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NCT ID: NCT03176238 Completed - Clinical trials for Post Menopausal Breast Cancer

Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

EVEREXES
Start date: March 29, 2013
Phase: Phase 3
Study type: Interventional

This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer after documented recurrence or progression following a non-steroidal aromatase inhibitors (NSAI) therapy in Novartis Oncology emergent growth market (EGM) countries.Data was presented by Asian countries vs Non-Asian countries to confirm no difference in safety and efficacy. Summary statistics were presented.

NCT ID: NCT03174652 Completed - Anemia Pregnancy Clinical Trials

Anemia Pregnancy Outcome on the Thai-Myanmar Border

AnPREG
Start date: July 20, 2017
Phase:
Study type: Observational

The global burden of maternal morbidity and mortality attributable to anemia is staggering, and this is especially true in low-resource settings. A recent review suggests 42% of pregnant women have anemia worldwide (1993-2005) with the vast majority of anemic women (90%) residing in Africa or Asia1; and in Asia, anemia was the second highest cause of maternal mortality2. Anemia was diagnosed in almost one third to one half of women presenting to the Shoklo Malaria Research Unit (SMRU) clinics on the Thai-Myanmar border for antenatal care (ANC) in a 2008 survey3, and anemia at first antenatal visit was associated with a two-fold increase in maternal mortality in this population4. Studies have also shown an association between anemia and small for gestational age infants, preterm delivery, infant and childhood anemia and developmental delays5. The anemia in pregnant women presenting to SMRU clinics is multifactorial, as hemoglobinopathies, Glucose-6-dehydrogenase (G6PD) deficiency, iron, folic acid and B12 deficiency, helminth infection, and malaria are all prevalent in this rural population. Though all of these pathologies can cause anemia, they require different and sometimes conflicting treatment and prevention strategies, interacting in a complex web of causes and effects. Iron supplementation is the mainstay of most anemia control programs, but some women with hemoglobinopathies suffer from potentially fatal iron overload6. Iron supplementation has also been associated with increased risk of malaria7. Some helminth infections are associated with increased rates of anemia and malaria, but others may be protective8. Malaria and G6PD deficiency have complex effects on one another, and some malaria treatments can cause acute and life-threatening hemolysis in G6PD deficient individuals9. Given the high prevalence and diverse causes of anemia in this population, and its potentially dire effects on maternal and infant health and survival, SMRU implemented increased clinical testing for pregnant women in 2012 to inform clinical care at the individual level. Further analysis of these data is urgently needed to improve care on a population scale. We propose to review existing data from ANC records to determine the causes and effects of anemia in this population, and use this information to improve treatment and prevention guidelines. Results would be integrated rapidly into local practice with the potential to have profound impacts on maternal and child health in this region.

NCT ID: NCT03174457 Completed - Clinical trials for Invasive Fungal Infections

Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

Start date: June 21, 2017
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric patients in Asia/Oceania.

NCT ID: NCT03174314 Active, not recruiting - Visual Impairment Clinical Trials

Feasibility and Efficacy of Assisstive Tactile and Auditory Communicating Devices

VIS4ION
Start date: July 26, 2017
Phase: N/A
Study type: Interventional

This pilot study will integrate multi-sensor fusion techniques (software) to effectively combine information obtained from the newly embedded infrared, ultrasound, and stereo-camera-based sensor systems (hardware) that are implemented into the VIS4ION platform. The core of this technology is based on 4 components: (1) a wearable vest with several distinct range and image sensors embedded. These sensors extract pertinent information about obstacles and the environment, which are conveyed to (2) a haptic interface (belt) that communicates this spatial information to the end-user in real-time via an intuitive, ergonomic and personalized vibrotactile re-display along the torso. (3) A smartphone serves as a connectivity gateway and coordinates the core components through WiFi, bluetooth, and/or 4G LTE, (4) a headset that contains both binaural, open-ear, bone conduction speakers (leaving the ear canal patent for ambient sounds) and a microphone for oral communication-based voice recognition during use of a virtual personal assistant (VPA). Blindfolded-sighted, and blind subjects in a real-world, combined obstacle avoidance / navigation task will serve as an independent measure of overall improvements in the system as well as a roadmap for future avenues to enhance performance. Further, a prospective, randomized crossover, controlled, non-blinded phase will be conducted in Thailand as part of this study to compare and evaluate effectiveness of the wearable vest for increasing navigation and quality of life.

