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NCT ID: NCT01547260 Completed - Clinical trials for Pancreatic Ductal Adenocarcinoma

Lenalidomide and Gemcitabine as First-line Treatment in Patients With Pancreatic Cancer

LENAGEM
Start date: October 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to ascertain whether treatment with lenalidomide or lenalidomide in combination with gemcitabine induces modulation of immune effector functions and to characterize the nature of immune functions.

NCT ID: NCT01545414 Completed - Depression Clinical Trials

Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease

Start date: February 2012
Phase: Phase 3
Study type: Interventional

The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.

NCT ID: NCT01544803 Completed - Problematic AOD Use Clinical Trials

Randomized Controlled Trial of eScreen for Problematic Alcohol Use

Start date: September 2009
Phase: Phase 2
Study type: Interventional

Objectives: This study compares the efficacy of eScreen and Alkoholhjalpen in a three-armed randomized controlled design, measuring outcomes in terms of changes in problematic alcohol use up to one year after study recruitment. The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels. A more extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum. Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: T1, eScreen referral (n=211); T2, Alkoholhjalpen referral (n=211); Control group (n=211). Outcomes on alcohol use as well as health-related symptoms are assessed after 3, 6 and 12 months. The first hypothesis is that all three groups will reduce their alcohol consumption and alcohol-related problems at follow-ups compared to the baseline level. The second hypothesis is that there will be no differences between participants in the eScreen and the Alkoholhjalpen group in reduction of alcohol consumption and alcohol-related problems at follow-ups. The third hypothesis is that participants in the eScreen and the Alkoholhjalpen group will show a greater reduction in alcohol consumption and alcohol-related problems compared to the control group (no intervention) at follow-ups. For a greater understanding of the study results possible other interventions received by the study participants for their problematic alcohol use during these 12 months of study participation will be investigated.

NCT ID: NCT01544595 Completed - Clinical trials for Moderate to Severe Plaque-type Psoriasis

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Start date: June 19, 2012
Phase: Phase 3
Study type: Interventional

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

NCT ID: NCT01544491 Completed - Clinical trials for Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant

Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients

Start date: August 17, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation. An additional purpose of the study is to assess the effect of the combination of EVR and reduced exposure CNI (TAC) on renal function. This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.

NCT ID: NCT01543919 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide

Start date: April 2012
Phase: Phase 2
Study type: Interventional

PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01543477 Completed - Pregnancy Clinical Trials

Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

PASCO II
Start date: July 7, 2010
Phase:
Study type: Observational

The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacritâ„¢ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacritâ„¢ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

NCT ID: NCT01543256 Completed - Biliary Stricture Clinical Trials

WallFlex Biliary Fully Covered (FC) Chronic Pancreatitis Study

Start date: September 18, 2012
Phase: N/A
Study type: Interventional

The purpose of this of this study is to compare the use of Self Expanding Metal Stents (SEMS) to plastic stents for the treatment of benign biliary strictures secondary to chronic pancreatitis as it pertains to stricture resolution rates, complication rates and number of endoscopic retrograde cholangiopancreatography (ERCP) procedures during 24 months. Statistical testing will be performed to determine if the rate of stricture resolution for the metal stent is non-inferior to the plastic stent group.

NCT ID: NCT01543087 Completed - Clinical trials for Meningococcal Infection

Duration of hSBA Response After a Primary Series of Bivalent rLP2086 Followed by a Booster Dose

Start date: September 7, 2012
Phase: Phase 3
Study type: Interventional

This study is to assess the longevity of immune response in adolescents for approximately 48 months after receipt of a primary series of bivalent rLP2086 vaccination, which is then followed by a booster dose and an assessment of immune response for 12 or 26 months post booster vaccination.

NCT ID: NCT01542970 Recruiting - Allergy Clinical Trials

Can Supplementation With Lactobacillus Reuteri and Omega-3 Fatty Acids During Pregnancy and Lactation Reduce the Risk of Allergic Disease in Infancy?

PROOM-3
Start date: February 2012
Phase: N/A
Study type: Interventional

The incidence of allergic disease has increased worldwide during the last decades. Initially, a lot of effort has been put in elucidating which of the known risk factors commonly associated to the development of allergic disease early in life was the cause of this increase. Studies showing a reduced incidence of allergic disease in the former socialist countries in comparison to countries with a "Western lifestyle" have shown that risk factors as allergen exposure, environmental pollution and tobacco exposure are also present in societies with a less affluent lifestyle. This suggests the disappearance of factor protecting against the development of allergic diseases in affluent environment.The development of allergic diseases begins during the first year of life with eczema, both non-IgE- and IgE-associated, and food allergy, progressing during childhood with the development of asthma bronchiale, also both non-IgE- and IgE-associated, and later development of allergic rhinoconjunctivitis, i.e. the atopic march. The immune system of the neonate is influenced by maternal immunity, both via the placenta and breast milk. Thus, the immunological interaction between the mother and her offspring is close during pregnancy and lactation. The association of cord blood IgE levels with maternal but not paternal atopic heredity, may depend on a possibly stronger placental Th2 shift in atopic mothers. Thus, factors influencing/protecting against the development of allergic disease early in life, would be important already during pregnancy, birth and early postnatal life. Two major hypotheses have been assessed during the last decade: Proper microbial stimulation, including the establishment of the gut flora in infancy and the relationship between low omega 3-polyunsaturated fatty acids in the western diet and the incidence of allergic disease. This is a double blind randomized study. Families with at least one parent/sibling with clinical symptoms/history of allergic disease will be invited to participate in this study. Pregnant mothers will be included in the study at the 20th week of gestation. They will be randomized to 4 study groups, one will receive placebo capsules, the second will receive omega-3 PUFA supplementation and placebo regarding L. reuteri, the third will receive L. reuteri and placebo regarding omega-3 PUFA and the fourth group will receive both omega-3 PUFA and L. reuteri supplementation. Omega-3 supplementation will be given to mothers from pregnancy and lactation while L. reuteri will be given to the mothers during pregnancy and later to the children during the first year of life.The children will be clinically followed by an allergy nurse regularly. Questionnaires regarding data on environment, siblings, pets, breast feeding, smoking exposure, upper respiratory and other infections and clinical symptoms of allergic disease will be filled regularly. Skin prick tests (SPTs) will be performed in the children at 6 and 12 months with milk, egg, wheat, peanut and cat. At 24 months, timothy and birch allergen extracts will be added. A pediatrician will assess the children at 24 months of life and whenever it is needed during the study period. Dietary habits will be assessed during pregnancy (25th gestational week) and 6 months after child birth. Blood samples in the children will be taken from cord blood and at 6, 12 and 24 months of life. Maternal blood samples will be taken at 20th weeks of gestation and at child birth. Milk samples will be collected 1-4 days after partus and monthly during the first 4 months of lactation. Maternal gastrointestinal function will be addressed by validated diary cards. Saliva from the children and fecal samples from mother and child will also be collected according to the following protocol.