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NCT ID: NCT01559272 Completed - Schizophrenia Clinical Trials

A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Paliperidone Palmitate in Patients With Schizophrenia

Start date: February 21, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics, safety, and tolerability of a paliperidone palmitate 3-month formulation in patients with schizophrenia.

NCT ID: NCT01558960 Terminated - Retinoblastoma Clinical Trials

Intravitreal Injections of Melphalan for Retinoblastoma

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

Retinoblastoma treatment has become more and more focused in the last years. New treatments developed by Dr. Kaneko from Japan in 1995 are now being tested in clinical trials. Intra-arterial chemotherapy with Melphalan has shown success in some patients but with limited response when there is marked vitreal seeding. For these cases Intravitreal injections of Melphalan have been successful in Japan. In this study the same chemotherapy (melphalan) will be administered intravitreally (directly through the eye wall) and the response (short and long term) will be monitored.

NCT ID: NCT01558635 Terminated - Clinical trials for Longstanding Persistent Atrial Fibrillation

Evaluation of the Cardioblate CryoFlex Surgical Ablation System in Longstanding Persistent Atrial Fibrillation

CRYO-AF
Start date: November 2011
Phase: N/A
Study type: Interventional

Studies have shown that taking drugs to stay out of AF has limited success. This research is designed to study heart rhythm after surgical therapy, namely by measuring if there are benefits to having surgery to treat Atrial Fibrillation (AF) with the Cardioblate CryoFlex Surgical Ablation System. The system is approved and commercially available with CE mark. The purpose of this study is to support clinical evidence that the Cardioblate System is safe and effective to treat AF.

NCT ID: NCT01557777 Completed - Clinical trials for Chronic Lymphocytic Leukemia

Open-label Extension Study of Navitoclax in Subjects With Chronic Lymphocytic Leukemia (CLL)

Start date: June 2012
Phase: Phase 2
Study type: Interventional

Open-label extension study of navitoclax in subjects with chronic lymphocytic leukemia (CLL).

NCT ID: NCT01557400 Completed - Clinical trials for Duchenne Muscular Dystrophy

Study of Ataluren for Previously Treated Participants With Nonsense Mutation Duchenne/Becker Muscular Dystrophy (nmDBMD) in Europe, Israel, Australia, and Canada

Start date: May 20, 2012
Phase: Phase 3
Study type: Interventional

Duchenne/Becker muscular dystrophy (DBMD) is a genetic disorder that develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability during childhood and teenage years. A specific type of mutation, called a nonsense (premature stop codon) mutation, is the cause of DBMD in approximately 10-15% of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. This study comprises a Phase 3, open-label study of ataluren in participants with nmDBMD who previously received ataluren at an Investigator site in a prior PTC-sponsored clinical study. A separate open-label study (PTC124-GD-016-DMD; NCT01247207) is being conducted for nmDBMD participants who previously received ataluren at an Investigator site in the United States (US).

NCT ID: NCT01555710 Active, not recruiting - Clinical trials for Extensive-Stage Small Cell Lung Cancer

Study of Palifosfamide-tris in Combination With Carboplatin and Etoposide in Chemotherapy Naïve Patients With Extensive-Stage Small Cell Lung Cancer (The MATISSE Study)

Start date: May 2012
Phase: Phase 3
Study type: Interventional

This is a multinational, multicenter, randomized controlled, open-label, adaptive study to evaluate the efficacy of PaCE chemotherapy in chemotherapy naive subjects with extensive-stage SCLC. Eligible subjects will be stratified according to age, gender, and Eastern Cooperative Oncology Group (ECOG) performance status, and randomized in a 1:1 ratio to receive either PaCE or CE chemotherapy. The study design uses an adaptive group sequential approach with sample size re-estimation at the interim analysis. Secondary efficacy endpoints include ORR, PFS, duration of response and changes in QOL and disease-related symptoms. Tumor-related endpoints will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guidelines. The safety of study treatments will be assessed by the frequency and severity of adverse events as determined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03. To provide an initial confirmation of safety, an early interim analysis of safety data only will be performed. An independent Data Monitoring Committee (DMC) will be convened to assess the safety and efficacy of the study interventions and to monitor the overall conduct of the clinical trial.

NCT ID: NCT01555359 Recruiting - Multiple Myeloma Clinical Trials

Telomerase Activity as a Marker For Mobilization Quality

Start date: February 2012
Phase: N/A
Study type: Observational

Autologous hematopoietic cell transplantation (HCT) is a treatment strategy used as advanced line therapy for different malignancies, mainly hematological. Its main advantage lies in the ability to provide hematologic and immune rescue after high dose chemotherapy therapy. The first requirement of a successful transplantation is recruitment of sufficient amount of cells. This is achieved by mobilizing CD34+ stem cells from the bone marrow to the peripheral blood, by G-CSF priming, and then harvesting the cells from the peripheral blood at the right timing by means of apheresis. Currently, the decision on the optimal collection timing is based on the pre-collection CD34 cells blood concentrations. The investigators goal is to investigate whether telomerase, the telomere elongation enzyme, which constitutionally and solely expressed in progenitor cells, is correlated with collection and post HCT engraftment characteristics. The investigators will collect blood from patients when starting GCSF and on the day of planned apheresis. Pearson correlation test will be used to correlate between telomerase activity in the samples and with collection and engraftment characteristics.

NCT ID: NCT01555164 Completed - Clinical trials for Type 2 Diabetes Mellitus

A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

Start date: June 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.

NCT ID: NCT01555112 Completed - Condyloma Acuminata Clinical Trials

Safety and Efficacy Study to Test Topical AS101 for External Genital Warts

Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to determine whether the improved topical ointment formulation, AS101, is safe and effective in the treatment of external genital warts in females.

NCT ID: NCT01555034 Completed - Obesity Clinical Trials

Movement Therapy and Childhood Obesity

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

The Child health and Sports Center, Meir Medical Center, has an intervention program to treat obese children. The program includes physical activity, nutritional intervention and behavioral treatment.The emphasis given in the center to physical activity and sport enables a strong connection with movement therapy. Movement therapy allows obese children to face and cope with the psychological and emotional aspects of obesity. The purpose of this study is to evaluate the contribution of the movement therapy intervention to our program.