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NCT ID: NCT04877652 Completed - Clinical trials for Acute Decompensated Heart Failure

DR REGISTRY: Prospective Observational Study of ADHF Patients With Insufficient Response to Diuretics

Start date: November 17, 2021
Phase:
Study type: Observational

The study objective is to observe and measure clinical outcomes, urine output, and safety events occurring during standard medical treatment of ADHF patients deemed to have insufficient diuretic response.

NCT ID: NCT04877366 Completed - Dietary Supplement Clinical Trials

Evaluate Effects of Sprinkled Format REDUCOSE in a Carbohydrate-rich, Mixed Meal on Post-prandial Glycemia

Stardust
Start date: July 21, 2021
Phase: N/A
Study type: Interventional

This is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format REDUCOSE compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in Asian patients with type 2 diabetes.

NCT ID: NCT04877262 Completed - Digestibility Clinical Trials

Effects of Time-restricted Eating on Nutrient Absorption in Healthy Adults

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

This 2-period, crossover, controlled-feeding trial will investigate the effects of early time-restricted eating (8am-2pm), compared to a control eating timeframe (8am-8pm), on energy and macronutrient digestibility, the thermic effect of food (TEF), postprandial blood metabolites, 24 h glucose concentrations, glycemic variability, intestinal hydrogen gas production, gastrointestinal transit time, and microbiome composition. This study will also seek to determine factors that may predict intestinal absorption efficiency (i.e., digestibility) including the microbial composition of stool, fasting and postprandial metabolomics, gastrointestinal transit time, thermic effect of food, 24 h glucose concentrations and variability, and hydrogen gas production.

NCT ID: NCT04877158 Completed - Anorexia Nervosa Clinical Trials

Pilot Intervention for Social Biases in Eating Disorders

SBPI
Start date: January 31, 2018
Phase: N/A
Study type: Interventional

Both behavioral, psychological, and cognitive differences related to social cognitive function have been related to illness-state in eating disorders, but interventions that directly target these problems are limited. This pilot intervention explores whether a brief art-therapy team-building intervention coupled with psychoeducation about social behavior can change self-concept or clinical symptoms in patients with eating disorders. Participants will complete pre-treatment assessments related to social behaviors and clinical symptoms, attend four two-hour group sessions, and provide two follow-up post-treatment assessments at 1-4 weeks after the treatment and 3-5 months later. Comparisons between the pre-intervention data and the first follow-up will be the primary outcome measures. The primary hypotheses are that participants will show increases in self-esteem and positive self-attributions and decreases in eating disorder symptoms after the intervention. The secondary hypothesis is that other clinical symptoms (depression, anxiety) will be improved after the intervention. Feedback from participants about their experience with the study will assess perceived benefits as well as acquisition of the psychoeducation targets.

NCT ID: NCT04877054 Completed - Sickle Cell Disease Clinical Trials

Pilot Evaluation of a Motivational Interviewing Intervention Targeting Adherence Behaviors in Youth With Sickle Cell Disease

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

Sickle cell disease (SCD) is a group of inherited blood disorders affecting 100,000 individuals in the United States. SCD often leads to complications, including pain crises and organ damage. Many individuals with SCD require medications (e.g., Hydroxyurea or Endari) that research has demonstrated reduce risk of complications and improve quality of life. Despite the need for strong medication adherence, adolescents and young adults (AYAs; 13-25 years) have the lowest adherence rates compared to other age groups. Efforts to reduce AYA non-adherence risk should include youth in earlier childhood and persist throughout the AYA developmental period, with the goal of maintaining adherence throughout childhood and young adulthood. Motivational Interviewing (MI) has been effective in increasing pediatric and adult medication adherence via in-person or telehealth delivery; however, researchers have yet to empirically evaluate MI for feasibility, acceptability, and/or efficacy in improving pediatric/AYA SCD medication adherence. The proposed feasibility trial will provide preliminary feasibility data for a newly developed MI+education intervention targeting medication adherence for pediatric and adolescents and young adults (AYA) patients who have sickle cell disease. This trial will also evaluate study design feasibility to inform a future randomized controlled trial (RCT). The investigators are interested in delivering the intervention to AYA patients and to parents of younger children who have sickle cell disease because the investigators anticipate that establishing strong adherence in younger childhood could prevent future non-adherence during the AYA developmental period. Participants will include 13-22 year-old patients with sickle cell disease as well as parents of 0-22 year-old patients with sickle cell disease. The investigators will randomize ten families to a 4-session telehealth MI+education intervention and five families to a one-session education-only control condition. All participants will complete assessments at three times. Intervention participants will complete the T2 assessment at their last intervention session (week 4-8), and the T3 assessment 16-20 weeks after study enrollment. Education arm participants will complete T2 assessments 4-8 weeks after study enrollment and will complete T3 assessments 16-20 weeks after study enrollment. Primary outcomes include intervention feasibility and acceptability and study design feasibility.

