Dataset Viewer
_id
stringlengths 11
11
| title
stringlengths 7
300
| text
stringlengths 14
35.2k
|
|---|---|---|
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 or female, age 18 to 45 years (inclusive) at the time ofenrollment.- Completion and review of comprehension test (achieved > 70% accuracy).- Signed informed consent document.- Available for the required follow-up period and scheduled clinic visits.- Women: Negative pregnancy test with understanding (through informed consent process)to not become pregnant nor to breastfeed during the study or within 3 monthsfollowing last vaccinationExclusion Criteria:- Health problems (for example, chronic medical conditions such as psychiatricconditions, diabetes mellitus, hypertension, or any other conditions that might placethe subjects at increased risk of adverse events)- study clinicians, in consultationwith the PI, will use clinical judgment on a case-by-case basis to assess safetyrisks under this criterion. The PI will consult with the Research Monitor asappropriate.- Clinically significant abnormalities on physical examination (chronic sinusitis orseasonal rhinitis) which compromise identification and interpretation of potentialvaccine associated adverse effects.- Use of immunosuppressive and/or immunomodulative drugs such as corticosteroids orchemotherapeutics that may influence antibody development.- Immunosuppressive illnesses (including IgA deficiency defined by serum IgA belowlevel of detection or <7mg/dL).- Participation in research involving another investigational product (defined asreceipt of an investigational product or exposure to an invasive investigationaldevice) 30 days before planned date of first vaccination or anytime throughout theduration of the study until the last study safety visit.- Positive blood test for HBsAG, HCV, HIV-1/HIV-2.- Clinically significant abnormalities on basic laboratory screening.- Presence of significant unexplained laboratory abnormalities that in the opinion ofthe PI may potentially confound the analysis of the study results.- Current smoker or smoker in past 1 year ('smoker' defined as daily cigarette, cigar,or pipe use for a period of at least 1 month).Research specific- Structural abnormalities on sinus/nasal cavity examination.- Rhinoplasty.- Nasal polyps.- Nasal ulcers.- Deviated nasal septum. This question is being used to determine whether the volunteerhas a clinically significant deviated septum that causes nasal obstruction (therebycausing difficulty breathing), interferes with normal sinus drainage, or obscuresvisualization of the posterior nasal cavity complicating examination and safetymonitoring..- Chronic sinusitis/rhinitis.- Current or planned use of nasal topical corticosteroids and/or nasal spraymedications in the 4 weeks prior to dosing or during the study vaccination period.- Current or recent history (in the past 5 years) of reactive airway disease (asthma),chronic obstructive pulmonary disease, or chronic bronchitis.- History of Bell's palsy.- Chronic use (weekly or more often) of anti-diarrheal, anti-constipation, or antacidtherapy (excluding use associated with spicy meals).- Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day)on a regular basis; loose or liquid stools on other than an occasional basis.- Personal or family history of inflammatory arthritis.- Positive blood test for HLA-B27.- History of allergy to any vaccine.Prior Exposure to Shigella- Serum IgG titer 2500 to Shigella flexneri 2a LPS.- History of microbiologically confirmed Shigella infection in the past 3 years.- Received previous experimental Shigella vaccine or live Shigella challenge.- Travel to countries with symptoms of travelers' diarrhea where Shigella or otherenteric infections are endemic (most of the developing world) within the past 6months prior to dosing.- Occupation involving handling of Shigella bacteria currently, or in the past 3 years.
|
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.Intervention Type is a Device (brain computer interface using EEG). Structure: (1) initialeligibility screening (within 1 week after admission), (2) pre-intervention (first week ofstudy, baseline outcome measures and additional evaluations), (3) intervention process (16weeks), (4) post-intervention (outcome measures and additional evaluations), and (5)follow-up (outcome measures at 6 months). Inclusion Criteria:- Positive diagnostic results for ASD in:Autism Diagnostic Interview-Revised; Autism Diagnostic Observation Schedule; TheDiagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.Exclusion Criteria:- Global Intelligence Quotient < 80- Associated medical condition such as epilepsy, neurocutaneous or other geneticsyndromes, or other usual comorbidity in ASD samples
|
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-morbidities that would limit walking ability, exercise capacity ormake exercise unsafe (e.g. unstable ischaemic heart disease, neuromuscular disease,severe hip/lower limb joint pain, peripheral vascular disease, lower limb amputation)- Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstablecardiovascular disease)- Any condition that precludes providing informed consent e.g. cognitive impairment orpoor English
|
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 confirmed inoperable locally advanced, recurrent, or metastaticadenocarcinoma of the stomach or gastro-oesophageal junction;- ECOG (Eastern Cooperative Oncology Group) performance status 0-2;- adequate renal, hepatic, and hematologic function;- measurable or nonmeasurable disease according to the Response Evaluation Criteria inSolid Tumors (RECIST). Patients with intraoperatively confirmed intraperitonealmetastases but without detectable disease in radiological studies were also eligibleExclusion Criteria:- HER2- positive tumors defined as either IHC 3+ or IHC 2+, the latter in combinationwith FISH+- previous chemotherapy for metastatic or locally advanced disease- surgery <3 weeks before the onset of the study treatment- congestive heart failure- significant dysphagia that would preclude oral administration of capecitabine- concurrent malignant disease, except for adequately treated tumors with highlikelihood of being cured (e.g. basal cell carcinoma of the skin, cervical cancer)- clinical evidence of brain metastases
|
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 health status and well being whilereceiving therapy. Inclusion Criteria:1. An 18 to 85 years old (inclusive) female or male patient2. Prescribed compound for the treatment of pain, wound healing or surface skin scar bytheir Principal Investigator3. Any systemic disease (cardiac, renal, or hepatic) must be well controlled.4. Has no skin lesions at the site of application of study medication except for woundunder treatment5. Able to provide informed consentExclusion Criteria:1. Pregnant or lactating females or women at the child bearing potential not usingeffective contraception.2. Use of other topical or transdermal medication. Patients may be withdrawn for aperiod of 2 weeks from all topical or transdermal medications prior to studyinitiation.3. Hypersensitivity to local anesthetic or other ingredients of the compounded creams tobe used in a study.4. Prior reconstruction skin surgery or skin grafts in the area of cream applicationpreventing absorption of cream except for the treatment of surface skin scar5. Chronic pain conditions not expected to respond to topical pain medication such asdeep abdominal pain, or from conditions such as cancer, or gouty arthritis.
