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NCT ID: NCT04368130 Withdrawn - Ovarian Cancer Clinical Trials

SIGNAL:Identifying Behavioral Anomalies Using Smartphones to Improve Cancer Care

SIGNAL
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

This research study is testing the use of a smartphone app to identify clinically meaningful changes in the behaviors of patients' with gynecological cancers by using passively collected smartphone data.

NCT ID: NCT04366336 Withdrawn - Clinical trials for Total Knee Arthroplasty

BFRT vs Standard PT After Total Knee Arthroplasty

BFRT-TKA
Start date: February 18, 2021
Phase: N/A
Study type: Interventional

Background Blood flow restriction training (BFRT) uses a specialized tourniquet system to restrict arterial inflow and venous outflow to the limb during low-load resistance exercise. BFRT has the potential to augment strength gains for rehabilitation patients who are unable to tolerate high intensity resistance training. Objective To determine if BFRT will accelerate the recovery of thigh muscle function and strength in post-operative TKA compared to a standard post-operative rehabilitation protocol. Primary Outcome Measures: Quadriceps Strength: dynamometry (hand held) Secondary Outcomes Measures: Patient Reported Outcomes Knee Injury and Osteoarthritis Outcome Score, Jr Veterans Rand -12 Functional Measures Timed stair ascent Four square Test 5x Sit to Stand Test Study Design Open label randomized clinical trial with a 1:1 allocation in random sized blocks Sample Size Based on a Pre-TKA Quadriceps Maximal Voluntary Isometric Contraction mean of 18 with a standard deviation of 8, expecting a 20% improvement of MVIC with BFRT compared to standard Physical Therapy, with an α of 0.05 and β of 0.20 (80% power), the sample size is 63 in each arm. To account for a 20% drop-out rate, a total of 75 subjects will be enrolled in each arm Study Arms Control arm: Subjects will receive American College of Sports Medicine guided-strength training Experimental: Subjects will receive BFRT strength training as part of their post-operative physical therapy program for two months during normal post-op rehab.

NCT ID: NCT04363866 Withdrawn - COVID-19 Clinical Trials

Assessing Hydroxychloroquine in Patients With SARS-CoV-2 (COVID-19)

Start date: August 2020
Phase: Phase 2
Study type: Interventional

This is a prospective, randomized, double-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.

NCT ID: NCT04361669 Withdrawn - Cancer Clinical Trials

Hospice Quality Score Assessment Post Pharmacist Intervention

Start date: April 22, 2020
Phase:
Study type: Observational

The study aims to investigate the impact of pharmacist delivered interventions on hospice patients quality metric scores.

NCT ID: NCT04361656 Withdrawn - Clinical trials for Colonoscopy Preparation

The Effect of Adding Lubiprostone to Standard Large-Volume PEG-ELS on The Quality of Inpatient Colonoscopy Preparation

Start date: May 1, 2020
Phase:
Study type: Observational

This is a multicenter interrupted-time series study. The study will include patients between the age of 18-85 year old, both males and females, who are scheduled for inpatient colonoscopy procedure. The study will be divided into two phases: The initial phase will be a prospective review of inpatient colonoscopy procedure between September, 1st 2020 and March, 31st 2021 to assess overall adequacy of inpatient colonoscopy preparation and patient satisfaction at the three participating sites using standard of care colonoscopy preparation prior to implement our intervention. The intervention phase will take place between April, 1st 2021 and October 31st 2021, where all patient undergoing inpatient colonoscopy procedures will receive Lubiprostone in addition to large-volume PEG-ELS. The patients will be evaluated with colonoscopy the next day. The preparation quality will be documented using the Boston Bowel Preparation Scale (BBPS).

NCT ID: NCT04361552 Withdrawn - Clinical trials for Coronary Artery Disease

Tocilizumab for the Treatment of Cytokine Release Syndrome in Patients With COVID-19 (SARS-CoV-2 Infection)

Start date: April 7, 2020
Phase: Phase 3
Study type: Interventional

This phase III trial compares the effect of adding tocilizumab to standard of care versus standard of care alone in treating cytokine release syndrome (CRS) in patients with SARS-CoV-2 infection. CRS is a potentially serious disorder caused by the release of an excessive amount of substance that is made by cells of the immune system (cytokines) as a response to viral infection. Tocilizumab is used to decrease the body's immune response. Adding tocilizumab to standard of care may work better in treating CRS in patients with SARS-CoV-2 infection compared to standard of care alone.

