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NCT ID: NCT06285071 Enrolling by invitation - Haemophilia A Clinical Trials

Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors

Start date: April 30, 2024
Phase:
Study type: Observational

The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor. The study will last for about 2 years.

NCT ID: NCT06289192 Enrolling by invitation - Tobacco Dependence Clinical Trials

Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community

Start date: April 30, 2024
Phase: Phase 4
Study type: Interventional

To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT). The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.

NCT ID: NCT06350981 Enrolling by invitation - Back Pain Clinical Trials

Analgesic Requirement for Post-Operative Pain Control in TLIP Interbody Fusion

Start date: April 30, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

The goal of this clinical trail is to to compare the efficacy of thoracolumbar interfascial plane block with Exparel vs with standard of care 0.25% Bupivacaine HCl in patients undergoing 1-3 level elective transforaminal lumbar interbody fusion. The investigators hypothesize that thoracolumbar interfascial plane block with Exparel will outperform standard of care (supplemented with interfascial plane block of 0.25% Bupivacaine HCl) with regards to pain reduction, narcotic use, length of hospital stay, time to mobilization with physical therapy, narcotic usage in the hospital, and post operative pain scores.

NCT ID: NCT06431893 Enrolling by invitation - Homocystinuria Clinical Trials

A Phase 3 Long-term Extension Study to Assess the Long-term Safety and Efficacy of Pegtibatinase Treatment in Participants ≥12 to ≤65 Years of Age With Classical Homocystinuria (HCU)

ENSEMBLE
Start date: April 30, 2024
Phase: Phase 3
Study type: Interventional

The goal of this long-term extension (LTE) study is to evaluate the safety and efficacy of pegtibatinase in patients with classical homocystinuria (HCU). Patients who are active in the Phase 1/2 COMPOSE study or those who complete the 24 weeks of treatment in the Phase 3 HARMONY are eligible to participate. Participants will be in this clinical study for up to about 13 months including: - a treatment period of up to 52 weeks - a 4-week safety follow-up period

NCT ID: NCT03257423 Enrolling by invitation - Acute Appendicitis Clinical Trials

Acute Appendicitis and Microbiota - Etiology of Appendicitis and Antibiotic Therapy Effects

MAPPAC
Start date: April 4, 2017
Phase: N/A
Study type: Interventional

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The previous APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings. On the other hand, antibiotic therapies have been shown to have an effect on the normal gut microbiota and are considered an increasing global health threat underlining the importance of evaluating both short- and long-term effects of the antimicrobial treatment in old and new indications. The aims of this randomized prospective study are: 1. To evaluate the possible role and differences in the microbiological etiology of complicated and uncomplicated appendicitis. 2. To determine the effects of both antibiotic and placebo treatment on the composition of gut microbiota, and to evaluate how it recovers after the appendicitis-related antimicrobial treatment (AMT) 3. To evaluate the effects of the duration of the hospital stay on the AMR reservoir of the gut microbiota.

NCT ID: NCT03538379 Enrolling by invitation - Hemorrhage Clinical Trials

Tourniquet Training Effectiveness Study

TRIAGE
Start date: April 4, 2018
Phase: N/A
Study type: Interventional

Trauma is the leading cause of death for individuals ages 1-45 years old, within this cohort, and uncontrolled hemorrhage is the leading cause of preventable death.1,2 Tourniquets have been shown to be effective in dramatically decreasing death from uncontrolled hemorrhage on the battlefield and there is level 4 evidence that EMS application of tourniquets in the civilian sector is effective though not to the same degree as in the military.3,4 Multiple national groups have advocated that to further decrease preventable deaths from hemorrhage, laypersons should apply tourniquets before the arrival of professional first responders. To this aim, the "Stop the Bleed" campaign has trained over 100,000 individuals in the US in hemorrhage control techniques and tourniquet use with the Bleeding Control Basic (B-Con) course.5 The "Stop the Bleed" campaign informs course participants all commercial tourniquets are equivalent, and improvised tourniquets should be applied if a commercial tourniquet is not available.6 The investigators are evaluating the ability of the B-Con course participants to apply three different types of commercial tourniquets, the Rapid Application tourniquet (RAT), the Stretch-Wrap-And-Tuck tourniquet (SWAT-T), and the Sof Tourniquet (Sof-T) as well as participants ability to fashion an improvised tourniquet. The investigators hypothesize B-Con in its current form does not enable course participants to apply other commercial tourniquets beyond the specific one taught, the CAT tourniquet, and does not teach how to apply an improvised tourniquet.

NCT ID: NCT03898479 Enrolling by invitation - Alopecia Areata Clinical Trials

Extension Study to Evaluate Safety and Efficacy of CTP-543 in Adults With Alopecia Areata

Start date: April 4, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The overall objectives of the study are to evaluate long-term safety of CTP-543 and to assess long-term effects of CTP-543 on treating hair loss in adult patients with chronic, moderate to severe alopecia areata.

NCT ID: NCT04064008 Enrolling by invitation - Joint Disease Clinical Trials

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems

Start date: April 4, 2019
Phase:
Study type: Observational

Single center, prospective follow-up of previously implanted subjects

NCT ID: NCT05296447 Enrolling by invitation - Clinical trials for Diabetic Retinopathy, DR

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy

Start date: April 4, 2022
Phase:
Study type: Observational

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR without center involved-diabetic macular edema (CI-DME) in which they received SCS administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for a total of 5 years post-RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.

NCT ID: NCT05330390 Enrolling by invitation - Epilepsy Clinical Trials

Study on the Population Pharmacokinetics of Levetiracetam in Epileptic Patients With Diabetic Kidney Disease

Start date: April 4, 2022
Phase:
Study type: Observational

The individualized drug delivery system of levetiracetam based on population pharmacokinetics and quantitative pharmacology model in patients with epilepsy complicated by diabetic kidney disease was established. To clarify the clinical feasibility of model-based individualized drug administration scheme.