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NCT ID: NCT04683718 Recruiting - Clinical trials for Chronic Low-back Pain

A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System With HomeStream Remote Management

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

The BENEFIT-03 Clinical Study is a first in human, prospective, multi-center, single-arm, interventional feasibility study to be conducted in Australia. The purpose of the BENEFIT-03 study is to collect initial safety and effectiveness data on the BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System with HomeStream Remote Management. Enrolled participants will complete a SCS trial period per the standard of care utilizing the BIOTRONIK Resilience percutaneous SCS trial leads and the BIOTRONIK Prospera External Pulse Generator (EPG). Following a successful trial period, participants will be implanted with a permanent BIOTRONIK Prospera Implantable Pulse Generator (IPG). Implanted participants will be followed for 24 months post-implant with in-office visits and remote management visits.

NCT ID: NCT04677569 Recruiting - Clinical trials for Mycobacterium Infections, Nontuberculous

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

ENCORE
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of ALIS (amikacin liposome inhalation suspension) + background regimen (azithromycin [AZI] + ethambutol [ETH]) compared to the ELC (empty liposome control) + background regimen on participant-reported respiratory symptoms at Month 13.

NCT ID: NCT04676828 Recruiting - Lung Cancer Clinical Trials

Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer

ASPECT
Start date: December 1, 2020
Phase: N/A
Study type: Interventional

Study aims to determine if functional lung avoidance based on perfusion single photon emission (SPECT)/CT scan, improves toxicity outcomes for patients with advanced lung cancer undergoing chemo-radiotherapy. Functional avoidance implies a dose plan that takes functional distribution in the lung into account, and avoids highly functional lung volumes sparing them from radiation.

NCT ID: NCT04676529 Recruiting - Myelofibrosis Clinical Trials

Study to Evaluate Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation and Expansion Study of PXS-5505 in Patients With Primary, Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis

Start date: February 18, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study will be an open-label phase 1/2a study to evaluate the safety and tolerability of PXS-5505 in patients with primary, postpolycythemia vera (PV) or post-essential thrombocythemia (ET) myelofibrosis.

NCT ID: NCT04675333 Recruiting - Clinical trials for Head and Neck Cancer

Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)

Start date: May 10, 2021
Phase: Phase 2
Study type: Interventional

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

NCT ID: NCT04675294 Recruiting - Clinical trials for Head and Neck Cancer

Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)

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

A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.

NCT ID: NCT04674969 Recruiting - Clinical trials for Peripheral Vascular Diseases

Drug-Eluting Registry: Real-World Treatment of Lesions in the Peripheral Vasculature

ELEGANCE
Start date: March 29, 2021
Phase:
Study type: Observational [Patient Registry]

The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.

NCT ID: NCT04674683 Recruiting - Clinical trials for Unresectable or Metastatic Melanoma

Study Comparing Investigational Drug HBI-8000 Combined With Nivolumab vs. Nivolumab in Patients With Advanced Melanoma

Start date: August 12, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3 study to compare the efficacy and safety of HBI-8000 or Placebo combined with nivolumab on patients with unresectable or metastatic melanoma and eligible patients who are not adolescents or patients with new, progressive brain metastasis will be stratified by PD-L1 expression and LDH level.

NCT ID: NCT04666610 Recruiting - Clinical trials for Childhood Absence Epilepsy

A Study to Evaluate the Efficacy, Safety, and Tolerability of Brivaracetam as Monotherapy in Patients 2 to 25 Years of Age With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

EXPAND
Start date: July 29, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to test the efficacy, safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE).

NCT ID: NCT04665206 Recruiting - Solid Tumor, Adult Clinical Trials

Study to Evaluate VT3989 in Patients With Metastatic Solid Tumors Enriched for Tumors With NF2 or mNF2 Gene Mutations

Start date: March 24, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, dose escalation and expansion study to evaluate the safety, tolerability, PK, and biological activity of VT3989 administered once daily in 3- or 4-week cycles in patients with mesothelioma and/or metastatic solid tumors that are resistant or refractory to standard therapy or for which no effective standard therapy is available.