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NCT02445963 | Safety and Immunogenicity of Artificial Invaplex (Shigella Flexneri 2a InvaplexAR) Administered Intranasally to Healthy, Adult Volunteers | Shigellosis This study is an open-label, dose-escalating Phase 1 investigation of S. flexneri 2aInvaplexAR vaccine. A total of up to 40 subjects will receive one of four S. flexneri 2aInvaplexAR vaccine doses. The vaccine will be administered intranasally (without adjuvant). Inclusion Criteria:- Healthy, adult, male o... |
NCT02445625 | BCI (Brain Computer Interface) Intervention in Autism | Autism Spectrum Disorder This study aims to demonstrate that improvements in identification of social clues (andimprovement of overall social behaviour) in subjects with ASD can be achieved using socialgames together with a BCI setup.The primary goal is to ensure increased rate of responses to joint attention cues.Inte... |
NCT02445157 | Reliability of the 4 Metre Gait Speed in Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis This study is investigating the reliability of the 4 metre gait speed test (4MGS) inpatients with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). Inclusion Criteria:- IPF diagnosis according to NICE guidelines- Provision of informed consentExclusion Criteria:- Significant co-... |
NCT02445209 | Comparison of Efficacy and Frequency of Adverse Events of 1st Line Palliative Chemotherapy EOX and mDCF Regimens in Advanced HER2-negative Gastric Carcinoma | HER2 Negative Gastric Cancer The purpose of the study is to compare efficacy and safety of palliative chemotherapy EOXand mDCF regimens in the first-line treatment of patients with advanced HER2-negativegastric and gastroesophageal junction (GEJ) adenocarcinoma Inclusion Criteria:- Patients 18 years- histologically ... |
NCT02445235 | Study to Evaluate Outcomes of Patients Receiving Treatment for Wound Care, Pain Management or Surface Skin Scar Therapy | Chronic Pain This observational study is designed to evaluate the reported outcomes for patientsreceiving topical therapy for the treatment of pain, fungal infections or skin scars. Thepatients will complete the Patient Reported Outcome (PRO) survey monthly and providevaluable data on the patients perception of their h... |
NCT02445547 | Umbilical Cord Mesenchymal Stem Cell Treatment for Crohn's Disease | Crohn Disease Stem cell transplantation has emerged as a relatively popular treatment that can help toregulate immunity, repair injury, and control inflammation. Several studies have usedautologous stem cells or adipose-derived stem cells to treat Crohn's disease and itsassociated complications, and have achieved good ... |
NCT02445976 | Once-daily Oral VT-464 in Patients With Castration-Resistant Prostate Cancer Progressing on Enzalutamide or Abiraterone. | Prostate Cancer The goal of this clinical study is to determine the safety and efficacy of VT-464, alyase-selective inhibitor of CYP17 and an androgen receptor antagonist, in patients withcastration-resistant prostate cancer (CRPC) who have been previously treated withenzalutamide or abiraterone. Inclusion Criteria1. P... |
NCT02445989 | Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity | Bacterial Vaginosis, The investigators propose to explore the hypothesissupported by limited datathat acontraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing,will enhance women's genital and reproductive health. The investigators propose that thisCVR will increase the bacteria that he... |
NCT02445586 | Safety Study of Pertuzumab (In Combination With Trastuzumab and Docetaxel) in Indian Patients With Breast Cancer | Breast Cancer Study of Pertuzumab (In Combination with Trastuzumab and Docetaxel) in Indian Patients withBreast Cancer Inclusion Criteria:1. Male or female patients aged >/= 18 years2. Signed written informed consent approved by the relevant Institutional ReviewBoard/Ethics Committee, prior to any study procedure3. For... |
NCT02445196 | PTSD Coach App Evaluation | PTSD PTSD Coach is a mobile application (app) that aims to teach individuals self-managementstrategies for symptoms of Post-traumatic Stress Disorder (PTSD). PTSD is a major publichealth concern. Although effective treatments exist, affected individuals face many barriersto receiving traditional care. As smartphones ar... |
NCT02445183 | COPDGene/Lung Cancer Center Database | Lung Cancer The COPDGene / Lung Cancer Database Study is a nested case-control study. This study is anancillary study to COPDGene Phase 1 and Phase 2. Lung cancer cases, which have beenreported by COPDGene subjects since the time of COPDGene study enrollment, will beretrospectively verified with additional medical data... |
NCT02445430 | Genetics of Arteriovenous Malformations | Arteriovenous Malformation The goal of this study is to identify genetic alterations resulting in the development ofarteriovenous malformation (AVM) in the central nervous system. Inclusion Criteria:- Age between 6 and 60 years inclusive- Diagnosis of AVM or nuclear family member of a patient with AVM- Grants access... |
