scholarly journals ACROSTUDY: the first 5 years

2009 ◽  
Vol 161 (suppl_1) ◽  
pp. S19-S24 ◽  
Author(s):  
Peter J Trainer
Keyword(s):  
Tumour Size ◽  
Safety Data ◽  
Liver Function Tests ◽  
Dose Titration ◽  
Serious Adverse Events ◽  
Once Daily ◽  
Injection Site Reactions ◽  
The Mean ◽  
Magnetic Resonance Imaging Mri

ACROSTUDY is an observational registry intended to collect safety and efficacy data on pegvisomant therapy. A total of 792 patients have been enrolled, of whom 83% had commenced pegvisomant prior to recruitment. The mean follow-up is 1.66 years with the mean duration of pegvisomant therapy 3.31 years representing 2625 patient years of treatment. About 90% of patients were on once daily pegvisomant, and 67% were on monotherapy. Disappointingly, IGF1 was normalised in <70% of patients; furthermore, in 80% of patients with an elevated IGF1, the daily dose of pegvisomant was 20 mg or less. A total of 56 serious adverse events (AEs) were reported, of which 13 were related to pegvisomant. A total of 276 AEs were reported, of which 56 were considered related to pegvisomant. The AEs most frequently attributed to pegvisomant were disturbed liver function tests and injection site reactions. Magnetic resonance imaging (MRI) was available in 684 patients. A total of 411 patients had at least one MRI on pegvisomant compared with a baseline. In 31 patients, a decrease in tumour size has been reported, of whom 20 had previously received radiotherapy. An increase in tumour size has been reported and confirmed in 22 patients. In 11 patients, there was contradictory data on tumour size, while, in six patients, central review of the films failed to confirm increase in tumour size. In conclusion, the safety data are generally reassuring, while the IGF1 normalisation rate is disappointing, which probably reflects a failure of dose titration. Further effort is needed to understand the reasons for the failure of dose titration.

scholarly journals Flow diverter stents in the treatment of recanalized intracranial aneurysms

2021 ◽  
pp. 159101992199050
Author(s):  
Erol Akgul ◽  
Hasan Bilen Onan ◽  
Irem Islek ◽  
Mehmet Tonge ◽  
Yavuz Durmus ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Demographic Data ◽  
Previous Treatment ◽  
Flow Diverter ◽  
Serious Adverse Events ◽  
Clinical Complications ◽  
Tertiary Hospitals ◽  
The Mean ◽  
Technical Complication

Background We assessed the safety and efficacy of flow diverter stents (FDSs) in the treatment of recanalized or residual intracranial aneurysms treated endovascularly. Materials & Methods Patients whose recanalized or residual aneurysms were treated with FDSs in five tertiary hospitals were reviewed retrospectively. The patients’ demographic data, aneurysm characteristics, types of previous treatment, and clinical complications, or serious adverse events associated with FDSs, as well as the results of neurological and angiographic follow-up assessments, were recorded. Results Eighty-six patients (37 males) with 87 aneurysms were included in this study. Eighty (91.9%) aneurysms were in the anterior and seven (8.1%) in the posterior circulation. The initial treatment methods were the primary coiling or balloon remodeling technique in 69 (79.3%) and stent-assisted coiling in 18 (20.7%) aneurysms. The endovascular procedure was successful in all patients. Complications occurred in four patients, for a total complication rate of 4.6%. A technical complication developed in one patient (1.2%). An in-stent thrombosis treated with tirofiban was seen in two cases. Late in-stent stenosis exceeding 50% was treated with balloon angioplasty in one patient. The mean length of follow-up was 21.0 months. The first angiographic follow-up (3–6 months) revealed the complete occlusion of 74 aneurysms (85.1%). While 76 aneurysms (87.4%) were occluded at the last angiographic follow-up (mean: 26.0 months), 11 aneurysms (12.6%) were still filling. Morbimortality was zero. Conclusion The drawback of endovascular treatment is aneurysmal remnants or recurrences, which is safely and durably amenable to flow diversion.

scholarly journals 797. Management of Patients with Multiple Clostridioides difficile Infection Recurrences using a Tapered-Pulsed Fidaxomicin Strategy

