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NCT ID: NCT03858062 Completed - Clinical trials for Diabetes Mellitus, Type 1

Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,

APPEL5
Start date: March 10, 2019
Phase: N/A
Study type: Interventional

In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.

NCT ID: NCT03857789 Completed - Clinical trials for Frailty at Older Adults

Social Robot Support for Healthcare Professionals

Start date: April 30, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of integrated care pathway steps supported by social robots. Half of the participants will receive regular care, while for the other half a social robot dialogue will be included as part of the pathway step.

NCT ID: NCT03857503 Completed - Clinical trials for Coronary Artery Disease

Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

ReVEAL
Start date: August 1, 2019
Phase:
Study type: Observational

The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.

NCT ID: NCT03856827 Completed - Other Clinical Trials

A Study of IW-6463 in Healthy Volunteers

Start date: February 6, 2019
Phase: Phase 1
Study type: Interventional

Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)

NCT ID: NCT03853187 Completed - Clinical trials for Non-small Cell Lung Cancer

Imaging Tumor-infiltrating T-cells in Non-small Cell Lung Cancer

Donan
Start date: September 19, 2019
Phase: Phase 2
Study type: Interventional

This is an interventional study, to assess feasibility and safety of durvalumab (MEDI4736) in neo-adjuvant setting in patients with resectable NSCLC. Additional analyses of potential imaging biomarkers, e.g. Zr-89 labelled durvalumab (MEDI4736), ex vivo In-111-oxine labelled CD8+ T-cells and high-resolution immune cell imaging, in relation to immunotherapy induced immune responses on quantitative immune histochemical analysis of the resected tumor specimen, will be performed.

NCT ID: NCT03852498 Completed - Clinical trials for Cerebral Adrenoleukodystrophy (CALD)

A Clinical Study to Assess the Efficacy and Safety of Gene Therapy for the Treatment of Cerebral Adrenoleukodystrophy (CALD)

Start date: January 24, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Lenti-D Drug Product (also known as elivaldogene autotemcel or Skysona, hereafter referred to as eli-cel) after myeloablative conditioning with busulfan and fludarabine in participants with CALD. A participant's blood stem cells will be collected and modified (transduced) using the Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein. After modification (transduction) with the Lenti-D lentiviral vector, the cells will be transplanted back into the participant following myeloablative conditioning. Enrollment and treatment in Study ALD-104 have been completed and further enrollment in this study is not expected, although participants follow-up remains ongoing in the long-term follow-up Study LTF-304 (NCT02698579).

NCT ID: NCT03849989 Completed - Clinical trials for Hailey Hailey Disease

M. Hailey-Hailey: hSPCA1 Expression and Skin Structure Upon Laser Therapy

Start date: December 21, 2018
Phase: N/A
Study type: Interventional

Hailey-Hailey disease is a genetic acantholytic dermatosis characterized by continuous erosion of the skin that results in a burning, painful sensation and restricts the patient in daily life. This disorder results from a genetic defect in a calcium pump, i.e. the hSPCA1 pump. Calcium pumps are crucial for the processing of cell-cell adhesion proteins such as E-cadherin, part of desmosomes, the major glue between keratinocytes in skin epidermis. Today therapy is mainly focussed on symptom relief and prevention of secondary infection. Ablative laser therapy is known to result in a speedy healing of the affected skin site within 2 weeks following laser therapy. The fact that the treated skin site remains clear from this acantholytic disorder in the months/years following ablation, regardless the existence of a germline mutation, suggests that an epigenetic modification occurs in the process of wound healing. Objective: to (1) study the expression of hSPCA1 in keratinocytes before and after laser therapy and (2) verify the loss of acantholysis by immunohistochemistry and electron microscopy of cell-cell adhesions before and after laser therapy

NCT ID: NCT03849872 Completed - Acromegaly Clinical Trials

Single-dose Study to Evaluate the Absolute Bioavailability and Mass Balance of ONO-5788

ONO-5788-02
Start date: February 27, 2019
Phase: Phase 1
Study type: Interventional

A phase 1 healthy volunteer study to assess the excretion and metabolism as well as the absolute bioavailability of oral ONO-5788. The study will be conducted in two parts: Part 1 to assess the absolute bioavailability using ONO-5788 and radiolabelled ONO-5788 as intravenous and oral forms; part 2 will assess the mass balance of ONO-5788 using orally administered radiolabelled ONO-5788

NCT ID: NCT03849118 Completed - Clinical trials for Clear Cell Renal Cell Carcinoma

89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study

89ZR-TLX250
Start date: August 15, 2019
Phase: Phase 3
Study type: Interventional

89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.

NCT ID: NCT03849105 Completed - Clinical trials for Glioblastoma Multiforme

131I-IPA and Concurrent XRT in Recurrent GBM

IPAX-1
Start date: April 9, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

A multi-centre, open-label, single-arm, dose-finding phase I/II study to evaluate safety, tolerability, dosing schedule, and preliminary efficacy of carrier-added 4-L-[131I]iodo-phenylalanine (131I-IPA), administered as single or repetitive injections in patients with recurrent glioblastoma multiforme (GBM), concomitantly to 2nd line external radiation therapy (XRT) - IPAX-1