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NCT ID: NCT04974606 Completed - Mood Clinical Trials

Effect of Coffeeberry on Mood, Motivation and Cognitive Performance

Start date: June 28, 2016
Phase: N/A
Study type: Interventional

The primary purpose is to test the short-term effects of the acute consumption of two novel beverages made from coffeeberries, the fruit of the coffee plant (Coffea arabica) benchmarked against caffeine on several aspects of cognitive performance. Preliminary studies suggest that flavanols and chlorogenic acids can enhance cognitive performance. It is unknown if drinks formulated with flavanols and chlorogenic acids (without high sugar or caffeine) improve cognition or mood to a similar extent as caffeine. Coffeeberry beverage comparisons will be made to a flavored positive control beverage containing caffeine and a flavored placebo beverage.

NCT ID: NCT04974515 Completed - Clinical trials for Obstructive Sleep Apnea

Adherence to Electrical Glossal In Situ Stimulation for Sleep Apnea (AEGIS Study)

AEGIS
Start date: August 17, 2021
Phase: N/A
Study type: Interventional

The purpose of this research is to assess how well people with mild obstructive sleep apnea (OSA) adhere to the eXciteOSA device and specifically examine whether adherence of the device is different with low versus high electrical stimulation. In addition, this research study will assess how well the device affects mild sleep apnea and if it improves sleepiness and quality of life.

NCT ID: NCT04974489 Completed - Clinical trials for Tobacco Use, Cigarette Use

Correcting Public Misperceptions About Very Low Nicotine Content Cigarettes

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

Tobacco use is the leading preventable cause of cancer and cancer deaths in the US. While most (69%) smokers want to quit, only 6% succeed in doing so each year. For many smokers, the addictiveness of nicotine makes quitting very difficult. To reduce cigarette smoking and resulting harms, FDA has announced a comprehensive approach to tobacco and nicotine regulation that includes moving toward a very low nicotine content (VLNC) standard for cigarettes. Greatly reduced nicotine levels would facilitate smoking cessation. However, the maximal success of the policy may require public understanding that, although these new cigarettes are less addictive, their high toxicity and carcinogenicity are unchanged. Yet, nearly half of adult smokers incorrectly think smoking VLNC cigarettes is less harmful than smoking current cigarettes (the VLNC misperception). Additionally, 24% of smokers said they would be less likely to quit if a VLNC regulation is enacted. Thus, the VLNC misperception may partially undermine a nicotine reduction policy. Although communication research suggests it is challenging to change people's incorrect understanding, new communication techniques may help reduce the VLNC misperception. In this randomized trial we will examine whether messages about the harm of VLNC cigarettes can reduce the VLNC misperception and increase intention to quit in a nicotine reduction scenario.

NCT ID: NCT04974476 Completed - Clinical trials for Overweight and Obesity

Onsite vs. Virtual Group Fitness in Overweight/Obese Women

Start date: July 24, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.

NCT ID: NCT04974385 Completed - Analgesia Clinical Trials

Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty

Start date: August 4, 2021
Phase: Phase 3
Study type: Interventional

The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.

NCT ID: NCT04974307 Completed - Low Vision Clinical Trials

Optic-to-Audio Device in a Pediatric Cohort With CLN3-related Conditions or Low Vision

Start date: September 30, 2021
Phase: N/A
Study type: Interventional

Background: CLN3 involves vision loss observed around the preschool years, with eventual progression to blindness within 1-3 years. Researchers want to test an assistive device that may help children with CLN3 or blindness. Objective: To learn if it is safe, easy, and useful for children with CLN3 or blindness to use the OrCam. Eligibility: People aged 6-18 years who have either CLN3-related disease or blindness. Design: Participants will be screened with the following: Medical history Physical exam Family history Eye exam and vision tests. They will get eyedrops to dilate their eyes. Psychological and neurocognitive tests. They will be asked questions and observed for how they do various tasks, such as talking, playing, writing, drawing, and solving problems. Hearing tests. They may wear headphones or earplugs. Electrodes may be taped to their head. Blood samples Skin biopsy, if needed Cheek cell, saliva, or urine samples The OrCam is the size of and weighs about half as much as a pack of gum. It is attached to eyeglass frames by magnets. Participants will do tasks before and after they have been trained on the OrCam. They will do these tasks without or with using the OrCam. Participants will be given an OrCam to use for 1 week or 1 month. They will have check-in sessions with the study team. Participants and/or their caregivers will be asked about abilities, behaviors, social skills, learning methods, intelligence, and health-related quality of life. Participants samples may be used for genetic testing and/or to make a type of stem cell. Participation will last for 1-5 weeks.

