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NCT ID: NCT03652870 Completed - Depression Clinical Trials

Antidepressants Trial in Parkinson's Disease

ADepT-PD
Start date: March 5, 2021
Phase: Phase 3
Study type: Interventional

This is a randomised trial in a NHS setting, comparing the clinical effectiveness and cost-effectiveness of the selective serotonin reuptake inhibitor, escitalopram, and of the tricyclic antidepressant, nortriptyline, to placebo, undertaken in a real-life setting in addition to standard psychological care for the treatment of patients with depression in Parkinson's disease. Participants will be randomly allocated 1:1:1 to receive escitalopram or nortriptyline or placebo.

NCT ID: NCT03652207 Completed - Clinical trials for Overweight and Obesity

Effects of Palatinoseā„¢ on Weight Management and Body Composition

Start date: April 20, 2009
Phase: N/A
Study type: Interventional

The study aims to assess body weight and body composition changes in overweight and obese persons consuming an energy-reduced diet containing foods with either sucrose or isomaltulose (Palatinose(TM)) over a period of 3 months.

NCT ID: NCT03652038 Completed - Asthma Clinical Trials

Single and Multiple Ascending Dose Study of TD-8236 by Inhalation

Start date: November 7, 2018
Phase: Phase 1
Study type: Interventional

This is a Phase 1, randomized, double-blinded, placebo controlled study. The study consists of 3 parts: Part A is a single ascending dose (SAD) study in healthy subjects, Part B is a multiple ascending dose (MAD) study in subjects with stable, mild asthma, and Part C (Biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.

NCT ID: NCT03649867 Completed - Clinical trials for Interpersonal Trauma

What Have Been the Experiences of Female Survivors of Interpersonal Trauma on the Survive & Thrive Course

EoFSoITotS&TC
Start date: October 17, 2018
Phase: N/A
Study type: Interventional

The study is aimed to explore female patients' experience of the Survive & Thrive course that has been designed for survivors of interpersonal trauma (e.g. childhood sexual abuse, domestic abuse, rape, physical abuse, neglect, harassment, stalking and similar). The course aims to help attendees develop an understanding of the normal range of reactions to trauma and introduce new ways of coping. It is a 10 week course that is structured to utilise cognitive behavioural skills training while delivering psychoeducation on how a history of victimisation can impacts on the survivors life. Female adult participants who attended the Survive & Thrive course will be invited to take part in a 30-45 minutes semi-structured interview exploring their experience of the course. The aim is to interview 12 participants; those individuals attended 6 or more sessions. Access to some demographic information will be gained through the Survive & Thrive team to gain additional insight to the participant's course experience. The rationale for this study is to evaluate the effectiveness of the Survive & Thrive course as a treatment option within the Stepped Care Approach for survivors of interpersonal trauma. There is an increasing number of individuals being exposed to traumatic life events. Most research has concentrated on the individual psychological input for patients with trauma history. Courtois and Ford (2009) argued that at a service level, group therapy is more efficient than individual as it can be offered more broadly. There is however limited research on the effectiveness of manualised approaches for the mental health and behavioural problems. Research shows that safety and stabilisation in trauma survivors can be achieved through psychoeducational approaches which emphasise present-time, coping strategies/skills, elimination of self-harming behaviour, control over acute symptoms, and increased self-care (Lubin & Johnson, 1997). Findings from this study will be published.

NCT ID: NCT03649412 Completed - Autoimmune Diseases Clinical Trials

A Study to Investigate the Pharmacokinetics (PK) of Modified Release (MR) Prototype Coated Tablet Formulations of GSK2982772

Start date: September 26, 2018
Phase: Phase 1
Study type: Interventional

Previous clinical studies of immediate release (IR) formulations of GSK2982772 resulted in a high peak to trough ratio of GSK2982772. Additionally, the short half-life for GSK2982772 (approximately 2 to 3 hours) necessitates twice a daily (BID) or thrice daily (TID) dosing of an IR formulation. As a result, MR formulations using a polymer matrix approach with minitablets in capsule and MR tablet formulations were investigated. The emerging PK data of the MR formulations investigated to date have demonstrated that a once daily (QD) PK profile can be achieved in the fasted state but the polymer matrix formulation is susceptible to food effects when administered with a high fat breakfast. The purpose of this study is to evaluate MR prototype coated tablet formulations. This study will evaluate the PK of MR prototype coated tablet formulations of GSK2982772. The study is divided into two parts; Part A and Part B. The MR tablet coating used in Part A and the initial periods of Part B will have an aperture drilled into the enteric coating of either side of the tablet. This allows some drug release to commence in the stomach whilst providing controlled release throughout the gastrointestinal (GI) tract. In Part B only, a new investigational medicinal product (IMP) will be manufactured to allow comparison of the tablet coating either with apertures (i.e., drilled) or without apertures (i.e., full coat/non drilled). Part A will be a 6-period, 6-way fixed sequence design, up to 4 MR tablet prototype coated formulations will be evaluated in fasted state at 240 milligrams (mg). Periods 1, 2 and 3 will evaluate MR1, IR tablet and MR2 respectively. Periods 4, 5 and 6 will be flexible and the dosing regimen will be dependent on the outcome of Periods 1 to 3. In addition, the impact of food (high fat meal, standard breakfast or administration 30 or 60 minutes before a standard breakfast) on selected MR prototype coated tablet formulations may also be evaluated in Period 4, 5 or 6 of Part A. Each inpatient period for MR regimens (Periods 1, 3, 4 to 6) will consist of 4 days and 3 nights, and the inpatient period for the IR tablet (Period 2) will consist of 3 days and 2 nights. There will be a minimum washout of 7 days between doses, and a follow-up visit will occur at 7 to 9 days after the last study treatment. The Part B of the study will be a 7-period fixed sequence which will evaluate the selected MR prototype coated tablet formulation(s) at different tablet strengths or as multiple unit doses and with or without apertures in the tablet coatings. There will be an interim review after each period 1 to 5 of Part B to select the dose level, formulation and prandial status for each subsequent period. An interim data review after Part B Period 6 will determine if optional Period 7 is required and the dose level, dosing time (morning or evening), formulation and prandial status for that period. Each inpatient period will consist of a 4-day and 3-night with a minimum of 7 days washout between doses. A follow-up visit will occur at 7 to 9 days after the last study treatment. Approximately 33 subjects will be enrolled in the study. The total duration for Part A will be approximately 10-12 weeks and 10-14 weeks for Part B (including screening period of approximately 4 weeks).

NCT ID: NCT03648541 Completed - Colitis, Ulcerative Clinical Trials

BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis

Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials

NCT ID: NCT03648320 Completed - Peanut Allergy Clinical Trials

The Grown Up Peanut Immunotherapy Study

GUPI
Start date: October 15, 2018
Phase: N/A
Study type: Interventional

To determine efficacy and safety of peanut oral immunotherapy in adults with peanut allergy.

NCT ID: NCT03647618 Completed - Ultrasound Imaging Clinical Trials

Anatomy Guidance for Regional Anaesthesia

Start date: December 20, 2018
Phase:
Study type: Observational

This mutlicentre study at three hospitals in south Wales, UK, will be used to determine if modern machine learning techniques can help the anaesthetist locate the target by highlighting key anatomical features on the ultrasound image in real time. The study consists of two phases: The objective of Phase I is to train a computer-aided system to identify target structures in regional anaesthesia when applied in the following categories: - Adductor canal - Popliteal - Fascia Iliaca - Rectus sheath - Axillary The objective of Phase II is to estimate the success rate and safety of the computer system being developed.

NCT ID: NCT03647566 Completed - Aortic Dissection Clinical Trials

18F Sodium Fluoride PET/CT in Acute Aortic Syndrome

FAASt
Start date: October 1, 2018
Phase:
Study type: Observational

The purpose of this study is to determine whether Sodium Fluoride imaging (using Positron Emission Tomography-Computed Tomography - PET-CT) is able to predict disease progression in acute aortic syndrome.

NCT ID: NCT03647228 Completed - Cystic Fibrosis Clinical Trials

A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis

Start date: December 13, 2018
Phase: Phase 1
Study type: Interventional

This Phase 1/2a study is a double-blinded (subject and Investigator), randomized, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple nebulized doses of IONIS-ENaCRx.