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NCT ID: NCT05599295 Recruiting - Clinical trials for Acute Bacterial Skin and Skin Structure Infection

Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin

Start date: June 15, 2023
Phase: Phase 2
Study type: Interventional

This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs). This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both). The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers.

NCT ID: NCT05598307 Recruiting - Pain, Postoperative Clinical Trials

A Study of the Effects of Intravenous Magnesium Sulphate on Anaesthesia and Analgesia in Elective General Surgery Patients

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

The aim of this double-blind randomized study will be to evaluate the effect an intravenous infusion of magnesium has on recovery outcomes after elective laparoscopic cholecystectomy

NCT ID: NCT05595642 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

ARNASA
Start date: December 29, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

NCT ID: NCT05594407 Recruiting - Pain, Postoperative Clinical Trials

Opioid Sparing Anesthesia in Lumbar Spine Surgery

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

The aim of this double blind randomized study will be to investigate the effect of an opioid-free anesthesia regimen with a mixture of dexmedetomidine-lidocaine-ketamine in the same syringe versus remifentanil analgesia in lumbar spine surgery

NCT ID: NCT05593783 Recruiting - Clinical trials for Complication,Postoperative

The Use of the "Comprehensive Complication Index" for Urinary Lithiasis Surgery.

Start date: October 21, 2022
Phase:
Study type: Observational

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Data regarding post operative descriptions will be recorded and comprehensive complication index will be used for the assesment of the burden.

NCT ID: NCT05591222 Recruiting - Clinical trials for Discoid Lupus Erythematosus

Study of Daxdilimab (HZN-7734) in Patients With Moderate-to-Severe Primary Discoid Lupus Erythematosus

Start date: October 12, 2022
Phase: Phase 2
Study type: Interventional

A Phase 2, double-blind, randomized, placebo-controlled parallel-group study to evaluate the efficacy and safety of daxdilimab in participants with moderate-to-severe active primary Discoid Lupus Erythematosus (DLE) refractory to standard of care.

NCT ID: NCT05583344 Recruiting - Clinical trials for Nonalcoholic Fatty Liver Disease

Phase 2b Study of GSK4532990 in Adults With NASH

HORIZON
Start date: January 2, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure improvements in liver fibrosis and inflammation with GSK4532990 compared with placebo in participants with NASH and advanced fibrosis on biopsy (F3 or F4). The study duration will be up to 76 weeks including the screening period. The treatment duration will be up to 52 weeks.

NCT ID: NCT05583227 Recruiting - Clinical trials for Eosinophilic Esophagitis

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

CROSSING
Start date: November 10, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo-controlled multicenter, phase 3 study to evaluate the efficacy and safety of tezepelumab administered subcutaneously (SC) using an accessorized pre-filled syringe (APFS) versus placebo in adult and adolescent patients with eosinophilic esophagitis (EoE).

NCT ID: NCT05582720 Recruiting - Clinical trials for Cardiometabolic Health

Cardioprotective Properties of Vegan Burger

VeganBurger
Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Several studies over the last decades have demonstrated the important role of nutrition in the development of chronic diseases, such as cardiovascular disease and cancer. One dietary component that has been in the center of scientific research is red meat and processed meat (e.g., cold cuts, sausages, burgers). Burger, in particular, is one of the most popular red meat products and its consumption has increased rapidly in recent years due to the expansion of fast-food restaurants, its wide availability and its low price. However, due to its high animal fat content which is mostly saturated and high degree of processing, its nutritional value and the safety of its long-term high consumption have been questioned. The wide acceptance of burger by the general population, combined with the perception that it is a "burdensome" food for health, makes it an ideal subject for interventions aiming at modifying its nutritional value without downgrading its organoleptic characteristics and increasing its cost. Such an approach could be applied to the meat industry in order to develop innovative, functional meat analogues of high nutritional and organoleptic value, which could find acceptance by both meat-eating and vegetarian/vegan populations. Therefore, the aim of the present double-blind, randomized, crossover clinical trial is to explore the potential cardioprotective properties of "vegan burger", a novel meat analogue developed through the substitution of animal proteins and lipids with plant-based constituents using innovative technologies, against the conventional animal-based burger, in apparently healthy volunteers.

NCT ID: NCT05581199 Recruiting - Clinical trials for Chronic Inflammatory Demyelinating Polyneuropathy

To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP

Start date: December 15, 2022
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, quadruple-blind, placebo-controlled study to evaluate the efficacy and safety of batoclimab in adult participants with active CIDP. The study includes an up to 4-week Screening Period, an up to 12-week Washout Period, a 12-week Randomized Treatment Period (Period 1), an up to 24-week Randomized Withdrawal Period (Period 2), an up to 52-week Long-term Extension (LTE) Period (optional), and Safety Follow-up 4 weeks after the last dose of study treatment. The total study duration will be up to approximately 109 weeks. Eligible participants will be assigned to one of four cohorts based upon their baseline CIDP treatment (Cohorts A and D - immunoglobulin [Ig] or plasma exchange [PLEX]; Cohort B - corticosteroids; Cohort C - naive or untreated in previous 3-24 months) and whether they meet diagnosis according to the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) criteria (Cohorts A, B, and C) or clinical criteria only (Cohort D) at the time of screening.