|
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 efficacy. Thus far, the use of umbilicalcord mesenchymal stem cells (UC-MSCs) to treat Crohn's disease has rarely been reported. Inthis study, UC-MSCs were used to treat patients with hormone-controlled Crohn's disease. Weobserved the disease control conditions, corticosteroid dosage changes, andtreatment-related adverse reactions. Inclusion Criteria:- above 18 years of age- moderate to severe Crohn's disease (Crohn's disease activity index (CDAI) between 220and 450)- had received hormone maintenance therapy for more than 6 monthsExclusion Criteria:- active tuberculosis- malignancy- HIV- syphilis- hepatitis B- hepatitis C
|
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. Patients must have documented histological or cytological evidence of adenocarcinomaof the prostate.2. Patients must have received enzalutamide or abiraterone for CRPC. Patients who havereceived combination enzalutamide/abiraterone or combination ARN509/abiraterone aspart of ongoing clinical trials are allowed and will be included in "PriorAbiraterone" arm of this study. Prior treatment with sequentialenzalutamide-abiraterone or abiraterone-enzalutamide will not be allowed. Priortreatment with first-generation AR antagonists (i.e., bicalutamide, nilutamide,flutamide) before abiraterone or enzalutamide is allowed.3. Patients must have demonstrated disease progression while on enzalutamide and/orabiraterone.Progressive disease is defined by one or more of the following:- A rise in PSA on two successive determinations at least one week apart and PSAlevel 2ng/ml.- Soft-tissue progression defined by RECIST 1.1- Bone disease progression defined by PCWG2 with two or more new lesions on bonescan4. Patients must have a minimum serum PSA level of 2 ng/ml that is rising based on thePCWG2 criteria.5. Patients must be 18 years of age.6. Patients must have castrate levels of testosterone (<50 ng/dl [1.74 nmol/l]).7. Patients must have undergone orchiectomy, or have been on LHRH agonists orantagonists, for at least 3 months prior to drug initiation. Patients on LHRHagonists/antagonists must remain on these agents for the duration of the study.8. Patients must have an ECOG Performance Score of 0-1.9. Patients must have adequate hematopoietic function as evidenced by:- WBC 3,000/l- ANC 1,500/l- Platelet count 100,000/l- HGB 10 g/dl10. Patients must have adequate hepatic function as evidenced by AST/ALT levels <3X theULN and bilirubin levels of <2.0 mg/dl.11. Patients must have adequate renal function as evidenced by a serum creatinine of <2.0mg/dl.12. Patients must have K+ >3.5 mEq/l.13. Patients or their legal representatives must be able to provide written informedconsent.14. Patients must have discontinued enzalutamide or abiraterone/prednisolone 4 weeksprior to study drug initiation.15. Patients who have partners of child-bearing potential must be willing to use at leasttwo forms of effective birth control (one form must be a barrier method) during thetreatment period and for 90 days after last dose of VT-464. Patients must also agreeto not donate sperm through 90 days following the last dose of VT-464.Exclusion Criteria1. 1. Patients who have received prior cytotoxic chemotherapy for castration-resistantprostate cancer. Prior docetaxel for castration-sensitive disease is permitted.2. Patients who have received TAK-700 (Orteronel), TOK-001 (Galeterone), ARN-509 orany other therapeutic investigational product directed towards the androgen receptor(AR) or androgen biosynthesis. Patients who receive ARN-509 in combination withabiraterone as part of a clinical trial are allowed.3. Patients who have received ketoconazole, aminoglutethimide, or high-dose estrogen forCRPC.4. Patients who have completed sipuleucel-T (Provenge ) treatment within 30 days ofstudy drug initiation.5. Patients on 5 alpha reductase inhibitors such as finasteride (PROSCAR, PROPECIA),or dutasteride (AVODART) within 3 months from study drug initiation.6. Patients who require pharmacologic or replacement doses of systemic corticosteroidsor who have received systemic corticosteroids within 30 days of study druginitiation; use of topical, inhaled or ophthalmic steroids is permitted.7. Patients who have received any therapeutic investigational agent within 2 weeks ofstudy drug initiation.8. Patients who have received palliative radiotherapy within 4 weeks of study druginitiation.9. Patients who have received herbal products or alternative therapies that may decreasePSA levels or that may have hormonal anti-prostate cancer activity (e.g., sawpalmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seedextract, etc.) within 4 weeks of study drug initiation or plans to initiate treatmentwith these products/alternative therapies during the entire duration of the study.10. Patients with active CNS metastases from prostate cancer. Patients with treatedepidural disease are eligible to enroll. Patients with treated brain metastases canbe included as long as >4 weeks have elapsed since last treatment (radiotherapy orsurgery) for brain metastases, the patient is neurologically and radiographicallystable, and is not receiving corticosteroids for brain metastases. Patients withuntreated brain metastases are excluded. Brain imaging (CT or MRI) is not required atbaseline if brain metastases are not clinically suspected.11. Patients with a history of adrenal insufficiency. Patients who have received systemiccorticosteroids for >2 weeks within 6 months of study drug initiation (includingthose receiving prednisolone with abiraterone) must have adrenal insufficiency ruledout by a morning plasma cortisol concentration 500 nmol/l or a plasma cortisolresponse to an ACTH stimulation test that is deemed clinically normal.12. Patients with a history within the last 3 years of another invasive malignancy(excluding non-melanoma skin cancer).13. Patients with a QTcF interval of >470 msec; if the Screening ECG QTcF interval is>470 msec, it may be repeated, and if repeat 470 msec, the patient may be enrolled.14. Patients with a history of clinically significant cardiac arrhythmias includingventricular tachycardia, ventricular fibrillation, torsades de pointes and seconddegree or third degree atrioventricular heart block without a permanent pacemaker inplace. Patients with resolved or rate-controlled atrial fibrillation/atrial flutterare allowed.15. Patients with NYHA Class III or IV congestive heart failure, unstable angina,myocardial infarction/acute coronary syndrome within the preceding 6 months.16. Patients with diabetes mellitus who have had more than 2 episodes of diabeticketoacidosis in the preceding 12 months.17. Inadequately controlled hypertension (defined as blood pressure >150mmHg systolicand/or >100 mmHg diastolic despite antihypertensive medication) or any history ofhypertensive crisis or hypertensive encephalopathy.18. Patients with a history of seizure within the past 2 years or those who requireprophylactic anti-seizure medications are excluded.19. History of loss of consciousness or transient ischemic attack within 12 months beforestudy drug initiation.20. Patients who have known active HIV, Hepatitis B, or Hepatitis C infections.21. Patients with any other medical, psychiatric, or social condition, includingsubstance abuse, which in the opinion of the Investigator would preclude safeparticipation in the study.
