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NCT ID: NCT04685772 Recruiting - Headache Clinical Trials

Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches

Start date: April 1, 2021
Phase:
Study type: Observational [Patient Registry]

This novel pilot project will assess the effectiveness of corticosteroids in treatment of acute post-concussion headache. The investigators hypothesize that the use of corticosteroids will cause significant headache reduction in frequency and/or intensity than individuals who undergo the current standard of care. Additionally, the investigators hypothesize that corticosteroid use will lead to a reduction in other somatic symptoms including vestibular symptoms, leading to quicker return to school, work, and/or ability to play sports.

NCT ID: NCT04697004 Recruiting - Clinical trials for Arthroplasty, Replacement

SMR Stemless Reverse vs SMR Reverse Shoulder System

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

The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System. Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months.

NCT ID: NCT04697251 Recruiting - Respiratory Disease Clinical Trials

Infant Forced Oscillations Technique (iFOT)

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

The aim of this study is the implementation of Forced Oscillations Technique (FOT) in newborns and small infants using a novel commercially available device. The objective is to assess the feasibility of the method, provide normative data for the first months of life and describe short- and long-term changes in neonatal respiratory disorders. The study population will consist of term and preterm newborns admitted to the Neonatal Intensive Care Unit (NICU) or the Well-Baby Nursery of the University Hospital of Patras, Greece. It is estimated that 200 full-term and 150 preterm newborns will be enrolled during a period of 36 months (March 2021 - September 2022). Measurements will be performed using the TremoFlo N-100 via a face mask, with the infant in the supine position during natural sleep. At least 3 technically acceptable measurements (duration 10s each) will be obtained, as follows: - Healthy full-term neonates: postnatal days 1, 2, 3 and at discharge - Preterm neonates: NICU admission, postnatal days 1, 2 and 3, and on the first day of each additional gestational week until discharge All participants will be also measured at the age of 3, 6 and 12 months.

NCT ID: NCT04698252 Recruiting - Breast Cancer Clinical Trials

Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

LARA
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.

NCT ID: NCT04698967 Recruiting - Unemployment Clinical Trials

Improving Vocational Outcomes of Veterans With Psychiatric Disorders: Career Counseling & Development

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

The Veterans Health Administration (VHA) offers robust vocational programming that have helped countless Veterans obtain competitive employment; however, these services are not uniformly effective as recent data suggests that only 35 to 43% of Veterans are competitively employed at time of discharge. For those who become competitively employed, job tenure may be brief, which is often attenuated by underemployment or poor person-job fit. Moreover, only 3.5% of Veterans experiencing vocational problems engage in vocational services offered by the VHA. On average, it takes Veterans more than four years to utilize vocational services. These Veterans are at high risk of acquiring multiple functional losses and developing chronic disabilities as their vocational needs go unmet for years. Research suggests that intrinsic factors like lacking clear vocational goals, perceiving barriers to employment, and negative beliefs about one's ability to work contribute to low engagement, outcomes, and tenure of some consumers of vocational rehabilitation services. Thus, the VA may be able to improve vocational engagement, outcomes, and tenure of Veterans with psychiatric disorders by enhancing vocational services with added interventions targeting unhelpful psychological factors. Career counseling and development services have been shown to be effective in helping civilian populations clarify vocational goals and identity, enhance vocational self-efficacy, and increase proactive vocational behaviors in the face of obstacles. Additionally, career counseling and development services help facilitate greater "match" between a person and their job, and person-job match is a key determinant of long-term career tenure among individual with psychiatric disorders. The researchers of this project propose a three-aim study to develop a career counseling and development intervention for Veterans with psychiatric disorders (Purposeful Pathways). The first aim will focus on the design and development of the Purposeful Pathways intervention with veteran and provider input (n=16). The second aim will pilot test the intervention in an open trial (n=10) to gather Veteran input on the initial intervention. The third and final aim will consist of a feasibility pilot randomized controlled trial (n=50) to examine acceptability and feasibility outcomes and to explore the impact of the Purposeful Pathways intervention in terms of functional improvement and other vocational outcomes. Purposeful Pathways consists of up to 12 individual sessions that will be offered concurrently with existing VHA vocational rehabilitation services, (e.g., transitional work experience [TWE]). The final product of this study is to produce a manual of Purposeful Pathways, and corresponding fidelity monitoring checklist, to be tested later in a larger efficacy trial.

NCT ID: NCT04699474 Recruiting - Clinical trials for Spinal Cord Injuries

Protocol for Rapid Onset of Mobilization in Patients With Traumatic Spinal Cord Injury

PROMPT-SCI
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

PROMPT-SCI (Protocol for Rapid Onset of Mobilization in Patients with Traumatic SCI) is a single-site single-arm proof-of-concept trial. Forty-five patients aged 18 years or older who have sustained a severe traumatic SCI (American Spinal Injury Association Impairment Scale grade A, B or C) from C0 to L1 and undergoing spinal surgery within 48 hours of the injury will be included. Participants will receive daily 30-minute sessions of in-bed leg cycling for 14 consecutive days, initiated within 48 hours after spinal surgery. The feasibility outcomes consist of the 1) absence of serious adverse events associated with cycling sessions, 2) completion of at least 1 full session within 48 hours after spinal surgery for at least 90% of participants, and 3) completion of at least 11 sessions for at least 80% of participants. Patient outcomes 6 weeks and 6 months after injury will be measured from neurofunctional assessments, quality of life questionnaires and inpatient length of stay. Feasibility and patient outcomes will be analysed with descriptive statistics. Patient outcomes will also be compared to a matched historical cohort not receiving in-bed cycling.

