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NCT ID: NCT04971226 Active, not recruiting - Clinical trials for Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Start date: October 6, 2021
Phase: Phase 3
Study type: Interventional

The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

NCT ID: NCT04967118 Recruiting - Pain, Acute Clinical Trials

Neonatal Pain Management and Pain Monitoring Using New Methods

Start date: May 2, 2023
Phase: N/A
Study type: Interventional

The aim of this randomized controlled study with crossover design is to examine the effectiveness of mother-driven interventions, skin-to-skin contact (SSC) and recorded mother's heartbeats as sound and vibration (MHB), compared to oral glucose in relieving neonatal acute pain related to heel lance as a painful procedure. The effectiveness of interventions will be assessed using validated pain scales (PIPP-R and NIAPAS), changes in sensory cortex activation (near-infrared spectroscopy, NIRS) and changes in physiological indicators (oxygen saturation, heart rate, respiratory rate). The secondary objectives will include evaluating the effectiveness of interventions in relation to infant recovery and evaluating the use of NIRS monitoring in relation to neonatal pain assessment scales.

NCT ID: NCT04961996 Recruiting - Early Breast Cancer Clinical Trials

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

Start date: August 27, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician's choice in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. In addition, an open-label exploratory substudy will explore the safety and efficacy of giredestrant in combination with abemaciclib in a subset of the primary study population.

NCT ID: NCT04958356 Active, not recruiting - Celiac Disease Clinical Trials

Newborn Screening for Genetic Susceptibility to Type 1 Diabetes and Celiac Disease and Prospective Follow-up Study

BABYSCREEN
Start date: November 19, 2018
Phase:
Study type: Observational [Patient Registry]

This is an observational study, in which newborn infants from the general population are screened at birth for HLA-conferred susceptibility to type 1 diabetes and celiac disease. The participants carrying genetic susceptibility to type 1 diabetes (approximately 9.5%) will be analyzed for diabetes-associated autoantibodies at the age of 1, 2 and 3 years, while those predisposed to celiac disease (about 14%) will be screened for tissue transglutaminase antibodies at the age of 1 and 3 years. The intention is to screen annually 10,400 newborn infants for a period of 3 years. About 988 infants are each year identified as a child at risk for type 1 diabetes, and it is expected that around 80% of the families with such a child are willing to join the autoantibody screening. Approximately 1456 infants are each year recognized as a child at risk for celiac disease, and again the expectation is that 80% of the families will join the antibody screening program.

NCT ID: NCT04957719 Enrolling by invitation - Clinical trials for Acute Myocardial Infarction

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction

SOS-AMI
Start date: August 14, 2021
Phase: Phase 3
Study type: Interventional

This study will randomize patients recently discharged from the hospital with a confirmed diagnosis of type 1 acute myocardial infarction (Thygesen et al. 2018) and having additional cardiovascular risk factors.

NCT ID: NCT04950712 Active, not recruiting - Herpes Genitalis Clinical Trials

An Epidemiological Study to Assess Performance of Using Healthcare Tools to Understand Genital Herpes Simplex Virus-2 (HSV-2) in Patients ≥ 18 Years of Age in the United States and Europe.

Start date: June 9, 2021
Phase:
Study type: Observational

The aim of this study is to assess performance of using healthcare tools to understand genital Herpes Simplex Virus-2 (HSV-2) in patients ≥ 18 years of age in the United States and Europe. More specifically, the study aims to evaluate patient-reported outcome and quality-of-life endpoints as well as the performance study procedures in a decentralised setting. Ultimately, this study will allow generating additional real-world evidence (RWE) on patterns of recurrences and other key parameters.

NCT ID: NCT04949022 Recruiting - Type 1 Diabetes Clinical Trials

Glycemic Outcomes and Safety With Minimed 780G System in Children With Type 1 Diabetes Aged 2-6 Years

Start date: August 23, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of advanced hybrid-closed loop system, Minimed 780G to glycemic control and safety in children aged 2-6 years with type 1 diabetes. Additionally, the study evaluates the perceived burden of the diabetes treatment to families during the advanced hybrid-closed loop system treatment (diabetes distress). This is a prospective, non-randomized, single-arm study, where primary endpoint is the change in TIR after hybrid-closed loop system initiation. Secondary endpoints are safety (number of severe hypoglycaemias and diabetic ketoacidosis, DKA), HbA1c, time below range (TBR), mean sensor glucose (SG), standard deviation of SG, and coefficient of variation (CV). The inclusion criteria are 1) TDD (total insulin daily dose) ≥ 8 units, 2) HbA1c < 10%, 3) capability to use pump and the CGM, and 4) time from diabetes diagnosis more than 6 months. The exclusion criteria are hemophilia or any other bleeding disorder, a condition, which in the opinion of the investigator would put the participant at risk during the trial.

NCT ID: NCT04938830 Active, not recruiting - RSV Infection Clinical Trials

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

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

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).

NCT ID: NCT04938284 Completed - Spinal Plasticity Clinical Trials

Combining PAS to Non-invasive VNS

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

Vagus nerve stimulation (VNS) and paired associative stimulation (PAS) have been shown to have efficacy in improving the results of motor rehabilitation after stroke and spinal cord injury, respectively. Here we will investigate in healthy subjects the synergistic effect of these stimulation modalities on motor-evoked potential (MEP) potentiation.

NCT ID: NCT04936685 Active, not recruiting - Healthy Volunteers Clinical Trials

Study on an Investigational Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Administered as a 5- and/or 10-year Booster Doses in Children and Adolescents Vaccinated 5 or 10 Years Earlier as Toddlers

Start date: August 23, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the MEQ00073 study is to assess the immunogenicity and safety of a booster dose in children who had been vaccinated with MenACYW conjugate vaccine approximately 5 years earlier as toddlers as part of the MET51 study, and to describe the persistence of a priming dose in children and adolescents who had been vaccinated with MenACYW conjugate vaccine approximately 5 years or 10 years earlier as toddlers as part of the MET51 study, the immunogenicity and safety of a booster dose in adolescents who had been primed with MenACYW conjugate vaccine as toddlers as part of the MET51 study, and the immunogenicity and safety of a second booster dose in adolescents approximately 5 years after a first booster dose as children approximately 5 years after the priming dose as toddlers.