|
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 help the vaginal environment protect against infectionby HIV and other STIs, and that in women who already have HIV, use of the CVR will lower thequantity of HIV that is shed in the female genital tract. Inclusion Criteria:- BV+ by Amsel Criteria- Not intending to become pregnant over the course of the study- If HIV infected, not taking ART- Capable of providing written informed consentExclusion Criteria:- Current pregnancy- Desire/intent to become pregnant over the course of the study- Contraindications to hormonal contraceptive use- Current cigarette smoking if age is older than 35 years- Unable to comprehend consent material because of language barrier or psychologicaldifficulty
|
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 women of childbearing potential and men with partners of childbearing potential,agreement to use a highly-effective non-hormonal form of contraception or twoeffective forms of non-hormonal contraception by the patient and/or partner.4. Histologically or cytologically confirmed and documented adenocarcinoma of the breastwith metastatic or locally recurrent disease not amenable to curative resection;patients with measurable and/or non-measurable disease are eligible5. Known and documented HER2-positive6. Known and documented left ventricular ejection fraction (LVEF) of at least 50%7. Adequate organ functionExclusion Criteria:1. Previous systemic non-hormonal anti-cancer therapy for the metastatic or locallyrecurrent disease2. Pregnant or lactating women3. Current clinical or radiographic evidence of central nervous system (CNS) metastases4. Disease progression while receiving or within 12 months of completion of trastuzumaband/or lapatinib treatment in the adjuvant or neoadjuvant setting
|
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 are now carried by more than half of the U.S.population, they have the potential to overcome many of these barriers by deliveringself-help interventions on apps. Despite PTSD Coach's use of evidence-based cognitivebehavioral strategies there is still a need to test the effectiveness of the app in managingPTSD symptoms. This controlled, two-arm, randomized (1:1) trial will evaluate the efficacy,feasibility and acceptability of PTSD Coach to reduce PTSD symptoms in a community sample oftrauma survivors with PTSD symptoms. After completing an eligibility phone screen or onlinescreen, individuals who score a 35 or above on the PTSD Checklist (PCL) and consent willcomplete a baseline assessment and then be randomized to the PTSD Coach app condition or awaitlist control group. Additionally, those assigned to the PTSD Coach intervention will beinstructed to download a research version of the app, called PTSD Explorer, that enablespassive and objective monitoring of app use. Each individual will be reassessed atpost-intervention (3 months) and follow-up (3 months later, or 6 months after completingbaseline). The investigators predict that those using the PTSD Coach app will demonstrate asignificant and sustained reduction in PTSD symptoms and increase in patient copingself-efficacy compared to the waitlist control group. The investigators will explore ifthere is a relationship between levels of engagement and PTSD symptom change. Inclusion Criteria:1. Experienced or witnessed an extremely traumatic event that involved actual orthreatened death or serious injury to you or someone else. Event must have occurredmore than 1 month ago.2. Significant PTSD symptoms. Total PTSD Checklist Score 35.3. Have a smartphone or smart device that can download apps (iPhone, iPod touch, iPad,or android phone or tablet).4. English is the primary language.5. Available for the next 6 months to participate in the study and use smart device.Exclusion Criteria:1. Unable to give informed consent.2. Is currently receiving mental health treatment.3. Currently participating in other PTSD-related research studies
|
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 collection pertaining to lung cancer.Additional 'control' subjects will also be identified and verified as a 'no lung cancercontrols'. Data previously collected through the COPDGene Study, including QCT results andclinical results (medication use, rate of acute exacerbations of COPD, etc) will be used asvariables for analysis. Inclusion Criteria:- Subjects must meet all of the following criteria1. Be enrolled in COPDGene Phase 1 with or without enrollment in Phase 2 withnewly diagnosed, (within the time of enrollment), non-small cell lung cancer(NSCLC) or small-cell lung cancer (SCLC).2. Documented GOLD stage 1-4 COPD or a history of smoking with no COPD3. Signed HIPAA Research Authorization and a Release of Protected HealthInformation form to collect and review medical records regarding lung cancerdiagnosis, treatment, and outcome
|
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 to saliva, blood, and/or tissueExclusion Criteria:- Age less than 6 years or greater than 61 years- Nuclear family members who do not share the same parents as the AVM patient
|
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 exposedto CD19 directed CAR T-cells (CD19 CART) for 15 years following last CD19 CART (e.g. CTL019)infusion to assess the risk of delayed adverse events (AEs), monitor for replicationcompetent lentivirus (RCL) and assess long-term efficacy, including vector persistence. Inclusion Criteria:- All patients who have received anti-CD19 directed CART therapy and completed ordiscontinued early from a Novartis sponsored treatment protocol that utilizedCD19-directed CART cells or from any CD19 CART trial sponsored by the University ofPennsylvania with which Novartis has a contractual agreement to co-develop the CARtechnology.- Patients who have provided informed consent for the long term follow up study priorto their study participation .Exclusion Criteria:- There are no specific exclusion criteria for this study.
|
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 informed consent form.- Patients with chronic Ph + CML who presented a non-optimal response at 3 months priorto ITK treatment (imatinib, nilotinib, dasatinib). It is defined as a non-optimalresponse:BCR-ABL> 10% per qRT-PCR (IS) at 3 months of initiation of treatment. BCR / ABL 1% perqRT-PCR (IS) at 6 months of initiation of treatment. BCR / ABL> 0.1% qRT-PCR (IS) at 12months of initiation of treatment. BCR-ABL1> 0.1% qRT-PCR (IS) at any time after 12 monthsof treatment initiation.- ECOG Performance Status of 0 or 1.- Recovery at Grade 0-1, or at the baseline value of any pretreatment toxicity, exceptfor alopecia. Cases with significant toxicity will be analyzed individually by thestudy coordinators- Able to take daily oral capsules- Adequate bone marrow function:1. Absolute neutrophil count > 1000/mm3 (>1000 x109/L)2. Platelets 100,000/mm3 (>100 x109/L)3. absent any platelet transfusions during the preceding 14 days.- Adequate hepatic, and renal function:- AST/ALT 2.5 upper limit of normal (ULN) or 5 ULN if attributable toliver involvement of leukemia- Total bilirubin 1.5 ULN- Creatinine 1.5 ULN- Age > 18 years- Willingness of male and female subjects, who are not surgically sterile orpostmenopausal, to use reliable methods of birth control (oral contraceptives,intrauterine devices, or barrier methods used with a spermicide) for the duration ofthe study and for 30 days after the last dose of Bosutinib.Exclusion Criteria- Subjects with Philadelphia chromosome and bcr-abl negative CML.- Overt leptomeningeal leukemia. Subjects must be free of CNS involvement for a minimumof 2 months. Subjects with symptoms of CNS involvement must have a diagnostic lumbarpuncture prior to study enrollment.- Subjects with extramedullary disease only.- Prior stem cell transplantation.- Major surgery within 14 days or radiotherapy within 7 days before the first dose ofBosutinib (recovery from any previous surgery should be complete before day 1)- A history of a clinically significant ventricular arrhythmia, congenital or acquiredprolonged QT interval, a baseline QTcF > 0.47 sec (average of triplicate readings) orunexplained syncope, uncontrolled or symptomatic congestive heart failure (CHF)within 3 months, or myocardial infarction (MI) within 6 months.- Concomitant use of or need for medications known to prolong the QT interval- Uncorrected hypomagnesemia or hypokalemia due to potential effects on the QT interval- Recent (within 30 days of study entry) or ongoing clinically significantgastrointestinal disorder (e.g., malabsorption, short bowel syndrome, bleeding, orgrade >1 diarrhea, nausea or emesis lasting more than 2 days, despite adequatemedical therapy)- Pregnant or breastfeeding women- Evidence of serious active infection, or significant medical or psychiatric illness- Known seropositivity to HIV, or current acute or chronic Hepatitis B or Hepatitis C(antigen positive), cirrhosis, hypokalemia (any grade), or clinically significantabnormal laboratory finding that would, in the investigator's judgment, make thesubject inappropriate for this study.