NCT02445222 | CD19 CART Long Term Follow Up (LTFU) Study | Safety LTFU, Pts Receiving CD19 Directed CAR T-Cell Therapy Per Health Authorities guidelines for gene therapy medicinal products that utilizeintegrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up oftreated patients is required. The purpose of this study is to monitor all patients expose... |
NCT02445742 | CML Treated With Bosutinib After Relapse | Chronic Myeloblastic Leukaemia Prospective, open label, multicenter, phase II study evaluating correlation of SNPs withefficacy and toxicity in patients treated with Bosutinib. A total of 50 patients withpreviously treated Ph+ chronic phase CML will be included in the study Inclusion Criteria:- Signed and dated inform... |
NCT02445781 | Differing Levels of Hypoglycemia | Hypoglycemia Hypoglycemia can produce a spectrum of pro-inflammatory and pro-atherothrombotic changes. Todate no studies appear to have investigated the effects of differing levels of hypoglycemiaon the vasculature and pro-atherothrombotic balance during hypoglycemia in healthy man. Thespecific aim of our study will be... |
NCT02445352 | Efficacy/Safety of DP-R207 Tablet Versus CRESTOR Tablet in Patients With Primary Hypercholesterolemia | Primary Hypercholesterolemia The purpose of this study is to evaluate efficacy and safety of DP-R207 in patients withprimary hypercholesterolemia. Inclusion Criteria:- Aged over 19 years- Signed informed consent form- At visit 1 and visit 2, LDL-Cholesterol 250mg/dL and Triglyderide 350mg/dLExclusion Criteria:- H... |
NCT02445391 | Platinum Based Chemotherapy or Capecitabine in Treating Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy | Estrogen Receptor Negative This randomized phase III trial studies how well cisplatin or carboplatin (platinum basedchemotherapy) works compared to capecitabine in treating patients with remaining (residual)basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant).Drugs used in chemoth... |
NCT02445144 | Establishment of Functional MRI Imaging Parameters for Use in the Evaluation of Sickle Cell Disease | Sickle Cell Anemia Patients with sickle cell anemia (SCA) are at an increased risk for damage to brain tissuedue to their disease. The investigators are interested in how blood flow and cerebralinflammation are different in SCA patients and how that affects brain tissue- theinvestigators will use a relatively new set o... |
NCT02445794 | A First in Human Study of RT001 in Patients With Friedreich's Ataxia | Friedreich's Ataxia The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics ofRT001 in patients with Friedreich's ataxia. Inclusion Criteria:1. Male or female 18 to 50 years of age2. Medical history consistent with the symptoms of FRDA at 25 years of age3. Homozygous for GAA repeat expan... |
NCT02445027 | Pilot Study for Imaging of the Esophagus Using a Tethered Capsule OCT Endomicroscopy in the Primary Care Setting | Healthy The goal of this study is to test the feasibility and acceptability of tethered capsuleOptical Coherence Tomography (OCT) endomicroscopy as a device for population-based screeningin the primary care practice environment. Inclusion Criteria:- Subjects must be scheduled for non-urgent appointment at primary care... |
NCT02445755 | Transcutaneous Bilirubinometry in Neonates With the Bilicare System | Transcutaneous Bilirubinometry The purpose of this study is to test the performance of a new transcutaneous ("measuredthrough skin") bilirubin device (BiliCare) to measure bilirubin levels. The investigatorsplan to evaluate the clinical performance of this device as a point of care test. If theinvestigators can validat... |
NCT02445807 | A Study of the Efficacy and Safety of DFD-06 Cream in the Treatment of Moderate to Severe Plaque Psoriasis | Chronic Stable Plaque Psoriasis This study will compare the efficacy and safety of DFD-06 Cream to Vehicle Cream for topicaltreatment of moderate to severe plaque psoriasis after 3, 7, and 14 days of treatment. Inclusion Criteria:1. Subject understands the study procedures and agrees to participate by giving writteninf... |
NCT02445378 | Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy | Acute Leukemia This randomized clinical trial studies aromatherapy and essential oils in improving insomniaand other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy andessential oils may help improve insomnia and other complications caused by chemotherapy. Inclusion Criteria:- Patients who are n... |
NCT02445768 | Functional Connectivity In Relation To Proprioception and Sensorimotor Recovery in Stroke Patients (Feasibility Study) | Stroke The purpose now is to:1. identify brain connections related to proprioception to have a better understanding ofdifferences between people with stroke and healthy persons2. evaluate how these brain connections will change in people with stroke when they areengaged in a 6-week neurocognitive therapeutic program. I... |
