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NCT ID: NCT03911869 Terminated - Brain Metastases Clinical Trials

An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis

POLARIS
Start date: April 30, 2019
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.

NCT ID: NCT03911713 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis

Start date: April 17, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.

NCT ID: NCT03911505 Recruiting - Clinical trials for Pompe Disease (Late-onset)

ZIP Study-OL Study of Safety, PK, Efficacy, PD, Immunogenicity of ATB200/AT2221 in Pediatrics Aged 0 to < 18 y.o. w/LOPD

Start date: February 13, 2020
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, multicenter study to evaluate the safety, PK, efficacy, PD, and immunogenicity of Cipaglucosidase Alfa/Miglustat treatment in enzyme replacement therapy (ERT)-experienced and ERT-naïve pediatric subjects with Pompe disease, aged 0 to < 18 years

NCT ID: NCT03909165 Completed - Clinical trials for Neuromuscular Blockade

Efficacy, Safety, and Pharmacokinetics of Sugammadex (MK-8616) for Reversal of Neuromuscular Blockade in Pediatric Participants Aged Birth to <2 Years (MK-8616-169)

Start date: July 23, 2019
Phase: Phase 4
Study type: Interventional

This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of sugammadex (MK-8616) for reversal of both moderate and deep neuromuscular blockade (NMB) in pediatric participants aged birth to <2 years. The primary hypothesis of this study is that sugammadex is superior to neostigmine in reversing moderate NMB as measured by time to neuromuscular recovery.

NCT ID: NCT03909100 Completed - Clinical trials for Non-invasive Fat Reduction

International CoolSculpting: Study to Evaluate Patient Satisfaction for Non-Invasive Fat Reduction in Abdomen and/or Flanks (iCOOL)

Start date: July 29, 2019
Phase: N/A
Study type: Interventional

This study aims to generate data that conveys participant's experiences such as their overall satisfaction with the CoolSculpting® treatment for their belly and love handles. By doing this, the study will provide insights for doctors to better inform participants about the expected outcomes.

NCT ID: NCT03907748 Completed - Depression Clinical Trials

Home-based Family Caregiver-delivered Music and Reading Interventions for People With Dementia

HOMESIDE
Start date: November 20, 2019
Phase: N/A
Study type: Interventional

This international study evaluates the impact of home-based caregiver-delivered music and reading interventions for people with dementia. The project aims to address the need for improved informal dementia care by training family caregivers to utilise a music or reading intervention with the person they are caring for. The interventions aim to decrease behavioural and psychological symptoms of dementia as well as improve quality of life and well being of both people living with dementia and their caregivers. Participants will be allocated into a music intervention group, a reading intervention group or standard care group. In addition, the researchers will seek to determine the cost-effectiveness of using the music intervention.

NCT ID: NCT03906669 Recruiting - Clinical trials for Early-stage Breast Cancer

A Window of Opportunity Study of Pre-operative Endocrine Therapy With and Without Prometrium in Postmenopausal Women With Early Stage Breast Hormone Receptor Positive (HR+) Human Epidermal Receptor 2 Negative (HER2-) Breast Cancer.

WinPro
Start date: March 20, 2018
Phase: Phase 2
Study type: Interventional

A phase II randomised, open label study of pre-operative endocrine therapy with & without prometrium in postmenopausal women with early stage breast hormone receptor positive (HR+) human epidermal receptor 2 negative (HER2-) breast cancer.

NCT ID: NCT03906331 Available - Breast Cancer Clinical Trials

Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

Start date: n/a
Phase:
Study type: Expanded Access

Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial. The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

NCT ID: NCT03905525 Completed - Sjögren Syndrome Clinical Trials

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

TWINSS
Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

NCT ID: NCT03905265 Completed - Scabies Clinical Trials

Dose-finding Study of Moxidectin for Treatment of Scabies

Start date: January 13, 2020
Phase: Phase 2
Study type: Interventional

The effective dose of moxidectin to treat human scabies is not known. This study aims to provide proof of concept that a single dose of moxidectin is effective in eliminating the scabies parasite in humans and to enable the determination of an optimal dose of moxidectin for treatment of scabies for further clinical studies.