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S441-S442
Author(s):  
Xing Tan ◽  
Andrew M Skinner ◽  
Benjamin Sirbu ◽  
Larry H Danziger ◽  
Dale N Gerding ◽  
...  
Keyword(s):  
First Episode ◽  
Initial Symptom ◽  
Once Daily ◽  
The Past ◽  
Clostridioides Difficile ◽  
Time To Recurrence ◽  
Clostridioides Difficile Infection ◽  
The Mean ◽  
Systemic Antibiotics

Abstract Background There is a paucity of data assessing outcomes of alternate fidaxomicin strategies in patients with recurrent Clostridioides difficile infection (rCDI). The objective of our study is to evaluate a tapered-pulsed (T-P) fidaxomicin regimen that was administered immediately following a course of CDI treatment with initial symptom resolution in patients with multiple rCDI. Methods We reviewed the characteristics and outcomes of 46 consecutive patients who received T-P fidaxomicin between January 1, 2014-June 30, 2019 in a specialty CDI clinic. The first episode in which fidaxomicin T-P was administered was analyzed. Failure was defined as the persistence of diarrhea and/or the need for additional CDI treatment at any time on T-P fidaxomicin. Sustained clinical cure (SCC) was defined as resolution of diarrhea without recurrence. Recurrence was defined as the return of diarrhea requiring retreatment with CDI therapy after completion of T-P fidaxomicin. Both SCC and recurrence were evaluated at 30 and 90 days after completion of T-P fidaxomicin. Results The mean±SD age of the 46 patients was 63.2±19.9 years, 71.7% were female, and the mean±SD CDI episodes within the past year was 3±1.4 . Most patients (73.9%) had previously failed a vancomycin tapered and/or pulsed regimen. Prior to administering T-P fidaxomicin, a treatment regimen was given to ensure resolution of symptoms. The CDI treatment most commonly used (58.7%) was vancomycin. The T-P fidaxomicin regimen used consisted of 200 mg given once daily for 7 days followed by 200 mg every other day for a median (min-max) duration of 33 (6-120) days. Two patients (4%) failed to respond to T-P fidaxomicin; 34 (74%) and 28 (61%) achieved SCC at 30 and 90 days, respectively. Among the 44 patients that successfully completed the T-P fidaxomicin regimen, recurrence developed in 10 (22.7%) and 16 (36.4%) of patients at 30 and 90 days, respectively, with a median (min-max) time to recurrence of 20 (3-87) days (Figure 1). Four patients with recurrence had received subsequent systemic antibiotics. Figure 1. Course of CDI therapy and follow-up Conclusion A tapered-pulsed fidaxomicin strategy may be effective in patients with multiply rCDI who are refractory to other treatments, including a vancomycin tapered and pulsed regimen. Disclosures Larry H. Danziger, PharmD, Merck (Speaker’s Bureau)

scholarly journals FXa Inhibition and Coagulation Changes During DVT Prophylaxis by Enoxaparin Over the Course of a 15-Day Follow-Up in Septic Patients

2009 ◽  
Vol 16 (5) ◽  
pp. 584-590 ◽  
Author(s):  
Zuzana Zenáhlíková ◽  
Jan Kvasnička ◽  
Zuzana Kudrnová ◽  
Magda Sudrová ◽  
Radka Brzežková ◽  
...  
Keyword(s):  
Severe Sepsis ◽  
Protein C ◽  
Factor Xa ◽  
Inclusion Criteria ◽  
C Reactive Protein ◽  
Once Daily ◽  
Reactive Protein ◽  
Factor Xa Inhibition ◽  
The Mean

