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NCT ID: NCT04246177 Active, not recruiting - Clinical trials for Carcinoma, Hepatocellular

Safety and Efficacy of Lenvatinib (E7080/MK-7902) With Pembrolizumab (MK-3475) in Combination With Transarterial Chemoembolization (TACE) in Participants With Incurable/Non-metastatic Hepatocellular Carcinoma (MK-7902-012/E7080-G000-318/LEAP-012)

Start date: May 22, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of lenvatinib and pembrolizumab in combination with TACE versus TACE plus oral and intravenous (IV) placebos in participants with incurable, non-metastatic hepatocellular carcinoma (HCC). The primary hypotheses are that pembrolizumab plus lenvatinib in combination with TACE is superior to placebo plus TACE with respect to progression-free survival (PFS) and overall survival (OS).

NCT ID: NCT04244968 Active, not recruiting - Clinical trials for Musculoskeletal Pain

Satisfaction, QoL,Health Status & Clinic Outcomes for Patients Attending MSK Triage Clinics in Rheumatology

Start date: January 22, 2020
Phase:
Study type: Observational

The aim of this study is to measure the impact of musculoskeletal (MSK) complaints on the quality of life and general health of MSK Patients attending MSK triage clinics. The investigators will also record the proposed management options for patients' complaints. This will be achieved by asking patients to complete questionnaires (MSK HQ) at musculoskeletal triage clinic appointment, by undertaking a clinical assessment, by recording the proposed management plan and assessing if patients have follow up appointments for the same complaint in the following year. The investigators will also measure patient satisfaction using VSQ 9 Questionnaire. After a year the investigators will repeat the MSK HQ to assess the longterm impact of MSK Triage appointment on the MSK complaint.

NCT ID: NCT04236609 Active, not recruiting - Clinical trials for Coronary Artery Disease

Randomized Comparison of Abluminus DES+ Sirolimus-Eluting Stents Versus Everolimus-Eluting Stents in Coronary Artery Disease Patients With Diabetes Mellitus Global

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

To compare in diabetic patients eligible for percutaneous coronary intervention (PCI) with minimal exclusion criteria, the efficacy and safety of Abluminus DES+ sirolimus- eluting stents (SES) versus XIENCE Everolimus-Eluting Stents (EES). At least 40% of patients are expected to be affected by multivessel coronary artery disease and 30% with acute coronary syndrome

NCT ID: NCT04222972 Active, not recruiting - Neoplasms Clinical Trials

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

AcceleRET-Lung
Start date: July 24, 2020
Phase: Phase 3
Study type: Interventional

This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.

NCT ID: NCT04221945 Active, not recruiting - Clinical trials for Uterine Cervical Neoplasms

Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

Start date: May 12, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus concurrent chemoradiotherapy compared to placebo plus concurrent chemoradiotherapy in participants with locally advanced cervical cancer. The primary hypotheses are that pembrolizumab plus concurrent chemoradiotherapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival and overall survival. Once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment.

NCT ID: NCT04191135 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: 1. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). 2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.

NCT ID: NCT04191096 Active, not recruiting - Clinical trials for Metastatic Hormone-Sensitive Prostate Cancer

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)

Start date: February 12, 2020
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.

NCT ID: NCT04185818 Active, not recruiting - Sleep Clinical Trials

Citizen Science: The People's Trial: A Randomised Controlled Trial

Start date: December 4, 2019
Phase: N/A
Study type: Interventional

The People's trial is an online pragmatic, randomised controlled trial to determine if reading a book in bed makes a difference to sleep in comparison to not reading a book in bed.

NCT ID: NCT04182204 Active, not recruiting - Clinical trials for Diffuse Large B-Cell Lymphoma

A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

POLARGO
Start date: February 7, 2020
Phase: Phase 3
Study type: Interventional

This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).

NCT ID: NCT04181879 Active, not recruiting - Polypharmacy Clinical Trials

Appropriate Polypharmacy in Older People in Primary Care

PolyPrime
Start date: September 1, 2019
Phase: N/A
Study type: Interventional

In the past, prescribing many medicines (polypharmacy) was seen in a negative light. However, because people are living longer and have several medical conditions at the same time, views on polypharmacy have changed. The challenge is to have the correct balance between enough medicines and too many medicines. Members of the research team have developed a new approach to achieving this balance. This approach has been tested in two general practices in Northern Ireland (NI). The approach (intervention package) currently consists of two parts: (1) a video showing how general practitioners (GPs) can prescribe appropriate polypharmacy for older patients, and (2) an appointment system for patients to visit a GP to have their medicines reviewed. As the intervention package was developed and tested in NI, further testing needs to be carried out in NI and the six border counties of the Republic of Ireland (ROI; Cavan, Donegal, Leitrim, Louth, Monaghan, and Sligo). This will be done in three stages or phases. In phase 1, which is now complete, 13 GPs were interviewed across 12 practices in the six border counties in the ROI; shown the video, asked about this new approach and asked if any changes are needed before doing more testing. In the next two phases (Phase 2 & 3) a small study will be carried out involving 12 practices: six practices in NI and six practices in the six border counties in the ROI and approximately 10 patients per practice. GP practices will either receive the intervention package and conduct medication reviews with recruited patients (intervention group) or continue to treat recruited patients as usual (control group). Interviews with up to 10 GPs and six members of practice staff (i.e. those involved in implementing the intervention within each practice) respectively in the six intervention group practices will also be conducted at the end of the intervention. Patients from the six intervention group practices will be asked to complete a feedback questionnaire after the delivery of the intervention (i.e. after completion of their final follow-up questionnaires).