|
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 to determine the effects of differing levels ofhypoglycemia on in-vivo vascular biologic mechanisms in a healthy population. Inclusion Criteria:Body mass index >21kg m-2Exclusion Criteria:- Pregnant women- Subjects unwilling or unable to comply with approved contraception measures- Subjects unable to give voluntary informed consent- Subjects on anticoagulant drugs, anemic or with known bleeding diatheses- Subjects with a history of severe, uncontrolled hypertension, heart disease,cerebrovascular incidents- Current tobacco use- Subjects with any known allergies to any of the study medications being usedPhysical Exam Exclusion Criteria- Uncontrolled severe hypertension (i.e., blood pressure greater than 160/100)- Clinically significant cardiac abnormalities (e.g. heart failure, arrhythmia)- Pneumonia treatment or hospitalization within 2 weeks prior to enrollment (studyvisit)- Hepatic failure / jaundice- Renal failure- Cerebrovascular accident occurrence or hospitalization within 4 weeks prior toenrollment- Fever greater than 38.0 degrees CScreening Laboratory Tests Exclusion Criteria- Hematocrit lower than 32 %- White blood cell (WBC) count lower than 3 thou/ul or greater than 14 thou/ul- Liver function tests: serum glutamic oxaloacetic transaminase (SGOT) and serumglutamic-pyruvic transaminase (SGPT) greater than twice upper limit of normal range- Alkaline phosphatase greater than 150U/L- Total bilirubin (TBil) greater than 2 mg/dl- Estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2- Positive human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C- Any abnormal cardiac response during multi-stage exercise test (if over 40 years ofage)
|
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:- Has a history of hypersensitivity to HMG-CoA reductase inhibitor and component ofezeimibe- Liver transaminases > 2 x upper limit of normal
|
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 chemotherapy, such as cisplatin, carboplatin and capecitabine, work indifferent ways to stop the growth of tumor cells, either by killing the cells, by stoppingthem from dividing, or by stopping them from spreading. It is not yet known whethercisplatin or carboplatin is more effective than capecitabine in treating patients withresidual triple negative basal-like breast cancer. Inclusion Criteria:- ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeksprior to screening- Female and male patients must have histologically confirmed triple negative (estrogenreceptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growthfactor receptor-2 negative [HER2-]) invasive breast cancer, clinical stage II-III atdiagnosis (American Joint Committee on Cancer [AJCC] 7th edition) based on initialevaluation by clinical examination and/or breast imaging- ER- and PR- should meet one of the following criteria:- =< 10% cells stain positive, with weak intensity score (Allred score =< 2)- =< 1% cells stain positive, with weak or intermediate intensity score(Allred score =< 2)- HER2 negative (not eligible for anti-HER2 therapy) will be defined as:- Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH)HER2/neu chromosome 17 ratio OR- IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio lessthan 2.0 and if reported average HER2 copy number < 6 signals/cells OR- ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 andif reported average HER2 copy number < 6 signals/cells without IHC- NOTE: Patients that originally present with synchronous bilateral tumorsare eligible provided both tumors are TNBC, and at least one of themfulfills the remainder eligibility criteria of the protocol- Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOThave received cisplatin or carboplatin or capecitabine as part of their neoadjuvanttherapy regimen- NOTE: Patients who received preoperative therapy as part of a clinical trial mayenroll- Must have completed definitive resection of primary tumor- Negative margins for both invasive and ductal carcinoma in situ (DCIS) aredesirable, however patients with positive margins may enroll if the treatmentteam believes no further surgery is possible and patient has receivedradiotherapy; patients with margins positive for lobular carcinoma in situ(LCIS) are eligible- Either mastectomy or breast conserving surgery (including lumpectomy or partialmastectomy) is acceptable- Sentinel node biopsy post neoadjuvant chemotherapy (i.e. at the time ofdefinitive surgery) is allowed; axillary dissection is encouraged in patientswith lymph node involvement, but is not mandatory- Post neoadjuvant chemotherapy, patients must be found to have residual invasivecancer in the breast at the time of definitive surgery; residual cancer is defined asa contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm indiameter, and with more than minimal cellularity, as per local pathologistdetermination- NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does notqualify as residual invasive disease in the breast- Post-mastectomy radiotherapy is required for all patients with the following:- Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at thetime of definitive surgery) or involvement of 4 or more lymph nodes at the timeof definitive surgery- For patients with primary tumors < 5 cm or with < 4 involved lymph nodes priorto neoadjuvant chemotherapy and at the time of definitive surgery, provision ofpost-mastectomy radiotherapy is at the discretion of the treating physician- NOTE: Radiation of regional nodal basins is at the discretion of thetreating radiation oncologist; patients enrolled in clinical trialsaddressing local therapy after neoadjuvant chemotherapy are allowed toenroll- Breast radiotherapy (whole breast or partial) is required for patients who underwentbreast-conserving therapy, including lumpectomy or partial mastectomy- Laboratory values must be obtained within 8 weeks prior to screening for protocoltherapy- Hemoglobin (Hgb) > 9.0 g/dL- Platelets > 100 mm^3- Absolute neutrophil count (ANC) > 1500 mm^3- Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula- Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documentedGilbert's disease, who must have a total bilirubin =< 3.0 mg/dL)- Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =<2.5 x upper limit of normal (ULN)- Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 xULN- No stage IV (metastatic) disease, however no specific staging studies are required inthe absence of symptoms or physical exam findings that would suggest distant disease- No clinically significant infections as judged by the treating investigator- Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE)version (v.) 4 grade 2 neuropathy are ineligible- Adjuvant chemotherapy after surgery other than that specified in this protocol is notallowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvantbisphosphonate or denosumab use is allowed- Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissuespecimen from the residual disease on the definitive surgical specimen available forPAM50 analysis for stratification- Tumor tissue specimen from the definitive surgery has been collected and isready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN)Central Biorepository and Pathology Facility (CBPF) within 12 weeks post-surgery- The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center willperform the PAM50 analysis and notify the ECOG-American College of RadiologyImaging Network (ACRIN) operations office within three (3) weeks of receipt ofthe tumor tissue specimen via secure electronic messaging to the ECOG-ACRINdatabase- NOTE: Every effort should be made to submit the tumor tissue specimen tothe ECOG-ACRIN CBPF immediately; tumor tissue cannot be accepted after 12weeks (post surgery) in order to allow for PAM50 analysis- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): For patients randomized to thechemotherapy arms, cycle 1/day 1 (platinum based or capecitabine) must start within 1week (5 working days) following randomization- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Must have PAM50 analysis by digitalmRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen(FFPE) of the residual disease in the breast or axilla resected at the time ofdefinitive surgery completed- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1within 2 weeks prior to randomization- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completedadjuvant radiotherapy >= 2 weeks prior to randomization for protocol