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NCT ID: NCT04495140 Completed - Healthy Volunteer Clinical Trials

Study To Characterize Mass Balance, Absolute Bioavailability, Fraction Absorbed And Pharmacokinetics Of 14C PF-06882961

Start date: July 22, 2020
Phase: Phase 1
Study type: Interventional

This study is a Phase 1, open-label, non-randomized, 2-period, fixed sequence study to characterize the metabolic profile and routes of excretion of oral [14C]PF-06882961 and to evaluate the absolute oral bioavailability of PF-06882961 and fraction absorbed of [14C]PF-06882961 in reference to intravenous [14C]PF-06882961 in healthy male participants.

NCT ID: NCT04492371 Completed - Multiple Myeloma Clinical Trials

COVID-19 Infection and Multiple Myeloma

EMN-COVID
Start date: July 1, 2020
Phase:
Study type: Observational

Collect in an observational study the outcomes of COVID19 infection in MM patients across Europe.

NCT ID: NCT04491513 Completed - Clinical trials for Coronary Artery Disease

Detection of Proximal Coronary Artery Disease in the Work-up for Transcatheter Aortic Valve Implantation Using CTA (From the DEPICT CTA Database)

DEPICT CTA
Start date: October 1, 2019
Phase:
Study type: Observational

Background: Computed tomography angiography (CTA) is already used in the work-up for transcatheter aortic valve implantation (TAVI) and could partially replace invasive coronary angiography (CAG) to rule out proximal coronary lesions. Objectives: To assess the diagnostic accuracy and yield of pre-TAVI CTA to detect coronary lesions (≥50% DS and ≥70% DS) in the proximal coronary segments on a per-patient and a per-segment level. Methods: The DEPICT CTA database consists of individual patient data of four studies that analysed the diagnostic accuracy of pre-TAVI CTA to detect coronary lesions. For this analysis, diagnostic accuracy was assessed in the left main and the three proximal coronary segments.

NCT ID: NCT04490551 Completed - Colorectal Cancer Clinical Trials

Combining Risk Factors and Faecal Immunochemical Testing in Colorectal Cancer Screening: a Randomized Controlled Trial

Start date: December 5, 2019
Phase: N/A
Study type: Interventional

Colorectal Carcinoma (CRC) is the third most frequent diagnosed cancer worldwide, with 1.4 million new cases every year. In an attempt to reduce this number many countries have implemented a nationwide screening programme targeted at detecting CRC in an early phase using fecal immunochemical tests (FITs). People with an elevated level of blood in their stool are offered a colonoscopy, an invasive medical procedure where CRCs and premalignant lesions (together also referred to as advanced neoplasia) can be detected accurately. However, the current screening method using FIT is not optimal. In FIT-based CRC screening studies, 1 in 4 participants with CRC and 2 in 3 participants with advanced neoplasia receive a negative FIT result. In contrast, an estimated 1 in 2 FIT-positives have advanced neoplasia at colonoscopy. Recent studies have demonstrated that a risk model that takes into account the FIT result and other risk factors for CRC could enhance the effectiveness of a FIT-based CRC screening programme. The objective of this study is to assess the yield of advanced neoplasia in the colon and rectum of a FIT-based risk model at colonoscopy, compared to that of a FIT-only CRC screening strategy. Our hypothesis is that a risk-based model yields significantly more advanced neoplasia at colonoscopy than the FIT by itself, and that it does not affect participation rate. To assess this hypothesis, the investigators have designed a clinical trial in which the investigators randomize 23,000 asymptomatic individuals between the age of 55 and 75 years old to either risk-based screening (intervention group) or FIT-only screening (control group). The intervention group will receive a questionnaire on risk factors of CRC (e.g. smoking, family history of CRC), and a FIT. The control group will only receive the FIT. The positivity threshold of the FIT in both groups will be set at 15 micrograms haemoglobin per gram faeces. The positivity threshold of the risk-based model in the intervention group will be set at 0.10 (out of a range of 0 to 1), a threshold that is calculated with a goal to match the positivity rate of the control group. Participants with a result that is above the thresholds of the FIT and/or the risk-based model will be invited to undergo a colonoscopy according protocol of the Dutch national screening program. After the study has ended, the investigators will compare both groups to assess our hypotheses.