NCT ID: NCT04876924 Completed - Healthy Clinical Trials

A Study of BBP-711 (ORF-229) in Healthy Adult Volunteers

Start date: April 29, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability of BBP-711 in healthy adult volunteers.

NCT ID: NCT04876807 Completed - Healthy Volunteers Clinical Trials

A Study to Evaluate the Effect of an Acidic Formulation of Acalabrutinib (ACP-196), Acidic Beverage, or Grapefruit Juice on the Pharmacokinetics (PK) of ACP-196 Alone and Coadministered With Omeprazole

Start date: January 28, 2016
Phase: Phase 1
Study type: Interventional

This study will evaluate the effect of an acidic formulation of Acalabrutinib (ACP-196), acidic beverage, or grapefruit Juice on the PK of ACP-196 alone and coadministered with omeprazole.

NCT ID: NCT04876768 Completed - Clinical trials for Post-ERCP Pancreatitis

Effects of High FIO2 on Post-ERCP Pancreatitis.

Start date: May 18, 2021
Phase: N/A
Study type: Interventional

Post-ERCP pancreatitis is one of the most common complications accounting for substantial morbidity and mortality. The incidence of post-ERCP pancreatitis (PEP) has been studied in several large clinical trials and ranges from 1.6-15%. However most studies have demonstrated rates around 5%. This complication alone is estimated to cost the US healthcare around $150 million annually. To prevent this complication several pharmacological agents have been studied and no medication has been proved to be consistently effective in preventing this complications. Cyclo-oxygenase, and phospholipase A2 pathways are believed to play an important role in the pathogenesis of acute pancreatitis and so non-steroidal anti-inflammatory drugs (NSAIDs) have been extensively studied in the prevention of post-ERCP pancreatitis. One of the landmark studies done on prophylactic NSAIDs for PEP showed that rectal indomethacin significantly reduce the incidence of PEP (PEP developed in 9.2% vs. 16.9% of indomethacin and placebo groups respectively). Since then the use of rectal NSAIDs has become a standard chemo-prophylaxis for prevention of PEP especially in high risk patients. However, newly published meta-analysis showed that the role of peri-procedural rectal Indomethacin is doubtful in patients with average risk for PEP. In this prospective randomized clinical study, we propose to study the effects of supplemental peri-operative oxygen on the incidence of PEP. The effects of high oxygen fraction (FIO2) has extensively been studied in reducing the incidence of surgical site infection, postoperative nausea, vomiting and to prevent postoperative atelectasis. Changing the FIO2 during a procedure can be a simple, inexpensive and low risk intervention to prevent post-procedure complications.

NCT ID: NCT04876625 Completed - Clinical trials for Obstructive Sleep Apnea

OA Therapy for Mouth-breathers Who Snore

OATMB
Start date: July 26, 2019
Phase: N/A
Study type: Interventional

Breathing is one of the body's vital functions that occur under normal conditions using the nose. When humans breathe primarily through the mouth instead of the nose, this is referred to as mouth breathing. Snoring and obstructive sleep apnea (OSA) occur frequently in mouth breathers. Mouth breathing impairs oral health, reduces quantity and quality of saliva, and increases dry mouth, risk of developing dental caries, gingival inflammation, bad breath and dry lips. Serious health conditions associated with an obstructed upper airway in those who snore include hypertension, cardiovascular disease and mild cognitive impairment. Oral appliances (OAs) that bring the lower jaw (mandible) forward have been shown to be highly effective in reducing snoring and interruptions in breathing (respiratory events) that occur in those who snore and/or have OSA. The myTAP™ OA (AMI, Dallas, TX) includes an optional mouth shield (MS) that is anticipated to promote nasal breathing. The purpose of this study is to investigate the effects of oral appliance plus mouth shield therapy on sleep cardio-respiratory dynamics (breathing and heart activity) and their effect on improving OSA and oral health, especially of the periodontal tissues, in confirmed mouth breathers who snore and/or have OSA. As many as 70 adults at least 18 years old will be recruited to participate. All participants will wear the OA during sleep for 8 weeks (Phase 1). Half of the participants will be randomly assigned to wear the OA only for the first 4 weeks; all will wear both the OA and MS for the last 4 weeks. Participants will wear an easy-to-use home sleep recording system (NOX T3) for 2 nights at the start of the study and again at 4 weeks and 8 weeks. Based on the investigators' experience, some participants will not have achieved maximal benefit from the OA at 8 weeks, and will require addition adjustment. These participants will enter a second phase of the study where they will have 1 or more sleep studies done at 2 week intervals, and will further adjust their OAs (that is, advance the mandible) to eliminate snoring.

NCT ID: NCT04876599 Completed - Cancer Clinical Trials

Mind-body Resiliency Intervention for Fear of Cancer Recurrence

Start date: July 9, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to test the feasibility of a virtual, group mind-body resiliency intervention adapted to target fear of recurrence (FOR) among cancer survivors.