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NCT ID: NCT06293469 Not yet recruiting - Clinical trials for Extremity Fracture Lower

Accelerated Flap Coverage in Severe Lower Extremity Trauma

FLAP ATTACK
Start date: July 2024
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

NCT ID: NCT06293456 Enrolling by invitation - End of Life Clinical Trials

Study of Poetic Dignity Therapy for Sexual and Gender Minority Patients at End of Life

Start date: January 29, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to find out if dignity therapy is practical and works well for sexual and gender (SGM) patients in hospice care. SGM includes, but is not limited to, people who identify as lesbian, gay, bisexual, transgender, and/or queer/questioning (LGBTQ+). Dignity therapy is a type of psychotherapy where the clinician asks the patient questions to allow the patient to express their individual life story and ultimately be able to create a legacy document of their experiences that can be shared with their loved ones.

NCT ID: NCT06293352 Not yet recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection

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

In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in. There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in. We know that both the one- and two-stage revision work equally well to heal the infection, but we don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction.

NCT ID: NCT06293300 Not yet recruiting - Clinical trials for Traumatic Brain Injury

Understanding and Treating Traumatic Brain Injury (TBI) Associated Photophobia With Botulinum Toxin Type A (BoNT-A)

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

The purpose of this research is to understand and treat Traumatic Brain Injury (TBI) associated photophobia (light sensitivity) and its impact on visual function.

NCT ID: NCT06293053 Recruiting - Prurigo Nodularis Clinical Trials

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis

Start date: May 15, 2024
Phase: Phase 3
Study type: Interventional

This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: - Screening period: 2 to 4 weeks. - Treatment period: 24 weeks. - Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods). The total number of planned study visits for each participant will be 6.

NCT ID: NCT06293040 Not yet recruiting - Clinical trials for Alcohol Intoxication

Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

Start date: August 2024
Phase: Phase 1
Study type: Interventional

This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states).

NCT ID: NCT06292988 Not yet recruiting - Clinical trials for Medullary Thyroid Cancer

Predictive Factors for Medullary Thyroid Cancer Aggressiveness

MYELO
Start date: March 1, 2024
Phase:
Study type: Observational

This study is a retrospective study trying to find the predictive factors for medullary thyroid aggressiveness in terms of tumor metastasis and patients' survival.

NCT ID: NCT06292936 Not yet recruiting - Obesity Clinical Trials

RemI for Post-Bariatric Surgery Weight Regain

Start date: March 4, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100). The main research aims are: 1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained > 5% of their weight and are randomly assigned to ABTi or Control. 2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups. 3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.

NCT ID: NCT06292923 Recruiting - Clinical trials for Secondary Progressive Multiple Sclerosis

A Study of Nasal Foralumab in Non-Active Secondary Progressive Multiple Sclerosis Patients

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

Foralumab is a human anti-CD3 monoclonal antibody being developed for the treatment of autoimmune and inflammatory diseases. The goal of this Phase 2a, randomized, double-blind placebo-controlled, multicenter dose-ranging study is to evaluate the use of nasal foralumab in patients with non-active secondary progressive multiple sclerosis (SPMS). The primary objectives that this study aims to answer are: 1. To determine the safety and tolerability of 50 μg/dose and 100 μg/dose of foralumab nasal compared to placebo 2. To investigate the effect of foralumab relative to placebo on the change from baseline [18F]PBR06-positron emission tomography (PET) scans for microglial activation, after 12 weeks (3) months of study treatment.

NCT ID: NCT06292793 Completed - Pain Clinical Trials

Cyclical Sighing for Pain

Start date: December 13, 2023
Phase: N/A
Study type: Interventional

This is a single-site, two-arm, parallel-group randomized clinical trial (RCT). The clinical effects of a 4-minute audio-recorded cyclical sighing intervention for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.