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NCT ID: NCT01383421 Completed - Clinical trials for Rheumatoid Arthritis

Observational Study to Research the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)

PASSION
Start date: September 2011
Phase: N/A
Study type: Observational

Post-marketing observational study to determine the effectiveness and patient satisfaction with adalimumab treatment in patients with Rheumatoid Arthritis in relation to utilization of a Patient Support Program (PSP).

NCT ID: NCT01383187 Completed - Burns Clinical Trials

Autologous Platelets Concentrate and Autologous Thrombin for the Treatment of Deep Burn Trauma

Start date: November 2008
Phase: Phase 2/Phase 3
Study type: Interventional

Deep skin burn injuries, especially extensive deep burns or/and deep burns extending on the face, hands, feet, genitalia and perineum, remain one of the most challenging therapeutic problems. Surgical excision of the necrotic burned tissue with subsequent skin grafting of the affected area has become the golden standard for the treatment of deep partial thickness and full thickness skin burns and represents the treatment of choice. Despite of all the progress achieved in the treatment process (artificial skin, cultured keratinocytes), the therapeutic results are sometimes unacceptable due to functional and cosmetic deficits causing severe psychological and emotional distress, particularly in the form of disfiguring and disabling scarring - i.e. hypertrophic scars, joint contractures restricted movement, peripheral neuropathy, psychiatric and physiological diseases, as well as thermoregulation disorders. Consequently, the quality of life is markedly decreased. That is why new methods of burn wounds covering are intensively searched. Based upon the results of available pre-clinical studies, the local use of autologous platelet concentrate with their active growth factors appears to be a good and promising possibility how to improve faster and higher quality of healing deep skin burn wounds.

NCT ID: NCT01381835 Completed - Hepatitis C Virus Clinical Trials

TMC435-TiDP16-C126 - Trial to Investigate the Effect of Severe Renal Impairment on the Pharmacokinetics and Safety of TMC435

Start date: July 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the steady-state pharmacokinetics of TMC435 in participants with severe renal impairment and to compare these with the TMC435 pharmacokinetics in matched participants with normal renal function. We will also study the short-term safety and tolerability of TMC435, when administered in participants with severe renal impairment and in participants with normal renal function. Steady-state is a term that means that the drug has been given long enough so that the plasma concentrations will remain the same with each subsequent dose. TMC435 is being investigated for the treatment of chronic hepatitis C virus (HCV) infection. Pharmacokinetics (PK) means how the drug is absorbed into the bloodstream, distributed in the body, and eliminated from the body.

NCT ID: NCT01381185 Completed - Clinical trials for Acute Myocardial Infarction

REsistance to Aspirin and Clopidogrel in acuTe Myocardial Infarction

REACT-MI
Start date: May 2011
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare 3 point-of-care methods for monitoring antiplatelet therapy to golden standard (Light transmittance aggregometry-LTA) in high risk population of acute myocardial infarction patients. If two methods (PFA-100, VerifyNOW,Multiplate or LTA) will indicate insufficient antiplatelet blockade/high residual reactivity for aspirin, clopidogrel or both, the dose of aspirin will be increased to 200mg qd and the dose of clopidogrel will be increased to 2x75mg qd.In addition genotyping of CYP2C19 (6 alleles) will be performed.

NCT ID: NCT01379703 Completed - HIV-1 Patients Clinical Trials

Multicountry, Multicenter Post-Marketing Observational Study of Clinical, Biological and Virological Outcomes, Compliance and Tolerability of Kaletra® in Routine Clinical Use

KaleEAST
Start date: February 2004
Phase: N/A
Study type: Observational

KaleEAST is a non-interventional, post-marketing observational study (PMOS) in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication. No additional procedures (other than the standard of care) are to be applied to the patients. The KaleEAST PMOS was conducted in a prospective, single-arm, multicountry, multicenter format. The study was carried out in two (2) parts: the first part was initiated in 2004 with the lopinavir/ritonavir capsule formulation, the second part started in 2006 after the lopinavir/ritonavir tablets had become available in the participating countries. The aim of this post-marketing observational study was to obtain further data on clinical, biological, and virological outcomes, compliance and tolerability of Kaletra®-containing regimen during routine clinical use in the participating countries.

NCT ID: NCT01378715 Recruiting - Clinical trials for Coronary Artery Disease

Rosuvastatin Pre-Treatment Influences the Risk of Coronary Intervention Study

TIPS-3
Start date: June 2010
Phase: Phase 3
Study type: Interventional

The aim of this study is to determine whether a pre-treatment with high-dose statin (one day prior and just before intervention, rosuvastatin 20mg/day) has a positive impact on the occurrence of periprocedural myocardial infarction during percutaneous coronary intervention (PCI).

NCT ID: NCT01377090 Completed - Systemic Sclerosis Clinical Trials

Digital Ulceration

CAP
Start date: January 2011
Phase: N/A
Study type: Observational

The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

NCT ID: NCT01376908 Active, not recruiting - Phenylketonuria Clinical Trials

Kuvan® in Phenylketonuria Patients Less Than 4 Years Old

SPARK
Start date: June 2011
Phase: Phase 3
Study type: Interventional

This is a Phase 3b, multicenter, open-label, randomized, controlled study to evaluate efficacy, safety and population pharmacokinetics of sapropterin dihydrochloride (Kuvan®) in less than 4 year-old infants and children with Phenylketonuria (PKU).

NCT ID: NCT01376297 Completed - Clinical trials for Chemotherapy-Induced Nausea and Vomiting

A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting

Start date: July 2011
Phase: Phase 3
Study type: Interventional

NETU-10-29 is a clinical study assessing safety of netupitant and palonosetron, two antiemetic drugs, both given with oral dexamethasone. The objective of the study is to evaluate if netupitant and palonosetron are safe when administered to prevent nausea and vomiting after administration of repeated cycles of chemotherapy.

NCT ID: NCT01375127 Completed - Clinical trials for Kidney Transplantation

Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Start date: August 2011
Phase: N/A
Study type: Observational

This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.