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NCT ID: NCT01895335 Completed - Multiple Sclerosis Clinical Trials

Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients

TERI-PRO
Start date: June 2013
Phase: Phase 4
Study type: Interventional

Primary Objective: To describe efficacy, tolerability and convenience of teriflunomide treatment through the evaluation of Patient Reported Outcomes (PROs). Secondary Objectives: To describe disease progression using Patient Reported Outcomes (PROs). To describe clinical outcomes (ie, treated relapses) in teriflunomide treated patients. To describe the change in cognition in teriflunomide treated patients. To describe safety of teriflunomide in patients treated (based on adverse events reporting). To describe adherence and persistence to teriflunomide treatment. To describe quality of life, activity and leisure over the period of teriflunomide treatment. To compare Patient Determined Disease Steps (PDDS) and Expanded Disability Status Scale (EDSS) in assessing Multiple Sclerosis (MS) disease progression.

NCT ID: NCT01895296 Completed - Clinical trials for Postoperative Dumping Syndrome

Study to Assess Safety and Efficacy of sc Pasireotide in Patients With Dumping Syndrome

CSOM230BBE01T
Start date: September 2008
Phase: Phase 2
Study type: Interventional

Dumping Syndrome consists of (1) a too rapid gastric emptying, (2) an inappropriate release of GI hormones (as a reaction to the hyperosmolar contents in the duodenum) and (3) an hyperinsulinemic response to a too rapid absorption of glucose. Because it is not well known which somatostatin receptor(s) (sst1-5) influence(s) Dumping Syndrome most, the goal of this trial is to evaluate : - the effect of pasireotide (sst1, 2, 3, 5 agonist) on the control of gastric emptying. - the effect of pasireotide (sst1, 2, 3, 5 agonist) on the release of GI hormones (during OGTT). - the effect of pasireotide (sst1, 2, 3, 5 agonist) on the hyperinsulimic response (during OGTT). - the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of objective parameters of Dumping Syndrome (hematocrit (Hct), pulse rate and occurrence of hypoglycemia after an Oral Glucose Tolerance Test (OGTT) with 75g of glucose) - the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of overall symptoms as measured by the combined Dumping Syndrome score - the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of symptoms as measured by (a) early and (b) late phase dumping symptom score separately - the efficacy of pasireotide (sst1, 2, 3, 5 agonist) for control of quality of life (QoL SF-36)

NCT ID: NCT01893866 Completed - Healthy Volunteers Clinical Trials

A Relative Bioavailability Study To Evaluate Safety, Tolerability And Pharmacokinetic Comparability Of Pegvisomant 1 X 30 Mg Vs 2 X 15 Mg Subcutaneously Administered In Healthy Subjects

Start date: August 2013
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate pharmacokinetic comparability of 1x30 mg pegvisomant injection administered as a single 1 mL injection versus 2x15 mg/mL pegvisomant administered as two separate 1 mL injections and to characterize the pharmacokinetics of the new 30 mg strength.

NCT ID: NCT01893697 Completed - Clinical trials for Healthy Participants

The Influence of Posture on Airway Diameter, Resistance and Airflow Distribution in Healthy Subjects

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

FRI could give the opportunity to investigate the possible effect of a lateral posture on airway diameter and airflow distributions. This physiological study in healthy subjects may help to identify the role of positioning as an aid in airway clearance techniques for patients with respiratory diseases.

NCT ID: NCT01893138 Completed - Clinical trials for Stress Urinary Incontinence

Autologous Muscle Derived Cells for Female Urinary Sphincter Repair

Start date: November 21, 2013
Phase: Phase 3
Study type: Interventional

This randomized, double-blind, placebo-controlled, multicenter, confirmatory study will evaluate the efficacy and safety of Cook MyoSite Incorporated Autologous Muscle-Derived Cells (generic name Iltamiocel) compared to a placebo (vehicle) control dose in the treatment of stress urinary incontinence (SUI) in adult female patients.

NCT ID: NCT01893008 Completed - Clinical trials for Esophageal Resection Candidates

Preoperative Inspiratory Muscle Training in Esophageal Resection

PREPARE
Start date: September 2013
Phase: N/A
Study type: Interventional

The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

NCT ID: NCT01892943 Completed - Clinical trials for Leber Hereditary Optic Neuropathy (LHON)

Leber Hereditary Optic Neuropathy (LHON) Historical Case Record Survey

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

The objective of this survey is to establish the clinical course of vision loss and recovery in patients with a genetically confirmed diagnosis of Leber Hereditary Optic Neuropathy (LHON). Visual acuity changes over time from onset of symptoms and from visual acuity nadir will be the main endpoint analysed. The survey will collect historically documented visual acuity data for all patients at participating sites with a genetically confirmed diagnosis of LHON. No exclusion criteria apply. Patients are not required to attend the clinic for the survey. Data will be collected in a completely anonymous manner. Ethical approvals and data release agreements will be obtained as required by local regulations.

NCT ID: NCT01892436 Completed - Psoriatic Arthritis Clinical Trials

Extension Study up to 3 Years for Secukinumab in Psoriatic Arthritis

FUTURE 1 ext
Start date: September 30, 2013
Phase: Phase 3
Study type: Interventional

This study was designed as a 3-year extension to the phase III core study CAIN457F2306. It aimed to provide continuous treatment with secukinumab in pre-filled syringes (PFS) for subjects who completed the core study CAIN457F2306, to obtain further long term efficacy, safety and tolerability information in subjects with active psoriatic arthritis receiving secukinumab every 4 weeks. At Week 104 of the study CAIN457F2306, eligible subjects completed the assessments associated with the core study visit and subsequently continued in this extension study on the same dose that they were receiving during the core study. The regular assessments of disease activity ensure that subjects who are experienced worsening of disease in any of the treatment groups could exit the study upon their own wish or based on the advice of the investigator at any time.

NCT ID: NCT01891851 Completed - Healthy Clinical Trials

A Study of Drug-drug Interaction Between Ritonavir and TMC435350 in Healthy Volunteers

Start date: October 2007
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the drug-drug interaction between steady-state concentrations of CYP3A4 or ritonavir and TMC435350 after its first and the last dose of the multiple dosing regimen and to explore the short term safety and tolerability of multiple doses of 200 mg of TMC435350 administered alone and in combination with 100 mg of ritonavir.

NCT ID: NCT01890746 Completed - Acute Leukaemia Clinical Trials

A Safety and Efficacy Study of Eltrombopag in Subjects With AML

Start date: September 5, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this randomized, blinded, placebo-controlled study was to provide clinical safety and exploratory efficacy data on the use of Eltrombopag in adult subjects with Acute Myeloid Leukemia (AML) receiving standard induction chemotherapy with daunorubicin plus cytarabine. A minimum of 120 evaluable subjects newly diagnosed with AML was stratified by antecedent malignant hematologic disorder and age.