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NCT ID: NCT02072525 Completed - Meningococcal Clinical Trials

A Protocol to Collect Human Serum Samples From Healthy Adults for Use as Quality Controls Samples in GlaxoSmithKline (GSK) Biologicals' Assays

Start date: April 1, 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to collect serum samples for use as quality control samples in GSK assays. The serum samples need to include samples with low, medium and high antibody titers/concentrations, which cover the assay range.

NCT ID: NCT02088216 Completed - Clinical trials for Non-Cystic Fibrosis Bronchiectasis

Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis

BENE
Start date: April 1, 2014
Phase: N/A
Study type: Interventional

Objective: To evaluate whether long-term oral N-acetylcysteine as an expectorant drug can reduce the frequency of acute exacerbations of patients with non-cystic fibrosis bronchiectasis and improve their quality of life. Methods: Patients with non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive 600 mg of oral N-acetylcysteine BID for 12 months) or the control group (participants receive oral tablet BID for 12 months). The primary endpoint was the frequency of acute exacerbations. Expected results: Compared with the control group, the frequency of acute exacerbations of the observer Group will decrease significantly. Hypothesis: Long-term oral N-acetylcysteine can reduce the frequency of acute exacerbations of patients with non-cystic fibrosis bronchiectasis and improve their quality of life.

NCT ID: NCT02089152 Completed - Melioidosis Clinical Trials

A Single-blind Stepped Wedge Cluster Randomized Controlled Behaviour Change Trial to Determine Effectiveness of Prevention Programme of Melioidosis in Diabetics in Ubon Ratchathani, Northeast Thailand

PREMEL
Start date: April 1, 2014
Phase: N/A
Study type: Interventional

Study hypothesis: Prevention programme for melioidosis can reduce incidences of overall hospitalization due to infectious diseases and due to culture-confirmed melioidosis in diabetic population in northeast Thailand This study is a prospective single-blind multicentre stepped wedge cluster randomized controlled behaviour change trial in 9,000 diabetics in Ubon Ratchathani, northeast Thailand.

NCT ID: NCT02092792 Completed - Neoplasms Clinical Trials

A Study Evaluating the Safety of Escalating Doses of DLYE5953A in Patients With Refractory Solid Tumors

Start date: April 1, 2014
Phase: Phase 1
Study type: Interventional

This is an open-label, multicenter, Phase I study to evaluate the safety, tolerability, and PK of escalating doses of DLYE5953A administered to patients with incurable, locally advanced, or metastatic solid malignancy that has progressed on standard therapy. The Phase I study consists of two stages: Stage 1 dose-escalation and Stage 2 expansion in selected patients. In Stage 1, a 3 + 3 dose-escalation design will be used to examine the safety, tolerability, and PK of increasing doses of DLYE5953A. In Stage 2, patients will be enrolled to further characterize the safety, tolerability, and PK of the proposed dose and schedule for future studies.

NCT ID: NCT02105922 Completed - Sarcopenia Clinical Trials

Effect of Strength Training and Protein Ingestion in Old Versus Very-old

Start date: April 1, 2014
Phase: N/A
Study type: Interventional

From 3 interventiongroups in the project with ClinicalTrials.gov ID NCT02034760, namely: HRTW: Heavy Strength Training x3/week & 20g whey protein twice daily. LITW: Light Intensity Training x3-5/week & 20g whey protein twice daily. WHEY: 20g whey protein twice daily. 15 subjects from each group will be recruited and tested after 3 months of intervention. Tests will include muscle cross sectional area (MRi), muscle biopsies (fiber types, size, cell- and capillary count), functional- and strength measurements, plasma lipids, HbA1c. Tests are to be compared with Project ID NCT01997320.

NCT ID: NCT02115698 Completed - Sarcopenia Clinical Trials

Counteracting Age-related Loss of Skeletal Muscle Mass (CALM)

CALM
Start date: April 1, 2014
Phase: N/A
Study type: Interventional

Up to 66 healthy elderly individuals (at least 65 years old) are recruited as subjects. They will be recruited as a subgroup to protocol ID: H-4-2013-070. Upon inclusion, each individual will be randomized into one of the five groups stratified according to gender (M/F) and 30s chair stand (<16 OR ≥16). The five groups are: Heavy Resistance Training (N=12), Light Intensity Training (N=12), Protein Whey (N=15), Protein Collagen (N=15) and Carbohydrate (N=12). The individuals randomized into one of the supplementation groups (Protein Whey, Protein Collagen or Carbohydrate) will be blinded to the supplement content. Assessments will be performed at Baseline (before intervention start) and after 12 months of intervention. The primary outcomes are measures of muscle protein synthesis rate measured as the fractional synthesis rate from Baseline to 12 months of intervention. The hypotheses are i) that basal and protein-stimulated muscle protein synthesis rates are elevated in the exercise training groups after 12 months of intervention. ii) prolonged intake of protein of different quality will improve the muscle protein synthetic response to protein intake after 12 months of intervention.

NCT ID: NCT02122770 Completed - Clinical trials for Advanced Solid Tumors

Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors

Start date: April 1, 2014
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to assess the effect of multiple-dose administration of fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to assess the effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.

NCT ID: NCT02124018 Completed - Clinical trials for Myocardial Infarction

Risk Stratification in Patients With Preserved Ejection Fraction

PRESERVE-EF
Start date: April 1, 2014
Phase:
Study type: Observational [Patient Registry]

The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)>40%.

NCT ID: NCT02140775 Completed - Fatigue Clinical Trials

Return to Work Randomized Controlled Trial: Counseling After Fatigue Treatment in HIV/AIDS

Start date: April 1, 2014
Phase: N/A
Study type: Interventional

The current study is a randomized clinical trial comparing Behavioral Activation counseling with supportive counseling for HIV+ participants presenting with clinically significant fatigue whose energy has improved with armodafinil, who have the goal of returning to work or vocational training but have not done so on their own. A second cohort of HIV+ participants without significant fatigue at baseline, but who also have the goal of returning to work, will also be randomized to either Behavioral Activation counseling or supportive counseling. In both cohorts, the primary outcome is level of success regarding an employment related goal.

NCT ID: NCT02151513 Completed - Clinical trials for Cancer-associated Pain

Pilot Study on the Effect of Intrathecal Opioids on Immune Function in Humans With Cancer Pain

Start date: April 1, 2014
Phase:
Study type: Observational

The purpose of this study is to examine the changes in immune function, as measured by biomarkers in the blood, that happen with intrathecal (spinal) delivery of opioid medications for the treatment of moderate to severe cancer pain. Hypothesis: Treatment of pain with intrathecal (spinal) therapy is associated with little alteration of immune function as measured by biomarkers in the blood of cancer patients with moderate to severe pain.