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NCT ID: NCT05147207 Completed - Hip Arthropathy Clinical Trials

SuperPath Versus Posterior Approach for THA

Start date: April 1, 2017
Phase: Phase 4
Study type: Interventional

The SuperPATH approach is a minimally invasive approach for total hip arthroplasty. This project randomized patients to the SuperPath versus posterior approach. Outcomes examined included functional, VAS pain, narcotic utilization, perioperative outcomes, and radiographic component positions. Participants were followed for 2 years. The aim was to examine if the SuperPATH approach provided significant advantages over the posterior approach on functional testing or return to work for patients.

NCT ID: NCT05146453 Terminated - Post-operative Pain Clinical Trials

Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology

SPIFFY
Start date: September 22, 2022
Phase: Phase 4
Study type: Interventional

This study is looking to see if a regional block placed on each side of the incision after surgery helps with pain relief. Ultrasound-guided pectointercostal fascia blocks will be placed at the conclusion of surgery following application of dressings. Patients will be in the supine position with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The investigators hypothesize that placement of PIF blocks and catheters will decrease acute postoperative pain from midline sternotomy in fast track cardiac surgery patients compared to the current standard of care. A physician will place an ultrasound guided pecto-intercostal fascial plane blocks bilaterally at the conclusion of surgery. They will also leave a catheter, similar to a small IV, between the muscle layers where the freezing medication goes. This will let the investigators give more freezing medication over the first 24 hours after surgery. The freezing medication blocks the pain signals from travelling to your brain from your incision, which might help participants need fewer narcotics after surgery. Some of the research on this block shows a trend toward reduced pain, but the use of a catheter to allow repeat doses of freezing medication has not been studied. The investigators hope to show that this regional block means participants need less opioids (narcotics) in the first 2 days after their heart surgery. In order to see whether the regional block is helpful there will be two groups of study participants. Both groups will receive infusion catheters covered with opaque bandages however one group will receive the study drug (ropivacaine) and the other will not (placebo). To reduce the risks to placebo group participants, those participants will have a catheter taped to their skin surface under an opaque dressing. This will give the illusion of block placement without the risks of a needle poking through skin. Both groups will still be given pain medications by IV or by mouth as needed after the surgery.

NCT ID: NCT05145621 Completed - Safety Clinical Trials

Oral Bio-equivalence Study

Start date: October 29, 2015
Phase: Phase 1
Study type: Interventional

Title of Study: An Open-Label, Balanced, Randomized, 2-Treatment, 2-Sequence, 2-Period, Single Dose, Crossover Oral Bioequivalence Study of Two Formulations of Fingolimod Capsules (3 x 0.5 mg) in Healthy Adult Human Subjects Under Fasting Conditions. Objective: The objective of this study is to compare the oral bioavailability and characterize the pharmacokinetic profile of the test formulation relative to that of reference formulation in healthy, adult, human subjects under fasting conditions and to assess the bioequivalence.

NCT ID: NCT05145608 Completed - Bioequivalence Clinical Trials

Comparative Bioavailability Study of Lamotrigine ER Tablets USP 50 mg

Start date: January 10, 2018
Phase: Phase 1
Study type: Interventional

Objective: To evaluate and compare the bioavailability and therefore to assess the bioequivalence of two different formulations of lamotrigine after a single oral dose administration under fasting conditions. The secondary objective is to monitor the safety of the subjects.

NCT ID: NCT05145582 Completed - Depression Clinical Trials

Exploring the Role of Online Discussion Forums in Internet-Delivered Therapy for Canadian Public Safety Personnel

Start date: December 1, 2021
Phase: N/A
Study type: Interventional

This study is a randomized trial designed to evaluate unguided (i.e., purely self-help), transdiagnostic internet-delivered cognitive behavioural therapy tailored specifically for public safety personnel both with and without a built-in online discussion forum.