The objective of our study was to examine the changes in coagulation parameters and inflammatory reaction over the course of 15 days in patients with severe sepsis. We tried to identify mechanisms by which sepsis-induced pathophysiological changes may influence the effectiveness of subcutaneously (SC) administered enoxaparin 40 mg once daily. A total of 16 patients (8 men, 8 women; age 35-83 years) meeting the inclusion criteria of severe sepsis were enrolled in this study. The follow-up was performed on days 1, 2, 3, 6, 9, 12, and 15 of hospitalization at the intensive care unit (ICU). Blood coagulation (activated partial thromboplastin time [aPTT], prothrombin time [PT], fibrinogen, antithrombin (AT), protein C [PC], D-dimer, fragment 1.2 [F1.2], factor Xa [FXa] inhibition) and inflammatory reactants (interleukin 6 [IL-6], C-reactive protein [CRP], orosomucoid, α-1-antitrypsin) were tested. The mean FXa inhibition was 0.17 (±0.17) IU/mL. The arbitrarily established range of FXa inhibition for prophylaxis, 0.2 to 0.4 IU/mL, was reached in 22 cases (20%), while in 74 cases (68%), it was below and in 13 cases (12%) above the aforementioned range. Factor Xa inhibition positively correlated with AT (r = .42; P < .001) and PC (r = .45; P < .001) activities. A negative correlation was found between the FXa inhibition and α-1-antitrypsin concentrations (r = —.33; P = .01) but only in the subgroup with α-1-antitrypsin concentrations ≥2.2 g/L. We confirmed that in most patients with sepsis, the prophylaxis with enoxaparin did not lead to the required FXa inhibition. The inhibition of FXa by enoxaparin depends mainly on the AT and PC activities.

scholarly journals Postarthroscopy Imaging in Femoroacetabular Impingement: Persistent Pain May Be Due to an Insufficient Correction of Preoperative Abnormalities

Joints ◽  
2017 ◽  
Vol 05 (01) ◽  
pp. 021-026 ◽  
Author(s):  
Cosimo Tudisco ◽  
Salvatore Bisicchia ◽  
Sandro Tormenta ◽  
Amedeo Taglieri ◽  
Ezio Fanucci
Keyword(s):  
Case Series ◽  
Persistent Pain ◽  
Retrospective Case ◽  
Level Of Evidence ◽  
Mean Values ◽  
Center Edge ◽  
Patient Groups ◽  
The Mean ◽  
Magnetic Resonance Imaging Mri

Purpose The purpose of this study was to evaluate the effect of correction of abnormal radiographic parameters on postoperative pain in a group of patients treated arthroscopically for femoracetabular impingement (FAI). Methods A retrospective study was performed on 23 patients affected by mixed-type FAI and treated arthroscopically. There were 11 males and 12 females with a mean age of 46.5 (range: 28–67) years. Center-edge (CE) and α angles were measured on preoperative and postoperative radiographic and magnetic resonance imaging (MRI) studies and were correlated with persistent pain at follow-up. Results The mean preoperative CE and α angles were 38.6 ± 5.2 and 67.3 ± 7.2 degrees, respectively. At follow-up, in the 17 pain-free patients, the mean pre- and postoperative CE angle were 38.1 ± 5.6 and 32.6 ± 4.8 degrees, respectively, whereas the mean pre- and postoperative α angles at MRI were 66.3 ± 7.9 and 47.9 ± 8.9 degrees, respectively. In six patients with persistent hip pain, the mean pre- and postoperative CE angles were 39.8 ± 3.6 and 35.8 ± 3.1 degrees, respectively, whereas the mean pre- and postoperative α angles were 70.0 ± 3.9 and 58.8 ± 2.6 degrees, respectively. Mean values of all the analyzed radiological parameters, except CE angle in patients with pain, improved significantly after surgery. On comparing patient groups, significantly lower postoperative α angles and lower CE angle were observed in patients without pain. Conclusion In case of persistent pain after arthroscopic treatment of FAI, a new set of imaging studies must be performed because pain may be related to an insufficient correction of preoperative radiographic abnormalities. Level of Evidence Level IV, retrospective case series.

scholarly journals Evaluation of endometrial thickness in postmenopausal women by using 3.0-T MRI

2014 ◽  
Vol 18 (1) ◽  
Author(s):  
Junko Nakamura ◽  
Takeharu Yoshikawa ◽  
Eriko Maeda ◽  
Hiroyuki Akai ◽  
Hiroshi Ohtsu ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Medical Records ◽  
Endometrial Thickness ◽  
Mr Images ◽  
Endometrial Thickening ◽  
3.0 T ◽  
The Mean ◽  
Magnetic Resonance Imaging Mri ◽  
3.0 T Mri

