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NCT ID: NCT05112939 Active, not recruiting - Healthy Clinical Trials

A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants

Start date: November 16, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with cabotegravir (CAB) LA extended release suspensions in different conditions in healthy adult participants.

NCT ID: NCT05111795 Completed - Clinical trials for Hepatocellular Carcinoma

Holmium-166 Retrospective Collection of Real-World Data

RECORD
Start date: January 17, 2022
Phase:
Study type: Observational

The primary objective of the study is to further describe the general safety and clinical performance of QuiremSpheresTM Holmium-166 Microspheres and QuiremScoutTM Holmium-166 Microspheres in a real-world post-market setting, with specific attention to outcomes per tumor origin.

NCT ID: NCT05110430 Completed - Clinical trials for Metastatic Bone Tumor

Automated Detection of Metastatic Bone Disease on Bone Scintigraphy Scans

Start date: March 10, 2021
Phase:
Study type: Observational

Bone scintigraphy scans are two dimensional medical images that are used heavily in nuclear medicine. The scans detect changes in bone metabolism with high sensitivity, yet it lacks the specificity to underlying causes. Therefore, further imaging would be required to confirm the underlying cause. The aim of this study is to investigate whether deep learning can improve clinical decision based on bone scintigraphy scans.

NCT ID: NCT05110027 Completed - Healthy Clinical Trials

Enpatoran Human Mass Balance and Absolute Bioavailability Study

Start date: November 5, 2021
Phase: Phase 1
Study type: Interventional

The purpose of Period 1 of this study is to provide a definitive quantitative characterization of the mass balance, and rates and routes of excretion of enpatoran, and to determine and quantify enpatoran and its metabolites in excreta (urine and feces) and plasma. The purpose of Period 2 of this study is to determine the absolute oral bioavailability of enpatoran. Total minimum duration of study participation for each participant is approximately 50 days.

NCT ID: NCT05109910 Recruiting - Prostate Cancer Clinical Trials

The Prognostic Role of Lymph Node Dissection In Men With Prostate Cancer Treated With Radical Prostatectomy

Start date: November 17, 2021
Phase: N/A
Study type: Interventional

An extended pelvic lymph node dissection (ePLND) is the most accurate staging method to assess the presence of lymph node metastases in prostate cancer (PCa) patients. The therapeutic value, however remains unclear. Prospective randomized trials to address this void are lacking. Since in intermediate and a proportion of high risk PCa the risk of nodal metastases is generally below 25%, the vast majority of men undergo a procedure that has no oncological benefit, but is not without toxicity. Therefore, the investigators aim to compare the oncologic outcomes of intermediate- and high-risk PCa patients with an estimated risk of lymph node invasion of 5-20% undergoing a radical prostatectomy (RP) with or without an ePLND.

NCT ID: NCT05108155 Completed - Hip Osteoarthritis Clinical Trials

Regression Discontinuity Design Search for Differences in Mortality and Revision for Fixation Type of THA

Start date: January 2007
Phase:
Study type: Observational [Patient Registry]

The goal of this study is to apply the regression discontinuity design (RD) methodology on arthroplasty registry data. The investigators aim to use an age-based cut-off for fixation type choice and estimate the causal effect of fixation type on short term mortality and revision, using a fuzzy regression discontinuity design.

NCT ID: NCT05107570 Completed - Cold Exposure Clinical Trials

The Effect of Cold Exposure on Energy Expenditure

Start date: May 17, 2021
Phase: N/A
Study type: Interventional

Cold-induced thermogenesis, or the increase in energy expenditure upon cold exposure, indicates metabolic stress, as such, cold-induced thermogenesis may signal an appropriate stimulus to improve metabolic health. Cold acclimation may alter cold-induced thermogenesis due to changes in (non)shivering thermogenesis and blood flow. The main aim of this research is to compare the energy expenditure responses, during a standardised cold stress (~ 9°C air temperature, maximum 1 hour), of Siberian adults with Western European adults. The subjects will be individually matched for age, sex, body mass and height. It was hypothesised that cold-induced thermogenesis will be reduced in the Siberian population.

NCT ID: NCT05107115 Completed - Clinical trials for Chronic Spontaneous Urticaria

Rilzabrutinib for the Treatment of Chronic Spontaneous Urticaria in Patients Who Remain Symptomatic Despite the Use of H1 Antihistamine

RILECSU
Start date: November 24, 2021
Phase: Phase 2
Study type: Interventional

The first phase of this study will be a parallel, 12-week treatment, Phase 2, double-blind, 4 arm study to assess the safety and effectiveness of 3 oral doses of SAR444671 (rilzabrutinib), i.e. dose A, B and C, compared with placebo for decreasing the frequency and severity of itch and urticaria in male and female participants aged 18 years inclusive or older with CSU. After completion of the double-blind phase of the study, participants will be given the option of enrolling in the 40-week open label extension (OLE) phase of the study. Participants will receive open-label rilzabrutinib at dose C (the dose may be modified based on the 12-week safety and efficacy data). Due to the fact that some participants may be receiving rilzabrutinib for the first time, all participants will be monitored at Week 14, Week 16, Week 20, and Week 24. Afterwards, participants will be monitored at Week 36 and Week 52.

NCT ID: NCT05105646 Completed - Clinical trials for Psychological Distress

Are Perception of Pain and Psychological Distress Before Knee Arthroplasty Associated With Reason for Revision?

Start date: January 1, 2014
Phase:
Study type: Observational

The aim of our study is to identify the influence of preoperative pain (NRS pain score and EQ5D pain score) and higher levels of anxiety and depression (EQ5D anxiety/depression score) and their interaction before primary total knee arthroplasty on revision surgery for unexplained symptoms after primary surgery.

NCT ID: NCT05104866 Active, not recruiting - Breast Cancer Clinical Trials

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Start date: October 18, 2021
Phase: Phase 3
Study type: Interventional

The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.