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NCT ID: NCT05149859 Recruiting - Clinical trials for Binge-Eating Disorder

Compuls-BED-Severity

Start date: March 7, 2023
Phase:
Study type: Observational

- Binge Eating Disorder (BED) has been fairly recently introduced into the Diagnostic and Statistical Manual 5 psychiatric classification and its severity criteria are still not well established. - Moreover, it remains unclear whether BED is associated with greater metabolic severity or more somatic comorbidities, especially in obesity. - Improved BED severity staging could lead to a better definition of management strategies and , therefore, facilitate screening and care. The investigators' hypothesis is that an improved assessment of the impulsivity-compulsivity spectrum, emotional regulation, attentional impairment and somatic or psychiatric comorbidities will result in a better distinction between the severe form of BED (e.g., highly impulsive and somatically complicated) from milder form (e.g., more compulsive and less somatically complicated).

NCT ID: NCT05149768 Recruiting - Clinical trials for Diffuse Cutaneous Systemic Sclerosis

Open Label Extension Study of Brentuximab Vedotin in Early dcSSc

Start date: February 14, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.

NCT ID: NCT05149755 Recruiting - Clinical trials for Moderate Aortic Valve Stenosis

Evolut™ EXPAND TAVR II Pivotal Trial

Start date: April 27, 2022
Phase: N/A
Study type: Interventional

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

NCT ID: NCT05148715 Recruiting - Brain Death Clinical Trials

Calcineurin Inhibitor in NEuRoloGically Deceased Donors to Decrease Kidney delaYed Graft Function (CINERGY)

CINERGY
Start date: July 11, 2022
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that preconditioning neurologically deceased organ donors with the calcineurin inhibitor tacrolimus will improve short and long-term transplant survival without causing harm. Organ donors will be randomized to receive either 0.02 mg/kg ideal body weight (IBW) of tacrolimus single infusion or placebo before organ recovery. All corresponding recipients are enrolled and data is collected up to 7 days post-transplant to determine graft function and at 1 year to collect outcomes of vital status, re-transplantation and dialysis. The CINERGY Pilot Trial assesses feasibility for the main trial.

NCT ID: NCT05148494 Recruiting - Surgery Clinical Trials

TES RCT Fleet Enema vs Oral Mechanical Bowel Prep

TESEO
Start date: March 16, 2022
Phase: Phase 4
Study type: Interventional

There is no consensus about the best bowel preparation prior to transanal endoscopic surgery TES). Cleanliness and visibility in the rectosigmoid and rectum are of utmost importance, possibly even more so than during colonoscopy, to facilitate safe, precise and efficient resection of the rectal lesion and potentially adequate closure of the defect. Both Fleet enemas and oral mechanical bowel preparation are considered standard of care in preparation for TES. This single center two arm single blinded randomized controlled trial will compare the effectiveness of Fleet enemas in comparison to Pico Salax oral mechanical bowel preparation in cleansing the rectum as measured by a modified version of the Ottawa Bowel Prep Scale.

NCT ID: NCT05148104 Recruiting - Clinical trials for Shoulder Arthropathy Associated With Other Conditions

Intra-Operative Evaluation of the Glenoid Implant Position With Structured Light

Start date: November 19, 2021
Phase:
Study type: Observational

Positioning of the glenoid component is one of the most challenging steps in shoulder replacement surgery. Prosthesis longevity and functional outcomes are considered highly dependent on accurate positioning. Currently, there are no adequate means to verify the position of the glenoid component during surgery which is a significant impediment to accurate positioning. We propose a non-interventional study to validate a novel technology for verifying the position of the glenoid component during shoulder replacement surgery.

NCT ID: NCT05147974 Recruiting - Chronic Pain Clinical Trials

The Young Adult Clinic (YAC) Study

YAC
Start date: April 20, 2023
Phase: N/A
Study type: Interventional

The overarching aim of the Young Adult Clinic (YAC) study is to evaluate the DOZE app, a digital, transdiagnostic behavioral sleep medicine and self-management approach in young adult patients (ages 18-25) with chronic pain.

NCT ID: NCT05147441 Recruiting - Spasticity, Muscle Clinical Trials

Obturator Cryoneurotomy for Hip Adductor Spasticity

Start date: August 10, 2021
Phase:
Study type: Observational

The purpose of the study is to measure the effects of obturator nerve cryoneurotomy, on clinical measures in adult (ages 19+) and paediatric (ages 12-18) patients with hip adductor spasticity, who will receive this procedure as a part of their treatment based on the spasticity treatment available guidelines. The results will provide us valuable information like how long cryoneurotomy is effective, before regeneration happens

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: NCT05143957 Recruiting - Clinical trials for Phlebotomy Dependent Polycythemia Vera

A Study to Evaluate Sapablursen (Formerly ISIS 702843, IONIS-TMPRSS6-LRx) in Patients With Polycythemia Vera

Start date: December 30, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of sapablursen in reducing the frequency of phlebotomy and in improving quality of life assessments in participants with polycythemia vera.