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NCT ID: NCT02457208 Completed - Tuberculosis Clinical Trials

PK Study of Anti-TB Drugs

Start date: July 7, 2015
Phase: Phase 1
Study type: Interventional

This is a prospective descriptive and pharmacokinetic study will be conducted among newly diagnosed patients registered in the two SMRU TB clinics located on the Thai-Myanmar border. This study aims to recruit (1) 30 adults with HIV co-infection and (2) 30 adults without HIV co-infection in one year. Patients will be given the standard 6 month anti-TB drugs as per WHO guidelines.

NCT ID: NCT02455934 Completed - Clinical trials for Impaired Glucose Tolerance

Effects of D-allulose (Psicose) With Sucrose Beverage on Glucose Tolerance and Insulin Level

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

Randomized, double-blind, crossover-trial, 30 subjects in each groups, either males or females, normal fasting glucose or pre-diabetes, aged > 18 years old to perform oral sucrose tolerance with either one of the 5 study products 1. Sucrose 50 g 2. Sucrose 50 g + D-allulose (psicose) 2.5 g 3. Sucrose 50 g + D-allulose (psicose) 5 g 4. Sucrose 50 g + D-allulose (psicose) 7.5 g 5. Sucrose 50 g + D-allulose (psicose) 10 g Primary endpoints: 1. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on glucose tolerance 2. To investigate the dose-response effects of D- allulose (psicose) with sucrose beverage on insulin levels

NCT ID: NCT02453685 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Study to Compare Insulin Intensification of Biphasic Insulin Aspart 30 and Insulin Analogues (Insulin Glargine and Insulin Aspart) in Insulin naïve Type 2 Diabetic Patients

Start date: August 31, 2015
Phase: Phase 4
Study type: Interventional

This trial is conducted globally. The aim of this trial is to compare stepwise insulin intensification of biphasic insulin aspart (BIAsp) 30 and basal-bolus therapy with insulin glargine and insulin aspart in insulin naïve type 2 diabetic patients inadequately controlled on oral anti-diabetic therapy.

NCT ID: NCT02453308 Completed - Malaria, Falciparum Clinical Trials

A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)

TRACII
Start date: August 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1 site in Africa. There are 2 arm study groups that have 2 treatment arms each. Study group A: A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. Study group B: B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. Study group C: C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. According to the WHO guideline, all patients except for children under the age of 1 year or a weight below 10 kilograms will also be treated with a single dose of low dose primaquine.

NCT ID: NCT02452242 Completed - Clinical trials for Human Immunodeficiency Virus Infections

Safety, PK and PD Study of ABX464 in Untreated HIV Patients

Start date: January 2015
Phase: Phase 2
Study type: Interventional

ABX464 is a first in class that showed efficacy as an anti-HIV therapy. The present study is intended to assess the safety, the tolerability, and pharmacokinetic parameters and to evaluate the effect on viral load of repeated oral administrations of ABX464 in patients infected by HIV, not previously treated for their HIV. Two types of design are intended in this protocol: dosing every 3 days or dosing every day. The goal is to determine the best dosing regimen to reduce viral load and minimize adverse events.

NCT ID: NCT02437318 Completed - Breast Cancer Clinical Trials

Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.

SOLAR-1
Start date: July 23, 2015
Phase: Phase 3
Study type: Interventional

To determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.

NCT ID: NCT02435212 Completed - Clinical trials for Transfusion-dependent Anemia

Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload

Start date: October 21, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox DT formulation in children and adolescents aged ≥ 2 and < 18 years at enrollment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden. Randomization will be stratified by age groups (2 to <10 years, 10 to <18 years) and prior iron chelation therapy (Yes/ No). There will be two study phases which include a 1 year core phase where patients will be randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all patients will receive the granules up to 5 years. Patients who demonstrated benefit to granules or DT in the core phase, and/or express the wish to continue in the optional extension phase on granules, will be offered this possibility until there is local access to the new formulation (granules or FCT) or up to 5 years, whichever occurs first.

NCT ID: NCT02434926 Completed - Pregnancy Clinical Trials

Anesthetic Management in Fetoscopic Surgery and Incidence of Complications

Start date: May 2015
Phase:
Study type: Observational

Fetoscopic surgery has been acknowledged to be a reliable procedure to correct several congenital anomalies e.g. shunt insertion in fetal bladder outlet obstruction, laser ablation of vessels in twin-twin transfusion syndrome (TTTS), balloon occlusion in congenital diaphragmatic hernia etc. The technique involves an introduction of small-caliber instruments into the amniotic cavity under ultrasound guidance. This procedure can be successfully done under either general anesthesia, regional anesthesia or local anesthesia with sedation. Each technique has both advantages and drawbacks. Several complications related to anesthetic after fetoscopic surgery can occur. For instance, pulmonary edema which is caused by intravenous fluid loading, irrigation fluid absorption or fluid flow through myometrium venous channel. Besides, maternal hypotension intraoperatively can arise from spinal anesthesia. The aim of the study is to report choice of anesthesia using in fetoscopic surgery in the tertiary care institute (Siriraj hospital) and incidence of complications which may relate to different anesthetic techniques.

NCT ID: NCT02431312 Completed - Hepatitis B Clinical Trials

Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects

Start date: January 12, 2015
Phase: Phase 1
Study type: Interventional

This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and Hepatitis B core antigen [HBcAg]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.

NCT ID: NCT02430298 Completed - Clinical trials for Head and Neck Cancer

Topical/Oral Melatonin for Preventing Concurrent Radiochemotherapy Induced Oral Mucositis/Xerostomia Cancer Patients

Start date: July 2013
Phase: Phase 2
Study type: Interventional

The study evaluates the effect of melatonin for preventing concurrent radiochemotherapy induced oral mucositis and xerostomia and improving quality of life in head and neck cancer patients. This is a randomized, double-blind, placebo controlled trial conducted in head and neck cancer patients. Mixed-block randomization is used to divide eligible patients into two groups: melatonin 40 mg or matched placebo. The patients are required to take the studied drugs 20 mg suspensions before radiation and 20 mg capsules at night (after 21.00 pm) on the first night of radiation and continue for 7 weeks. Standard treatment is Radiation 2 Gy 5 fraction/week not more than 7 weeks with Cisplatin chemotherapy base regimen according to standard hospital protocol. Study endpoints are level of mucositis (CTCAE scale, WHO scale and MTS scores), level of xerostomia (CTCAE scale, VAS), QOL (FACT-H&N), pain (VAS 0-10) and adverse event frequency.