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NCT ID: NCT04770779 Active, not recruiting - Clinical trials for Transfusion-dependent Beta-Thalassemia

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-TDT)

ENERGIZE-T
Start date: November 30, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare the effect of mitapivat versus placebo on transfusion burden in participants with transfusion-dependent alpha- or beta-thalassemia (TDT).

NCT ID: NCT04770753 Active, not recruiting - Clinical trials for Non-Transfusion-dependent Beta-Thalassemia

A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)

ENERGIZE
Start date: November 8, 2021
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to compare the effect of mitapivat versus placebo on anemia in participants with alpha- or beta-non-transfusion dependent thalassemia (NTDT).

NCT ID: NCT04769154 Completed - Intensive Care Unit Clinical Trials

Adult Airway Management in the Intensive Care Units and Regular Floors

Start date: March 2, 2021
Phase:
Study type: Observational [Patient Registry]

The goal of this descriptive observational study is to assess the success rate of endotracheal intubation at first attempt outside the operating room with direct laryngoscopy or with the use of an assisting device and identify adverse events; mainly hypoxemia (SpO2 < 85%), hypotension (SBP < 80 mmHg), and cardiac arrest in patients requiring elective or emergent endotracheal intubation. The main question it aims to answer is whether endotracheal intubation outside the OR at AUBMC has higher success rates and lower complication rates as compared to the literature. Participants will be evaluated according to the inclusion criteria and data extraction will be performed from the electronic health record (EHR). Researchers will compare success and complication rates with previous literature and international benchmarks.

NCT ID: NCT04761445 Completed - Implant Stability Clinical Trials

Comparison Between Two Different Tissue-Level Implant Systems: A Prospective Clinical Study

Start date: January 10, 2019
Phase: N/A
Study type: Interventional

The objective of this prospective study is to compare clinically and radiographically two different tissue-level implants, in partially edentulous patients in the posterior area of the maxilla and mandible. The primary objective of the study was to track the crestal bone level changes around the two implant systems. Secondary objectives were implant stability as well as initial soft tissue thickness which were evaluated throughout this study.

NCT ID: NCT04758078 Recruiting - Clinical trials for Respiratory Distress

Inhaled Budesonide in Transient Tachypnea of the Newborn

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

Background: Transient tachypnea of the newborn (TTN) caused by lung edema resulting from delayed absorption of fetal alveolar lung fluid and is a common cause of admission of late preterm and full-term infants to neonatal intensive care units. Infant born by C-section and those with perinatal asphyxia, umbilical cord prolapse or certain maternal condition (asthma, diabetes, or analgesia) are more prone to develop TTN. Conventional treatment involves appropriate oxygen administration and continuous positive airway pressure in some cases. Hastening the clearance of lung liquid should shorten the duration of the symptoms and reduce complications. Objectives: This study aims to determine the effectiveness of inhaled budesonide in the treatment of this disorder through determining whether it reduces the duration of oxygen therapy and respiratory symptoms and shortens hospital stay in term infants with transient tachypnea of the newborn

NCT ID: NCT04729907 Enrolling by invitation - Clinical trials for Muscular Atrophy, Spinal

Extension Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy Who Previously Participated in a Study With Nusinersen

ONWARD
Start date: April 19, 2021
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA) who previously participated in study 232SM203 (NCT04089566). The secondary objective of this study is to evaluate the long-term efficacy of nusinersen administered intrathecally at higher doses to participants with SMA who previously participated in study 232SM203 (NCT04089566).

NCT ID: NCT04717414 Recruiting - Anemia Clinical Trials

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

INDEPENDENCE
Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.

NCT ID: NCT04709874 Recruiting - Pain, Shoulder Clinical Trials

Paravertebral Block vs. Suprascapular Block for Treatment of Frozen Shoulder

Start date: January 2, 2022
Phase: N/A
Study type: Interventional

Background: Adhesive capsulitis, or frozen shoulder, is a major orthopedic condition that causes pain and functional limitation. Although different nonsurgical conservative therapies such as physical therapy, nonsteroidal anti-inflammatory drugs, and corticosteroid injections have been used, yet there is no standard treatment for frozen shoulder. Objectives: The primary objective of this study is to compare the effectiveness of nerve stimulator guided paravertebral block versus suprascapular block for treatment of frozen shoulder. The primary outcome is pain measured through the Visual Analogue Scale (VAS) over a follow up period of 6 months. Methods: This is a prospective randomized clinical trial that will be conducted between February 2021 and January 2022. Patients will be randomly allocated into two groups. Group I will receive paravertebral block guided by a nerve stimulator. Group II patients will receive suprascapular nerve block. Patients will be followed up at week 1, month 1, month 3 and month 6.

NCT ID: NCT04704362 Completed - Depression Clinical Trials

Ensuring Quality in Psychological Support

EQUIP
Start date: June 20, 2020
Phase: N/A
Study type: Interventional

The goal of this project is to test tools that will be part of a platform for training and supervision of mental health and psychosocial support helpers, including providers without specialized training in mental health. This platform, entitled Ensuring Quality in Psychological Support, is an online resource being developed to include: materials for evaluating core and specific competencies, training on core competencies, implementation guidance to conduct competency-based training. The Ensuring Quality in Psychological Support platform is designed to aid trainers and supervisors working with providers being trained to deliver World Health Organization and non-World Health Organization low-intensity psychological interventions. The research will address two study objectives: Objective 1. Determine feasibility, acceptability, and perceived utility of the Ensuring Quality in Psychological Support platform; Objective 2. Evaluate the reliability, validity, and sensitivity to change of Ensuring Quality in Psychological Support competency assessment tools. To maximize generalizability of findings, Ensuring Quality in Psychological Support will be evaluated in seven countries: Ethiopia, Kenya, Lebanon, Peru, Uganda, Zambia and Jordan. The sites are varied by types of psychological intervention, beneficiaries, experience of trainers, and background of trainees. In each site, trainers will train non-specialist providers on a low-intensity psychological intervention.

NCT ID: NCT04659863 Active, not recruiting - Clinical trials for Familial Hypercholesterolemia - Homozygous

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial Hypercholesterolemia

ORION-13
Start date: February 16, 2021
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein cholesterol (LDL-C).