NCT02445690 | Thrombin Generation in Crohn's Disease | Crohn Disease One hundred and fifty patients with Crohn's disease involving the terminal ileum or thecolon, in clinical remission, with or without endoscopic activity will be included. Thrombingeneration will be measured and correlated with the simplified endoscopic activity score.The patients will be evaluated for dev... |
NCT02445040 | Safety and Efficacy Study of the Draeger Babylog VN500 Device in HFOV Mode in VLBW Neonates | Respiratory Distress Syndrome In Premature Infants The purpose of this study is to determine the safety and effectiveness of the Babylog VN500in high frequency oscillatory ventilation (HFOV) mode as a method for treating very lowbirth weight (VLBW) neonates requiring invasive respiratory support in the treatment ofresp... |
NCT02445651 | Physiological Effects of Nutritional Support in Patients With Parkinson's Disease | Parkinson Disease Parkinson's disease (PD) is a neurodegenerative disorder of unknown cause that affects morethan a million Americans. It's most prominent pathology is the degeneration of dopaminergicneurons in the brain. It is believed that oxidative stress and inflammation play animportant role in the pathophysiology... |
NCT02445053 | Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study) | Cystic Fibrosis To describe the effectiveness of Kalydeco treatment in patients with cystic fibrosis (CF)who have 1 of 8 non G551D gating CFTR mutations (G178R, S549N, S549R, G551S, G1244E, S1251N,S1255P, or G1349D). Inclusion Criteria:- Male or female with confirmed diagnosis of CF16- At least 1 allele with 1 of the... |
NCT02445443 | LEGION Hinge Safety and Efficacy Study | Knee Arthroplasty, Total The purpose of the current investigation is to assess the safety and efficacy of a newhinged revision knee device. This device is designed to provide efficient, reproduciblereconstructions with optimal limb and implant alignment, durable implant fixation, andfunctional outcomes that increasingl... |
NCT02445872 | Safety and Efficacy of Aprepitant for CINV in Patients With Lung Cancer Receiving Multiple-day Cisplatin Chemotherapy | Chemotherapy-Induced Nausea and Vomiting Aprepitant is an oral neurokinin-1(NK-1) antagonist which is used for the prevention ofchemotherapy-induced nausea and vomiting (CINV). This phase II clinical trial was designedto evaluate the efficacy of aprepitant in the prevention of CINV with lung cancer patientsreceiving 3-... |
NCT02445898 | Effect of Methylprednisolone on Orthostatic Intolerance and Heart Rate Variability in Hip-arthroplasty Patients | Osteoarthrosis The study evaluates the pathophysiological effects of a single dose Methylprednisoloneadministered prior to total hip-arthroplasty (THA) surgery. The investigators examine theeffect on orthostatic intolerance, orthostatic hypotension and heart rate variability (HRV)to evaluate the efficacy of Methylpredn... |
NCT02445495 | Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis | Onychomycosis The purpose of this study is to determine if toenail onychomycosis can be reduced by meansof exposure to laser energy from the Cutera GenesisPlus 1064 Nd:YAG laser system. Inclusion Criteria:1. Male or Female subjects, age 18 to 80 years (inclusive).2. Subject with a clinical diagnosis of onychomycosis of... |
NCT02445456 | Feasibility of Sentinel Lymph Node Biopsy in Rectal Cancer | Rectal Cancer This study will assess whether the Sienna+/Sentimag system, which involves a magnetictracer, is effective in identifying the sentinel lymph node in rectal cancer and whether itis then feasible to remove this lymph node during surgery to locally excise early rectalcancer. Inclusion Criteria:- diagnosed wi... |
NCT02445287 | Clinical Evaluation of CARESTREAM Cone Beam Computed Tomography (CBCT) | Healthy The purpose of this study is to evaluate the 2D and 3D imaging performance of the CARESTREAMCone Beam Computed Tomography (CBCT) scanner ("investigational device") against thecommercially available 2D and 3D predicate devices. The results of this study will beincluded in a Traditional 510(k) FDA Submission to o... |
NCT02445911 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of KQ-791 in Diabetes Mellitus | Diabetes Mellitus, Type 2 This study will consist of multiple ascending oral doses in up to 3 groups, for 29 days. Inclusion Criteria:- Have a diagnosis of Type 2 Diabetes Mellitus (T2DM)- Be an adult between the ages of 18 (19 for Lincoln site) and 70 years- Female participants must be of non-childbearing potential... |
NCT02445508 | Effect of Bile Acid Secretion and Sequestration on GLP-1 Secretion | Diabetes Mellitus, Type 2 Accumulating evidence suggests that bile acids in our intestines may constitute essentialcomponents in the complex mechanisms regulating gut hormone secretion and glucosehomeostasis. Thus, it is likely that modification of the enterohepatic circulation of bileacids can lead to changes in gut h... |
NCT02445534 | Registry of Cell Therapy in Non-Ischemic Dilated Cardiomyopathy | Cardiomyopathy, Dilated Although several studies have demonstrated beneficial effects of stem cell therapy inpatients with non-ischemic dilated cardiomyopathy, the long term benefits and predictors ofresponse to therapy remain undefined. The aim of this registry is to pool long-term clinicaldata in patients with non-is... |
NCT02445326 | Study Evaluating Efficacy and Safety of OTX-DP for Treatment of Chronic Allergic Conjunctivitis | Allergic Conjunctivitis The purpose of this study is to evaluate the efficacy and safety of OTX-DP as a sustainedrelease drug (dexamethasone) depot when placed in the canaliculus of the eyelid for thetreatment of the signs and symptoms of chronic allergic conjunctivitis. Inclusion Criteria:- Be at least 18 years of ag... |
NCT02445118 | Allograft Adipose Matrix (AAM) in Subcutaneous Dorsal Wrist | Aesthetic Rejuvenation This is a 16 week pilot study to assess short term outcomes of an injectable allograftadipose matrix (AAM) in the subcutaneous space in the dorsum of the wrist. A total of 30patients will be enrolled at 2 sites and will be followed for sixteen weeks. Volumeretention and local skin changes will be... |
NCT02445859 | Continuous Antibiotic Prophylaxis in Colorectal Surgery | Surgical Site Infection We propose to randomise patients due to undergo colorectal surgery to standard antibioticprophylaxis or an interventional antibiotic prophylaxis regimen and assess surgical woundinfection rates. Standard antibiotic prophylaxis is a pre-operative injection of cefuroxime,repeated every 4 hours. Th... |
NCT02445131 | Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG) | Chronic Lymphocytic Leucemia The CLL2-BCG-trial is a prospective, open-label, multicenter phase-II-trial to evaluate theefficacy and safety of a sequential regimen of a debulking with bendamustine followed by aninduction with GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 andGA101-maintenance in CLL ... |
NCT02445482 | SOLTI Breast Cancer Molecular Screening Program (AGATA) | Metastatic Breast Cancer In recent years, the advance in high-throughput techniques, such as microarrays and next gensequencing (NGS) technologies, have allowed a more precise classification of the breastcancer molecular subtypes and a more personalized approach to anti-cancer therapy. To date,conventional methods to s... |
NCT02445469 | Magnetic Resonance Imaging in the Diagnosis of Parkinsonian Syndromes | Parkinson's Disease Parkinsonian syndrome is clinically characterized by the presence of resting tremor,rigidity, bradykinesia and postural instability. Parkinsonian disorders include Parkinson'sdisease (PD), progressive supranuclear palsy (PSP), corticobasal dementia (CBD), multiplesystem atrophy (MSA) and vascular pa... |
NCT02445521 | Testing of Four Home Phenylalanine Monitoring Prototype Devices | Phenylketonurias The objective of this study is to test four home phenylalanine monitoring prototype devices,selected out of a pool of candidates by the National PKU Alliance Scientific Committee. Inclusion Criteria:- diagnosis of PKU or hyperphenylalaninemia (PKU group)- any age- in good health (PKU and control gro... |
NCT02445092 | The Effect of Pre-washing the Insemination Catheter on Pregnancy Outcome | Infertility The investigators hypothesize that washing the insemination catheter prior to performing theIUI (intrauterine insemination) will improve the pregnancy outcome in IUI cycles whencompared to controls (without pre-washing the catheter).Catheter washing is performed routinely before embryo transfer, however it ... |
NCT02445079 | Ugandan Non-Communicable Diseases and Aging Cohort | HIV Longitudinal cohort study of older-aged people living with HIV infection in southwesternUganda and age and gender-matched HIV uninfected controls with the primary aim of measuringthe epidemiology of cardiovascular and pulmonary disease in this study setting, andparticularly the contribution of HIV infection to it. ... |
NCT02445261 | Mobile Phone Effects on Umbilical Artery Doppler and Heart Rate Tracing | Umbilical Artery Doppler Women were instructed not to use the mobile phones for 24 hours before carrying out theinitial CTG trace and Doppler ultrasound. For each patient, initial 15 minutes CTG tracerecording was done followed by umbilical artery Doppler ultrasound using high resolutionultrasound unit with 3-5 MHz tra... |
NCT02445664 | Effect of a Tablet-administered Educational Video on Patients Knowledge on Osteoporosis and Treatment | Osteoporosis Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognizedproblem. Non-adherence may be due to patients lack of knowledge, understanding, andinvolvement. In this study the investigators aimed to determine the effect of an educationalvideo displayed on a tablet-device. The invest... |
NCT02445300 | Efficacy of Wound Care and Reduction of Wound Complications by Use of AQUACEL Ag Surgical Dressing in MIS TKA | Postoperative Complication The investigators hypothesized that AQUACEL Ag Surgical dressing would have a significantimprovement in the efficacy of wound care and wound complications compared with traditionalSofra-Tulle dressings after minimally invasive total knee arthroplasty (MIS-TKA). Inclusion Criteria:- Two hundr... |
