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NCT ID: NCT03666767 Completed - Clinical trials for Congenital Diaphragmatic Hernia

Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries

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

This study is a multi-centre, international, prospective cohort study of congenital anomalies to compare outcomes between LMICs and high-income countries (HICs) globally.

NCT ID: NCT03666702 Completed - Stroke Clinical Trials

Additional Physiotherapy Sessions Focussing on Arm Rehabilitation for People After Stroke During the Early Inpatient Period? A Feasibility Study

Start date: November 22, 2018
Phase: N/A
Study type: Interventional

Weakness in the arm is common after stroke and can affect stroke survivors' ability to perform some tasks. Studies show that extra sessions of arm exercise can help them to improve their arm function and that the first 3 months is the best time to gain these benefits. A website (www.webbasedphysio.com) has been developed and evaluated for delivering and monitoring physiotherapy exercise programmes. This website has been modified for people after stroke. The purpose of this study is to assess if doing extra physiotherapy for the arm through our web-based physio website gives any extra benefits to the usual physiotherapy received on the ward. A total of 30 stroke survivors will be recruited from the acute stroke unit of Hairmyres Hospital, NHS Lanarkshire, and will be randomised into two groups: intervention (15) and control (15). The control group will receive usual care and the intervention group will receive usual care plus an augmented and individualised 4 weeks upper limb exercise programme delivered by the web-based physio. The augmented programme will comprise upper limb and trunk exercises. The duration and intensity of the programme will be based on participants' level of functional ability. For participants with low exercise capacity, the overall time of the exercise will be less to begin with and will build up over time to 30 minutes, five sessions per week (including weekends), in addition to their usual physiotherapy care. Study assessments will be at baseline, and four weeks post-intervention or just before stroke survivors are discharged, if earlier. At the end of the study, the feedback from physiotherapy staff, stroke survivors in the intervention group and their carer on the augmented web-based physiotherapy will be evaluated qualitatively and quantitatively by three questionnaires.

NCT ID: NCT03666156 Completed - Obesity Clinical Trials

Adult Weight, Genetics and Lifestyle Factors

Start date: September 1, 2018
Phase:
Study type: Observational

Childhood obesity leads to adulthood obesity, demonstrated in many retrospective and longitudinal studies. Genetics as a predictor of obesity is less established. Morandi et al, (2012) assessed whether lifestyle and genetic factors can be used to predict childhood obesity, concluding that genetics had minimal predictive effect. More recently Seyednasrollah, (2017) demonstrated that genetic information, when alongside clinical factors for cardiovascular disease, increased the predictive accuracy of obesity risk in adults. This study aims to investigate if known lifestyle and genetic risk factors are associated with BMI and if they can be used as predictors of overweight/obesity in adults.

NCT ID: NCT03665441 Completed - Clinical trials for Pancreatic Adenocarcinoma

Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC

Trybeca-1
Start date: September 15, 2018
Phase: Phase 3
Study type: Interventional

This is an open-label, multicenter, randomized, Phase 3 study in patients with ductal adenocarcinoma of the pancreas who have failed only one prior line of systemic anti-cancer therapy for advanced pancreatic cancer and have measurable disease.

NCT ID: NCT03665194 Completed - Healthy Volunteers Clinical Trials

A Study to Investigate the Effects of Cortexolone 17α-propionate (and Its Metabolites) on Healthy Volunteers' Heart

Start date: June 6, 2018
Phase: Phase 1
Study type: Interventional

This is a randomised, double blind placebo controlled Phase I study which will assess the safety, tolerability and PK of Cortexolone 17α-propionate (and its metabolites), and its effects on the QTc interval when administered as multiple doses to healthy adult volunteers. Volunteers will receive a morning and evening dose (12 hours apart) of 225 mg (3 mL Cortexolone 17α-propionate applied topically as a 7.5 % solution (75 mg in 1 mL), giving a total daily dose of 450 mg (6 mL) per individual.

NCT ID: NCT03664804 Completed - Clinical trials for Huntington's Disease

Study to Measure Cerebrospinal Fluid Mutant Huntingtin Protein in Participants With Early Manifest Stage I or Stage II Huntington's Disease

Start date: December 5, 2018
Phase: Phase 1
Study type: Interventional

The study is designed as a multi-site, prospective, 15-month longitudinal, cohort study measuring CSF mHTT in participants with early manifest Stage I or Stage II Huntington's Disease (HD).

NCT ID: NCT03664674 Completed - Meniere Disease Clinical Trials

Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

Start date: August 27, 2018
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

NCT ID: NCT03664258 Completed - Clinical trials for Non-muscle-invasive Bladder Cancer

A Multi-National Study In Bladder Cancer Patients to Detect Recurrences After TURB (Trans-urethral Resection of the Bladder) Earlier With the Xpert Bladder Cancer Monitor Assay (ANTICIPATE X)

ANTICIPATE X
Start date: June 6, 2018
Phase:
Study type: Observational

Bladder cancer is the 5th most common cancer in Europe, with more than 151,000 new cases diagnosed in 2012 (4% of the total). Bladder cancer has the highest recurrence rate of any malignancy, often as high as 70% within 5 years of successful treatment. This high recurrence rate requires diligent and accurate monitoring as a means for early diagnosis and treatment. Considering the burden associated to repeated invasive cystoscopies, there is a need for robust but accurate tests for surveillance. In that prospect, urinary molecular tests have been developed although none were deemed adequate in the European clinical guidelines to replace cystoscopies. The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with this cancer. The test provides a fast and accurate result, is non-invasive and easy to perform. The aim of this study is to assess the non-inferiority of the Xpert Bladder Cancer Monitor assay in detecting recurrences in comparison to cystoscopy in the follow-up of patients with low or intermediate risk non-muscle-invasive bladder cancer (NMIBC).

NCT ID: NCT03663335 Completed - Clinical trials for Kidney Transplant Rejection

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

CIRRUS I
Start date: November 28, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of three CFZ533 dose regimens in kidney transplant recipients. This study will allow assessment of the ability of CFZ533 to replace Calcineurin inhibitors (CNIs) in terms of anti-rejection efficacy, while providing better renal function with a better safety and tolerability profile. Results of this study will be used to inform the CFZ533 dose and regimen selection for investigation in later phases of clinical development.

NCT ID: NCT03663101 Completed - Chronic Scar Pain Clinical Trials

Dysport in Post-Surgical Neuralgia

PMOD03
Start date: October 30, 2018
Phase: Phase 2
Study type: Interventional

The study is designed to determine whether a currently licensed version of botulinum toxin (Dysport®) is effective for the treatment of pain that has developed and/or persisted for months or years around the scar of a previous surgical site, and whether this condition could be suitable for the testing of similar new medicines. The study will compare three different doses of Dysport® to see if there is benefit and/or a best dose for treating persistent post-surgery scar pain.