Clinical Trials Logo

Filter by:
NCT ID: NCT04273854 Active, not recruiting - Pre-Eclampsia Clinical Trials

Physician Optimised Post-partum Hypertension Treatment Trial

POP-HT
Start date: February 21, 2020
Phase: N/A
Study type: Interventional

It has been shown in a pilot randomised controlled study [SNAP-HT [4]; REC 14/SC/1316] that blood pressure self-management during the post-partum period after hypertensive pregnancies, results in lower blood pressure after six months; even when medication has been stopped. The team now want to assess whether this blood pressure reduction can be reproduced in a larger, randomised, study (data analysis blinded) and whether the blood pressure lowering has additional benefits in terms of other cardiovascular and cerebrovascular changes known to occur in women who have had a hypertensive pregnancy. The investigators therefore plan to run a trial of self-management in the post-partum period, using updated Blue-tooth® enabled blood pressure monitoring coupled to physician-assisted dose titration to further advance the self-management aspect of the intervention. The physicians will be specialist clinicians who form part of the research team. The investigators will measure additional structural and functional end organ differences, using magnetic resonance imaging of the brain and heart as well as echocardiography and retinal imaging. This will provide insight into the impact of post-partum blood pressure control on the maternal cardiovascular system and how this associates with blood pressure changes. Together, these studies will help refine future intervention strategies in this cohort of patients.

NCT ID: NCT04273425 Active, not recruiting - Multiple Myeloma Clinical Trials

Bone Pain in Multiple Myeloma- a Translational Study

BPMM
Start date: October 23, 2019
Phase:
Study type: Observational

While the survival expectancy of myeloma patients continues increasing due to the discovery of novel treatments, bone pain remains one of the main symptoms of this patient population, impairing their mood and quality of life. The aim of this study is to characterize the subjective experience of pain in myeloma patients, and its correlation with disturbances in serum biomarkers and bone innervation. Primary research questions: How is the bone pain experienced by myeloma patients (intensity, location and type of pain) and how does it affect their quality of life? Do myeloma cells induce changes in the density and/or location of nerve fibres innervating the bone, and if so, are these correlated to the pain experience? Secondary research questions: Are the alterations in the bone innervation of myeloma patients similar to those of immunocompetent animal models of the disease (the 5TGM1 model)? Is serum paraprotein correlated with the subjective experience of myeloma-induced bone pain? Are the bone turnover biomarkers (C-terminal telopeptides Type 1 collagen, CTX, and procollagen type 1 N-terminal propeptide, P1NP) and inflammatory serum biomarkers correlated with the subjective experience of myeloma-induced bone pain? Do myeloma cells affect the location, number or density of bone cells (e.g. osteoblasts, osteoclasts)?

NCT ID: NCT04273113 Active, not recruiting - Clinical trials for Emotional Dysfunction

Does Heart Rate Variance (HRV) Biofeedback Help Regulate Emotions and Improve Mindfulness in Mentally Unwell Offenders?

Start date: October 11, 2017
Phase: N/A
Study type: Interventional

14 participants residing in a forensic psychiatric hospital completed 15 Heart Rate Variance (HRV) biofeedback sessions. They completed 4 psychometric questionnaires, pre, during and post biofeedback training.

NCT ID: NCT04272931 Active, not recruiting - Clinical trials for Colorectal Cancer Liver Metastases

DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

DRAGON
Start date: May 8, 2020
Phase: N/A
Study type: Interventional

Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2).

NCT ID: NCT04272892 Active, not recruiting - Stroke Clinical Trials

Improving Sleep in Rehabilitation After Stroke

INSPIRES
Start date: February 14, 2020
Phase: N/A
Study type: Interventional

This study evaluates the efficacy of digital cognitive behavioural therapy for insomnia (Sleepio) in chronic stroke survivors. Half of the participants will receive access to the digital (online) programme, half will receive a leaflet with sleep hygiene information. The primary outcome will be changes in sleep quality, assessed as the score on the Sleep Condition Indicator.

