Σάββατο, 26 Ιανουαρίου 2019

Thoracoscopic truncal vagotomy versus surgical revision of the gastrojejunal anastomosis for recalcitrant marginal ulcers

Abstract

Introduction

Marginal ulcer is a common complication following Roux-en-Y gastric bypass with incidence rates between 1 and 16%. Most marginal ulcers resolve with medical management and lifestyle changes, but in the rare case of a non-healing marginal ulcer there are few treatment options. Revision of the gastrojejunal (GJ) anastomosis carries significant morbidity with complication rates ranging from 10 to 50%. Thoracoscopic truncal vagotomy (TTV) may be a safer alternative with decreased operative times. The purpose of this study is to evaluate the safety and effectiveness of TTV in comparison to GJ revision for treatment of recalcitrant marginal ulcers.

Methods

A retrospective chart review of patients who required surgical intervention for non-healing marginal ulcers was performed from 1 September 2012 to 1 September 2017. All underwent medical therapy along with lifestyle changes prior to intervention and had preoperative EGD that demonstrated a recalcitrant marginal ulcer. Revision of the GJ anastomosis or TTV was performed. Data collected included operative time, ulcer recurrence, morbidity rate, and mortality rate.

Results

Twenty patients were identified who underwent either GJ revision (n = 13) or TTV (n = 7). There were no 30-day mortalities in either group. Mean operative time was significantly lower in the TTV group in comparison to GJ revision (95.7 ± 16 vs. 227.5 ± 89 min, respectively, p = 0.0022). Recurrence of ulcer was not significant between groups and occurred following two GJ revisions (15%) and one TTV (14%). Complication rates were not significantly different with 62% in the GJ revision group and 57% in the TTV group. Approximately 38% (5/13) of GJ revisions and 28% (2/7) of TTV patients experienced complications with Clavien–Dindo scores > 3. There was no difference in postoperative symptoms between both groups.

Conclusions

Our results demonstrate that thoracoscopic vagotomy may be a better alternative with decreased operative times and similar effectiveness. However, further prospective observational studies with a larger patient population would be beneficial to evaluate complication rates and ulcer recurrence rates between groups.



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Closed Facebook™ groups and CME credit: a new format for continuing medical education

Abstract

Background

The International Hernia Collaboration (IHC) is a closed Facebook™ group that allows international surgeons to post clinical questions and exchange transparent feedback with the intent to optimize patient outcomes. Despite the educational value of closed FB groups, CME credits have not been available to members. To determine feasibility of and user interest in earning CME credit through social media, the IHC piloted a series of expert lectures followed by an interactive Facebook Live session as a novel pathway offering CME credit.

Methods

Nine monthly lectures and Facebook Live sessions were presented. CME credit was offered for the final seven lectures. Participation in the form of views, comments, and likes was quantified by a Facebook analytics service and an engagement score, defined as [(the number of comments × 2) + (the number of reactions)], was calculated for each lecture and Facebook Live session. CME credit was obtained through a two-question quiz.

Results

Of 5400 + Facebook members of the IHC, an average of 1116 (20.4 ± 4.0%) viewed the live session event following each lecture (n = 9 events). The average Facebook engagement score for Facebook Live was 259 ± 75, a significant difference with the average Facebook engagement score on the IHC (40.8) over the same time period (p < 0.001). On average, 16 users [range 8–35, (n = 7 events)] claimed CME credit for each educational series.

Conclusions

Closed Facebook groups can be a useful media to offer educational content and CME credit. The pilot IHC Lecture and Facebook Live series offering CME credit resulted in significantly more engagement amongst its members compared to other posts during the same time period. A small portion of participants qualified for CME credit. Future social media educational series may increase participants qualifying for CME by streamlining the interface to obtain CME credit.



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Laparoscopic duodenum-preserving total pancreatic head resection: a novel surgical approach for benign or low-grade malignant tumors

Abstract

Background

Duodenum-preserving total pancreatic head resection (DPPHRt) is an accepted alternative surgical procedure for benign or low-grade malignant tumors of the pancreatic head by preserving the duodenum with its intact blood supply from the pancreatic duodenal arterial arcade. This study describes our experience in laparoscopic DPPHRt (LDPPHRt). To our knowledge, this is the first description of this novel minimally invasive operation.

Methods

From August 2016 to May 2017, all consecutive patients who underwent LDPPHRt for pancreatic head lesions at the HPB Surgery Department, Sun Yat-Sen Memorial Hospital in Guangzhou, China were enrolled into this retrospective study.

Results

There were ten women and two men. The average age was 37.3 years (range 8–61 years). The average diameter of the pancreatic head lesions on pre-operative CT/MR was 3.7 cm (range 2–4.8 cm). All the LDPPHRt procedures were performed successfully. There was no peri-operative death. The average operative time was 272.5 min (range 210–320 min). The average blood loss was 215 ml (range 50–450 ml). Post-operative complications included pancreatic fistula grade B (two patients, or 16.7%) and biliary fistula (two patients, or 16.7%). All the complications responded well to conservative treatment. The mean post-operative hospital stay was 11.5 days (range 6–25 days).

Conclusions

LDPPHRt provided a minimally invasive approach with good organ-preservation for benign or low-grade malignant tumors of the pancreatic head. The long-term oncological outcomes, and the exocrine and endocrine pancreatic functions after this operation require further studies.



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EUS-guided irreversible electroporation using endoscopic needle-electrode in porcine pancreas

Abstract

Background

Endoscopic irreversible electroporation (IRE) can be performed using a flexible, thin, needle-shaped electrode for an endoscopic ultrasound (EUS)-guided procedure. This study aimed to evaluate the feasibility and efficacy of performing EUS-guided IRE with endoscopic needle-electrode in porcine pancreas.

Methods

Experimental endoscopic IRE on the pancreas were performed by EUS-guided approach in three pigs and compared with surgical approach in three pigs. The animals were killed after 24 h and their pancreases collected.

Results

IRE ablation using endoscopic needle-electrode was successful technically in EUS-guided approaches for the pancreas. Immediately following IRE, the ablated pancreatic tissue showed no gross change except focal hemorrhage. H&E staining presented a well-demarcated ablation site measuring 1.0–1.5 cm in diameter in the pancreas. TUNEL immunohistochemistry showed diffuse cell death along the puncture site 24 h after IRE. No complication was observed in pigs after endoscopic IRE ablation.

Conclusion

EUS-guided IRE ablation was feasible and effective for pancreas using the newly developed device.



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A task and performance analysis of endoscopic submucosal dissection (ESD) surgery

Abstract

Background

ESD is an endoscopic technique for en bloc resection of gastrointestinal lesions. ESD is a widely-used in Japan and throughout Asia, but not as prevalent in Europe or the US. The procedure is technically challenging and has higher adverse events (bleeding, perforation) compared to endoscopic mucosal resection. Inadequate training platforms and lack of established training curricula have restricted its wide acceptance in the US. Thus, we aim to develop a Virtual Endoluminal Surgery Simulator (VESS) for objective ESD training and assessment. In this work, we performed task and performance analysis of ESD surgeries.

Methods

We performed a detailed colorectal ESD task analysis and identified the critical ESD steps for lesion identification, marking, injection, circumferential cutting, dissection, intraprocedural complication management, and post-procedure examination. We constructed a hierarchical task tree that elaborates the order of tasks in these steps. Furthermore, we developed quantitative ESD performance metrics. We measured task times and scores of 16 ESD surgeries performed by four different endoscopic surgeons.

Results

The average time of the marking, injection, and circumferential cutting phases are 203.4 (σ: 205.46), 83.5 (σ: 49.92), 908.4 s. (σ: 584.53), respectively. Cutting the submucosal layer takes most of the time of overall ESD procedure time with an average of 1394.7 s (σ: 908.43). We also performed correlation analysis (Pearson's test) among the performance scores of the tasks. There is a moderate positive correlation (R = 0.528, p = 0.0355) between marking scores and total scores, a strong positive correlation (R = 0.7879, p = 0.0003) between circumferential cutting and submucosal dissection and total scores. Similarly, we noted a strong positive correlation (R = 0.7095, p = 0.0021) between circumferential cutting and submucosal dissection and marking scores.

Conclusions

We elaborated ESD tasks and developed quantitative performance metrics used in analysis of actual surgery performance. These ESD metrics will be used in future validation studies of our VESS simulator.

Graphical abstract



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Regression of intestinal metaplasia following magnetic sphincter augmentation device placement

Abstract

Background

Intestinal metaplasia represents an esophageal mucosal transformation due to uncontrolled gastroesophageal reflux disease. Fundoplication has been shown to lead to regression of disease. Magnetic sphincter augmentation is an alternative to fundoplication that effectively treats reflux disease. Initially, patients with intestinal metaplasia were not considered candidates for device placement, so outcomes in these patients are unknown.

Methods

A retrospective review of all patients who underwent magnetic sphincter augmentation device placement between 2007 and 2017 was performed. All patients underwent pre-operative endoscopic evaluation and were categorized as having ultra-short segment (less than 1 cm), short-segment (1–3 cm), or long-segment (greater than or equal to 3 cm) disease. To be included in the study, pathologic examination demonstrating columnar mucosa with goblet cells was required.

Results

There were 86 patients with biopsy-proven non-dysplastic intestinal metaplasia. 35 patients had ultra-short segment, 37 patients had short-segment, and 14 patients had long-segment disease. At a median follow-up of 1.2 years, 67/86 (78%) patients completed endoscopic follow-up. 48/67 (71.6%) patients had regression of intestinal metaplasia. There was no progression to dysplasia or carcinoma. Patients with abnormal post-operative DeMeester scores were less likely to have regression of disease. Regression was more likely in the ultra-short segment (82.8%) and short-segment (73.3%) groups compared to the long-segment group (25.0%).

Conclusions

Magnetic sphincter augmentation is effective in achieving regression of intestinal metaplasia. Longer-term follow-up is needed to assess durability of effect and make meaningful comparisons to fundoplication.



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Outcome of endoscopic small-bore naso-jejunal tube stenting in early postoperative jejunal limb obstruction after gastrectomy

Abstract

Background

Early postoperative jejunal limb obstruction is a rare complication following gastric surgery with jejunal reconstruction. The condition is mainly attributed to kinking of the jejunal limbs, gastrojejunal or jejunojejunal anastomosis. There has been currently limited information regarding the safety and efficacy of endoscopic treatment in patients with early postoperative jejunal obstruction. We aimed to investigate outcome of endoscopic small-bore naso-jejunal (N-J) tube stenting across the obstructed segment in patients with uncomplicated early postoperative partial jejunal limb obstruction.

Methods

All patients diagnosed of jejunal limb obstruction within 8 weeks after gastric-related surgery were reviewed. Patients with malignant obstruction, complete closed loop obstruction, sepsis, instability, intestinal strangulation, or perforation were excluded. All patients underwent endoscopic dekinking and stenting for 2 weeks with an N-J tube using 16-French single lumen plastic nasogastric tube across the obstruction segment after failed conservative therapy. Successful N-J tube placement across the obstruction point was confirmed by contrast study. Complications, technical, and clinical success were evaluated.

Results

Twenty-one patients met the criteria. The primary operations were 7 partial gastrectomies with Billroth-II reconstruction, 7 total or partial gastrectomies with Roux-en-Y reconstruction and 4 Whipple's operations, 2 bypass procedures, and 1 proximal gastrectomy. Most common site of obstruction was jejunojejunal anastomosis and gastrojejunal anastomosis following Roux-en-Y and Billroth-II reconstruction, respectively. Endoscopic N-J tube placement was technically successful in 20 out of 21 patients (95%). One patient had aspirated pneumonia. There was no procedure-related mortality. After N-J tube removal, clinical success was demonstrated in 19 out of 20 patients (95%) at the median duration of 6 months. One patient underwent reoperation due to repeated tube dislodgement.

Conclusions

Endoscopic stenting with a 16-F naso-jejunal tube across the angulated segment is safe and effective for treatment of patients with uncomplicated early postoperative partial jejunal limb obstruction following gastric surgery with jejunal reconstruction.



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Implementation of 3D printed superior mesenteric vascular models for surgical planning and/or navigation in right colectomy with extended D3 mesenterectomy: comparison of virtual and physical models to the anatomy found at surgery

Abstract

Background

Three-dimensional (3D) printing technology has recently been well approved as an emerging technology in various fields of medical education and practice; e.g., there are numerous studies evaluating 3D printouts of solid organs. Complex surgery such as extended mesenterectomy imposes a need to analyze also the accuracy of 3D printouts of more mobile and complex structures like the diversity of vascular arborization within the central mesentery. The objective of this study was to evaluate the linear dimensional anatomy landmark differences of the superior mesenteric artery and vein between (1) 3D virtual models, (2) 3D printouts, and (3) peroperative measurements.

Methods

The study included 22 patients from the ongoing prospective multicenter trial "Safe Radical D3 Right Hemicolectomy for Cancer through Preoperative Biphasic MDCT Angiography," with preoperative CT and peroperative measurements. The patients were operated in Norway between January 2016 and 2017. Their CT datasets underwent 3D volume rendering and segmentation, and the virtual 3D model produced was then exported for stereolithography 3D printing.

Results

Four parameters were measured: distance between the origins of the ileocolic and the middle colic artery, distance between the termination of the gastrocolic trunk and the ileocolic vein, and the calibers of the middle colic and ileocolic arteries. The inter-arterial distance has proven a strong correlation between all the three modalities implied (Pearson's coefficient 0.968, 0.956, 0.779, respectively), while inter-venous distances showed a weak correlation between peroperative measurements and both virtual and physical models.

Conclusion

This study showed acceptable dimensional inter-arterial correlations between 3D printed models, 3D virtual models and authentic soft tissue anatomy of the central mesenteric vessels, and weaker inter-venous correlations between all the models, reflecting the highly variable nature of veins in situ.



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Surgical techniques for advanced transverse colon cancer using the pincer approach of the transverse mesocolon

Abstract

Background

Laparoscopic surgery for colorectal cancer, not only early cancer but also advanced cancer, has become standardized by some randomized controlled studies. However, cases involving advanced transverse colon cancer were excluded from these studies due to the technical difficulty of the surgery. Hence, laparoscopic surgery for advanced transverse colon cancer is still a theme that we need to overcome. To solve these issues, it is necessary to establish a standardized approach and surgical technique.

Surgical techniques

The advantage of our method, which approaches from both sides of the transverse mesocolon, is that it is easier to achieve hemostasis when active bleeding occurs because this approach provides space for ligating and sealing. This allows the surgeon to perform lymphadenectomy around the superior mesenteric artery and vein.

Conclusions

We introduced the usefulness of the "Pincer approach of the transverse mesocolon" to standardize laparoscopic surgery for advanced transverse colon cancer.



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Colorectal endoscopic submucosal dissection using novel articulating devices: a comparative study in a live porcine model

Abstract

Background and aims

Colonic endoscopic submucosal dissection (ESD) is time-consuming and bears a high risk of perforation. The aim of the present study was to compare the safety and efficacy between novel articulating devices and conventional ESD in live porcine colon models.

Methods

Thirty ESDs in ten pigs were carried out at three different locations (15, 25, and 35 cm from the anus) by the conventional method (n = 15) and by the new method (n = 15). Procedure times, adverse events (perforation, bleeding), and damage to the muscular layer were recorded, and the ESD time per unit area of the specimens was calculated.

Results

The perforation rate using the conventional method was 6.7% (1/15), whereas that using the new method was 0.0%. The number of sites of muscular damage was significantly lower in the new than conventional method (6 vs. 37, respectively; P = 0.024). The mean procedure time was significantly shorter in the new than conventional method (4.6 ± 2.0 vs. 7.0 ± 4.1 min/cm2, respectively; P = 0.042).

Conclusions

Use of the new ESD method allows for reduced adverse events and a shortened resection time.



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New experience of endoscopic papillectomy for ampullary neoplasms

Abstract

Aim

To establish the clinical value of endoscopic papillectomy for duodenal papillary tumor based on endoscopic and clinical characteristics.

Patients and methods

This single-center, retrospective study included 110 patients with duodenal papillary tumor who underwent endoscopic papillectomy between January 2006 and April 2017 at the gastrointestinal endoscopic center of the Chinese PLA General Hospital. Clinical data, postoperative pathology, procedure-related complications, and therapeutic outcomes were analyzed.

Results

Endoscopic papillectomy was technically feasible in all patients, and was mainly performed by four experienced endoscopists. The primary success rate of endoscopic papillectomy for ampullary neoplasms was 78.2%. A total of 13 patients experienced recurrence during a mean follow-up period of 16.28 months (range 6–132 months), the predictive factors that were related to recurrence were complete resection (53.8% vs. 94.2%; P = 0.001), and final pathology findings (P = 0.001). Delayed hemorrhage, the most common procedure-related complication, occurred in 20% (22/110) of patients and was significantly related to intraoperative bleeding (P = 0.042). Pancreatitis was the second most common complication, which was closely related to intraoperative bleeding requiring intervention (P = 0.040) and larger tumor size (P = 0.044). Histology, type of resection, stent placement, sphincterotomy, and duration of procedure were not related to post-procedure hemorrhage or pancreatitis. Older age (63.7 ± 13.5 vs. 57.4 ± 12.2; P = 0.033), jaundice (47.8% vs. 13.8%; P = 0.001), endoscopic forceps biopsy diagnosis of high-grade intraepithelial neoplasia (82.6% vs. 14.9%; P = 0.001), tumor size ≥ 2 cm (60.9% vs. 34.5%; P = 0.022), and dilation of the bile duct (34.8% vs. 9.2%; P = 0.006) were clinical features for ampullary carcinoma. The rate of complete resection (52.2% vs. 92.0%; P = 0.001) and recurrence (34.8% vs. 6.8%; P = 0.001) were also related to the diagnosis of ampullary carcinoma at final pathology.

Conclusions

Endoscopic papillectomy is a feasible and reasonable option for both diagnosis and treatment of tumors of the duodenal papilla in properly selected patients.



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Preoperative anemia: a common finding that predicts worse outcomes in patients undergoing primary hiatal hernia repair

Abstract

Background

The increased incidence of anemia in patients with hiatal hernias (HH) and resolution of anemia after HH repair (HHR) have been clearly demonstrated. However, the implications of preoperative anemia on postoperative outcomes have not been well described. In this study, we aimed to identify the incidence of preoperative anemia in patients undergoing primary HHR at our institution and sought to determine whether preoperative anemia had an impact on postoperative outcomes.

Methods

Using our IRB-approved institutional HH database, we retrospectively identified patients undergoing primary HHR between January 2011 and April 2017 at our institution. We identified patients with anemia, defined as serum hemoglobin levels less than 13 mg/dL in men and 12 mg/dL in women, measured within two weeks prior to surgery, and compared this group to a cohort of patients with normal preoperative hemoglobin. Perioperative outcomes analyzed included estimated blood loss (EBL), operative time, perioperative blood transfusions, failed postoperative extubation, intensive care unit (ICU) admission, postoperative complications, length of stay (LOS), and 30-day readmission. Outcomes were compared by univariable and multivariable analyses, with significance set at p < 0.05.

Results

We identified 263 patients undergoing HHR. The median age was 66 years and most patients were female (78%, n = 206). Seventy patients (27%) were anemic. In unadjusted analyses, anemia was significantly associated with failed postoperative extubation (7 vs. 2%, p = 0.03), ICU admission (13 vs. 5%, p = 0.03), postoperative blood transfusions (9 vs. 0%, p < 0.01), and postoperative complications (41 vs. 18%, p < 0.01). On adjusted multivariable analysis, anemia was associated with 2.6-fold greater odds of postoperative complications (OR 2.57; 95% CI 1.36–4.86; p < 0.01).

Conclusions

In this study, anemia had a prevalence of 27% in patients undergoing primary HHR. Anemic patients had 2.6-fold greater odds of developing postoperative complications. Anemia is common in patients undergoing primary HHR and warrants consideration for treatment prior to elective repair.



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Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities

Abstract

Background

One-Anastomosis Gastric Bypass (OAGB) has exponentially increased in the last decade, as it is associated with very low complications, mortality, readmissions and reoperations rates, and shows excellent short- and long-term benefits of weight loss and resolution of comorbidities. The aim of this study was to compare the effect of SG, RYGB, and OAGB, on short- and long-term weight loss and comorbidities resolution.

Methods

A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB, and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT), and dyslipidemia (DL) were assessed.

Results

600 patients were included in the study, 200 in each group. Follow-up rate at 5 years postoperatively was 91% in SG group, 92% in RYGB, and 90% in OAGB. OAGB achieves significantly greater EBMIL than RYGB and SG at 1, 2, and 5 years (p < 0.001, respectively). At 5 years, OAGB achieves significantly greater remission of T2DM (p = 0.027), HT (p = 0.006), and DL (p < 0.001) than RYGB and SG. RYGB did not show significant superiority than SG in short- and long-term remission of T2DM and HT, but achieves greater remission of DL (p < 0.001).

Conclusion

OAGB achieves superior mid- and long-term weight loss than RYGB and SG. There are no significant differences in weight loss between SG and RYGB at 1, 2, and 5 years. OAGB achieves better short- and long-term resolution rates of DM, HT, and DL than SG and RYGB. RYGB and SG obtain similar T2DM and HT remissions, but RYGB reaches significantly greater rates of DL remission. ClinicalTrials.gov Identifier: NCT03467646.



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Fluorescence lymphangiography-guided full-thickness oncologic gastric resection

Abstract

Background

We aimed to assess the feasibility of a novel hybrid endoscopic/laparoscopic non-exposed, full-thickness, single-wall gastric resection technique guided by a fluorescence lymphangiography to identify the lymphatic pathway and the sentinel node basin.

Methods

Eight large white pigs (4 acute and 4 survival models) were included. Indocyanine green was injected submucosally around a pseudo-tumor at four points (1 ml, 0.1 mg/ml). The lymphatic spreading pathway was identified by the means of near-infrared (NIR) laparoscopic camera, and the resection line was planned outside of the fluorescent signals, to include all the potential lymphatic channels. Lymph node (LN) dissection was performed at greater curvature side and the infrapyloric area preserving the infragastric artery for all pigs. At the lesser curvature, 3–4 branches of the gastric artery were preserved in all acute and in two survival (group A), while in the remaining animals, 1–2 branches were preserved (group B). Perfusion of the remaining stomach was examined by NIR angiography. The gastric motility and function were evaluated by the means of a dynamic MRI immediately after the procedure and repeated after 1 week in surviving animals.

Results

The hybrid full-thickness resection with bilateral sentinel LN basin dissection were successfully performed with no intra-operative or post-operative complications. The removed specimen was including all the area with florescent signal. The remaining stomach demonstrated a good perfusion at the NIR angiography. The dynamic MRI revealed a preserved emptying function in the acute animals and in the group A, and a loss of function in the group B.

Conclusions

Fluorescence-lymphangiography guided hybrid resection was feasible to remove a relatively large part of the stomach including the lymphatic spreading pathway and sentinel basin. The extent of dissection in the lesser curvature side can affect the post-operative function and further researches are warranted to optimize the concept.



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A systematic review of the learning curve in robotic surgery: range and heterogeneity

Abstract

Background

With the rapid adoption of the robotic surgery, more and more learning curve (LC) papers are being published but there is no set definition of what should constitute a rigorous analysis and represent a true LC. A systematic review of the robotic surgical literature was undertaken to determine the range and heterogeneity of parameters reported in studies assessing the LC in robotic surgery.

Methods

The search was conducted in July 2017 in PubMed. All studies reporting a LC in robotic surgery were included. 268 (25%) of the identified studies met the inclusion criteria.

Results

102 (38%) studies did not define nor explicitly state the LC with appropriate evidence; 166 studies were considered for quantitative analysis. 46 different parameters of 6 different outcome domains were reported with a median of two parameters (1–8) and 1 domain (1–5) per study. Overall, three domains were only technical and three domains were both technical and clinical/patient-centered outcomes. The two most commonly reported domains were operative time [146 studies (88%)] and intraoperative outcomes [31 studies (19%)]. Postoperative outcomes [16 studies (9%)] and surgical success [11 studies (7%)] were reported infrequently. Purely technical outcomes were the most frequently used to assess LC [131 studies (79%)].

Conclusions

The outcomes reported in studies assessing LC in robotic surgery are extremely heterogeneous and are most often technical indicators of surgical performance rather than clinical and patient-centered outcomes. There is no single outcome that best represents the surgical success. A standardized multi-outcome approach to assessing LC is recommended.



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Robotic transanal minimally invasive surgery (TAMIS) with the newest robotic surgical platform: a multi-institutional North American experience

Abstract

Background

Transanal minimally invasive surgery (TAMIS) offers intra-luminal full-thickness excision of rectal neoplasia. Robotic TAMIS (RT) allows for greater versatility in motion while operating in the limited space of the rectum. We present our experience with this technique in practice using the DaVinci Xi™ platform.

Method

This is a multi-institutional retrospective analysis for patient undergoing Robotic TAMIS for resection of rectal lesions at two tertiary referral hospitals in the United States. Morbidity, mortality, anatomic measurement, and final pathology were analyzed.

Results

Thirty-four patients planned for Robotic TAMIS were identified. Average follow-up was 188 days. The average BMI was 29.5 ± 5.9. All patients had an American Society of Anesthesiologist (ASA) Class of 2 or greater and 21 (62%) were ASA 3 or greater. Rectal lesions located from 2 to 15 cm from the dentate line were successfully resected. Lesions up to 4.5 cm in the longest dimension were successfully resected. The average operative time was 100 ± 70 min, which correlated to a robotic console time of 76 ± 67 min. Patients were placed in Lithotomy in 32 (94%) cases and were prone in only 2 (6%) cases. There were no intraoperative complications or conversions to another technique. The only postoperative complication was a medically managed Clostridium difficile infection in 1 patient. Three patients were upstaged to T2 on final pathology and underwent successful formal resections. BMI was a statistically significant predictor of a longer operation.

Conclusions

With increased reach and operative range of motion, Robotic TAMIS is a safe and effective method for excising low-risk rectal neoplasia with a wide range of anatomical measurements. Higher BMI is a significant predictor of a longer and likely more challenging operation.



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Potential biomarkers to predict outcome of faecal microbiota transfer for recurrent Clostridioides difficile infection

Faecal microbiota transplantation (FMT) has proven high clinical efficacy in the management of recurrent Clostridioides difficile infection (rCDI) with cure rates of over 80% after a single treatment. Nevertheless, the reasons for failure in the remaining 20% remain elusive. The aim of the present study was to investigate different potential predictors of response to FMT.

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Subthalamic and pallidal oscillatory activity in patients with Neurodegeneration with Brain Iron Accumulation type I (NBIA-I)

Publication date: Available online 25 January 2019

Source: Clinical Neurophysiology

Author(s): Julius Huebl, Anahita Poshtiban, Christof Brücke, Sandy Siegert, Antje Bock, Henryk Koziara, Tomasz Kmiec, Rafał Rola, Tomasz Mandat, Andrea A. Kühn

Abstract
Objectives

Neurodegeneration with Brain Iron Accumulation type I (NBIA-I) is a rare hereditary neurodegenerative disorder with pallidal degeneration leading to disabling generalized dystonia and parkinsonism. Pallidal or subthalamic deep brain stimulation can partially alleviate motor symptoms. Disease-specific patterns of abnormally enhanced oscillatory neuronal activity recorded from the basal ganglia have been described in patients with movement disorders undergoing deep brain stimulation (DBS). Here we studied oscillatory activity recorded from the internal globus pallidus (GPi) and the subthalamic nucleus (STN) to characterize neuronal activity patterns in NBIA-I.

Methods

We recorded local field potentials (LFP) from DBS electrodes in 6 juvenile patients with NBIA-I who underwent functional neurosurgery. Four patients were implanted in the STN and two patients in the GPi. Recordings were performed during wakeful rest. An FFT-based approach was used to analyze the power spectrum in the target area.

Results

In all patients we found distinct peaks in the low frequency (7-12 Hz) and in 5 out 6 also in the beta frequency range (15-30 Hz) with the largest beta peak in the patient that presented with the most prominent bradykinesia. No distinct peaks occurred in the gamma frequency range (35-100 Hz). The oscillatory pattern did not differ between STN and GPi.

Conclusions

Here we show for the first time the oscillatory activity pattern in the STN and the GPi in juvenile patients with dystonia plus syndrome due to NBIA-I. The low frequency peak we found is in line with previous studies in patients with isolated idiopathic dystonia. In our cohort, the pallidal beta band activity may be related to more severe motor slowing in dystonia plus syndrome such as NBIA-I.

Significance

Our results further support the link between hyperkinetic motor symptoms such as dystonia and enhanced basal ganglia low frequency activity irrespective of the underlying etiology of dystonia.



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Cortical inhibitory dysfunction in epilepsia partialis continua: a high frequency oscillation somatosensory evoked potential study

Publication date: Available online 25 January 2019

Source: Clinical Neurophysiology

Author(s): Angelo Insola, Vincenzo Di Lazzaro, Giovanni Assenza

Abstract
Objective

The pathophysiology of epilepsia partialis continua (EPC) is still unclear, a thalamo-cortical circuit dysfunction has been hypothesized.

The aim of present study is the functional evaluation of the thalamo-cortical network in EPC by means of the study of low- and high- frequency somatosensory evoked potentials (LF-SEP and HF-SEP).

Methods

Median LF-SEP and HF-SEP were recorded in 3 patients with EPC and in 2 patients with rolandic lesions without EPC (non-EPC). Recording electrodes were placed on P3, C3, F3 and P4, C4, F4 of scalp regions. HF-SEP were obtained by an offline 400-800 Hz filtering of P3-F3 and P4-F4 traces.

Results

In EPC patients, we found a significant suppression of post-synaptic HF-SEP burst and an amplitude reduction of the P24 wave of the LF-SEPs. Both these components are related to cortical inhibitory interneuron activity. HF-SEP and LF-SEP were normal in non-EPC patients.

Conclusion

The different results obtained in patients with a rolandic lesion with and without EPC supports the hypothesis that EPC might be correlated to a dysfunction of gabaergic interneurons of a cortical sensory-motor network.

Significance

Our results might contribute to the understanding of the physiological basis of the cortical dysfunction causing epilepsia partialis continua.



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Enhancement of repeated applications of chelates on phytoremediation of uranium contaminated soil by Macleaya cordata

Publication date: April 2019

Source: Journal of Environmental Radioactivity, Volumes 199–200

Author(s): Nan Hu, Tao Lang, Dexin Ding, Jingsong Hu, Changwu Li, Hui Zhang, Guangyue Li

Abstract

A greenhouse pot experiment was performed to investigate the enhancement of repeated applications of citric acid (CA), ethylenediamine disuccinic acid (EDDS), and Oxalic acid (OA) on phytoremediation of uranium (U) contaminated soil by Macleaya Cordata. The chelates followed the order CA > EDDS > OA in terms of the enhancement on uranium uptake by M. cordata. The repeated applications of the chelates were found to be more effective than the one time application at the equal dose as the U concentration of soil solution increased significantly from the 8th to 14th day. The repeated applications of 10 mmol kg-1 CA promoted the solubilization of U in the U-contaminated soil by significantly decreasing the pH of soil solution, achieved the maximum U concentration of soil solution (1463.6 µg L−1), bioconcentration factors (BCFs, 11.4), bioaccumulation factors (BAFs, 21.4) and transfer factors (TFs, 1.9), which were 215.2, 5.7, 30.6 and 16.3 times as compared with the control group, respectively. The three applied chelates significantly affected the activities of the antioxidant enzymes in the leaves. Repeated applications of CA further enhanced the activities of the antioxidant enzymes in the leaves of M. cordata as compared with the control, EDDS and OA, mitigated the oxidative stress induced by uranium and chelates, and maximized the enhancement on the uranium uptake, which will be beneficial for the enhancement on the phytoremediation of uranium contaminated soil by U hyperaccumulating plants. These results indicated that the phytoavailability of uranium in soil solution as well as the accumulation of U by M. cordata were both significantly increased after repeated applications of CA, and that the repeated applications of 10 mmol kg-1 CA increased the activities of the antioxidant enzymes and promoted U accumulation by M. cordata. The study provided an environmentally friendly alternative for the enhancement on the phytoremediation of uranium contaminated soil using M. cordata.



