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NCT ID: NCT01142726 Completed - Clinical trials for Rheumatoid Arthritis

Efficacy and Safety Study of Abatacept Subcutaneous Plus Methotrexate in Inducing Remission in Adults With Very Early Rheumatoid Arthritis

Start date: December 2010
Phase: Phase 3
Study type: Interventional

The primary purpose of the protocol is to demonstrate the ability of abatacept plus methotrexate to induce remission in patients with very early rheumatoid arthritis after 12 months of treatment and to maintain remission following 6 months of drug withdrawal.

NCT ID: NCT01140451 Completed - Cystic Fibrosis Clinical Trials

Extension Study of Ataluren (PTC124) in Cystic Fibrosis

Start date: August 12, 2010
Phase: Phase 3
Study type: Interventional

Cystic fibrosis (CF) is a genetic disorder caused by a mutation in the gene that makes the cystic fibrosis transmembrane conductance regulator (CFTR) protein. A specific type of mutation called a nonsense (premature stop codon) mutation is the cause of CF in approximately 10% of patients with the disease. Ataluren is an orally delivered investigational drug that has the potential to overcome the effects of the nonsense mutation. This study is a Phase 3 extension trial that will evaluate the long-term safety of ataluren in adult and pediatric participants with nonsense mutation CF (nmCF), as determined by adverse events and laboratory abnormalities. The study will also assess changes in pulmonary function, CF pulmonary exacerbations, health-related quality of life, antibiotic use for CF-related infections, CF-related disruptions to daily living, body weight, and CF pathophysiology. Funding source for this study is the FDA OOPD.

NCT ID: NCT01140347 Completed - Clinical trials for Hepatocellular Carcinoma

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib

REACH
Start date: October 2010
Phase: Phase 3
Study type: Interventional

This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison. Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study. Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm. Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo. The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.

NCT ID: NCT01140139 Completed - HIV-1 Clinical Trials

Dermal HIV-1 Immunization During Anti-retroviral Therapy Followed by Repeated Treatment Interruptions

Vac09
Start date: September 2006
Phase: Phase 1
Study type: Interventional

In this study, the investigators evaluated a therapeutic HIV-1 DNA vaccine administered with a novel topical application method to 12 chronically HIV-infected cART treated patients. The HIV DNA plasmids used in this study encode for envelope gp160 of HIV-1 subtypes A, B and C, rev B, Gag A and B and reverse transcriptase (RT) B. The patients were randomly assigned to three groups; group 1 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically, group 2 (n=4) were immunized six times with 0.4 mg of HIV DNA plasmids topically and treated with 500 mg of hydroxyurea daily until visit 10, group 3 (n=4) four patients received placebo. The immunization was performed during three cycles of 7 weeks of cART followed by four weeks of therapy interruption. After the last cycle of cART the patients were maintained on a definitive treatment interruption until CD4+ T cell counts dropped below 350/ mm3 at two time points. Cellular and humoral immune responses, viral load and CD4+ T a cell count was analysed throughout the study.

NCT ID: NCT01139619 Completed - Clinical trials for Non Small Cell Lung Cancer

A Retrospective Study to Investigate the Current Situation of Biopsy Testing in Swedish Inoperable Non Small Cell Lung Cancer (NSCLC) Patients

