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NCT ID: NCT04740827 Completed - Episodic Migraine Clinical Trials

Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments.

ELEVATE
Start date: March 5, 2021
Phase: Phase 3
Study type: Interventional

This study will assess the safety, tolerability, and efficacy of Atogepant 60 mg compared with placebo in participants with episodic migraine and who have previously failed 2 to 4 classes of oral prophylactic treatments.

NCT ID: NCT04739761 Completed - Breast Cancer Clinical Trials

A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer

DESTINY-B12
Start date: June 22, 2021
Phase: Phase 3
Study type: Interventional

This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic HER2-positive breast cancer whose disease has progressed on prior anti-HER2-based regimens and who received no more than 2 lines/regimens of therapy in the metastatic setting (excluding tucatinib).

NCT ID: NCT04737356 Completed - Self Esteem Clinical Trials

SIA - Internet-administered CBT for Adolescents With Low Self-esteem

Start date: February 15, 2021
Phase: N/A
Study type: Interventional

The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.

NCT ID: NCT04736706 Active, not recruiting - Clinical trials for Carcinoma, Renal Cell

A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)

Start date: April 14, 2021
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.

NCT ID: NCT04736628 Completed - Clinical trials for Chronic Kidney Disease

A Study to Test the Effect of Different Doses of Avenciguat (BI 685509) on Kidney Function in People With Chronic Kidney Disease

Start date: April 27, 2021
Phase: Phase 2
Study type: Interventional

This study is open to adults who have kidney disease that is not caused by diabetes. The purpose of the study is to find out whether a medicine called avenciguat (BI 685509) improves kidney function. Three different doses of avenciguat are tested in this study. Participants get either one of the three doses of avenciguat or placebo. It is decided by chance who gets which avenciguat dose and who gets placebo. Participants take avenciguat or placebo as tablets 3 times a day. Placebo tablets look like avenciguat tablets but do not contain any medicine. Participants continue taking their usual medicine for kidney disease throughout the study. Participants are in the study for about 7 months. During this time, they visit the study site about 11 times. Where possible, about 6 of the 11 visits can be done at the participant's home instead of the study site. The trial staff may also contact the participants by phone or video call. Kidney function is assessed based on the analysis of urine samples, which participants collect at home. At the end of the trial the results are compared between the different doses of avenciguat and placebo. During the study, the doctors also regularly check the general health of the participants.

NCT ID: NCT04736407 Completed - Clinical trials for Ventriculitis, Cerebral

Diagnostics of External Ventricular Drain Infections in Neurosurgical Patients

EVD-Infect
Start date: October 5, 2017
Phase:
Study type: Observational

External ventricular drains (EVD) are small tubes used in neuro-critical care inserted to measure pressure and treat acute build-up of fluid in the brain by draining the cerebrospinal fluid (CSF) in the ventricles, often following an event of traumatic or spontaneous bleeding. While essential to the care of these patients, EVDs run the risk of introducing bacteria into the brain of the patient, causing an EVD associated infection (EVDI). EVDIs are feared complications that are difficult to identify and predict in an intensive care setting. In order to allow for early identification of these infections, CSF is routinely sampled from the EVDs and its constitution analyzed for signs of infection. However, the constitution of the CSF in neuro-critical care patients are often difficult to assess as it is frequently mixed with blood that often clouds clinical decision making. No fast parameter has been found to yet reliably predict or identify these infections, resulting in excessive treatment with broad-spectrum antibiotics in this patient group. EVDI diagnostics rely on mainly CSF analyses and cultures (growth of bacteria in the laboratory). Growing bacteria in the lab may take many days and can seldom guide early decision-making for these infections. Thus, EVDI diagnostics mainly rely on the analysis of the CSF constitution. Many diagnostic criteria rely on the relationship between white and red blood cells in the CSF, with red blood cells being introduced in the CSF following the brain bleed , and white blood cells being seen as a response to infection. These criteria assume that the blood is homogeneous in the CSF. However, from computed tomography (CT) imaging of these patients, it is seen that blood can settle in the brain ventricles. In this study we aim to test the assumption that blood is homogeneously distributed in the CSF by sampling from the CSF in patients. Two samples are serially drawn allocated to a period between where patients are planned for a clinical repositioning, or not. We hypothesise that a heterogeneous distribution of blood in the CSF (as seen on CT imaging) may allow for the CSF constitution to change in serially drawn CSF samples, and that these changes may be exacerbated in repositioned patients as it may disturb the blood that has settled at the bottom of the ventricles as a result of gravity sedimentation. We further believe that these changes may affect clinical decision making and further complicate EVDI diagnostics.

NCT ID: NCT04734886 Completed - Covid19 Clinical Trials

The Effect of Probiotic Supplementation on SARS-CoV-2 Antibody Response After COVID-19

Start date: November 27, 2020
Phase: N/A
Study type: Interventional

This study will explore how a well-known probiotic strain L. reuteri DSM 17938 impacts SARS-CoV-2 specific antibody response upon and after infection in healthy adults.

NCT ID: NCT04732221 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study of the Efficacy and Safety of MK-5475 in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)

Start date: May 19, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

This is a two-part (Phase 2/Phase 3) study of MK-5475, an inhaled soluble guanylate cyclase stimulator, in participants with pulmonary arterial hypertension (PAH). The first part (Phase 2) will assess three different doses of MK-5475 compared to placebo in a base period of 12 weeks, followed by comparison of three different doses of MK-5475 during an optional 24 month extension period. The treatment dose with the best efficacy and safety profile in the phase 2 cohort base period will be selected for use in the second part (Phase 3) of the study. The primary hypothesis of Phase 2 is that at least one MK-5475 dose is superior to placebo in reducing pulmonary vascular resistance (PVR) from baseline at week 12. The purpose of the second part (Phase 3) of the study is to confirm the efficacy, safety, and tolerability of MK-5475 at the selected dose compared to placebo during a 12 week base period followed by an extension period of up to 5 years. The primary hypothesis of Phase 3 is that MK-5475 is superior to placebo in increasing 6-minute walk distance (6MWD) from baseline at week 12.

NCT ID: NCT04731454 Completed - Depression Clinical Trials

Feasibility and Acceptability of a Healthy Nordic Diet Intervention in Depressed and Non-depressed Adults

Start date: September 15, 2020
Phase: N/A
Study type: Interventional

In the future, we plan to conduct an 8-week diet intervention to investigate whether a healthy Nordic diet improves depression symptoms. The present pilot study tested whether the planned meals and diets were well-liked and accepted by participants (both depressed and non-depressed) in order to ensure that the future diet intervention will be feasible and successful. We also investigated whether any changes in health occurred after 8 days of this diet intervention.

NCT ID: NCT04731077 Recruiting - Osteoarthritis, Hip Clinical Trials

Avenir Complete Post-Market Clinical Follow-Up Study

Start date: September 27, 2021
Phase: N/A
Study type: Interventional

The main objectives of this study are to confirm the long-term safety, performance and clinical benefits the Avenir Complete femoral stem and its instrumentation when used in primary total, hemi, and revision hip arthroplasty.