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NCT ID: NCT03842852 Completed - Inguinal Hernia Clinical Trials

LAPAROSCOPIC TEP (TOTAL EXTRA-PERITONEAL) REPAIR VS OPEN PHS (PROLENE HERNIA SYSTEM)

Start date: January 1, 2003
Phase:
Study type: Observational

Abdominal wall hernias are common, with a lifetime risk of 27% in men and 3% in women. Inguinal and femoral hernias are the most common affections faced by primary care physicians that require surgical intervention. The most common hernia in both sexes is the indirect inguinal hernia. The male-to-female ratio is 9:1 for inguinal hernias and 1:3 for femoral hernias. Inguinal hernia repair is one of the most common operations undertaken in routine surgical practice. Since the introduction of the Bassini method in 1887, more than 70 types of pure tissue repair have been reported in the surgical literature. Throughout the years, attention was paid to the recurrences that occur after the use of tissue approximation technique, in the literature it has been reported that they occur in up to 34% of cases, being that the actual incidence of recurrences it is underreported, therefore, the repair of the hernia with approximation of tissue has practically been abandoned. The concept of tension free repair for hernias was introduced by Lichtenstein who explain that the prime etiologic factor behind most herniorrhaphy failures is the suturing together, under tension, of structures that are not normally in apposition. The technique of the hernioplasty with the use of mesh was not widely accepted at first, the expansion of the use of mesh expanded for years. The use of mesh increased from 7 per cent of all operations in 1992 to 51 per cent in 1996. Currently, groin hernia treatment is not standardized but, today, tension free mesh repair technique is regarded as gold standard. Based in the Stoppa technique, the laparoscopic hernia repair was developed in 1991. The most common laparoscopic techniques for inguinal hernia repair are transabdominal preperitoneal (TAPP) repair and total extraperitoneal (TEP) repair. The use of the laparoscopic technique was progressively increasing based on the advantages of minimal invasive procedures, but since the publication of Neumayer in 2004, where he reports a recurrent incidence in laparoscopic hernia of 10.1 % compared with 4% for open surgery, the use of laparoscopic repair declines considerably. Surgeons remain divided on the best technique for inguinal hernia repair: while more than half never perform laparoscopic inguinal hernia repair, today the laparoscopic technique for hernia repair is used in 28% of cases, of which 25% is used the TEP approach and is considered the best approach for bilateral inguinal hernia repair (17). Advantages and disadvantages of TEP are: faster return to usual activities, operation times are longer and there appears to be a higher risk of serious complication rate in respect of visceral (especially bladder) and vascular injuries (18). In 1999, Gilbert published the use of bilayer patch device, known as prolene ® hernia system (Ethicon; Somerville, NJ, USA) (PHS) to repair inguinal hernia. The unique feature of this polypropylene mesh device is that it has attached the component, its underlay patch provides a pre-peritoneal repair, a connector that has the desirable attributes of a plug and an onlay patch covers the back wall. In the literature, better results have been reported for PHS repair than for Lichtenstein repair. The advantages of the anterior repair of inguinal hernias are: low operative costs, short learning curve, reproducible results at all levels and the possibility of the use of local anesthesia. The objective of this study is to compare the results of laparoscopic totally extra-peritoneal repair (LTEPR) with open prolene hernia system repair (OPHSR) retrospectively.

NCT ID: NCT03841045 Recruiting - Crohn Disease Clinical Trials

Unraveling a Potential Connection Between Bilirubin Metabolism, Gut Microbiota and Inflammatory Bowel Diseases

Start date: September 14, 2016
Phase:
Study type: Observational

Inflammatory Bowel Diseases (IBDs) are a set of recurrent inflammatory conditions that include the colon and small intestine. The two principal conditions include Crohn's disease (CD) and ulcerative colitis (UC). The etiology of which is likely to stem from the interplay of gut microbial imbalances and host. In this study stool cultures, saliva and skin samples will be taken from all participants.

NCT ID: NCT03840512 Recruiting - Prevention aGVHD Clinical Trials

An Open Label Study of Multiple Doses of Cannabidiol in the Prevention of Acute Graft-Versus-Host Disease (GVHD)

Start date: August 1, 2018
Phase: Phase 2
Study type: Interventional

A prospective, open-label, phase 2a study, to evaluate the pharmacokinetic (PK) profile, safety, and efficacy of multiple doses of Cannabidiol (CBD) in participants Graft-Versus-Host Disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT)

NCT ID: NCT03840226 Not yet recruiting - Heart Failure Clinical Trials

The Impact of Magnesium on Exercise Tolerance, Quality of Life and Clinical Outcomes in Chronic Heart Failure Patients

Start date: May 1, 2019
Phase: Phase 3
Study type: Interventional

Magnesium supplementation could improve cardiac performance. Patients with chronic heart failure (CHF) are magnesium deficient and we hypothesized that 1 year supplementation of oral magnesium comparted to placebo will improve exercise duration time and quality of life.

NCT ID: NCT03838640 Recruiting - Clinical trials for To Assess Feasibility of the New Application

Feasibility of Transnasal ECHO for Identification of Parapharyngeal Internal Carotid Artery

Start date: March 2019
Phase: N/A
Study type: Interventional

Identification and preservation of internal carotid artery during endoscopic nasopharyngectomy in cases of malignancy is a main difficulty of this kind of surgery, especially when anatomy is distorted by previous radiation. Intraoperative navigation based on preoperative imaging cannot remain precise throughout the process of resection. We aim to check a feasibility of internal carotid artery localization with the help of transnasal ultrasonic scanning. The most appropriate for this method existing device is an echocardiography system with pediatric transesophageal transducer. We plan to use it in 20 patients undergoing elective surgery for inflammatory sino-nasal disease. After initiatioin of general anesthesia and local decongestion, transducer will be placed transnasally to nasopharynx in order to scan a parapharyngeal space.

NCT ID: NCT03838029 Not yet recruiting - Clinical trials for Pancreatic Neoplasms

Perioperative Intervention to Reduce Metastatic Processes in Pancreatic Cancer Patients Undergoing Curative Surgery

BC-PC
Start date: February 28, 2019
Phase: Phase 2
Study type: Interventional

In Israel, of the ~1000 patients diagnosed annually with pancreatic cancer (PC), approximately 250 (25 percent) will be eligible for curative surgery, of which 80 percent will succumb to post-surgical metastatic disease. A reduction in post-surgical metastatic disease will save dozens of patients in Israel annually, and tens-of thousands-around the world. The short perioperative period (days to weeks around surgery) is characterized by stress-inflammatory responses, including catecholamines (CAs, e.g., adrenaline) and prostaglandins (PGs, e.g., prostaglandin-E2) release, and induce deleterious pro-metastatic effects. Animal studies implicated excess perioperative release of CAs and PGs in facilitating cancer progression by affecting the malignant tissue, its local environment, and anti-metastatic immune functions. Congruently, our animal studies indicate that combined use of the beta-adrenergic blocker, propranolol, and the prostaglandins inhibitor, etodolac - but neither drug separately - efficiently prevented post-operative metastatic development. We recently conducted two clinical trials in three medical centers in Israel, recruiting breast (n=38) and colorectal (n=34) cancer patients, assessing the safety and short-term efficacy of perioperative propranolol and etodolac treatment. Drugs were well tolerated, without severe adverse events. Importantly, molecular/biological analyses of the excised primary tumor indicated that drug treatment caused promising anti-metastatic transformations, as well as improvements in immune and inflammatory indices. These included (i) decreased tumor cell capacity to migrate, (ii) reduced pro-metastatic capacity of the malignant tissue, and (iii) improvement in immune infiltrating into the tumor (Paper published in Clinical Cancer Research, 2017). Herein, we propose to conduct a double-blind placebo-controlled two-arm Phase II clinical trial in 210 pancreatic cancer patients undergoing curative surgery in Israel. A perioperative 35-day drug treatment will be initiated 5 days before surgery. Primary outcomes will include (i) 1-year disease-free-survival (DFS), and 5-year overall survival (OS); and (ii) biological markers in blood samples, and in the excised tumor tissue. Secondary outcomes will include safety indices and psychological measures of depression, anxiety, distress, and fatigue.