MAPSY
Start date: October 2010
Phase: N/A
Study type: Observational

Lung cancer is one of the most deadly types of cancer and the leading cause of death in cancer in Sweden. Five year survival is 10% in men and 15% in women. Approximately 3300 individuals in Sweden are diagnosed each year and the incidence of adenocarcinoma is increasing. Lung cancer patients are to a great extent currently being diagnosed by exfoliative cytology. However, new drugs leading to more personalized treatments will demand more specific classification of tumour types. Today EGFR mutation status is becoming an important factor when deciding treatment strategy for patients with Non-Small Cell Lung cancer. Sufficient tumour material must be available if EGFR mutation status is to be tested. Core needle biopsy is one way to obtain the quantity of material needed when testing mutation status. The portion of patients having core needle biopsies is believed to vary greatly between hospitals in Sweden, a difference from 20% to 70 % have been assumed, but is not yet confirmed in studies. This study will investigate the current situation and procedures when patients are diagnosed with lung cancer. The results can be used to describe any possible adverse events connected to the procedure and possibly contribute to development of a better decision tool to be used when deciding if a core needle biopsy is to be performed or not. More and more therapeutical targets having similar problems are likely to be developed in the future. An investigation of current quality and procedures when diagnosing lung cancer by biopsies will facilitate future diagnosing of lung cancer and ensure that personalized treatments can be offered to patients.

NCT ID: NCT01138982 Completed - Substance Use Clinical Trials

Effectiveness Study of a Swedish Youth Mentoring Program

Start date: October 2007
Phase: N/A
Study type: Interventional

This study aims to investigate the effectiveness of a one-to-one, adult-to-youth primary preventive mentoring program in Sweden. Outcome domains and criteria for inclusion and exclusion of study participants are elaborated in collaboration with the providing NGO, and the program is given as customary.

NCT ID: NCT01137630 Completed - Clinical trials for Seborrhoeic Dermatitis of the Scalp

Two Topical K40 Formulations in Adults With Seborrhoeic Dermatitis (SD) of the Scalp

Start date: February 2007
Phase: Phase 2/Phase 3
Study type: Interventional

Seborrhoeic dermatitis (SD) is a papulosquamous (presence of both papules and scales) disorder patterned on the sebum-rich areas of the scalp, face, and trunk. The current treatment does not cure the disease permanently. Therefore it must be repeated when the symptoms recur, or even prophylactically. Corticosteroids and antifungals are the mainstay of therapy. Topical corticosteroids rapidly reduce the cutaneous signs of disease, but are associated with a high frequency of relapse when treatment is stopped. They are reserved for acute flare-ups only as they may precipitate recurrences and dependence. In addition, chronic use of corticosteroids is associated with side-effects. The scientific rationale for the use of K40 for treatment of SD was based on clinical evidence that K40 improves erythema and desquamation with mild adverse reactions in a few cases. The primary objective of the study was to evaluate the efficacy of K40 (K40a and K40b combined) compared to placebo after 4 weeks treatment as measured by the sum of erythema and desquamation scores at Week 4.

NCT ID: NCT01137331 Completed - Clinical trials for Seborrhoeic Eczema of the Scalp

K301 for the Treatment of Seborrhoeic Eczema (SE) of the Scalp

Start date: February 2008
Phase: Phase 3
Study type: Interventional

Seborrhoeic eczema (SE) is a chronic, inflammatory skin disorder confined to areas of the head and trunk where sebaceous glands are most prominent. The severity varies from mild dandruff to exfoliative erythroderma that ranges from mild, patchy scaling to widespread, and thick, adherent crusts. The worldwide prevalence of SE is 3-5%, although dandruff, the mildest form of the disorder affects up to 15-20% of the population. In this multicentre, randomised, double-blind, placebo-controlled phase III study, adult SE patients are treated once daily for 4 weeks. The population for this study is patients with mild to moderate SE. The primary endpoint for this study is the efficacy of K301 compared to placebo which was based on the sum score for erythema and desquamation after 4 weeks of daily application. Secondary endpoints are to evaluate safety and tolerability as well as efficacy.

NCT ID: NCT01137201 Completed - Clinical trials for The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.

Internal Hernia After Laparoscopic Gastric Bypass

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

To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.

NCT ID: NCT01135745 Completed - Clinical trials for Obsessive Compulsive Disorder

Deep Brain Stimulation for Obsessive Compulsive Disorder (OCD PMCF)

Start date: April 2010
Phase: Phase 4
Study type: Interventional

The purpose of the study is to monitor the safety and performance of Reclaim® Deep Brain Stimulation (DBS) Therapy in patients with chronic, severe, treatment-resistant Obsessive Compulsive Disorder.