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NCT ID: NCT06378086 Not yet recruiting - Pain Clinical Trials

RHA® Redensity With New Anesthetic Agent Perioral Rhytids (PAS)

Start date: June 2024
Phase: N/A
Study type: Interventional

This is a randomized, controlled, double-blinded, within-subject (split-face), multicenter, prospective study to investigate whether RHA® Redensity with new anesthetic agent is non-inferior to RHA® Redensity with lidocaine in terms of injection site pain felt by the subject during injection. At screening, the Principal Investigator (PI) evaluated subjects' perioral rhytid severity (using the Perioral Rhytid Severity Rating Scale; PR-SRS) to confirm eligibility and to establish a pre-treatment score for assessing aesthetic improvement. At Visit 1, RHA® Redensity with new anesthetic agent was administered in a random sequence (first or second injection) and side of the mouth (left or right) and RHA® Redensity with lidocaine was administered to the other side. Study subjects and the PI injecting study devices were blinded. Immediately after injection of an upper perioral quadrant, subjects rated the injection site pain experienced during injection using a 100 mm Visual Analog Scale (VAS). Injection site pain in each side of the mouth was also assessed at 15, 30, 45 and 60 minutes after injection of the upper quadrant. Safety evaluation consisted of AE assessments, a 30-day CTR (Common Treatment Response) diary and a follow-up call performed by the study site at 72 hours after injection. Subjects attended Visit 2 (30 days post-injection) where effectiveness and safety assessments were conducted. Subjects who presented with an unresolved clinically significant device related AE at Visit 2 received a optional follow-up phone call no later than 30 days after Visit 2. If the clinically significant AE remained unresolved, the Investigator requested that the subject attended the optional in-clinic follow-up visit (i.e., Visit 3) within 5 working days. Follow-up of the clinically significant AE continued until the AE was resolved or the TI determines that additional follow-up was not necessary.

NCT ID: NCT06377917 Not yet recruiting - Infertility Clinical Trials

Investigating Micro-Manipulation Procedures for Assisted Hatching Timing

IMPACT
Start date: May 2024
Phase: N/A
Study type: Interventional

This study aims to assess the clinical significance of cleavage stage (Day 3) assisted hatching compared to assisted hatching at the blastocyst stage (Day 5,6,7) of embryo development at the time of trophectoderm (TE) biopsy for patients undergoing in vitro fertilization (IVF) and preimplantation genetic testing for aneuploidy (PGT-A) for treatment of their infertility.

NCT ID: NCT06377553 Not yet recruiting - Endometriosis Clinical Trials

PET/MRI for Evaluation of Endometriosis

Start date: May 3, 2024
Phase:
Study type: Observational

This study aims to determine if PET/MRI can detect endometriosis and potentially improve upon currently available non-invasive diagnostic capabilities. Specifically, the authors will investigate the ability of PET/MRI to detect and quantify endometriosis, as well as differentiate among subcategories such as inflammatory peritoneal lesions, fibrotic deep infiltrating endometriosis lesions (DIE), and ovarian endometriomas. The authors will compare [68Ga]CBP8 or [18F]-FAPI-74 PET/MRI imaging versus the current gold standard diagnostic methods, including laparoscopic surgery, clinical follow-up, and follow-up imaging.

NCT ID: NCT06377527 Not yet recruiting - Clinical trials for Mesonephric-like Adenocarcinoma

Establishing a Tumor Registry of Patients With Mesonephric-like Adenocarcinoma (MLA)

Start date: October 31, 2024
Phase:
Study type: Observational

To develop a database of medical information about patients with MLA in an effort to increase our understanding of the characteristics of MLA, which is the rarest form of endometrial carcinoma.

NCT ID: NCT06377371 Not yet recruiting - Meningioma Clinical Trials

Feasibility of Intraoperative Tracing of Meningioma Using [Cu64]DOTATATE

Start date: May 2024
Phase: Phase 4
Study type: Interventional

The study team hypothesizes that it is feasible to intraoperatively detect tumor following [CU64]DOTATATE injection using the gamma probe device.

NCT ID: NCT06377215 Not yet recruiting - Aging Clinical Trials

Understanding Aided Speech Perception in Noise

Start date: April 15, 2024
Phase:
Study type: Observational

The overarching hypothesis to be evaluated using this protocol is that age-related hearing loss (ARHL) leads to shifts in the functional spatial boundaries between segregated and integrated auditory streams, and that hearing aid intervention that relies on directional processing schemes is most effective for those that have the poorest spatial sensitivity. One key component of the research design is to measure both behavioral and neurophysiological indices of an individual's spatial segregation boundary. The second key component is to measure the cost or benefit associated with hearing aid intervention in older hearing-impaired listeners. The final component is to relate cost and benefit of hearing aid intervention to spatial sensitivity measures that might predict the efficacy of clinical intervention.

NCT ID: NCT06376994 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Multi-Center Clean Air Randomized Controlled Trial in COPD

Clean Air
Start date: September 2024
Phase: Phase 3
Study type: Interventional

This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.

NCT ID: NCT06376877 Not yet recruiting - Anxiety Disorders Clinical Trials

Connectomic Targeted TMS Target for Refractory Anxiety

ConTRA
Start date: August 1, 2024
Phase: Phase 2
Study type: Interventional

We will perform a randomized sham-controlled trial of aiTBS to an anxiosomatic circuit in patients with anxiety-related disorders (i.e., panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder). 80 participants with an anxiety-related disorder (defined below) will receive 50 active or sham TMS treatments over 5 days (following the SAINT protocol, which is FDA-cleared for MDD. The primary outcome will be the BAI, with a modified recall window to reflect the short treatment interval. Participants randomized to sham will be offered an open-label crossover extension.

NCT ID: NCT06376565 Not yet recruiting - Clinical trials for Colorectal Carcinoma

Improving Colonoscopy Surveillance for Patients With High Risk Colon Polyps

Start date: July 5, 2024
Phase: N/A
Study type: Interventional

This clinical trial tests a multilevel intervention at the clinic, provider and patient levels, to improve colonoscopy surveillance in patients with high risk colon polyps. Colorectal cancer (CRC) is a common and deadly disease that is largely preventable through the detection and removal of colorectal polyps. One million Americans are diagnosed with high risk polyps of the colon or rectum annually and are at increased risk for CRC; however, uptake of recommended repeat colonoscopy in 3 years to reduce CRC risk is low in this group. This multilevel intervention may work to improve timely colonoscopy screening for patients with high risk colon polyps.

NCT ID: NCT06376526 Not yet recruiting - Multiple Myeloma Clinical Trials

IMMUNOPLANT for Newly Diagnosed Multiple Myeloma

IMMUNOPLANT
Start date: June 30, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether Linvoseltamab therapy in patients with newly diagnosed multiple myeloma will convert the disease status from minimal residual disease (MRD)-positive to MRD-negative, and increase the length of time that the disease is controlled. The researchers also want to find out the effects (good and bad) that Linvoseltamab has on participants and the condition.