NCT ID: NCT04706936 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

Novel BCMA-targeted CAR-T Cell Therapy for Multiple Myeloma

Start date: April 1, 2021
Phase: Phase 1
Study type: Interventional

This study evaluates the safety and efficacy of novel BCMA-targeted CAR-T cell therapy (CBG-002) for patients with relapsed or refractory multiple myeloma (r/r MM). CBG-002 is designed based on the fourth-generation of CAR-T techonology.

NCT ID: NCT04718701 Recruiting - Clinical trials for Metastatic Pancreatic Cancer

Anlotinib, Toripalimab and Nab-paclitaxel in Locally Advanced/Metastatic Pancreatic Cancer

ATNPA
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, non-randomized, single-arm phase Ⅱ study aiming to evaluate the efficacy and safety profile of above-mentioned combination strategy in first-line therapy-failed advanced pancreatic cancer. Totally 53 patients with locally advanced or metastatic pancreatic cancer are to be enrolled and receive anlotinib plus toripalimab and nab-paclitaxel.

NCT ID: NCT04730154 Recruiting - Breast Neoplasms Clinical Trials

PI-targeted PNE+MI Compared to BIOMEDICAL Education in BCS

BCS-PI
Start date: April 1, 2021
Phase: N/A
Study type: Interventional

Breast cancer is the most frequently diagnosed cancer in women worldwide. An important portion of the breast cancer survivors will face chronic pain complaints. These pain complaints do not only impact the patient's quality of life but also prevents resumption of activities, leading to huge economic costs. 30% of all breast cancer survivors with pain present with perceived injustice which has been conceptualized as a multidimensional appraisal process characterized by a tendency to interpret one's losses as severe and irreparable, to attribute blame to others for one's suffering and to experience a sense of unfairness. Perceived injustice is also associated with increased opioid prescription and use, urging the need for targeted interventions to diminish perceived injustice. Despite the fact that specific treatment plans for perceived injustice are not yet proven, pain neuroscience education (PNE) is proven to reassure and encourage towards activity. In order to obtain the targeted behavioural change, motivational interviewing (MI) is used as the communication process throughout PNE. A multi-centre, parallel, two-arm, investigator-blinded study with 4-weeks intervention and two years follow-up will be conducted in 156 BCS with PI and pain. These will be randomly assigned to the intervention or usual care group. The groups will receive 1 online session, an information leaflet and 3 live sessions of education spread over 4 weeks. Pain neuroscience education in combination with motivational interviewing will be given in the experimental group and biomedically-focused education to the control group. The primary scientific objective of the study is to examine whether perceived injustice-targeted PNE is superior to biomedically-focused pain education in reducing pain after 12 months in breast cancer survivors with perceived injustice and pain. The secondary objectives of the study are to examine whether perceived injustice-targeted PNE, compared to biomedically-focused pain education, results in improving health-related quality of life, reducing perceived injustice and opioid use after 24 months in breast cancer survivors with perceived injustice and pain, and to conduct a health-care cost analysis which will finally result in a recommendation concerning the use of perceived injustice-targeted PNE in breast cancer survivors with perceived injustice and pain.

NCT ID: NCT04733287 Recruiting - Aging Clinical Trials

Heat Therapy and Muscle Function Study

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

Exercise tolerance decreases with age and a sedentary lifestyle. Muscle critical power (CP), is a sensitive measure of exercise tolerance that is more even more relevant to and predictive of endurance performance than VO2max. While recent evidence indicates that CP and muscle function decrease with aging, the cause of this decrease in CP and the best way to mitigate the decrease in CP are unknown. This study will: 1. Measure knee extensor CP in young and old individuals and determine the extent to which changes in muscle oxygen delivery (e.g. resistance artery function, maximum exercise blood flow), muscle mass and composition (e.g. whole-muscle size, muscle fiber cross-sectional area) and mitochondrial oxygen consumption (e.g. maximal coupled respiration of permeabilized fibers biopsied from the knee extensors) contribute to the decrease in CP with age. 2. Examine the effectiveness of two different therapies (1. High Intensity Interval Training, HIIT and 2. Muscle Heat Therapy) at improving muscle function and critical power in young and older adults. 3. Examine the impact of muscle disuse (2 weeks of leg immobilization), a potential contributor to the decrease in muscle function with aging, on muscle function and critical power and determine if heat therapy is an effective means of minimizing the impact of disuse on muscle function and critical power.