Background: The accepted threshold for normal endometrial thickness is 5 mm; lesions with endometrial thickness < 5 mm are considered benign, whilst those > 5 mm areconsidered malignant. However, endometrium ≥ 5 mm on transvaginal ultrasonography inpostmenopausal woman is considered as asymptomatic endometrial thickening. However, recent studies suggest that asymptomatic endometrial thickness of even 8 mm – 11 mm in postmenopausal women may be normal.Objectives: The present study investigated the normal endometrial thickness range in 297 asymptomatic postmenopausal women using 3.0-T magnetic resonance imaging (MRI) T2-weighted sagittal images measured retrospectively by a single radiologist.Method: The data were classified according to patient age and postmenopausal duration, and the medical records and follow-up MR images were reviewed to assess the clinical outcome.Results: The mean endometrial thickness was 2.4 ± 0.1 mm (range: 0.1–11.6). The endometriumin 21 of 297 subjects was ≥ 5 mm thick. Follow-up MR images were obtained in 17 of these 21 women, and their endometrial thickness was found to have decreased in all of them. To date,none of the subjects has been diagnosed with endometrial cancer.Conclusion: Although 5 mm is considered the conservative threshold of normal endometrial thickness on MRI of postmenopausal women, this figure should not, to avoid excessive false-positive diagnoses, be assumed as an indication of malignancy.

scholarly journals Selective Arterial Embolization of Renal Angiomyolipomas with a N-Butyl Cyanoacrylate-Lipiodol Mixture: Efficacy, Safety, Short- and Mid-Term Outcomes

2021 ◽  
Vol 10 (18) ◽  
pp. 4062
Author(s):  
François-Victor Prigent ◽  
Kévin Guillen ◽  
Pierre-Olivier Comby ◽  
Julie Pellegrinelli ◽  
Nicolas Falvo ◽  
...  
Keyword(s):  
Arterial Embolization ◽  
Volume Reduction ◽  
Renal Angiomyolipoma ◽  
Cyanoacrylate Glue ◽  
Selective Arterial Embolization ◽  
Before And After ◽  
The Mean ◽  
Magnetic Resonance Imaging Mri ◽  
Postembolization Syndrome

Selective arterial embolization (SAE) for renal angiomyolipoma (rAML) is effective to treat or prevent bleeding. We report our experience using a cyanoacrylate–Lipiodol mixture. We performed a single-center retrospective review of all rAMLs embolized with cyanoacrylate glue between July 2014 and June 2020. Demographics, tuberous sclerosis complex (TSC) status, clinical presentation, angiography features, and follow-up data were recorded. Pre- and post-procedure rAML sizes and volumes were estimated from computed tomography (CT) or magnetic resonance imaging (MRI) studies. Kidney function was assessed before and after the procedure. We identified 24 patients (22 females and 2 males, mean age 51 years) treated for 27 AMLs, either prophylactically (n = 20) or as an emergency (n = 4). Technical success was achieved for 25/27 AMLs; two patients, each with a single AML, required nephrectomy and repeated embolization, respectively. Major complications occurred in three patients and minor complications such as postembolization syndrome in 15 patients. AML volume reduction after embolization was 55.1% after a mean follow-up of 15 months (range, 1–72 months). Factors associated with greater volume reduction were a smaller percentage of fat (p = 0.001), larger initial rAML volume (p = 0.014), and longer follow-up (p = 0.0001). The mean creatinine level did not change after SAE. Embolization of rAMLs with a mixture of cyanoacrylate and Lipiodol is feasible, safe, and effective in significantly decreasing tumor volume.

scholarly journals Twelve-Month Follow-Up of Dexamethasone Implants for Macular Edema from Various Diseases in Vitrectomized and Nonvitrectomized Eyes

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Eduardo A. Novais ◽  
Mauricio Maia ◽  
Paulo Augusto de Arruda Mello Filho ◽  
João Rafael de Oliveira Dias ◽  
José Maurício B. B. Garcia ◽  
...  
Keyword(s):  
Macular Edema ◽  
Safety Data ◽  
Common Adverse Event ◽  
Dexamethasone Implant ◽  
Intravitreal Dexamethasone Implant ◽  
The Mean ◽  
Pro Re Nata ◽  
Intravitreal Dexamethasone

