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NCT ID: NCT03080987 Completed - Healthy Clinical Trials

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants

Start date: June 27, 2017
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.

NCT ID: NCT03080779 Completed - Clinical trials for Chronic Low Back Pain

Long Term Outcomes After Accidental Dural Puncture ADP Study

Start date: February 3, 2017
Phase:
Study type: Observational

Post Dural Puncture Headache (PDPH) causes significant short-term disability, prevents mobilisation, affects childcare activities and results in prolonged hospital stay. Initial treatment involves painkillers and if patient fails to respond, an Epidural Blood Patch (EBP). EBP involves taking patient's blood and injecting into the epidural space. It is generally agreed that PDPH is a self-limiting condition and resolves in two weeks. However there is emerging evidence that patients with PDPH could be at an increased risk of developing longstanding (chronic) headaches. Retrospective case studies show that between 28 - 34% of patients who developed PDPH had longstanding headaches at 18 months after the insertion of the epidural. There is also recent evidence of new onset low back pain developing in patients who have received an epidural blood patch that was performed to treat PDPH. Nearly two thirds of patients from a hospital in UK had new onset low back pain after they had received epidural blood patch treatment. Presently, there is no prospective clinical study evaluating the development of longstanding headaches and new onset low back pain after the development of PDPH. Aim of the present study is to evaluate the incidence of longstanding headache after accidental dural (ADP) puncture and the incidence of new onset low back pain after epidural blood patch treatment.

NCT ID: NCT03078907 Completed - Clinical trials for Pulmonary Arterial Hypertension

Effect of Selexipag on Daily Life Physical Activity of Patients With Pulmonary Arterial Hypertension.

TRACE
Start date: November 8, 2017
Phase: Phase 4
Study type: Interventional

The primary objective of this study is to evaluate the effect of selexipag on the physical activity of patients with pulmonary arterial hypertension (PAH) in their daily life, by using a wearable wrist device (actigraph). The actigraph will collect data on daily life physical activity in the patient's real environment. In addition, the PAH symptoms and their impacts will be assessed by using an electronic patient reported outcome measure in the patient's real environment. Patients will be assigned randomly to either selexipag or placebo.

NCT ID: NCT03078881 Completed - Clinical trials for Crigler-Najjar Syndrome

Clinical Assessment Study in Crigler-Najjar Syndrome

LUSTRO
Start date: March 10, 2017
Phase:
Study type: Observational

This is a Pre-Phase 1 prospective, non-interventional clinical assessment study to evaluate Crigler-Najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.

NCT ID: NCT03078582 Completed - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)

Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients

Start date: March 8, 2017
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the safety and efficacy of zilucoplan (RA101495) in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). There will be two groups of patients in the study: the first group will include patients who have never received eculizumab for treatment of PNH. The second group will include patients who have received treatment with eculizumab for at least 6 months prior to the study. Patients will be treated with RA101495 for 12 weeks.

NCT ID: NCT03078036 Completed - Breast Cancer Clinical Trials

International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study

BREAKOUT
Start date: March 13, 2017
Phase:
Study type: Observational

BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.

NCT ID: NCT03077412 Completed - Clinical trials for Fistulizing Crohn's Disease

Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

Divergence2
Start date: April 6, 2017
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. Participants will have the option to enter a separate Long-Term Extension (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.

NCT ID: NCT03077295 Completed - Obesity Clinical Trials

The Big Breakfast Study

Start date: April 5, 2017
Phase: N/A
Study type: Interventional

This weight loss study will investigate the impact of diet composition and meal size (large breakfast meals and smaller evening meals) on body weight, energy balance and eating behaviour, by altering calorie (meal) distribution.

NCT ID: NCT03076736 Completed - Aphasia Clinical Trials

Singing for People With Aphasia

SPA
Start date: June 1, 2017
Phase: N/A
Study type: Interventional

To undertake a pilot study that will evaluate the feasibility and acceptability of procedures to inform the design and delivery of a definitive RCT of SPA (which would assess the clinical and cost effectiveness of SPA for people with aphasia)

NCT ID: NCT03076645 Completed - Epilepsy Clinical Trials

Measure of Engagement of Epilepsy Patients in Messaging Groups

Start date: October 1, 2016
Phase: N/A
Study type: Interventional

This study will measure the engagement of people with epilepsy in a mobile phone based messaging platform as well as understand if there is an impact on their self-management