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NCT ID: NCT01867125 Completed - Asthma Clinical Trials

A Study of Lebrikizumab in Participants With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

Start date: July 31, 2013
Phase: Phase 3
Study type: Interventional

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

NCT ID: NCT01866761 Completed - Atherosclerosis Clinical Trials

Relationship Analysis Between Periodontal Disease and Atherosclerosis in Japanese Medical Cooperation Services

RAPA-JMCS
Start date: November 2008
Phase: N/A
Study type: Observational [Patient Registry]

Objective: We aimed at analyzing the relationship between periodontal disease and atherosclerosis in medical treatment and periodontal treatment under medical and dental care across borders in a local cooperation system of Japanese medical services. Materials and methods: - A prospective multi-center case cohort study was conducted on 37 ambulatory medical patients (with lifestyle-related diseases under consultation in either of the medical clinics registered as collaborative investigation facilities) and 79 periodontal patients (who were seen by the dental clinics registered as collaborative investigation facilities). - Medical treatment and clinical periodontal treatment were provided on the subjects under medical and dental care across borders by each internal medicine and dental clinics. - Systemic examination of lifestyle-related disease and periodontal examination were performed before and after periodontal treatment, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed before and after periodontal treatment.

NCT ID: NCT01864746 Completed - Breast Cancer Clinical Trials

A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

PENELOPE-B
Start date: October 30, 2013
Phase: Phase 3
Study type: Interventional

The PENELOPEB study is designed to demonstrate that, in the background of standard anti-hormonal therapy, palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

NCT ID: NCT01863771 Completed - Colitis, Ulcerative Clinical Trials

A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.

Start date: April 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese participants with moderately to severely active ulcerative colitis.

NCT ID: NCT01863745 Completed - Clinical trials for Gastrointestinal Stromal Tumors

Nilotinib Roll-over Protocol for Patients in Novartis-sponsored Nilotinib Study and Benefiting From Nilotinib Treatment

Start date: June 25, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to collect and assess long-term safety of nilotinib in patients who are on nilotinib treatment in a Novartis-sponsored, Oncology CD&MA study and are benefiting from the treatment as judged by the investigator.

NCT ID: NCT01863680 Completed - Embryo Transfer Clinical Trials

Phase 3 Trial to Evaluate the Efficacy and Safety of COL-1620 Vaginal Progesterone Gel

Start date: July 2013
Phase: Phase 3
Study type: Interventional

The primary objective of this trial is to demonstrate the non-inferiority of the clinical pregnancy rate per embryo transfer to the historical standard value in in-vitro fertilization (IVF)/embryo transfer (ET) cycles in Japan (Japan Society of Obstetrics and Gynecology [JSOG] 2009 registry data: 24.3 percent [%]). The secondary objectives of this trial are to assess the biochemical pregnancy rate per ET, pharmacokinetics, and safety of COL-1620.

NCT ID: NCT01862627 Completed - Clinical trials for Normal Tension Glaucoma

Macular Retinoschisis and Detachment Associated With Glaucomatous Optic Neuropathy

Start date: December 2004
Phase: N/A
Study type: Observational

Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.

NCT ID: NCT01862276 Completed - Clinical trials for Intrahepatic Cholangiocarcinoma

Role of Bile Duct Resection in Major Hepatectomy Due to Intrahepatic Cholangiocarcinoma

Start date: March 2013
Phase: N/A
Study type: Observational

To investigate the prognosis due to presence or absence of bile duct resection in intrahepatic cholangiocarcinoma that require hepatic lobectomy.

NCT ID: NCT01861522 Completed - Clinical trials for Perennial Allergic Rhinitis

The Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis

Start date: April 2013
Phase: Phase 3
Study type: Interventional

The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis and to investigate safety of TAU-284.

NCT ID: NCT01861483 Completed - Clinical trials for Biliary Tract Cancer

Vessel Resection and Reconstruction of Biliary Tract Cancers

Start date: March 2013
Phase: N/A
Study type: Observational

To investigate the vessel resection and reconstruction in biliary tract cancer.