anxiety, i.e., anxiety experience due to the actual perioperative events and the actual pain endured. The group receiving parecoxib had statistically significant lower anxiety levels both for personality trait anxiety and state anxiety, as compared to the placebo group. Based on our findings, parecoxib had both analgesic and anxiolytic effects in patients undergoing TKA with CFNB. Current Controlled Trials: NCT02185924.

TVT versus TOT, 2-year prospective randomized study.

PubMed

Wadie, Bassem S; El-Hefnawy, Ahmed S; Elhefnawy, Ahmed S

2013-06-01

To evaluate in a comprehensive way TVT in comparison with TOT, the results of a single-center RCT are presented. Many studies addressed efficacy and safety of TVT and TOT. Women included were adults having predominant SUI with positive stress test. They were randomized to get either TVT (Gynecare(®)) or TOT (Aris(®)). All women were seen 1 week, 3, 6, 12, 18, and 24 months. Seventy-one women completed 2-year follow-up. Median age was 47 (range 33-60 years). Mean ± SD BMI in TVT group was 34 ± 5 while in TOT group was 32 ± 5 kg/m(2). POP of any degree was seen in 50 % (35 women). At 1 year, pad test-negative women were 31 and 29 for TVT and TOT, respectively. At 2 years, figures became 28 in TVT group and 27 in TOT. At 1 year, UDI 6 and IIQ 7 decreased by 78.5 and 81 % for TVT and by 69 % and 75 % for TOT group. At 2 year, comparable percentages were 73 and 79 % for TVT and 69 and 82 % for TOT. Fifteen unique patients had adverse events, 10 of them had TOT. Both tapes have similar efficacy, regarding cure of incontinence. TVT is more effective, albeit insignificantly, than TOT at 2 years. However, serious adverse events were more frequent with TVT, yet TOT has more unique adverse events.

A Randomized Clinical Trial Evaluating rh-FGF-2/β-TCP in Periodontal Defects.

PubMed

Cochran, D L; Oh, T-J; Mills, M P; Clem, D S; McClain, P K; Schallhorn, R A; McGuire, M K; Scheyer, E T; Giannobile, W V; Reddy, M S; Abou-Arraj, R V; Vassilopoulos, P J; Genco, R J; Geurs, N C; Takemura, A

2016-05-01

Biological mediators have been used to enhance periodontal regeneration. The aim of this prospective randomized controlled study was to evaluate the safety and effectiveness of 3 doses of fibroblast growth factor 2 (FGF-2) when combined with a β-tricalcium phosphate (β-TCP) scaffold carrier placed in vertical infrabony periodontal defects in adult patients. In this double-blinded, dose-verification, externally monitored clinical study, 88 patients who required surgical intervention to treat a qualifying infrabony periodontal defect were randomized to 1 of 4 treatment groups-β-TCP alone (control) and 0.1% recombinant human FGF-2 (rh-FGF-2), 0.3% rh-FGF-2, and 0.4% rh-FGF-2 with β-TCP-following scaling and root planing of the tooth prior to a surgical appointment. Flap surgery was performed with EDTA conditioning of the root prior to device implantation. There were no statistically significant differences in patient demographics and baseline characteristics among the 4 treatment groups. When a composite outcome of gain in clinical attachment of 1.5 mm was used with a linear bone growth of 2.5 mm, a dose response pattern detected a plateau in the 0.3% and 0.4% rh-FGF-2/β-TCP groups with significant improvements over control and 0.1% rh-FGF-2/β-TCP groups. The success rate at 6 mo was 71% in the 2 higher-concentration groups, as compared with 45% in the control and lowest treatment groups. Percentage bone fill in the 2 higher-concentration groups was 75% and 71%, compared with 63% and 61% in the control and lowest treatment group. No increases in specific antibody to rh-FGF-2 were detected, and no serious adverse events related to the products were reported. The results from this multicenter trial demonstrated that the treatment of infrabony vertical periodontal defects can be enhanced with the addition of rh-FGF-2/β-TCP (ClinicalTrials.gov NCT01728844). © International & American Associations for Dental Research 2016.

Radiosurgery with the world's first fully robotized Leksell Gamma Knife PerfeXion in clinical use: a 200-patient prospective, randomized, controlled comparison with the Gamma Knife 4C.

PubMed

Régis, Jean; Tamura, Manabu; Guillot, Cécile; Yomo, Shoji; Muraciolle, Xavier; Nagaje, Mariko; Arka, Yasser; Porcheron, Denis

2009-02-01

The world's first Leksell Gamma Knife PerfeXion (Elekta Instrument AB, Stockholm, Sweden) for radiosurgery of the head and neck became operational at Timone University Hospital in Marseille on July 10, 2006. To allow strict evaluation of the capabilities, advantages, disadvantages, and limitations of this new technology, patients were enrolled in a prospective, randomized trial. In 66 working days, between July 10 and December 20, 2006, 363 patients were treated by gamma knife surgery at Timone University Hospital, Marseille. Of these patients, 200 were eligible for the comparative prospective study (inclusion criteria were informed consent obtained, tumor or vascular indication, and no previous radiosurgery or radiotherapy). In accordance with the blinded randomization process, 100 patients were treated with the Leksell Gamma Knife 4C (Elekta Instrument AB) and Gamma Knife 100 (Elekta Instrument AB) with the Leksell Gamma Knife PerfeXion. Dose planning parameters, dosimetry measurements on the patient's body, workflow, patient comfort, quality assurance procedure, and a series of other treatment-related parameters were systematically and prospectively evaluated in both arms of the trial. No technical failure of the treatment procedure was encountered. The new dose-planning system led to the use of composite shots in 39.4% of the patients. The median number of different collimator sizes used was larger with the PerfeXion than with the 4C (2 and 1, respectively). The mean number of isocenters used was lower (10.67 and 13.08, respectively). The median total treatment time was significantly shorter with the PerfeXion (40 and 60 minutes, respectively), but there was no significant difference in the median radiation time (34.02 and 33.40 minutes, respectively). The procedure was performed using only a single run in 98.99% of the PerfeXion cases and in 42% of the 4C cases. Collision risk on the 4C forced us to change the frame gamma angle for at least 1 shot in 24% of

A new challenge in clinical research in childhood ALL: the prospective meta-analysis strategy for intergroup collaboration.

PubMed

Valsecchi, M G; Masera, G

1996-12-01

We consider the problems arising in clinical research on childhood acute lymphoblastic leukemia (ALL). Given the therapeutic progress achieved over the last few decades, any improvement in the outcome for the majority of children with ALL is difficult to assess with the usual size trials. Furthermore, the progress in genetics and molecular biology has now led to the identification of subgroups of children, typically with rare characteristics, for whom new treatments still await evaluation. For both these aspects of clinical research, there is an increasing need for international intergroup cooperation. After a discussion on the role of retrospective meta-analysis and randomized controlled trials in ALL research, we suggest that intergroup studies could be made more feasible, but still scientifically rigorous, by adopting a strategy of prospective meta-analysis. This strategy can be described as follows: i) different groups prospectively plan to ask the same randomized question within their protocols which may differ in other aspects, and to pool their data in order to evaluate treatment effect; ii) the management of the study can be de-centralized, by allowing each group to be responsible for conducting its own protocol. We would like to stimulate the debate on the methodological and practical aspects of research perspectives in ALL (and in pediatric oncology).

The efficacy of nasal tip hold-press on venous cannulation pain in children: a prospective randomize controlled study.

PubMed

Maghsoudi, Behzad; Jookar, Mehrdad; Haddad, Hosein; Zoonobi, Zahra; Rakhshan, Mahnaz

2016-12-22

Venipuncture is a common and quiet unpleasant experience for pediatric patients. The pain associated with venous cannulation disturbs the children. Different methods have been used to minimize the pain. The present study evaluated the efficacy of holding and pressing the tip of the nose on the venipuncture pain in pediatric patients. A prospective randomize controlled study carried out using the Visual analogue scale (YAS) for assessment cannulation pain and the Yale preoperative anxiety scale (YPAS) for the assessment of anxiety before cannulation. 60 patients, 6-12 years old, who needed venipuncture for general anesthesia were divided in to two groups of 30 each: the control and the study group. Nasal tip was held and pressed during venipuncture by the parents in the study group. No intervention was done in the control group. The anxiety scale (YPAS) was not different between the two groups before venous cannulation (P = 0.136). Comparing the two groups. There was no different regarding the change in HR and BP during venous cannulation. There was significantly lower cannulation pain in the study in comparison with the control group (P value = 0.010). Holding and pressing the tip of the nose during venipuncture reduce the severity of venipuncture pain in pediatric patients. This could be secondary to distraction along with the physiological effect of the valsalva maneuver on pain. Therefore, we recommend that holding and pressing the tip of the nose is a safe and effective method for reducing the severity of pain from venipuncture in pediatric patients.

Depression and prospection.