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Transcranial direct current stimulation for the treatment of motor impairment following traumatic brain injury

After traumatic brain injury (TBI), motor impairment is less common than neurocognitive or behavioral problems. However, about 30% of TBI survivors have reported motor deficits limiting the activities of daily...

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Improving walking ability in people with neurological conditions: A theoretical framework for biomechanics driven exercise prescription

Publication date: Available online 26 January 2019

Source: Archives of Physical Medicine and Rehabilitation

Author(s): Gavin Williams, Leanne Hassett, Ross Clark, Adam Bryant, John Olver, Meg E. Morris, Louise Ada

Abstract

The purpose of this paper is to discuss how knowledge of the biomechanics of walking can be used to inform the prescription of resistance exercises for people with mobility limitations. Muscle weakness is a key physical impairment that limits walking in commonly occurring neurological conditions such as cerebral palsy, traumatic brain injury and stroke. Few randomised trials to date have shown conclusively that strength training improves walking in people living with these conditions. This appears to be because 1) the most important muscle groups for forward propulsion when walking have not been targeted for strengthening, and 2) strength training protocols have focused on slow and heavy resistance exercises, which do not improve the fast muscle contractions required for walking. We propose a theoretical framework to improve exercise prescription by integrating the biomechanics of walking with the principles of strength training outlined by the American College of Sports Medicine (ACSM), to prescribe exercises that are specific to improving the task of walking. The high angular velocities that occur in the lower limb joints during walking indicate that resistance exercises targeting power generation would be most appropriate. Therefore, we propose the prescription of plyometric and ballistic resistance exercise, applied using the ACSM guidelines for task-specificity, once people with neurological conditions are ambulating, to improve walking outcomes. This new theoretical framework for resistance training ensures that exercise prescription matches how the muscles work during walking.



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Clinical Determinants of Fitness to Drive in Persons with Multiple Sclerosis: Systematic Review

Publication date: Available online 26 January 2019

Source: Archives of Physical Medicine and Rehabilitation

Author(s): Sarah Krasniuk, Sherrilene Classen, Sarah A. Morrow, Marisa Tippett, Melissa Knott, Abiodun Akinwuntan

Abstract
Objective

To critically appraise the evidence for the clinical determinants of fitness to drive in adults with Multiple Sclerosis (MS).

Data Sources

The research librarian and lead author searched seven databases for driving simulator and on-road studies for adults with MS published in the English language from 1991 to 2018.

Study Selection

Three reviewers independently screened titles/abstracts and full-texts for studies with: cohort, case-control, or cross-sectional designs; participants, 18 years or older, with relapsing or progressive MS; visual, cognitive, or motor clinical assessments as predictors; and driving performance through simulator or fitness to drive through on-road assessment as outcomes.

Data Extraction

Using the 2017 American Academy of Neurology guidelines, reviewers independently classified each study from Class I—highest to Class IV—lowest amount of rigor. For each clinical assessment, reviewers independently rated the level of confidence for predicting driving performance or fitness to drive from Level A—highly probable, B—probable, C—possible, to Level U—insufficient conclusions.

Data Synthesis

Through qualitative synthesis, two Class III and four Class IV driving simulator studies employed twenty-four clinical assessments with Level C (n=4) or Level U (n=20) confidence for predicting driving performance. Six Class II and three Class IV on-road studies employed thirty-five clinical assessments with Level B (n=9), Level C (n=22), or Level U (n=4) confidence for predicting fitness to drive.

Conclusions

This systematic review identified mostly insufficient conclusions for predicting driving performance in driving simulator studies, and possible conclusions for predicting fitness to drive in on-road studies. The best available evidence suggests that the Stroke Driver Screening Assessment and Useful Field of View™ probably predict fitness to drive in adults with MS (Level B). Class I studies that compare predictors of fitness to drive with large prospective samples of adults with and without MS are necessary for highly probable conclusions.



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Treatment Documentation in Practice-Based Evidence Research for Patients Receiving Physical Therapy Due to Lymphedema

Publication date: Available online 26 January 2019

Source: Archives of Physical Medicine and Rehabilitation

Author(s): Dorit Tidhar, Daniel Deutscher, Susan D. Horn, Jane M. Armer

Abstract
Objectives

To describe development and testing of a physical therapy treatment code documentation taxonomy.

Design

Clinician survey within a practice-based evidence (PBE) study framework for patients with lymphedema.

Setting

Outpatient physical therapy clinics within a large public healthcare service using a central electronic medical record.

Participants

Forty-three certified lymphedema therapists (CLTs).

Intervention

Treatment coding of 10 treatment vignettes representing real-life clinical scenarios. CLTs were asked to accurately select 35 activity-intervention combination codes.

Main outcome measures

The CLT score represented percentage of treatment codes accurately selected by each therapist. The code score represented percentage of CLTs who accurately selected each treatment code.

Results

The mean CLTs score was 91%, with 72% CLTs meeting the 90% criterion. Personal feedback was provided to each CLT. The mean code score was also 91%; with 71% of treatment codes meeting the 90% criterion. We identified 9 low-score codes needing additional education or found to be redundant. These codes were either clarified or removed.

Conclusions

The proposed treatment code documentation system for lymphedema therapy was found to be clear and accurately used by most CLTs. Specific needs for improvement were identified. Follow-up testing is warranted to ensure ongoing accurate implementation of the treatment documentation system.



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Relationship Between Observational Wisconsin Gait Scale, Gait Deviation Index And Gait Variability Index In Individuals After Stroke

Publication date: Available online 26 January 2019

Source: Archives of Physical Medicine and Rehabilitation

Author(s): Agnieszka Guzik, Mariusz Drużbicki, Lorenza Maistrello, Andrea Turolla, Michela Agostini, Paweł Kiper

Abstract
Objective

To compare results of the observational Wisconsin Gait Scale (WGS) and global gait indexes such as GDI/GVI, constituting an objective method of assessing gait, and taking into account parameters identified during 3-dimensional gait analysis.

Design

A validation study.

Setting

Rehabilitation Clinic.

Participants

50 individuals after a stroke and 50 healthy individuals without gait disorders

Interventions

Not applicable.

Main Outcome Measures

Gait was evaluated using the WGS. GDI and GVI values were acquired using a movement analysis system. The global gait indexes GDI and GVI were determined based on the kinematic and spatiotemporal parameters respectively.

Results

The study showed statistically significant correlations between the parameters of GDI affected leg and WGS total score (R=-0.87), GVI affected leg and WGS total score (R=-0.93), GVI unaffected leg and WGS total score (R=-0.88), GVI affected/unaffected leg and the total score in the assessment of spatiotemporal parameters on the WGS (R=-0.81) as well as GDI affected leg and the total score in the assessment of kinematics parameters on the WGS (R=-0.85). All correlations were strong (0.7≤|R|<0.9) or very strong (0.9≤|R|<1).

Conclusions

WGS scores have a strong or very strong correlation with GDI and GVI. The WGS may be recommended as a substitute tool to be used when 3DGA is unavailable, as it is a useful ordinal scale, enabling simple and accurate observational assessment of gait in patients after stroke, with effectiveness that is comparable to the GDI and GVI indexes.



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Cover Image, Volume 179A, Number 1, January 2019

American Journal of Medical Genetics Part A Cover Image, Volume 179A, Number 1, January 2019

The cover image is based on the Research Article An N‐terminal heterozygous missense CASK mutation is associated with microcephaly and bilateral retinal dystrophy plus optic nerve atrophy by Leslie E. W. LaConte et al., DOI: 10.1002/ajmg.a.60687.




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Table of Contents, Volume 179A, Number 1, January 2019



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In This Issue



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Gene Editing Successfully Corrects 2 Amino Acid Disorders: In 2 preclinical studies using CRISPR‐mediated gene editing, phenylketonuria and hereditary tyrosinemia type 1 were corrected



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Publication schedule for 2019



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The UK Sets Goal for Sequencing 5 Million Genomes in 5 Years



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Whole-brain patterns of the presynaptic inputs and axonal projections of BDNF neurons in the paraventricular nucleus

Publication date: Available online 26 January 2019

Source: Journal of Genetics and Genomics

Author(s): Fang Luo, Yuling Mu, Cuicui Gao, Yan Xiao, Qian Zhou, Yiqing Yang, Xinyan Ni, Wei L. Shen, Jiajun Yang

Abstract

Brain-derived neurotrophic factor (BDNF) plays a crucial role in human obesity. Yet, the neural circuitry supporting the BDNF-mediated control of energy homeostasis remains largely undefined. To map key regions that might provide inputs to or receive inputs from the paraventricular nucleus (PVN) BDNF neurons, a key type of cells in regulating feeding and thermogenesis, we used rabies virus-based transsynaptic labeling and adeno-associated virus based anterograde tracing techniques to reveal their whole-brain distributions. We found that dozens of brain regions provide dense inputs to or receive dense inputs from PVN BDNF neurons, including several known weight control regions and several novel regions that might be functionally important for the BDNF-mediated regulation of energy homeostasis. Interestingly, several regions show very dense reciprocal connections with PVN BDNF neurons, including the lateral septum, the preoptic area, the ventromedial hypothalamic nucleus, the paraventricular thalamic nucleus, the zona incerta, the lateral parabrachial nucleus, the subiculum, the raphe magnus nucleus, and the raphe pallidus nucleus. These strong anatomical connections might be indicative of important functional connections. Therefore, we provide an outline of potential neural circuitry mediated by PVN BDNF neurons, which might be helpful to resolve the complex obesity network.