NCT ID: NCT04272073 Active, not recruiting - Clinical trials for Cardiovascular Diseases

A High-PRotein Mediterranean Diet and Resistance Exercise for Cardiac Rehabilitation

PRiMER
Start date: May 9, 2022
Phase: N/A
Study type: Interventional

Cardiovascular disease is responsible for a quarter of all deaths in the UK and risk seems to be higher in cardiac rehabilitation (CR) with lower body weight which may be due to sarcopenci obesity (SO) or low muscle mass with high fat mass. The investigators aim to investigate the effect of a high protein Mediterranean diet and resistance exercise on improving lean mass and reducing risk markers of cardiovascular disease

NCT ID: NCT04272034 Active, not recruiting - Cervical Cancer Clinical Trials

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099318 in Participants With Advanced Solid Tumors

Start date: March 26, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of INCB099318 in select solid tumors.

NCT ID: NCT04270409 Active, not recruiting - Plasma Cell Myeloma Clinical Trials

A Phase 3 Randomized, Open-label, Multicenter Study of Isatuximab (SAR650984) in Combination With Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients With High-risk Smoldering Multiple Myeloma

Start date: June 16, 2020
Phase: Phase 3
Study type: Interventional

Primary Objectives: - Safety run-in: To confirm the recommended dose of isatuximab when combined with lenalidomide and dexamethasone in participants with high-risk smoldering multiple myeloma (SMM) - Randomized Phase 3: To demonstrate the clinical benefit of isatuximab in combination with lenalidomide and dexamethasone in the prolongation of progression-free survival when compared to lenalidomide and dexamethasone in subjects with high-risk SMM Secondary Objectives: Safety run-in - To assess overall response rate (ORR) - To assess duration of response (DOR) - To assess minimal residual disease (MRD) negativity in participants achieving very good partial response (VGPR) or complete response (CR) - To assess time to diagnostic (SLiM CRAB) progression or death - To assess time to first-line treatment for multiple myeloma (MM) - To assess the potential immunogenicity of isatuximab - Impact of abnormal cytogenetic subtype on participant outcome Randomized Phase 3 - Key Secondary Objectives: To compare between the arms - MRD negativity - Sustained MRD negativity - Second progression-free survival (PFS2) - Overall survival Other Secondary Objectives: To evaluate in both arms - CR rate - ORR - DOR - Time to diagnostic (SLiM CRAB) progression - Time to biochemical progression - Time to first-line treatment for MM - Safety and tolerability - Pharmacokinetics (PK) - Potential of isatuximab immunogenicity - Clinical outcome assessments (COAs)

NCT ID: NCT04269304 Active, not recruiting - Clinical trials for Age-related Macular Degeneration

Deciphering AMD by Deep Phenotyping and Machine Learning- Prospective Study - PINNACLE

PINNACLE
Start date: October 28, 2019
Phase:
Study type: Observational

We will conduct a prospective non-interventional study including 400 early AMD patients (=600 untreated early AMD eyes, including both unilateral (AREDS IV) and bilateral (≥AREDS II)) over a minimum of 1 year to specifically investigate the morphological sequence of events preceding the conversion towards late AMD. All patients will be followed by Optical Coherence Tomography (OCT) imaging every 4 months to detect the earliest focal sites of disease progression. As soon as focal areas of change are observed by the Vienna Reading Center (VRC), a targeted follow-up schedule will be triggered to investigate the events at that area of change in a targeted manner.

NCT ID: NCT04266301 Active, not recruiting - Clinical trials for Myelodysplastic Syndromes

Study of Efficacy and Safety of MBG453 in Combination With Azacitidine in Subjects With Intermediate, High or Very High Risk Myelodysplastic Syndrome (MDS) as Per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2)

STIMULUS-MDS2
Start date: April 14, 2013
Phase: Phase 3
Study type: Interventional

This is a Phase III multi-center, randomized, two-arm parallel-group, double-blind, placebo-controlled study of MBG453 or placebo added to azacitidine in adult subjects with intermediate, high or very high-risk myelodysplastic syndrome (MDS) as per IPSS-R, or Chronic Myelomonocytic Leukemia-2 (CMML-2) who are not eligible for intensive chemotherapy or hematopoietic stem cell transplantation (HSCT) according to medical judgment by the investigator. The purpose of the current study is to assess clinical effects of MBG453 in combination with azacitidine in adult subjects with IPSS-R intermediate, high, very high risk MDS and CMML-2.