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NCT ID: NCT01957163 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study to Compare the Addition of Umeclidinium Bromide (UMEC) to Fluticasone Furoate (FF)/Vilanterol (VI), With Placebo Plus FF/VI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Start date: October 1, 2013
Phase: Phase 3
Study type: Interventional

After screening, subjects will enter a 4 week open-label run-in period with fluticasone furoate (FF)/vilanterol (VI) 100/25 mcg administered once daily via dry powder inhaler (DPI). Subjects will then be randomized to receive any one of the 3 treatments (umeclidinium bromide [UMEC] [62.5 mcg] administered once daily via a DPI; OR UMEC [125 mcg] administered once daily via a DPI; OR matching placebo administered once daily via a DPI), while continuing treatment with open label FF/VI 100/25 mcg during a 12-week treatment period. There will be a total of eight scheduled clinic visits at Pre-Screening (Visit0), Screening (Visit 1), blinded treatment Day 1(Visit2), 2(Visit3), 28 (Visit4), 56 (Visit5), 84 (Visit6) and 85 (Visit7). A follow-up phone contact will be conducted approximately 7 days after the last clinic visit. The total duration of subject participation in the study from Screening to Follow-up will be approximately 17 weeks.

NCT ID: NCT01957150 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Start date: January 28, 2014
Phase: Phase 4
Study type: Interventional

This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.

NCT ID: NCT01957033 Completed - Whiplash Injuries Clinical Trials

Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study

Start date: October 2013
Phase: N/A
Study type: Interventional

The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.

NCT ID: NCT01956669 Completed - Solid Tumours Clinical Trials

Pazopanib Paediatric Phase II Trial Children's Oncology Group (COG) in Solid Tumors

Start date: October 8, 2014
Phase: Phase 2
Study type: Interventional

The study design was an open-label Phase II pediatric clinical study. The purpose of Study X2203 was to identify any efficacy signal in subjects with the disease subtypes under study, when treated with pazopanib monotherapy. Furthermore, it was to define the toxicities of pazopanib in children, as well as examine biological markers, e.g. cytokines and angiogenic factors, that could help further characterize any response of pazopanib in children. Pazopanib was administered as monotherapy in tablet and powder suspension formulations at daily doses of 450 mg/m2/dose or 225 mg/m2/dose, respectively. The first 6 enrolled subjects receiving oral suspension formulation were assessed for tolerability and extended PK sampling; and, only if pazopanib was tolerated, subsequent subjects were enrolled at the same starting dose with the suspension. Dose escalation was not permitted. For the tablet, a dosing nomogram was used based on the subject's BSA. Dose reduction was dependent upon the toxicity of pazopanib and disease status of the infants, toddlers, children, adolescents, and young adults. Subjects could be as young as 1 year-old infants to screen for enrollment. Subjects were assessed for initial response after 8 weeks of treatment prior to Cycle 3. A cycle was defined as 28 days of pazopanib treatment with no rest period between cycles. Treatment was administered continuously once daily. Treatment was to be discontinued if there was evidence of disease progression, unacceptable treatment-related toxicity, pregnancy. Histological classification was an important diagnostic inclusion in these subjects with a wide variety of refractory solid tumors, i.e. 7 different tumor types and each being a cohort.

NCT ID: NCT01956123 Completed - Infertility Clinical Trials

Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2

ESTHER-2
Start date: March 26, 2014
Phase: Phase 3
Study type: Interventional

This trial investigates the immunogenicity of FE 999049 in repeated cycles.

NCT ID: NCT01956110 Completed - Infertility Clinical Trials

Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1

ESTHER-1
Start date: October 2013
Phase: Phase 3
Study type: Interventional

This trial investigates the effects of FE 999049 compared to GONAL-F.

NCT ID: NCT01955330 Completed - Clinical trials for Coronary Artery Disease

Long Term Follow-up Hybrid Revascularization

Start date: September 2013
Phase:
Study type: Observational

OBJECTIVES: The objectives of the year study are two-fold: 1. To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft and stent of patients who have already had robotically-assisted Hybrid CABG surgery using CTA and MPS-MIBI. 2. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid CABG surgery

NCT ID: NCT01955161 Completed - Alzheimer's Disease Clinical Trials

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil

STARSHINE
Start date: October 2013
Phase: Phase 3
Study type: Interventional

To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).

NCT ID: NCT01955109 Completed - Peanut Allergy Clinical Trials

Follow-up of the VIPES Study to Evaluate Efficacy and Safety of Viaskin Peanut in Adults and Children

OLFUS-VIPES
Start date: September 2013
Phase: Phase 2
Study type: Interventional

The objectives of this open-label follow-up study for subjects who previously were randomized and have completed the VIPES study for the treatment of peanut allergy, are: - To assess the efficacy of Viaskin Peanut after up to 36 months of treatment. - To evaluate the safety of long-term treatment with Viaskin Peanut. - To evaluate sustained unresponsiveness to peanut after a period of 2 months without treatment in subjects showing desensitization to peanut after treatment with Viaskin Peanut.

NCT ID: NCT01954940 Completed - Clinical trials for Duchenne Muscular Dystrophy

Whole Body Vibration Therapy in Boys With Duchenne Muscular Dystrophy

Start date: March 2013
Phase: N/A
Study type: Interventional

Whole-body vibration therapy (WBVT) is a novel, non-pharmacological intervention aimed at improving muscle strength and endurance as well as bone density. It holds promise for children with neuromuscular disorders such as Duchenne muscular dystrophy (DMD) since muscle weakness results not only from muscle breakdown but also physical inactivity and muscle disuse atrophy. Weak DMD patients may increasingly limit their physical activity due to fear of falling or loss of independence (e.g. difficulty rising to stand without assistance). Prolonging the length of time boys with DMD are ambulatory is important for delaying complications of this disease (lung hypoventilation, scoliosis) as well as maintaining bone health. We propose to conduct a pilot study of WBVT in young boys with Duchenne muscular dystrophy (DMD). The primary outcome will be to document safety and feasibility of WBVT in this patient population. The secondary outcomes will evaluate changes in muscle strength and endurance. Bone health will also be examined as part of routine clinical care. The study will include 20 ambulatory boys with DMD; patients will be randomized (1:1 allocation) into 2 groups: WBVT treatment or no WBVT treatment (controls). Treatment groups will consist of 10 boys undergoing daily WBVT in an 8-week, open-label trial.