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Region‐specific differences and areal interactions underlying transitions in epileptiform activity

Key points

Local neocortical and hippocampal territories show different and sterotypical patterns of acutely evolving, epileptiform activity. Neocortical and entorhinal networks show tonic‐clonic‐like events, but the main hippocampal territories do not, unless it is relayed from the other areas. Transitions in the pattern of locally recorded epileptiform activity can be indicative of a shift in the source of pathological activity, and which may spread through both synaptic and non‐synaptic means. Hippocampal epileptiform activity is promoted by 4‐aminopyridine and inhibited by GABAB receptor agonists, and appears far more sensitive to these drugs than neocortical activity. These signature features of local epileptiform activity can provide useful insight into the primary source of ictal activity, aiding both experimental and clinical investigation.

Abstract

Understanding the nature of epileptic state transitions remains a major goal for epilepsy research. Simple in vitro models offer unique experimental opportunities, which we exploit to show that such transitions can arise from shifts in the ictal source of the activity. These transitions reflect the fact that cortical territories differ both in the type of epileptiform activity they can sustain, and their susceptibility to drug manipulation. In the zero Mg2+ model, the earliest epileptiform activity is restricted to neocortical and entorhinal networks. Hippocampal bursting only starts much later, and triggers a marked transition in neo‐/entorhinal cortical activity. Thereafter, the hippocampal activity acts as a pacemaker, entraining the other territories to their discharge pattern. This entrainment persists following transection of the major axonal pathways between hippocampus and cortex, indicating that it can be mediated through a non‐synaptic route. Neuronal discharges are associated with large rises in extracellular [K+], but we show that these are very localised, and therefore are not the means of entraining distant cortical areas. We conclude instead that the entrainment occurs through weak field effects distant from the pacemaker, but which are highly effective at recruiting other brain territories that are already hyperexcitable. The hippocampal epileptiform activity appears unusually susceptible to drugs that impact on K+ conductances. These findings demonstrate that the local circuitry gives rise to stereotypical epileptic activity patterns, but these are also influenced by both synaptic and non‐synaptic long‐range effects. Our results have important implications for our understanding of epileptic propagation, and anti‐epileptic drug action.

This article is protected by copyright. All rights reserved



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Unmasking of estrogen dependent changes in left ventricular structure‐function in aged female rats: A potential model for pre‐HFpEF

Key points

Heart failure with preserved ejection fraction (HFpEF) is seen more frequently in older women and risk factors include age, hypertension and excess weight No female animal models of early stage remodelling (pre‐HFpEF) have examined the effects that the convergence of such factors have on cardiac structure and function In this study, we demonstrate that aging can lead to the development of mild chamber remodelling, diffuse fibrosis and loss of diastolic function The loss of estrogens further aggravates such changes by leading to a notable drop in cardiac output (while preserving normal ejection fraction) in the presence of diffuse fibrosis that is more predominant in endocardium and is accompanied by papillary fibrosis Excess weight did not markedly aggravate such findings This animal model recapitulates many of the features recognized in older, female HFpEF patients and thus, may serve to examine the effects of candidate therapeutic agents

Abstract

Two‐thirds of patients with heart failure with preserved ejection fraction (HFpEF) are older women and risk factors include hypertension and excess weight/obesity. Pathophysiological factors that drive early disease development (before heart failure ensues) remain obscure and female animal models are lacking. The study evaluated the intersecting roles of aging, estrogen depletion and excess weight on altering cardiac structure/function. Female, 18 month old, Fischer F344 rats were divided into aging group, aging + ovariectomy (OVX) and aging + ovariectomy plus 10% fructose (OVF) in drinking water (n = 8‐16/group) to induce weight gain. Left ventricular (LV) structure/function was monitored by echocardiography. At 22 months of age, animals were anaesthetized and catheter‐based hemodynamics evaluated, followed by histological measures of chamber morphometry and collagen density. All aged animals developed hypertension. OVF animals increased body weight. Echocardiography only detected mild chamber remodelling with aging while intraventricular pressure‐volume loop analysis showed significant (P < 0.05) decreases vs. aging in stroke volume (13% OVX and 15% for OVF), stroke work (34% and 52%), cardiac output (29% and 27%), and increases in relaxation time (10% OVX) with preserved ejection fraction. Histology indicated papillary and interstitial fibrosis with aging, which was higher in the endocardium of OVX and OVF groups. With aging, ovariectomy leads to the loss of diastolic and global LV function while preserving ejection fraction. This model recapitulates many cardiovascular features present in HFpEF patients and may help understand the roles that aging and estrogen depletion play in early (pre‐HFpEF) disease development.

This article is protected by copyright. All rights reserved



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Adults' facial reaction to affective facial expressions of children and adults

Publication date: Available online 26 January 2019

Source: International Journal of Psychophysiology

Author(s): Tobias Müller, Ralf Schäfer, Sina Hahn, Matthias Franz

Abstract

Facial mimicry, the unconscious imitation of others' affective facial expressions, serves as an important basis for interpersonal communication. Although there are many studies dealing with this phenomenon regarding the interaction between adults, only few experiments have explored facial mimicry in response to affective facial expressions of children. In the following study affect-prototypical video clips of children's and adults' faces were presented to 44 adults while the activity of corrugator supercilii and zygomaticus muscles was electromyographically measured. A discrete mimic reaction was detected in response to each basic affect (fear, disgust, happiness, sadness, surprise and anger). The activity of corrugator supercilii muscle was significantly lower when affective facial expressions of children were presented in contrast to those of adults. In addition, negative correlations between alexithymia and the averaged facial EMG activity were detected.