PubMed

Roepke, Ann Marie; Seligman, Martin E P

2016-03-01

Prospection, the mental representation of possible futures, is usually adaptive. When it goes awry, however, it disrupts emotion and motivation. A negative view of the future is typically seen as one symptom of depression, but we suggest that such negative prospection is the core causal element of depression. Here, we describe the empirical evidence supporting this framework, and we explore the implications for clinical interventions. We integrate several literatures: Using the database PsycInfo, we retrieved empirical studies with the keywords prospection, prediction, expectation, pessimism, mental simulation, future-thinking, future-directed thinking, foresight, and/or mental time travel, in conjunction with depression, depressed, or depressive. Three kinds of faulty prospection, taken together, could drive depression: Poor generation of possible futures, poor evaluation of possible futures, and negative beliefs about the future. Depressed mood and poor functioning, in turn, may maintain faulty prospection and feed a vicious cycle. Future-oriented treatment strategies drawn from cognitive-behavioural therapy help to fix poor prospection, and they deserve to be developed further. Prospection-based techniques may lead to transdiagnostic treatment strategies for depression and other disorders. © 2015 The British Psychological Society.

Evaluation of some random effects methodology applicable to bird ringing data

USGS Publications Warehouse

Burnham, K.P.; White, Gary C.

2002-01-01

Existing models for ring recovery and recapture data analysis treat temporal variations in annual survival probability (S) as fixed effects. Often there is no explainable structure to the temporal variation in S1,..., Sk; random effects can then be a useful model: Si = E(S) + ??i. Here, the temporal variation in survival probability is treated as random with average value E(??2) = ??2. This random effects model can now be fit in program MARK. Resultant inferences include point and interval estimation for process variation, ??2, estimation of E(S) and var (E??(S)) where the latter includes a component for ??2 as well as the traditional component for v??ar(S??\\S??). Furthermore, the random effects model leads to shrinkage estimates, Si, as improved (in mean square error) estimators of Si compared to the MLE, S??i, from the unrestricted time-effects model. Appropriate confidence intervals based on the Si are also provided. In addition, AIC has been generalized to random effects models. This paper presents results of a Monte Carlo evaluation of inference performance under the simple random effects model. Examined by simulation, under the simple one group Cormack-Jolly-Seber (CJS) model, are issues such as bias of ??s2, confidence interval coverage on ??2, coverage and mean square error comparisons for inference about Si based on shrinkage versus maximum likelihood estimators, and performance of AIC model selection over three models: Si ??? S (no effects), Si = E(S) + ??i (random effects), and S1,..., Sk (fixed effects). For the cases simulated, the random effects methods performed well and were uniformly better than fixed effects MLE for the Si.

78 FR 42532 - Prospective Grant of Start-Up Exclusive Evaluation Option License: Methods of Treating Giardiasis...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-16

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Prospective Grant of Start-Up Exclusive Evaluation Option License: Methods of Treating Giardiasis Using Available Compounds.../2013 filed April 22, 2013 (E-211- 2010/2-IN-05); each entitled ``Methods of Treating Giardiasis'' by...

Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem-Cell Transplantation for Patients With Myelodysplastic Syndrome: A Prospective Randomized Phase III Study of the EBMT (RICMAC Trial).

PubMed

Kröger, Nicolaus; Iacobelli, Simona; Franke, Georg-Nikolaus; Platzbecker, Uwe; Uddin, Ruzena; Hübel, Kai; Scheid, Christof; Weber, Thomas; Robin, Marie; Stelljes, Matthias; Afanasyev, Boris; Heim, Dominik; Deliliers, Giorgio Lambertenghi; Onida, Francesco; Dreger, Peter; Pini, Massimo; Guidi, Stefano; Volin, Liisa; Günther, Andreas; Bethge, Wolfgang; Poiré, Xavier; Kobbe, Guido; van Os, Marleen; Brand, Ronald; de Witte, Theo

2017-07-01

Purpose To compare a reduced-intensity conditioning regimen (RIC) with a myeloablative conditioning regimen (MAC) before allogeneic transplantation in patients with myelodysplastic syndrome (MDS) within a randomized trial. Patients and Methods Within the European Society of Blood and Marrow Transplantation, we conducted a prospective, multicenter, open-label, randomized phase III trial that compared a busulfan-based RIC with MAC in patients with MDS or secondary acute myeloid leukemia. A total of 129 patients were enrolled from 18 centers. Patients were randomly assigned in a 1:1 ratio and were stratified according to donor, age, and blast count. Results Engraftment was comparable between both groups. The CI of acute graft-versus-host disease II to IV was 32.3% after RIC and 37.5% after MAC ( P = .35). The CI of chronic graft-versus-host disease was 61.6% after RIC and 64.7% after MAC ( P = .76). The CI of nonrelapse mortality after 1 year was 17% (95% CI, 8% to 26%) after RIC and 25% (95% CI, 15% to 36%) after MAC ( P = .29). The CI of relapse at 2 years was 17% (95% CI, 8% to 26%) after RIC and 15% (95% CI, 6% to 24%) after MAC ( P = .6), which resulted in a 2-year relapse-free survival and overall survival of 62% (95% CI, 50% to 74%) and 76% (95% CI, 66% to 87%), respectively, after RIC, and 58% (95% CI, 46% to 71%) and 63% (95% CI, 51% to 75%), respectively, after MAC ( P = .58 and P = .08, respectively). Conclusion This prospective, randomized trial of the European Society of Blood and Marrow Transplantation provides evidence that RIC resulted in at least a 2-year relapse-free survival and overall survival similar to MAC in patients with MDS or secondary acute myeloid leukemia.

Anterior cervical fusion with interbody cage containing β-tricalcium phosphate augmented with plate fixation: a prospective randomized study with 2-year follow-up

PubMed Central

Jiang, Lei-Sheng

2008-01-01

A variety of bone graft substitutes, interbody cages, and anterior plates have been used in cervical interbody fusion, but no controlled study was conducted on the clinical performance of β-tricalcium phosphate (β-TCP) and the effect of supplemented anterior plate fixation. The objective of this prospective, randomized clinical study was to evaluate the effectiveness of implanting interbody fusion cage containing β-TCP for the treatment of cervical radiculopathy and/or myelopathy, and the fusion rates and outcomes in patients with or without randomly assigned plate fixation. Sixty-two patients with cervical radiculopathy and/or myelopathy due to soft disc herniation or spondylosis were treated with one- or two-level discectomy and fusion with interbody cages containing β-TCP. They were randomly assigned to receive supplemented anterior plate (n = 33) or not (n = 29). The patients were followed up for 2 years postoperatively. The radiological and clinical outcomes were assessed during a 2-year follow-up. The results showed that the fusion rate (75.0%) 3 months after surgery in patients treated without anterior cervical plating was significantly lower than that (97.9%) with plate fixation (P < 0.05), but successful bone fusion was achieved in all patients of both groups at 6-month follow-up assessment. Patients treated without anterior plate fixation had 11 of 52 (19.2%) cage subsidence at last follow-up. No difference (P > 0.05) was found regarding improvement in spinal curvature as well as neck and arm pain, and recovery rate of JOA score at all time intervals between the two groups. Based on the findings of this study, interbody fusion cage containing β-TCP following one- or two-level discectomy proved to be an effective treatment for cervical spondylotic radiculopathy and/or myelopathy. Supplemented anterior plate fixation can promote interbody fusion and prevent cage subsidence but do not improve the 2-year outcome when compared with those treated

Water-soluble contrast medium (gastrografin) value in adhesive small intestine obstruction (ASIO): a prospective, randomized, controlled, clinical trial.

PubMed

Di Saverio, Salomone; Catena, Fausto; Ansaloni, Luca; Gavioli, Margherita; Valentino, Massimo; Pinna, Antonio Daniele

2008-10-01

Patients with adhesive small intestine obstruction (ASIO) are difficult to evaluate and to manage and their treatment is still controversial. The diagnostic and therapeutic role of water-soluble contrast medium (Gastrografin) in ASIO is still debated. This study was designed to determine the therapeutic role of Gastrografin in patients with ASIO. The study was a multicenter, prospective, randomized, controlled investigation. The primary end points were the evaluation of the operative rate reduction and shortening the hospital stay after the use of Gastrografin. A total of 76 patients were randomized into two groups: the control group received traditional treatment (TT), whereas the study group (GG) received in addition a Gastrografin meal and follow-through study immediately. Patients with Gastrografin in the colon within 36 hours were considered to be partially obstructed and submitted to nonoperative management. If after 36 hours, the Gastrografin had not entered the colon, the subjects were submitted to laparotomy. No significant differences were found in age, sex, intravenous administration of prokinetics, incidence and characteristics of the previous procedures in surgical history of the patients, previous episodes of ASIO and surgery for adhesiolysis, or duration of symptoms before admission. In the GG group obstruction resolved subsequently in 31 of 38 cases (81.5%) after a mean time of 6.4 hours. The remaining seven patients were submitted to surgery, and one of them needed bowel resection for strangulation. In the control group, 21 patients were not submitted to surgery (55%), whereas 17 showed persistent untreatable obstruction and required laparotomy: 2 of them underwent bowel resection for strangulation. The difference in the operative rate between the two treatment groups reached statistical significance (p = 0.013). The time from the hospital admission for obstruction to resolution of symptoms was significantly lower in the GG group (6.4 vs. 43 hours

Evaluating hospital discharge planning: a randomized clinical trial.