Purpose. To evaluate the best-corrected visual acuity (BCVA), central retinal thickness (CRT), and the number of dexamethasone implants needed to treat cystoid macular edema (CME) from various etiologies over 12 months in vitrectomized and nonvitrectomized eyes.Methods. This multicenter retrospective cohort study included 112 patients with CME secondary to retinal diseases treated pro re nata (PRN) with a 0.7 mg intravitreal dexamethasone implant for 12 months. The BCVA, CRT, adverse events, safety data, and number of implants were recorded.Results. Vitrectomized and nonvitrectomized eyes received means of three implants and one implant, respectively, over 12 months (P<0.001). The mean BCVA of all patients improved from 0.13 at baseline to 0.33 (P<0.001) 12 months after one (P=0.001), two (P=0.041), and three (P<0.001) implants but not four implants (P=0.068). The mean baseline CRT decreased significantly (P<0.001) from 463 to 254 microns after 12 months with one (P<0.001), two (P=0.002), and three (P=0.001) implants but not with four implants (P=0.114). The anatomic and functional outcomes were not significantly different between vitrectomized and nonvitrectomized eyes. Increased IOP was the most common adverse event (23.2%).Conclusions. Dexamethasone implant administered PRN improved VA and decreased CRT in CME, with possible long-term clinically relevant benefits for treating CME from various etiologies. Vitrectomized eyes needed more implants compared with nonvitrectomized eyes.

scholarly journals Comparison of the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma

2013 ◽  
Vol 5 (1) ◽  
pp. 75-80 ◽  
Author(s):  
Ashish Chander ◽  
H Kapoor ◽  
S Thomas
Keyword(s):  
Intraocular Pressure ◽  
Side Effect ◽  
Primary Open Angle Glaucoma ◽  
Open Angle Glaucoma ◽  
Open Angle ◽  
Efficacy And Safety ◽  
Once Daily ◽  
The Mean ◽  
To Receive

Purpose: To compare the efficacy and safety of bimatoprost (0.03 %) and travoprost (0.004 %) in patients with primary open angle glaucoma (POAG). Subjects and methods: Patients with POAG were randomized to receive either bimatoprost or travoprost once daily. Detailed ocular examination was done and intraocular pressure (IOP) was measured at 9.00 am, 1.00 pm and 4.00 pm at the baseline and at 1, 2, 4, 6 and 12 weeks of therapy. Results: A total of 31 patients were analysed. The patients were randomly divided into two groups (Bimatoprost group = 16; Travoprost group = 15). Both the groups had a statistically significant reduction from the baseline IOP at all follow up visits at 9.00 am, 1.00 pm and 4.00 pm. The mean IOP decreased from a baseline of 25 ± 2.32 mm Hg to 15.93 ± 1.79 mm Hg after 12 weeks in the bimatoprost group (p < 0.001), and from 24.2 ± 1.60 mm Hg to 16.53 ± 1.56 mm Hg in the travoprost group (p < 0.001). A better mean reduction of IOP was obtained with bimatoprost than with travoprost at the end of the study at 12 weeks (p = 0.03). Mild ocular redness was the commonest side effect in both the groups but was not significant in either group. Conclusion: Both drugs lowered IOP effectively but bimatoprost showed a greater reduction in the mean IOP than did travoprost at 12 weeks and both are safe for ocular use. Nepal J Ophthalmol 2013; 5(9):75-80 DOI: http://dx.doi.org/10.3126/nepjoph.v5i1.7831

Phase 1 Clinical Trial of Prion-Filtered Red Cell Concentrates (pfRCC) in Patients Requiring Allogeneic Blood Transfusion.

