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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: NCT02437981 Enrolling by invitation - HIV Prevention Clinical Trials

Evaluation of PrEP-30: a Demonstration Project of Pre-exposure Prophylaxis for MSM and Other High-risk Group Clients at the Thai Red Cross Anonymous Clinic

PrEP-30
Start date: December 2014
Phase:
Study type: Observational

PrEP-30 is a demonstration project to assess the feasibility of providing oral PrEP to MSM and other individuals at-risk for HIV in Bangkok, Thailand as a service that is funded entirely through user fees. Tenofovir disoproxil fumarate/emtricitabine PrEP is provided part of a combined HIV prevention program that includes risk-reduction counseling, regular HIV testing, and the provision of condoms and lubricants. PrEP-30 is implemented at the Thai Red Cross AIDS Research Centre, at the site of the largest HIV counseling and testing center in Thailand.

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: NCT02437266 Not yet recruiting - Clinical trials for Myofascial Pain Syndrome

Effect of Scapular Mobilization on Patients With Scapular Pain

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

The purpose of this study is to determine the effect of scapular mobilization on pain related parameters including pain intensity, pressure pain threshold, muscle tension, anxiety, Scapular range of motion, patient satisfaction in patients with scapular pain associated with myofascial trigger point:

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: NCT02434263 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

Start date: August 13, 2015
Phase: N/A
Study type: Interventional

The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients. Following initial implantation, all patients will have clinical follow up at 30 days, 3, months, 6 months and 12 months

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.

NCT ID: NCT02427360 Completed - Clinical trials for P. Falciparum Malaria

Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers

MMA
Start date: May 2015
Phase:
Study type: Observational

This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum species). The review of patients' records and blood samples will be performed for patients treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to December 2013.