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NCT ID: NCT01405872 Completed - Multiple Sclerosis Clinical Trials

Persistence, Adherence, Quality of Life, and Treatment Satisfaction With Avonex® PEN™.

PERSIST
Start date: September 2011
Phase: N/A
Study type: Observational

The primary objective of the study is to determine physician reported persistence with the Avonex PEN at Month 12/End of Study as well as determining factors associated with persistence. The secondary objectives for this study are as follows: To evaluate the tolerability for treatment administration of the Avonex PEN at Months 3, 6, and 12; To evaluate patient quality of life (QoL) while using the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate clarity of directions for use of the Avonex PEN at Month 3; To evaluate ease of use and the patient's assessment of the injection procedure with the Avonex PEN at Months 3, 6, and 12; To evaluate patient reported adherence at Months 6 and 12; To evaluate physician reported persistence at Month 6; To evaluate overall patient satisfaction with the use of the Avonex PEN for treatment administration at Months 3, 6, and 12; To evaluate patient reported fear of injection at Months 3, 6, and 12; and To evaluate the percentage of patients switching from caregiver to self-injection at Months 3, 6, and 12.

NCT ID: NCT01405417 Terminated - Achalasia Clinical Trials

Endoscopic Peroral Myotomy for Treatment of Achalasia

Start date: April 2011
Phase: N/A
Study type: Interventional

This study intends to investigate the feasibility, safety and efficacy of peroral endoscopic myotomy for the treatment of achalasia in a multi center setting.

NCT ID: NCT01405287 Completed - Clinical trials for Coronary Artery Disease

Study of Vascular Healing With the Combo Stent Versus the Everolimus Eluting Stent in ACS Patients by Means of OCT

REMEDEE-OCT
Start date: October 2011
Phase: Phase 2
Study type: Interventional

OBJECTIVE It is the objective of the REMEDEE OCT study to assess vascular healing after deployment of the Abluminal Sirolimus Coated Bio-Engineered Stent (Combo Bio-Engineered Sirolimus Eluting Stent) in patients with Acute Coronary Syndrome (ACS) with single de novo native coronary artery lesions ranging in diameter from ≥2.5 mm to ≤3.5 mm and ≤ 20 mm in length. STUDY DESIGN The REMEDEE OCT study is a prospective, multicenter, randomized study designed to enroll 60 patients with ACS who will be randomized 1:1 to be treated with the Combo stent versus the commercially available everolimus eluting stent (Xience V or Promus). Patients will receive Optical Coherence Tomography (OCT) and Quatitative Coronary Angiography (QCA) follow-up imaging at 60 days post procedure. Clinical follow-up is scheduled at 30, 60, 180, 360 and 540 days. Furthermore, QCA and OCT will also be performed at baseline in all participants of the study.

NCT ID: NCT01405040 Completed - Clinical trials for Lung Water Assessment

Clinical Evaluation of a New Transpulmonary Thermodilution Method to Assess Thermodilution Cardiac Output, Global End Diastolic Volume and Extravascular Lung Water

Start date: January 2010
Phase: N/A
Study type: Observational

The primary objective of this study is to obtain the TPTD, GEDV and EVLW measurements from existing indwelling femoral arterial Volume View™ catheter and central venous catheters.

NCT ID: NCT01404533 Completed - Iron Deficiency Clinical Trials

Iron Interventions and Non-transferrin-bound Iron (NTBI) in Women

NTBIwomen
Start date: November 2009
Phase: N/A
Study type: Interventional

The overall goal of this research is to develop safe and effective iron interventions that can be administered without production of plasma non-transferrin-bound iron (NTBI: iron in the systemic circulation not bound to the iron-transport protein transferrin). The appearance of plasma non-transferrin-bound iron has been reported in uninfected adult volunteers after oral administration of iron supplements in doses similar to those used in the Pemba trial. This research project will (i) confirm the appearance of plasma non-transferrin-bound iron after administration of an iron supplement like that in the Pemba trial (~1 mg Fe/kg body weight, without food), and then determine the effects on production of plasma non-transferrin-bound iron and on iron absorption measured with stable isotopes (ii) of giving the supplemental iron (~1 mg Fe/kg) with the standard rice meal, and (iii) of giving a lower dose of iron (~0.1 mg Fe/kg) — like that used in home fortification — with the standard rice meal.

NCT ID: NCT01402089 Completed - Clinical trials for Non Small-cell Lung Cancer

Cytochrom p450 3A4 and 1A2 Phenotyping for the Individualization of Treatment With Sunitinib or Erlotinib in Cancer Patients

Start date: January 2012
Phase: Phase 4
Study type: Interventional

It is well known that substantial interindividual variability of CYP3A4/1A2-phenotype activity is an important contributor to individual differences in the sensitivity to the frequently used tyrosine kinase inhibitors sunitinib and erlotinib. This study tests the potential for CYP-phenotyping to predict individual pharmacology and derive dosing algorithms for more tailored treatment of these drugs.

NCT ID: NCT01401166 Active, not recruiting - Breast Cancer Clinical Trials

Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This randomized, open-label, crossover study evaluated participants' preference and healthcare professional satisfaction with trastuzumab (Herceptin) subcutaneous (sc) versus intravenous (iv) administration in participants with HER2-positive early breast cancer.

NCT ID: NCT01400386 Completed - Healthy Clinical Trials

Bioavailability of Chlorogenic and Phenolic Acids From Soluble Coffees

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

Coffee contributes to a large extent to our daily intake of phenolic compounds which have been associated with potential health benefits. A study by Richelle et al. (2001), using an LDL oxidation assay, showed that phenolic compounds in coffee possessed antioxidant activity which varied depending on the coffee bean source and the degree of roasting. Little is known about the bioavailability of phenolic compounds from coffee at various roasting degrees. Therefore, further human studies are required in order to demonstrate the absorption, and bioavailability of metabolites that may also be efficient in vivo. The main objective of this clinical trial is to investigate the possible difference in the bioavailability of chlorogenic and phenolic acids from coffee at various roasting levels.

NCT ID: NCT01400282 Recruiting - Clinical trials for Lowback and Leg Pain

Analgesic Efficacy of High Frequency Spinal Cord Stimulation

Start date: July 2011
Phase: Phase 4
Study type: Interventional

The aim of the study is to compare the efficacy of high frequency (HF SCS) stimulation and sham stimulation (Sham SCS - i.e. no stimulation) and conventional spinal cord stimulation (Conv SCS) on the patient reported global impression of change, pain intensity and health related quality of life.

NCT ID: NCT01399619 Completed - Clinical trials for Hepatitis C, Chronic

Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

Start date: September 2011
Phase: Phase 3
Study type: Interventional

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV