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NCT ID: NCT02343705 Terminated - Osteoarthritis Clinical Trials

Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

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

The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.

NCT ID: NCT02341625 Terminated - Advanced Cancer Clinical Trials

A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

Start date: June 19, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine the safety, tolerability, pharmacokinetics, immunogenicity, antitumor activity and pharmacodynamics of BMS-986148 administered alone and in combination with nivolumab in patients with mesothelioma, non-small cell lung cancer, ovarian cancer, pancreatic cancer and gastric cancer.

NCT ID: NCT02340221 Terminated - Breast Cancer Clinical Trials

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

SANDPIPER
Start date: April 9, 2015
Phase: Phase 3
Study type: Interventional

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

NCT ID: NCT02337699 Terminated - Clinical trials for Post Surgical Groin Pain

Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain

GASPA
Start date: January 2015
Phase:
Study type: Observational

25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.

NCT ID: NCT02336425 Terminated - Asthma Clinical Trials

Efficacy and Safety of QGE031 Compared With Placebo in Patients Aged 18-75 Years With Asthma

Start date: September 2015
Phase: Phase 2
Study type: Interventional

This study planned to assess the effect on the reduction in rate of severe asthma exacerbations of different dose levels of QGE031 in asthma patients that are inadequately controlled with inhaled steroid plus beta-2 agonist medication with or without oral steroid. However, this study was terminated due to the efficacy results from an interim analysis (at the end of treatment epoch) of the Phase II study CQGE031B2201 (NCT01716754). Planned data analyses were not performed for this study due to the early termination and the very limited dataset (only 10 participants received study medication of the 440 participants planned).

NCT ID: NCT02335229 Terminated - Clinical trials for Chronic Post Surgical Pain

A Post Market Study to Assess the Spinal Modulation Dorsal Root Ganglion Stimulator System in Chronic Post Surgical Pain

Start date: June 2013
Phase:
Study type: Observational

20-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical pain

NCT ID: NCT02335216 Terminated - Clinical trials for Failed Back Surgery Syndrome

A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)

SYMPATHY
Start date: January 2014
Phase:
Study type: Observational

18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)

NCT ID: NCT02333916 Terminated - Clinical trials for Overfeeding and Exercise

Effect of Exercise and Training on Fat Oxidation During Overfeeding - the FeedEX Study

FeedEX
Start date: June 2014
Phase: N/A
Study type: Interventional

Rationale: Body weight is not well regulated in all individuals. In an obesogenic environment, where overeating is common, some individuals are more prone to weight gain and therefore overweight than others. Yet, the reasons behind this are unclear. "Resistant" individuals often have higher physical activity levels (PALs). It seems that - at higher levels of physical activity and therefore energy expenditure - satiety signals are more precisely regulated, making one better at matching energy intake with expenditure. In other words, active people may not overeat where sedentary people would. However, this does not explain the differences in weight gain observed when subjects all have to overeat (imposed overfeeding). It could be that active people are better able to cope metabolically with the extra calories because of already higher levels of carbohydrate and fat oxidation compared to their inactive counterparts. Objectives: 1/ To study the effects of overfeeding (normal diet composition) on substrate balance and oxidation and more specifically fat balance and oxidation; 2/ to study the effects of exercise and training on fat oxidation during overfeeding (normal diet composition). Study design: This controlled intervention study will follow a cross-over design. Each subject will spend 5 nights and 4 days in a respiration chamber on two occasions, separated by a 10-week training period.

NCT ID: NCT02329769 Terminated - Clinical trials for Duchenne Muscular Dystrophy

Open Label, Extension Study of PRO044 in Duchenne Muscular Dystrophy (DMD)

Start date: December 2014
Phase: Phase 2
Study type: Interventional

The purpose of this study is to see whether PRO044 is safe and effective to use as medication for Duchenne Muscular Dystrophy (DMD) patients with a mutation around location 44 in the DNA for the dystrophin protein.

NCT ID: NCT02329171 Terminated - Clinical trials for Cervical Intraepithelial Neoplasia

Imiquimod Treatment of CIN Lesions

TOPIC
Start date: December 2014
Phase: Phase 3
Study type: Interventional

Rationale: Cervical Intraepithelial Neoplasia (CIN) is the premalignant condition of cervical cancer. High grade CIN (CIN 2-3) is currently treated by large loop excision of the transformation zone (LLETZ). This treatment has potential complications, such as hemorrhage, infection and preterm birth in subsequent pregnancies. For this reason, non-invasive therapies are needed. Imiquimod (an immunomodulator) was proven effective in the treatment of HPV-related vulvar intraepithelial neoplasia (VIN) and may also be effective in HPV-related CIN. [van Seters, 2012] However, the evidence is limited and study results are not consistent. [Grimm, 2012; Pachman, 2012; Lin, 2012] Objectives: Primary objectives: (1) to investigate the efficacy of imiquimod 5% cream for the treatment of CIN2-3 lesions and (2) to develop biomarker panels to predict clinical response to imiquimod therapy. Secondary objectives: to assess side effects of imiquimod treatment and LLETZ, disease recurrence and quality of life. Hypothesis: The investigators hypothesize that imiquimod will be an effective treatment modality in approximately 50-75% of CIN lesions treated without surgical intervention. Study design: Single-centre randomized controlled intervention trial. Study population: 140 women with a histological diagnosis of CIN2-3, equally divided over two study arms. Intervention: Patients will be randomized into one of two arms: 1. Imiquimod treatment arm. Patients in this group are treated by a 16-week regime of imiquimod 5% cream. 2. Standard treatment arm. LLETZ will be performed on patients in this group. Colposcopy with diagnostic biopsies will be performed after 10 weeks for the imiquimod treatment arm. In case progressive disease, the treatment will be ended and appropriate surgical excision will be performed. Treatment efficacy will be evaluated after 20 weeks, by colposcopy with diagnostic biopsies. A histological biomarker panel will be developed, consisting of markers representing both host and viral factors. Main study parameters/endpoints: The primary endpoint of the study is regression-or-not of CIN2-3, defined as CIN1 or less at the colposcopy at 20 weeks for the imiquimod arm and PAP 1 cytology at 6 months for the LLETZ group.