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NCT ID: NCT01530971 Completed - Clinical trials for Peer Review, Research

Effect of Maternal and Neonatal Oxygenation

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

Intraoperative supplemental oxygen has been given for most parturients undergoing cesarean section under spinal anesthesia. However, evidences supporting the practice is not clear nowadays, especially for healthy parturients who are monitored continuously with pulse oximeter. Furthermore, hyperoxia may produce free radicles which could harm fetus and newborns. Changing practice is not that easy. This study has been conducted to prove that supplemental oxygen is not necessary for healthy parturients during cesarean section.

NCT ID: NCT01528514 Completed - Clinical trials for Coronary Artery Bypass Grafting

Effects of CUrcuminoids on Coronary Artery byPass graftIng-related myocarDial Infarction Study

CUPID
Start date: September 2009
Phase: N/A
Study type: Interventional

It is well-established that myocardial infarction (MI) associated with coronary artery bypass graft surgery (CABG) predicts the poor outcome. Nevertheless, the cardioprotective therapies to limit myocardial injury after CABG are lacking. Previous studies have shown that curcuminoids suppress pro-inflammatory cytokines during cardiopulmonary bypass surgery and decrease the occurrence of cardiomyocytic apoptosis after cardiac ischemia/reperfusion injury in animal models. The investigators aim to evaluate whether curcuminoids prevent MI after CABG, compared to placebo.

NCT ID: NCT01525511 Completed - Healthy Clinical Trials

Pharmacokinetic Study of Primaquine and Dihydroartemisinin-Piperaquine in Healthy Subjects

Start date: June 2012
Phase: Phase 1
Study type: Interventional

The observed changes of P. falciparum sensitivity to artemisinin leads to the intensification of early detection as well as treatment monitoring in malaria infection. It is widely accepted that the development of resistance can be delayed by the use of combination therapy, especially artemisinin-based combination therapies (ACTs). The resistance problem is considered extremely serious and as the consequence WHO has recommended that all monotherapy for malaria should be stopped Current WHO guideline recommends the drug combination regimens using ACT with effective partner medicines to decrease the risk of development or spreading of artemisinin resistance. Dihydroartemisinin-piperaquine (DHA-PQP); the fixed-dose combination of Dihydroartemisinin (DHA) and Piperaquine phosphate (PQP) is now one of the recommended drugs by WHO as the oral treatment for uncomplicated P. falciparum. DHA-PQP composes of both blood schizonticidal drugs, with different mechanism of action and different half-life to improve the therapeutic efficacy and to prevent the development of drug resistance to the individual drug. Moreover, it is beneficial for the mutual protection against resistance and long lasting protection against new infection, due to long half-life of PQP. Primaquine is an effective gametocytocidal for P. falciparum transmission prevention and as tissue killing for the radical cure in Plasmodium vivax and Plasmodium ovale infection. It will be given only in the presence of other antimalarials, so it is necessary that the data of the potential drugs interaction of primaquine and DHA-PQP should be characterized. It is inevitable that in the near future, Dihydroartemisinin-piperaquine (DHA-PQP) and primaquine combination treatment becomes necessary. These drugs are metabolized by cytochrome P450 enzyme which potentially causes pharmacokinetic alteration, resulting in clinically significant drug-drug interactions that can cause unanticipated adverse reactions or therapeutic failures because of the suboptimal exposure of the parasite. This study is planned to evaluate potential pharmacokinetic interaction of orally administered primaquine (PQ) and dihydroartemisinin-piperaquine (DHA-PQP) in healthy adult subjects. The results of these interaction studies are important in order to provide clinical guidance for the optimum combination of primaquine and DHA-PQP treatment regimens in malaria infections.

NCT ID: NCT01524783 Completed - Clinical trials for Neuroendocrine Tumors

Everolimus Plus Best Supportive Care vs Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Neuroendocrine Tumors (GI or Lung Origin)

RADIANT-4
Start date: March 30, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the antitumor activity of everolimus plus best supportive care versus placebo plus best supportive care in patients with progressive nonfunctional neuroendocrine tumor (NET) of gastrointestinal (GI) or lung origin without a history of, or current symptoms of carcinoid syndrome.

NCT ID: NCT01524341 Completed - Malaria Clinical Trials

Efficacy, Safety, Tolerability and Pharmacokinetics of KAE609 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection

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

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with P. vivax or P. falciparum infection after 3 day dosing with KAE609 at 30 mg/day

NCT ID: NCT01520909 Completed - Clinical trials for Idiopathic Thrombocytopenic Purpura

Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.

PETIT2
Start date: March 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.

NCT ID: NCT01519674 Completed - Clinical trials for Diabetes Mellitus, Type 2

Treatment Intensification With Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Inadequately Controlled on Sitagliptin and Metformin

SIT2MIX
Start date: June 2012
Phase: Phase 4
Study type: Interventional

This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)). The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.

NCT ID: NCT01516060 Completed - HIV Clinical Trials

The Neurocognitive Sub-study of Encore1

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

The purpose is to investigate whether HIV and HIV medication can affect certain areas of brain function. This study will look at possible changes in brain function including memory, concentration and thought processes to see if there are any differences between the two doses of efavirenz used in the Encore1 study and also the level of efavirenz in the blood

NCT ID: NCT01513122 Completed - HIV Clinical Trials

Bone and Body Comp: A Sub Study of the SECOND-LINE Study

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

The use of anti HIV drugs (ART), and in particular a class of drugs known as nucleoside reverse transcriptase inhibitors (N(t)RTI), has been associated with changes in body fat and in particular loss of peripheral fat in the limbs. Low bone mineral density and osteoporosis are also common in HIV-infected patients. There appears to be some association between ART and bone loss, but this is poorly understood and requires further research. The SECOND-LINE study provides an opportunity to examine if a new anti-HIV drug (raltegravir) can result in greater increase in limb fat than a drug regimen containing N(t)RTI, which is currently standard of care. This study also provides an opportunity to examine if additional bone loss occurs with the second regimen of anti-HIV drugs and whether non-N(t)RTI regimens of ART used in second line therapy result in more or less bone loss than use of other classes of anti-HIV drugs such as protease inhibitors or N(t)RTI combinations. It is hypothesized that subjects randomised into Raltegravir arm will demonstrate greater increases in limb fat and smaller reductions in bone density at the proximal femur over 48 weeks than those randomised into the control arm (LPV/r + 2-3N(t)RTIs).

NCT ID: NCT01512979 Completed - Clinical trials for Diabetes Mellitus, Type 2

Linagliptin and Metformin Versus Linagliptin in Newly Diagnosed, Untreated Type 2 Diabetes

Start date: January 2012
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to determine whether a initial combination of linagliptin and metformin compared to linagliptin alone for 24 weeks is effective in newly diagnosed, treatment-naïve patients with Type 2 Diabetes.