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NCT ID: NCT05231187 Active, not recruiting - Clinical trials for Resistance Bacterial

T2Resistance - Detection of Resistance Related Genes

Start date: January 10, 2022
Phase:
Study type: Observational

The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms: 1. Prospective arm: positive percent agreement (PPA) and negative percent agreement (NPA) against genetic determinants of resistance detected in whole blood clinical samples or isolates collected from positive blood cultures prospectively collected clinical samples of whole blood. 2. Contrived arm: positive percent agreement (PPA) and negative percent agreement (NPA) against samples with known status, via spiking healthy whole blood samples with bacterial strains harboring the resistance gene targets on the T2Resistance Panel. 3. Healthy donor arm: negative percent agreement (NPA) with presumed negativity of healthy donor whole blood samples. The data from all arms of the study will be used to support the Premarket Notification for the T2Resistance Panel to the U.S. Food and Drug Administration. Primary Endpoints The primary endpoints of this study with the T2Resistance Panel are estimated sensitivity, specificity, and safety.

NCT ID: NCT05229718 Active, not recruiting - Type 2 Diabetes Clinical Trials

Understanding and Optimizing Care for Young Adults With Type 1 and Type 2 Diabetes Mellitus Transitioning to Adult Care

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

In this study, we will determine the feasibility of an innovative care model for young adults with diabetes and compare the primary and secondary outcomes in the innovative model to those in the usual care model for adult diabetes management at Massachusetts General Hospital (MGH) Diabetes Center.

NCT ID: NCT05229601 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

A Study of HFB301001 in Adult Patients With Advanced Solid Tumors

Start date: April 20, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to test the safety and tolerability of HFB301001 in patients with advanced cancers. There are two parts in this study. During the escalation part, groups of participants will receive increasing doses until a safe and tolerable doses of HFB301001 is determined. During the expansion part, participants will take the dose of study drug that was determined from the escalation part of the study and will be assigned to a group based on the type of cancer they have.

NCT ID: NCT05228964 Active, not recruiting - Depression Clinical Trials

Focused Ultrasound Amygdala Neuromodulation

Start date: January 13, 2022
Phase: Phase 2
Study type: Interventional

The purpose of the study is to examine the feasibility and potential efficacy of low-intensity focused ultrasound as a method of modulating amygdala function to promote improvements in symptoms of an affective disorder. Ultrasound is frequently and safely utilized for diagnostic purposes. In this study, the investigators will utilize magnetic resonance imaging (MRI) and neuronavigation to target the left amygdala and apply ultrasound. This will be conducted once a day, 5 days a week, for 3 weeks. This will be an open-label, single-arm trial.

NCT ID: NCT05228184 Active, not recruiting - Clinical trials for Congenital Hypothyroidism

Use of Tirosint®-SOL or Tablet Formulations of Levothyroxine in Pediatric Patients With Congenital Hypothyroidism (CH)

Start date: January 21, 2022
Phase: Phase 4
Study type: Interventional

This is a multi-center, prospective, parallel-group, open-label, randomized clinical study in one hundred and twenty-six (126) neonates and infants diagnosed with CH. Subjects will be randomized in a 2:1 ratio to Treatment (Tirosint®-SOL) or Control (conventional therapy with levothyroxine sodium crushed tablets).

NCT ID: NCT05228015 Active, not recruiting - Solid Tumor Clinical Trials

Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects With Advanced Solid Tumors

Start date: January 7, 2022
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first-in-human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of IK-930, an oral TEAD inhibitor, administered orally (PO) as monotherapy in subjects with advanced solid tumors with or without gene alterations in the Hippo pathway for whom there are no further treatment options known to confer clinical benefit. The study consists of two phases, an initial Dose Escalation phase followed by a Dose Expansion phase.

NCT ID: NCT05227898 Active, not recruiting - Cancer Clinical Trials

Virtual Trial to Compare Two Digital Therapeutics as Interventions for Physical and Mental Health in People With Cancer

RESTORE
Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This is a 2-arm randomized controlled study comparing how effective two therapeutic digital software devices are at improving anxiety and other indicators of psychological and physical health in patients with cancer. The study will be completely virtual, meaning participants can take part completely from home without visiting a clinic or study site. The digital software devices, called called attune™ and cerena™, are designed to be used for approximately 12 weeks alongside oncology usual care regimens (medical, psychosocial). The study will enroll at least 352 stage I-III cancer patients with elevated anxiety symptoms who are currently receiving systemic treatment (radiation, chemotherapy, immunotherapy), have received systemic treatment within the last 6 months, or who have an established treatment plan that includes systemic treatment.

NCT ID: NCT05227326 Active, not recruiting - Clinical trials for Refractory Malignant Solid Neoplasm

AOH1996 for the Treatment of Refractory Solid Tumors

Start date: August 12, 2022
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT05226598 Active, not recruiting - Clinical trials for Metastatic Non-Small Cell Lung Cancer

Study of Pembrolizumab/Vibostolimab Coformulation (MK-7684A) in Combination With Chemotherapy Versus Pembrolizumab Plus Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (MK-7684A-007/KEYVIBE-007)

Start date: March 24, 2022
Phase: Phase 3
Study type: Interventional

The primary hypothesis is that pembrolizumab/vibostolimab (MK-7684A) in combination with chemotherapy is superior to pembrolizumab in combination with chemotherapy with respect to overall survival (OS) in treatment-naïve metastatic participants with non-small cell lung cancer (NSCLC).

NCT ID: NCT05226286 Active, not recruiting - Overactive Bladder Clinical Trials

Evaluation of Implantable Tibial Neuromodulation Pivotal Study

TITAN 2
Start date: January 31, 2022
Phase: N/A
Study type: Interventional

The purpose of this prospective, multicenter study is to assess the safety and efficacy of tibial neuromodulation using the Medtronic Tibial Neuromodulation (TNM) system.