NCT ID: NCT04361058 Withdrawn - Clinical trials for Myelodysplastic Syndromes

Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide

Start date: April 13, 2020
Phase: Phase 1
Study type: Interventional

There are no strategies developed post-stem cell transplant (SCT) for patients who receive allogenic SCT with a significant amount of blasts prior SCT. Novel strategies to treat relapsed AML/MDS and to reduce the incidence of relapse after allogeneic SCT are needed. This study is being done in patients with high-risk MDS or AML who undergo an allogeneic SCT. The study will have two arms, participants who receive an HLA-matched unrelated donor SCT (Arm A) or HLA- haploidentical SCT (Arm B). Following myeloablative conditioning (MAC), GVHD prophylaxis with post-transplantation cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil will be given per standard of care. At 40-60 days post SCT, If the patient has not had any evidence of Grade II-IV acute graft-versus-host-disease (aGVHD), Nivolumab will be given intravenously every 2 weeks for 4 cycles of consolidation or treatment with Nivolumab. Dose-escalation of Nivolumab will follow the standard 3+3 design where a maximum of three dose levels will be evaluated, with a maximum of 18 patients treated with nivolumab per arm. As the maximum tolerated dose (MTD) of Nivolumab may differ between Arm A and Arm B, dose escalation of nivolumab in each arm will be followed separately following allogeneic SCT. Immunosuppression with tacrolimus will be continued during the cycles of PD-1 blockade to provide a moderate level of GVHD prophylaxis during consolidation or treatment with nivolumab.

NCT ID: NCT04360135 Withdrawn - Post Operative Pain Clinical Trials

Preemptive Acetaminophen for Postoperative Pain Control Following Minimally Invasive Hysterectomy

Start date: May 6, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

This study is investigating whether administration of acetaminophen the day before surgery improves post operative pain following minimally invasive hysterectomy. Patients will receive either acetaminophen or placebo to take twice per day the day prior to their scheduled surgery. The morning of surgery all participants will receive oral acetaminophen at least 30 minutes prior to surgery. The investigators will examine whether there is a difference in post operative pain between the two groups.

NCT ID: NCT04359017 Withdrawn - Pediatrics Clinical Trials

Systemic Absorption of Lidocaine After Hematoma Block

Start date: November 1, 2020
Phase: Phase 4
Study type: Interventional

This study will measure in children how much numbing medicine, lidocaine, is absorbed into the bloodstream after it is injected into a blood clot (hematoma) around a forearm fracture for pain control when the broken bone is moved back into place (fracture reduction). This is called a hematoma block and is commonly used in the Emergency Unit. To help with anxiety and to add additional pain control, nitrous oxide (laughing gas) is given while the lidocaine hematoma block is placed and continued during the fracture reduction. Advantages of using this technique for pain control instead of an intravenous anesthetic such as ketamine include faster recovery and discharge home, and longer pain control. Of concern, if too much lidocaine is absorbed into the bloodstream, seizures and irregular heart beating may occur. Bloodstream concentrations of lidocaine after a hematoma block have been measured in only one study of 8 adults and found to be at significant but safe levels. No study has been published in children to measure bloodstream lidocaine levels when a hematoma block is used. Because children's bones are still growing and more metabolically active than adult bones, the investigators believe it is important to determine whether lidocaine blood levels in children are also at safe levels when using a standard lidocaine hematoma block for reduction of fractures. The investigators also want to determine whether bloodstream lidocaine levels correlate with type of fracture. The investigators also aim to determine if there is a difference in absorption pattern between different types of distal radius fractures, if there is a correlation between fracture type and systemic lidocaine absorption, and if there is a correlation between fracture type and ability to provide adequate pain and sedation control with lidocaine hematoma block/inhaled nitrous combination. The investigators believe blood lidocaine levels after hematoma block in children will peak at safe levels, but will be higher than those observed in adults.

NCT ID: NCT04357951 Withdrawn - Tourette Syndrome Clinical Trials

D-cycloserine Augmented Treatment for Youth With Tic Disorders

Start date: April 15, 2023
Phase: Early Phase 1
Study type: Interventional

This pilot study aims evaluate the feasibility and initial efficacy of behavior therapy augmented by d-cycloserine (DCS) compared to behavior therapy augmented by placebo. After an initial assessment to determine eligibility, youth with TD will be randomly assigned to receive four sessions of behavior therapy augmented by either DCS or placebo. D-cycloserine is an FDA-approved antibiotic medication that has been shown to enhance extinction learning in several studies. The investigators' proof-of-concept work has found that a single session of DCS-augmented behavior therapy reduced the severity of tics targeted in treatment on the Hopkins Motor/Vocal Tic Scale (HM/VTS) compared to placebo-augmented behavior therapy. This highlights the exciting potential of combining DCS with behavior therapy to improve reductions in tic severity. However, prior to a large-scale clinical trial, it is essential to determine the feasibility and efficacy of augmenting behavior therapy with DCS over multiple treatment sessions.