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NCT ID: NCT03944876 Recruiting - Cluster Headache Clinical Trials

Botulinum Toxin Type A Blockade of the Sphenopalatine Ganglion in Treatment-refractory Chronic Cluster Headache

BASIC
Start date: November 1, 2019
Phase: Phase 3
Study type: Interventional

Cluster headache is a primary headache condition characterized by clusters of one-sided, high-intensity pain attacks. The headache may be episodic or chronic. Treatment options are limited and their effects unsatisfactory. An important nerve pathway involved in the pain attacks has a switching station at the sphenopalatine ganglion (SPG) located in the depth of the facial bones. SPG is a known therapy target for cluster headache. The area can be identified on CT images, but is difficult to access due to its location. Thus, the Multiguide navigation system has been developed to enable precise delivery of the drugs that target SPG activity. In Trondheim, two phase 1 / Phase 2 study have been carried out using botulinum toxin A (Botox®) against SPG in patient with chronic cluster headache and chronic migraine. The results indicate that such a treatment strategy is safe and beneficial. The current study is a randomized, placebo-controlled, triple-blinded study to investigate whether precise single-injection of botulinum toxin A reduces the frequency of attacks in chronic cluster headache .

NCT ID: NCT03940092 Recruiting - Breast Cancer Clinical Trials

Sodium (23Na) MRI for Tumour Characterisation and Assessment of Therapy Response in Breast Cancer

NaRNIA
Start date: August 13, 2020
Phase:
Study type: Observational

The scope of this study is the methodological development and optimisation of sodium MRI (23Na-MRI) protocols for breast cancer imaging. The study further proposes to utilise biomarkers obtained from 23Na-imaging (cell integrity), FDG-PET (metabolism), multi-parametric MRI (perfusion, vascularity, cellularity, morphology) to generate parameter maps specific for physiological processes in breast cancer.

NCT ID: NCT03938428 Recruiting - Accidental Fall Clinical Trials

The Patient Experience of a Paramedic-Pharmacist Referral Pathway for Clinical Medication Reviews

PEPPR
Start date: July 24, 2019
Phase:
Study type: Observational

This study seeks to understand how patients feel about their medicines before and after receiving a clinical medication review.

NCT ID: NCT03937947 Recruiting - Clinical trials for Traumatic Brain Injury

Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study

TARDIS
Start date: September 28, 2019
Phase:
Study type: Observational

Whilst deep vein thrombosis (DVT) is common following traumatic brain injury (TBI), optimal timing and safety of pharmacological prophylaxis is uncertain. Paradoxically the harm associated with the occurrence of is also unclear. This study is an observational pilot that aims to define the incidence of proximal DVT in patients with moderate to severe TBI. It seeks prospectively to determine if there is an association between DVT and outcome. It also seeks to explore possible associations between the occurrence of DVT and the incidence of lung injury and/or ventilator associated pneumonia.

NCT ID: NCT03936634 Recruiting - Clinical trials for Type 1 Diabetes Mellitus

An Innovative Approach Towards Understanding and Arresting Type 1 Diabetes (INNODIA)

INNODIA
Start date: November 14, 2016
Phase:
Study type: Observational [Patient Registry]

INNODIA is a global consortium linking 26 academic institutions, 4 industrial partners, a small to medium enterprise (SME), and 2 patient organisations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu). The project, approved in November 2015 and launched in January 2016, runs under the framework of the Innovative Medicines Initiative - Joint Undertaking (https://www.imi.europa.eu/projects-results/project-factsheets/innodia) with a dedicated governance structure ensuring close interaction, communication and adherence to the objectives and deliverables of the consortium. The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe, with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families. One of the objectives of INNODIA is to develop a new European clinical research network with standardized protocol based on repeated measures of C-peptide (including home measurements) and comprehensive collection of appropriate biological samples for 'omics', immune, viral and microbiome studies in new onset T1D patients and high-risk auto-antibody positive subjects. A protocol for the harmonization of sample collections in newly diagnosed type 1 diabetic patients and first degree relatives of patients with type 1 diabetes was developed following extensive preliminary work involving partners from across all specialities. Core laboratories with experience in their respective field were set up for analysis of auto-antibodies, fresh immune cells, handling of frozen immune cells, C-peptide measures. A series of standard operating procedures for sample collections and analysis were agreed. Sample tracking between clinical centres and central laboratories was included into a purposely designed electronic case report form (eCRF) into which all clinical and laboratory data collected are captured.

