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NCT ID: NCT04853368 Terminated - Clinical trials for Cystic Fibrosis (CF)

Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 Combination Therapies in Adult Participants With Cystic Fibrosis

Start date: September 20, 2021
Phase: Phase 2
Study type: Interventional

Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objective of this study is to assess how safe and effective is the combination therapy of galicaftor/navocaftor/ABBV-119 or Galicaftor/Navocaftor/ABBV-576 in adult participants with CF who are homozygous or heterozygous for the F508del mutation in each arm. Galicaftor/Navocaftor/ABBV-119 combination therapy and Galicaftor/Navocaftor/ABBV-576 is being developed as an investigational drug for the treatment of CF. Study doctors place participants in 1 of the 4 groups, called treatment arms. Each group receives a different treatment. Around 90 adult participants with a diagnosis of CF will be enrolled in the study around approximately 35 sites worldwide. Participants in arm 1 will receive oral capsules of galicaftor/navocaftor dual combination for 28 days followed by galicaftor/navocaftor/ABBV-119 triple combination for 28 days. Participants in arms 2 and 3 will receive the galicaftor/navocaftor/ABBV-119 triple combination or placebo for 28 days. Participants in arm 4 will receive galicaftor/navocaftor/ABBV-576 triple combination therapy for 28 days. For all study arms, ABBV-576, galicaftor, navocaftor, will be given once daily and ABBV-119 twice a day. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT04853108 Terminated - Covid19 Clinical Trials

Remote Monitoring of COVID-19 Positive Outpatients

Start date: June 25, 2021
Phase:
Study type: Observational

This study seeks to evaluate how secondary data retrieved from remote physiological monitoring performed during routine outpatient/at-home care periods can allow for the discovery of novel physiomarkers that predict acute deterioration or hospitalization among people testing positive for Coronavirus Disease 2019 (COVID-19).

NCT ID: NCT04853043 Terminated - Colorectal Cancer Clinical Trials

Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer

APK Mutant
Start date: November 3, 2021
Phase: Phase 2
Study type: Interventional

A prospective, multi-center, phase II study of 21 patients to evaluate the efficacy of the epidermal growth factor receptor (EGFR) inhibitor, Cetuximab in patients with metastatic colorectal cancer (mCRC) harboring Adenomatous polyposis coli (APC), tumor protein p53 (TP53) and RAS mutations.

NCT ID: NCT04852029 Terminated - Infertility, Female Clinical Trials

Prospective Assessment of Impact of Personalized Dosing of Low-dose Human Chorionic Gonadotropin (hCG) on in Vitro Fertilization (IVF) Outcomes

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

The purpose of the study is to determine the effect of tailoring dosage of low-dose hCG secondary to serum hCG levels during IVF ovarian stimulation on sustained implantation rates of preimplantation genetically tested euploid embryos.

NCT ID: NCT04850313 Terminated - Clinical trials for Bacterial Corneal Ulcer

Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers

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

The study design is a prospective, randomized, controlled interventional study to compare the outcome of ProKera Plus® with conventional treatment in patients with vision-threatening bacterial corneal ulcers. The study will be conducted at the University of Arkansas Medical Sciences (UAMS) in two phases for patients who present to an Ophthalmology clinic or Emergency Department at UAMS.

NCT ID: NCT04849273 Terminated - Clinical trials for Non-Small Cell Lung Cancer

A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC

Start date: July 28, 2021
Phase: Phase 1
Study type: Interventional

A phase 1, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC).

NCT ID: NCT04848220 Terminated - Clinical trials for Microvascular Obstruction

A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention

Start date: May 20, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether intravenous temanogrel is a safe and effective treatment for microvascular obstruction (MVO) in adult participants undergoing percutaneous coronary intervention (PCI).

NCT ID: NCT04847921 Terminated - Clinical trials for Substance Use Disorders

Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition

SUDDEN-OUT
Start date: April 30, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

The Investigators aim to study the outcomes of serious infections due to vancomycin susceptible infections in gram-positive organisms susceptible to vancomycin in people who use drugs (PWUD). The Investigators hypothesize, that a simplified 2-dose dalbavancin regimen, will improve compliance with antimicrobial therapy and that it may facilitate engagement in the treatment of the underlying substance use disorder, and particularly injection drug use - often the true etiology behind these severe infections.

NCT ID: NCT04847674 Terminated - Asthma Clinical Trials

A Study to Test if TEV-53275 is Effective in Relieving Asthma

Start date: May 4, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of TEV-53275 administered subcutaneously (sc) in adult participants with persistent asthma and an eosinophilic phenotype compared to placebo. A secondary objective is to evaluate the efficacy of TEV-53275 compared to placebo assessed by lung function, asthma symptoms, rescue medication use, and quality of life measures. Another secondary objective is to evaluate the safety and tolerability of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype compared with placebo, and lastly, to evaluate the immunogenicity of TEV-53275 administered sc in adult participants with persistent asthma and an eosinophilic phenotype.

NCT ID: NCT04847232 Terminated - Hyperkalemia Clinical Trials

Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)

Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.