NCT ID: NCT04488562 Completed - COVID-19 Clinical Trials

Home Monitoring and Evaluation After Admission for COVID-19 in the Netherlands

HOMECOMIN'
Start date: March 19, 2020
Phase:
Study type: Observational [Patient Registry]

To date, little is known about the short and long-term complications of COVID-19. In order to obtain more insights in disease course and recovery of COVID-19 and to improve care after hospital admission, patients with COVID-19 will be monitored at home using an online home monitoring program for a period of 1 year.

NCT ID: NCT04487431 Completed - Overactive Bladder Clinical Trials

A Trial to Learn How a New Liquid Form of BAY1817080 is Tolerated and Taken up by the Body of Healthy Male Participants (Part A). By Labeling BAY1817080 With a Radioactive Substance (Carbon 14) Researchers Want to Learn How the Study Drug is Processed and Excreted by the Body After Dosing (Part B)

Start date: August 5, 2020
Phase: Phase 1
Study type: Interventional

Researchers are looking for a new way to treat people suffering either from a condition where the bladder is unable to hold urine normally (overactive bladder), or a condition in which tissue similar to the tissue that normally lines the inside of the womb grows outside the womb (endometriosis) or a condition where the cough lasts longer than 8 weeks in adults (chronic cough). BAY1817080 is a new drug that is in development as a potential treatment for these conditions. In this trial, the researchers want to learn how a new liquid form of BAY1817080 is taken up by the body in a small number of healthy participants. The trial will include men who are aged 18 to 54. The trial will have 2 parts: A and B. The participants in Part A will stay at the trial site for about 5 days. During this time, the participants will take 1 dose of a liquid form of BAY1817080 by mouth. The doctors will take blood and urine samples and check the participants' health. Part A will be done so the researchers can see how much BAY1817080 gets into the participants' blood. The participants in Part B will stay at the trial site for about 16 days followed by a maximum of 4 re-admission visits over 24 hours at intervals of 7 days. These participants will take 1 dose of a liquid form of BAY1817080 labeled with a radioactive substance (carbon 14), which means it is "radiolabeled". This allows the researchers to understand how BAY1817080 moves through and leaves the body. During Part B, the doctors will take blood, urine, stool, and vomit samples if applicable. They will also check the participants' health.

NCT ID: NCT04485338 Completed - Covid19 Clinical Trials

Chest Radiography in COVID-19 Patients

Start date: August 1, 2020
Phase:
Study type: Observational

To assess the prognostic performance of the RALE score with respect to duration of ventilation, and to describe changes in the RALE score over time.

NCT ID: NCT04485234 Completed - Clinical trials for Coronary Artery Disease

Inclusive Invasive Physiological Assessment in Angina Syndromes Registry

ILIAS Registry
Start date: June 1, 2019
Phase:
Study type: Observational [Patient Registry]

This study evaluates the prognostic value and potential therapeutic impact of combined pressure and flow measurements in the evaluation of epicardial coronary stenosis and microvascular function.

NCT ID: NCT04482725 Completed - Obesity Clinical Trials

Injection Site Pain Comparison of Excipient Solutions

Start date: July 20, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate different solutions used to inject drugs under the skin. The solutions used in the study do not contain the drugs they will be used for, but they do contain excipients, which are inactive substances added to drug solutions to ensure the stability (shelf life and correct activity) of the drug product. The excipients are considered 'inactive substances' compared to the drug, but they may cause an undesirable effect at the injection site in the form of pain. However, their pain-causing potential has never been tested in a systematic way. The purpose of the study is to determine if there is a difference in the injection site pain experience after an injection under the skin (subcutaneous) with 12 different study products. These study products are excipient solutions, which are substances in medications next to the active substance. None of the 12 products include active medication. This study will be performed in 108 healthy male and female volunteers.

NCT ID: NCT04480840 Completed - Clinical trials for Primary Sclerosing Cholangitis

Phase 2a Evaluation of Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Patients With Primary Sclerosing Cholangitis (PSC)

Start date: July 27, 2020
Phase: Phase 2
Study type: Interventional

A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis