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NCT ID: NCT04959253 Recruiting - Clinical trials for Treatment Resistant Depression

Psilocybin in Depression Resistant to Standard Treatments

PsiDeR
Start date: September 1, 2020
Phase: Phase 2
Study type: Interventional

A single centre clinical trial to evaluate the feasibility, safety and efficacy of psilocybin, given under supportive conditions, in a randomised, blinded design in adult participants with treatment resistant major depressive disorder. The primary objective is to evaluate feasibility by measuring recruitment rates, dropout rates and by estimating the variance of the primary outcome measure (MADRS).

NCT ID: NCT04957433 Recruiting - Cancer Clinical Trials

'Lung Health Check' Biomarker Study

Start date: September 28, 2020
Phase:
Study type: Observational

CT screening of lung cancer offers an opportunity to diagnose early stage lung cancers which is associated with better prognosis - indeterminate results delay diagnosis whilst interval imaging is awaited to assess risk of cancer. This study will allow us to examine the potential of blood-based biomarkers to augment CT screening for lung cancer. Hypotheses 1. Blood and sputum samples can be collected in patients attending lung health checks as part of the Lung Health Check pilot in West London at fixed and mobile scanners and safely transported for processing and storage in preparation for biomarker development. 2. The biomarkers will help to identify cohorts of 1. High-risk patients in whom CT surveillance should be conducted more readily/frequently and diagnostic procedures performed earlier. 2. Low-risk patients who might need reduced surveillance intensity. 3. Patients with interstitial lung abnormalities that share similar biomarker characteristics to patients with clinically significant interstitial lung disease

NCT ID: NCT04955899 Recruiting - Clinical trials for Rheumatoid Arthritis

Safety of Splenic Stimulation for RA

Start date: October 20, 2021
Phase: N/A
Study type: Interventional

This study will evaluate the safety and tolerability of stimulating the splenic neurovascular bundle (NVB) with the Galvani System, which consists of a lead, implantable pulse generator, external components and accessories. Participants eligible for implant will have active rheumatoid arthritis (RA) and have an inadequate response or intolerance to at least two biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) or JAK inhibitors (JAKis). Five participants will be implanted with the device and receive neurostimulation for 12 weeks.

NCT ID: NCT04954937 Recruiting - Healthy Clinical Trials

Convalescent Plasma Donor Vaccine Study An Observational Antibody Level Study.

C-VELVET
Start date: April 20, 2021
Phase:
Study type: Observational

There is a need to understand antibody responses following SARS-COV-2 infection and subsequent vaccination.

NCT ID: NCT04954859 Recruiting - Hepatitis B Clinical Trials

Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

Start date: November 25, 2021
Phase: Phase 2
Study type: Interventional

This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.

NCT ID: NCT04951778 Recruiting - Clinical trials for Myelodysplastic Syndromes

Study to Evaluate Safety and Tolerability of CC-91633 (BMS-986397) in Participants With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

Start date: December 2, 2021
Phase: Phase 1
Study type: Interventional

Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 dose (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 40 participants may be enrolled in Part A of the study. The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Separate expansion cohorts for participants with R/R AML and R/R HR-MDS may enroll approximately 20 to 40 response evaluable participants per cohort. Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

NCT ID: NCT04950764 Recruiting - Hepatic Impairment Clinical Trials

An Open-Label Study Following Oral Dosing of Seladelpar to Subjects With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

Start date: September 17, 2021
Phase: Phase 1
Study type: Interventional

The Effect of Hepatic Impairment on The Pharmacokinetics of Seladelpar: An Open-Label Study Following Oral Dosing of Seladelpar to Subjects with Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI)

NCT ID: NCT04950530 Recruiting - HIV-1-infection Clinical Trials

The Effect of Biktarvy (B/F/TAF) on Whole-body Insulin Sensitivity, Lipid and Endocrine Profile in Healthy Volunteers

Start date: December 22, 2022
Phase: Phase 1
Study type: Interventional

This study will investigate changes in insulin sensitivity, lipid metabolism and endocrine profile in HIV-negative subjects exposed to Biktarvy (B/F/TAF) compared to subject not exposed to B/F/TAF for 28 days.

NCT ID: NCT04950075 Recruiting - Clinical trials for Conventional Chondrosarcoma

Study of INBRX-109 in Conventional Chondrosarcoma

ChonDRAgon
Start date: September 23, 2021
Phase: Phase 2
Study type: Interventional

Randomized, blinded, placebo-controlled, Phase 2 study of INBRX-109 in unresectable or metastatic conventional chondrosarcoma patients.

NCT ID: NCT04949256 Recruiting - Clinical trials for Metastatic Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)

Start date: July 28, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) and progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).