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NCT ID: NCT01801228 Withdrawn - Cirrhosis Clinical Trials

Eplerenone Versus Spironolactone as Treatment of Ascites Due to Liver Cirrhosis; a Study of Efficacy and Side Effects

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

This study compares Spironolactone, a non-selective aldosterone antagonist, with Eplerenone, a selective aldosterone antagonist, regarding efficacy and hormonal side effects when treating male cirrhotic patients with uncomplicated ascites over a 6 month period. The investigators hypothesis is that Eplerenone is as effective as Spironolactone as treatment of ascites with less side effects such as painful gynecomastia.

NCT ID: NCT01801111 Completed - Clinical trials for Non-Small-Cell Lung Carcinoma

A Study of Alectinib (RO5424802) in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase (ALK) Mutation and Failed Crizotinib Treatment

Start date: June 20, 2013
Phase: Phase 1/Phase 2
Study type: Interventional

This open-label, non-randomized, multicenter, Phase 1/2 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment. In Part 1, cohorts of participants will receive escalating doses of alectinib orally twice daily. In Part 2, participants will receive the recommended phase 2 dose (RP2D) of alectinib as determined in Part 1. Treatment will continue in Part 1 and Part 2 on the same dose until disease progression. In Part 3, following disease progression, participants without epidermal growth factor receptor (EGFR) mutation will be offered continued treatment with alectinib, participants with EGFR mutations will be offered a combination of alectinib and erlotinib.

NCT ID: NCT01800253 Completed - Sleep Clinical Trials

The Effects of Acute Total Sleep Deprivation Versus Normal Sleep on Metabolism

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

The study proposes to investigate whether acute total deprivation affects metabolism as measured through blood and peripheral tissues. Its aim is also to investigate how acute total sleep deprivation affects neurodegenerative markers, as well as hormones, memory performance and aspects of appetite regulation.

NCT ID: NCT01799239 Completed - Ileostomy - Stoma Clinical Trials

Safety and Performance of Newly Developed 1-piece Ostomy Product Compared With SenSura

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

The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.

NCT ID: NCT01798953 Completed - Ulcerative Colitis Clinical Trials

Surgical Reconstruction in Ulcerative Colitis With Primary Sclerosing Cholangitis

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

Primary sclerosing cholangitis (PSC) occurs in approximately 10 % of patients with ulcerative colitis (UC), but the outcome of reconstructive surgery is not clear. The purpose of this study was to determine the functional outcome after surgery, frequency of pouchitis, complications and failure-rate in UC-PSC patients compared to patients with UC alone. Both ileal pouch-anal anastomosis (IPAA) and ileo-rectal anastomosis (IRA) were studied.

NCT ID: NCT01798706 Completed - Type 2 Diabetes Clinical Trials

Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients

GetGoal-O
Start date: June 2013
Phase: Phase 3
Study type: Interventional

Primary objective: - To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by HbA1c reduction, in older type 2 diabetes patients (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen. Main secondary objective: - To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM patients (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects). Other secondary objectives: - To assess the effect of lixisenatide compared to placebo after 24-week treatment on: - Fasting plasma glucose (FPG) - During liquid standardized breakfast meal challenge test : 2 hour- PPG and Plasma Glucose Excursion - 7-point Self-monitored plasma glucose (SMPG) profile - Body weight - Change in total daily dose of basal insulin (if taken) - Percentage of patients requiring rescue therapy - Safety and tolerability - To assess lixisenatide pharmacokinetic profile - To assess anti-lixisenatide antibody development.

NCT ID: NCT01798472 Recruiting - Clinical trials for Femoral Neck Fractures

Hip Fractures Treated With Uncemented Arthroplasties

HUA
Start date: November 2009
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to compare the functional and radiological outcome after displaced, femoral neck fractures treated with either cemented or uncemented arthroplasties. The primary hypothesis is that the uncemented arthroplasty shows the same functional outcome at 12 month as the cemented arthroplasty.

NCT ID: NCT01798355 Completed - Dental Anxiety Clinical Trials

Children and Adolescents With Dental Anxiety - Randomized Controlled Study of Cognitive Behavioral Therapy

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

The purpose of this study is to determine whether cognitive behaviour therapy is effective in the treatment of children and adolescents with dental anxiety. Our hypothesis is that children and adolescents who have been offered CBT shows significant better performance on outcome measures compared with patients in control group who have received treatment as usual.

NCT ID: NCT01798108 Completed - Neoplasm Metastasis Clinical Trials

Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases

Start date: August 14, 2001
Phase: Phase 1
Study type: Interventional

A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as "Alpharadin"), is currently under development. It is an injectable aqueous solution containing radium-223, a radionuclide that emits radiation of another quality and with a different distribution than radiopharmaceuticals currently in use. After injection of the drug into the blood, a large portion of the drug will accumulate in the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer in the painful sites of bone than in other sites of the body, and may alleviate pain through its radiation. Radium-223 is expected to be both efficacious as regards the targeted localised irradiation, and also to have a favourable safety profile. The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of various radioactivity doses of Radium-223 will be evaluated.

NCT ID: NCT01797965 Terminated - Multiple Sclerosis Clinical Trials

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019

EXTEND
Start date: February 15, 2013
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).