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NCT ID: NCT05517889 Completed - Clinical trials for Artificial Intelligence

Repeatability and Stability of Healthy Skin Features on OCT

Start date: September 1, 2022
Phase:
Study type: Observational

A test-retest study on the stability and repeatability of healthy skin features on OCT

NCT ID: NCT05517096 Recruiting - Asthma in Children Clinical Trials

AmbuLatory Pediatric Asthma CAre

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

The ALPACA study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. The study is divided into two phases of 3 months using eHealth and observational monitoring.

NCT ID: NCT05516498 Recruiting - Liver Cirrhosis Clinical Trials

Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)

ZEAL
Start date: October 31, 2022
Phase: Phase 2
Study type: Interventional

This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.

NCT ID: NCT05515588 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How BI 690517 is Taken up and Handled by the Body

Start date: September 19, 2022
Phase: Phase 1
Study type: Interventional

The trial is intended to investigate the basic pharmacokinetics, excretion pathways and metabolism of BI 690517 and its metabolites.

NCT ID: NCT05515328 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test How BI 685509 is Processed in the Body

Start date: September 8, 2022
Phase: Phase 1
Study type: Interventional

The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects. The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.

NCT ID: NCT05514444 Recruiting - Neoplasms Clinical Trials

Study of MK-4464 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced/Metastatic Solid Tumors (MK-4464-001)

Start date: September 25, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of MK-4464 as monotherapy and in combination with pembrolizumab in participants with advanced/metastatic solid tumors.

NCT ID: NCT05514054 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

EMBER-4
Start date: October 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

NCT ID: NCT05513469 Recruiting - Clinical trials for Neuroendocrine Tumors

Biomarker Identification of Radionuclide Therapy-induced Radiation Responses

Radio-Marker
Start date: January 1, 2023
Phase: N/A
Study type: Interventional

Peptide receptor radionuclide therapy (PRRT) with [177Lu]Lu-DOTA-[Tyr3]octreotate (177Lu-DOTATATE) is a form of internal radiation treatment for patients with neuroendocrine tumors (NET) to reduce tumor growth and stabilize disease. Due to limited response rates, there is a need to improve this therapy. A better understanding of therapeutic radiobiological responses, such as transcriptional and DNA damage responses, could contribute to identification of biomarkers for toxicity and/or efficacy prediction. Easy access to biological samples for biomarker discovery would be via a so-called liquid biopsy (drawing blood) to collect healthy peripheral blood mononuclear cells (PBMCs) or circulating tumor DNA (ctDNA) for further investigation. Exposure to ionizing radiation (IR) such as by PRRT leads to complex cellular responses including activation of the DNA damage response and changes in gene expression which can differ between individuals. This was previously shown for ex vivo external beam radiation of blood cells in which radiation responsive genes were identified. These genes were also similarly up- or downregulated following in vivo exposure to total-body irradiation of patients. In addition, different studies have shown a good correlation between radiation dose to the blood and DNA double strand break induction in PBMCs for various PRRT-like treatments. These results show that such events can be measured in PBMCs and indicate that ex vivo irradiation can mimic the in vivo transcriptional regulation and DNA damage induction. Therefore, to identify PRRT-induced cellular responses, the investigators will analyze the effects of 177Lu-DOTATATE IR on the transcriptional regulation in PBMCs and compare this regulation to radiation dose and DNA damage induction. In addition, it was shown that levels of ctDNA can be associated with treatment response and anticancer treatment is also shown to influence ctDNA methylation patterns. The investigators will therefore explore dynamics of ctDNA levels and methylation patterns before and after PRRT to provide more knowledge of the effect of radiation response on ctDNA. This is a pilot study to validate the possibility of determining the radiation response of PRRT with 177Lu-DOTATATE in PBMCs and ctDNA.

NCT ID: NCT05513365 Recruiting - Clinical trials for Salivary Duct Carcinoma

Phase II Dutasteride in Combination With CAB vs CAB in SDC

DUCT
Start date: September 27, 2022
Phase: Phase 2
Study type: Interventional

Phase 2 clinical trial on the addition of dutasteride to combined androgen blockade (CAB) therapy in recurrent and/or metastatic (R/M) salivary duct carcinoma (SDC) patients. The study included two cohorts of patients: Cohort A, which comprises ADT-naïve patients, and Cohort B, which comprises ADT-resistant patients. Cohort A is closed for inclusion as of April 18, 2024.

NCT ID: NCT05511922 Recruiting - Clinical trials for Hereditary Angioedema

PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

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

This is a multicenter pharmacokinetic (PK) subtrial to investigate the PK profile of KVD900 in adolescent patients 12 to 17 years of age with Hereditary Angioedema (HAE) type I or II.