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NCT ID: NCT03816683 Completed - Clinical trials for Mantle Cell Lymphoma

A Disease Registry of Patients With Mantle Cell Lymphoma

SUMMIT
Start date: April 1, 2019
Phase:
Study type: Observational

The purpose of this study is to create a patient registry in order to assess treatment patterns, physician reported clinical outcomes and patient-reported health-related quality of life among patients diagnosed with Mantle Cell Lymphoma (MCL) who newly initiated a novel therapy in the past 6 months and whose treatment is ongoing at the time of enrollment.

NCT ID: NCT03818113 Completed - Clinical trials for Mitral Valve Reconstruction

Clinical Comparative Analysis of Bretschneider and St. Thomas Cardioplegia Solution in Case of Mitral Valve Repair Via Anterolateral Right Thoracotomy

Start date: April 1, 2019
Phase:
Study type: Observational

Mitral valve reconstruction via minimal invasive antero- lateral thoracotomy is done in cardioplegia with a cardioplegic solution, either HTK-Bretschneider (Custidiol®) (a crystalloid intracellular solution) or St. Thomas (a crystalloid extracellular solution). This study investigates HTK-Bretschneider versus St. Thomas cardioplegic solution regarding peri- and postoperative outcome, especially for cardiac biomarkers.

NCT ID: NCT03818711 Completed - Clinical trials for Type 1 Diabetes Mellitus

Communication and Coping for Mothers of Adolescents With Type 1 Diabetes

T1D
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Mothers of adolescents with type 1 diabetes experience high levels of depressive symptoms, which impair their ability to monitor and manage diabetes treatment effectively. Further, maternal depressive symptoms are one of the strongest predictors of negative outcomes in adolescents, including deteriorating glycemic control, problems with adherence, poorer quality of life, and greater risk for depression. Given that adolescents are a high-risk population for suboptimal glycemic control - with only 17% meeting treatment goals - there is a critical need for novel interventions to improve outcomes in adolescents with T1D. Yet, previous behavioral interventions for youth with diabetes have had only modest effects on glycemic control, and none have directly targeted maternal depressive symptoms. Building on effective interventions to treat depression in adults, and our own pilot work in this population, the proposed study will use a rigorous approach to evaluate the efficacy of a cognitive-behavioral intervention for mothers of adolescents with type 1 diabetes to promote the use of adaptive coping strategies and positive parenting practices. The aims of this study are to: 1) evaluate the effects of the Communication & Coping intervention on diabetes-related outcomes; 2) evaluate the effects of the Communication & Coping intervention on psychosocial outcomes; and 3) explore the differential impact of the intervention across demographic factors. Mothers who are randomized to the Communication & Coping Intervention will receive individual cognitive-behavioral therapy sessions by phone, as well as access to a Facebook group to augment the material covered in calls and provide social support. Mothers randomized to the Attention Control condition will receive educational materials and phone check-ins, as well as a Facebook group with educational posts. Adolescents and their mothers will be assessed at baseline and again post-intervention, at 3 months, 6 months, and 12 months.

NCT ID: NCT03822871 Completed - Prostate Cancer Clinical Trials

A Trial of CTT1403 for Metastatic Castration Resistant Prostate Cancer

Start date: April 1, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to find the highest dose level of study drug, CTT1403, that can be safely administered to patients with metastatic castration resistant prostate cancer (mCRPC).

NCT ID: NCT03823274 Completed - Ischemic Stroke Clinical Trials

Multi-center, Prospective, Cohort Study to Evaluate the Relationship of Stroke Recurrence and Anti-platelet Resistance in Ischemic Stroke Patients

Start date: April 1, 2019
Phase:
Study type: Observational [Patient Registry]

This cohort study will evaluate the relatiobship of stroke recurrence and anti-platelet resistance in ischemic stroke patients

NCT ID: NCT03825354 Completed - Suicidal Behavior Clinical Trials

Brief Intervention and Contact (BIC) Program

BIC
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Suicide is a significant public health concern and causes approximately 1.5 % of all deaths in the general population in Canada. Suicide is a multi-faceted issue that is often comorbid with psychiatric illness and associated with diverse sociodemographic risk factors. Consequently, there are several domains of suicide risk management. The proposed intervention, the brief intervention, and contact (BIC) model will be tested for feasibility using a pilot pragmatic randomized trial.

