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NCT ID: NCT01989286 Completed - Plagiocephaly Clinical Trials

Postural Assessment in Plagiocephaly

Start date: November 2013
Phase: N/A
Study type: Observational

The positional plagiocephaly is a condition involving craniofacial asymmetry. The purpose of this study is to evaluate the spine, the posture and the psychomotor state in children who were diagnosed with infant plagiocephaly.

NCT ID: NCT01988844 Completed - Cerebral Palsy Clinical Trials

Upper Limbs Assessment in Children With Cerebral Palsy

Start date: November 2013
Phase: N/A
Study type: Observational

Cerebral palsy is the leading cause of physical disability among children. Manual dexterity and upper limbs functionality is limited between these children. The purpose of this study is to stablish a specific profile of school children with cerebral palsy based on the upper limbs assessment.

NCT ID: NCT01987895 Completed - Clinical trials for Clostridium Difficile Infection

Efficacy and Safety of Cadazolid Versus Vancomycin in Subjects With Clostridium Difficile - Associated Diarrhea

Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

This clinical study is conducted to assess the efficacy of cadazolid compared to vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD).

NCT ID: NCT01987570 Completed - Clinical trials for Patients With Grade II Ankle Sprain

Effect of Allopurinol Administration on the Prevention of Muscle Mass Loss in Subject Immobilized.

Start date: April 2012
Phase: Phase 3
Study type: Interventional

Generating critical levels of power is a prerequisite for performing simple daily activities, such as rising from a chair or climbing stairs. For a young healthy person these activities can be performed easily, however after a prolonged period of forced inactivity (such as during the recovery from a sports injury, prolonged bed rest or spaceflight) a loss of muscle mass occurs. It has been suggested that this loss may be triggered by oxidative stress. An enzyme involved in the production of free radicals in various experimental models, including immobilization, is xanthine oxidase (XO). Although allopurinol is an inhibitor of XO widely used in clinical practice, its effect on the maintenance of muscle mass after an immobilization protocol is unknown. Thus, the major aim of this clinical trial is to determine the effect of allopurinol administration on the prevention of muscle mass loss in immobilized subjects. This is a prospective, randomized study in which fifty young male subjects (aged between 25 and 40 years) diagnosed with grade II ankle sprain will be recruited. After immobilization the patients will be assigned randomly to one of two experimental groups, one treated with allopurinol (n=25) and the other with placebo (n=25). The dosage of allopurinol will be the same as recommended for gout patients, i.e. 300 mg/day orally, during all the immobilization period, which will last fifteen days. This medication will be delivered to the patients when they agree to participate in the clinical trial. They will be immobilized by posterior knee splint, preventing use of that leg. We will determine muscle mass loss by performing two magnetic resonances of both legs before and after the immobilization period. We will also take two blood samples (before and after immobilization) to measure oxidative stress parameters (malondialdehyde, protein carbonyls, and XO activity), inflammatory parameters (IL-6, C-reactive protein and 1-antichymotrypsin), as well as vitamin D levels.

NCT ID: NCT01987505 Completed - Clinical trials for Lymphoma, Non Hodgkin

MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma

Start date: November 11, 2013
Phase: Phase 3
Study type: Interventional

This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.

NCT ID: NCT01987492 Completed - Asthma Clinical Trials

A Study of Lebrikizumab (RO5490255) in Participants With Severe Oral Corticosteroids (OCS) Dependent Asthma

Start date: February 28, 2014
Phase: Phase 2
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy of lebrikizumab compared with placebo, as measured by the ability of participants to achieve lower daily doses of OCS, among those with severe corticosteroid-dependent asthma. Prednisone/prednisolone will be the OCS therapy prescribed. Participants will be randomized to receive lebrikizumab or matching placebo for 44 weeks in a double-blind, placebo-controlled (DBPC) period. Those who complete the 44-week period may continue into a 32-week active treatment extension (ATE) period, during which all participants will receive lebrikizumab treatment. Following completion of the ATE period, participants who have both tolerated and derived benefit from treatment with lebrikizumab may continue their lebrikizumab treatment into a long-term extension (LTE) period. Participants will transition to 24 weeks of safety follow-up upon discontinuation of study drug.

NCT ID: NCT01987453 Completed - HCV Infection Clinical Trials

Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Start date: July 2014
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

NCT ID: NCT01986998 Completed - Multiple Sclerosis Clinical Trials

Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse

Start date: October 2013
Phase: Phase 4
Study type: Interventional

The investigators plan to carry out a multicenter randomized clinical trial and MRI study of high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this therapeutic regimen because it is safer for the patient (less adverse effects) and less costly to the healthcare system.

NCT ID: NCT01986803 Completed - Clinical trials for Acute ST Segment Elevation Myocardial Infarction

ABSORB STEMI: the TROFI II Study

Start date: January 6, 2014
Phase: N/A
Study type: Interventional

This is a Prospective, randomized (1:1), active control, single-blind, non-inferiority, European multicenter clinical trial. The primary objective of this study is to assess the neointimal healing score (as evaluated by intra-coronary OFDI) in patients with ST-elevation Myocardial Infarction (STEMI) and treated with Abbott Vascular ABSORB everolimus eluting bioresorbable vascular scaffold (BVS) at 6 months follow-up by comparing with a metallic drug eluting stent (XIENCE). Furthermore, the safety and feasibility of implanting ABSORB BVS in patients with STEMI is assessed. It is hypothesized that acutely and at 6 months follow-up implantation of the ABSORB fully bioresorbable everolimus-eluting scaffold is at least as safe as implantation of metallic drug-eluting stent, and that at late follow-up the ABSORB scaffold could improve the arterial healing process and potentially reduce late stent thrombosis in patients presenting with STEMI. This is a preparatory trial in anticipation of a major outcome study.

NCT ID: NCT01986166 Completed - Neoplasms Clinical Trials

A Study of MEHD7945A and Cobimetinib in Patients With Locally Advanced or Metastatic Cancers With Mutant KRAS

Start date: November 2013
Phase: Phase 1
Study type: Interventional

This open-label, multicenter, global Phase Ib study will evaluate the safety, tolerability and pharmacokinetics of intravenous (IV) dosing of MEHD7945A in combination with oral dosing of cobimetinib in patients with locally advanced or metastatic solid tumors that carry a Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation and for which standard therapies do not exist, have proven ineffective or intolerable or are considered inappropriate. The study comprises a dose-escalation (Stage 1) and an indication-specific cohort expansion stage (Stage 2).