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NCT ID: NCT02004873 Completed - Clinical trials for Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines

Micra Transcatheter Pacing Study

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.

NCT ID: NCT02004522 Completed - Clinical trials for Chronic Lymphocytic Leukemia

A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory CLL/SLL (DUO)

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

A Phase 3 clinical trial to examine the efficacy of duvelisib monotherapy versus ofatumumab monotherapy in subjects with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL).

NCT ID: NCT02003118 Completed - Osteoarthritis Clinical Trials

A Placebo Controlled, Double Blind, Randomised, 8-week Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of AKR 202 in Patients With Osteoarthritis Pain

Start date: October 2013
Phase: Phase 2
Study type: Interventional

This proof of concept study will be a placebo controlled, randomised, double blind, parallel study. The purpose of the study is to determine efficacy for AKR 202 in the treatment of osteoarthritis (OA) pain in the knee.

NCT ID: NCT01999777 Completed - Epilepsy Clinical Trials

Study to Evaluate the Safety and Efficacy of USL261 in Patients With Increased Bouts of Seizure Activity in the EMU

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

This study is designed to evaluate the efficacy, safety, and tolerability of USL261 compared with that of intranasal (IN) placebo for the treatment of intermittent bouts of increased seizure activity.

NCT ID: NCT01999101 Completed - Clinical trials for Non Alcoholic Fatty Liver Disease

Safety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients

Start date: October 2013
Phase: Phase 2
Study type: Interventional

The primary aim of the study is to evaluate the safety and tolerability of Px-104 in NAFLD patients and to assess the influence of Px-104 on hepatic fat.

NCT ID: NCT01998906 Completed - Breast Cancer Clinical Trials

A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

Start date: May 2002
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. In a parallel observational study patients with HER2-negative disease will receive the same chemotherapy without Herceptin.

NCT ID: NCT01998880 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)

Start date: December 22, 2009
Phase: Phase 3
Study type: Interventional

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.

NCT ID: NCT01998516 Completed - Schizophrenia Clinical Trials

Emotional Intelligence in Schizophrenia and Bipolar-I- Disorder

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

Scientific Background Emotional Intelligence (EI) as a part of social cognition is a rather new area of interest which focuses on personality traits and abilities enabling people to cope with both their own feelings as well as those of others. The "Mayer-Salovey-Caruso-Emotional-Intelligence-Test" (MSCEIT) (1) represents a valid and reliable instrument which exclusively covers the emotional components of social cognition. Recent findings indicate, that social cognitive impairments are useful vulnerability indicators and that EI could be an endophenotype for schizophrenia and bipolar I disorder (BD I). To confirm the endophenotype theory, studies concerning EI in relatives of schizophrenia and bipolar patients are needed. To date, studies on EI in BD patients as well as in first degree relatives of patients with schizophrenia or BD haven`t been conducted yet. Accordingly, the current study focuses on the four categories assessed by the MSCEIT and aims to compare the task performance of patients, their first degree relatives and healthy control subjects. We assume that the task performance of relatives lies between that of patients and controls. The confirmation of this assumption would verify the trait marker hypothesis and could be a next step to identify a heritable endophenotype for schizophrenia and BD. Hypotheses Compared to healthy control subjects patients suffering from schizophrenia or BD I show deficits in EI. Siblings of patients with schizophrenia or BD I show deficits in EI and their task performance lies between that of patients and healthy controls. Deficits in EI are more pronounced in schizophrenia patients than in patients with BD I and are more pronounced in siblings of schizophrenia patients than in siblings of patients with BD I. Independently of diagnosis, deficits in EI affect patients' functional and subjective outcomes. Methods Emotional Intelligence will be examined using the MSCEIT in patients with schizophrenia, siblings of schizophrenia patients, patients with BD I, siblings of BD I patients and healthy volunteers matched for age, sex, and educational level. Structured clinical interviews according to DSM-IV (M.I.N.I. + SCID II) will be carried out to assure the diagnosis of schizophrenia or bipolar disorder as well as to detect (comorbid) Axis I and Axis II psychiatric disorders (patients, siblings, control subjects). Functional outcome will be assessed by using the GAF (Global Assessment of Functioning Scale) and the PSP (Personal and Social Performance Scale), subjective quality of life will be examined using the BELP (Berliner Lebensqualiätsprofil). The MWT-B (Multiple choice vocabulary test) will be used to assess premorbid intelligence.

NCT ID: NCT01995630 Completed - Cataract Clinical Trials

Optical Quality After Implantation of a Spherical or Aspherical Intraocular Lens in Hypermetropic Patients

Start date: November 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric IOL in hypermetropic and emmetropic patients. After implantation of a spherical IOL hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.

NCT ID: NCT01991795 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus

THEMIS
Start date: February 10, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the effect of ticagrelor versus placebo in patients with Type 2 Diabetes Mellitus.