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Abbott Clinical Trials

12:23 EDT 17th July 2019 | BioPortfolio

Study to Evaluate the Superior Efficacy of Cardiac Resynchronization (SyncAVTM) Using the SyncAVTM Algorithm

Heart Failure (HF) is a cardiovascular disease secondary to a structural and / or functional alteration of the heart that prevents its correct function. The Cardiac resynchronization therapy (CRT) aims to restore atrioventricular, inter and intraventricular synchrony in patients with systolic HF and wide depolarization of the ventricles (QRS). Although CRT has been shown t...

Performance Evaluation of Malaria Plus RDTs

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific H...

PROLONG Prospective, Multi-center, Open-label, Post-market Study

Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will p...

Assessment of the Accuracy of Continuous Glucose Sensors in People With Diabetes Undergoing Haemodialysis

The purpose of the study is to assess the accuracy of the Dexcom G6 CGM system and the Abbott FreeStyle Libre flash system compared to the reference standard YSI (Yellow Spring Instruments) glucose in people with diabetes undergoing haemodialysis. The Dexcom G6 is a continuous glucose monitoring system that gives blood glucose values in real-time and includes alarms if the ...

Formulas for Diabetes With Sucromalt & Isomaltulose on Glycemic Index, Hormones & Subjective Appetite in Type 2 Diabetes

Consumption of nutritional supplements with low glycemic carbohydrates induce favorable glycemic responses in subjects with type 2 diabetes. The aim of this study was to compare the effect of the intake of specific formulas for diabetes, with different types of carbohydrates (isomaltulose and sucromaltose) on the glycemic response, release of intestinal peptides and subject...

Abbott Brady 3T MRI PMCF

The objective of this post-market, clinical follow up (PMCF) study, is to confirm the long-term safety of the Tendril STS and Isoflex leads, implanted with the Assurity MRI™ or Endurity MRI™ pacemakers, in patients undergoing a clinically indicated 3T MRI scan.

Confirm Rx™ Versus Reveal LINQ™ - Which is More Reliable in Data Transmission? A Randomized Clinical Study

This study will compare the reliability and timeliness in data transmission of the Abbott Confirm Rx™ loop recorder with the Medtronic Reveal LINQ™ loop recorder.

CRyoAblation vs AntiaRrhythmic Drugs for Persistent Atrial Fibrillation Trial

The ablation of pulmonary veins is a very effective treatment for the treatment of paroxysmal atrial fibrillation. The benefit of the isolation of pulmonary veins in persistent atrial fibrillation seems to be minor and the level of scientific evidence available requires additional clinical trials to define the value of ablation in this type of patients. The symptomatology ...

Paediatric Use of the Abbott Sensor Based Glucose Monitoring System

Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by children with diabetes.

Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil

Evaluation of the bioavailability and safety of one oral preparation containing fixed dose 18 mg ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) or two oral preparations containing fixed dose 18 mg ivermectin (IVM 36 MG TABLETS, LICONSA S.A., Spain) vs. reference dosing (weight based) of reference drug containing 6 mg ivermectin (REVECTINA®, Abbott Laboratórios do Bra...

Evaluation of the Accuracy and Precision of Flash Glucose Monitoring Sensors in Different Sites

On the first of July 2016, reimbursement for the Freestyle Libre Flash Glucose Monitoring (FGM) was introduced by the Belgian healthcare authority by means of a new diabetes convention. Making this the only way to receive the device in Belgium. Since then, many type 1 diabetes (T1D) patients switched to FGM. But some patients found the sensor on the upper arm too visible. A...

Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data

Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypogly...

Long Superficial Femoral Artery Stenting With SuperA Interwoven Nitinol Stents

Endovascular treatment with stenting is currently used in the treatment of femoro-popliteal lesions. This technique tends to extend to lesions for which the gold standard remains until now the open surgery treatment (lesions TASC C and D). The primary objective of the study was to evaluate the clinical efficacy at 12 months of the SuperA stent (Abbott) in the treatment of ...

ABSORB II Randomized Controlled Trial

Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)

Effectiveness and Safety Study of the Abbott Sensor Based Glucose Monitoring Systems

The purpose of the study is to evaluate the safety and effectiveness of the Abbott Sensor Based Glucose Monitoring System Personal (System-P) and Abbott Sensor Based Glucose Monitoring System Professional (System-Pro) when used as an adjunct to blood glucose testing over a 14-day wear period in adult subjects. The Abbott Sensor Based Glucose Monitoring System - Professional...

Abbott Sensor Based Glucose Monitoring System Paediatric Study

To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.

Multi-Site Study of Rapid Diagnostic Syphilis Assays

The performance of an investigational immunochromatographic strip (ICS) test for the diagnosis of syphilis is compared with the Abbott Laboratories Determine ICS test. The study population consists of patients with and without syphilis presenting to sexually transmitted disease clinics in five cities in the United States. Specimens include finger-stick whole blood (invest...

Compliance With Once-Daily Divalproex Extended-Release Tablets (Depakote-ER) Versus Multiple-Daily Dose Valproic Acid Capsules (Depakene) in Epilepsy:

To determine, in a randomized, parallel open-label fashion, compliance rates between once-daily extended-release divalproex sodium tablets (Depakote-ER®, Abbott Labs) versus multiple-daily dose valproic acid capsules (Depakene®, Abbott Labs) in an epilepsy population.

Use of OraQuick for Screening HIV in Children Less Than Eighteen Months Old

Blood is the most commonly used specimen to test for HIV. In the past 20 years, use of saliva as an alternative specimen for HIV testing has been explored. Today, very sensitive tests have been formulated and have been used for diagnosing HIV in adults and older children. OraQuick, a rapid test, is one such example. It is a devise that can be used to collect as well test t...

Myocardial Hemodynamic Effects of Levosimendan

This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan. Levosimendan (SimdaxTM, Abbott Laboratories, Abbott Park, IL) is a calcium sensitizer which has been shown to have beneficial hemodynamic effects in patients with decompensated congesti...

Star-Close Versus Angio-Seal for Femoral Artery Hemostasis

This study was designed to evaluate the efficacy and safety of Starclose (Abbott Vascular Devices) for femoral access site closure in patients undergoing PCI compared to Angio-Seal STS Plus (St. Jude Medical).

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fed State

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fed conditions. Forty-four (44) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-period...

Comparative Bioavailability Study of Clarithromycin 500 mg Tablets in Fasting State

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 500 mg (1 x 500 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasting conditions. Sixty-four (64) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this two-pe...

Comparative Bioavailability Study of Clarithromycin 250 mg Tablets

The objective of this study was to investigate the bioequivalence of Genpharm's clarithromycin tablets following a single, oral 250 mg (1 x 250 mg) dose compared to the Biaxin® filmtab® (Abbott Laboratories USA) administered under fasted conditions. Thirty-four (34) healthy, light-, non- or ex-smoking subjects of at least 18 a years of age were randomized, in this four-p...

Fasting Study of Levothyroxine Sodium Tablets 200 mg to Synthroid Tablets 200 mg

The objective of this study was to investigate the bioequivalence of Mylan's levothyroxine sodium 200 μg tablets to Abbott's Synthroid® 200 μg tablets following a single 600 μg (3 x 200 μg) dose administration in healthy volunteers under fasting conditions. Twenty-nine healthy, non-smoking, subjects between the ages of 18 and 47 completed this open-label, randomized, ...

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