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NCT ID: NCT05614245 Withdrawn - COVID-19 Clinical Trials

Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901e With E6020 Adjuvant

Start date: March 2023
Phase: Phase 1
Study type: Interventional

VBI-2901e is an investigational vaccine candidate that uses enveloped virus-like particles (eVLPs) to express the spike proteins of three coronaviruses: SARS-CoV-2 (the virus that causes COVID-19 disease), SARS-CoV-1 and MERS-CoV. The trivalent vaccine candidate is designed to induce neutralizing antibody and cell-mediated immune responses against the spike protein of the original strain of SARS-CoV-2 coronavirus, variants and subvariants of SARS-CoV-2 (such as Beta, Delta and Omicron BA.5) and other related coronaviruses that could emerge in the future. VBI-2901e contains two adjuvants: aluminum phosphate and E6020. The role of the adjuvants is to create a stronger immune response to the vaccine. This Phase 1 study will be an open-label study of VBI-2901e comparing three dose levels of the E6020 adjuvant component (1, 3, or 10 µg per dose) in adults 18 to 40 years of age who had previously received two or more vaccinations with licensed COVID-19 vaccine(s). VBI-2901e at each dose level of E6020 will be administered as either a single dose or two-dose regimen. The purpose of the study is to test the safety of VBI-2901e and to learn more about its ability to boost immune responses against SARS-CoV-2 and the two related coronaviruses SARS-CoV-1 and MERS-CoV.

NCT ID: NCT05594667 Withdrawn - Depression Clinical Trials

Effect of SSRIs on Response to Psilocybin Therapy

Start date: January 1, 2023
Phase: Phase 2
Study type: Interventional

This study is an open-label, single-arm, within-subjects design in individuals with mild-moderate Major Depressive Disorder (MDD). All participants will receive a single dose of 25mg of psilocybin in a therapeutic setting. In order to investigate the effects of length of time on SSRI therapy, 30 participants with varying lengths of time on SSRI therapy will be enrolled, stratified into four groups: - Group 1: ≤ 1 year - Group 2: 1 to ≤ 5 years - Group 3: 5 to ≤ 10 years - Group 4: > 10 years

NCT ID: NCT05571241 Withdrawn - Osteoarthritis Clinical Trials

Ligament Reconstruction in an Accelerated Rehabilitation Protocol

Start date: February 2014
Phase:
Study type: Observational

The investigators have found that their patients who get earlier rehabilitation following ligament reconstruction and tendon interposition (LRTI) surgery with interference screws have experienced better outcomes. The investigators hypothesis is that when formally comparing these patients who are exposed to the rehabilitation protocol earlier compared to later, the investigators will see statistically better outcomes.

NCT ID: NCT05465876 Withdrawn - COVID-19 Clinical Trials

Passive Antibodies Against COVID-19 With EVUSHELD in Vaccine Non-responsive CLL

PACE-CLL
Start date: October 2023
Phase: Phase 2
Study type: Interventional

Chronic lymphocytic leukaemia (CLL) is a common lymphoid malignancy affecting older adults. CLL patients are immunocompromised by the disease itself and by several of its therapies. It has now been shown that many CLL patients do not mount an antibody response following COVID-19 vaccination and are therefore at risk of COVID-19 infection. Furthermore, patients with hematologic malignancies are known to be at increased risk of severe infection if they do acquire COVID-19 infection. The purpose of this trial is to document evidence of passive immunity to COVID-19 infection after EVUSHELD administration with serologic and neutralization assays at multiple post administration time points in patients with no response to standard of care vaccination to COVID-19. This trial will include a single dose of EVUSHELD to be administered, with a 1-year follow-up period, comprising of 8 health status visits. Blood samples will be taken at screening, baseline and at multiple health status visits over the course of the year for various antibody testing and analysis. T cell reactivity to COVID-19 epitopes will be studied at baseline and again monthly for 3 months in any participants that become infected with COVID-19.

NCT ID: NCT05374330 Withdrawn - Knee Osteoarthritis Clinical Trials

Electroacupuncture Treatment for Those With End Stage Knee Osteoarthritis on a Total Knee Arthroplasty Waitlist

Start date: September 2023
Phase: N/A
Study type: Interventional

A 3-armed pilot randomized controlled trial: electroacupuncture, sham acupuncture and waitlist groups.

NCT ID: NCT05338281 Withdrawn - Breast Cancer Clinical Trials

NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT

NPWTinDIEP
Start date: September 2023
Phase: N/A
Study type: Interventional

The current study is a single center randomized control trial that will examine the effect of closed incision negative pressure wound therapy (ciNPT) versus conventional dressing on abdominal incision in a deep inferior epigastric perforator (DIEP) flap based reconstruction. Patients will be followed by 30 days post-operatively to compare outcomes including the rate of surgical site infection, seroma, and the scar quality.

NCT ID: NCT05321251 Withdrawn - Clinical trials for Neurotrophic Keratitis

Topical Insulin Drops for the Treatment of Neurotrophic Keratopathy.

Start date: June 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Many diseases can affect corneal nerves. Corneas that lack normal sensation are considered neurotrophic. Neurotrophic corneas are predisposed to persistent epithelial defects, recurrent erosions, and corneal ulcers. These can lead to a variety of complications, from subjective pain, discomfort, and blurry vision, to corneal perforation and endophthalmitis. Neurotrophic corneas and the persistent epithelial defects associated with them can be very difficult to treat. Non-invasive measures include topical drops (artificial tears, antibiotics, or steroids), bandage contact lens, and punctal plugs. More invasive surgical treatments include membrane grafts, tarsorrhaphy, and keratoplasty. Despite these treatments, many neurotrophic corneas still do not heal. This study aims to test the efficacy of topical insulin in the treatment of neurotrophic keratopathy.

NCT ID: NCT05301595 Withdrawn - Breast Cancer Clinical Trials

TAP vs QL for Postoperative Analgesia After DIEP Free Flap Breast Reconstruction

Start date: April 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the efficacy of Transversus abdominus plane (TAP) block and Quadratus Lumborum (QL) block on the quality of recovery after breast reconstruction with deep inferior epigastric perforator (DIEP) flap.

NCT ID: NCT05295771 Withdrawn - Thin Gingiva Clinical Trials

Evaluation of Geistlich Fibro-Gide ® and Autogenous Connective Tissue Graft Prior to Orthodontic Maxillary Expansion.

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

Teenage children and adults often undergo orthodontic treatment each year to improve their dental esthetics and chewing function. One common problem they present with is having a small maxilla compared to the mandible. The standard of treatment to correct this issue is to expand the maxilla using either a tooth-anchored expander, a bone-anchored expander, or braces. Unfortunately, these treatment options can sometimes result in a loss of gum tissue and supporting structures of the teeth. Certain patients, especially ones that have thin gum tissue, are at a higher risk of this gum tissue loss. Orthodontic treatment for these patients will expand their jaw, causing further pressure on already thin gums. An increasingly common treatment to prevent this is to proactively modify patient's thin tissue surgically prior to their orthodontic treatment so they can withstand the tooth movement. The gold standard of doing this surgical intervention consists of harvesting a connective tissue from the palate which is not well tolerated by the younger population. Our study will evaluate the use of a biomaterial substitute instead of harvesting the patient's own tissue to thicken the gingival tissues. Surgical healing, patient satisfaction, pain index, as well as tissue contour post orthodontic treatment will be assessed thoroughly. This study will help us understand: 1) if biomaterials can be a substitute for traditional autogenous gum grafts to help thicken the patient's gum tissue prior to orthodontic treatment, and 2) if they are able to withstand the pressure of orthodontic movement. This will be the first long-term study of this kind.

NCT ID: NCT05289882 Withdrawn - Clinical trials for Well-Being (Psychological Flourishing)

Purpose After Service Through Sport (PASS)

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

The purpose of this study is to evaluate the efficacy of a gender-sensitized social-connectedness physical activity program in relation to key markers of well-being among military veteran men over 6 months.