NCT ID: NCT03837795 Recruiting - Clinical trials for Sensory Over-Responsivity

Examining the Efficiency of Neurofeedback Therapy on Adults With Sensory Over Responsivity

Start date: February 17, 2019
Phase: N/A
Study type: Interventional

Sensory Over-Responsivity (SOR) is characterized by a disruption in regulating sensory stimuli and can significantly impact pain perception and restrict daily participation and quality of life. Altered neurophysiological processes in SOR are documented, revealing reduced electroencephalogram at rest and P300 amplitudes, the latter tested through event-related potentials (ERP). Both may explain the failure to regulate incoming sensory stimuli. Neurofeedback (NF) therapy, a remedial treatment approach, aims at self-regulating the brain's neural activity and has proven its efficiency in treating comorbid SMD syndromes. Our study aims to investigate NF therapy efficiency in decreasing pain sensitivity, enhancing auditory ERP components of P300, increasing the power of the alpha band, life-satisfaction and Goal Attainment Scaling (GAS) scores in adults with SOR.

NCT ID: NCT03832413 Recruiting - Healthy Clinical Trials

Characterization of the DELPhI System in Assessing Brain's Functionality in Different Neurological Disorders

Start date: April 23, 2018
Phase:
Study type: Observational

We use Transcranial magnetic stimulation (TMS), combined with simultaneous registration of electroencephalograph (EEG),for examining human cortical functionality. TMS-EEG is a noninvasive brain stimulation method that allows to study human cortical function in vivo. EEG provides an opportunity to directly measure the cerebral response to TMS, measuring the cortical TMS Evoked potential (TEP). In this study we measure TEPs, in a wide variety of neurological conditions and healthy as a measure of cerebral reactivity across wide areas of neocortex.

NCT ID: NCT03830281 Not yet recruiting - Clinical trials for Type 1 Diabetes Mellitus

A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy

PRONTO-Pump-2
Start date: February 14, 2019
Phase: Phase 3
Study type: Interventional

The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).

NCT ID: NCT03823989 Recruiting - Cancer Clinical Trials

Intravenously Administered Liposomal PROMITIL in Combination With External Beam Radiotherapy in Cancer Patients

Start date: January 3, 2019
Phase: Phase 1
Study type: Interventional

This will be a multi-center, open-label, single-arm, prospective study, in which up to 18 adult patients requiring radiotherapy for metastatic disease or for an inoperable primary tumor with no definitive curative treatment option,, will undergo a combination treatment of intravenously (IV) delivered PROMITIL and standard of care radiotherapy. The treatment regimen will involve administration of two PROMITIL doses, delivered at a 21-day interval, and a 30 Gy course of EBR delivered in 10 fractions (3 Gy/fraction), initiated 1-3 days after the first PROMITIL dose and completed within a 2-week period. Treatment safety will be assessed on a weekly basis throughout the two 21-day treatment courses (42 days) and throughout the follow-up period (up to Day 127). AEs will only be logged until 6 weeks after the last PROMITIL dose (up until Day 64). Disease status will be reevaluated between days 43-50 of the study, and every 6 weeks thereafter (Days 85 and 127±7 days). In addition, following completion of the treatment schedule, all patients will be followed up by phone every 12 weeks, until either death, disease progression (PD), withdrawn consent or trial cut-off date, i.e., for up to 2 years after patient accrual to study, (whichever occurs first). No other anticancer treatments will be allowed during the 6-week treatment period and until disease reevaluation.