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NCT ID: NCT03088540 Active, not recruiting - Clinical trials for Non-small-cell Lung Carcinoma

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

Start date: May 29, 2017
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are: - To compare the overall survival (OS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 in ≥50% of tumor cells - To compare the progression-free survival (PFS) of cemiplimab versus standard-of-care platinum-based chemotherapies in the first-line treatment of patients with advanced or metastatic NSCLC whose tumors express PD-L1 in ≥50% of tumor cells The key secondary objective of the study is to compare the objective response rate (ORR) of cemiplimab versus platinum-based chemotherapies

NCT ID: NCT03087214 Completed - Epidemiology Clinical Trials

Human Movement Patterns on the Thailand-Myanmar Border

Start date: March 14, 2017
Phase:
Study type: Observational

The epidemiology and ecology of malaria in humans includes complex interactions between human hosts and mosquito vectors. These interactions are spatio-temporal in nature and are heavily dependent on transportation capabilities and seasonal conditions. Where and when infections are acquired is not well understood in the Greater Mekong Subregion (GMS), where there are numerous vectors, many with different behaviours and habitats. For example, many infections appear to be associated with forests or forest edges and some of the most important mosquito vectors in the region are forest dwellers (Obsomer, Defourny, and Coosemans 2007). Interventions that target houses at night-time (e.g. mosquito nets), have had limited success in the GMS, most likely because at least some infections are acquired during the day or outside of the home (Dolan et al. 1993; Luxemburger et al. 1994). While overall malaria incidence in the region appears to be declining, the disease remains persistent in small subregions, for example along international borders joining Thailand with Myanmar. It will be crucial for elimination efforts to address the persistent malaria in these regions, most likely requiring the use of novel and spatially targeted approaches. Increasingly, spatial data and analyses are used in disease research (Linard and Tatem 2012; Pybus et al. 2016; Tatem et al. 2012), however most spatial analyses are at aggregate scales, using data from provincial or state levels. More detailed studies have a single geographic reference point per individual in the study, frequently the home (Mosha et al. 2014; Parker et al. 2015). These studies allow researchers to investigate potential clustering of cases within and between houses ("hotspots") (Bejon et al. 2014; Bousema et al. 2012; Mosha et al. 2014). Even these detailed studies typically ignore the spaces in which people spend time outside of their home and where they may acquire infection: schools; places of worship and work; forest camps and temporary shelters. Given that many malaria infections in the GMS are acquired outside of the home, in areas that are not usually mapped, this information is important for developing strategies to prevent transmission and will be crucial for achieving elimination. Researchers in other substantive areas have already begun mapping the movement patterns of study subjects so that exposure to a variety of environmental exposures outside of the home can be assessed (Matthews and Yang 2013; Vazquez-Prokopec et al. 2010). Early approaches relied on travel surveys or travel diaries, both having bias of unknown magnitude. Modern wearable global positioning satellite (GPS) instruments (loggers or trackers) and geographic information science (GIS) enable detailed mapping and quantification of human movement patterns. Through analysing differences in the movement patterns between humans who do versus those that do not acquire infectious diseases, it may be possible to identify a narrower set of geographic spaces in which disease transmission is occurring. Public health interventions could then target those risk areas. Most of these detailed studies have been done in economically developed settings and urban environments. Infectious diseases such as malaria remain persistent in resource-poor, rural, and remote areas - the very regions that are least likely to be studied with detailed approaches (Sachs and Malaney 2002).

NCT ID: NCT03087162 Completed - Clinical trials for H Pylori Eradication

Once Daily Dose Dexlansoprazole Quadruple Therapy for Helicobacter Pylori

Start date: January 1, 2017
Phase: Phase 4
Study type: Interventional

New drug regimen for Helicobacter pylori eradication, the investigators compare once daily dose dexlansoprazole levofloxacin based quadruple therapy and twice daily dose dexlansoprazole levofloxacin quadruple therapy for helicobacter pylori eradication.

NCT ID: NCT03083938 Recruiting - Pancreatic Fistula Clinical Trials

Trial of Omental Roll-up Technique on Pancreato-jejunostomy Anastomosis for Reducing Perioperative Complication in Patients Undergoing Pancreatoduodenectomy

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

Despite the fact that pancreatoduodenectomy is the standard treatment of malignant tumor at periampullary area, the morbidity and mortality rate with intra-abdominal collection, post pancreatectomy hemorrhage, and delayed gastric emptying, is still high at approximately 50-60%. The causes of these complications usually come from post-operative pancreatic fistula. Nowadays, several methods have been reported to reduce the incidence of pancreatic fistula after undergoing pancreatoduodenectomy, such as pancreatic stenting, the use of intravenous somatostatin, the use of sealant material and wrapping anastomosis by soft tissue. Wrapping pancreato-jejunal anastomosis with omentum is not a complicate procedure and requires no extra treatment expenses of the patient. It has been reported this technique has been applied in the non-randomized controlled trials and their data have significantly shown that the technique could reduce pancreatic fistula rate. Therefore, the researchers want to conduct an RCT study to compare complication rates between omental roll-up pancreato-jejunal anastomosis and non-omental roll-up groups.