NCT ID: NCT03935750 Recruiting - Clinical trials for Anterior Cruciate Ligament Reconstruction

STABILITY 2: Anterior Cruciate Ligament Reconstruction +/- Lateral Tenodesis With Patellar vs Quad Tendon

STABILITY 2
Start date: July 28, 2020
Phase: N/A
Study type: Interventional

Anterior cruciate ligament (ACL) rupture is one of the most common musculoskeletal injuries in young individuals, particularly those that are active in sports. Up to 30% of individuals under the age of 20 years suffer a re-injury to the reconstructed ACL. Revision ACLR has been associated with degeneration of the articular cartilage and increased rates of meniscal tears, increasing the risk of post-traumatic osteoarthritis (PTOA), additional surgical procedures, reduced physical function and quality of life. As such, strategies to reduce ACLR failure, particularly in young active individuals, are critical to improving short and long-term outcomes after ACL rupture. There is ongoing debate about the optimal graft choice and reconstructive technique. Three autograft options are commonly used, including the bone-patellar-tendon-bone (BPTB), quadriceps tendon (QT) and hamstring tendon (HT). Additionally, a lateral extra-articular tenodesis (LET) may provide greater stability to the ACLR; however, its effect on failure rate is unclear and surgery-induced lateral compartment OA is a concern. To definitively inform the choice of autograft and the need for a LET, this multicenter, international randomized clinical trial will randomly assign 1236 young, active patients at high risk of re-injury to undergo ACLR using BPTB or QT autograft with our without LET.

NCT ID: NCT03935477 Recruiting - Surgery Clinical Trials

Surrogate of Adequate Perfusion: Bladder Tissue Oxygen Monitoring

SoAP-BOx
Start date: April 10, 2019
Phase:
Study type: Observational

The extent and duration of tissue hypoxia is a major determinant of outcome following major, high-risk surgery and in critical illness. Prompt restoration of tissue oxygenation through resuscitation in all likelihood improves outcomes. There are currently no bedside monitors in clinical practice that track tissue perfusion per se, instead clinicians rely on crude surrogates such as heart rate and blood pressure, urine output, serum lactate of global flow (cardiac output) monitoring. This is a first-in-man trial of a new device to measure tissue oxygenation in real time in a major, high-risk surgical and critical care cohort. The device consists of an oxygen sensing probe incorporated into a modified urinary catheter, which relies on photoluminescence technology and the quenching properties of oxygen. Once inserted, the drained bladder collapses round and envelopes the probe which continuously measures tissue oxygenation of the bladder urothelium. The investigators hope to (i) Establish that tissue oxygenation can be safely monitored using this technology, deployed in this way. (ii) Define a normal range for bladder tissue oxygenation in man as measured using this device. (iii) Compare tissue oxygenation against other markers of perfusion status in current clinical practice and assess its performance at detecting inadequate perfusion against these other modalities. (iv) assess the diagnostic and prognostic capabilities of the tissue oxygenation monitoring at detecting hypo-perfusion and predicting outcome. (v) Further assess the tissue response to an 'oxygen challenge' in identifying occult hypo-perfusion. (vi). Provide pilot work required to inform future, interventional studies where similar patients would be resuscitated to tissue oxygenation targets alongside routine clinical practice.

NCT ID: NCT03935035 Recruiting - Clinical trials for Post Traumatic Stress Disorder

Online PTSD Treatment for Young People and Carers - Case Series

OPTYC
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

Post Traumatic Stress Disorder (PTSD) is prevalent and impairing in children and young people. Effective face to face treatments exist, including Cognitive Therapy for PTSD (CT-PTSD), developed by the researchers' group. However, few young people access effective treatments. The researchers are therefore developing a website and smart-phone App that will improve accessibility of this treatment by allowing trained therapists to deliver CT-PTSD over the internet (iCT) to young people (12-17 years old) with PTSD. This study aims to provide an initial evaluation of iCT. This will be done by running an uncontrolled case series with 6 young people. The objectives of the case series are to: to gauge acceptability of the programme to young people, carers, and therapists; to measure adherence to the programme; to test the battery of measures for acceptability; and to obtain estimates of clinical change.

NCT ID: NCT03934372 Recruiting - Lymphoma Clinical Trials

Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors

Start date: January 29, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors.

NCT ID: NCT03934164 Recruiting - Clinical trials for Metastatic Prostate Cancer

Molecular Stratification Profiling Protocol in Metastatic Castration Resistant Prostate Cancer (mCRPC) - MAESTRO

MAESTRO
Start date: November 28, 2019
Phase:
Study type: Observational

This study is a prospective, observational, molecular stratification profiling study. Patients with mCRPC who have received at least one standard treatment for mCRPC will be approached to participate in MAESTRO. Patients must have archival tumour available and be willing to undergo a fresh tumour biopsy for molecular analyses. Tumour tissue (archival and fresh), research blood samples and saliva will be sent to the central laboratory for analysis to identify molecular aberrations through targeted or broader molecular analyses (e.g. exome, transcriptome) and orthogonal assays (e.g. immunohistochemistry; digital droplet PCR). When the results are available, depending on patients choice, the results will be discussed. If significant results are indicated, patients will be recommended to have follow up with a cancer geneticist to discuss the implications of these results for their personal and family's health. There is a safety follow up 30 days after collection of study biopsy or blood samples. Patients will also be followed up for overall survival and subsequent anticancer treatment every 6 monthly via medical notes or telephone calls.