Clinical Trials Logo

Filter by:
NCT ID: NCT02706951 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Start date: March 23, 2016
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.

NCT ID: NCT02706886 Completed - Clinical trials for Primary Hyperoxaluria Type 1 (PH1)

Study of Lumasiran in Healthy Adults and Patients With Primary Hyperoxaluria Type 1

Start date: March 8, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single-ascending doses (SAD) and multiple-ascending doses (MAD) of lumasiran in healthy adult volunteers and subjects with primary hyperoxaluria type 1 (PH1). In Part A, single ascending dose (SAD) part, healthy adults were dosed with lumasiran or placebo once. In Part B, multiple ascending doses (MAD) part, patients with primary hyperoxaluria type 1 (PH1) were dosed with lumasiran or placebo. All patients that initially received placebo received lumasiran after completing placebo dosing.

NCT ID: NCT02706873 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

SELECT-EARLY
Start date: February 23, 2016
Phase: Phase 3
Study type: Interventional

The objectives of Period 1 were the following: - To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; - To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

NCT ID: NCT02706847 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

SELECT-BEYOND
Start date: March 15, 2016
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

NCT ID: NCT02705781 Completed - Clinical trials for Aspiration Pneumonia

Functionality and Accuracy of the smARTrack System in Real-Life ICU Settings

Start date: March 23, 2016
Phase: N/A
Study type: Interventional

This study conducted in order to validate the functionality and accuracy of the smARTrack™ System in a real-life ICU setting. The smARTrack™ Feeding Tube System is a novel system with nasogastric tube developed by ART Healthcare Ltd, based on sensor-lined tubes that transmit real-time information to an external console. The smARTrack™ feeding tube is equipped with reflux sensors which alert when gastric contents regurgitating into the esophagus. In addition, the smARTrack™ feeding tube is equipped with sensors designed to provide information about the location of the tube thus assisting in reducing the incident of misplacement during first positioning. The smARTrack™ feeding tube is also automatically and in real-time stops feeding if the feeding tube moves out of position during ongoing use or detect gastric content in esophagus. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.

NCT ID: NCT02704429 Completed - Pemphigus Vulgaris Clinical Trials

A Study of PRN1008 in Adult Patients With Pemphigus Vulgaris

Start date: January 22, 2016
Phase: Phase 2
Study type: Interventional

Open-label cohort study in adult patients with newly diagnosed or relapsing pemphigus vulgaris, with intra-patient dose-adjustment based on clinical response and BTK occupancy, and with conventional immunosuppressive "rescue treatment", if indicated. The duration of therapy in Part A will be 12 weeks, followed by 12 weeks of follow up. The extension phase, Part B includes 24 weeks of therapy, followed by 4 weeks of follow-up.

NCT ID: NCT02702388 Completed - Thyroid Cancer Clinical Trials

A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

Start date: June 8, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

NCT ID: NCT02702180 Completed - Clinical trials for Autoimmune Pulmonary Alveolar Proteinosis

Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis

IMPALA
Start date: March 21, 2016
Phase: Phase 2
Study type: Interventional

This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor [rhGM-CSF]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.

NCT ID: NCT02698007 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy

Start date: April 2016
Phase: N/A
Study type: Interventional

Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years. Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough. Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide. Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation. Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients. Or benefits and safety LMA in front of intubation during bronchoscopy. Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy . Another objective, to examine whether there is a special group of patients enjoy the LMA more than others. Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control. Study group : LMA is inserted under sedation and used during the procedure. Control group - performing bronchoscopy under sedation without LMA. About 50 people are needed each group.

NCT ID: NCT02697981 Completed - Pregnancy Clinical Trials

Effect of Personalized Nutrition Counseling in Pregnant Women After Bariatric Surgery on Nutritional Status and Habits

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

Background: Nutrition challenges follow bariatric surgery can intensify during pregnancy and may have a crucial effect on fetus. To the best of the investigators knowledge, the effect of nutritional counseling on improvement of maternal diet quality and eating habits among post- bariatric pregnant women has not been evaluated. Objective: study aims to expand the existing limited knowledge in respect to post bariatric pregnant women's eating habits and quality of food intake, and to investigate the impact of nutrition counseling on these factors. Design: This is a controlled clinical trial comparing post Laparoscopic sleeve gastrectomy (LSG) pregnant women who received nutritional counseling with age-matched control healthy pregnant women. Counseling will focus on improving quality of food consumption, eating habits and behavioral changes in order to improve the mother and the fetus' nutritional status Nutritional data and eating behavior will be obtained using 24 hours recall dietary records and the Family Eating and Activity Habit Questionnaire (FEAHQ).