NCT02445248 | Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients | Diffuse Large B-cell Lymphoma (DLBCL) This is a multi-center, phase II study to determine the efficacy and safety of CTL019 inadult patients with relapsed or refractory DLBCL. Inclusion Criteria:- Written informed consent must be obtained prior to any screening procedures- Histologically confirmed DLBCL at last relap... |
NCT02445274 | Two Different Cataract Surgical Procedures to Prevent Posterior Capsule Opacification | Cataract In this study, the investigators introduce a new "capsule-reserved" cataract surgicalprocedure in which anterior lens capsule is reserved and attached onto posterior lenscapsule in the purpose of preventing posterior capsule opacification (PCO). A prospectiverandomized controlled study is reported to compare t... |
NCT02445937 | PARTNER II: Improving Patient and Family Centered Care in Advanced Critical Illness | Anxiety This is a comparative, effectiveness trial with the overarching goal of this researchproject to ensure patient-centered decisions about the use of intensive treatments forpatients with advanced critical illness. In a prior project, the investigators developed thePARTNER program (PAiring Re-engineered ICU Teams ... |
NCT02445066 | A Pilot Study to Examine the Effects of Vitamin D Supplementation on Mitochondrial Bioenergetics in Older Adults | Low 25-hydroxyvitamin D Concentrations This pilot study is a 4-month open label trial in 15 older (65-89 yrs) men and women withinitial 25(OH)D concentrations of 12-<18 ng/mL to explore the effect of increasing 25(OH)Dconcentrations to 30 ng/mL through vitamin D3 supplementation on changes in mitochondrialbioenergetics... |
NCT02445846 | Dual Rapid HIV & Syphilis Tests in Zambia | HIV The purpose of this study is to provide evidence on the performance and operationalcharacteristics of commercially available dual HIV/syphilis Rapid Diagnostic Tests (RDTs) inZambia for their introduction into antenatal care and other settings. Inclusion Criteria:- Pregnant women attending their first antenatal ca... |
NCT02445885 | Late Reperfusion With Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction | Ischemic Heart Disease Although recommended therapy for patients with ST-segment elevation myocardial infarction isprimary PCI, it remains unestablished whether patients with a symptom duration of more 12hours benefit from acute revascularisation.This study aims to investigate whether acute intervention is superior to ... |
NCT02445339 | Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users | Alcohol Dependence Our primary aim is to assess the feasibility of initiating treatment in the ED withextended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care andcontinuing care in cooperation with clinic providers as well as how best to assess outcomes.Secondarily, the investigators will explor... |
NCT02445729 | Impact of Timing of Wound Dressing Removal After Cesarean Section | Abdominal Wall Wound The purpose of this study is to determine if surgical dressings removed at 24 hours or 48hours improves wound healing and appearance, and to determine if surgical dressings removedafter 24 hours or 48 hours decreases the incidence of post-operative wound infections. Inclusion Criteria:- Pregnant P... |
NCT02445703 | Comparison of Immunization Schedules of Inactivated Hepatitis A Vaccine and Combined Hepatitis A and Hepatitis B Vaccine | Hepatitis A The purpose of this study is to compare the immunogenicity and safety of three differentimmunization schedules of inactivated hepatitis A vaccine (HAV) and/ or combined hepatitis Aand B vaccine (HABV) in healthy Chinese infants. Inclusion Criteria:- Healthy infants between 18 and 24 months old;- Have not ... |
NCT02445924 | Micro RNA Genetic Signature in NSCLC Egyptian Patients | Non-small Cell Lung Cancer This study will be carried out on 40 subjects at Chest department Tanta university hospitalThe subjects will be classified into three groups:- Group I: will include ten non smoker volunteers (control group I).- GroupII: will include ten smoker volunteers (control groupII).- Group III: will... |
NCT02445313 | Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device | Age-related Macular Degeneration (AMD) The investigators would like to know if different imaging devices can improve the quality ofimages and visualization of imaged tissues. Also, the investigators would like to find outwhether these changes are useful in the diagnosis and treatment of eye diseases. Usingimages of pre... |
NCT02445677 | Using TENS to Relieve Pain and Potentiate the Rehabilitation of Pain Patients | Chronic Pain Introduction: Chronic pain affects more than half of elderly individuals. Past studies haveshown that pain can interfere with motor learning and rehabilitation. It was suggested thatrelieving pain before physical therapy sessions might be an interesting strategy topotentiate the rehabilitation of older pat... |
NCT02445105 | Mobilizing Community Systems to Engage Families in Early Autism Spectrum Disorder (ASD) Detection & Services | Autism Spectrum Disorder This multisite study will compare the effectiveness of universal screening by 3 communityservice systems using Autism Navigator, a highly interactive web platform that includes anautomated screening tool, information about autism for families, and a professionaldevelopment course on the early s... |
NCT02445716 | Transdermal Testosterone Nanoemulsion in Women Libido | Menopause This is a double-blind, randomized, placebo-controlled study. Seventy women, aged 35-75years, with treatment-emergent loss of libido will be randomly allocated to the treatmentwith a Transdermal nanoemulsion of Testosterone (500mcg) delivering 300 mcg oftestosterone/day or an identical placebo nanoemulsion (P... |
NCT02445573 | Efficacy of Electroacupuncture (EA) for Women With Pure Stress Urinary Incontinence (SUI) | Stress Urinary Incontinence The purpose of this study is to preliminarily assess the efficacy of electroacupuncture (EA)for women with pure stress urinary incontinence (SUI). Inclusion Criteria:- Eligible women were 40 to 75 years of age, and met the clinical diagnosisrecommendations of SUI by the International Consul... |
NCT02445638 | HDL Lipidomic, Proteomic and Functional Changes in Women After Eating Eggs | Overweight The objective of this randomized, single blinded cross-over study is to investigate effectsof daily egg versus yolk-free egg substitute consumption on High Density Lipoprotein (HDL)composition and function in a population of overweight and obese postmenopausal women. Inclusion Criteria:- Female- 45-70 year... |
NCT02445599 | Diclofenac Premedication, as the Effect of Preemptive Analgesia After Post-thoracotomy Chest and Shoulder Pain | Pain The purpose of the study is to examine if the hyposthesis of the preventive analgesticcharacteristic of diclofenac given preoperatively has any effect on postoperative thoracicwall and shoulder pain sensation. We also want to examine the rescue analgetic consumptionand the postoperative lung function test values. ... |
NCT02445014 | Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule | Healthy The goal of this research is to test the feasibility and tolerability of the modified,larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthysubjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal refluxdisease (GERD). This information will be used... |
NCT02445404 | Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma | Peripheral T-cell Lymphoma It recommends that the CHOP regimen in the primary T-cell lymphoma therapies currently usedbut did not get satisfactory effect of therapy (progression-free survival 40%), primarily toconsider the clinical trial at NCCN guideline.But why the CHOP regimen is widely usedbecause physicians are ac... |
NCT02445612 | Long Term Follow Up of Sub-retinal Transplantation of hESC Derived RPE Cells in Stargardt Macular Dystrophy Patients | Stargardt's Macular Dystrophy This is the long term follow-up of a safety and tolerability trial to evaluate the effect ofsubretinal injection of human embryonic stem cell derived retinal pigment epithelium cellsin patients with Stargardt's Macular Dystrophy (SMD). Inclusion Criteria:- Must have met the eligibility of... |
NCT02445820 | HES and Acute Kidney Injury in Adult Cardiac Surgery | Acute Kidney Injury After Adult Cardiac Surgery This study retrospectively assess the effect or using balanced hydroxyethyl sctarch (HES)130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluidtherapy on the risk of early acute postoperative kidney injury in adult cardiac surgerypatients.... |
NCT02445001 | Erythrocyte Ghost Mediated Retinal Diagnosis | Retinal Disease Instead of the usual procedure of injecting ICG dye directly into an arm vein, now the dyecan be placed inside of RBCs. When a small volume of the RBC's with the dye is injected intoa person's arm, the individual RBCs can be seen as they flow through the retinal bloodvessels. Inclusion Criteria:1. A mal... |
NCT02445950 | With-Me - Technology-Aided Phone Coaching for Occupational Health Study | Psychological Stress The purpose of this study is to examine whether the technology (web-based coaching,profiling and suggestion tool) brings added value to the traditional phone coaching inoccupational health context. The interventions are phone counseling interventions. The otherintervention exploits additionally a s... |
NCT02445170 | Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users | Amputees The present study assesses the health-related quality of life of diabetic transmetatarstaland below-knee prosthetic user. The study design is cross-sectional with a retrospectivereview of patient hospital records and an assessment with patient-reported outcome measure. Inclusion Criteria:- Patients with diabe... |
NCT02445560 | The Effects of a High Protein Diet on Microbiota, Gastrointestinal Function and Wellness in Older Women | Aging The purpose of the proposed study is to determine the effects of consuming a high proteindiet on fecal microbial communities, gastrointestinal function and symptoms, and generalwellness in older adults. Inclusion Criteria:To participate in the study you must- be a woman 65 years of age or older- be willing to c... |