therapy, ifapplicable- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completedtreatment with any investigational agent >= 30 days prior to randomization forprotocol therapy, if applicable- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within24 weeks from surgery- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women must not be pregnant orbreast-feeding; all females of childbearing potential must have a blood test or urinestudy within 2 weeks prior to randomization to rule out pregnancy- A female of childbearing potential is any woman, regardless of sexualorientation or whether they have undergone tubal ligation, who meets thefollowing criteria: 1) has not undergone a hysterectomy or bilateraloophorectomy; or 2) has not been naturally postmenopausal for at least 24consecutive months (i.e., has had menses at any time in the preceding 24consecutive months- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women of childbearing potential andsexually active males must be strongly advised to use an accepted and effectivemethod of contraception or to abstain from sexual intercourse for the duration oftheir participation in the study- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Hemoglobin (Hgb) > 9.0 g/dL- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100 mm^3- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Absolute neutrophil count (ANC) >1500 mm^3- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): International normalized ratio (INR)=< 2 for subjects not on anticoagulants; INR =< 3 for subjects on warfarin- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of >50 mL/min- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except inpatients with documented Gilbert's disease, who must have a total bilirubin =< 3.0mg/dL)- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST,SGOT) =< 2.5 x ULN- ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT)=< 2.5 x ULN
|
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 of dynamic MRI techniques to evaluate theseparameters. The investigators will image participants with both SCA and matched controlswith non-invasive MRI. Inclusion Criteria:- Patient with HbSS/HbSB0,- age between 18 and 55 years or age/gender/race/education matched peerExclusion Criteria:- Previous history of a stroke/transient ischemic attack,- neurosurgery,- head trauma,- seizures,- pulmonary embolism,- deep-vein thrombosis,- bleeding/clotting disorders,- current or previous use of anticoagulation medications
|
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 expansions in the Frataxin gene in the affected range forFRDA4. FARS-Neurological score of 20-90 points5. Ambulatory (with or without assistive device) and capable of performingassessments/evaluations6. Body Mass Index 29.9 kg/m27. Agrees to dietary restrictions and agrees to receive calls from a dietary coach8. Signed the informed consent form prior to entry into the study9. Agrees to spend the required number of overnight clinic days10. Able to provide the necessary repeated blood samplesExclusion Criteria:1. Received treatment with other experimental therapies within the last 30 days prior tothe first dose2. Known point mutation in the FXN gene3. History of malignancies (other than basal cell carcinomas)4. Impaired renal function at screening5. Alanine transaminase (ALT) or aspartate transaminase (AST) laboratory values > 2 xupper limit of normal (ULN) at screening6. Known hepatitis B surface antigen (HBsAg)-positive, or known or suspected activehepatitis C infection, or is known to be human immunodeficiency virus (HIV) positive7. Female who is breastfeeding or has a positive pregnancy test8. Male participant or female participant of child bearing potential, who is sexuallyactive and unwilling/unable to use a medically acceptable and effective doublebarrier birth control method throughout the study9. Unwilling or unable to comply with the requirements of the protocol10. Clinically significant cardiac abnormalities at screening that, in the opinion of theInvestigator, would make the patient unsuitable for enrollment11. Diabetes mellitus (Type 1 or 2)12. Suicidal ideation as determined by the Columbia-Suicide Severity Rating Scale13. History, within the last 2 years, of alcohol abuse, significant mental illness, orphysical opioid dependence14. Cannot adhere to the dietary guidance required to be followed by the protocol15. Cannot take the medication due to impairment in swallowing capsules
|
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 practiceincluding annual wellness visits and routine follow-up appointments.- Subjects must be over the age of 18- Subjects must be able to give informed consent- Subjects must have no solid food for 4 hours prior to the procedure, and only clearliquids for 2 hours prior to the procedure.Exclusion Criteria:- Subjects with current symptoms of dysphagia- Subjects with any history of intestinal strictures, prior GI surgery, or history ofintestinal Crohn's disease.- Subjects with current symptoms of fever, nausea or sore throat at the time of theappointment.- Pregnancy
|
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 validate the BiliCare with bilirubin from your baby's blood they couldverify a non-invasive alternative for measuring bilirubin. Inclusion Criteria:1. Parental informed consent2. Male and female newborns with a GA 35 wks3. Enrollment at age > 6 hrs until neonatal discharge4. Pre-phototherapyExclusion Criteria:1. Infants requiring respiratory assistance (such as mechanical ventilation)2. Severe or life-threatening congenital anomalies3. Hematomas at the point of measurement on both ears4. Neonates undergone blood transfusion
|
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 writteninformed consent. Subjects must be willing to authorize use and disclosure ofprotected health information collected for the study.2. Subject must be at least 18 years of age.3. Subject must present with a clinical diagnosis of stable (at least 3 months)plaque-type psoriasis.4. Subject with psoriasis involving 3% or greater BSA, not including the face, scalp,groin, axillae and other intertriginous areas.5. Subject must have an IGA grade of 3 or 4 (moderate to severe) at the Baseline Visit.6. Female subjects of childbearing potential must agree to use contraception during thestudy which can include abstinence with an adequate secondary option should thesubject become sexually active. All women of childbearing potential must complete aurine pregnancy test (test must have a sensitivity of at least 25mIU/ml for humanchorionic gonadotropin) at the Baseline Visit (Visit 2) and the test result must benegative to be eligible for enrollment.7. Subject must be in good general health as determined by the investigator andsupported by the medical history and normal or not clinically significant abnormalvital signs (blood pressure and pulse).Exclusion Criteria:1. Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic,exfoliative or pustular psoriasis.2. Other inflammatory skin disease that may confound the evaluation of the plaquepsoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).3. Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn whichcould interfere with the rating of efficacy parameters.4. History of psoriasis unresponsive to biological or topical treatments.5. History of organ transplant requiring immunosuppression, HIV, or otherimmunocompromised state.6. Use within 180 days prior to Baseline Visit of biologic treatment for psoriasis(e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).7. Have received treatment for any type of cancer within 5 years of the Baseline Visitexcept skin cancer and cervical cancer (in situ) are allowed if at least 1 yearbefore the Baseline Visit.8. Use within 60 days prior to the Baseline Visit of: 1) systemic or topicalimmunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatictreatment (e.g., methotrexate, cyclosporine, hydroxyurea) or 3) oral retinoids (e.g.,acitretin, isotretinoin).9. Use within 30 days prior to the Baseline Visit of: 1) systemic steroids, 2) PUVAtherapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil,sulfasalazine, 6-thioguanine), or 4) UVB therapy. Inhaled, intraocular, andintranasal steroids are allowed.10. Use within 14 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs(e.g., salicylic acid, anthralin, coal tar, calcipotriene), 2) topical retinoids(e.g., tazarotene, tretinoin) or 3) topical corticosteroids.11. Subjects who have participated in a study of an investigational drug 60 days prior tothe Baseline Visit.