PubMed

Evans, R L; Hendricks, R D

1993-04-01

To select patients for early discharge planning, a randomized clinical trial evaluated a protocol that used risk factors identified upon hospital admission. The goal of the study was to determine if intervention with high-risk patients could reduce the need for hospital admission or skilled care. Of 13,255 patients screened, 835 study participants were identified as "at risk" for frequent health care resource use. Half of the high-risk patients were randomly assigned to the experimental group (n = 417) and received discharge planning from day 3 of their hospital stay, while the control group (n = 418) received discharge planning only if there was a written physician request. Those patients receiving early, systematic discharge planning experienced an increased likelihood of successful return to home after hospital admission and a decreased chance of unscheduled readmission for the 9-month study period. Length of the index hospital stay was not affected by early planning, however. The major clinical implication is the potential for discharge planners to decrease the need for, and use of, health care resources after hospital admission.

Comparing adductor canal block with local infiltration analgesia in total knee arthroplasty: A prospective, blinded and randomized clinical trial.

PubMed

Tong, Qian Jun; Lim, Yean Chin; Tham, Huae Min

2018-05-01

Total knee arthroplasty (TKA) is associated with significant pain post-operatively. Our hypothesis is that adductor canal block (ACB) would be superior to local infiltration analgesia (LIA) in terms of providing analgesia, while still preserving quadriceps strength and enabling early postoperative rehabilitation. A prospective, blinded and randomized clinical trial between LIA and ACB was conducted. Tertiary care urban hospital. 40 patients (ASA I to III) undergoing primary TKA under single-dose spinal anesthesia were prospectively randomized from January 2014 to October 2015. The LIA group received local infiltration of Ropivacaine 150 mg, Ketorolac 30 mg, Morphine 10 mg, and Adrenaline 200 mcg in a total volume of 75 mls, administered intraoperatively by the surgeon. The ACB group was given an ACB postoperatively by one of the study investigators at the end of surgery with 30 mls of 0.5% Ropivacaine. The primary outcome was total Morphine consumption in the first 24 h. Secondary outcomes included total Morphine consumption in the first 48 h, pain scores, quadriceps strength, the Timed Up and Go test (TUG), the 30 s Chair Stand Test (30s-CST) and length of hospital stay. The median (interquartile range) 24 h Morphine consumption was 6 mg (2.3-18.3) in the ACB group and 17.5 mg (12-24.3) in the LIA group, p = 0.004. The 48 h Morphine consumption was 14.5 mg (7.5-28.5) in the ACB group as compared to 24 mg (14-33.8) in the LIA group, p = 0.03. There were no statistically significant differences in the other secondary outcomes. ACB group had statistically significant reduced total Morphine consumption in the first 24 and 48 hours as compared to LIA group, with no statistically significant differences in functional outcomes of TKA patients. Copyright © 2018 Elsevier Inc. All rights reserved.

Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.

PubMed

Surran, B; Visintainer, P; Chamberlain, S; Kopcza, K; Shah, B; Singh, R

2013-12-01

To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.

A prospective evaluation of open face masks for head and neck radiation therapy.

PubMed

Wiant, David; Squire, Sarah; Liu, Han; Maurer, Jacqueline; Lane Hayes, T; Sintay, Benjamin

Head and neck (HN) radiation therapy patients are typically immobilized with closed thermoplastic masks that cover the face and may cause discomfort. In this work, we examine the use of open masks for HN radiation therapy. Fifty HN patients were prospectively randomized into 2 groups (25 closed masks, 25 open masks). The open-mask group was monitored with surface imaging to evaluate intrafraction motion. Both groups underwent daily volumetric imaging. All daily images were rigidly registered to their respective planning images to evaluate spinal canal and mandible position as a check for interfraction posture change. Posture changes were determined by the amount the spinal canal and mandible contours from the planning images had to be expanded to cover the structures on each daily image set. The vector length (VL) of the intrafraction linear translations, spine, and mandible positions for each open-mask patient were checked for correlation with fraction number using the Pearson r value. All patients were given a weekly survey ranking anxiety and claustrophobia from 0 to 10 (0 = no issue, 10 = extreme issue). The mean VL for all open-mask patients was 0.9 ± 0.5 mm (1 standard deviation). Only 1 patient showed significant correlation between VL and fraction number. The mean contour expansions to cover the spine and mandible were 1.5 ± 0.9 mm and 1.8 ± 1.3 mm for the closed-mask group, and 1.6 ± 0.8 mm and 1.8 ± 1.1 mm for the open-mask group. Both groups showed similar behavior relative to fraction number. The mean anxiety and claustrophobia scores were 1.63 and 1.44 for the closed-mask group, and 0.81 and 0.63 for the open-mask group. The groups were not significantly different. Open masks provide comparable immobilization and posture preservation to closed masks for HN radiation therapy. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Succinylcholine versus rocuronium for rapid sequence intubation in intensive care: a prospective, randomized controlled trial

PubMed Central

2011-01-01

Introduction Succinylcholine and rocuronium are widely used to facilitate rapid sequence induction (RSI) intubation in intensive care. Concerns relate to the side effects of succinylcholine and to slower onset and inferior intubation conditions associated with rocuronium. So far, succinylcholine and rocuronium have not been compared in an adequately powered randomized trial in intensive care. Accordingly, the aim of the present study was to compare the incidence of hypoxemia after rocuronium or succinylcholine in critically ill patients requiring an emergent RSI. Methods This was a prospective randomized controlled single-blind trial conducted from 2006 to 2010 at the University Hospital of Basel. Participants were 401 critically ill patients requiring emergent RSI. Patients were randomized to receive 1 mg/kg succinylcholine or 0.6 mg/kg rocuronium for neuromuscular blockade. The primary outcome was the incidence of oxygen desaturations defined as a decrease in oxygen saturation ≥ 5%, assessed by continuous pulse oxymetry, at any time between the start of the induction sequence and two minutes after the completion of the intubation. A severe oxygen desaturation was defined as a decrease in oxygen saturation ≥ 5% leading to a saturation value of ≤ 80%. Results There was no difference between succinylcholine and rocuronium regarding oxygen desaturations (succinylcholine 73/196; rocuronium 66/195; P = 0.67); severe oxygen desaturations (succinylcholine 20/196; rocuronium 20/195; P = 1.0); and extent of oxygen desaturations (succinylcholine -14 ± 12%; rocuronium -16 ± 13%; P = 0.77). The duration of the intubation sequence was shorter after succinycholine than after rocuronium (81 ± 38 sec versus 95 ± 48 sec; P = 0.002). Intubation conditions (succinylcholine 8.3 ± 0.8; rocuronium 8.2 ± 0.9; P = 0.7) and failed first intubation attempts (succinylcholine 32/200; rocuronium 36/201; P = 1.0) did not differ between the groups. Conclusions In critically ill

Drain Management after Pancreatoduodenectomy: Reappraisal of a Prospective Randomized Trial Using Risk Stratification.

PubMed

McMillan, Matthew T; Malleo, Giuseppe; Bassi, Claudio; Butturini, Giovanni; Salvia, Roberto; Roses, Robert E; Lee, Major K; Fraker, Douglas L; Drebin, Jeffrey A; Vollmer, Charles M

2015-10-01

A recent randomized trial used the Fistula Risk Score (FRS) to develop guidelines for selective drainage based on clinically relevant fistula (CR-POPF) risk. Additionally, postoperative day (POD) 1 drain and serum amylase have been identified as accurate postoperative predictors of CR-POPF. This study sought to identify patients who may benefit from selective drainage, as well as the optimal timing for drain removal after pancreatoduodenectomy. One hundred six pancreatoduodenectomies from a previously reported RCT were assessed using risk-adjustment. The incidence of CR-POPF was compared between FRS risk cohorts. Drain and serum amylase values from POD 1 were evaluated using receiver operating characteristic (ROC) analysis to establish cut-offs predictive of CR-POPF occurrence. A regression analysis compared drain removal randomizations (POD 3 vs POD 5). Three-quarters of patients had moderate/high CR-POPF risk. This group had a CR-POPF rate of 36.3% vs 7.7% among negligible/low risk patients (p = 0.005). The areas under the ROC curve for CR-POPF prediction using POD 1 drain and serum amylase values were 0.800 (p = 0.000001; 95% CI 0.70-0.90) and 0.655 (p = 0.012; 95% CI 0.55-0.77), respectively. No significant serum amylase cut-offs were identified. Moderate/high risk patients with POD 1 drain amylase ≤ 5,000 U/L had significantly lower rates of CR-POPF when randomized to POD 3 drain removal (4.2% vs 38.5%; p = 0.003); moreover, these patients experienced fewer complications and shorter hospital stays. A clinical care protocol is proposed whereby drains are recommended for moderate/high FRS risk patients, but may be omitted in patients with negligible/low risk. Drain amylase values in moderate/high risk patients should then be evaluated on POD 1 to determine the optimal timing for drain removal. Moderate/high risk patients with POD 1 drain amylase ≤ 5,000 U/L have lower rates of CR-POPF with POD 3 (vs POD ≥ 5) drain removal; early drain removal is

Model-based choices involve prospective neural activity

PubMed Central

Doll, Bradley B.; Duncan, Katherine D.; Simon, Dylan A.; Shohamy, Daphna; Daw, Nathaniel D.

