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NCT ID: NCT04165824 Completed - ALS Clinical Trials

Safety Study of Oral Edaravone Administered in Subjects With ALS

Start date: November 18, 2019
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

NCT ID: NCT04165707 Completed - Clinical trials for Overweight and Obesity

A Weight Loss RCT Comparing Keyto vs Weight Watchers

Start date: December 9, 2019
Phase: N/A
Study type: Interventional

Very low-carbohydrate ketogenic diet may have beneficial metabolic and weight loss effects, however, adhering to this diet may be challenging. Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote dietary change and weight loss. The purpose of this research is to test the Keyto self-monitoring + app intervention against a "standard of care" weight loss dietary app (Weight Watchers). 144 participants will be recruited through Facebook ads, provide online consent, and will be randomized to one of the two conditions. Weight loss after 12 weeks will be assessed as the primary outcome, with weight loss at 24 and 48 weeks being secondary outcomes. Blood samples will be collected at baseline and 12 weeks with optional blood samples at 48 weeks follow up.

NCT ID: NCT04165408 Recruiting - Clinical trials for Urinary Incontinence

Trial to Assess the Safety and Clinical Performance of Contino® in Preventing Urinary Incontinence

Start date: November 19, 2019
Phase: N/A
Study type: Interventional

This trial is to assess the safety and clinical performance of Contino device is preventing Urinary Incontinence in male subjects with Sphincteric Incompetence

NCT ID: NCT04165395 Recruiting - Clinical trials for Spinal Cord Injuries

Evaluate the Incidence of Sacral and Heel Pressure Ulcers During Acute Care After SCI

Start date: August 19, 2019
Phase: N/A
Study type: Interventional

This study evaluates the effect of the application of a five-layer foam dressing on the sacrum as well as a boot applied on the heels as preventive measures in the development of pressure ulcers in patients hospitalized with spinal cord injury. In order to study their effectiveness in preventing wounds, we will compare the number of wounds that developed on the sacrum and heels in participants with and without preventive treatments. The study will also assess the severity of pressure ulcers in participants with and without preventive treatment if they do develop. Half of the participants will receive the usual standard care for the prevention of pressure ulcers without dressing and boot, while the other half, in additon to standard of care, will also have a preventive dressing on the sacrum as well as Heelmedix boot applied alternately on each foot.

NCT ID: NCT04165317 Active, not recruiting - Clinical trials for Non-muscle Invasive Bladder Cancer

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

CREST
Start date: December 30, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B). In Part A (enrollment closed), each participant was assigned to one of three study treatment groups. - One group is given sasanlimab and BCG at the study clinic. - The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only. - The third group is given BCG only and will not receive sasanlimab. In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor. - Both groups will be given sasanlimab at the study clinic. On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

NCT ID: NCT04164901 Active, not recruiting - Recurrent Glioma Clinical Trials

Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

Start date: January 5, 2020
Phase: Phase 3
Study type: Interventional

Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.

NCT ID: NCT04164719 Completed - Healthy Subjects Clinical Trials

Dose-Proportionality and Food Effect Study of TNX-102 SL

Start date: October 14, 2019
Phase: Phase 1
Study type: Interventional

This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.

NCT ID: NCT04164264 Active, not recruiting - Anesthesia Clinical Trials

Genetic Differences in Propofol Pharmacodynamics in Children

Start date: March 11, 2020
Phase: Phase 4
Study type: Interventional

Propofol is an extensively utilized intravenous sedative and general anesthetic. However, propofol has a narrow therapeutic index, and this means that there is only a small difference in the dose required to produce loss of consciousness and the dose required to produce potentially life-threatening effects such as loss of protective airway reflexes and cessation of spontaneous breathing. Moreover, there is substantial variation between individuals in the doses required to achieve these pharmacodynamic endpoints. Given the inexorable rise in demand for pediatric sedation and the increasing use of propofol in sedation protocols by non-anaesthesiologists, the purpose of this study is to refine the propofol dosing recommendations to account for pharmacogenomic variability to make procedural sedation safer for children. Experienced users already adjust for age and body weight. This study may enable further refinements according to sex and - novelly - ancestry.

NCT ID: NCT04163978 Completed - Chronic Sinusitis Clinical Trials

Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS)

Start date: October 27, 2019
Phase: Phase 2
Study type: Interventional

This a single center, randomized controlled trial to evaluate safety & efficacy of topical nitric oxide releasing sinus irrigation (NOSi) as compared to budesonide-Saline (Control) in the management of biofilm-associated recalcitrant chronic rhinosinusitis (RCRS). It is hypothesized that a daily treatment of NOSi over a 6-week period will be safe and effective at reducing clinical symptoms associated with RCRS.

NCT ID: NCT04163900 Terminated - Clinical trials for Biliary Tract Cancer

Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

Start date: December 24, 2019
Phase: Phase 3
Study type: Interventional

NuTide:121 compares NUC-1031 with gemcitabine, both in combination with cisplatin, in patients with previously untreated advanced biliary tract cancer. The primary hypotheses are: - The combination of NUC-1031 plus cisplatin prolongs overall survival compared to the gemcitabine plus cisplatin standard of care - The combination of NUC-1031 plus cisplatin increases overall response rate compared to the gemcitabine plus cisplatin standard of care