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NCT ID: NCT04693520 Active, not recruiting - Clinical trials for Early Alzheimer's Disease

Biomarker Effects of ALZ-801 in APOE4 Carriers With Early Alzheimer's Disease

Start date: September 30, 2020
Phase: Phase 2
Study type: Interventional

The study will investigate the effects of oral ALZ-801, in subjects with Early AD who have the APOE4/4 or APOE3/4 genotype, on the biomarkers of core AD pathology. The objectives of this study include determining the efficacy and safety/tolerability of ALZ-801. In addition, the study will evaluate the extended PK profile over 8 hours in 16 subjects after 65 weeks of treatment.

NCT ID: NCT04693351 Recruiting - Clinical trials for Obsessive-Compulsive Disorder

Efficacy and Safety Study of Adjunctive Troriluzule in Obsessive Compulsive Disorder

Start date: January 29, 2021
Phase: Phase 3
Study type: Interventional

The study's purpose its to evaluate the efficacy and safety of troriluzole as adjunctive therapy compared to placebo in subjects with Obsessive Compulsive Disorder (OCD)

NCT ID: NCT04693325 Recruiting - Clinical trials for End Stage Renal Disease

PROlonged Ex-vivo Normothermic Machine PERfusion for Kidney Regeneration

PROPER
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

The investigators would like to introduce and clinically evaluate prolonged normothermic machine perfusion (PNMP) to preserve and assess high-risk donor kidneys prior to transplantation.

NCT ID: NCT04691245 Not yet recruiting - Clinical trials for Ultrasound Therapy; Complications

3D US Guided Femoral Artery Access for TAVI

3D-US-TAVI
Start date: February 2021
Phase: N/A
Study type: Interventional

Rationale: Bleeding and vascular complications of the femoral artery still account for significant morbidity and mortality in transcatheter aortic valve implantation procedures. Although steadily declining over the past years through smaller diameter devices and use of ultrasound, major complications still occur in 3-4 % of patients. Femoral access is often obtained using 2D US guidance already. New 3D US probes can aid in increasing anatomical awareness. This can improve first pass success during procedures. Furthermore, for new closure devices, entering the artery at a straight angle at precisely 12 o'clock probably reduces complications. Therefore, the investigators hypothesize improved real time needle guidance using three dimensional ultrasound can decrease procedure related complications.

NCT ID: NCT04689828 Active, not recruiting - Prostatic Neoplasms Clinical Trials

177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer

PSMAfore
Start date: June 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings. Approximately 450 participants will be randomized (225 per treatment group).

NCT ID: NCT04689321 Recruiting - Glioma Clinical Trials

Revision of the EORTC QLQ-BN20 Questionnaire

QLQBN20
Start date: December 19, 2018
Phase:
Study type: Observational

Despite the fact that use of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Brain Neoplasm (QLQ-BN20) has tremendously contributed to insight into the health-related quality of life (HRQoL) of brain tumor patients, certain items of the questionnaire have raised issues, and new treatments have been introduced, with different toxicity profiles not covered by the current measure. These observations have led to the recognition that a revision of the QLQ-BN20 is warranted. The aim of this project is to update the current EORTC QLQ-BN20 questionnaire.

NCT ID: NCT04688775 Completed - Clinical trials for Cluster Headache, Episodic

Eptinezumab in Participants With Episodic Cluster Headache

ALLEVIATE
Start date: December 23, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

NCT ID: NCT04688723 Recruiting - Clinical trials for Coronary Artery Disease

Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI

RE-DUAL PCI
Start date: December 23, 2020
Phase: Phase 4
Study type: Interventional

A real world registry to compare dual therapy with Dabigatran/Ticagrelor to dual therapie with Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with Dabigatran/Ticagrelor will be non-inferior in reducing the risk of bleeding compared to Dual therapy with Dabigatran/Clopidogrel (RE-DUAL PCI trial based) in patients with an indication for NOAC undergoing PCI in the setting of ACS. Thromboembolic events, stent thrombosis and death will be evaluated for estimation of events between both groups. Data will be pooled for this secondary endpoint with data from the upcoming WOEST-3 trial to compare both treatments.

NCT ID: NCT04687501 Completed - Anxiety Clinical Trials

Effect of VR on Anxiety and Pain in Gynecological Surgery

VRAP-G
Start date: October 22, 2020
Phase: N/A
Study type: Interventional

Rationale: Lack of postoperative acute pain management is associated with increased morbidity, longer recovery time, more opioid use and subsequently increased health care costs. There is increasing evidence virtual reality (VR) is effective in the reduction of acute pain. Alternative methods to reduce postoperative pain and multimodal analgesia are necessary for acute postoperative pain management and to reduce opioid use and their adverse effects. Objective: The aim of this study is to explore the effect of VR on pain in the immediate postoperative period after elective gynecological surgery. Secondary objectives are evaluating pre-and postoperative anxiety, pain catastrophizing, analgesic use, length of hospital stay between both groups and to explore tolerability, feasibility and satisfaction of VR use. Study design: The study concerns a non-blinded, single centre, randomised controlled trial. Study population: Eligible women fulfill the inclusion criteria and receive elective gynecological surgery in the Zuyderland Medical Centre location Heerlen. Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care- group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the pre- and postoperative period additional to the usual standard care. The participants randomised to the standard care- group will receive only the usual standard care pre-and postoperative. Main study parameters: The primary outcome is postoperative pain measured on a numeric rating scale (NRS). A total of 30 patients have to be included in each group. This means that a total of 60 women will have to be included in the study. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study population experiences a small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults. Participants of the study have to fill in a questionnaire before randomization and pre-and postoperative score of pain and anxiety on a zero to ten score scale.

NCT ID: NCT04686305 Recruiting - Clinical trials for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

DL03
Start date: March 9, 2021
Phase: Phase 1
Study type: Interventional

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.