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 994-994
Author(s):  
Tracy Murphy ◽  
Mary R Cahill ◽  
Jim Fagan ◽  
Croxon Harry ◽  
Mohammed Khan ◽  
...  
Keyword(s):  
Blood Transfusion ◽  
Blood Donors ◽  
Phase 1 ◽  
Autologous Blood ◽  
Safety Data ◽  
Full Blood Count ◽  
Red Cell ◽  
Serious Adverse Events ◽  
Degree Of Protection

Abstract Background; Transmission of vCJD by blood transfusion from pre-symptomatic blood donors has occurred in 4 reported cases to date. Screening blood donors for infectivity is unlikely to be feasible for several years. Removing infectivity from blood using selective filtration may provide a useful degree of protection from transfusion transmission of the disease. A filter that may remove infectivity from red cell concentrates has been developed and trialed in volunteers receiving autologous blood. No studies have been carried out to date of pfRCC in allogeneic transfusions in the clinical setting. Aims; To establish safety and tolerability of transfusion of prion filtered red cell concentrates. Methods; Twenty patients scheduled to receive transfusion were recruited following ethical approval and with informed consent. Prion filtered units were prepared by the Irish Blood Transfusion Service. A mean loss of 9 gm of haemoglobin per unit of RCC occurred during the filtration process. Each patient received one unit of pfRCC, and a median of 2 units overall (range 1 to 4 units) per transfusion episode. A cross-match sample, full blood count (FBC), renal and liver profile was taken from each patient prior to transfusion. Patients were observed for adverse reactions. After 24 hours, FBC, renal and liver profile were repeated. Six weeks after the transfusion a further sample was tested for red cell antibodies. Six of these patients have consented to undergo re-transfusion with pfRCC. Two re-infusions have taken place uneventfully six months after the first exposure to pfRCC and 4 more are planned. Results No serious adverse events were encountered during the study, or at 24 hour and 6 week follow up after the initial transfusion episode. Mean haemoglobin increment per unit transfused was 0.68g (SD 0.45g; range −0.5 to 1.35g ). Recruitment and follow-up is ongoing in patients exposed to repeat transfusion challenge. Summary The first clinical transfusions of pfRCC were well tolerated. Two patients were rechallenged with transfusions of pfRCC without adverse effect. Further studies with transfusions of prion filtered red cells are now warranted to extend the safety data and to determine whether efficacy is comparable to standard transfusions in adult and paediatric populations.

scholarly journals Time to seroconversion of HBsAg to anti-HBs in individuals who lost HBsAg during follow-up

2016 ◽  
Vol 144 (12) ◽  
pp. 2648-2653 ◽  
Author(s):  
M. R. H. ROUSHAN ◽  
M. MOHAMMADPOUR ◽  
M. BAIANY ◽  
S. SOLEIMANI ◽  
A. BIJANI
Keyword(s):  
Hepatitis B ◽  
Surface Antigen ◽  
Hepatitis B Surface Antigen ◽  
Liver Function Tests ◽  
Hbsag Clearance ◽  
Positive Antibody ◽  
B Virus ◽  
The Mean ◽  
Cumulative Probabilities

SUMMARYTo determine the time to appearance of antibody against hepatitis B surface antigen (anti-HBs) after clearance of hepatitis B surface antigen (HBsAg) in chronically infected individuals, we followed up 3963 cases with positive antibody against hepatitis B e antigen (anti-HBe) from 1991 to 2014. Of these, 101 (67 males, 34 females) lost HBsAg. These serocleared cases were checked every 6-month interval regarding HBsAg, anti-HBs, liver function tests, and liver sonography. Hepatitis B virus DNA was assessed at the time of seroclearance or the appearance of anti-HBs. The mean age of these patients at entry to this study was 34·4 ± 13 years. The mean follow-up duration until seroclearance of HBsAg was 6·6 ± 4·3 years. After the mean follow-up of 43·7 ± 45 months, anti-HBs appeared in 64 (63·4%) cases. The cumulative probabilities of anti-HBs appearance for 2, 5 and 10 years were 24·3%, 58% and 78·2%, respectively. The appearance of anti-HBs was associated with age ⩾35 years and seroclearance of HBsAg (hazard ratio 1·96, 95% confidence interval 1·32–3·38,P= 0·016) but not with sex. The results show that anti-HBs may develop in 78·2% of cases within 10 years of HBsAg clearance. Age ⩾35 years at HBsAg loss was associated with earlier development of anti-HBs.

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