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NCT ID: NCT02543489 Active, not recruiting - Clinical trials for Osteoarthritis of the Knee

Flex Intramedullary Rod Study

Start date: December 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the effect of post-operative ROM between Flex IM rod and Rigid IM rod, to collect bone morphology of Japanese lower extremity and to research the incidence of overhung with Flex IM rod.

NCT ID: NCT02543476 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

SUPREME-HN A Retrospective Cohort Study of PD-L1 in Recurrent and Metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN)

SUPREME-HN
Start date: September 16, 2015
Phase: N/A
Study type: Observational

This is a retrospective international, multi-center, non-interventional cohort study based on use of data derived from established medical records and secondary analysis of archival tumor samples. The study will collect data on patient and tumor characteristics, PD-L1 status, patterns of treatment, and clinical outcomes, in up to 600 adult patients with recurrent/metastatic SCCHN. SCCHN of interest for this study are defined as the diseases falling into specific ICD-10 or International Classification of Diseases, Ninth Revision (ICD-9) codes (Table 1), depending on anatomical sub-site of the primary tumor. For patient selection, the date of diagnosis of recurrent/metastatic disease will be used as the index date. The patient selection period extends from the 1st March 2011 to the 30th June 2015. This allows for the inclusion of patients with tumor samples of approximately ≤ 5 years age, and ensures approximately 10 months follow-up for living patients recruited at last day of the enrollment window. All patients with a diagnosis of recurrent/metastatic SCC of the oral cavity (tongue, gum, floor of mouth, and other/unspecified part of the mouth), oropharynx, hypopharynx, or larynx during that period will be considered for inclusion in the study (Figure 1). Patients will be identified and followed up through their medical records until death or end of data collection in approximately 20 centers in the US, Asia and Europe. Patients' demographic, clinical characteristics, and medical history will be described. Clinical outcomes including PFS, best response, duration of response, and ORR will be described for the first line and second line of therapy (if any), and OS will be collected A mandatory archived tumor samples will be used to determine PD-L1 status. If a patient has more than one suitable tissue sample, the most recent sample will be used as the mandatory tissue sample. Where available, additional tumor samples obtained at any other time points of the disease will be also collected (optional). The enrolment target is up to 600 patients. Statistical analyses will be performed for the whole cohort, per PD-L1 status and for predefined subgroups.

NCT ID: NCT02543463 Completed - Clinical trials for Degenerative Joint Disease

Navigation With X3 vs Non-Navigation With X3 Study

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

The purpose of this study is to compare the effect of the large head in THA with a navigation system and without a navigation system.

NCT ID: NCT02543437 Active, not recruiting - Clinical trials for Degenerative Joint Disease

Large Head X3 Study

Start date: July 2010
Phase: N/A
Study type: Interventional

The purpose of this study is to explore the benefit of X3 polyethlene inserts with larger diameter heads used in the Japanese population. Range of Motion (ROM) and lift-off distance for both 28mm, 32mm and 36mm in patients will be examined intraoperatively by using the Stryker computerized tomography (CT) based Navigation system. Another aspect of this study is to observe wear resistance performance of X3 over historical liner existing highly crosslinked polyethylene.

NCT ID: NCT02542293 Active, not recruiting - Clinical trials for Non Small Cell Lung Carcinoma NSCLC

Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE)

NEPTUNE
Start date: November 3, 2015
Phase: Phase 3
Study type: Interventional

This is a randomized, open-label, multi-center, global, Phase III study to determine the efficacy and safety of durvalumab + tremelimumab combination therapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type advanced or metastatic NSCLC.

NCT ID: NCT02541942 Completed - Clinical trials for Congenital Bleeding Disorder

Pharmacogenetic Testing of Saliva Samples From Patients With Five or More Exposure Days to rFVIIa Analogue in the Adept™2 Trial

Start date: April 3, 2015
Phase: Phase 2
Study type: Interventional

This study is conducted globally. This study describes pharmacogenetic testing of saliva samples from patients who participated in the NN1731-3562 trial (adept™2) (NCT01392547). The objective is to determine the HLA (human leukocyte antigen) type and polymorphisms in the FVII gene in patients previously exposed to rFVIIa analogue.

NCT ID: NCT02541084 Completed - Clinical trials for Wet Macular Degeneration

Caregiver Burden of Wet Age-related Macular Degeneration (wAMD) in Japan

Start date: August 18, 2015
Phase: N/A
Study type: Observational

This study aims at investigation of the caregiver burden of Wet Age-related Macular Degeneration (wAMD) patients and at the assessment of how much of caregiver burden could be reduced in transitioning from Pro Re Nata to proactive therapy especially in real-life rural settings where public transportations are not readily available.

NCT ID: NCT02540993 Completed - Clinical trials for Chronic Kidney Disease

Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease

FIDELIO-DKD
Start date: September 17, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study was to demonstrate whether, in addition to standard of care, finerenone is superior to placebo in delaying the progression of kidney disease, as measured by the composite endpoint of time to first occurrence of kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥40% from baseline over at least 4 weeks, or renal death.

NCT ID: NCT02540967 Completed - Clinical trials for Magnetic Resonance Imaging

Drug Use Investigation of Gadovist.

Start date: October 27, 2015
Phase:
Study type: Observational

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

NCT ID: NCT02539225 Completed - Clinical trials for Gastroesophageal Junction Adenocarcinoma

A Study of Ramucirumab in Participants With Gastric or Gastroesophageal Junction Adenocarcinoma

Start date: October 5, 2015
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the effectiveness of S-1 and oxaliplatin with or without ramucirumab as first line therapy in participants with metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.