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NCT ID: NCT02626221 Completed - Chronic Urticaria Clinical Trials

A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)

AWARE-LACan
Start date: December 24, 2014
Phase:
Study type: Observational [Patient Registry]

This is a non-interventional, multi-country, Latin American study utilizing a prospective single-cohort design. Eligible CU patients will be enrolled in the study and will be followed for 24 months (± 6 weeks). In accordance with the observational nature of the study, there will be no interventions or interference with the routine care of the patient which will be based solely on the clinical judgment of the treating physician. However, with respect to the frequency and schedule of assessments, the schedule included in Table 7-1 will be recommended. The selection of the treatment for CU will be clearly separated from the decision to include the patient in the study, and will be made at the discretion of the treating physician in accordance with standard medical practice, the investigator's clinical judgment, and global urticarial guidelines. In order to prevent selection bias, investigators should offer enrollment to all consecutive patients meeting study criteria, likely to be available for the full duration of the follow-up period of 24 months, and willing to participate in the study. The overall objective of the study is to evaluate in real-life the CU disease burden, the current treatment patterns and the use of health care resources in patients refractory to H1-antihistamine treatment

NCT ID: NCT02625974 Completed - Chagas Disease Clinical Trials

Prospective Study of a Pediatric Nifurtimox Formulation for Chagas' Disease

Start date: January 27, 2016
Phase: Phase 3
Study type: Interventional

The study consists of two parts. Part I (CHICO) was designed to develop a better understanding of the efficacy, safety and pharmacokinetics of nifurtimox in children with a diagnosis of Chagas' disease (Trypanosoma cruzi infection) using pediatric formulations. Part II (CHICO SECURE) was designed at request of the FDA to assess the incidence of sero-negative conversion in children with diagnosis of Chagas' disease treated with nifurtimox.

NCT ID: NCT02624947 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.

NCT ID: NCT02620046 Active, not recruiting - Crohn's Disease Clinical Trials

A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

Start date: April 15, 2016
Phase: Phase 3
Study type: Interventional

The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis and Crohn's disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC. Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study. For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens. Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study. After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

NCT ID: NCT02618499 Terminated - Clinical trials for Placental Transfusion

Delayed Cord Clamping and Use of Oxytocin

Start date: May 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if oxytocin administration immediately after delivery of the infant modifies the volume of placental transfusion in healthy term infants.

NCT ID: NCT02617563 Active, not recruiting - Clinical trials for Intervertebral Disc Degeneration

5-Year Global Study on MAST™ Minimally Invasive Fusion Procedures to Treat Degenerative Lumbar Spine (MASTERS-D2)

MASTERS-D2
Start date: December 2015
Phase:
Study type: Observational [Patient Registry]

The purpose of this study is - to evaluate the effectiveness of MAST techniques for anterior/lateral and posterior approaches in Degenerative Disc Disease (DDD) patients with spondylolisthesis (≥ grade I). - To assess how single or double level MAST(Minimal Access Spinal Technologies) fusion procedures PLIF (Posterior Lumbar Interbody Fusion), TLIF (Transforaminal Lumbar Interbody Fusion), DLIF (Direct Lateral Interbody Fusion), OLIF (Oblique Lumbar Interbody Fusion), ALIF (Anterior Lumbar Interbody Fusion), or MIDLF (Midline Lumbar Interbody Fusion) are used in surgical practice and to describe long-term safety and effectiveness in a broad patient population of patients with degenerative lumbar disc disease .

NCT ID: NCT02614261 Completed - Chronic Migraine Clinical Trials

Evaluation of Galcanezumab in the Prevention of Chronic Migraine

REGAIN
Start date: November 30, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of the study drug known as galcanezumab in participants with chronic migraine.

NCT ID: NCT02614196 Completed - Migraine Clinical Trials

Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

EVOLVE-2
Start date: December 4, 2015
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as galcanezumab in participants with episodic migraine.

NCT ID: NCT02611830 Completed - Colitis, Ulcerative Clinical Trials

Efficacy and Safety of Vedolizumab Subcutaneously (SC) as Maintenance Therapy in Ulcerative Colitis

Start date: December 18, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) maintenance treatment on clinical remission at Week 52 in participants with moderately to severely active ulcerative colitis (UC) who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.

NCT ID: NCT02610296 Completed - Clinical trials for Delayed Graft Function

QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant

ReGIFT
Start date: March 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function with kidney allografts from donors >45 years after brain death (DBD).