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NCT ID: NCT01688960 Completed - Solid Tumors Clinical Trials

Nesvacumab (REGN910/ SAR307746) and Aflibercept ("Ziv-aflibercept" in the U.S.) in Patients With Advanced Solid Malignancies

Start date: October 2012
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, ascending, multiple dose study of nesvacumab (REGN910/ SAR307746) in combination with aflibercept ("ziv-aflibercept" in the U.S.)

NCT ID: NCT01688843 Completed - Bradycardia Clinical Trials

Safety and Performance Study of the INGEVITY Lead

Start date: October 2012
Phase: N/A
Study type: Interventional

The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.

NCT ID: NCT01688531 Completed - Acne Clinical Trials

A Pilot Study to Investigate Filiation Between Primary and Secondary Lesions in Acne Patients

Start date: August 2012
Phase: Phase 1
Study type: Interventional

Exploratory, international, multi-centre, randomized, investigator blinded study in acne

NCT ID: NCT01686958 Completed - Prostate Cancer Clinical Trials

Safety Study of MRI-guided Transurethral Ultrasound Ablation of Prostate Tissue to Treat Localized Prostate Cancer

Start date: March 13, 2013
Phase: N/A
Study type: Interventional

This study is to evaluate that the magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system is safe and feasible to ablate prostate tissue in men with localized prostate cancer.

NCT ID: NCT01686802 Completed - Post-operative Pain Clinical Trials

Post-operative Oral Morphine Versus Ibuprofen

Start date: September 2012
Phase: Phase 2
Study type: Interventional

Children 5-17 years of age who have undergo orthopedic day surgical procedures for definitive management of fractures, tendon release, etc. will be randomized to receive either ibuprofen or oral morphine as needed for pain relief for 48 hours post-operatively at home. Pain will be assessed using the self-report Faces pain scale revised (FPS-R). We hypothesize that oral morphine will result in significantly lower pain scores on the Faces Pain Scale Revised (FPS-R) compared to ibuprofen. It is hoped that the results of this trial will create a new option for post-operative pain management in children.

NCT ID: NCT01686009 Completed - Pain Clinical Trials

Intra-nasal Ketamine for Analgesia in the Emergency Department

INKA
Start date: October 2012
Phase: Phase 4
Study type: Interventional

The provision of analgesia to patients in pain is a fundamental necessity of emergency department practice and is usually accomplished using IV opioids. However, significant barriers exist to the provision of timely analgesia by the IV route. The use of the IN route for medication delivery provides an efficient and relatively painless mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid, easy-administered and well-tolerated method for providing analgesia in the ED setting.

NCT ID: NCT01685697 Completed - Clinical trials for Respiration; Insufficient or Poor, Newborn

Mask Ventilation With Different Face Masks During Neonatal Resuscitation

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

Most premature babies have difficulty breathing at birth and need help (what we call resuscitation). The treatment for this is to gently inflate their lungs with a resuscitation device and a facemask. The device commonly used is a T-Piece infant resuscitator (which we call the T-Piece) and is used at The Royal Alexandra Hospital and all round the world. To gentle inflate an infants lung the clinical team put a face mask around your baby's mouth and nose. The clinical team tries to achieve a good seal between the face and the mask. A problem of mask ventilation is that air can escape between the mask and the face (what we call mask leak). Currently, two different types of facemasks ("Laerdal mask" or "Fisher & Paykel mask") are routinely used in the delivery room at The Royal Alexandra Hospital. The purpose of this study is to find out if one facemask is leaking less between the face and the mask.

NCT ID: NCT01685619 Completed - Clinical trials for Acute Myeloid Leukemia (AML)

AML-MDS Novel Prognostic Tests Clinical Study

Start date: October 2, 2012
Phase:
Study type: Observational

This clinical study will provide the study specimens (samples of bone marrow and blood) and the clinical data for a pan-Canadian collaborative research project developed by the MDS/AML Research Consortium. The goal of this project involves the evaluation and potential validation of five novel prognostic tests for myelodysplasia (MDS) and/or acute myeloid leukemia (AML), as well as an analysis of health economic and socio-ethical implications related to the potential introduction of these tests into the clinical setting. The over-arching goal is to improve the outcomes of patients with MDS and AML. The primary hypothesis is that one or more of the laboratory tests being evaluated in conjunction with this study, either alone or in combination with other laboratory tests (either established or under investigation in this project), will have statistically significant prognostic value either alone or in combination with established clinical risk factors. The clinical study will involve the enrollment of 200 adults with AML and 200 adults with MDS over a 2.5 year period. Participants will be followed on study for two years. Bone marrow and blood specimens will be collected at diagnosis and at other time points as required for the development of the five laboratory tests. Participants will be assigned to treatment according to local institutional practice and will be followed for up to 2 years. Health economic and quality of life questionnaires will be administered at key time points. Data will be collected regarding participant characteristics, diagnosis, disease features, treatment and clinical outcome.

NCT ID: NCT01685268 Completed - Prostate Cancer Clinical Trials

A Study of HSP90 Inhibitor AT13387 Alone or in Combination With Abiraterone Acetate

Start date: September 2012
Phase: Phase 1/Phase 2
Study type: Interventional

A 2-part, Phase 1-2, open-label, parallel group, randomized study in patients with Castration-Resistant Prostate Cancer (CRPC) who are no longer responding to treatment with abiraterone and steroids. In Part A (Phase 1), patients will continue to receive the same doses of abiraterone and steroids they were receiving prior to study entry and will be randomized to receive 1 of 2 different treatment regimens of AT13387 in combination with abiraterone. Once the best regimen is established in Part A, based on safety and antitumor activity, patients will be randomized to the selected treatment regimen and dose of AT13387 in combination with abiraterone or AT13387 alone in Part B (Phase 2).

NCT ID: NCT01685138 Completed - Clinical trials for Non-Small Cell Lung Cancer

LDK378 in Crizotinib naïve Adult Patients With ALK-activated Non-small Cell Lung Cancer

Start date: December 20, 2012
Phase: Phase 2
Study type: Interventional

A single-arm, open-label, two-stage multicenter, phase II study. Patients were pre-screened for ALK positive status. Treatment with LDK378 at 750 mg qd was continued until the patient experienced unacceptable toxicity that precluded further treatment, discontinued treatment at the discretion of the investigator or patient, started a new anticancer therapy and/or died. LDK378 was continued beyond RECIST defined progressive disease (PD) as assessed by the investigator, if in the judgment of the investigator, there was evidence of clinical benefit. Patients who discontinued the study medication in the absence of progression continued to be followed for tumor assessment until the time of PD as assessed by the investigator. Male and female patients aged 18 or over with ALK-rearranged non-small cell cancer (NSCLC) were screened for eligibility. Patients had to have received no prior crizotinib, and had to be chemotherapy-naïve or been pretreated with cytotoxic chemotherapy (up to three prior lines).