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Clinical Trials News

Mon Jan 07, 2019 00:00
Clinical Trials Survey
Would you like to help improve the clinical research experience for patients? We are interested in your opinion about reporting your symptoms for clinical trials. Please click the link below to complete this short, 5-minute survey. Your anonymous responses will be used for research purposes to better understand how to improve patient care. Complete the survey and provide your email address to be entered to win a $100 Visa gift card! Thank you for taking the time to provide your opinion.
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Data Highlighting Potential Benefits of Lm Platform Presented at 2019 Keystone Symposia Conference on Cancer Vaccines
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Fri Jan 25, 2019 15:05
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Fri Jan 25, 2019 14:00
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Fri Jan 25, 2019 08:54
Navitor Pharmaceuticals commences phase 1 clinical evaluation of NV-5138 for treatment-resistant depression
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Fri Jan 25, 2019 08:54
FDA accepts X-Rx's IND application for X-165 to treat IPF
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PBR - Clinical Trials News
Fri Jan 25, 2019 08:54
EC approves Clovis' Rubraca to treat women with relapsed ovarian cancer
The second indication of Rubraca has been approved as monotherapy for the maintenance treatment of adults with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer The post EC approves Clovis' Rubraca to treat women with relapsed ovarian cancer appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Fri Jan 25, 2019 06:56
ImmunoGen Announces Conference Call to Discuss Its 2018 Operating Results
WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that the Company will host a conference call at 8:00 a.m. ET on Friday, February 8, 2019 to discuss its 2018 operating results. Management will also provide a brief update on the business. Conference Call InformationTo access the live call by phone, dial 323-794-2093; the conference ID is 6271602. The call may also be a
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 23:30
Immunomic to Present at the 2019 BIO CEO & Investor Conference
ROCKVILLE, Md.--(BUSINESS WIRE)--Immunomic Therapeutics, Inc. announced today that its' founder and CEO, William Hearl, Ph.D., will present an overview of the company and its UNITE technology platform at the 2019 BIO CEO & Investor Conference on February 12, 2019 at 2:00 pm EST in the Hudson/Empire Room at the Marriott Marquis in New York City. About UNITE ITI's investigational UNITE platform, or UNiversal Intracellular Targeted Expression, is thought to work by encoding the Lysosomal Assoc
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 23:05
Vermont Collaborative Partners with Netsmart to Alter Trajectory of Care for State's Most Vulnerable
OVERLAND PARK, Kan.--(BUSINESS WIRE)--Four member agencies of Vermont Care Partners (VCP) have come together to reshape the delivery and coordination of care through a partnership with Netsmart to deploy a unified technology platform. As value-based care quickly becomes reality, Lamoille County Mental Health Services, Northwestern Counseling and Support Services, United Counseling Services of Bennington and Washington County Mental Health Services will leverage the full suite of solutions from
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 22:00
Ibrutinib for the treatment of Bing-Neel syndrome: a multicenter study
The treatment of patients with Bing-Neel syndrome (BNS) is not standardized. We included patients with Waldenström macroglobulinemia (WM) and a radiologic and/or cytologic diagnosis of BNS treated with ibrutinib monotherapy. Response assessment was based on criteria for BNS from the 8th International Workshop for WM. Survival from BNS diagnosis (BNS survival), survival from ibrutinib initiation to last follow-up or death (ibrutinib survival), and time from ibrutinib initiation to ibrutinib discontinuation...
Blood CLINICAL TRIALS AND OBSERVATIONS
Thu Jan 24, 2019 19:00
Oyster Point Pharma to Present at the BIO CEO & Investor Conference
PRINCETON, N.J.--(BUSINESS WIRE)--Oyster Point Pharma to present a corporate overview at the BIO CEO & Investor Conference.
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 17:33
Midwest Vision Research Foundation at Pepose Vision Institute Joins the AcuFocus IC-8® Lens Clinical Study for Patients with Cataracts
ST. LOUIS, Mo.--(BUSINESS WIRE)--Midwest Vision Research Foundation at Pepose Vision Institute joins the AcuFocus IC-8® Lens clinical study for cataracts.
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 16:05
Tamr Joins Accenture's Life Sciences Ecosystem to Help Drive Innovation in Drug Discovery and Scientific Research
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Tamr Inc. today announced it has joined Accenture's open partner ecosystem, designed to help independent software vendors (ISVs) and life science companies team more effectively to accelerate drug discovery efforts and improve patient outcomes. The ecosystem is an integral part of Accenture's cloud-based informatics research platform, which has been designed to help life sciences organizations improve productivity, efficiency, and innovation in drug discovery.
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 16:00
Gamida Cell Announces Data from NAM-NK and NiCord® Programs to Be Presented at 2019 TCT Annual Meeting
BOSTON--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24GMDA&src=ctag" target="_blank"gt;$GMDAlt;/agt;--Gamida Cell announces data from NAM-NK and NiCord® programs to be presented at 2019 TCT Annual Meeting
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 15:32
X-Rx Announces FDA Acceptance of IND Application for X-165
WALTHAM, Mass.--(BUSINESS WIRE)--X-Rx Announces FDA Acceptance of IND Application for X-165
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 15:15
Can-Fite BioPharma CEO Letter to Shareholders
PETACH TIKVA, Israel--(BUSINESS WIRE)--Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, today announced that Pnina Fishman, Chief Executive Officer of Can-Fite Biopharma, has issued a Letter to Shareholders, the full text of which follows below. Dear Can-Fite Shareholders, It has been a very busy and productive year at Can Fite BioPharma, filled with c
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 14:30
Dicerna Evolves Its Board of Directors to Support Continued Growth
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Dicerna announced several changes to its board of directors, reflecting the company's ongoing growth.
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 14:30
Basilea Announces Collaboration to Study Derazantinib and Atezolizumab (Tecentriq®) in Urothelial Cancer
BURLINGTON, Mass.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24ARQL&src=ctag" target="_blank"gt;$ARQLlt;/agt; lt;a href="https://twitter.com/hashtag/arql?src=hash" target="_blank"gt;#arqllt;/agt;--ArQule, Inc.'s (Nasdaq: ARQL) partner, Basilea Pharmaceutica Ltd. (SIX: BSLN), announced today that it entered into a collaboration with Roche (SIX: RO, ROG) to explore a combination of derazantinib (BAL087) and Roche's PD-L1-blocking immune-checkpoint inhibitor, atezolizumab (Tecentriq®),...
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 14:00
Concert Pharmaceuticals Initiates Phase 1 Single-Ascending Dose Trial of CTP-692 as an Adjunctive Treatment for Schizophrenia
LEXINGTON, Mass.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24CNCE&src=ctag" target="_blank"gt;$CNCElt;/agt; lt;a href="https://twitter.com/hashtag/CNCE?src=hash" target="_blank"gt;#CNCElt;/agt;--Concert began a Phase 1 single-ascending dose trial to evaluate the safety, tolerability, and PK profile of CTP 692 in healthy volunteers.
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 14:00
Navidea Biopharmaceuticals Announces Decision by Ohio Supreme Court
DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced that the Ohio Supreme Court has dismissed a Petition filed by Capital Royalty Partners II, L.P. and affiliated entities. On August 27, 2018, Capital Royalty Partners II, L.P. and several affiliated entities ("CRG") filed a Petition with the Ohio Supreme Court seeking a
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 14:00
Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results
NEW YORK--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24BMY&src=ctag" target="_blank"gt;$BMYlt;/agt;--Bristol-Myers Squibb Reports Fourth Quarter and Full Year Financial Results
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 13:59
BridgeBio Pharma raises $299.2m in financing round
BridgeBio Pharma will also use the funds to expand its efforts on the development of medicines for patients with unmet needs. Both existing investors KKR and Viking Global The post BridgeBio Pharma raises $299.2m in financing round appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Thu Jan 24, 2019 13:17
Ironwood Pharmaceuticals initiates phase 1 trial of IW-6463
Data from the Phase 1 study are expected in the second half of 2019. "The initiation of this Phase 1 study with IW-6463 marks an important milestone for The post Ironwood Pharmaceuticals initiates phase 1 trial of IW-6463 appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Thu Jan 24, 2019 11:20
BioNTech to acquire MAB Discovery's antibody generation unit
Under the terms of the agreement, BioNTech will acquire all assets, employees and proprietary know-how for mAb generation from MAB Discovery. MAB Discovery will retain ownership of and The post BioNTech to acquire MAB Discovery's antibody generation unit appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Thu Jan 24, 2019 13:17
ChemoCentryx Announces Withdrawal of Phase II-Based Conditional Marketing Authorisation (CMA) Application for ANCA-Associated Vasculitis in Europe, Phase III Advocate Trial Data Release Planned for Q4 2019
ZURICH & MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Regulatory News: ChemoCentryx, Inc. and Vifor Fresenius Medical Care Renal Pharma Ltd., a company of Vifor Pharma Group, today announced that in light of the upcoming availability of data from the pivotal Phase III ADVOCATE trial – the largest controlled trial in active anti-neutrophil cytoplasmic antibody associated vasculitis (ANCA-associated vasculitis) – they have decided to withdraw the application for Conditional Marketing Authorisation (CM
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 08:00
Gossamer Bio Announces Commencement of Initial Public Offering
SAN DIEGO--(BUSINESS WIRE)--Gossamer Bio, Inc., a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced that it has filed a registration statement on Form S-1 with the U.S. Securities and Exchange Commission (the "SEC") in connection with the commencement of a proposed initial public offering of its common stock. Gossamer Bio is offering 14,375,000 sha
Business Wire Health: Clinical Trials News
Thu Jan 24, 2019 00:24
Advaxis' Phase 3 AIM2CERV Study Placed on Partial Clinical Hold by FDA Related to CMC Requests
PRINCETON, N.J.--(BUSINESS WIRE)--Advaxis, Inc. (NASDAQ:ADXS), a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, today announced receipt of notification from the U.S. Food and Drug Administration (FDA) that the Company's ongoing Phase 3, randomized, double-blinded, placebo-controlled, pivotal study of axalimogene filolisbac (AXAL) in high-risk, locally advanced cervical cancer (AIM2CERV) has been placed on partial clinical
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 23:05
Ironwood Pharmaceuticals Initiates Phase 1 Trial of IW-6463, the First CNS-penetrant sGC Stimulator to Enter Clinical Trials
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) today announced the initiation of a Phase 1 study evaluating IW-6463 in healthy volunteers. IW-6463 is an orally administered central nervous system (CNS)-penetrant soluble guanylate cyclase (sGC) stimulator that is being developed for the treatment of serious and orphan CNS disorders. Data from the Phase 1 study are expected in the second half of 2019. "The initiation of this Phase 1 study with IW-6463 marks an im
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 23:01
Vedanta Biosciences Announces Publication in Nature of Seminal Research Revealing A New Mechanism of Human Microbiota-Driven Antitumor Immunity Involving Induction of IFNy+ CD8+ T Cell Accumulation in the Gut and Tumors
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vedanta Biosciences announced a publication in Nature that revealed a newly discovered mechanism underlying antitumor immunity.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 20:07
Modulated Imaging Raises $7M in Series B Funding
IRVINE, Calif.--(BUSINESS WIRE)--Modulated Imaging has raised $7 million in Series B funding to fund the commercialization of its Clarifi technology and clinical studies.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 19:30
Vascular Dynamics Names Prof. Martin Rothman Chief Medical Officer
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--World-renowned interventional cardiologist Martin Rothman has been named chief medical officer at VDI.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 19:05
Redx gets regulatory nod to restart RXC004 clinical trial
An oral porcupine inhibitor, RXC004 has been designed to target the Wnt signaling pathway. The early-stage trial of the small molecule drug was temporarily stopped in March 2018 The post Redx gets regulatory nod to restart RXC004 clinical trial appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 17:43
U.S. Patent Office Issues CEL-SCI Two Patents for Its LEAPS Vaccine Platform Technology
VIENNA, Va.--(BUSINESS WIRE)--U.S. patent office issues CEL-SCI two patents for its LEAPS vaccine platform technology.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 16:20
Medidata Joins the World Economic Forum
