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NCT ID: NCT03338036 Completed - Clinical trials for Post-Concussion Syndrome

The Effectiveness of Biofeedback for Individuals With Long-term Post-concussive Symptoms

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

Most concussions resolve within 7-10 days, but approximately 40% of individuals do not fully recover and suffer from persistent post-concussive symptoms. This 8-week intervention study will evaluate the efficacy of heart rate variability (HRV) biofeedback and neurofeedback on reducing the number and severity of concussion symptoms.

NCT ID: NCT03337724 Completed - Breast Cancer Clinical Trials

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer

IPATunity130
Start date: January 6, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) breast adenocarcinoma who are not suitable for endocrine therapy.

NCT ID: NCT03337659 Completed - Premature Birth Clinical Trials

A Cluster Randomized Controlled Trial of FICare at 18 Months

Start date: September 27, 2017
Phase: N/A
Study type: Interventional

In Alberta, one in every twelve babies is born preterm. Compared with their full term counterparts, preterm infants who survive are at higher risk for respiratory problems, jaundice, infections, feeding problems, behavioural problems, and neuro-developmental disabilities, including cognitive delays, and visual and hearing impairments. As a result, parents must leave their preterm babies in the hospital to fully develop enough to care for them at home. When it is time for discharge, parents are often unprepared to look after their baby because they may have limited involvement in the care of their baby in hospital. In addition to the distress and costs to parents of having a baby in hospital, health system costs are also increased the longer a baby is in hospital. The aim of this novel health services study is to assess the longer-term outcomes and costs, to 18 months corrected age, of Family Integrated Care (FICare) for moderate and late preterm infants admitted to a Level II neonatal intensive care unit (NICU). A cluster randomized controlled trial (cRCT) of FICare is currently in progress. FICare is a psycho-educational intervention that empowers parents (mothers and fathers) to sequentially build their knowledge, skill, and confidence so the family is well-prepared to care for their preterm infant before discharge. The FICare cRCT evaluates outcomes related to infant global development and maternal psychosocial distress at 2 months. At 2 months, it is difficult to predict longer term outcomes for moderate and late preterm infants. A follow-up study at 18 months will provide evidence of the sustainability of any effects, and longer-term cost savings upon which to inform policy decisions about full-scale implementation of FICare in Level II NICUs.

NCT ID: NCT03337646 Completed - Clinical trials for Autism Spectrum Disorder

Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism

Start date: September 26, 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect and safety of Lisdexamfetamine dimesylate (Vyvanse®) in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents with ADHD and comorbid Autism Spectrum Disorder (ASD). This would be a novel study as there is no known safety or efficacy data for amphetamine based medications in this population. In addition, although health related quality of life and executive function are known to improve with the treatment of lisdexamfetamine dimesylate in the ADHD population (Banaschewski 2013; Findling 2009; Turgay 2010), it has not been shown in the co-morbid ADHD and ASD population. ADHD is the most common pediatric neurobiological condition affecting approximately five percent of the pediatric population (Feldman 2009). ASD is being increasingly recognized as affecting a substantial amount of the pediatric population, with recent prevalence data showing 1 in 68 affected (Baio, 2014). Prior to the introduction of DSM-5 (APA, 2013), exclusion criteria precluded the diagnosis of ADHD when ASD was present. Studies have shown that 41%-71% of children with ASD also meet criteria for ADHD (Goldstein 2004, Sturm 2004,Yoshida 2004, Gadow 2006). This means that up to 1% of the population may have co-morbid ADHD and ASD. With the official recognition of this comorbidity, treatment of comorbid ADHD when ASD is also present has been increasingly recognized as an important strategy in improving executive functioning and quality of life in those affected. Studies have indicated that some of the medications commonly used to treat ADHD, are effective and safe when used in comorbid ADHD and ASD. At this time, there have been well designed studies demonstrating safety and efficacy for methylphenidate (Ghuman et al. 2009; Handen et al. 2000; Quintana et al. 1995; RUPP 2005), guanfacine XR (Posey 2004; Scahill 2015), and atomoxetine (Arnold 2006; Harfterkamp 2012).

NCT ID: NCT03337542 Completed - Peanut Allergy Clinical Trials

AR101 Real-World Open-Label Extension Study

Start date: October 18, 2017
Phase: Phase 3
Study type: Interventional

This study is enrolling participants by invitation only. This is an open-label, safety extension study for subjects who participated in the ARC007 study.

NCT ID: NCT03337464 Completed - Parkinson Disease Clinical Trials

Single Exercise Bout in Parkinson's Disease (PD)

Start date: April 2, 2013
Phase: N/A
Study type: Interventional

To assess 30 active people (15 with PD, 15 without) before and after 30 minutes of pedaling exercise using EEG-EMG, cognitive, mood and motor assessments.

NCT ID: NCT03337126 Completed - Bioequivalence Clinical Trials

Bioavailability of ATI-1501 With Taste Test Sub Study

Start date: November 6, 2017
Phase: Phase 1
Study type: Interventional

Appili Therapeutics Inc. is developing an oral suspension formulation of metronidazole (ATI-1501), a taste-masked reformulation of metronidazole. The purpose of this study is to compare the relative bioavailability of ATI-1501 with the Reference Listed Drug (RLD) in healthy, adult volunteers to determine that it is Bioequivalent.

NCT ID: NCT03337022 Completed - Psoriasis Clinical Trials

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CC-90006 in Subjects With Mild to Moderate Plaque-type Psoriasis

Start date: January 4, 2018
Phase: Phase 1
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and immunogenicity of CC-90006 following administration of multiple subcutaneous doses in subjects with mild to moderate plaque-type psoriasis.

NCT ID: NCT03336216 Completed - Clinical trials for Advanced Pancreatic Cancer

A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

Start date: December 19, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.

NCT ID: NCT03335904 Completed - Hypoxia Clinical Trials

AT1R Blockade and Periodic Breathing During Sleep in Hypoxia

Start date: January 1, 2018
Phase: Phase 4
Study type: Interventional

Sleep disordered breathing (SDB) is characterized by regular periods of no breathing (apnea) or low levels of breathing (hypopnea) and leads to repeated periods of low oxygenation, termed intermittent hypoxia that causes fluctuations in blood oxygen levels. This leads to increased peripheral chemoreflex sensitivity that is thought to occur through the stimulation of angiotensin-II, type-I receptors (AT1R) that are expressed primarily on glomus cells within the peripheral chemoreflex and ultimately results in long lasting hypertension. The goal of this study is to determine if AT1R receptor blockade can prevent the increase in chemoreflex sensitivity following one night of hypoxia and improve the severity of SDB.