NCT ID: NCT03173820 Recruiting - Clinical trials for Kidney Transplantation

Clinical Trial in Assigning of Tacrolimus Dosage Regimen According to CYP3A5 Genotype in Kidney Transplant Recipients

Start date: April 30, 2015
Phase: N/A
Study type: Interventional

Kidney transplantation is the most appropriated treatment in end stage renal failure patients in order to improve quality of life. However, patients have to take immunosuppressive drugs to prevent graft rejection. Tacrolimus is the most common immunosuppressive drug used now. However, tacrolimus has narrow therapeutic level and needs regularly therapeutic monitor because of inter-individual variation in dosage regimen. Not only age, body weight and drug interaction but also genetic factor in metabolic pathway of tacrolimus plays an important role in tacrolimus blood level. Previous data showed CYP3A5 genetic polymorphism was significant effect tacrolimus blood level. From previous study showed the mean dose of tacrolimus required for the induction phase was significantly higher (P= 0.006) in the CYP3A5*1/*1 group at 0.142±0.050 mg/kg/day than that required by patients who carried either the CYP3A5*1/*3 group of 0.097±0.040 mg/kg/day or the CYP3A5*3/*3 group of 0.077±0.020 mg/kg/day. Tacrolimus maintenance dose required for CYP3A5*1/*1 group of 0.12±0.03 mg/kg/day was 1.3 times higher (P<0.0001) than used for the CYP3A5*1/*3 at 0.09±0.03 mg/kg/day and 2.4 times higher than the CYP3A5*3/*3 group of 0.05±0.02 mg/kg/day. Therefore, the investigators plan to investigate a prospective study to determine the clinical outcome of tacrolimus treatment in kidney transplant recipients between genotype guided dosage regimen group and conventional group.

NCT ID: NCT03173768 Completed - Clinical trials for Anti-Infectives Adverse Reaction

Appropriateness of Intravenous Antibiotics Prescriptions at Hospital Discharge

Start date: November 1, 2015
Phase: N/A
Study type: Interventional

A quasi-experimental study was conducted among patients receiving care at the medicine units of the Maharaj Nakorn Chiang Mai Hospital to determine the appropriateness of intravenous antibiotics at hospital discharge with and without ID consultation.

NCT ID: NCT03170687 Completed - Clinical trials for Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

Comparative Outcomes Between Foot Cast and Short Leg Cast in the Patients With Acute Closed Fracture of Proximal Fifth Metatarsal (Zone II)

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

This study aims to compare outcomes of short leg cast and foot cast for treatment acute fifth metatarsal fracture (Zone II).

NCT ID: NCT03169725 Completed - Poliomyelitis Clinical Trials

A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants

Start date: May 31, 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.

NCT ID: NCT03167944 Recruiting - Seroma Clinical Trials

Traditional Electrosurgery System Versus Low Thermal Tissue Dissection System for Total Mastectomy

Start date: March 15, 2017
Phase: N/A
Study type: Interventional

Breast cancer is one of the most common cancer among women nowadays. There are lots of modality of treatment and one of them is Mastectomy. We found out that seroma is one of the disturbing postoperative complications after mastectomy. In our study we want to compare the outcome between using the conventional electrocautery and the low thermal tissue dissection. We expected that the serum production should be lower in cases using low thermal system electrosurgery system.

NCT ID: NCT03167242 Completed - Clinical trials for Acute Uncomplicated Plasmodium Falciparum Malaria

Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Start date: August 2, 2017
Phase: Phase 2
Study type: Interventional

This study was designed to determine the most effective and tolerable dose at the shortest dosing regimen of the investigational drug KAF156 in combination with a solid dispersion formulation of lumefantrine (LUM-SDF) in adult/adolescent and pediatric patients with uncomplicated Plasmodium falciparum malaria. There is unmet medical need for anti-malarial treatment with new mechanism of action to reduce probability of developing resistance, and for duration shorter than 3 days of treatment and/or reduced pill burden.