Clinical Trials Logo

Filter by:
NCT ID: NCT03808116 Completed - Breast Cancer Clinical Trials

Evaluation of the SmartBx System for Breast Biopsy

Start date: June 10, 2019
Phase: N/A
Study type: Interventional

Performance evaluation of a novel, semi-automated device and method for needle core biopsy download compared to standard methods in terms of: 3. Biopsy core length obtained (i.e. collecting all tissue fragments) 4. Biopsy core yield (i.e. percent of tissue loss during the pathologic processing)

NCT ID: NCT03807050 Completed - Clinical trials for Absorption; Chemicals

Safety and Pharmacokinetics of Phaffia Rhodozyma Astaxanthin

Start date: November 19, 2018
Phase: N/A
Study type: Interventional

Astaxanthin is a xanthophyll carotenoid, a naturally occurring lipid-soluble red pigment. Apart from its coloring ability it is also a strong antioxidative ingredient and contains health-promoting properties. Study aim is to monitor the safety and tolerability of AstaFerm™, an astaxanthin dietary supplement derived from the yeast Phaffia rhodozyma. Pharmacokinetics profile is tested in 12 healthy male adults who received a single dose of AstaFerm™ in a single-center, open-label, non-randomized, single-dose study. Subjects are admitted to the clinical research center on the evening before dosing. On the next morning, after overnight fast, pre-dosing plasma sampling is performed, then they receive a fat balanced breakfast followed by a single administration of AstaFerm™ capsules. The capsules contain 50 milligram astaxanthin derived from Phaffia rhodozyma. Following dosing, blood sampling is performed for 24 hours in-house (2, 4, 6, 8, 10, 12 and 24-hours post-dose) and ambulatory at 48, 72- and 168-hours post-dose. Blood for antioxidant activity assessment is also drawn.

NCT ID: NCT03805100 Completed - Clinical trials for Macular Degeneration

Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

XPLORE
Start date: April 19, 2019
Phase: Phase 3
Study type: Interventional

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

NCT ID: NCT03802942 Recruiting - Hypoglycemia Clinical Trials

Prevention of Hypoglycemia Among Diabetes Patients Admitted to Internal Medicine Departments With Nutritional Care

MENU-DM
Start date: July 1, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective randomized study to evaluate the efficacy of nutritional intervention for the prevention of hypoglycemia among diabetes patients with low albumin level that are admitted to internal medicine units, regardless of the reason for admission. All patients suitable for participation in the study will be asked to participate and be randomized to the interventional arm or the control arm. After admission to the internal medicine unit, eligible patients will be asked to participate in the study. After signing an informed consent form, patients will be randomized to the treatment or control arms. For patients allocated to the treatment arm, the physician in charge will prescribe 2 portions of GlucernaTM per day as part of the treatment protocol. The nurse in charge of the patient (at either the morning or evening shifts) will make sure the patient is receiving and consuming the ONS. For every patient included in the interventional arm, 2 bottles of GlucernaTM will be supplied to the patient, one at 08:00 with the morning medications, and one at 16:00 with the evening medications. For clarification purposes, the GlucernaTM will be supplied on top of the designated meal plan, as "over-feeding". Evaluation of adequate ONS consumption will be performed 2-3 hours after the dispensing of the ONS (at 10:00-11:00 and 19:00-21:00), and the amount consumed will be documented. Patients in the control arm will receive no oral nutritional supplementation, and their caloric intake will be composed of the food supplied by the hospital. Other analysis will be considered usual care. Additional diet consultations as requested by the medical staff will constitute usual care, and the patient will continue the study. The duration of ONS treatment will be the entire length of hospital stay. Upon discharge, a recommendation to continue nutritional care will be added to the patients' discharge letters but no oral nutritional supplement (ONS) will be prescribed or dispensed. Following discharge, a 30-day follow-up call will be made to ascertain whether the patient is alive, whether the patient was re-admitted or re-hospitalized, and the usage of ONS prescribed by the family/general practitioner that was consumed after the hospital discharge.

NCT ID: NCT03802630 Terminated - Clinical trials for Branch Retinal Vein Occlusion

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion

RAPTOR
Start date: July 2, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to branch retinal vein occlusion (BRVO).

NCT ID: NCT03800563 Completed - Clinical trials for Laser Assisted Liposuction

Laser Assisted Liposuction and Facial Autologous Fat Grafting With the LipoLife System

Start date: November 6, 2018
Phase: N/A
Study type: Interventional

Multi-center, prospective, open-label, single arm study. The study aims to evaluate the safety and efficacy of Laser Assisted Liposuction procedure performed with the LipoLife system. The study will include twenty (20) eligible subjects, that are willing to undergo abdominal or outer thighs laser-assisted liposuction. Five to twenty (5-20) subjects out of this study group should also be eligible for facial fat grafting. Follow up visits to evaluate study endpoints will take place at 1, 3 and 6 months after the surgery.

NCT ID: NCT03799250 Recruiting - Ringer's Lactate Clinical Trials

Fluid Management in the Post Anesthesia Care Unit

Start date: June 30, 2019
Phase: Phase 4
Study type: Interventional

Fluid therapy is a cornerstone in patient therapy perioperatively. Many studies have addressed the amount of fluid administered (restrictive vs liberal strategies). Other studies focused on the type of fluids (colloid vs crystalloids), and in the last twenty years a more common subject of research was- the correct evaluation of the dynamic fluid status of patients.Bolus driven fluid therapy has been investigated in many goal-directed hemodynamic therapy (GDHT) trials and has become a widely used approach in intraoperative fluid management. While there are numerous studies on the intraoperative outcome of GDHT, research on the immediate postoperative outcome of GDHT therapy use is scarce. In this study the investigators aim to evaluate the efficacy of bolus-based fluid management guided by common clinical parameters in postoperative period in post-anesthesia care unit. In this randomized clinical trial all patients will be randomized to one of the following groups: The control group will receive standard care which includes fluid maintenance program as dictated by the operating room anesthesiologist and as needed boluses through the PACU stay. The GDT group will not receive any maintenance fluid. Fluid boluses will be given according to the flowchart attached. Measurements of hemodynamic variables including heart rate and automatic non-invasive blood pressure measurements as well pulse oximetry as routine procedures will be recorded and stored by Metavision system (iMDsoft company) at regular intervals, all according to standard clinical practice. Blood gases measurement will be performed upon admission and at discharge. Urine output will be measured and recorded every hour.

NCT ID: NCT03799081 Not yet recruiting - Abortion, Missed Clinical Trials

Use of Fetoscopy in Missed Abortion

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

The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.

NCT ID: NCT03798964 Completed - Preterm Birth Clinical Trials

The Expression Heparanase in Term and Preterm Placentas

Start date: January 23, 2019
Phase:
Study type: Observational

Heparanase is an endo-β-glucuronidase that cleaves heparin-sulfate (HS) side chains of heparan sulfate proteoglycans, an integral constituent of the extra cellular matrix (ECM). This study aims to investigate the association between heparanase expression in the human placenta and preterm birth (PTB) . The investigators hypothesize that an abnormal placentation causes relative placental ischemia that induces higher rates of heparanase expression.

NCT ID: NCT03798626 Active, not recruiting - Colorectal Cancer Clinical Trials

Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers

Start date: May 22, 2019
Phase: Phase 1
Study type: Interventional

This study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.