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NCT ID: NCT04739865 Completed - Clinical trials for Treatment Resistant Depression

The Safety and Efficacy Of Psilocybin as an Adjunctive Therapy in Participants With Treatment Resistant Depression

Start date: August 10, 2020
Phase: Phase 2
Study type: Interventional

The Safety and Efficacy of Psilocybin as an Adjunctive Therapy in Participants with Treatment-Resistant Depression

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: 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: NCT04729712 Completed - Pain, Postoperative Clinical Trials

Efficacy of Ultrasound Guided ESP Vs Video-assisted PVB Catheter Placement in Minimally Invasive Thoracic Surgery

Start date: May 12, 2021
Phase: N/A
Study type: Interventional

Minimally Invasive Thoracic Surgery (MITS) is a surgical method used to perform lung surgery through small incisions between the ribs and includes both Video-Assisted Thoracic Surgery (VATS) and Robotic assisted Thoracic Surgery (RATS). MITS can cause a significant amount of postoperative pain and if this is not adequately controlled, it can delay the patient's recovery and it may be a precipitating factor for the development of Chronic Persistent Surgical Pain (CPSP). Regional anaesthesia is the use of nerve numbing medications known as local anaesthetics to block sensations of pain from a specific area of the body. For MITS, blocking pain arising from the chest wall/rib cage would improve the patient's recovery after the operation and overall patient satisfaction. There have been significant advancements made in thoracic (chest wall) regional anaesthesia techniques. Ultimately, this involves injecting local anaesthetics around the nerves that supply the chest wall. A single injection of these medications will only have a maximum effect for up to 12 hours and often this is considerably less. To prolong the pain free benefit, a thin tube known as a catheter will be placed so that the local anaesthesia medication can be continuously given by a specific mechanical pump designed for this purpose. This mechanical pump will be located at the patient's bedside and can precisely deliver the medication in question at a rate between 10-15 ml/hr. This infusion of local anaesthesia medication will continue for 48 hours after the operation and will be monitored by the hospital's pain team. The primary aim of this study is to compare the efficacy of two techniques for thoracic regional anaesthesia after this type of surgery. Participants will be randomly assigned (like tossing a coin) to receive either an Anaesthesiologist ultrasound guided Erector Spinae Plane Block (ESP) with catheter insertion or surgeon video-assisted Paravertebral block (PVB) with catheter insertion. Both these regional anaesthesia techniques are well established in clinical practice, but there is little evidence published comparing them for this type of surgery, in terms of quality of patient's short term (1-2 days) and longer-term (3 months) recovery.

NCT ID: NCT04728893 Recruiting - Clinical trials for Hematologic Malignancies

Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)

Start date: April 5, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of nemtabrutinib (formerly ARQ 531) in participants with hematologic malignancies of chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Richter's transformation, marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), and Waldenström's macroglobulinemia (WM).

NCT ID: NCT04723836 Recruiting - Pregnancy Clinical Trials

Optimal Nutrition for Prevention of Hypertension in Pregnancy

OptiPREG
Start date: March 1, 2017
Phase: N/A
Study type: Interventional

The aim of this study is to investigate the role of the 677C→T polymorphism in the methylenetetrahydrofolate reductase (MTHFR) gene on blood pressure (BP) during pregnancy, and to examine the effect of intervention with riboflavin, alone or in combination with 5-methyltetrahydrofolate (5-MTHF), as a non-drug approach for managing BP in pregnancy in women with the variant TT genotype. In addition, we aim to examine the effect of maternal supplementation with riboflavin, alone or combined with 5-MTHF, on BP in the offspring in early infancy. Study design: A double-blind randomized controlled trial in pregnant women will be conducted. Women with a singleton pregnancy who are in their first trimester will be recruited from antenatal clinics in Northern Ireland and the Republic of Ireland. Women interested in the study will provide informed consent, complete a screening questionnaire and will provide a buccal swab to collect DNA to screen for the MTHFR 677C→T polymorphism. Women with multiple pregnancies, a previous NTD-affected pregnancy and those who are taking medication interfering with B-vitamin metabolism will be excluded from participation in the study. At approximately the 16th gestational week (GW), those with the variant TT genotype and age-matched heterozygous women (CT genotype) will be randomised to receive riboflavin (5 mg/day) alone, or in combination with 5-MTHF (400µg/day), or placebo, until the end of pregnancy. A non-fasting blood sample will be collected for biomarker assessment of B-vitamin status and other relevant variables from each participant before intervention and at the 36th GW. At the same time points, anthropometric and BP measurements will be taken. Women will also complete a health and lifestyle questionnaire and a 4-day dietary record. Samples of cord blood, umbilical cord and placenta will be collected after delivery and anthropometric parameters of the newborns will be retrieved postpartum. Maternal and infant BP will be measured 2-4 months after birth. In parallel with the intervention trial, age-matched pregnant women who do not carry the variant gene (CC genotype) and have not been randomized to treatment, will be monitored in order to control for any changes associated with normal pregnancy in the study outcome measurements. In the pilot phase, the feasibility and acceptability of the study procedures and treatment will be evaluated for clarification of the sample size and refinement of the study protocol.

NCT ID: NCT04721002 Completed - Clinical trials for Multiple Myeloma (MM)

Study to Evaluate t(11;14) Status and BCL2 Expression in Adult Participants With Multiple Myeloma (MM)

MEDICI
Start date: July 7, 2021
Phase:
Study type: Observational

Multiple myeloma (MM) is a rare cancer caused by abnormal survival of plasma cells (blood cells). Most trial participants with MM relapse (cancer has come back) or become non- responsive to treatment and remission gets shorter after each line of treatment. This is a study to assess t(11;14) and BCL2 expression in adult participants with newly diagnosed and relapsed/refractory (R/R) MM. Approximately 500 adult participants with newly confirmed or relapsed/refractory (R/R) multiple myeloma (MM) will be enrolled in around 15-20 countries. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide bone marrow and blood samples.

NCT ID: NCT04719832 Completed - Asthma Clinical Trials

Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype

SWIFT-1
Start date: March 17, 2021
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype

NCT ID: NCT04718389 Recruiting - Asthma Clinical Trials

A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

NIMBLE
Start date: January 26, 2021
Phase: Phase 3
Study type: Interventional

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

NCT ID: NCT04717414 Recruiting - Anemia Clinical Trials

An Efficacy and Safety Study of Luspatercept (ACE-536) Versus Placebo in Subjects With Myeloproliferative Neoplasm-Associated Myelofibrosis on Concomitant JAK2 Inhibitor Therapy and Who Require Red Blood Cell Transfusions

INDEPENDENCE
Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions. The study is divided into Screening Period, a Treatment Phase (consisting of a Blinded Core Treatment Period, a Day 169 Response Assessment, a Blinded Extension Treatment Period, and an Open-label Extension Treatment Period), and a Posttreatment Follow-up Period. Following the Day 169 Response Assessment, subjects who did not show clinical benefit will have the option to unblind. Subjects who were on placebo during the Blinded Core Treatment Period will have the opportunity to crossover into the Open-Label Extension Treatment Period and receive Luspatercept.