NCT02445833 | On-Line Intervention For Promoting Healthy Habits And Weight Loss In Hypertensive Patients | Obesity Efficacy of an Internet-based self-guided intervention for promoting healthy habits andweight loss in hypertensive people with overweight and obesity: A Randomized ControlledTrial Inclusion Criteria:- Overweight or obese grade I (BMI> 25 and <35)- Age between 18-65 years- Being in clinical medical treatment ... |
NCT02445365 | Remote Ischemic Conditioning in Patients With Ulcerative Colitis | Colitis, Ulcerative Ulcerative colitis (UC) is a chronic relapsing inflammatory bowel disease (IBD). At the timeof diagnosis it is not possible to predict the course of the disease, which can range from afew flares in a lifetime to uncontrollable disease leading to hospitalization, surgery andstoma. There is a continuo... |
NCT02445417 | Brain Activity During Birth for Prediction of Newborns at Risk for Brain Injury | Encephalopathy The purpose of this study is early identification of asphyxiated newborns through eegstarting in the delivery room. Inclusion Criteria: Term infants- Signed Informed consentExclusion Criteria:- Known congenital anomalies |
NCT02489825 | Study About the Effect of Preventive Adjacent Level Cement Augmentation After Osteoporotic Vertebral Compression Fractures | Osteoporosis Vertebroplasty itself is challenged regarding its clinical efficacy. While two randomizedcontrolled trials (RCTs) with substantial methodological problems have led to an intensediscussion another RCT with larger case numbers, more representative inclusion criteria anda more consistent and sound methodology... |
NCT02489617 | The Incidence of Adjacent Synchronous Ipsilateral Infiltrating Carcinoma and/or DCIS in Patients Diagnosed With Intraductal Papilloma Without Atypia or Flat Epithelial Atypia by Core Needle Biopsy | Flat Epithelia Atypia This research study is studying a surgical intervention to rule out the presence of cancerin participants that have been diagnosed with flat epithelial atypia (FEA) or intraductalpapilloma without atypia (IPWA) by core needle biopsy. Inclusion Criteria:- Women all races and ethnic groups are elig... |
NCT02489006 | A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer | Ovarian Cancer This is a study that will look at the effects and how useful investigational drug olaparibis as a neoadjuvant treatment (treatment given as to shrink a tumor before the maintreatment) prior to surgery in patients with recurrent ovarian, primary peritoneal orfallopian tube cancer. Inclusion Criteria:- Hi... |
NCT02489760 | Etanercept Versus Adalimumab in the Treatment of Patients With Ankylosing Spondylitis. A Switch Study | Ankylosing Spondylitis To determine the safety and efficacy of switch effects to adalimumab in etanercept-treatedAS patients. Inclusion Criteria:- Diagnosis of AS, as defined by 1984 Modified New York Criteria for AS.- Stable background therapy as non-steroid anti-inflammatory for 2 weeks.- Stable glucocorticoid for... |
NCT02489370 | CHF Home Telemonitoring: A Home Telemonitoring Service for Chronic Heart Failure Patients on Trial | Congestive Heart Failure Providing patients with chronic heart failure (CHF) access to remote monitoring, for exampleby telephone or telemonitoring using wireless technology, reduces deaths andhospitalisations and may provide benefits on health care costs and quality of life. Remotemonitoring of patients with chronic h... |
NCT02489162 | The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients | Facial Nerve Palsy The objective of the research is to determine whether the MyotonPRO has a valid and reliableapplication in facial, head and neck surgery. In addition, the study aims to compare thisnew technology with current electromyography. Inclusion Criteria:1. unilateral peripheral facial nerve palsy2. Mental ca... |
NCT02489604 | Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-DOTATATE in Advanced Gastro-entero Pancreatic Neuroendocrine Tumors | Neuroendocrine Tumors This is a randomized phase II non-comparative study. Patients with gastroenteropancreaticNeuroendocrine tumour (GEP-NET) G1-G2 with progressive disease, SSR positive and FDGnegative will be enrolled in the study and will be randomly assigned to 2 different dosages(total activity of 25.9 GBq and to... |
NCT02489994 | Performance of the ePrime System for Cellulite | Cellulite Clinical Study to Evaluate the Performance of the ePrime System for the Treatment ofCellulite. Inclusion Criteria:1. Subjects seeking treatment of cellulite in the upper thighs and buttocks areas.2. Subject have cellulite stage II or III as graded using Nurnberger-Muller scaleclasification (Appendix III)3. He... |
NCT02489214 | Donafenib Monotherapy for Previously Treated Metastatic Gastric Cancer | Gastric Cancer This open-label, one-center, noncomparative, two-stage phase 1B trial assessed the donafenibin advanced gastric cancer. Inclusion Criteria:- All patients provided written, informed consent.- Have histological or cytological documentation of gastric adenocarcinoma;- Have received currently approved sta... |
