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NCT ID: NCT02374060 Completed - Macular Edema Clinical Trials

PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial

POINT
Start date: June 16, 2015
Phase: Phase 3
Study type: Interventional

To evaluate the relative efficacy of three commonly utilized regional corticosteroids for the regional treatment of uveitic macular edema: periocular triamcinolone acetonide; intravitreal triamcinolone acetonide; intravitreal dexamethasone implant. The primary efficacy measure will be percent change in central subfield thickness as measured by OCT at 8 weeks. Participants will continue in the study for 24 weeks in order to evaluate relative effects of the 3 treatment strategies on the duration of treatment effects, requirement for additional injections, and adverse effects. Note: The planned sample size for the POINT Trial was 267 subjects. On 17 July 2017, with 192 subjects enrolled, the Data and Safety Monitoring Committee (DSMC) reviewed the planned interim analysis and recommended that the goals of the trial could be accomplished by completing follow-up of enrolled subjects without the recruitment of additional subjects. Per the DSMC recommendations, recruitment was suspended and follow-up of enrolled subjects was completed according to the protocol.

NCT ID: NCT02373176 Completed - Healthy Clinical Trials

[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study

Start date: July 2014
Phase: Phase 1
Study type: Interventional

[14C]PRC-4016 (Icosabutate) - A Phase I, Open-Label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects. Objective: To evaluate the pharmacokinetics of total radioactivity in blood and plasma and PRB-01022 (icosabutate) (unchanged drug) in plasma following a single oral administration of [14C]PRC-4016 to healthy male subjects. To obtain a mass balance of oral [14C]PRC-4016 by quantifying the urinary and faecal excretion of radioactivity. To examine the profile of metabolites in plasma, urine and faeces. To further assess the safety and tolerability of a single oral dose of [14C]PRC 4016 in healthy male subjects.

NCT ID: NCT02373150 Completed - Clinical trials for Type 2 Diabetes Mellitus

Safety, Tolerability and PK of Imeglimin in Japanese Volunteers

Start date: February 2015
Phase: Phase 1
Study type: Interventional

This study will assess the pharmacokinetics of single and repeated doses of imeglimin in healthy Japanese subjects, and the safety and tolerability of single and repeated doses of imeglimin in healthy Japanese subjects.

NCT ID: NCT02372552 Completed - Clinical trials for Polyp of Large Intestine

Microwave Coagulation Using CROMA Electrosurgical System

Start date: August 2015
Phase: N/A
Study type: Interventional

This is a single centre, prospective, non-randomised pivotal clinical investigation to be undertaken at St Mark's Hospital, Harrow, UK.

NCT ID: NCT02372006 Completed - Rhabdomyosarcoma Clinical Trials

Trial of Afatinib in Pediatric Tumours

Start date: April 29, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour activity in included tumour types

NCT ID: NCT02371707 Completed - Healthy Clinical Trials

Bioequivalence Study of Idalopirdine Tablets 60 mg

Start date: March 2015
Phase: Phase 1
Study type: Interventional

This study aims to establish bioequivalence between two tablet formulations of idalopirdine

NCT ID: NCT02371616 Completed - Dentine Sensitivity Clinical Trials

Clinical Study to Evaluate the Efficacy of Two Dentifrices for Dentine Hypersensitivity

Start date: September 29, 2014
Phase: N/A
Study type: Interventional

An 8 week clinical study to evaluate the ability of an experimental dentifrice containing calcium sodium phosphosilicate and sodium fluoride to provide relief from dentine hypersensitivity compared to a marketed dentifrice containing calcium sodium phosphosilicate and sodium monofluorophosphate.

NCT ID: NCT02371369 Completed - Clinical trials for Tenosynovial Giant Cell Tumor

Phase 3 Study of Pexidartinib for Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCT-TS)

ENLIVEN
Start date: May 11, 2015
Phase: Phase 3
Study type: Interventional

This is a Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called pexidartinib for the treatment of certain tumors for which surgical removal could cause more harm than good. The main purpose of this study is to gather information about the investigational drug pexidartinib, which may help to treat tumors of pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS). The study consists of two parts with a follow-up period. In Part 1, eligible study participants will be assigned to receive either pexidartinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Some subjects, assigned to placebo in Part 1 transitioned to pexidartinib for Part 2. Then a protocol amendment was written to allow only pexidartinib patients to continue into Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label pexidartinib. There was also a follow-up period added to Part 2.

NCT ID: NCT02371291 Completed - Clinical trials for Major Depressive Disorder

Memory Flexibility Training for Depression

Start date: January 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Our collection of memories for personal experiences plays an important role in shaping our sense of who we are as people. These memories, termed autobiographical memories, can also be helpful in social situations, for sharing the details of our experiences with other people, reminiscing about pleasant times and solving problems by remembering what has and hasn't worked in the past. Different types of autobiographical memory are helpful to us depending on the particular situation the investigators are in at the time. Recent research has shown that experiencing depressed mood can affect how we relate to our autobiographical memories, so that instead of providing a rich source of personal information in a helpful and flexible way, the types of memories that come to mind are more narrowly focused on difficult or negative experiences. This can cause low mood to persist over time. The purpose of this study is to test a newly-developed therapeutic training package for depressed mood (MemFlex), designed to encourage helpful and flexible ways of relating to autobiographical memories. The MemFlex programme consists of a one-to-one orientation session with the researcher to introduce the training package, followed by a workbook that is completed at home.

NCT ID: NCT02371109 Completed - Infection Clinical Trials

SYSTEMATIC: NAATS of Pooled Selftaken Versus Clinicantaken Swabs 1

Start date: December 9, 2014
Phase:
Study type: Observational

Routine screening for gonorrhoea and chlamydia involves urine samples in males and selftaken vulvovaginal swabs (VVSs) in females. As well as infecting the urethra (pee tube) and cervix (neck of womb), gonorrhoea and chlamydia may also infect the rectum (bottom) and throat (both called extragenital sites), often with no symptoms. In some people infection will be found at more than one site, but in others it will only be in one, and if all anatomical sites are not tested some infections will be missed. In certain women one third of infections may be missed, in men who have sex with men (MSM) up to 90% may be missed, if extragenital swabs are not taken. Currently, routine community testing does not include extragenital sites. Until recently these samples could not easily be taken outside clinical settings (hospitals, clinics or surgeries), but new DNA tests for gonorrhoea, called NAATs, now make this possible. However, they are expensive, and taking samples from extragenital sites would treble the costs. We propose that swabs from the three sites per person are pooled and analysed together rather than tested separately. This method would identify whether the person had the infection but not the anatomical site; this would not alter the management of the individual. Swabs from the rectum and throat have historically been taken by clinicians (doctors or nurses). The main attraction of community screening is that it is client led using selftaken samples. Recent studies suggest that selftaken swabs from the rectum and throat are acceptable to clients and may be as good as swabs taken by clinicians, but the costeffectiveness of this approach has not been investigated. Our aim is to establish whether in MSM and females selftaken samples that are pooled and processed by NAATs are as effective as the individual tests taken by clinicians.