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NCT ID: NCT03906071 Active, not recruiting - Clinical trials for Metastatic Non-Squamous Non-Small Cell Lung Cancer

Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

SAPPHIRE
Start date: July 15, 2019
Phase: Phase 3
Study type: Interventional

This study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

NCT ID: NCT03905707 Recruiting - Clinical trials for Short Bowel Syndrome

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

EASE SBS 2
Start date: May 7, 2019
Phase: Phase 3
Study type: Interventional

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

NCT ID: NCT03905525 Completed - Sjögren Syndrome Clinical Trials

Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjogren's Syndrome

TWINSS
Start date: October 1, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of CFZ533 (iscalimab) in patients with Sjögren's Syndrome.

NCT ID: NCT03905408 Completed - Clinical trials for Postoperative Air Leak

Pleurodesis Using Hypertonic Glucose to Treat Post-operative Air Leaks

PLUG-I
Start date: September 17, 2019
Phase: Phase 1
Study type: Interventional

The investigators will define the most appropriate safe dose of D50 to heal air leaks in patients that have undergone lung resection surgery

NCT ID: NCT03905330 Completed - Clinical trials for Progressive Familial Intrahepatic Cholestasis (PFIC)

A Study to Evaluate the Efficacy and Safety of Maralixibat in Subjects With Progressive Familial Intrahepatic Cholestasis (MARCH-PFIC)

MARCH-PFIC
Start date: July 9, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).

NCT ID: NCT03904836 Completed - Renal Dialysis Clinical Trials

Tobramycin Administered at the Beginning of Dialysis

ESRD
Start date: January 31, 2019
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate whether the administration of a full tobramycin dose (5 mg/kg) during the first 30 minutes of a hemodialysis session provides favorable pharmacokinetic parameters in subjects with end-stage renal disease who are suspected or has been diagnosed with Gram-negative rod-type infection. It is anticipated that the administration of a single 5 mg/kg dose of tobramycin during the first 30 minutes of a hemodialysis session will achieve an optimal ratio of maximum tobramycin concentration to minimal inhibitory concentration (Cmax/CMI) of 8 to 10 while limiting the accumulation (trough < 2 mg/L before the next hemodialysis session) in end-stage renal disease subjects requiring intermittent hemodialysis sessions.

NCT ID: NCT03904693 Active, not recruiting - Clinical trials for Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)

Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)

A DUE
Start date: July 29, 2019
Phase: Phase 3
Study type: Interventional

Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.

NCT ID: NCT03904511 Completed - Anxiety Clinical Trials

Safety, Tolerability and Behavioural Effects of Souroubea-Platanus in Healthy Volunteers

Start date: May 15, 2019
Phase: Phase 1
Study type: Interventional

Souroubea sympetala extracts have shown anxiolytic properties in animal models. Souroubea and its active principle betulinic acid appear to exert these effects by acting as an agonist for the benzodiazepine (BZD) binding site of the GABAA receptor with no withdrawal effects on food intake, locomotor activity, or other symptoms typically associated with BZD agonism. As such, this may offer a valuable source for an alternative anti-anxiety treatment. The primary objective of this study is to (1) to evaluate the safety and tolerability of a single daily dose of an extract of a mixture of Souroubea spp. leaf and small branch material and Platanus spp. bark when administered orally over two weeks in healthy volunteers. Based on its safety in canine trials, we hypothesize that Souroubea-Platanus (SP) preparation will be well tolerated with adverse event profile similar to placebo. The secondary objective is (2) to establish whether some of the anxiolytic properties of Souroubea-platanus seen in animal models will translate to human participants. We hypothesize that Souroubea-Platanus preparation will demonstrate anxiolytic and/or stress-reduction properties as indicated by salivary cortisol levels and self-report measures of anxiety.

NCT ID: NCT03904147 Active, not recruiting - Clinical trials for Tricuspid Regurgitation

TRILUMINATE Pivotal Trial

Start date: August 21, 2019
Phase: N/A
Study type: Interventional

The primary objective of this trial is to demonstrate the safety and effectiveness of the TriClip device in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (TriClip device) to Control (Medical Therapy).

NCT ID: NCT03903913 Recruiting - Cystic Fibrosis Clinical Trials

Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis

Start date: August 8, 2019
Phase: Phase 2
Study type: Interventional

This is a single center, open label, Phase IIa, multiple-ascending dose study in which subjects with mild to moderate Cystic Fibrosis and non CF bronchiectasis (n≤12) will be enrolled. The safety and tolerability of S-1226 composed of PFOB with ascending doses of carbon dioxide (4%, 8%, and 12% CO2) administered twice daily in subjects with Cystic Fibrosis and non CF bronchiectasis will be evaluated. This will be followed by 5 day consecutive treatment using the highest tolerated dose of S1226. Participants can choose additional use of a further four weeks (28 days) of S-1226 therapy at home, using same or a lower tolerated dose.