NCT ID: NCT03825588 Completed - Suicidal Ideation Clinical Trials

Establishing Efficacy of an Inpatient Intervention and Phone App to Reduce Suicidal Risk

ASAP+BRITE
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

In this 2-site study, University of Texas Southwestern Medical Center (UTSW) and Western Psychiatric Institute and Clinic (WPIC), the investigators will conduct a randomized clinical trial (RCT) in 240 psychiatrically hospitalized suicidal adolescents, examining the single and additive effects of two components of an inpatient unit intervention for suicidal adolescents, As Safe As Possible (ASAP), which focuses on emotion regulation and safety planning, and an emotion regulation/safety plan phone app (BRITE).

NCT ID: NCT03828058 Completed - Clinical trials for Recipients of Liver Transplant

Envarsus XL Immunosuppression Following Liver Transplantation

Start date: April 1, 2019
Phase: Phase 2
Study type: Interventional

The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak concentrations are thought to have lower rates of nephrotoxicity. Additionally, compliance with once daily medications is felt to be easier than twice daily medications. Our aim is to look at our prospective liver transplant group and see if once daily tacrolimus (Envarsus XR) results in improved renal function as well as improved health care quality of life.

NCT ID: NCT03828331 Completed - Amputation Clinical Trials

Optimizing Prosthetic and Bicycle Fit for Veterans With Transtibial Amputations

BestBikeFit
Start date: April 1, 2019
Phase:
Study type: Observational

Bicycling is a promising form of low-impact exercise that could prevent/treat Type 2 diabetes. However, Veterans with transtibial amputations (TTAs) may not effectively utilize bicycling for rehabilitation and exercise due to improper bike fit, socket discomfort, and/or the potential for injury. An optimized prosthetic/bicycle fit could improve comfort and reduce injury risk by decreasing asymmetries between legs, lowering metabolic costs, and improving efficiency for Veterans with TTAs during bicycling. Moreover, the use of objective prosthetic/bicycle fit guidelines would allow clinicians to facilitate shorter appointment times and fewer revisits for Veterans with TTAs. The investigators will determine the physiological and biomechanical effects of different prosthetic and bicycle configurations for Veterans with a TTA to develop optimal prosthetic/bicycle fit guidelines. The investigators hypothesize that a longer prosthetic pylon length and shorter bicycle crank arm length for the affected compared to the unaffected leg along with a pedal attachment position beneath the pylon compared to beneath the forefoot will optimize performance for Veterans with TTAs the investigators' research will integrate evidence-based guidelines to advance rehabilitation and enhance the lives of Veterans with an amputation, thus improving and restoring their function.

NCT ID: NCT03829098 Completed - Esophageal Cancer Clinical Trials

TreatmENT of AnastomotiC Leakage After Esophagectomy

TENTACLE
Start date: April 1, 2019
Phase:
Study type: Observational

Rationale: Anastomotic leakage (0% - 30%) is a severe complication after esophagectomy with mortality rates approximately ranging from 2% - 12%. In addition, it is associated with a prolonged ICU treatment and hospital stay. Anastomotic leakage severity is currently graded according to how it is treated (grade I: conservative treatment, grade II endoscopic or radiologic intervention and grade III surgical intervention). However, this scoring system cannot be used to guide decision making when anastomotic leakage is diagnosed in a clinical setting. Factors that may influence the severity of the anastomotic leakage are (amongst others) location of the anastomosis, estimated surface of the defect, estimated circumference of the defect, extent of contamination, degree of sepsis and time from diagnosis until therapy. However, little is known about to what extent these and other factors contribute to anastomotic leakage severity. In addition, there is a paucity of data on what leakage characteristics dictate the success of a specific treatment. Primary study objectives 1. To investigate what factors contribute to anastomotic leakage severity and to compose an evidence based anastomotic leakage severity score. 2. To investigate what anastomotic leakage characteristics are associated with success of different anastomotic leakage treatments and to compare the effectiveness of different initial anastomotic leakage treatments for leakages classified according to severity and leakage characteristics. Study design: International multicenter retrospective cohort study. Study population: Adult patients with anastomotic leakage after esophagectomy and gastric conduit reconstruction for esophageal cancer. Cohort size: 1000-2000 patients with anastomotic leakage after esophagectomy for cancer. Primary outcome parameter: 90 day mortality. Secondary outcome parameters: in-hospital mortality, 30-day mortality, 180-day mortality, comprehensive complications index, total number of reinterventions, hospital and ICU length of stay, hospital related costs. Funding: Radboudumc