NCT ID: NCT03083665 Completed - Epilepsy Clinical Trials

A Study to Evaluate the Efficacy and Safety of Brivaracetam in Study Participants (>=16 to 80 Years of Age) With Epilepsy

Start date: August 22, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate the efficacy of brivaracetam (BRV) compared to placebo (PBO) as adjunctive treatment in subjects (>=16 to 80 years of age) with partial seizures with or without secondary generalization despite current treatment with 1 or 2 concomitant antiepileptic drugs (AEDs) and to assess the safety and tolerability of BRV in subjects >= 16 years to 80 years of age.

NCT ID: NCT03083197 Recruiting - Scrub Typhus Clinical Trials

Scrub Typhus Antibiotic Resistance Trial

START
Start date: October 15, 2017
Phase: Phase 4
Study type: Interventional

Study type: Randomized Control Treatment Trial Study population: Male and female patients with ≥15 years of age and acute scrub typhus Duration: 2 years Study Design: Prospective, open-label, randomized-controlled treatment trial in patients ≥15 years old admitted to hospital with acute scrub typhus. Randomization into 3 oral treatment arms (each n=59 patients, total n=177): i) 7 days of doxycycline, ii) 3 days of doxycycline, and iii) 3 days of azithromycin Primary Objective: To evaluate the clinical and microbiological responses in scrub typhus patients to three oral treatment regimens: 7 days of doxycycline, 3 days of doxycycline, and 3 days of azithromycin Secondary Objectives: 1. To perform pharmacokinetic/pharmacodynamics (PK/PD) characterization of the therapeutic responses for doxycycline and azithromycin, incl. serial bacterial load measurements. 2. To define clinical, bacterial, pathophysiological and pharmacological factors associated with disease severity, fever-clearance times (FCT), treatment failures and relapse/re-infection. 3. To determine the minimum inhibitory concentrations (MIC) of clinical Orientia tsutsugamushi isolates to doxycycline, azithromycin and chloramphenicol, using in vitro growth-inhibition assays 4. To genotype all clinical isolates using whole genome sequencing for comparative genomics. 5. To dissect the natural immune response in scrub typhus, using antigen-specific cellular immune and antibody studies, and cytokine profiling

NCT ID: NCT03080610 Completed - Clinical trials for Post-Dural Puncture Headache

The Occurrence of Post Dural Puncture Headache After Epidural Blood Patch

Start date: January 1, 2006
Phase: N/A
Study type: Observational

Spinal anesthesia is commonly used for cesarean section.However, the procedure is still have some adverse events such as high spinal block, nerve injuries or postdural puncture headache (PDPH).This is a potential complication of neuraxial anesthesia in clinical practice. The investigators are curious regarding factors determining the incidence of postdural puncture headache in parturients undergoing cesarean section after epidural blood patch.

NCT ID: NCT03080506 Completed - Clinical trials for Cesarean Section Complications

Abdominal Binder Following Cesarean Delivery

Start date: April 18, 2017
Phase: N/A
Study type: Interventional

Cesarean delivery is a common obstetrical procedure and is associated with increased maternal morbidity and mortality. Pain and limited mobilization are major contributing factors that result in delayed functional recovery and complications. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use have not been properly examined. The aim of this study is to examine the effect of postcesarean elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test [6MWT]) in postcesarean mothers who use versus do not use the elastic abdominal binder to support incisional site.

NCT ID: NCT03078764 Completed - Clinical trials for Type 2 Diabetes Mellitus

The Adaptation, Usability, and Feasibility of a Mobile Health (mHealth) System to Improve Type 2 Diabetes Self-management in Thailand

Start date: June 9, 2017
Phase: N/A
Study type: Interventional

This project explores the feasibility of using automated telephone calls to adult patients with type 2 diabetes to improve diabetes self-management in Thailand. This line of work could significantly extend Thai nurses' ability to manage this growing epidemic, and ultimately reduce the suffering and costs caused by diabetes in Thailand.

NCT ID: NCT03078543 Active, not recruiting - Clinical trials for Arthroplasty, Replacement, Knee

Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System

ANTHEM PS
Start date: June 28, 2017
Phase: N/A
Study type: Interventional

The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature