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NCT ID: NCT05454020 Completed - Pain Clinical Trials

A Study of Topical XG004 in Participants With Osteoarthritis of the Knee

Start date: June 7, 2022
Phase: Phase 1
Study type: Interventional

This is phase 1 placebo controlled study to evaluate the safety, tolerability and pharmacokinetics of XG004 applied topically in participants with osteoarthritis of the knee

NCT ID: NCT05450848 Completed - Clinical trials for Radiation Dermatitis

StrataXRT vs. Standard Clinical Practice in the Prevention and Treatment of Radiation Dermatitis

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Current clinical practice for preventing and treating radiation dermatitis across Queensland (QLD) Health Radiation Oncology departments involves the application of aqueous cream daily to the skin of the treatment site, commencing from Day 1 of EBRT. The primary aim of this study is to assess the efficacy of StrataXRT when compared to current clinical practice in preventing and managing radiation dermatitis.

NCT ID: NCT05449795 Completed - Diabetes Mellitus Clinical Trials

Evaluation of the Performance of Contour Next® and Contour Plus Elite® BGMS in Arterial Blood Samples From Hospitalized Adults

Start date: November 29, 2022
Phase:
Study type: Observational

The purpose of the study is to extend the intended use of two BGMSs to include testing of arterial blood by Health Care Professionals (HCP) in a clinical setting.

NCT ID: NCT05444972 Completed - Myelofibrosis Clinical Trials

A Study to Explore Treatment Patterns, Treatment Outcomes, Healthcare Resource Utilization in Adult Participants With Myelofibrosis Through Chart Review

METER
Start date: August 23, 2022
Phase:
Study type: Observational

Myelofibrosis (MF) is a rare blood cancer, characterized by extensive fibrosis (scarring) of the bone marrow. It is one of a group of cancers known as myeloproliferative neoplasms (MPNs) in which bone marrow cells that produce blood cells develop and function abnormally. This study will evaluate treatment patterns, treatment outcomes, healthcare resource utilization in adult participants with Myelofibrosis. Data from approximately 1000 participants will be collected. No participants will be enrolled in this study. Participants' charts will be reviewed. No drug will be administered as a part of this study. The duration of the observation period is up to 156 weeks. There is no additional burden for participants in this trial. All visits must be completed prior to data extraction and participants will be followed for up to 156 weeks.

NCT ID: NCT05442918 Completed - Diabetes Mellitus Clinical Trials

Expected Normal Ketone Values After Very Low and Bariatric Surgery

Start date: January 15, 2020
Phase:
Study type: Observational

The investigators propose a multicenter prospective study in patients undergoing either an elective bariatric procedure or an elective benign procedure, including laparoscopic/open cholecystectomy, laparoscopic/open hiatus hernia repair, laparoscopic/open inguinal hernia repair, laparoscopic/open umbilical hernia repair or laparoscopic ventral wall hernia repair. Perioperative blood ketone and venous blood gas levels will be measured pre-surgery, post-surgery and on post-operative days until discharge. Our primary research objective is to clarify the expected perioperative ketone and blood gas levels in elective bariatric patients who have been on a VLCD and fasting for surgery, compared to elective surgical patients who have only been fasting prior to surgery.

NCT ID: NCT05438602 Completed - COVID-19 Clinical Trials

A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System

Start date: August 3, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The study is seeking participants who: - Have a confirmed COVID-19 infection - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir. For this group, the study is seeking participants who: - Have a confirmed COVID-19 infection - Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir - The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study.

NCT ID: NCT05434247 Completed - Biopsy, Needle Clinical Trials

Comparing the Diagnostic Adequacy of 25-gauge Fork-tip, Franseen and Reverse-bevel Type Needles in Endoscopic Ultrasound Guided Tissue Acquisition

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Endoscopic ultrasound guided fine needle aspiration (EUS-FNA) and fine needle biopsy (EUS-FNB) are well established techniques for the acquisition of tissue to classify a number of lesions of the gastrointestinal tract and surrounding organs. These include pancreatic, lymphoid, subepithelial and other abdominal lesions. Historically, FNA was the sole available modality used to obtain cytological samples for analysis. The major shortcoming of this technique is the lack of a histological tissue core. In recent years attention has turned to optimizing needle design to improve sample quality. New needles have been developed which aim to obtain a core of tissue with preserved architecture. These needles include the first generation Reverse-bevel Echo Tip® HD ProCore™ (Wilson-Cook Medical Inc., Winston-Salem, NC, United States), and the second generation Fork-tip SharkCore™ (Medtronic Inc., Sunnyvale, CA, United States) and Franseen Acquire™ (Boston Scientific, Marlborough, MA, United States). Currently there are a paucity of studies comparing the performance of these needles, and only two of these are prospective randomized controlled trials. Real world performance of these needles has seldom been reported, with only one RCT including non-pancreatic masses in their analysis. The investigators hypothesize that second generation needles have equivalent or better diagnostic performance than the prior first-generation needle. To test this, the investigators aim to conduct a prospective randomized controlled study comparing the performance of Fork-tip and Franseen needles for the sampling of pancreatic, subepithelial, lymphoid and other abdominal or mediastinal lesions. They also aim to include a retrospective control arm of consecutive cases using the first-generation Reverse-bevel needle. The investigatora aim to assess the diagnostic yield of each needle, as well as number of needle passes used, and specimen quality.

NCT ID: NCT05426746 Completed - ARDS, Human Clinical Trials

First-In-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALT-100

Start date: July 5, 2022
Phase: Phase 1
Study type: Interventional

ALT-100 is a monoclonal antibody developed by Aqualung Therapeutics Corp. as a treatment for Acute Respiratory Distress Syndrome (ARDS). ARDS can occur as a serious complication in patients with respiratory infections such as COVID-19 and Influenza or have acquired trauma to their lungs. 32 healthy male or female participants between the ages of 18 and 55 years will be enrolled into 4 cohorts of single ascending doses. The doses being investigated are 0.1mg/kg, 0.4mg/kg, 1mg/kg and 4mg/kg administered by intravenous infusion. Participants will be screened within 28 days of study treatment, be admitted to the clinical research unit for 3 nights and attend 7 outpatient visits on study days 8, 15, 22, 29, 60, 90 and 120 respectively. This study will collect data to evaluate safety and tolerability, Pharmacokinetics of ALT-100, Pharmacodynamics of ALT-100 and determine if Anti-drug Antibodies are produced in the participants.

NCT ID: NCT05425732 Completed - Clinical trials for Pneumococcal Infection

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

Start date: July 13, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine ([Prevnar 20™ / APEXXNAR™]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.

NCT ID: NCT05418426 Completed - Clinical trials for Vulvovaginal Atrophy

A Phase 1, Open-Label, Parallel Group Study to Evaluate the Pharmacokinetics and Safety of DARE-HRT1 in Healthy PostMenopausal Women

Start date: August 18, 2020
Phase: Phase 1
Study type: Interventional

An open-label study to assess the PK of estradiol, estrone and progesterone from the DARE-HRT1 intravaginal rings at two different dose strengths.