NCT02489201 | A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer | Oesophageal Cancer This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosinekinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced,inoperable oesophageal cancer progressing after chemotherapy .The primary endpoint is the safety.The secondary endpoint... |
NCT02489942 | Long Term Daily Use of JARDIANCE Tablets in Japanese Patients With Type 2 Diabetes Mellitus | Diabetes Mellitus, Type 2 Study to investigate the safety and efficacy of long-term daily use of JARDIANCE Tablets inJapanese patients with type 2 diabetes mellitus Inclusion criteria:Male and female Japanese patients with type 2 diabetes mellitus who have never beentreated with JARDIANCE Tablets before the enrolmentEx... |
NCT02489981 | Specific Use-result Surveillance of Spiriva Respimat in Asthmatics | Asthma The safety of Spiriva 2.5 g Respimat 60 puffs (hereinafter referred to as SpirivaRespimat) in patients with severe persistent asthma under the real-world use was notconfirmed in clinical trials. Inclusion criteria:- Patients diagnosed with severe persistent bronchial asthma- Patient aged >= 15 years- Patients... |
NCT02489188 | Gait Asymmetry Assessed Using Portable Gait Analysis System | Ankle Osteoarthritis To date, detailed analysis of movement patterns in orthopaedic conditions are mainlyperformed in research projects. Because these tests are time consuming, they are notfeasible in clinical routine or in standard examinations. Novel technologies allow capturingdetailed movement patters within a few ... |
NCT02489175 | Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia | Parastomal Hernia Parastomal hernia (PSH) is one of the most frequent stoma complications with a high impacton patients' quality of life. Half of the stomas created each year are permanent and up to50% of the patients will develop a PSH. PSH rates depend on the type of ostomy, ileo- orcolostomy. End colostomy carries t... |
NCT02489149 | Food and Nutrition Education in Quilombolas Communities With Food Insecurity: Multi-sector Intervention | Obesity To optimize the food security in quilombolas communities with high prevalence of foodinsecurity and obesity, the present study proposes to test a multi-sector interventionincluding agriculture sectors, health professionals and family members of communities, basedon promotion of traditional food practices, healt... |
NCT02489773 | Lucica Glycated Albumin-L Clinical Program - Pivotal Study | Diabetes To confirm that Lucica Glycated Albumin-L is useful for the intermediate term (preceding2-3 weeks) monitoring of glycemic control in patients with diabetes. Inclusion Criteria:Subjects may be included in the study if they meet all the following criteria:1. Male and female subjects 18 years of age and older2. ... |
NCT02489968 | Linagliptin as Add on Therapy to Empagliflozin 10 mg or 25 mg With Japanese Patients With Type 2 Diabetes Mellitus | Diabetes Mellitus, Type 2 Two independent study parts (i.e. Part A and Part B) are included in this trial. Part A willevaluate empagliflozin 10 mg + linagliptin and Part B will evaluate empagliflozin 25 mg +linagliptin. All analyses will be carried out separately for these study parts. Theobjective of Part A is to inve... |
NCT02489565 | Telemedicine Qualifying Transition Between Tertiary and Primary Health Care in Stable Coronary Artery Disease Patients | Coronary Artery Disease The purpose of this study is to determine whether the telemedicine use in primary healthcare is effective in the accompaniment of stable coronary artery disease patients who weredischarged from the tertiary health care clinics. Inclusion Criteria:- individuals with diagnosis of Coronary Artery ... |
NCT02489799 | Utilizing Advance Care Planning Videos to Empower Perioperative Cancer Patients and Families | Cancer Through close engagement with our patient and family member co-investigators, theinvestigators have developed a video-based advance care planning aid for cancer patients andtheir family members who are preparing for major surgery. In this study, patients arerandomized to see either the intervention video (involv... |
NCT02489955 | Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis | Cystic Fibrosis Adult patients with cystic fibrosis (CF) are treated with high dose antibiotics to reducethe long term damage to their lungs from infection. This would typically be with a two weekcourse of intravenous antibiotics each time they have a chest infection (typically three tofour times a year).The most effec... |
NCT02489305 | Study to Evaluate Potential Predictors of Relapse in Participants With Major Depressive Disorder (MDD) | Depressive Disorder, Major The purpose of this study is to identify if there are self-reported or objective measuresrelated to mood parameters that can predict near-term relapse (within 1 month or at anotheridentified time point before meeting the criteria for relapse) or early symptomatic changesindicative of relapse ... |
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