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NCT ID: NCT05084729 Completed - Clinical trials for Breast Abnormality Diagnosis

CONFIDENCE Registry

CONFIDENCE
Start date: September 11, 2020
Phase:
Study type: Observational [Patient Registry]

This registry has been designed to obtain real-life, post-market data on the use of the Imagio breast imaging system. This registry is sponsored by Seno Medical Instruments, Inc., the manufacturer of the device.

NCT ID: NCT05084456 Withdrawn - Solid Tumor, Adult Clinical Trials

Oral Docetaxel in Patients With Normal or Impaired Liver Function

Start date: July 2017
Phase: Phase 1
Study type: Interventional

This is an open label, single centre pharmacological and safety study to define the safety and pharmacokinetics of ModraDoc006/r in a weekly dosing schedule in patients with impaired liver function who might have benefit from a weekly docetaxel regime. The safety of ModraDoc006 in combination with ritonavir for the patients with mild and moderate impaired liver function will be evaluated with a dose escalation design.

NCT ID: NCT05083169 Active, not recruiting - Multiple Myeloma Clinical Trials

A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (Tec-Dara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma

MajesTEC-3
Start date: October 14, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab daratumumab (Tec-Dara) with daratumumab subcutaneously (SC) in combination with pomalidomide and dexamethasone (DPd) or daratumumab SC in combination with bortezomib and dexamethasone (DVd).

NCT ID: NCT05082688 Completed - Influenza Clinical Trials

Age Differences in Influenza and Herpes Zoster Vaccine Responses (INFLUENZA-SHINGRIX)

Start date: September 20, 2021
Phase: Phase 2
Study type: Interventional

Vaccines are used to prevent infectious diseases worldwide. Unfortunately, many vaccines, like the flu vaccine, are less effective in older adults. This single-centre open label partially randomised, partially placebo-controlled trial evaluates the differences in immune response between young and older adults after vaccination with a quadrivalent inactivated influenza vaccine and an adjuvanted herpes zoster vaccination. Exploring the underlying mechanisms between the differences in immunogenicity can provide important information for future vaccine development.

NCT ID: NCT05079919 Active, not recruiting - Clinical trials for Severe Hypertriglyceridemia

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

Start date: October 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

NCT ID: NCT05079386 Completed - Laryngectomy Clinical Trials

Clinical Feasibility of a New Voice Prosthesis

Start date: January 7, 2022
Phase: N/A
Study type: Interventional

The objective of this clinical investigation is to evaluate the short-term clinical feasibility of a new voice prosthesis and explore its acceptability, limitations and advantages. As a result of the evaluations, design changes may be implemented and evaluated until the optimal design has been determined, or until it is decided not to pursue further development of the device. Main outcome will be the patient's acceptance of the voice prosthesis, secondary outcomes are stickiness of the valve mechanism and speech.

NCT ID: NCT05079256 Active, not recruiting - Psoriasis Vulgaris Clinical Trials

Laser Induced Changes to Innervation and Vascularisation of Psoriatic Skin

LPA-01
Start date: December 9, 2022
Phase: N/A
Study type: Interventional

The researchers investigate the effect of a treatment with selective photothermolysis using a 595 nm pulsed dye laser on the blood vessel density and the nerve fibre density of a psoriatic lesion. By comparing tissue samples collected before and after two treatments, the researchers determine the relative effect of laser therapy on the (hyper)innervation of psoriatic skin.

NCT ID: NCT05079230 Terminated - Clinical trials for Acute Myeloid Leukemia

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

ENHANCE-3
Start date: July 7, 2022
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to compare the study drugs, magrolimab + venetoclax + azacitidine, versus placebo + venetoclax + azacitidine in participants with untreated acute myeloid leukemia (AML) who are not able to have chemotherapy.

NCT ID: NCT05078671 Recruiting - Cancer Clinical Trials

Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness

PROACTIVE
Start date: December 15, 2021
Phase: Phase 4
Study type: Interventional

Olaparib is a poly-adenosine diphosphate ribose polymerase (PARP) inhibitor, originally used for the maintenance treatment of women with platinum-sensitive relapsed breast cancer gene (BRCA)-mutated high grade serious epithelial ovarian, fallopian tube, or peritoneal cancer, who are in response to platinum-based chemotherapy. Over the last two years, several therapeutic indications have been added to the drug label, such as first-line platinum-sensitive BRCA-mutated high grade serious epithelial ovarian, fallopian tube, or peritoneal cancer, germline BRCA1/2-mutated, human epidermal growth factor 2 (HER2-)negative, locally advanced or metastatic breast cancer and BRCA1/2-mutated metastatic castration-resistant prostate cancer, who have progressed following prior therapy. Since olaparib is very expensive, this increase of treatment population will have a significant impact on health care expenditures. To keep healthcare affordable and accessible for all patients, innovative strategies are warranted to reduce the dose of expensive drugs, without reduction of efficacy. For olaparib, pharmacokinetic (PK) boosting can be applied. PK boosting is the lay term for administering a non-therapeutic active strong inhibitor of a metabolic enzyme, for example the cytochrome p450 enzyme 3A (CYP3A), together with a therapeutic drug that is metabolized by the same enzyme. Boosting thus increases the concentration of the therapeutic drug and allows lower doses to be administered to patients. Hence, coadministration of a reduced dose of olaparib with cobicistat, a non-therapeutic, strong inhibitor of the CYP3A can lead to equivalent exposure to olaparib. Furthermore, inhibition of CYP3A could lead to less PK variability since metabolic capacity is a prominent cause for (intra- and inter-individual) variability in systemic exposure. Predictable olaparib exposure will reduce the number of patients who are unintentionally under- or overtreated. Lastly, tumor tissue itself may express CYP3A as a detoxification or resistance mechanism. Theoretically, PK boosting may also overcome CYP3A-mediated drug resistance. The purpose of this study is to establish the efficacy, safety and feasibility of co-administering olaparib with the PK booster cobicistat with the aim to implement boosting approach for olaparib in routine practice. The study is subdivided in two parts. In part A of the study the equivalent exposure of boosted low dose olaparib is determined compared to the normal dose. In part B of the study, non-inferiority of the boosted olaparib regimen will be confirmed.

NCT ID: NCT05078619 Recruiting - Clinical trials for Coronary Artery Disease

Percutaneous Coronary Intervention Before Transcatheter Aortic Valve Implantation

PRO-TAVI
Start date: October 5, 2021
Phase: N/A
Study type: Interventional

The aim of this trial is to evaluate the safety and cost effectiveness of omission of percutaneous coronary intervention of significant coronary artery disease in patients scheduled to undergo transcatheter aortic valve implantation.