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NCT ID: NCT04014634 Completed - Clinical trials for Cluster Headache, Episodic

GON-injection for a Sooner and Better Treatment of Cluster Headache

CHIANTI
Start date: August 1, 2019
Phase: Phase 4
Study type: Interventional

Cluster headache is a very severe primary headache disorder. In episodic cluster headache, attacks occur in 'bouts' (clusters) lasting weeks to months. Management of cluster headache entails a combination of attack and prophylactic treatment. Current first choice prophylactic treatment (verapamil) has considerable side effects which can be serious and include possibly fatal cardiac arrhythmias; and it can take weeks to titrate to an effective dose. Evidence has emerged that local steroid injection of the greater occipital nerve (GON) may be effective in cluster headache, but this method has not been investigated as a first line prophylactic treatment in a large, well-documented group of episodic cluster headache patients who are still free of prophylactic medication and just entered a new cluster headache episode. As such, GON-injection has not yet found its way into current treatment protocols. The investigators plan to perform this multicentre double-blind randomized controlled trial to investigate whether GON-injection is efficacious as a first-line prophylactic treatment, aiming to remove the need for high doses of daily medication - such as verapamil - with associated side effects.

NCT ID: NCT04014530 Recruiting - Colorectal Cancer Clinical Trials

Pembrolizumab With Ataluren in Patients With Metastatic pMMR and dMMR Colorectal Carcinoma or Metastatic dMMR Endometrial Carcinoma: the ATAPEMBRO Study

ATAPEMBRO
Start date: August 1, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

Single Center, open label, Phase I-II trial designed to test the safety and efficacy of the combination of Ataluren and Pembrolizumab for the treatment of metastatic mismatch repair deficient and proficient colorectal adenocarcinoma and metastatic mismatch repair deficient endometrial carcinoma.

NCT ID: NCT04013633 Completed - Cardiac Arrest Clinical Trials

Lowlands Saves Lives: A Randomized Trial Comparing CPR-quality Between Face-to-face vs. Lifesaver VR Training

Start date: August 16, 2019
Phase: N/A
Study type: Interventional

The objective of the Lowlands Saves Lives trial is to compare the quality of cardiopulmonary resuscitation (CPR) between face-to-face versus Lifesaver Virtual Reality smartphone application trained participants using a randomized controlled trial.

NCT ID: NCT04013607 Completed - Metabolism Clinical Trials

Fiber Fermentation Kinetics Inside the Gut, and Utilization of Bacterial Metabolites

Start date: July 8, 2019
Phase: N/A
Study type: Interventional

In this study, the life course of SCFA and their regulatory role in human metabolism will be traced using a nose-intestine catheter. The investigators have methodological questions: investigate the envisioned kinetic profiles of stable isotope tracers of SCFAs, and to establish the time points of plasma sampling (to determine systemic availability of SCFAs). The resulting timepoints established in this pilot study will be applied during a future human intervention study.

NCT ID: NCT04012060 Completed - Quality of Life Clinical Trials

Patient Reported Health-Related Quality of Life After Limited Access and Conventional Aortic Valve Replacement

LIAR
Start date: June 13, 2016
Phase: N/A
Study type: Interventional

The LIAR-Trial is a single-center, single blind randomized controlled clinical trial comparing patients undergoing isolated AVR via J-shaped upper hemi-sternotomy (UHS) and conventional AVR through a full median sternotomy (FMS). Primary outcome is cardiac-specific quality of life, measured by two domains of the Kansas City Cardiomyopathy Questionnaire (KCCQ), up to one year after surgery.

NCT ID: NCT04011735 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Re-usable Respimat® Soft MistTM Inhaler Study

Start date: September 30, 2019
Phase:
Study type: Observational

The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-experienced and Respimat SMI-naïve. This study also aims to examine patient preference for the re-usable Respimat SMI compared to the disposable Respimat SMI in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry.

NCT ID: NCT04009720 Terminated - Clinical trials for Aortic Valve Stenosis

RESPOND EDGE Post Market Study

RESPOND EDGE
Start date: October 11, 2019
Phase:
Study type: Observational [Patient Registry]

The purpose of the RESPOND EDGE post market study is to collect real world clinical and device performance outcomes data with the Lotus Edge™ Valve System used in routine clinical practice to demonstrate that the commercially available Lotus Edge Valve System is a safe and effective treatment for patients with severe calcific aortic stenosis.

NCT ID: NCT04008992 Completed - Clinical trials for Healthy Participants

An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants

Start date: June 18, 2019
Phase: Phase 1
Study type: Interventional

A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.

NCT ID: NCT04008706 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients

ASSURE
Start date: September 17, 2019
Phase: Phase 3
Study type: Interventional

This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL). Participants will be enrolled into 3 following cohorts: treatment-naive (TN), relapsed/refractory (R/R), and prior ibrutinib therapy. For this study, participants in the UK will be enrolled ONLY into the R/R cohort or the prior ibrutinib cohort. Participants in the US will be enrolled ONLY into the TN or R/R cohort. Participants will remain on study intervention until completion of 48 cycles (28 days per cycle), or until study intervention discontinuation due to, for example disease progression, or toxicity, withdrawal of consent, loss to follow-up, death, or study termination by the sponsor whichever occurs first. The duration of the study will be approximately 72 months from the first participant enrolled. This duration includes an estimated 24-month recruitment time and an assumed 48 cycles of study intervention (28 days per cycle); additional study time will be accrued during the Disease Follow up period for those participants remaining on study intervention after completion of 48 cycles prior to the final data cutoff (DCO) (the amount of time will vary by participant).

NCT ID: NCT04008030 Recruiting - Clinical trials for Metastatic Colorectal Cancer

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC)

CheckMate 8HW
Start date: August 5, 2019
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the clinical benefit, as measured by Progression-Free Survival (PFS), Objective Response Rate (ORR), and Overall Survival (OS), achieved by nivolumab in combination with ipilimumab or by nivolumab monotherapy in participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) metastatic colorectal cancer (mCRC). This study will also compare nivolumab plus ipilimumab combination vs chemotherapy for treatment of MSI-H/dMMR mCRC participants.