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NCT ID: NCT05279456 Active, not recruiting - COVID-19 Clinical Trials

A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen)

Start date: August 15, 2022
Phase: Phase 3
Study type: Interventional

This study will determine the immunogenicity of Spikogen in vaccine naïve individuals. Spikogen will be administered as two doses 1 month apart with a third booster dose either 1 or 3 months after the second dose. This study will provide key data on SARS-CoV-2 antibody responses.

NCT ID: NCT05277805 Active, not recruiting - Cancer Clinical Trials

The Development and Validation of EMPOWER-UP: a Generic Questionnaire for Measuring Empowerment in Patient-provider Relationships

Start date: January 1, 2020
Phase:
Study type: Observational

Empowerment is widely acknowledged as an important approach in long-term care. The concept relates to the individual's ability to manage their own life and make rational decisions. Despite good intentions of working empowerment-based, research has shown that it can be difficult to realize and achieve in everyday practice within the healthcare system. To this date, no measurement instrument (questionnaire) exists that evaluate people's perceptions of whether their relationship with a healthcare provider promotes their empowerment process. The EMPOWER-UP questionnaire was therefore developed to provide such a measure. The EMPOWER-UP study aims to finalize the development process of the questionnaire and to test whether it is a valid and reliable measure. People at the age of 18 years or above can participate if they have ever been diagnosed with a type of cancer, diabetes, or a mental illness and because of that diagnosis have been in contact with the healthcare system within the past six months. The study is conducted online and requires participants to fill out an online questionnaire on a single occasion. Participation is expected to take no more than 10-15 minutes. By participating, people may experience an increased awareness as to the nature of their interactions with healthcare providers. For some, this awareness may be beneficial and may alone enable them to ask for better care, while others may experience it as a burden if they are not able to seek better care. By participating, people are helping to ensure that EMPOWER-UP will be a good questionnaire that may help raise awareness of the quality of relationships within the healthcare system and in term lead to better care. The study is led by a team of researchers at the Danish University Hospital Rigshospitalet and the University of Copenhagen, Denmark. The UK lead of the study is located at King's College London, UK. The Australian lead of the study is located at Deakin University, Melbourne, Australia. This study is financially supported by the Novo Nordisk Foundation's Steno Collaborative Grant and by the Trygfonden foundation (Denmark)

NCT ID: NCT05270044 Active, not recruiting - Melanoma Clinical Trials

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

COLUMBUS-AD
Start date: May 2, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

NCT ID: NCT05269355 Active, not recruiting - Leiomyosarcoma Clinical Trials

A Study of Unesbulin in Participants With Advanced Leiomyosarcoma (LMS)

SUNRISELMS
Start date: May 23, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This study will compare the efficacy and safety of unesbulin plus dacarbazine versus placebo plus dacarbazine in participants with unresectable or metastatic, relapsed or refractory LMS who have received at least 1 prior line of systemic therapy.

NCT ID: NCT05269004 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

OLERO
Start date: May 3, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

NCT ID: NCT05267600 Active, not recruiting - Bullous Pemphigoid Clinical Trials

A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid (BALLAD)

Start date: June 9, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

ARGX-113-2009 is an operationally seamless 2-part, phase 2/3, prospective, global, multicenter, randomized, double-blinded, placebo-controlled study to investigate the efficacy, safety, tolerability, immunogenicity, participant-reported outcome measures (including those assessing participant QoL), PK, and PD of efgartigimod PH20 SC administered via subcutaneous (SC) injection in adult participants with moderate to severe BP. This study intends to demonstrate that efgartigimod is an effective and safe treatment for BP, providing participants with control of disease activity (CDA) and eventually remission while reducing their cumulative exposure to OCS. study will consist of 2 parts: - Part A of the study is a phase 2 evaluation that intends to provide proof of concept for the therapeutic activity of efgartigimod PH20 SC in participants with BP. - Part B of the study is a phase 3 evaluation that intends to confirm the results obtained from part A in a separate, larger group of participants with BP. An interim analysis will be performed during part A (on data obtained through week 26 for all Part A participants) to assess the primary endpoint and several secondary endpoints, confirm the appropriate sample size for part B of the study, and determine whether the efficacy results observed through week 26 of part A warrant continued study of efgartigimod PH20 SC for the treatment of participants with BP (futility analysis). Other than differences in main goals, endpoints, and statistical analyses, parts A and B are identical in schedule, structure, assessments, and conduct.

NCT ID: NCT05266105 Active, not recruiting - Breast Cancer Clinical Trials

A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

Start date: December 10, 2021
Phase: Phase 1
Study type: Interventional

This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).

NCT ID: NCT05260021 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Study to Evaluate Tirzepatide (LY3298176) in Pediatric and Adolescent Participants With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin or Basal Insulin or Both

SURPASS-PEDS
Start date: April 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn more about the safety and efficacy of tirzepatide compared to placebo in children or teenagers with type 2 diabetes taking metformin, or basal insulin, or both. The overall study will last about 60 weeks with up to 14 clinic visits and 6 phone visits. Clinic visits will include blood sample collection, physical exam and questionnaire.

NCT ID: NCT05260008 Active, not recruiting - Clinical trials for Acute Postoperative Pain

Study Assessing Pain Relief After Replacement of the Knee

SPARK
Start date: June 7, 2022
Phase: Phase 2
Study type: Interventional

This is a Phase 2B randomized, double blind, active controlled, multi-center clinical trial to evaluate the safety and efficacy of ATX-101 in participants following total knee arthroplasty. The following is short title and acronym for the study: Study Assessing Pain Relief after Replacement of the Knee (SPARK)

NCT ID: NCT05257408 Active, not recruiting - Clinical trials for Peritoneal Neoplasms

Relacorilant in Combination With Nab-Paclitaxel in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer

Start date: June 29, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate progression-free survival (PFS) by blinded independent central review (BICR) in patients treated with intermittent regimen of relacorilant in combination with nab-paclitaxel compared with patients treated with nab-paclitaxel monotherapy.