NEW YORK--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/MDSO?src=hash" target="_blank"gt;#MDSOlt;/agt;--Medidata (NASDAQ:MDSO) today announced that it has entered into a three-year strategic collaboration with the World Economic Forum. The company becomes a Partner Member Associate and will participate in the WEF System Initiative focused on Shaping the Future of Health and Healthcare. The initiative has a goal of transforming the continuum of care – from prevention to diagnosis, treatment,...
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 15:30
Ferring Pharmaceuticals appoints Sophie Opdyke to lead its new U.S. oncology division
PARSIPPANY, N.J.--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/Ferring?src=hash" target="_blank"gt;#Ferringlt;/agt;--Sophie Opdyke, Pharm.D., MBA, will be responsible for building the Ferring Pharmaceuticals (U.S.) oncology division
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 15:25
InGeneron Expands Development Pipeline with Two Osteoarthritis Programs
HOUSTON--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/backpain?src=hash" target="_blank"gt;#backpainlt;/agt;--InGeneron expands development pipeline with two studies for chronic backpain and wrist osteoarthritis, setting focus on orthopedic indications.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 15:00
BridgeBio Pharma Closes $299.2 Million Financing Round to Support Its Efforts to Target Genetic Disease at the Source
PALO ALTO, Calif.--(BUSINESS WIRE)--BridgeBio Pharma, a clinical-stage biopharmaceutical company focused on genetic diseases, today announced a new financing round of $299.2 million. The round was co-led by existing investors KKR and Viking Global Investors. Other existing investors participating included Perceptive Advisors, AIG, Aisling Capital, Cormorant Capital, and Hercules Capital; and they were joined by new investors Sequoia Capital, and a blue-chip long-term investor. The financing wil
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 15:00
Talee Bio Announces $4.5 Million Award from the Cystic Fibrosis Foundation to Advance Development of Two Gene Therapy Product Candidates
PHILADELPHIA--(BUSINESS WIRE)--Talee Bio, Inc., a development stage biopharmaceutical company focused on developing gene therapy treatments for cystic fibrosis, today announced agreements with the Cystic Fibrosis Foundation (CF Foundation) to fund the preclinical development of two mutation-agnostic gene therapy product candidates, TL-101 and TL-102. The CF Foundation committed up to $4.5 million to expedite the development of both product candidates for all people with cystic fibrosis, and par
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 14:00
Sage Therapeutics Appoints Elizabeth Barrett and George Golumbeski to Board of Directors
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the addition of Elizabeth (Liz) Barrett and George Golumbeski, Ph.D., to the company's board of directors. "We are extremely pleased to add these two experienced executives to Sage's board of directors. As Sage continues to advance its programs in development, adding an executive
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 14:00
Triumvira Announces Build out of Senior Management Team with Addition of Industry-Experienced Professionals in R&D and Business Development
AUSTIN, Texas & HAMILTON, Ontario--(BUSINESS WIRE)--Triumvira appoints Andreas Bader as Senior Vice President of Research & Development and Joshua Carle as Vice President of Business Development.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 14:00
New Study Shows Supplementation with Nicotinamide Riboside (NR) During Breastfeeding Yields Measurable, Lasting Benefits to Mothers and Offspring in Animal Model
LOS ANGELES--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/Breastfeeding?src=hash" target="_blank"gt;#Breastfeedinglt;/agt;--Supplementation with unique B3 vitamin nicotinamide riboside confers significant and enduring physiological benefits to mouse mothers and offspring.
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 13:30
Idiopathic Pulmonary Fibrosis Report - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019-2021 - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Idiopathic Pulmonary Fibrosis - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering. Idiopathic Pulmonary Fibrosis - Global API Manufacturers, Marketed and Phase III Drugs Landscape, 2019" report provides comprehensive insights about marketed and Phase III products for Idiopathic Pulmonary Fibrosis . The report includes information of marketed products including their product des
Business Wire Health: Clinical Trials News
Wed Jan 23, 2019 13:24
EC approves Blincyto in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL
The approval was based on data from the Phase 2 BLAST study in frontline and relapsed/refractory ALL, the largest prospective trial for MRD-positive ALL ever conducted. BLINCYTO, a The post EC approves Blincyto in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 11:52
Rocket Pharmaceuticals announces clearance of IND for RP-A501 gene therapy for Danon disease
RP-A501 is the Company's first adeno-associated viral vector (AAV)-based gene therapy for the treatment of Danon disease that is in development under a collaboration with the University of The post Rocket Pharmaceuticals announces clearance of IND for RP-A501 gene therapy for Danon disease appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 11:52
GSK closes acquisition of Tesaro for $5.1bn
Tesaro acquisition will enable GSK to strengthen its pharmaceutical business; and expand its pipeline and commercial capability in oncology. Tesaro president and COO Dr Mary Lynne Hedley said: The post GSK closes acquisition of Tesaro for $5.1bn appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Wed Jan 23, 2019 11:52
UroGen Pharma Announces Proposed Public Offering of Ordinary Shares
NEW YORK--(BUSINESS WIRE)--UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, today announced that it intends to offer and sell $150 million of its ordinary shares in an underwritten public offering. The company also intends to grant the underwriters a 30-day option to purchase up to an additional 15 percent of the number of ordinary shares sold in the offering at the pu
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 23:01
LabCorp Named to FORTUNE Magazine's 2019 List of 'World's Most Admired Companies,' Making the Annual List for the Second Consecutive Year
BURLINGTON, N.C.--(BUSINESS WIRE)--LabCorp® (NYSE: LH), a leading global life sciences company, today announced that it has been named to FORTUNE magazine's 2019 List of World's Most Admired Companies, making the annual list for the second consecutive year. The annual survey, conducted by FORTUNE and Korn Ferry, a global organizational consulting firm, is given to top executives, directors, and financial analysts to identify the companies that enjoy the strongest reputations within their indust
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 17:35
Gamida Cell and Be The Match BioTherapies® Announce Strategic Collaboration
BOSTON & MINNEAPOLIS--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24GMDA&src=ctag" target="_blank"gt;$GMDAlt;/agt;--Gamida Cell and Be The Match BioTherapies® announced a collaboration to improve outcomes for patients undergoing bone marrow transplantation.
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:30
Bio-Thera Solutions Announces Initiation of Phase III Clinical Trial for BAT1806, a Proposed Biosimilar of Actemra® (Tocilizumab)
GUANGZHOU, China--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/arthritis?src=hash" target="_blank"gt;#arthritislt;/agt;--Bio-Thera Solutions announces the initiation of a Phase III clinical trial for BAT1806, a proposed biosimilar of Actemra® (Tocilizumab).
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:08
LabConnect Announces Global Sample Processing Network
SEATTLE--(BUSINESS WIRE)--LabConnect is pleased to announce a new service: LabConnect's global sample processing network (GSPN).
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:00
Seattle Genetics to Host Conference Call and Webcast Discussion of Fourth Quarter and Full Year 2018 Financial Results on February 7, 2019
BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN) announced today that it will report its fourth quarter and full year 2018 financial results on Thursday, February 7, 2019 after the close of financial markets. Following the announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows: LIVE access on Thursday, February 7, 20191:30 p.m. Pacific Time / 4
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:00
Rainier Therapeutics Announces Oral Abstract Presentation on Fierce 21 Phase 2 Trial of Vofatamab in Metastatic Urothelial Cell Carcinoma (Bladder Cancer) at the 2019 ASCO Genitourinary Cancers Symposium
SAN LEANDRO, Calif.--(BUSINESS WIRE)--Data from ongoing P2 trial of Rainier's FGFR3-targeted antibody vofatamab to be presented at 2019 ASCO Genitourinary Cancers Symposium Feb 14 in SF
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 15:00
Resumen: Gore presenta en Europa la endoprótesis para aorta torácica adaptable GORE® TAG® con perfiles reducidos
FLAGSTAFF, Arizona--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) ha introducido hoy perfiles reducidos para los diámetros más utilizados de la endoprótesis para aorta torácica adaptable GORE® TAG® con el sistema de CONTROL ACTIVO. El perfil reducido permite a los médicos realizar reparaciones endovasculares torácicas (TEVAR) en pacientes con vasos más pequeños donde el acceso es difícil y la anatomía aórtica es tortuosa, lo que amplía la disponibilidad de la endoprótesis para aorta
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:47
Samenvatting: Gore introduceert GORE® TAG® Conformable Thoracic Stent Graft met gereduceerde profielen in Europa
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) introduceerde vandaag gereduceerde profielen voor de meest gebruikte diameters van de GORE® TAG® Conformable Thoracic Stent Graft met ACTIVE CONTROL System. Het gereduceerde profiel stelt artsen in staat om TEVAR uit te voeren bij patiënten met kleinere vaten waar de toegang moeilijk is en de aorta anatomie kronkelig is, waardoor de beschikbaarheid van Gore's thoracale stenttransplantaat wordt uitgebreid naar een groter
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:47
Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease
WILMINGTON, Del.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24INCY&src=ctag" target="_blank"gt;$INCYlt;/agt;--Incyte Announces First Patient Treated in Phase 3 Clinical Trial of Itacitinib for Chronic Graft-Versus-Host Disease
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:30
Data Presented at LINC Confirm the Safety and Effectiveness of Zilver® PTX®
BLOOMINGTON, Ind.--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/cookmedical?src=hash" target="_blank"gt;#cookmedicallt;/agt;--Today at the Leipzig Interventional Course (LINC), Cook Medical participated in significant discussion about the use of paclitaxel to treat patients suffering from PAD. Through several presentations to meeting attendees, data supported the use of paclitaxel-coated devices to help the more than 200 million1 patients globally who are fighting the disease. "We believe...
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:10
Aurinia Announces Voclosporin Ophthalmic Solution Demonstrates Statistically Superior Efficacy Versus Restasis® in a Phase 2 Head-to-Head Study for the Treatment of Dry Eye Syndrome
VICTORIA, British Columbia--(BUSINESS WIRE)--Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH/TSX:AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced positive results for its exploratory Phase 2 head-to-head study evaluating the efficacy, safety and tolerability of voclosporin ophthalmic solution (VOS 0.2%) versus Restasis®(cyclosporine ophthalmic emulsion 0.05%) for the treatment of dry eye syndrome (DES). Both drugs were shown to be well-tolerate
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:00
Concert Pharmaceuticals Completes Enrollment of 12 mg Cohort in Phase 2a Trial of CTP-543 in Alopecia Areata
LEXINGTON, Mass.--(BUSINESS WIRE)--lt;a href="https://twitter.com/search?q=%24CNCE&src=ctag" target="_blank"gt;$CNCElt;/agt; lt;a href="https://twitter.com/hashtag/AlopeciaAreata?src=hash" target="_blank"gt;#AlopeciaAreatalt;/agt;--Concert completed enrollment in its Phase 2a trial evaluating CTP-543 for the treatment of moderate-to-severe alopecia areata.
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:00
Immunochina Raises $20.4 Million USD in Series C Financing
BEIJING--(BUSINESS WIRE)--Beijing-based Immunochina Pharmaceuticals today announced the closing of its $140 million RMB Series C financing (approximately $20.4 million in US Dollars). This financing will enable the company to expand its GMP-grade manufacturing capabilities while continuing clinical trials for its lead IM19 product targeting B-Cell Acute Lymphoblastic Leukemia (B-ALL) and Non Hodgkin's Lymphoma, as well as advancing the development of its pipeline targeting multiple solid and li
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 14:00
Aplastic Anemia - Pipeline Insight, 2019 - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Aplastic Anemia - Pipeline Insight, 2019" drug pipelines report has been added to ResearchAndMarkets.com's offering. This report offers comprehensive Insight of the pipeline (under development) therapeutics scenario and growth prospects across Aplastic Anemia development. The report provides detailed coverage of the pipeline landscape for this mechanism of action, equipped with data from multiple sources with complete pipeline analysis by developmental stage, assoc
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Tue Jan 22, 2019 13:40
