Clinical Trials Logo

Filter by:
NCT ID: NCT06350461 Completed - Cystic Fibrosis Clinical Trials

Impact of Discontinuing Hypertonic Saline in People With CF on Highly Effective CFTR Modulators- A SIMPLIFY Sub-Study

SIMPLIFY-HS
Start date: August 25, 2020
Phase: N/A
Study type: Interventional

Despite the increasingly common use of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies in treating cystic fibrosis (CF), it is still largely unknown whether or not other chronic therapies can be safely stopped. This SIMPLIFY sub-study is being done to test whether or not it is safe to stop taking inhaled hypertonic saline in those people that are also taking elexacaftor/tezacaftor/ivacaftor (ETI). ETI is a combination CFTR modulator therapy that was approved by the Food and Drug Administration for people with CF who have at least one F508del mutation. The three drugs that make up ETI work together to allow many more chloride ions to move into and out of the cells, improving the balance of salt and water in the lungs. These changes result in better clearance of mucus from the lungs and improvements in lung function. Inhaled hypertonic saline (HS) also improves clearance of mucus from the lungs to support lung function and has been available to people with CF for many years. HS is considered to be relatively burdensome and it is not known whether HS can improve or maintain lung function above what is already gained through ETI use. The goal of this SIMPLIFY sub-study is to get information about whether or not it is safe to stop hypertonic saline by testing if there is a change in lung function in participants with cystic fibrosis (CF) who are assigned to stop taking HS as compared to those who are assigned to keep taking HS while continuing to take ETI. This is a sub study of master protocol SIMPLIFY-IP-19, NCT04378153. The sub study investigating the impact of discontinuing and continuing dornase alfa is registered under NCTXXXXXXX (will add once available).

NCT ID: NCT06350409 Not yet recruiting - Pain, Chronic Clinical Trials

Adolescent Outcomes of Post-operative Opioid EXposure

APEX
Start date: August 10, 2024
Phase:
Study type: Observational

The goal of this observational study is to examine the factors associated with the transition from medical exposure to opioids with "signposts" of future opioid use disorder among adolescent surgical patients. The main question aims to identify factors (moderators, mediators, and covariates) associated with risk factors for opioid use disorder (ROUD) in the 12 months following major surgery with opioid exposure among adolescents aged 12-17. Participants will be asked to complete electronic surveys pre- and post-operatively and approve the collection of peri-operative data from the Electronic Medical Record to assess correlations.

NCT ID: NCT06350318 Recruiting - Follicular Lymphoma Clinical Trials

Rituximab and Zanubrutinib in Patients With Indolent B-cell Lymphomas

Start date: March 13, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to establish the safety and efficacy of zanubrutinib in combination with rituximab for people with untreated B-cell lymphomas (marginal zone lymphoma and follicular lymphomas).

NCT ID: NCT06350292 Recruiting - Clinical trials for Oppositional Defiant Disorder

SLEEP-COPE: Sleep Intervention for Oppositional Children

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.

NCT ID: NCT06350266 Recruiting - Clinical trials for Emergency Service, Hospital

Informing Low-acuity Emergency Department Patients of Non-emergent Resources

Start date: April 25, 2024
Phase: N/A
Study type: Interventional

The goal of this campaign is to reduce unnecessary emergency department (ED) visits/encourage patients with low acuity visits to follow up with an appropriate provider and/or to seek care outside of the ED in the future. In this campaign, patients will be assigned to receive or not receive outreach following ED discharge that is aligned with the goal. Outreach will occur via a text message, as well as information added to the patient's after visit summary, and will include one or more calls to action that make patients aware of other Geisinger resources and avenues through which they can seek care outside of the ED. These may include, but are not limited to, walk-in urgent care, virtual urgent care, primary care provider (PCP) appointments, and/or other ways in which to contact Geisinger. The study will assess whether ED use differs across patients in different outreach conditions. It will also examine whether patients followed through on the message-specific calls to action in the messages differently across conditions.

NCT ID: NCT06350253 Recruiting - Body Weight Clinical Trials

Comparison Of Measured To Predicted Resting Metabolism

Start date: March 14, 2023
Phase:
Study type: Observational

The purpose of this study is to compare RMR values from the BIA, predicted equations, and indirect calorimetry.

NCT ID: NCT06350175 Not yet recruiting - Clinical trials for Tobacco Use Disorder

Emergency Department Management of Tobacco Use Disorder

Start date: June 2024
Phase: Phase 4
Study type: Interventional

The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.

NCT ID: NCT06350149 Recruiting - Cystic Fibrosis Clinical Trials

A Pilot and Feasibility Study to Evaluate High vs Low Glycemic Index Mixed Meal Tolerance Test in Adolescents and Young Adults With Cystic Fibrosis

Start date: March 22, 2024
Phase: N/A
Study type: Interventional

The goal of this study is to determine the extent to which excess dietary simple sugars serve as a secondary mediating factor in Cystic fibrosis-related diabetes (CFRD) development. The main questions it aims to answer are: - Whether conducting a randomized 2x2 factorial design that evaluates acute postprandial changes in glucose over 2 hours following ingestion of a mixed meal challenge that varies by glycemic index and consumption of a sugar-sweetened beverage is acceptable and feasible. - What are the preliminary changes in postprandial hyperglycemia, islet cell function, and incretin response to a high or low Glycemic Index mixed meal tolerance test (MMTT) with and without Sugar-Sweetened Beverages (SSB) in adolescents and young adults with CF Participants will be randomized to a mixed diet and blood will be drawn before and after the mixed meal challenge.

NCT ID: NCT06350123 Recruiting - Clinical trials for Chronic Kidney Disease

Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease

MIRO-CKD
Start date: May 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.

NCT ID: NCT06349759 Recruiting - Night Vision Loss Clinical Trials

Safety and Efficacy of 0.75% Phentolamine Ophthalmic Solution in Subjects With Post-refractive Surgery Visual Disturbances

LYNX-2
Start date: April 1, 2024
Phase: Phase 3
Study type: Interventional

Safety and efficacy of 0.75% Phentolamine Ophthalmic Solution to improve mesopic low contrast visual acuity in subjects with post-refractive surgery visual disturbances.