2015-01-01

Decisions may arise via “model-free” repetition of previously reinforced actions, or by “model-based” evaluation, which is widely thought to follow from prospective anticipation of action consequences using a learned map or model. While choices and neural correlates of decision variables sometimes reflect knowledge of their consequences, it remains unclear whether this actually arises from prospective evaluation. Using functional MRI and a sequential reward-learning task in which paths contained decodable object categories, we found that humans’ model-based choices were associated with neural signatures of future paths observed at decision time, suggesting a prospective mechanism for choice. Prospection also covaried with the degree of model-based influences on neural correlates of decision variables, and was inversely related to prediction error signals thought to underlie model-free learning. These results dissociate separate mechanisms underlying model-based and model-free evaluation and support the hypothesis that model-based influences on choices and neural decision variables result from prospection. PMID:25799041

Effects of fixed orthodontic treatment and two new mouth rinses on gingival health: A prospective cohort followed by a single-blind placebo-controlled randomized clinical trial.

PubMed

Sobouti, Farhad; Rakhshan, Vahid; Heydari, Mohaddeseh; Keikavusi, Shohreh; Dadgar, Sepideh; Shariati, Mahsa

2018-03-01

Routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. Antimicrobial mouth rinses are favorable in this regard. This two-phase study evaluated the effects of orthodontic treatment and the application of two mouthwashes not studied before on oral health indices. In this two-phase study (a prospective cohort followed by a parallel randomized controlled trial), plaque index (PI), gingival index (GI), gingival bleeding index (GBI), and pocket probing depth (PPD) were measured in 54 orthodontic patients before orthodontic treatment and 4 months later. Then patients were randomized into three groups of mouthrinses: Persica (herbal), Ortho-Kin (containing diluted chlorhexidine), and Placebo (n=18×3). The effects of orthodontic treatment and mouthrinses were analyzed statistically (α=0.05). All the 4 indices increased between the baseline and 4th month of treatment (P values<0.01, paired t-test). They decreased back to baseline levels or below them, after one month of mouthwash application (P values<0.002). Both mouthwashes showed therapeutic effects compared to placebo in terms of PI and GBI. In the case of GI, only Persica showed significantly better results compared to placebo. Regarding PPD, only Ortho-Kin acted better than placebo (P values≤0.05, Tukey). Lack of positive control (regular chlorhexidine mouth rinse) and negative control (a group with no mouthwashes, even without the placebo). Lack of sample size predetermination based on a priori power calculations. The difference between the regime of Persica with that of Ortho-Kin and placebo (which had similar application protocols) disallowed perfectly effective blinding of the patients (hence, single-blind). Fixed orthodontic treatment might disrupt gingival health. Antimicrobial mouthwashes might reverse this. Both evaluated mouthwashes might have therapeutic effects. Copyright © 2018 CEO. Published by Elsevier Masson SAS. All rights reserved.

The Relationship between Prospective Teachers' Critical Thinking Dispositions and Their Educational Philosophies

ERIC Educational Resources Information Center

Aybek, Birsel; Aslan, Serkan

2017-01-01

The aim of this research is to investigate the relationship between prospective teachers' critical thinking dispositions and their educational philosophies. The research used relational screening model. The study hosts a total of 429 prospective teachers selected by the simple random sampling method. Research data has been collected through…

Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device.

PubMed

Richardson, Travis D; Hale, Leslie; Arteaga, Christopher; Xu, Meng; Keebler, Mary; Schlendorf, Kelly; Danter, Matthew; Shah, Ashish; Lindenfeld, JoAnn; Ellis, Christopher R

2018-02-23

Ventricular arrhythmias are common in patients with left ventricular assist devices (LVADs) but are often hemodynamically tolerated. Optimal implantable cardioverter defibrillator (ICD) tachy-programming strategies in patients with LVAD have not been determined. We sought to determine if an ultra-conservative ICD programming strategy in patients with LVAD affects ICD shocks. Adult patients with an existing ICD undergoing continuous flow LVAD implantation were randomized to standard ICD programming by their treating physician or an ultra-conservative ICD programming strategy utilizing maximal allowable intervals to detection in the ventricular fibrillation and ventricular tachycardia zones with use of ATP. Patients with cardiac resynchronization therapy (CRT) devices were also randomized to CRT ON or OFF. Patients were followed a minimum of 6 months. The primary outcome was time to first ICD shock. Among the 83 patients studied, we found no statistically significant difference in time to first ICD shock or total ICD shocks between groups. In the ultra-conservative group 16% of patients experienced at least one shock compared with 21% in the control group ( P =0.66). There was no difference in mortality, arrhythmic hospitalization, or hospitalization for heart failure. In the 41 patients with CRT ICDs fewer shocks were observed with CRT-ON but this was not statistically significant: 10% of patients with CRT-ON (n=21) versus 38% with CRT-OFF (n=20) received shocks ( P =0.08). An ultra-conservative programming strategy did not reduce ICD shocks. Programming restrictions on ventricular tachycardia and ventricular fibrillation zone therapy should be reconsidered for the LVAD population. The role of CRT in patients with LVAD warrants further investigation. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01977703. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Long-term prospective evaluation of an inpatient voiding reeducation program for lower urinary tract conditions in children.

PubMed

Golli, Tanja; Meglič, Anamarija; Kenda, Rajko B

2013-04-01

Our aim was to evaluate the efficacy of our treatment program for children with lower urinary tract conditions, developed at the Department of Pediatric Nephrology of the University Children's Hospital in Ljubljana. Sixty-four patients with lower urinary tract conditions were randomly allocated to two groups. Group A received treatment immediately, whereas patients of group B received no treatment for a period of 3 months-the amount of time it takes to complete our program. No child in group B experienced spontaneous regression of their symptoms in the 3-month delay period, while the patients of group A were already being treated and were achieving results. Thus, all the patients of group B then entered the program in exactly the same way as patients of group A. The final success rate in both groups did not differ significantly (p = 0.706-1.000) and ranged from 86.2 % for group A and 86.7 to 90 % for group B. Long-term follow-up showed statistically identical success rates (p = 1.000). This prospective controlled study with long-term follow-up (48 months) shows that our treatment program, applied as an inpatient voiding school program, is an effective method, with durable results.

PROspective Multicenter Imaging Study for Evaluation of chest pain: rationale and design of the PROMISE trial.

PubMed

Douglas, Pamela S; Hoffmann, Udo; Lee, Kerry L; Mark, Daniel B; Al-Khalidi, Hussein R; Anstrom, Kevin; Dolor, Rowena J; Kosinski, Andrzej; Krucoff, Mitchell W; Mudrick, Daniel W; Patel, Manesh R; Picard, Michael H; Udelson, James E; Velazquez, Eric J; Cooper, Lawton

2014-06-01

Suspected coronary artery disease (CAD) is one of the most common, potentially life-threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. The PROMISE study is a prospective, randomized trial comparing the effectiveness of 2 initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either (1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram) or (2) anatomical testing with ≥64-slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians, and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core laboratory quality and completeness assessment. All subjects are followed up for ≥1 year. The primary end point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis, and renal failure), or hospitalization for unstable angina. More than 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care, and anesthesiology sites. Multispecialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. The PROMISE trial will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomical testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost-effectiveness, and radiation exposure will be assessed. Copyright © 2014 Mosby, Inc. All rights reserved.