|
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 newly diagnosed with acute leukemia and hospitalized to receivetheir initial 4 weeks of intensive induction chemotherapy for this diseaseExclusion Criteria:- Asthma or other reactive airway disease- Sleep apnea- Planned less than two week hospitalization- Change in pain medications/sleeping medications/anxiety medications/antiemeticsduring the trial- Patients who have not completed their initial steroids- Patients who are confused and unable to give informed consent
|
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. Inclusion Criteria:- Inclusion criteria for healthy subjects are:- medically stable;- 18 - 99 years of age;- able to hear the instructions given during the studyInclusion criteria for stroke patients are:- at least 6 months post-stroke;- medically stable;- 18 - 99 years of age;- subcortical or cortical infarct confirmed with MRI;- Mini-mental State Exam > 24/30 (Folstein et al., 1975);- able to hear the instructions given during the study;- able to comprehend the instructions given during the study;- able to commit time to participate in a 6-12-weeks rehabilitation programExclusion Criteria:- having ever experienced a stroke or another brain injury or illness related to thebrain that has lasting effects or effects experienced at the moment of recruitment;- severe sensory impairments such that different movements of the finger, hand orwrist are not reliably felt;- contractures in tested arm that hinder persons from keeping the outstretched armin a relaxed position;- interfering comorbidities (e.g. fracture, cancer, peripheral neuropathy);- exhibit contra-indications to enter the magnetic field of the 3T (pacemakers,metal parts in the body etc);- pregnant or nursing mother;- adults lacking capacity to consent
|
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 development of deep vein thrombosis after one-year offollow-up. Inclusion Criteria:- Established Crohn's disease diagnosis for at least 6 months- Disease involvement of the terminal ileum and/or colon- Clinical remission- Stable treatment for at least 3 monthsExclusion Criteria:- Colectomy- Neoplasia- Surgery in the last 6 months- Anticoagulant treatment- Major liver disease
|
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 ofrespiratory distress. Inclusion Criteria:- Gestational Age between 23 to 30 weeks; within first 4 days of life- very low birth weight between 400 g and 1200 g, inclusive- 5-minute Apgar score >3- documented respiratory distress requiring invasive respiratory Support- A priori: primary intention for either HFOV or high-frequency jet ventilation ORSeverity of Illness: mechanical ventilation with a fraction of inspired oxygen of0.25% and a mean airway pressure of 7 cm H2O, more than 2 hours after an initialdose of surfactant required and clinical care team believes that treatment with HFOVis indicated- anticipated availability of investigational device at the study center beforescreening for enrollment- written informed consent to participate in the study provided by a parent or legalguardianExclusion Criteria:- anticipation to require intubation and mechanical ventilation for less than 12 hours- previous exposure to any mechanical ventilation for 96 hours before planned HFOVtreatment- obvious chromosomal or major congenital abnormalities involving the respiratory tractor upper airway- known congenital heart disease, excluding Patent Ductus Arteriosus (PDA),ventricular-septal defect, or atrial-septal defect- pre-existing air leak, including pneumothorax, pneumomediastinum, pneumopericardium,or extensive bilateral Pulmonary Interstitial Emphysema (PIE)- severe metabolic acidosis with a base deficit of 15 before planned HFOV treatment- severe hypotension (a mean blood pressure more than 2 standard deviations below themean neonate's birth weight despite a total combined dose of dopamine, dobutamine, orboth, of 20 g(kg/min)- moribund subject not expected to survive, or a subject in whom there is a decision tolimit care- currently receiving or previous treatment with inhaled nitric oxide- currently receiving or previous treatment with corticosteroids specifically for BPDprevention- evidence of severe sepsis (neutropenia, severe hypotension, shock)- evidence of Nectrotising Enterocolitis (NEC), defined as Modified Bell's Stage II orgreater- documented Grade III/IV intraventricular hemorrhage- current enrollment in another Investigational Device Exemption or Investigational NewDrug clinical study where treatment, testing, or follow-up may interfere with theresults
|
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 of Parkinson's disease as well.The object of this study is to evaluate whether nutritional supplementation with compoundsthat have been shown to have either anti- inflammatory, or antioxidant effects, mightsupport brain function in patients with Parkinson's disease, particularly in regards to thedopamine system. Enrolled patients will be randomly assigned to receive oral and intravenousn-acetyl cysteine (NAC), or standard PD care. This study will utilize Ioflupane (DaTscan)single photon emission computed tomography (SPECT) to measure dopamine function, magneticresonance spectroscopy (MRS) to measure inflammatory and oxidative stress markers, andneurological measures to assess clinical symptoms, in patients with PD. Subjects willreceive a DaTSCAN and MRS initially and after completing the supplement or NAC regimen. Inclusion Criteria:- Clinical Diagnosis of Parkinson's disease- Subject is between 30 - 80 years of age- Subject has a Hoehn and Yahr score of I - II inclusive- Subject is on stable or on antiparkinsonian medication for at least a month- Women of Childbearing potential will confirm a negative pregnancy testExclusion Criteria:- Subject is allergic to iodine, cobalt, or any of the supplements that will be givenin the study- Subject has had previous brain surgery- Subject has a score of 25 or less on Mini-Mental Status examination- Subject is wheelchair-bound or bed-ridden; non ambulatory- Subject has intracranial abnormalities that may complicate interpretation of thebrain scans(e.g., stroke, tumor, vascular abnormality affecting the target area)- Subject has a history of head trauma with loss of consciousness greater than 48 hours- Subject has any medical disorder or physical condition that could reasonably beexpected to interfere with the assessment of parkinsonian syndrome symptoms, or withany of the study assessments including the SPECT imaging.- Subject has evidence of a significant psychiatric disorder by history/examinationthat would prevent completion of the study- Subject has a current alcohol or drug abuse- Subject is pregnant or lactating- Subject is enrolled in active clinical (drug or device) trial within the prior 30days- Subject is pending surgery during the course of the study- History of very low blood pressure- History of thrombocytopenia or clotting disorders- Cancer patients receiving active chemotherapy- History of active gallstone problems or a bile duct obstruction- History of uncontrolled diabetes, asthma, gastroesophageal reflex disease, or thyroid- History of severe kidney disease (if the patient reports this problem, a serumcreatinine will be checked to assess GFR; if it is less than 30, the patient will beexcluded)- History of Leber's disease, a hereditary eye disease- History of uncontrolled hypercalcemia- History of active sarcoidosis, histoplasmosis, or lymphoma- Patients taking medication that might interact with the supplements involved in thisstudy will be evaluated on a case-by-case basis by PI study physician
