Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome...
Tourette SyndromeThis is an open-label, rollover study to collect long-term safety, tolerability, and investigator- and participant-reported pharmacodynamic (PD) data after chronic administration of NBI-98854 in pediatric participants with Tourette Syndrome (TS), as well as to provide open-label access to NBI-98854 for the treatment of TS for pediatric participants who have taken part in a Phase 2 NBI-98854 study.
Viveye Ocular Magnetic Neurostimulation System (OMNS) for the Management of Severe Dry Eye Disease...
Dry Eye SyndromesATD1 moreThe objective of this study is to evaluate the safety and effectiveness of Viveye OMNS non-invasive treatment for management of the signs and symptoms of severe dry eye disease.
Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of...
Tourette SyndromeThis is an otherwise open-label, single-arm study that includes a 2-week, double-blind, placebo controlled, randomized drug withdrawal period followed by a 3 week blinded maintenance or re-titration, and then a maintenance period. This study aims to evaluate the safety and efficacy of TEV-50717 tablets in patients with tics associated with TS who have previously completed participation in any of the parent studies.
Botox for the Treatment of Chronic Exertional Compartment Syndrome
Compartment Syndrome of LegAfter diagnosis of Chronic Exertional Compartment Syndrome (CECS), the participants will be referred to both physical therapy and Botox injection. In physical therapy, the therapist will perform strength measurements of the lower leg (ankle plantarflexion and dorsiflexion) which will be repeated 2 months following the injection. An ultrasound-guided injection of 50 units of Botox will be administered into the tibialis anterior. 25 units will be injected into two different spots in the muscle one being more proximal and the other distal. This will be a one-time injection and will be observed as to how it effects participant symptoms over the next 6 months at either a clinic visit (at 2 months) or telephone call (at 4 and 6 months after injection) via the University of Wisconsin Running Index. Two months following the injection, the participant will undergo repeat measurements of strength using the Kiio Force Sensor. Should potential participants of childbearing potential wish to enroll in the study, a urine pregnancy test will be performed prior to enrollment; participants will not be enrolled if test is positive.
An Open-Label Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of OV101 in Individuals...
Angelman SyndromeThis open-label study (OV101-18-002) will evaluate the long-term (52 weeks) safety of OV101 in subjects with AS and provide additional OV101 treatment to those subjects who completed Study OV101-15-001 (NCT02996305). Subjects with AS who completed the pharmacokinetic Study OV101-16-001 (NCT03109756) will also be permitted to participate, provided they meet all entry criteria.
Breath Biomarkers for Sleep Loss and Circadian Timing
Shift-Work Sleep DisorderShift Work Type Circadian Rhythm Sleep Disorder11 moreInsufficient sleep has both health and safety risks, but currently there are no quick, accurate and inexpensive ways to measure sleep deficiency. The current study aims to use a cutting-edge technology, small molecule analysis (e.g. metabolomics), to detect compounds in breath that reliably change with sleep-wake state and those whose levels vary by time of day.
CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal SyndromeA Phase II, multicenter, double blind, double dummy, randomized, 2 arms parallel study to evaluate the efficacy, safety and pharmacokinetics of CHF6563 in babies with Neonatal Opioid Withdrawal Syndrome
Adverse Long-term Consequences of Sleep Disordered Breathing: The Ottawa Hospital (TOH) Sleep Database...
PolysomnographySleep Apnea Syndromes6 moreThe primary purpose of the proposed study is to validate our previously developed predictive model for adults with obstructive sleep apnea using (i) clinical data from multiple large academic centers, (ii) a longer follow-up period, and (iii) an extended definition of outcomes of interest. The TOH sleep database was created as a part of the project: "Validation of provincial health administrative data algorithms to identify patients with obstructive sleep apnea (OSA): Feasibility project". Protocol ID: 20170591-01H (AMENDMENT APPROVED on December 19, 2018) to be used for future clinical, research, educational and quality improvement purposes.
Efficacy, Safety and Tolerability of Enteric-Coated Cholestyramine Capsules for Adult Short Bowel...
Short Bowel SyndromeA new Enteric-Coated Cholestyramine (ECC) capsule has been developed to manage diarrhea associated with Short Bowel Syndrome (SBS) in adults. The formulation is expected to release cholestyramine in the remaining segment of the small intestine in SBS patients, thus binding bile acids after fat digestion, but before induction of diarrhea in the colon. The delayed-release profile is also expected to help reduce the potential for drug-drug interactions occurring in the proximal small intestine. Two doses of ECC will be studied for efficacy, safety and tolerability in this Phase IIa trial.
Olorinab in Irritable Bowel Syndrome With Predominant Constipation (IBS-C) and Irritable Bowel Syndrome...
Irritable Bowel SyndromeThe purpose of this study is to determine whether olorinab is a safe and effective treatment for abdominal pain in participants with irritable bowel syndrome (IBS).