PROspective Multicenter Imaging Study for Evaluation of Chest Pain: Rationale and Design of the PROMISE Trial

PubMed Central

Douglas, Pamela S.; Hoffmann, Udo; Lee, Kerry L.; Mark, Daniel B.; Al-Khalidi, Hussein R.; Anstrom, Kevin; Dolor, Rowena J.; Kosinski, Andrzej; Krucoff, Mitchell W.; Mudrick, Daniel W.; Patel, Manesh R.; Picard, Michael H.; Udelson, James E.; Velazquez, Eric J.; Cooper, Lawton

2014-01-01

Background Suspected coronary artery disease (CAD) is one of the most common, potentially life threatening diagnostic problems clinicians encounter. However, no large outcome-based randomized trials have been performed to guide the selection of diagnostic strategies for these patients. Methods The PROMISE study is a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies in patients with symptoms suspicious for CAD. Patients are randomized to either: 1) functional testing (exercise electrocardiogram, stress nuclear imaging, or stress echocardiogram); or 2) anatomic testing with >=64 slice multidetector coronary computed tomographic angiography. Tests are interpreted locally in real time by subspecialty certified physicians and all subsequent care decisions are made by the clinical care team. Sites are provided results of central core lab quality and completeness assessment. All subjects are followed for ≥1 year. The primary end-point is the time to occurrence of the composite of death, myocardial infarction, major procedural complications (stroke, major bleeding, anaphylaxis and renal failure) or hospitalization for unstable angina. Results Over 10,000 symptomatic subjects were randomized in 3.2 years at 193 US and Canadian cardiology, radiology, primary care, urgent care and anesthesiology sites. Conclusion Multi-specialty community practice enrollment into a large pragmatic trial of diagnostic testing strategies is both feasible and efficient. PROMISE will compare the clinical effectiveness of an initial strategy of functional testing against an initial strategy of anatomic testing in symptomatic patients with suspected CAD. Quality of life, resource use, cost effectiveness and radiation exposure will be assessed. Clinical trials.gov identifier NCT01174550 PMID:24890527

A prospective, randomized, comparative clinical study of resin composite and glass ionomer cement for retrograde root filling.

PubMed

Jensen, S S; Nattestad, A; Egdø, P; Sewerin, I; Munksgaard, E C; Schou, S

2002-12-01

To compare the clinical and radiographic treatment outcome of retrograde root filling with either dentin-bonded resin composite (Retroplast, RP) or glass ionomer cement (Chelon-Silver, CS). A prospective, randomized clinical study of 134 consecutive patients with indication of retrograde root filling of an incisor, canine, premolar, or first molar. Either RP or CS was chosen at random as retrograde filling material. Either material was applied onto the entire resection surface after prepared slightly concave. This preparation technique makes a sealing of the entire resection surface possible and prevents marginal contraction gaps during polymerization. A total of 122 patients were available for 1-year follow-up. After 1 year the proportion of successful cases was significantly higher in the RP group (73%) than in the CS group (31%) (p<0.001). Doubtful healing with a need for a longer observation period was seen in 17% of the RP cases and 19% of the CS cases. The proportion of failures in the RP group (10%) was significantly lower than that in the CS group (50%) (p<0.001). Most of the unsuccessful CS cases failed due to loosening of the retrograde filling. Dentin-bonded RP applied onto the entire, slightly concave resection surface is a predictable apical sealant characterized by a high success rate. In contrast, retrograde root filling with CS results in an unacceptably high failure rate due to insufficient bonding strength to the concave resection surface.

Evaluation of lumbar transforaminal epidural injections with needle placement and contrast flow patterns: a prospective, descriptive report.

PubMed

Manchikanti, Laxmaiah; Cash, Kim A; Pampati, Vidyasagar; Damron, Kim S; McManus, Carla D

2004-04-01

Transforaminal epidural steroid injection is one of the commonly employed modalities of treatment in managing nerve root pain. However, there have been no controlled prospective evaluations of epidural and nerve root contrast distribution patterns and other aspects of fluoroscopically directed lumbosacral transforaminal epidural steroid injections. To evaluate contrast flow patterns and intravascular needle placement of fluoroscopically guided lumbosacral transforaminal epidural injections. A prospective, observational study. A total of 100 consecutive patients undergoing fluoroscopically guided transforaminal epidural steroid injections were evaluated. The contrast flow patterns, ventral or dorsal epidural filling, nerve root filling, C-arm time, and intravascular needle placement were evaluated. Ventral epidural filling was seen in 88% of the procedures, in contrast to dorsal filling noted in 9% of the procedures. Nerve root filling was seen in 97% of the procedures. Total intravenous placement of the needle was noted in 22% of the procedures, whereas negative flashback and aspiration was noted in 5% of the procedures. Lumbosacral transforaminal epidural injections, performed under fluoroscopic visualization, provide excellent nerve root filling and ventral epidural filling patterns. However, unrecognized intravascular needle placement with negative flashback or aspiration was noted in 5% of the procedures.

Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.

PubMed

Marasco, Silvana F; Fuller, Louise; Zimmet, Adam; McGiffin, David; Seitz, Michael; Ch'ng, Stephanie; Gangahanumaiah, Shivanand; Bailey, Michael

2018-04-16

Midline sternotomy remains the most common access incision for cardiac operations. Traditionally, the sternum is closed with stainless steel wires. Wires are well known to stretch and break, however, leading to pain, nonunion, and potential deep sternal wound infection. We hypothesized that biocompatible plastic cable ties would achieve a more rigid sternal fixation, reducing postoperative pain and analgesia requirements. A prospective, randomized study compared the ZIPFIX (De Puy Synthes, West Chester, Pa) sternal closure system (n = 58) with standard stainless steel wires (n = 60). Primary outcomes were pain and analgesia requirements in the early postoperative period. Secondary outcome was sternal movement, as assessed by ultrasound at the postoperative follow-up visit. Groups were well matched in demographic and operative variables. There were no significant differences between groups in postoperative pain, analgesia, or early ventilatory requirements. Patients in the ZIPFIX group had significantly more movement in the sternum and manubrium on ultrasound at 4 weeks. ZIPFIX sternal cable ties provide reliable closure but no demonstrable benefit in this study in pain or analgesic requirements relative to standard wire closure after median sternotomy. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

The Medical Treatment of New-Onset Peripartum Cardiomyopathy: A Systematic Review of Prospective Studies.

PubMed

Desplantie, Olivier; Tremblay-Gravel, Maxime; Avram, Robert; Marquis-Gravel, Guillaume; Ducharme, Anique; Jolicoeur, E Marc

2015-12-01

Peripartum cardiomyopathy (PPCM) is a rare disorder with potentially fatal consequences, which occurs mainly in previously healthy women. The aetiology of PPCM remains unknown and various pathologic mechanisms have been proposed, including immune-mediated injuries and impaired response to oxidative stress and inflammatory cytokines. Several therapies have been studied, but few have been validated in a well-designed randomized controlled trial. In the present study we sought to review the medical treatment intended for acute PPCM. To this end, we performed a systematic review of the literature of randomized and nonrandomized prospective clinical studies. We identified 2 randomized controlled trials that evaluated the dopamine agonist bromocriptine and the inotrope levosimendan, respectively, and 1 nonrandomized study that evaluated the nonselective phosphodiesterase inhibitor pentoxifylline. We reviewed the pathophysiological, pharmacological, and clinical properties for each treatment option identified. Bromocriptine and pentoxifylline both improved left ventricular systolic function and patient-oriented clinical end points and levosimendan did not improve mortality or echocardiographic findings of PPCM. In this review we identified bromocriptine and pentoxifylline, but not levosimendan, as potentially useful agents to improve left ventricle function and outcomes in PPCM. Copyright © 2015 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Evaluation of random plasma glucose for assessment of glycaemic control in type 2 diabetes mellitus.

PubMed

Ain, Qurratul; Latif, Atif; Jaffar, Syed Raza; Ijaz, Aamir

2017-09-01

To evaluate the accuracy of random plasma glucose in outpatients with type 2 diabetes mellitus for assessing glycaemic control. This comparative, cross-sectional study was conducted at the chemical pathology department of PNS Shifa Hospital, Karachi, from August 2015 to March 2016, and comprised data of subjects with type 2 diabetes mellitus who reported for evaluation of glycaemic control in non-fasting state. All blood samples were analysed for random plasma glucose and glycated haemoglobin. Random plasma glucose was compared as an index test with glycated haemoglobin considering it as reference standard at a value of less than 7% for good glycaemic control. SPSS 20 was used for data analysis. Of the 222 subjects, 93(42%) had good glycaemic control. Random plasma glucose showed strong positive correlation with glycated haemoglobin (p=0.000).Area under curve for random plasma glucose as determined by plotting receiver operating characteristic curve against glycated haemoglobin value of 7% was 0.89 (95% confidence interval: 0.849-0.930). Random plasma glucose at cut-off value of 150 mg/dl was most efficient for ruling out poor glycaemic control among patients with type 2 diabetes mellitus with 90.7% sensitivity and69.9% specificity and Youden's index of 0.606. Random plasma glucose may be used to reflect glycaemic control in adults with type 2 diabetes mellitus in areas where glycated haemoglobin is not feasible.

A Prospective, Randomized Trial in the Emergency Department of Suggestive Audio-Therapy under Deep Sedation for Smoking Cessation.

PubMed

Rodriguez, Robert M; Taylor, Opal; Shah, Sushma; Urstein, Susan

2007-08-01

In a sample of patients undergoing procedural deep sedation in the emergency department (ED), we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. We asked subjects about their smoking, including desire to quit (0-10 numerical scale) and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone) or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 +/- 2.6 and mean cigarettes per day was 17.5 +/- 12.1. We successfully contacted 69 (62%) patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: -22.0% to 18.8%). Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: -8.7% to 35.6%). Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

Motion versus fixed distraction of the joint in the treatment of ankle osteoarthritis: a prospective randomized controlled trial.

