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NCT ID: NCT02515838 Completed - Sickle-Cell Disease Clinical Trials

Sevuparin Infusion for the Management of Acute VOC in Subjects With SCD

Start date: July 2015
Phase: Phase 2
Study type: Interventional

A Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to investigate Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in Subjects with Sickle-Cell Disease (SCD).

NCT ID: NCT02482298 Completed - Sickle Cell Disease Clinical Trials

A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease

Hestia2
Start date: July 9, 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether ticagrelor is effective in reducing the number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle cell disease

NCT ID: NCT02482142 Completed - Obesity Clinical Trials

The Role of Phosphorus in Diet Induced Thermogenesis (DIT) of Both Lean and Obese Subjects

PinDIT
Start date: July 30, 2016
Phase: N/A
Study type: Interventional

The study aim at: Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high carbohydrate meal. Investigating the impact of phosphorus ingestion on DIT of lean and obese subjects consuming high protein-low phosphorus meal.

NCT ID: NCT02463370 Completed - Clinical trials for Submucosal Resection of the Nasal Septum (SMR)

Four vs. Ten Local Anesthetic Injections for SMR

Start date: May 2015
Phase: N/A
Study type: Interventional

Submucosal resection of the nasal septum (SMR) could be performed under local anesthetic infiltration performed through ten injections in addition to general anesthesia which was associated with less postoperative pain and shorter hospital stay. However, the local infiltration technique is time-consuming and requires a large number of facial injections. This gave rise to the idea of reducing the number of injections while retaining the effectiveness of the local anesthetic technique. Decreasing the number of injections could be achieved by blocking the superior maxillary nerve (V2) and the infra-orbital nerve since it would result in anesthetizing the surgical area as well after induction of general anesthesia. The purpose of this prospective double-blind clinical trial was to compare the effectiveness of four versus ten local anesthetic injections in terms of postoperative pain relief. The secondary objective was to compare patients' and surgeons' satisfaction between the two techniques.

NCT ID: NCT02437318 Completed - Breast Cancer Clinical Trials

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR-1
Start date: July 23, 2015
Phase: Phase 3
Study type: Interventional

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

NCT ID: NCT02435212 Completed - Clinical trials for Transfusion-dependent Anemia

Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload

Start date: October 21, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden. Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core phase where patients will be randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all patients will receive the granules up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or express the wish to continue in the optional extension phase on granules, will be offered this possibility until there is local access to the new formulation (granules or FCT) or up to 5 years, whichever occurs first.

NCT ID: NCT02434432 Completed - Music Therapy Clinical Trials

Music Therapy for Pain Management in the NICU Setting

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

Background: Music therapy has been recommended as an adjuvant therapy for both preterm infants and mothers throughout their stay in the Neonatal Intensive Care Unit (NICU), and has been shown to have some beneficial effects, although conclusive evidence remains lacking. Objectives: To study the usefulness of two forms of music, as well as no music, on pain and physiological and behavioral parameters of preterm infants during a heel stick procedure for obtaining blood in the Neonatal Intensive Care Unit (NICU). Hypotheses: Infants hearing music chosen by their mothers will have less pain and optimal behavioral and physiologic responses as compared to infants who hear the lullaby or no music. Methods: An analytical observational study with a randomized cross-over design will be utilized. Inclusion will be stable infants born between 28 to 36 weeks of gestation, with normal hearing. Neonatal Physiologic responses [heart rate (HR), oxygen saturation, (02 sat) and respiratory rate(RR)] and Behavioral States will be recorded before and after the heel stick procedure. Maternal age, education, and pregnancy complications will be also be documented. Pain responses will be recorded using the Neonatal Pain, Agitation and Sedation Scale (NPASS). Ethical considerations: The study imposes minimal risk on infants. One potential risk is that the infant may become agitated while listening to music, especially if it is time for feeding. Based on previous research, infants tend to calm down while listening to music. However, in the infants who may be hungry or fussy, music exacerbate their agitation. To prevent this from occurring the investigators will not perform the heel stick close to feeding time and the investigators will be vigilantly timing and monitoring the infant's agitation. Because music has been shown to calm infants and stop them from crying, the benefits outweigh this risk. The heel stick is performed routinely on infants (often 3-6 times a day). The investigators will not perform any additional heel sticks for this study, but will rather intervene during one of the scheduled heel stick procedures.

NCT ID: NCT02434380 Completed - Clinical trials for Pregnancy Complications

Effect of Vitamin D Replacement on Maternal and Neonatal Outcomes

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

The optimal vitamin D replacement dose during pregnancy remains undefined. Therefore, the aim of this study is to test the hypothesis that a daily equivalent dose of vitamin D of 3,000 IU/day is needed for Middle Eastern women, to optimize maternal vitamin D level and neonatal musculoskeletal parameters, specifically knee-heel length at birth and bone mineral content at one month of age.

NCT ID: NCT02422615 Completed - Clinical trials for Advanced Breast Cancer

Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

MONALEESA-3
Start date: June 9, 2015
Phase: Phase 3
Study type: Interventional

The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

NCT ID: NCT02414139 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Oral cMET Inhibitor INC280 in Patients With EGFR Wild-type (wt), Advanced Non-small Cell Lung Cancer (NSCLC) (Geometry Mono-1)

Start date: June 11, 2015
Phase: Phase 2
Study type: Interventional

Study to evaluate the efficacy and safety of capmatinib as a single-agent treatment for subjects with advanced/metastatic (stage IIIB or IV) non-small cell lung cancer (NSCLC) who had wild-type epidermal growth factor receptor (EGFR wt) (for exon 19 deletions and exon 21 L858R substitution mutations), anaplastic lymphoma kinase (ALK)-negative rearrangement, and mesenchymal epithelial transition (MET) mutations leading to exon 14 deletion (referred to as MET mutation hereafter) and/or MET amplification.