|
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 following CFTR mutations: G178R, S549N, S549R, G551S,G1244E, S1251N, S1255P, G1349D- Six years of age or older on the date of signed (Informed Consent Form) ICF, andwhere appropriate, date of assent- Signed ICFs and, where appropriate, signed Assent Form- Able to understand the study requirements and comply with study data collectionproceduresExclusion Criteria:- Previously exposed to Kalydeco, except currently treated patients who startedKalydeco treatment within 6 months of enrollment- Currently enrolled in a Kalydeco interventional study or other interventionaltherapeutic clinical study directed at CFTR modulation- History of organ transplantation
|
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 increasingly approach those of primary Total Knee Arthroplasty(TKA). Inclusion Criteria:- Subject has gross knee instability resulting from loss of collateral ligamentfunction, gross bone loss, comminuted fractures of the proximal tibia or distalfemur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerativearthritis, failed osteotomies, unicompartmental replacement or total kneereplacement, or absent or incompetent posterior cruciate ligament and one or both ofthe collateral ligaments- Subject has a failed primary or revision knee replacement- Subject is 18-80 years of age- Subject is skeletally mature in Investigator's judgment i.e., subject is not activelygrowing or does not have immature bones for any reason- Subject has met an acceptable preoperative medical clearance and is free of ortreated for cardiac, pulmonary, hematological, infection or other conditions thatwould pose excessive operative risk- Subject is willing to sign and date an IRB/EC-approved consent form- Subject plans to be available through the five (5) year postoperative follow-up- If of child bearing potential, Subject reports she is not pregnant nor plans tobecome pregnant during the study- Subject agrees to follow the study protocolExclusion Criteria:- Subject is receiving the study device as a primary knee replacement- Subject has presence of malignant tumor, metastatic, or neoplastic disease- Subject is not expected to return to normal ambulatory function (i.e., morbid obesityor other limiting co-morbidities)- Subject is pregnant or plans to become pregnant during the course of the study- Subject has conditions that may interfere with the revision arthroplasty survival oroutcome (i.e., Paget's or Charcot-Marie-Tooth disease, vascular insufficiency,muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency orneuromuscular disease)- Subject has known (Subject reported) metal hypersensitivity- Subject has an emotional or neurological condition that would pre-empt their abilityor willingness to participate in this study- Subject has BMI>45- Subject is participating in any other pharmaceutical, biologic, or medical deviceclinical investigation or has been treated with an investigational product in thepast 30 days- Subject is facing current or impending incarceration- Subject is not a good candidate for the study based on Investigator opinion
|
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-day cisplatin-based chemotherapy. Inclusion Criteria:1. Patient who was confirmed lung cancer by pathologic histology or cytology.2. Males or females aged 18 years, <80 years.3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Life expectancy 12weeks.4. Males and females should be contraceptive during the period of the trial until 8weeks after the last administration of the drug.5. Patients with asymptomatic, treated brain metastases are eligible for trialparticipation.6. Adequate bone marrow, renal, and liver function are required.7. Able to comply with the required protocol and follow-up procedures, and able toreceive oral medications.8. Institutional review board-approved informed consent will be obtained for everypatient before initiation of any trial-specific procedure or treatment.Exclusion Criteria:1. History of sensitivity/idiosyncrasy to aprepitant or excipients2. Condition that might interfere with drug absorption, distribution metabolism orexcretion.3. Concomitant use of agents that are known to interfere with aprepitantpharmacokinetics4. Any unstable systemic disease (including active infection, uncontrolled hypertension,unstable angina, congestive heart failure, myocardial infarction within the previousyear, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolicdisease).5. Lack of physical integrity of the upper gastrointestinal tract, or malabsorptionsyndrome, or inability to take oral medication, or have active peptic ulcer disease.6. Female subjects should not be pregnant or breast-feeding.7. Inadequate hematological function.8. Abnormal liver and renal function.9. Patient assessed by the investigator to be unable or unwilling to comply with therequirements of the protocol.
|
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 Methylprednisolone regarding blood pressure regulation andautonomic responses after THA.Half of participants will receive intravenous Solu-Medrol 125 mg, while the other half willreceive placebo.The investigators hypothesize that the group receiving Methylprednisolone will be lessorthostatic intolerant, experience less orthostatic hypotension and have an improvedautonomic response compared to the placebo-group, early after THA. Inclusion Criteria:- Osteoarthrosis- Undergoing total unilateral hip-arthroplasty surgery- Speak and understand Danish- Have given informed contentExclusion Criteria:- Revision or bilateral hip-arthroplasty surgery- General anaesthesia- Allergy or intolerance towards Methylprednisolone- Local or systemic infection- Permanent systemic treatment with steroids within 30 days peroperatively- Insulin-dependent diabetes- Atrial fibrillation- Neurological disease incl. Parkinsons- Daily use of hypnotics or sedatives- Alcohol abuse >35 units per week- Active treatment of ulcer within 3 months preoperatively- Cancer disease- Autoimmune disease incl. rheumatoid arthritis- Pregnant or breast feeding women- Menopause <1 year
|
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 one or both great toenails atbaseline.3. Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.4. Subject has baseline and post treatment digital photographs of target great toenails.5. Subjects provided informed consent for treatment of nails with the Cutera GenesisPluslaser system.Exclusion Criteria:1. Subjects have received laser treatment of the infected great toenail(s) with anon-Cutera laser system within twelve (12) months prior to Cutera GenesisPlus lasertreatment.2. Subjects have had a history or clinical diagnosis of moccasin type tinea pedis,lichen planus, psoriasis or bacterial nail infection.3. Subjects had a history or clinical diagnosis of coexisting disorders that maypotentially demonstrate nail manifestations.4. Systemic antifungal medication within six (6) months prior to or following CuteraGenesisPlus laser treatment.5. Subjects who have had a history or clinical diagnosis of repetitive nail trauma priorto treatment.6. Subjects who have participated in any clinical research study within thirty (30) daysprior to or within 210 days following final Cutera GenesisPlus laser treatment.7. Subjects who were pregnant or breastfeeding.
