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NCT ID: NCT05092282 Active, not recruiting - Clinical trials for Brain Injuries, Traumatic

HITT for the Identification of Mild Traumatic Brain Injury

Start date: August 1, 2021
Phase:
Study type: Observational

Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 100 TBI patients and 100 controls.

NCT ID: NCT05091970 Active, not recruiting - Clinical trials for Mild Traumatic Brain Injury

Symptom-Targeted Approach to Rehabilitation for Concussion

STAR-C
Start date: November 10, 2021
Phase: N/A
Study type: Interventional

Throughout the course of the wars in Iraq and Afghanistan, more than 250,000 service members sustained traumatic brain injuries, mostly characterized as mild traumatic brain injuries (mTBI) or concussions. While most with mTBI recover over days to weeks, a significant percentage continue to experience post-concussive symptoms such as headaches, cognitive difficulties, and dizziness for months to years. As a result, treatment of post-concussive symptoms after mTBI is of significant importance in the Department of Defense and Veterans healthcare systems. Several studies have shown that cognitive rehabilitation can be effective for individuals with mTBI, including Service Members and Veterans with post concussive symptoms. Cognitive rehabilitation is a type of treatment in which patients work with a therapist to improve everyday memory and thinking skills and develop strategies to reduce the impact of cognitive difficulties in their everyday lives. While these treatments have great potential benefits, protocols studied to date are time intensive, requiring up to 60 hours of treatment. These time demands are impractical for many Service Members and Veterans, and place a time-burden on clinics providing the treatment. The current study proposes to identify key ingredients of an evidence-based cognitive rehabilitation protocol to develop a streamlined version that is feasible and acceptable to Service Members and Veterans. This briefer protocol will increase the number of Service Members and Veterans who can access treatment. To accomplish this goal the investigators will first spend six months analyzing manualized treatments from a successful cognitive rehabilitation intervention developed for Service Members. The investigators will analyze manuals using a framework developed to identify active ingredients in rehabilitation. Based on those results the investigators will develop a manualized streamlined treatment protocol, which the investigators will deliver to 25 Service Members and 50 Veterans over 18 months in person or via telehealth. The investigators will determine feasibility and acceptability of this intervention, and collect preliminary efficacy data. The project addresses access to therapy services and enhanced treatment compliance, a key barrier to participation in cognitive rehabilitation by Veterans and Service Members with TBI. Additionally, although this study focuses on Service Members and Veterans with mTBI, the investigators expect that this streamlined intervention can also be translated to civilian populations with mTBI.

NCT ID: NCT05091931 Active, not recruiting - Clinical trials for Urinary Tract Infections

Diagnosis, Antibiotic Prescribing Practices and Outcomes of cUTI in an Outpatient Setting

Start date: March 28, 2022
Phase:
Study type: Observational

This prospective, multicenter, comparative cohort observational study is to determine if Guidance® UTI pathway compared to traditional diagnostic pathways reduces the rates of empiric antibiotic therapy, adverse events, and improves therapeutic accuracy of treatment

NCT ID: NCT05091567 Active, not recruiting - Clinical trials for Small-Cell Lung Cancer

A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer

IMforte
Start date: November 18, 2021
Phase: Phase 3
Study type: Interventional

Study GO43104 is a Phase III, randomized, open-label, multicenter study of lurbinectedin in combination with atezolizumab compared with atezolizumab alone administered as maintenance therapy in participants with extensive-stage small-cell lung cancer (ES-SCLC) after first-line induction therapy with carboplatin, etoposide, and atezolizumab. The study consists of 2 phases: an induction phase and a maintenance phase. Participants need to have an ongoing response or stable disease per the Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 criteria after completion of 4 cycles of carboplatin, etoposide, and atezolizumab induction treatment in order to be considered for eligibility screening for the maintenance phase. Eligible participants will be randomized in a 1:1 ratio to receive either lurbinectedin plus atezolizumab or atezolizumab in the maintenance phase.

NCT ID: NCT05091346 Active, not recruiting - Melanoma Clinical Trials

A Study of E7386 in Combination With Pembrolizumab in Previously Treated Participants With Selected Solid Tumors

Start date: October 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The Phase 1b part of this study is conducted to assess the safety and tolerability of E7386 in combination with pembrolizumab in participants with previously treated selected solid tumors, and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with pembrolizumab. The Phase 2 part of this study is conducted to assess the objective response rate (ORR) of E7386 in combination with pembrolizumab (melanoma, colorectal cancer [CRC], hepatocellular carcinoma [HCC]) or of E7386 in combination with pembrolizumab plus lenvatinib (HCC) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

NCT ID: NCT05090514 Active, not recruiting - Reading Clinical Trials

Ready to Read: Ready to Read: A School-Based Intervention to Promote Growth Mindset and Reading

Start date: November 2, 2021
Phase: N/A
Study type: Interventional

Primary Aim/Objective: To determine if a school-based intervention promoting reading with a growth mindset framework improves student reading achievement in the intervention group compared to a wait-list comparison group of children in kindergarten through 2nd grade. Secondary Aim/Objective: To determine if students whose parents endorse a fixed mindset with regard to student reading abilities show more improvement post-intervention than parents that endorse growth mindset. Secondary Aim/Objective: To determine if more parents endorse growth than fixed mindset post-intervention.

NCT ID: NCT05090358 Active, not recruiting - Breast Cancer Clinical Trials

Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

Start date: October 8, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study to find out whether a very low carbohydrate diet (ketogenic diet), a low carbohydrate diet, or the study drug canagliflozin can prevent high blood sugar and may improve the effectiveness of cancer therapy in people who are receiving standard treatment with alpelisib and fulvestrant for their metastatic PIK3CA-mutant breast cancer.

NCT ID: NCT05089877 Active, not recruiting - Atrial Fibrillation Clinical Trials

FREEZE-AFIB Post-Market Study

Start date: April 29, 2022
Phase:
Study type: Observational

This study is proposed herein is to gather clinical data on the safety and performance of the CRYOF device. Specifically, data from this study will be used for submission to regulatory authorities in Europe, China and other geographies as needed.

NCT ID: NCT05089734 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Study of Sacituzumab Govitecan (SG) Versus Docetaxel in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

EVOKE-01
Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drug, sacituzumab govitecan-hziy (SG), versus docetaxel in participants with advanced or metastatic (cancer that has spread) non-small cell lung cancer (NSCLC).

NCT ID: NCT05089656 Active, not recruiting - Clinical trials for Type 2 Spinal Muscular Atrophy

Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)

STEER
Start date: February 1, 2022
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy, safety and tolerability of intrathecal (IT) OAV101 in treatment naive patients with Type 2 spinal muscular atrophy (SMA) who are ≥ 2 to < 18 years of age over a 15 month trial duration.