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NCT ID: NCT03163446 Completed - Clinical trials for Staphylococcus Aureus Bacteremia

Safety, Efficacy and Pharmacokinetics of CF-301 vs. Placebo in Addition to Antibacterial Therapy for Treatment of S. Aureus Bacteremia

Start date: May 23, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, efficacy and pharmacokinetics (PK) of CF-301 in addition to background standard of care (SOC) antibacterial therapy for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia), including endocarditis in adults. Patients will be randomized to receive a single intravenous dose of CF-301 or placebo in addition to SOC antibacterial therapy. Patients will be prescribed standard of care antibiotics selected by the investigators based on their professional experience, practice guidelines and local antibiotic susceptibility information for the treatment of S. aureus bacteremia. CF-301 is a lysin and member of a new class of targeted protein-based antimicrobials that has demonstrated activity against S. aureus in laboratory (in vitro) and animal studies, alone and in addition to conventional antibiotics.

NCT ID: NCT03163160 Completed - Clinical trials for Musculoskeletal Pain

Electrolysis Technique vs Manual Therapy in Pelvic Pain

Start date: June 20, 2017
Phase: N/A
Study type: Interventional

Pelvic floor muscle physical therapy is recommended in clinical guidelines for women dyspareunia and pelvic pain. This study compare pelvic floor manual therapy and intratissue percutaneous electrolysis (EPI) technique in the treatment of pelvic pain in women with dyspareunia. Half of participants will receive pelvic floor manual therapy while the other half will receive intratissue percutaneous electrolysis technique.

NCT ID: NCT03163056 Completed - Clinical trials for Tobacco Use Disorder

Smoking Cessation Treatment for Depressed Smokers

Start date: January 26, 2015
Phase: N/A
Study type: Interventional

The present research project aims to develop an innovative and empirically validated intervention protocol for smoking cessation among patients with depressive symptoms. For this purpose, two smoking cessation treatments tailored for managing depression will be compared with a standard smoking cessation treatment. Participants will be assigned to one of the following three treatment conditions: 1) Cognitive-behavioral treatment for smoking cessation (CBT); 2) CBT plus Behavioral Activation (BA); 3) CBT+BA+ Contingency Management (CM). The main goals are: 1. To assess abstinence rates in each of the above-mentioned treatment conditions conditions at short and long-term follow-ups: post-treatment, once during the first three months, and at at six after post-treatment. 1. To assess the effectiveness (relapse rate) of each treatment condition at short and long-term follow-ups: post-treatment, once during the first three months,and at six after post-treatment. 3. To analyze efficiency (cost-efficacy) and feasibility of the treatments to a community setting. 4. To analyze the moderating effect of individual variables over treatment outcomes. In particular, moderating variables will be: sociodemographic characteristics, severity of nicotine dependence, severity of depressive symptomatology and impulsivity. The study hypothesis are: 1-Adding a voucher-based CM component to CBT+BA will enhance abstinence rates and decrease both short and long-term relapse rates. 2. Providing smoking cessation treatments that include a mood management component (BA or BA+CM) will have a positive impact in ameliorating depression. 3. Certain individual variables (e.g., gender, nicotine dependence and depression severity and impulsivity) will have a moderating effect on treatment outcomes. 4. Both CBT+BA and CBT+BA+CM will prove cost-effectiveness and thus may be generalized to a clinical and community context.

NCT ID: NCT03162874 Completed - Parkinson Disease Clinical Trials

Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's Patients

AMBLED
Start date: July 4, 2017
Phase: Phase 2
Study type: Interventional

This will be a double-blind, randomised, placebo-controlled parallel-arm phase II proof of concept in subjects with PD treated with a stable dose of levodopa who are experiencing both end-of-dose wearing off and Levodopa-Induced Dyskinesia (LID)

NCT ID: NCT03162796 Completed - Clinical trials for Arthritis, Psoriatic

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

Discover-1
Start date: August 24, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

NCT ID: NCT03162250 Completed - Bacteremia Clinical Trials

Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics

Start date: July 13, 2017
Phase: Phase 1
Study type: Interventional

This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S when given in addition to anti-staphylococcal SOC antibiotics to participants with methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.

NCT ID: NCT03161483 Completed - Clinical trials for Lupus Erythematosus, Systemic

A Study to Evaluate the Efficacy and Safety of CC-220 in Subjects With Active Systemic Lupus Erythematosus

Start date: August 31, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this Phase 2, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of an oral treatment regimen of CC-220 versus placebo in adult subjects with active systemic lupus erythematosus. Approximately 280 subjects with a documented diagnosis of SLE will be randomized 2:2:1:2 to receive CC-220 (0.45 mg QD, 0.3 mg QD or 0.15 mg QD) or identically appearing placebo.

NCT ID: NCT03161132 Completed - Clinical trials for Advanced Ovarian Cancer

Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin

ROLANDO
Start date: December 13, 2017
Phase: Phase 2
Study type: Interventional

Impact of the combination of Olaparib and Pegylated Liposomal Doxorubicin on improvement of progression-free survival at 6 months in patients with platinum resistant advanced ovarian cancer.

NCT ID: NCT03161093 Completed - Clinical trials for Osteoarthritis, Knee

A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

FACT OA1
Start date: August 17, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the efficacy of fasinumab compared with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip

NCT ID: NCT03160898 Completed - Clinical trials for Amyotrophic Lateral Sclerosis

A Study to Evaluate Efficacy, Safety and Tolerability of CK-2127107 in Patients With Amyotrophic Lateral Sclerosis (ALS)

FORTITUDE-ALS
Start date: July 24, 2017
Phase: Phase 2
Study type: Interventional

The purpose of this study was to assess the effect of CK-2127107 (hereafter referred to as reldesemtiv) versus placebo on respiratory function and other measures of skeletal muscle function in patients with ALS.