PubMed

Saltzman, Charles L; Hillis, Stephen L; Stolley, Mary P; Anderson, Donald D; Amendola, Annunziato

2012-06-06

Initial reports have shown the efficacy of fixed distraction for the treatment of ankle osteoarthritis. We hypothesized that allowing ankle motion during distraction would result in significant improvements in outcomes compared with distraction without ankle motion. We conducted a prospective randomized controlled trial comparing the outcomes for patients with advanced ankle osteoarthritis who were managed with anterior osteophyte removal and either (1) fixed ankle distraction or (2) ankle distraction permitting joint motion. Thirty-six patients were randomized to treatment with either fixed distraction or distraction with motion. The patients were followed for twenty-four months after frame removal. The Ankle Osteoarthritis Scale (AOS) was the main outcome variable. Two years after frame removal, subjects in both groups showed significant improvement compared with the status before treatment (p < 0.02 for both groups). The motion-distraction group had significantly better AOS scores than the fixed-distraction group at twenty-six, fifty-two, and 104 weeks after frame removal (p < 0.01 at each time point). At 104 weeks, the motion-distraction group had an overall mean improvement of 56.6% in the AOS score, whereas the fixed-distraction group had a mean improvement of 22.9% (p < 0.01). Distraction improved the patient-reported outcomes of treatment of ankle osteoarthritis. Adding ankle motion to distraction showed an early and sustained beneficial effect on outcome.

Do Clinical and Radiological Assessments Contribute to the Understanding of Biomaterials? Results From a Prospective Randomized Sinus Augmentation Split-Mouth Trial.

PubMed

Lorenz, Jonas; Korzinskas, Tadas; Chia, Poju; Maawi, Sarah Al; Eichler, Katrin; Sader, Robert A; Ghanaati, Shahram

2018-02-01

The present prospective randomized split-mouth trial reports on the 3-year clinical and radiological follow-up investigation of implants placed 7 months after sinus augmentation with 2 different bone substitute materials. The aim of the study was to complete the histologic observation of cellular reactions by analyses of the implants and the volumetric changes of the augmented bone substitute materials. A sinus augmentation split-mouth trial was performed in 14 patients with the synthetic bone substitute material Nanobone (NB) and the xenogeneic Bio-Oss (BO). Changes in volume and density of the augmented biomaterials were investigated by analysis of computed tomography scans, taken immediately after augmentation and after 7 months. Clinical implant parameters were assessed after 3 years of loading. Both bone substitute materials underwent nonsignificant volume reduction and significant increase in bone density over an integration period of 7 months. No significant differences concerning volume and bone density were observed between the groups. Three years after loading, 51 of 53 implants were in situ with no peri-implant infections, and only a few soft-tissue variations were present. The present prospective randomized study showed that no differences could be observed clinically and radiologically. Accordingly, it seems that both biomaterials, independent of their physicochemical composition, enable clinical success and long-time stability for dental implants. Interestingly, the histological results showed distinct differences in cellular reactions: While the xenogeneic BO induced a mild tissue reaction with only few multinucleated giant cells and comparably low vascularization, the synthetic NB induced a multinucleated giant cell-triggered tissue reaction with an increase of vascularization. Thus, the present study showed that a combination analysis-histological, clinical, and radiological-is necessary for a detailed assessment of a biomaterial's quality for

A quasi randomized-controlled trial to evaluate the effectiveness of clowntherapy on children's anxiety and pain levels in emergency department.

PubMed

Felluga, Margherita; Rabach, Ingrid; Minute, Marta; Montico, Marcella; Giorgi, Rita; Lonciari, Isabella; Taddio, Andrea; Barbi, Egidio

2016-05-01

The aim of the study is to investigate if the presence of medical clowns during painful procedures in the emergency department (ED) affects children's anxiety and pain. Forty children (4-11 years) admitted to the ED with the need of painful procedures were prospectively enrolled. They were randomly assigned to the clown group, where children interacted with clowns or to the control group in which they were entertained by parents and ED nurses. The children's anxiety was assessed by the Children's Anxiety and Pain Scales; pain was evaluated with the Numerical Rating Scale and Wong-Backer Scale, according to the children's age. Staff and clown's opinions were evaluated by means of dedicated questionnaires. Children's anxiety levels in the clown group were significantly lower than those compared with the control group, while children's pain levels did not change between the two groups. The presence of clowns in the ED before and during painful procedures was effective in reducing children's anxiety. • Anxiety and fear caused by medical procedures exacerbate children's pain and may interfere with the procedure. • To reduce anxiety, fear, and pain and to facilitate patient's evaluation, different non-pharmacological approaches have been proposed and positive effects of laughter and humor have been reported. What is New: • The presence of clowns in the waiting room and in the ED during medical evaluation and painful procedures helps to reduce children's anxiety.

Impact of Intravenous Lysine Acetylsalicylate Versus Oral Aspirin on Prasugrel-Inhibited Platelets: Results of a Prospective, Randomized, Crossover Study (the ECCLIPSE Trial).

PubMed

Vivas, David; Martín, Agustín; Bernardo, Esther; Ortega-Pozzi, María Aranzazu; Tirado, Gabriela; Fernández, Cristina; Vilacosta, Isidre; Núñez-Gil, Iván; Macaya, Carlos; Fernández-Ortiz, Antonio

2015-05-01

Prasugrel and ticagrelor, new P2Y12-adenosine diphosphate receptor antagonists, are associated with greater pharmacodynamic inhibition and reduction of cardiovascular events compared with clopidogrel in patients with an acute coronary syndrome. However, evidence is lacking about the effects of achieving faster and stronger cyclooxygenase inhibition with intravenous lysine acetylsalicylate (LA) compared with oral aspirin on prasugrel-inhibited platelets. This was a prospective, randomized, single-center, open, 2-period crossover platelet function study conducted in 30 healthy volunteers. Subjects were randomly assigned to receive a loading dose of intravenous LA 450 mg plus oral prasugrel 60 mg or loading dose of aspirin 300 mg plus prasugrel 60 mg orally in a crossover fashion after a 2-week washout period between treatments. Platelet function was evaluated at baseline, 30 minutes, 1 h, 4 h, and 24 h using light transmission aggregometry and vasodilator-stimulated phosphoprotein phosphorylation. The primary end point of the study, inhibition of platelet aggregation after arachidonic acid 1.5 mmol/L at 30 minutes, was significantly higher in subjects treated with LA compared with aspirin: 85.3% versus 44.3%, respectively, P=0.003. This differential effect was observed at 1 hour (P=0.002) and 4 hours (P=0.048), but not at 24 hours. Subjects treated with LA presented less variability and faster and greater inhibition of platelet aggregation with arachidonic acid compared with aspirin. The administration of intravenous LA resulted in a significant reduction of platelet reactivity compared with oral aspirin on prasugrel-inhibited platelets. Loading dose of LA achieves an earlier platelet inhibition and with less variability than aspirin. URL: http://www.clinicaltrials.gov. Unique identifier: NCT02243137. © 2015 American Heart Association, Inc.

Efficacy of Ketorolac Buccal Infiltrations and Inferior Alveolar Nerve Blocks in Patients with Irreversible Pulpitis: A Prospective, Double-blind, Randomized Clinical Trial.

PubMed

Akhlaghi, Nahid Mohammadzadeh; Hormozi, Behnoush; Abbott, Paul V; Khalilak, Zohreh

2016-05-01

The purpose of this prospective, randomized, double-blind, placebo-controlled study was to determine whether ketorolac buccal infiltrations (BIs) helped to improve the success of inferior alveolar nerve blocks (IANBs) in patients with acute irreversible pulpitis (AIP). Forty adult volunteers with AIP in a mandibular molar were included in this study. Patients were instructed to evaluate their pain by using a Heft-Parker visual analog scale. They were randomly divided into 2 groups (n = 20). All patients received standard IANB injection and after that a BI of 4% articaine with 1:100,000 epinephrine. After 5 minutes, 20 patients received a BI of 30 mg/mL ketorolac, and the other received a BI of normal saline (control group). Endodontic access cavity preparation (ACP) was initiated 15 minutes after the IANB when the patient reported lip numbness and had 2 electric pulp tests with no responses. The patient's pain during caries and dentin removal, ACP, and canal length measurements (CLM) was recorded by using Heft-Parker visual analog scale. Successful anesthesia was defined as no or mild pain during any of these steps, without the need for additional injection. Data were statistically analyzed by using Mann-Whitney U and χ(2) tests. Successful anesthesia after an IANB plus BI of articaine was obtained in 15% of patients in the control group at the end of CLM. Adding BI of ketorolac significantly increased the success rate to 40% (P < .05). Patient's pain during ACP and CLM was significantly lower in the ketorolac group (P < .05). Ketorolac BI can increase the success rate of anesthesia after IANB and BI with articaine in patients with AIP. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Complications of fluoroscopically directed facet joint nerve blocks: a prospective evaluation of 7,500 episodes with 43,000 nerve blocks.