NCT ID: NCT04974086 Completed - Clinical trials for Sexual and Reproductive Health

Electronic Sexual Reproductive Health CDS Tool at the Children's Hospital of Philadelphia

Start date: September 26, 2023
Phase: N/A
Study type: Interventional

Many studies show early detection of sexual activity in adolescents can improve their health management and that primary care pediatricians would benefit from supports to address adolescent health, including sexual and reproductive health. The primary objective of this study is to develop and evaluate the feasibility, acceptability, and usability of a sexually transmitted infection (STI) testing clinical decision support (CDS) tool within the electronic health record (EHR) among clinicians, adolescent patients, and their parents. Secondary objectives include assessment of the CDS tool's impact on clinical measures. The STI Testing CDS tool will be embedded within clinical practice and evaluated through a single-armed prospective cohort study of primary care clinicians, adolescent patients, and parents. The STI Testing CDS tool that will support pediatric clinicians by providing evidence-based sexual health-related screening, treatment, and referrals, as needed.

NCT ID: NCT04974008 Completed - Bone Cancer Clinical Trials

Osteosarcoma Maintenance Therapy With OST31-164

OST-164-01
Start date: October 21, 2021
Phase: Phase 2
Study type: Interventional

Up to 45 Patients aged 12 to 39 with osteosarcoma (bone cancer) that had recurred in the lungs and has recently been surgically removed will be enrolled. Patients will receive OST31-164 infusions every 3 weeks over 48 weeks and be followed after that for 3 years.

NCT ID: NCT04973696 Completed - Clinical trials for Acute Orthopedic Injury

Toolkit for Optimal Recovery After Orthopedic Injury

TOR
Start date: October 5, 2021
Phase: N/A
Study type: Interventional

This is a multi-site randomized feasibility trial of the Toolkit for Optimal Recovery after Orthopedic Injury (TOR), a mind-body program to prevent persistent pain and disability in at-risk patients with acute orthopedic injury, versus a minimally-enhanced usual care (MEUC) control. TOR is a 4-session program delivered via secure live video to patients at risk for chronic pain, 1-2 months after an orthopedic traumatic injury. The primary aim of this study is to determine whether the study methodology (i.e., implementation, randomization, procedures and assessment of outcome measures) and delivery of TOR meet a priori set benchmarks for feasibility, acceptability, and appropriateness, necessary for the success of the subsequent efficacy trial.

NCT ID: NCT04973436 Completed - Clinical trials for Lung Cancer Metastatic

DBT for Metastatic Lung Cancer

LiveWell
Start date: May 18, 2022
Phase: N/A
Study type: Interventional

Metastatic lung cancer patients experience significantly greater psychological distress (i.e., depression, anxiety) compared to other cancers. Psychological distress is as a prognostic indicator for worse clinical outcomes and poorer overall survival in cancer patients. Dialectical behavioral therapy (DBT) is a trans-diagnostic, evidence-based psychotherapy that teaches participants a core set of behavioral skills (distress tolerance, emotion regulation, mindfulness, interpersonal effectiveness) to cope more effectively with emotional and physical symptoms. The proposed study seeks to adapt and pilot test DBT skills training for patients with metastatic lung cancer using the ADAPT-ITT framework. Participants will be metastatic lung cancer patients who score >=3 on the National Comprehensive Cancer Network distress thermometer. Phase I aims to use focus groups and interviews with key stakeholders (metastatic lung cancer patients (N=20), thoracic oncology providers (N=6), clinicians with expertise in survivorship and behavioral symptom management (N=6)) to determine if and how DBT skills training must be modified for implementation with metastatic lung cancer patients. Adapted material will be reviewed by topical experts in DBT and implementation science to produce a manualized, adapted DBT skills training protocol for metastatic lung cancer patients (LiveWell). Phase II aims to pilot test LiveWell (N=30) to assess feasibility, acceptability, and examine pre-to-post intervention outcomes of psychological distress, (i.e., depression and anxiety) fatigue, dyspnea, pain, emotion regulation, tolerance of uncertainty, and DBT coping skill use. LiveWell will consist of coping skills training sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.