NCT ID: NCT05145127 Recruiting - Hemophilia A Clinical Trials

Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors

Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

Study B7841007 is an open-label extension study to assess the long-term safety, tolerability, and efficacy of prophylaxis treatment with marstacimab in participants who did not require "Early Termination" from the Phase 3 Study B7841005 and from the Phase 3 Study B7841008. Study B7841005: approximately 145 adolescent and adult participants 12 to <75 years of age with severe hemophilia A or moderately severe to severe hemophilia B (defined as FVIII activity <1% or FIX activity ≤2%, respectively) with or without inhibitors are expected to be enrolled in Study B7841005 during which they will receive prophylaxis (defined as treatment by SC injection of marstacimab). Study B7841008: this is an ongoing Phase 3, open-label study in pediatric participants <18 years of age with severe hemophilia A (FVIII Coagulation Factor Activity <1%) or moderately severe to severe hemophilia B (FIX Coagulation Factor Activity ≤2%). A sequential approach will be used in enrolling at least 100 pediatric participants, at least 20 of which will be aged ≥12 to <18 years and at least 80 participants will be aged ≥1 to <12 years. At the start of study B7841008, the dosing and data available in adolescent and adult participants in Study B7841005 supported the initiation of B7841008 study in participants aged ≥12 to <18 years. Subsequently, additional safety and efficacy data from adolescent participants in Study B7841005 became available for benefit/risk assessment in support of dosing participants aged ≥6 to <12 years. Based on the positive benefit/risk assessment conducted by both internal Pfizer review and eDMC review, dosing of the ≥6 to <12 years age group was initiated in June 2023 in B7841008 Study. Data from participants ≥6 years from B7841008 Study and Study B7841005 will support the dosing of participants aged ≥1 to <6 years. All participants will be provided the prefilled pen (PFP) for administration of marstacimab in the study. Use of the prefilled syringe (PFS) will be permitted at the investigator's discretion for those participants who have difficulty with administration of the PFP. Additionally, participants will be provided the PFS for use in this study in countries where the PFS is anticipated to be the only presentation available commercially. An optional, open-label, single arm, substudy using the PFP was completed in the first 23 participants rolled over from Study B7841005 who agreed to participate in the substudy.

NCT ID: NCT05145010 Enrolling by invitation - Achondroplasia Clinical Trials

Extension Study of Infigratinib in Children With Achondroplasia (ACH)

Start date: December 6, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, multicenter, open-label, extension (OLE) study to evaluate the long-term safety, tolerability, and efficacy of infigratinib, an FGFR 1-3-selective tyrosine kinase inhibitor, in subjects with ACH who previously completed a QED-sponsored interventional study, and potentially in additional subjects who are naïve to infigratinib treatment. Quality of Life assessments for this subject population will also be evaluated. Treatment-naïve subjects must have at least a 6-month period of growth assessment in the PROPEL study (Protocol QBGJ398 001) and will be enrolled in this OLE study only after a dose to be explored further is identified in Phase 2 Study QBGJ398-201.

NCT ID: NCT05144841 Active, not recruiting - Clinical trials for Relapsed or Refractory Diffuse Large B-Cell Lymphoma

A Study to Evaluate Zilovertamab Vedotin (MK-2140) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (MK-2140-004)

Start date: January 8, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate zilovertamab vedotin with respect to objective response rate and duration of response per Lugano Response Criteria as assessed by blinded independent central review (BICR). Safety and tolerability will also be evaluated in this Phase 2, single arm, interventional study.

NCT ID: NCT05144724 Not yet recruiting - Clinical trials for Neonatal Respiratory Distress

Volume Targeted Mask Ventilation Versus Pressure Ventilation in Preterm Infants

VOLT
Start date: July 1, 2024
Phase: N/A
Study type: Interventional

This is a pilot trial to assess the feasibility of volume Targeted Ventilation in the Delivery Room. Preterm infants will be randomized to pressure guided or volume targeted ventilation during respiratory support in the delivery room

NCT ID: NCT05144490 Completed - Exercise Clinical Trials

The Effect of Brief Bodyweight Exercise on Acute Glycemic Control in Healthy Inactive Adults

Start date: December 6, 2021
Phase: N/A
Study type: Interventional

This study will investigate whether an 11-minute bodyweight exercise session can improve short-term glycemic control. Glycemic control refers to the process of how the body regulates blood sugar. The process can be measured in different ways. This study will use a small device called a continuous glucose monitor to measure changes in glucose levels over a 24-hour period. Participants will complete two trials and the investigators will compare glycemic control after the exercise session and a control period that does not involve exercise. Food intake will be controlled such that each participant will consume the same diet in both conditions. This study will help determine whether a single session of bodyweight exercise affects glycemic control.