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NCT ID: NCT03403205 Not yet recruiting - Wilson Disease Clinical Trials

Efficacy and Safety of WTX101 Administered for 48 Weeks Versus Standard of Care in Wilson Disease Subjects

Start date: January 31, 2018
Phase: Phase 3
Study type: Interventional

Wilson Disease (WD) is an autosomal recessive disorder of impaired copper (CU) transport caused by mutations in the ATP7B gene. WTX101 (bis-choline tetrathiomolybdate) is a first-in-class copper-protein-binding agent with a unique mechanism of action, under investigation as a novel therapy for WD. It is formulated as an enteric coated tablet (15 mg strength) for oral administration. The purpose of this study is to evaluate the efficacy of WTX101 administered for 48 weeks compared to standard of care (SOC) in WD subjects aged 18 and older.

NCT ID: NCT03401229 Not yet recruiting - Nasal Polyposis Clinical Trials

Efficacy and Safety Study of Benralizumab for Patients With Severe Nasal Polyposis

OSTRO
Start date: January 15, 2018
Phase: Phase 3
Study type: Interventional

The aim of this present study is to investigate the use of benralizumab as treatment for severe nasal polyposis. The effect of benralizumab on nasal polyps will be assessed over a 56 weeks of treatment period in patients with severe bilateral nasal polyposis who are still symptomatic despite standard of care therapy, i.e current use of intranasal corticosteroids (INCS) and prior surgery and/or use of systemic corticosteroids. The first 200 patients that complete the 56-week treatment will have a 6 month follow-up (FU) period without dosing.

NCT ID: NCT03400800 Recruiting - Clinical trials for Elevated Cholesterol

Inclisiran for Subjects With Atherosclerotic Cardiovascular Disease and Elevated Low-density Lipoprotein Cholesterol

ORION-11
Start date: November 1, 2017
Phase: Phase 3
Study type: Interventional

This is a Phase III, placebo-controlled, double-blind, randomized study in participants with ASCVD and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of subcutaneous (SC) inclisiran injection(s). The study will be an international multicenter study (non-United States).

NCT ID: NCT03390036 Enrolling by invitation - Clinical trials for Osteo Arthritis Knee

Study of Cingalâ„¢ for the Relief of Knee Osteoarthritis Compared to Triamcinolone Hexacetonide at 39 Weeks Follow up

Cingal17-02
Start date: December 7, 2017
Phase: Phase 3
Study type: Interventional

The objective of this sub-study is to evaluate the efficacy and safety at 39 week follow up of a single injection of Cingal for relief of joint pain in subjects with OA of the knee who have not responded to conservative treatment (weight reduction, physical therapy, pain medications, etc.).

NCT ID: NCT03385642 Recruiting - Clinical trials for Osteochondral Defect

Follow-Up Study Evaluating the Long Term Outcome of ChondroMimetic in the Treatment of Osteochondral Defects in the Knee

Start date: May 29, 2017
Phase: N/A
Study type: Observational

To investigate the long-term efficacy and safety of the medical device, ChondroMimetic, in subjects who were treated in the interventional study 0MCM0107 for osteochondral defects of the knee.

NCT ID: NCT03377075 Active, not recruiting - Healthy Clinical Trials

Study of the Choroidal and Retinal Thickness in Relation to Axial Length.

CHORAL
Start date: February 6, 2017
Phase: N/A
Study type: Observational

The aim of the study is the non-invasive morphological evaluation of the choroid and the retina in relation to the length of the eyeball in healthy, young man and women.

NCT ID: NCT03374488 Recruiting - Clinical trials for Recurrent or Progressive Metastatic Urothelial Carcinoma

Pembrolizumab + Epacadostat vs Pembrolizumab + Placebo in Recurrent or Progressive Metastatic Urothelial Carcinoma

Start date: December 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of pembrolizumab + epacadostat vs pembrolizumab + placebo as a treatment for recurrent or progressive metastatic urothelial carcinoma in patients who have failed a first-line platinum-containing chemotherapy regimen for advanced/metastatic disease.

NCT ID: NCT03373422 Recruiting - Endometriosis Clinical Trials

A Study to Test Whether Study Drug BAY1128688 Brings Pain Relief to Women With Endometriosis and if so to Get a First Idea Which Dose(s) Work Best

AKRENDO1
Start date: November 30, 2017
Phase: Phase 2
Study type: Interventional

Purpose of the study is to test whether study drug BAY1128688 brings relief for pain to women with endometriosis and if so to get a first impression which dose(s) work best.

NCT ID: NCT03371017 Recruiting - Clinical trials for Triple Negative Breast Neoplasms

A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients With Early Relapsing Recurrent Triple-Negative Breast Cancer

IMpassion132
Start date: January 31, 2018
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy and safety of atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent triple-negative breast cancer (TNBC).

NCT ID: NCT03364465 Active, not recruiting - Pneumonia Clinical Trials

Lung Protective One-lung Ventilation With Fix and Variable Tidal Volume

Start date: February 1, 2017
Phase: N/A
Study type: Interventional

During One-lung ventilation, the use of lower tidal volumes (VT) is helpful to avoid over-distension, provide sufficient oxygenation, but can result in increased atelectasis. Nevertheless, it is not known if, during one-lung ventilation with constant low VT, moderate levels of PEEP combined with lung recruitment maneuvers are superior to variable low tidal volume for intraoperative oxygenation and protection against PPCs. Aim of the study is to compare a strategy using constant tidal volume with recruitment maneuvers versus variable tidal volume with recruitment maneuvers during thoracic surgery in adults. We hypothesize that in adult, non-obese patients undergoing thoracic surgery under standardized OLV with variable tidal volumes, modearte PEEP and recruitment maneuvers as compared to constant without recruitment maneuvers prevent PPCs. Patients will be randomly assigned to one of two groups: FIX TIDAL VOLUME GROUP (Groupfix): mechanical ventilation with constant (6 ml/kgIBW) tidal volume and PEEP of 5 cmH2O with recruitment maneuvers VARIABLE TIDAL VOLUME GROUP (Groupvar): mechanical ventilation with variable (6 ml/kgIBW ± 33%) tidal volume with variable respiratory rate to maintain constant minute ventilation and PEEP of 5 cmH2O with recruitment maneuvers.