PubMed

Manchikanti, Laxmaiah; Malla, Yogesh; Wargo, Bradley W; Cash, Kimberly A; Pampati, Vidyasagar; Fellows, Bert

2012-01-01

Chronic spinal pain is common along with numerous modalities of diagnostic and therapeutic interventions utilized, creating a health care crisis. Facet joint injections and epidural injections are the 2 most commonly utilized interventions in managing chronic spinal pain. While the literature addressing the effectiveness of facet joint nerve blocks is variable and emerging, there is paucity of literature on adverse effects of facet joint nerve blocks. A prospective, non-randomized study of patients undergoing interventional techniques from May 2008 to December 2009. A private interventional pain management practice, a specialty referral center in the United States. Investigation of the incidence in characteristics of adverse effects and complications of facet joint nerve blocks. The study was carried out over a period of 20 months including almost 7,500 episodes of 43,000 facet joint nerve blocks with 3,370 episodes in the cervical region, 3,162 in the lumbar region, and 950 in the thoracic region. All facet joint nerve blocks were performed under fluoroscopic guidance in an ambulatory surgery center by 3 physicians. The complications encountered during the procedure and postoperatively were evaluated prospectively. This study was carried out over a period of 20 months and included over 7,500 episodes or 43,000 facet joint nerve blocks. All of the interventions were performed under fluoroscopic guidance in an ambulatory surgery center by one of 3 physicians. The complications encountered during the procedure and postoperatively were prospectively evaluated. Measurable outcomes employed were intravascular entry of the needle, profuse bleeding, local hematoma, dural puncture and headache, nerve root or spinal cord irritation with resultant injury, and infectious complications. There were no major complications. Multiple side effects and complications observed included overall intravascular penetration in 11.4% of episodes with 20% in cervical region, 4% in lumbar

Prospective memory: effects of divided attention on spontaneous retrieval.

PubMed

Harrison, Tyler L; Mullet, Hillary G; Whiffen, Katie N; Ousterhout, Hunter; Einstein, Gilles O

2014-02-01

We examined the effects of divided attention on the spontaneous retrieval of a prospective memory intention. Participants performed an ongoing lexical decision task with an embedded prospective memory demand, and also performed a divided-attention task during some segments of lexical decision trials. In all experiments, monitoring was highly discouraged, and we observed no evidence that participants engaged monitoring processes. In Experiment 1, performing a moderately demanding divided-attention task (a digit detection task) did not affect prospective memory performance. In Experiment 2, performing a more challenging divided-attention task (random number generation) impaired prospective memory. Experiment 3 showed that this impairment was eliminated when the prospective memory cue was perceptually salient. Taken together, the results indicate that spontaneous retrieval is not automatic and that challenging divided-attention tasks interfere with spontaneous retrieval and not with the execution of a retrieved intention.

Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy: results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial.

PubMed

Sugano, Kentaro; Kontani, Teiji; Katsuo, Shinichi; Takei, Yoshinori; Sakaki, Nobuhiro; Ashida, Kiyoshi; Mizokami, Yuji; Asaka, Masahiro; Matsui, Shigeyuki; Kanto, Tatsuya; Soen, Satoshi; Takeuchi, Tsutomu; Hiraishi, Hideyuki; Hiramatsu, Naoki

2012-05-01

Low-dose lansoprazole has not been intensively evaluated for its efficacy in the prevention of recurrent gastric or duodenal ulcers in patients receiving long-term non-steroidal anti-inflammatory drug (NSAID) therapy for pain relief in such diseases as rheumatoid arthritis, osteoarthritis, and low back pain. This multi-center, prospective, double-blind, randomized, active-controlled study involving 99 sites in Japan was designed to compare the efficacy of lansoprazole (15 mg daily) with gefarnate (50 mg twice daily). Patients with a history of gastric or duodenal ulcers who required long-term NSAID therapy were randomized to receive lansoprazole 15 mg daily (n = 185) or gefarnate 50 mg twice daily (n = 181) and followed up for 12 months or longer prospectively. The cumulative incidence of gastric or duodenal ulcer at days 91, 181, and 361 from the start of the study was calculated by the Kaplan-Meier method as 3.3, 5.9, and 12.7%, respectively, in the lansoprazole group versus 18.7, 28.5, and 36.9%, respectively, in the gefarnate group. The risk for ulcer development was significantly (log-rank test, P < 0.0001) lower in the lansoprazole group than in the gefarnate group, with the hazard ratio being 0.2510 (95% CI 0.1400-0.4499). A long-term follow-up study showed an acceptable safety profile for low-dose lansoprazole therapy, with diarrhea as the most frequent adverse event. Lansoprazole was superior to gefarnate in reducing the risk of gastric or duodenal ulcer recurrence in patients with a definite history of gastric or duodenal ulcers who required long-term NSAID therapy.

Patterns of response and relapse in primary CNS lymphomas after first-line chemotherapy: imaging analysis of the ANOCEF-GOELAMS prospective randomized trial

PubMed Central

Tabouret, Emeline; Houillier, Caroline; Martin-Duverneuil, Nadine; Blonski, Marie; Soussain, Carole; Ghesquières, Herve; Houot, Roch; Larrieu, Delphine; Soubeyran, Pierre; Gressin, Remy; Gyan, Emmanuel; Chinot, Olivier; Taillandier, Luc; Choquet, Sylvain; Alentorn, Agusti; Leclercq, Delphine; Omuro, Antonio; Tanguy, Marie-Laure

2017-01-01

Abstract Background. Our aim was to review MRI characteristics of patients with primary CNS lymphoma (PCNSL) enrolled in a randomized phase II trial and to evaluate their potential prognostic value and patterns of relapse, including T2 fluid attenuated inversion recovery (FLAIR) MRI abnormalities. Methods. Neuroimaging findings in 85 patients with PCNSL enrolled in a prospective trial were reviewed blinded to outcomes. MRI characteristics and responses according to International PCNSL Collaborative Group (IPCG) criteria were correlated with progression-free survival (PFS) and overall survival (OS). Results. Multivariate analysis showed that objective response at 2 months (P < .001) and at end of treatment (P = .015) were predictors of prolonged OS. Infratentorial location (P = .008) and large (>11.4 cm3) enhancing tumor volume (P = .006) were associated with poor OS and PFS, respectively. Ratio of change in product of largest diameters at early MRI evaluation but not timing of complete response achievement (early vs delayed) was prognostic for OS. Sixty-nine patients relapsed. Relapse in the brain (n = 52) involved an initial enhancing site, a different site, or both in 46%, 40%, and 14% of patients, respectively. At baseline, non-enhancing T2-FLAIR hypersignal lesions distant from the enhancing tumor site were detected in 18 patients. These lesions markedly decreased (>50%) in 16 patients after chemotherapy, supporting their neoplastic nature. Of these patients, 10/18 relapsed, half (n = 5) in the initially non-enhancing T2-FLAIR lesions. Conclusions. Baseline tumor size and infratentorial localization are of prognostic value in PCNSL. Our findings provide evidence that non-enhancing FLAIR abnormalities may add to overall tumor burden, suggesting that response criteria should be refined to incorporate evaluation of T2-weighted/FLAIR sequences. PMID:27994065

Random regression models using Legendre orthogonal polynomials to evaluate the milk production of Alpine goats.

PubMed

Silva, F G; Torres, R A; Brito, L F; Euclydes, R F; Melo, A L P; Souza, N O; Ribeiro, J I; Rodrigues, M T

2013-12-11

The objective of this study was to identify the best random regression model using Legendre orthogonal polynomials to evaluate Alpine goats genetically and to estimate the parameters for test day milk yield. On the test day, we analyzed 20,710 records of milk yield of 667 goats from the Goat Sector of the Universidade Federal de Viçosa. The evaluated models had combinations of distinct fitting orders for polynomials (2-5), random genetic (1-7), and permanent environmental (1-7) fixed curves and a number of classes for residual variance (2, 4, 5, and 6). WOMBAT software was used for all genetic analyses. A random regression model using the best Legendre orthogonal polynomial for genetic evaluation of milk yield on the test day of Alpine goats considered a fixed curve of order 4, curve of genetic additive effects of order 2, curve of permanent environmental effects of order 7, and a minimum of 5 classes of residual variance because it was the most economical model among those that were equivalent to the complete model by the likelihood ratio test. Phenotypic variance and heritability were higher at the end of the lactation period, indicating that the length of lactation has more genetic components in relation to the production peak and persistence. It is very important that the evaluation utilizes the best combination of fixed, genetic additive and permanent environmental regressions, and number of classes of heterogeneous residual variance for genetic evaluation using random regression models, thereby enhancing the precision and accuracy of the estimates of parameters and prediction of genetic values.

