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NCT ID: NCT03661320 Active, not recruiting - Clinical trials for Urinary Bladder Neoplasms

A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer

Start date: November 6, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare nivolumab plus neoadjuvant gemcitabine/cisplatin (GC) chemotherapy, followed by post-surgery continuation of immuno-oncology (IO) therapy, with neoadjuvant GC chemotherapy alone in adult participants with previously untreated muscle-invasive bladder cancer (MIBC).

NCT ID: NCT03659916 Active, not recruiting - Clinical trials for Progressive Familial Intrahepatic Cholestasis

Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC

Start date: September 28, 2018
Phase: Phase 3
Study type: Interventional

Open Label Extension Study to evaluate long term safety and persistence of effect of A4250 in children with PFIC.

NCT ID: NCT03657342 Active, not recruiting - Clinical trials for Bronchiolitis Obliterans

Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)

BOSTON-1
Start date: April 2, 2019
Phase: Phase 3
Study type: Interventional

The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in single lung transplant recipients.

NCT ID: NCT03657303 Active, not recruiting - Osteoarthritis Clinical Trials

Functional Exercise Response on osteoArthritis Relaxation Imaging

FERARI
Start date: November 21, 2019
Phase:
Study type: Observational

Osteoarthritis (OA) is the most prevalent cause of mobility impairment and disability in the elderly. Indications at early stages of OA include decreased organisation of the collagen matrix, loss of proteoglycans and increased hydration. Late-stage joint disease can be diagnosed with X-ray, CT, and conventional MRI, but there are no validated methods to image early changes in cartilage microstructure, which are direly needed in early phase clinical development. Newly developed therapies and evaluation techniques are required at earlier stages of disease to offset the growing numbers and costs of end-stage disease. MRI can probe soft-tissue with physical measurements that are not available through other methods. Quantitative MRI signal relaxation properties are particularly promising for assessing early changes in the cartilage composition. These relaxation properties are sensitive to water content and cartilage macromolecular structure. Mechanical joint-loading and exercise affects quantitative MRI through cartilage compression and nonuniform deformation. A study measuring MRI relaxation times and using static joint-loading weights has shown differences between OA and healthy subjects. Cartilage volume, which is expected to be related to these relaxation times, recovers within an hour after exercise in healthy runners, with the menisci lagging in their volume recovery rate. Previous exercise studies have not measured post-exercise cartilage recovery using compositional techniques, such as physiologically-sensitive T1ρ and T2, nor probed compositional responses with OA subjects. The investigators will examine a single knee of an initial 18 participants with MR. Participants will be drawn from two groups: (1) 12 participants aged 40-60 years old with clinical and x-ray features of OA and (2) 6 control subjects (matched to cases for age, sex and body mass index in a 1:2 ratio) who do not have clinical features of OA. Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination. This will allow the investigators to explore the possibility of mechanical joint-loading and exercise to differentiate early stage OA from healthy subjects and assess both the reliability of the MR measurements and the expected progression in the MR measurements in OA subjects in the absence of any disease-modifying intervention.

NCT ID: NCT03656926 Active, not recruiting - Clinical trials for Bronchiolitis Obliterans

Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-2)

BOSTON-2
Start date: March 29, 2019
Phase: Phase 3
Study type: Interventional

The objective of the trial is to assess efficacy and safety of add-on aerosolized liposomal cyclosporine A (L-CsA) to Standard of Care (SoC) therapy as compared to SoC therapy alone in the treatment of Bronchiolitis obliterans syndrome (BOS) in double lung transplant recipients.

NCT ID: NCT03656718 Active, not recruiting - Neoplasms by Site Clinical Trials

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Start date: October 31, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate the effects of nivolumab when given under the skin with or without rHuPH20. This study will include participants with 1 of the following advanced or metastatic tumors approved for treatment with nivolumab monotherapy: - non-small cell lung cancer (NSCLC) - renal cell carcinoma (RCC) - unresectable or metastatic melanoma - hepatocellular carcinoma (HCC) - microsatellite instability-high or mismatch repair deficient colorectal cancer (MSI-H/dMMR CRC) - in Part B, other solid tumors may be considered at the discretion of the Clinical Trial Physician - In addition to the above tumors, Part E will also include participants with metastatic urothelial carcinoma (mUC).

NCT ID: NCT03655678 Active, not recruiting - Clinical trials for Hematologic Diseases

A Safety and Efficacy Study Evaluating CTX001 in Subjects With Transfusion-Dependent β-Thalassemia

Start date: September 14, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

This is a single-arm, open-label, multi-site, single-dose Phase 1/2/3 study in subjects with transfusion-dependent β-thalassemia (TDT). The study will evaluate the safety and efficacy of autologous CRISPR-Cas9 Modified CD34+ Human Hematopoietic Stem and Progenitor Cells (hHSPCs) using CTX001.

NCT ID: NCT03654833 Active, not recruiting - Clinical trials for Mesothelioma, Malignant

Mesothelioma Stratified Therapy (MiST) : A Multi-drug Phase II Trial in Malignant Mesothelioma

MiST
Start date: January 28, 2019
Phase: Phase 2
Study type: Interventional

MiST is a British Lung Foundation funded, University of Leicester Study, a multi-arm stratified therapy based clinical trial for patients with relapsed mesothelioma. The goal of MiST is to enable acceleration of novel, effective personalised therapy as a basis for improving survival outcomes for patients with mesothelioma.

NCT ID: NCT03653507 Active, not recruiting - Clinical trials for Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma

A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

GLOW
Start date: November 28, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of zolbetuximab plus capecitabine and oxaliplatin (CAPOX) compared with placebo plus CAPOX (as first-line treatment) as measured by Progression Free Survival (PFS). This study will also evaluate efficacy, physical function, safety, and tolerability of zolbetuximab, as well as its effects on quality of life. Pharmacokinetics (PK) of zolbetuximab and the immunogenicity profile of zolbetuximab will be evaluated as well.

NCT ID: NCT03653052 Active, not recruiting - Oesophageal Cancer Clinical Trials

Do Changes in ctDNA Predict Response for Patients With Oesophageal Cancer Receiving Durvalumab

CALIBRATION
Start date: October 30, 2018
Phase: Phase 2
Study type: Interventional

Patients with cancer are increasingly being treated with drugs designed to modulate the response of their immune system, broadly to boost their body's defences against cancer. However, there is an unmet need to identify which patients are unlikely to benefit. Deciding on benefit from therapy uses standard imaging methods (e.g. CT scans), which can take time (months) whereas DNA in the bloodstream could be measured more rapidly. The main aim of this study is to assess whether changes in the level of circulating tumour DNA (ctDNA) can quickly determine a patients response. This would enable patients to change therapies more quickly if they are not responding and reduce exposure to unnecessary side effects.