Cluster Headache Syndrome - Pipeline Insight, 2019 - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Cluster Headache Syndrome - Pipeline Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering. This report offers comprehensive Insight of the pipeline (under development) therapeutics scenario and growth prospects across Cluster Headache Syndrome development. The report provides detailed coverage of the pipeline landscape for this mechanism of action, equipped with data from multiple sources with complete pipeline analysis by developmental
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 13:34
TC BioPharm creates allogeneic cell banks for CAR-T cancer therapy products
GLASGOW, Scotland--(BUSINESS WIRE)--TC BioPharm (TCB), a developer of CAR-T immuno-oncology products, including Gamma Delta T (GDT) cell therapies, today announced it has completed formulation of its first allogeneic GDT cell banks. The T cell banks provide TCB with core technology to develop a deep portfolio of next-generation CAR-T products directed against a wide variety of different cancer types, both hematological and solid tumors. The project was supported by funding from the European Uni
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 12:55
Rationale and study design of the MyHEART study: A young adult hypertension self-management randomized controlled trial
Publication date: Available online 21 January 2019Source: Contemporary Clinical TrialsAuthor(s): Heather M. Johnson, Lisa Sullivan-Vedder, KyungMann Kim, Patrick E. McBride, Maureen A. Smith, Jamie N. LaMantia, Jennifer T. Fink, Megan R. Knutson Sinaise, Laura M. Zeller, Diane R. LauverAbstractYoung adults (18–39 year-olds) with hypertension have a higher lifetime risk for cardiovascular disease. However, less than 50% of young adults achieve hypertension control in the United States. Hypertension...
ScienceDirect Publication: Contemporary Clinical Trials
Tue Jan 22, 2019 13:13
EC approves Vertex's CF treatment Orkambi for children aged two to five years
The label extension has been granted to treat the most common form of CF based on data from a phase 3 open-label safety study in 60 patients. According The post EC approves Vertex's CF treatment Orkambi for children aged two to five years appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Tue Jan 22, 2019 12:25
Nash's NASH NP-160 shows repeated positive results in second pre-clinical study
In addition, a second compound, NP-135 was identified as an additional lead. Both NP-135 and NP-160 are one of a number of already approved compounds that Nash has The post Nash's NASH NP-160 shows repeated positive results in second pre-clinical study appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Tue Jan 22, 2019 12:25
Global Clinical Trials 2007-2018: Current Trends and Recent Advancements - ResearchAndMarkets.com
DUBLIN--(BUSINESS WIRE)--The "Global Clinical Trials - Current Trends and Recent Advancement" report has been added to ResearchAndMarkets.com's offering. "Global Clinical Trials Current Trends and Recent Advancement", provides an in-depth assessment of the current trends in the number of clinical trials globally, Top 10 therapy area, geography wise clinical trials, YOY clinical trials in top 10 therapy area. An overview of clinical guidelines reforms has also been provided to show how regulator
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 11:17
PredictImmune Confirms Canadian Patent Grant
CAMBRIDGE, England--(BUSINESS WIRE)--lt;a href="https://twitter.com/hashtag/IBD?src=hash" target="_blank"gt;#IBDlt;/agt;--PredictImmune confirm Canadian patent grant which covers PredictImmune's intellectual property relating to methods for predicting autoimmune disease
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 11:00
PCI announces further investment in infrastructure for packaging of controlled substances
PCI has extended onsite controlled substance storage at its US commercial packaging locations in Philadelphia, PA and Rockford, IL, and will undertake further expansions as demand increases for The post PCI announces further investment in infrastructure for packaging of controlled substances appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Tue Jan 22, 2019 12:25
Wren Therapeutics Completes £18 Million Series A Financing
CAMBRIDGE, United Kingdom--(BUSINESS WIRE)--Wren Therapeutics ("Wren"), a biopharmaceutical company focused on drug discovery and development for protein misfolding diseases, today announces it has completed a Series A financing round. The company, formally founded in 2016, raised a total of £18 million from an international syndicate led by The Baupost Group with participation from LifeForce Capital and a number of high net worth individual investors. Protein molecules form the machinery that
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 09:30
EMMAC Life Sciences PLC: Acquisition of a Majority Interest in Medalchemy, a GMP Certified Laboratory, in Alicante Spain
LONDON--(BUSINESS WIRE)--EMMAC, the European independent medical cannabis company, is pleased to announce the acquisition of a majority interest in Medalchemy, a fully-licensed GMP certified laboratory in Alicante, Spain. Medalchemy, a technology-based manufacturing company located on the premises of the University of Alicante, has more than a decade of experience in the research, development and manufacture of active pharmaceutical ingredients (APIs) and has submitted license applications to i
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 09:00
Updated Analysis of Pivotal Study Reveals: Proactive, High Dosage of Venofer® Significantly Reduces Risk of Death or Major Cardiovascular Events in Haemodialysis Patients
ZURICH--(BUSINESS WIRE)--Re-analysis of pivotal study reveals: Proactive, High DOSAGE OF venofer®...
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 08:00
Ferring, Rebiotix and Karolinska Institutet Extend Collaboration to Research Next Generation of Microbiome Treatments
SAINT-PREX, Switzerland--(BUSINESS WIRE)--Ferring Pharmaceuticals and Karolinska Institutet announced today a five-year extension of their collaboration to explore the potential of the human microbiome in reproductive medicine and women's health and gastroenterology. The collaboration brings together specialist expertise from Karolinska Institutet in early stage research, Rebiotix Inc. (acquired by Ferring in 2018), a late-stage clinical microbiome company, and Ferring's therapeutic area and co
Business Wire Health: Clinical Trials News
Tue Jan 22, 2019 08:00
Proteus Digital Health Launches Digital Oncology Medicines to Improve Patient Outcomes
January 17, 2019 – REDWOOD CITY, Calif. and MINNEAPOLIS, Minn. – Proteus Digital Health®, Inc., Fairview Health Services, and University of Minnesota Health announced today that for the first time cancer patients are using digital...
Drugs.com - Clinical Trials
Thu Jan 17, 2019 22:01
Two Positive Phase III studies of Tafenoquine for the Radical Cure of Plasmodium vivax Malaria Published in The New England Journal of Medicine
London UK; Philadelphia US; Geneva Switzerland - January 16, 2019 -- GSK and Medicines for Malaria Venture (MMV) today announced the publication of positive results from two phase III studies of single-dose tafenoquine for the radical cure...
Drugs.com - Clinical Trials
Wed Jan 16, 2019 23:01
vTv Therapeutics Announces Publication of Comprehensive Data in Science Translational Medicine Detailing the Discovery and Clinical Development of TTP399, including Results of Phase 2 AGATA Study
HIGH POINT, N.C.--(BUSINESS WIRE)--Jan. 16, 2019-- vTv Therapeutics Inc. (Nasdaq: VTVT) today announced the publication of a paper in Science Translational Medicine showcasing the discovery and development of TTP399, an investigational, oral, small...
Drugs.com - Clinical Trials
Wed Jan 16, 2019 22:01
Amgen Makes All Repatha (evolocumab) Device Options Available In The US At A 60 Percent Reduced List Price
THOUSAND OAKS, Calif., Jan. 7, 2019 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that as part of the Company's commitment to improve patient affordability for an innovative biologic medicine for people with high cholesterol who are at...
Drugs.com - Clinical Trials
Mon Jan 07, 2019 22:01
Gore führt GORE® TAG® Conformable Thoracic Stent Graft mit reduzierten Profilen für die Vermarktung in Europa ein
FLAGSTAFF, Arizona--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) meldete heute die Markteinführung reduzierter Profile für die am häufigsten verwendeten Durchmesser von GORE® TAG® Conformable Thoracic Stent Graft mit ACTIVE CONTROL System. Das reduzierte Profil ermöglicht es den Ärzten, bei Patienten mit kleineren Blutgefäßen eine thorakale endovaskuläre Aortenreparatur (TEVAR) durchzuführen, wenn der Zugang anspruchsvoll und die Aorta gewunden ist, um auf diese Weise die Einsatzmö
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 22:37
Gore lance sur le marché européen GORE® TAG®, une endoprothèse thoracique conformable à profils réduits
FLAGSTAFF, Arizona--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) a présenté aujourd'hui des profils réduits des diamètres les plus couramment utilisés de l'endoprothèse thoracique conformable implantable GORE® TAG® dotée du système ACTIVE CONTROL. La réduction du profil permet aux médecins de procéder à une procédure TEVAR (réparation endovasculaire des anévrismes de l'aorte thoracique) chez les patients dont les vaisseaux sont étroits et difficiles d'accès et l'anatomie aortique t
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 19:30
Riassunto: Gore lancia in Europa lo stent graft toracico conformabile GORE® TAG® con profili ridotti
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) ha oggi lanciato profili ridotti per i diametri più comunemente utilizzati dello stent graft toracico conformabile GORE® TAG® con sistema ACTIVE CONTROL. Il profilo ridotto consente al personale medico di eseguire trattamenti endovascolari dell'aorta toracica (TEVAR) nei pazienti con vasi sanguigni più piccoli, di difficile accesso e con anatomia aortica tortuosa, ampliando la disponibilità dello stent graft toracico di
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 16:18
Antibe Therapeutics Receives Approval to Initiate Part Two of Phase 2B Dose-Ranging, Efficacy Study for ATB-346
TORONTO--(BUSINESS WIRE)--Antibe Therapeutics Receives Approval to Initiate Part Two of Phase 2B Dose-Ranging, Efficacy Study for ATB-346
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 14:00
Vertex Announces European Commission Approval for ORKAMBI® (lumacaftor/ivacaftor) for Treatment of Children with Cystic Fibrosis Aged 2 to 5 Years Old with Most Common Form of the Disease
LONDON--(BUSINESS WIRE)--Vertex Pharmaceuticals (Europe) Limited today announced that the European Commission has granted approval of the label extension for ORKAMBI® (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis (CF) aged 2 to 5 years old who have two copies of the F508del mutation, the most common form of the disease. "Today's approval by the European Commission brings us one step closer to our goal of bringing treatment to all people living with CF," said Reshma K
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 11:00
Gore Introduces GORE® TAG® Conformable Thoracic Stent Graft with Reduced Profiles in Europe
FLAGSTAFF, Ariz.--(BUSINESS WIRE)--Gore Introduces GORE® TAG® Conformable Thoracic Stent Graft with Reduced Profiles in Europe
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 10:00
Promentis Pharmaceuticals commences phase 2 studies for SXC-2023 targeting Glutamatergic mechanism
Promentis is developing SXC-2023 along with other compounds that engage System xc-, a central nervous system target addressing glutamatergic imbalance and oxidative stress, to treat trichotillomania and other The post Promentis Pharmaceuticals commences phase 2 studies for SXC-2023 targeting Glutamatergic mechanism appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Mon Jan 21, 2019 12:58
Kyn Therapeutics, Celgene partner on immuno-oncology therapies development
The collaboration will combine the immuno-oncology expertise and pipeline of Kyn Therapeutics with the capabilities of Celgene in development and commercialization of drugs in areas of high unmet The post Kyn Therapeutics, Celgene partner on immuno-oncology therapies development appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Mon Jan 21, 2019 09:02
Lilly's second immune-oncology candidate using Zymeworks' Azymetric platform to start clinical trials
In accordance with Zymeworks' 2014 licensing and collaboration agreement with Lilly, Zymeworks will receive a milestone payment of US$8.0 million for Lilly's submission of an IND application for The post Lilly's second immune-oncology candidate using Zymeworks' Azymetric platform to start clinical trials appeared first on Pharmaceutical Business review.
PBR - Clinical Trials News
Mon Jan 21, 2019 12:58
SanBio: Addition of a Cerebral Hemorrhage Program for SB623 Regenerative Cell Medicine
TOKYO--(BUSINESS WIRE)--At a meeting held today, the Board of Directors of SanBio Co., Ltd. (hereinafter, the "Company") resolved to add a program for treatment of chronic motor deficit from cerebral hemorrhage as a new indication for SB623, a regenerative cell medicine developed by the Group. (Hereinafter, the "Group" refers to two companies, SanBio Co., Ltd., and SanBio, Inc.) 1. Details of the Decision As part of its mission to introduce new therapeutic drugs for the central nervous system,
Business Wire Health: Clinical Trials News
Mon Jan 21, 2019 02:05
Design of a randomized trial testing a multi-level weight-control intervention to reduce obesity and related health conditions in low-income workers
Publication date: Available online 19 January 2019Source: Contemporary Clinical TrialsAuthor(s): Richard I. Stein, Jaime R. Strickland, Rachel G. Tabak, Ann Marie Dale, Graham A. Colditz, Bradley A. EvanoffAbstractWeight-control is a major public health focus for preventing multiple obesity-related health conditions. While clinic-based intensive lifestyle interventions are successful, low-socioeconomic-status (SES) populations, which have a higher burden of obesity, are difficult to reach; thus,...
ScienceDirect Publication: Contemporary Clinical Trials
Sun Jan 20, 2019 13:44