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NCT ID: NCT04821661 Recruiting - Bacteremia Clinical Trials

T2 and SeptiCyte RAPID Duration Project

Start date: January 11, 2022
Phase:
Study type: Observational

Infection with bacteria and other germs in the blood can be deadly. How long germs stay in the blood is important for two reasons. The first is that if they stay in the blood for many days it is a sign that antibiotics may need to be changed. The second is that if they stay in the blood for only a short time it may give doctors confidence to switch to tablets and consider early discharge from hospital. This study is evaluating the diagnostic and prognostic performance of two novel technologies when used to measure the duration of the bloodstream infection.

NCT ID: NCT04819607 Recruiting - Aplastic Anemia Clinical Trials

The Evaluating Multidisciplinary Bone Marrow Failure Care in Bone Marrow Failure and Related Disorders.

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

This is a prospective hybrid implementation-effectiveness study of a model of care for patients with bone marrow failure syndromes and inherited predisposition to haematological malignancy that includes comprehensive diagnostic genomic evaluation, multidisciplinary case review, provision of clinical care including from clinical haematologists, medical geneticists and genetic counsellors.

NCT ID: NCT04819100 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)

LIBRETTO-432
Start date: December 20, 2021
Phase: Phase 3
Study type: Interventional

The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

NCT ID: NCT04819074 Recruiting - Aneurysm, Brain Clinical Trials

Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms

PRAEMIUM
Start date: May 20, 2021
Phase:
Study type: Observational

Accurate preoperative identification of patients at high risk for adverse outcomes would be clinically advantageous, as it would allow enhanced resource preparation, better surgical decision-making, enhanced patient education and informed consent, and potentially even modification of certain modifiable risk factors. The aim of the Prediction of adverse events after microsurgery for intracranial unruptured aneurysms (PRAEMIUM) study is therefore to develop and externally validate a clinically applicable, robust ML-based prediction tool based on multicenter data from a range of international centers.

NCT ID: NCT04818476 Recruiting - Barrett Esophagus Clinical Trials

Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus

Start date: February 10, 2020
Phase:
Study type: Observational

The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.

NCT ID: NCT04816721 Recruiting - Clinical trials for Respiratory Syncytial Virus (RSV)

A Study to Evaluate EDP 938 Regimens in Children With RSV

RSVPEDs
Start date: April 26, 2022
Phase: Phase 2
Study type: Interventional

A 2-part study to evaluate the safety, pharmacokinetics and efficacy of EDP-938 in children with RSV infection.

NCT ID: NCT04816604 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)

Start date: April 5, 2021
Phase: Phase 2
Study type: Interventional

This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.

NCT ID: NCT04811560 Recruiting - Clinical trials for Acute Myeloid Leukemia

A Study of JNJ-75276617 in Participants With Acute Leukemia

Start date: May 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D[s]) of JNJ-75276617 in Part 1 (Dose Escalation) and to determine safety and tolerability at the RP2D(s) in Part 2 (Dose Expansion).

NCT ID: NCT04811092 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Study of Sotatercept in Newly Diagnosed Intermediate- and High-Risk PAH Participants (MK-7962-005/A011-13)

HYPERION
Start date: March 18, 2022
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the effects of sotatercept (MK-7962, formerly called ACE-011) treatment (plus background pulmonary arterial hypertension (PAH) therapy) versus placebo (plus background PAH therapy) on time to clinical worsening (TTCW) in participants who are newly diagnosed with PAH and are at intermediate or high risk of disease progression.

NCT ID: NCT04802759 Recruiting - Clinical trials for Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

Start date: June 20, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER-positive, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib or neratinib). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. During Stage 1, participants in each cohort will be randomly assigned to treatment arms. Participants in the control or experimental arms who experience unacceptable toxicity, disease progression as determined by the investigator according to RECIST v1.1, or loss of clinical benefit as determined by the investigator during Stage 1 will be given the option of receiving a different treatment combination during Stage 2, provided they meet eligibility criteria and a treatment arm is open for enrollment. No Stage 2 treatment is currently available.