Random Access Frame (RAF) System Neutral Buoyancy Evaluations

NASA Technical Reports Server (NTRS)

Howe, A. Scott; Polit-Casillas, Raul; Akin, David L.; McBryan, Katherine; Carlsen, Christopher

2015-01-01

The Random Access Frame (RAF) concept is a system for organizing internal layouts of space habitats, vehicles, and outposts. The RAF system is designed as a more efficient improvement over the current International Standard Payload Rack (ISPR) used on the International Space Station (ISS), which was originally designed to allow for swapping and resupply by the Space Shuttle. The RAF system is intended to be applied in variable gravity or microgravity environments. This paper discusses evaluations and results of testing the RAF system in a neutral buoyancy facility simulating low levels of gravity that might be encountered in a deep space environment.

Evaluation of physiotherapy in a prospective cohort of early axial spondyloarthritis. Data from the DESIR cohort.

PubMed

Escalas, Cécile; Dalichampt, Marie; Dougados, Maxime; Poiraudeau, Serge

2016-03-01

To evaluate the effect of physiotherapy on functional limitation in an observational cohort of early axial spondyloarthritis. prospective population-based cohort study. 708 patients with early axial spondyloarthritis between 2007 and 2010 naive of TNF blockers. early physiotherapy defined by at least eight supervised sessions of physical therapy during the first six months. the primary outcome was functional improvement defined by a relative improvement of at least 20% in BASFI at six months. Secondary outcomes were improvement in BASFI at one and two years and ASAS20 response criteria at six months. a propensity score of having physiotherapy was developed and multivariate analysis using propensity score weighting were used to assess the effect of physiotherapy on outcome. Overall, 166 (24%) patients had physiotherapy during the first six months. After using propensity score weighting, there was no functional improvement on the primary outcome in patients treated with early physical therapy (relative risk [IC95%]: 1.15 [0.91-1.45]). No differences were observed on secondary outcomes (relative risk [IC95%]: 0.94 [0.80-1.11]). It seems there is no functional benefit for patients with early spondyloarthritis to be treated early by physiotherapy in daily practice, even though the efficacy of physiotherapy has been shown in several randomized controlled studies. Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Prospecting for marine gas hydrate resources

USGS Publications Warehouse

Boswell, Ray; Shipp, Craig; Reichel, Thomas; Shelander, Dianna; Saeki, Tetsuo; Frye, Matthew; Shedd, William; Collett, Timothy S.; McConnell, Daniel R.

2016-01-01

As gas hydrate energy assessment matures worldwide, emphasis has evolved away from confirmation of the mere presence of gas hydrate to the more complex issue of prospecting for those specific accumulations that are viable resource targets. Gas hydrate exploration now integrates the unique pressure and temperature preconditions for gas hydrate occurrence with those concepts and practices that are the basis for conventional oil and gas exploration. We have aimed to assimilate the lessons learned to date in global gas hydrate exploration to outline a generalized prospecting approach as follows: (1) use existing well and geophysical data to delineate the gas hydrate stability zone (GHSZ), (2) identify and evaluate potential direct indications of hydrate occurrence through evaluation of interval of elevated acoustic velocity and/or seismic events of prospective amplitude and polarity, (3) mitigate geologic risk via regional seismic and stratigraphic facies analysis as well as seismic mapping of amplitude distribution along prospective horizons, and (4) mitigate further prospect risk through assessment of the evidence of gas presence and migration into the GHSZ. Although a wide range of occurrence types might ultimately become viable energy supply options, this approach, which has been tested in only a small number of locations worldwide, has directed prospect evaluation toward those sand-hosted, high-saturation occurrences that were presently considered to have the greatest future commercial potential.

A random walk model for evaluating clinical trials involving serial observations.

PubMed

Hopper, J L; Young, G P

1988-05-01

For clinical trials where the variable of interest is ordered and categorical (for example, disease severity, symptom scale), and where measurements are taken at intervals, it might be possible to achieve a greater discrimination between the efficacy of treatments by modelling each patient's progress as a stochastic process. The random walk is a simple, easily interpreted model that can be fitted by maximum likelihood using a maximization routine with inference based on standard likelihood theory. In general the model can allow for randomly censored data, incorporates measured prognostic factors, and inference is conditional on the (possibly non-random) allocation of patients. Tests of fit and of model assumptions are proposed, and application to two therapeutic trials of gastroenterological disorders are presented. The model gave measures of the rate of, and variability in, improvement for patients under different treatments. A small simulation study suggested that the model is more powerful than considering the difference between initial and final scores, even when applied to data generated by a mechanism other than the random walk model assumed in the analysis. It thus provides a useful additional statistical method for evaluating clinical trials.

The evaluation of off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) randomized controlled trial: study design and rational.

PubMed

Mohammedi, Kamel; Potier, Louis; François, Maud; Dardari, Dured; Feron, Marilyne; Nobecourt-Dupuy, Estelle; Dolz, Manuel; Ducloux, Roxane; Chibani, Abdelkader; Eveno, Dominique-François; Crea Avila, Teresa; Sultan, Ariane; Baillet-Blanco, Laurence; Rigalleau, Vincent; Velho, Gilberto; Tubach, Florence; Roussel, Ronan; Dupré, Jean-Claude; Malgrange, Dominique; Marre, Michel

2016-01-01

Off-loading is essential for diabetic foot management, but remains understudied. The evaluation of Off-loading using a new removable oRTHOsis in DIABetic foot (ORTHODIAB) trial aims to evaluate the efficacy of a new removable device "Orthèse Diabète" in the healing of diabetic foot. ORTHODIAB is a French multi-centre randomized, open label trial, with a blinded end points evaluation by an adjudication committee according to the Prospective Randomized Open Blinded End-point. Main endpoints are adjudicated based on the analysis of diabetic foot photographs. Orthèse Diabète is a new removable off-loading orthosis (PROTEOR, France) allowing innovative functions including real-time evaluation of off-loading and estimation of patients' adherence. Diabetic patients with neuropathic plantar ulcer or amputation wounds (toes or transmetatarsal) are assigned to one of 2 parallel-groups: Orthèse Diabète or control group (any removable device) according to a central computer-based randomization. Study visits are scheduled for 6 months (days D7 and D14, and months M1, M2, M3, and M6). The primary endpoint is the proportion of patients whose principal ulcer is healed at M3. Secondary endpoints are: the proportion of patients whose principal ulcer is healed at M1, M2 and M6; the proportion of patients whose initial ulcers are all healed at M1, M2, M3, and M6; principal ulcer area reduction; time-related ulcer-free survival; development of new ulcers; new lower-extremity amputation; infectious complications; off-loading adherence; and patient satisfaction. The study protocol was approved by the French National Agency for Medicines and Health Products Safety, and by the ethics committee of Saint-Louis Hospital (Paris). Comprehensive study information including a Patient Information Sheet has been provided to each patient who must give written informed consent before enrolment. Monitoring, data management, and statistical analyses are providing by UMANIS Life Science (Paris

Lumbar Intradiskal Platelet-Rich Plasma (PRP) Injections: A Prospective, Double-Blind, Randomized Controlled Study.

PubMed

Tuakli-Wosornu, Yetsa A; Terry, Alon; Boachie-Adjei, Kwadwo; Harrison, Julian R; Gribbin, Caitlin K; LaSalle, Elizabeth E; Nguyen, Joseph T; Solomon, Jennifer L; Lutz, Gregory E

2016-01-01

To determine whether single injections of autologous platelet-rich plasma (PRP) into symptomatic degenerative intervertebral disks will improve participant-reported pain and function. Prospective, double-blind, randomized controlled study. Outpatient physiatric spine practice. Adults with chronic (≥6 months), moderate-to-severe lumbar diskogenic pain that was unresponsive to conservative treatment. Participants were randomized to receive intradiskal PRP or contrast agent after provocative diskography. Data on pain, physical function, and participant satisfaction were collected at 1 week, 4 weeks, 8 weeks, 6 months, and 1 year. Participants in the control group who did not improve at 8 weeks were offered the option to receive PRP and subsequently followed. Functional Rating Index (FRI), Numeric Rating Scale (NRS) for pain, the pain and physical function domains of the 36-item Short Form Health Survey, and the modified North American Spine Society (NASS) Outcome Questionnaire were used. Forty-seven participants (29 in the treatment group, 18 in the control group) were analyzed by an independent observer with a 92% follow-up rate. Over 8 weeks of follow-up, there were statistically significant improvements in participants who received intradiskal PRP with regards to pain (NRS Best Pain) (P = .02), function (FRI) (P = .03), and patient satisfaction (NASS Outcome Questionnaire) (P = .01) compared with controls. No adverse events of disk space infection, neurologic injury, or progressive herniation were reported following the injection of PRP. Participants who received intradiskal PRP showed significant improvements in FRI, NRS Best Pain, and NASS patient satisfaction scores over 8 weeks compared with controls. Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up. Although these results are promising, further studies are needed to define the subset of participants most likely to respond to biologic intradiskal

A Prospective Randomized Study Comparing Disposable with Reusable Blades for a Morcellator Device.