|
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 with operable rectal cancer- case discussed at Oxford Colorectal Cancer multi-disciplinary team (MDT) meeting- willing and able to give informed consent- willing and able to comply with all trial requirements, in the investigator's opinionExclusion Criteria:- females who are pregnant or lactating- known intolerance or hypersensitivity to iron, dextran compounds, magnetic tracers orsuperparamagnetic iron oxide particles (SPIO)- cancer involvement of anal sphincter complex- adults who are not able to give consent or are deemed vulnerable
|
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 obtain clearance to market the newCARESTREAM Cone Beam Computed Tomography (CBCT) scanner in the US. The study was designed inaccordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for SolidState X-ray Imaging Devices", issued on August 6, 1999. Inclusion Criteria:- Subject 18 years or older- Subject has provided informed consent- Subject is able to be positioned properly in the investigational device and be stillduring the exam to reduce the potential of motion in the images.- Subject(s) may have a metal screw, plate or artificial jointExclusion Criteria:- Subject is pregnant- Not able or willing to provide Informed Consent, or consent is withdrawn- Not able to collect all required case information- Subject has a history of high radiation exposure:- Has undergone radiation therapy
|
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, and must be either 1)postmenopausal with amenorrhea for at least 1 year prior to the first dose andFollicle Stimulating Hormone (FSH) serum levels consistent with postmenopausalstatus, or 2) have undergone one of the following sterilization procedures at least 6months prior to the first dose:- hysteroscopic sterilization- bilateral tubal ligation or bilateral salpingectomy- hysterectomy- bilateral oophorectomy- Non-vasectomized males must agree to use a condom with spermicide or abstain fromsexual intercourse during the study until 100 days beyond the last dose of studydrug. (No restrictions are required for a vasectomized male provided his vasectomyhas been performed 4 months or more prior to first dosing. A male who has beenvasectomized less than 4 months prior to first dosing must follow the samerestrictions as a non-vasectomized male)- Males must agree to not donate sperm during the study and for 100 days following thelast dose- Have an HbA1c value between 7.0-10.0%- Be on a stable treatment regimen of metformin, with or without diet/exercise, for atleast 8 weeks- Weigh 60 kilograms (kg) or more at screening and have a body mass index (BMI) greaterthan or equal to () 25.0 and less than or equal to () 40.0 kilograms/meters squared(kg/m2)- Have laboratory test results within the normal range for T2DM population, or withabnormalities deemed clinically insignificant. Urine protein levels must be withinnormal limits- Absence of active diabetic retinopathy (Stage 2 or greater by the InternationalClinical Disease Severity Scale for Diabetic Retinopathy)- Are willing to comply with specific dietary restrictions (that is, [i] able to fastovernight for at least 8-12 hours on several days and [ii] able to consume thestandard meals provided during specified confinement days)- Have given written consent to allow collection of samples for Peripheral BloodMononuclear Cells (PBMC) analysis and for possible biomarkers/safety analysis- Have given written informed consent approved by the institutional review board (IRB)governing the siteExclusion Criteria:- Are currently enrolled in a clinical trial involving an investigational product oroff-label use of a drug or device, or are concurrently enrolled in any other type ofmedical research judged not to be scientifically or medically compatible with thisstudy- Participated (defined as the last dose of study drug) within 30 days prior to dosingin a clinical trial involving an investigational product or non-approved use of adrug with a short half-life or within 5 half-lives of an investigational product witha half-life longer than 6 days- - Have a (QTcF) greater than (>) 450 milliseconds (msec), or clinical significanthypokalemia, a family history of long QT syndrome or any abnormality in the 12-leadElectrocardiogram (ECG)- Abnormal blood pressure (sitting) defined as diastolic blood pressure > 95 or lessthan (<) 50 millimeter of mercury (mmHg) and/or systolic blood pressure > 160 or < 90mmHg- Have a history or presence of cardiovascular, respiratory, hepatic, renal,gastrointestinal, endocrine, hematological, or neurological disorders capable ofsignificantly altering the absorption, metabolism, or elimination of drugs- Show evidence of regular use of known drugs of abuse and/or positive findings onurinary drug screening- Evidence of human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis Cand/or positive results at screening for the respective antibodies for HIV, hepatitisB surface antigen (HBsAg), or hepatitis C antibodies (HCV)- Have anemia that would interfere with the trial or have donated 500 mL of bloodwithin 56 days before the first dose or have donated plasma within 7 days before thefirst dose or provided any blood donation within last 30 days- Have an average weekly alcohol intake that exceeds 14 units per week (males) and 7units per week (females) [1 unit = 12 ounces (oz) or 360 mL of beer, 5 oz or 150 mLof wine, or 1.5 oz or 45 mL of distilled spirits] or are unwilling to stop alcoholconsumption 48 hours prior to the first dosing and throughout the study- Consume more than 10 cigarettes per day or the equivalent or are unable or unwillingto adhere to restricted smoking policies- Have had >1 episode of documented severe hypoglycemia within last 6 months or arecurrently diagnosed as having hypoglycemia unawareness- Have any of the following clinical laboratory test results:- estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 (impaired renalfunction)- alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels > 1.5times (x) the upper limit of normal (ULN)- triglycerides (TG) > 500 milligrams/deciliter (mg/dL)- Have used insulin or other glycemic control medications, except metformin, fordiabetic control within 3 months- Intend to use non-steroidal anti-inflammatory drugs (except aspirin) and drugs knownto prolong QT interval, herbal products, or vitamin supplements that change glucoselevels. The following medications are allowed for participants:- drugs for treatment of hypertension or lipid disorders (except bile acid resins,niacin or fish oils), platelet inhibitors, and on stable dose for 12 weeks priorto first dose- thyroid replacement therapy, proton pump inhibitors, antidepressants,antihistamines, regularly taken over-the-counter (OTC) and anti-emetics that donot cause a corrected QT interval (QTc) prolongation, provided such drugs arenot specifically excluded- hormonal replacement therapy
|
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 hormone secretion and consequently affect glucosehomeostasis.The current study is a human interventional randomized controlled cross-over study includingfour study days for each participant. As a tool to sequester bile acids we will usesevelamer, a phosphate binding resin used in the treatment of hyperphosphataemia in adultpatients with chronic kidney disease. Surprisingly, sevelamer has been shown to improveglycaemic control in patients with chronic kidney disease and type 2 diabetes. Intravenousinfusion of cholecystokinin will be used to elicit gallbladder contraction and emptying. Theaim is to examine how (and if) bile acid sequestration can influence postprandialglucagon-like peptide-1 (GLP-1) secretion and glucose homeostasis in patients with type 2diabetes.The investigators hypothesize that higher luminal concentrations of bile acids in the distalgut will elicit changes in gut hormone secretion. The current study will help to clarifythis hypothesis and improve our general understanding of the association between bile acidcirculation and signalling, gut hormone secretion and glucose metabolism. Inclusion Criteria:- Type 2 diabetes for at least 3 months (diagnosed according to the criteria of theWorld Health Organization (WHO))- Men and postmenopausal women- Metformin applied as the only anti-diabetic drug- Caucasian ethnicity- Normal haemoglobin- Age above 40 years and below 70 years- BMI >23 kg/m2 and <35 kg/m2- Informed and written consentExclusion Criteria:- Liver disease (alanine aminotransferase (ALAT) and/or serum aspartateaminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder- Gastrointestinal disease, previous intestinal resection, cholecystectomy or any majorintra-abdominal surgery- Nephropathy (serum creatinine >150 M and/or albuminuria)- Hypo- and hyperthyroidism- Hypo- and hypercalcaemia- Hypo- and hyperphosphataemia- Active or recent malignant disease- Treatment with medicine that cannot be paused for 12 hours- Treatment with oral anticoagulants- Any treatment or condition requiring acute or sub-acute medical or surgicalintervention- Any condition considered incompatible with participation by the investigators
|
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-ischemic dilated cardiomyopathy undergoing autologous cell therapyin an attempt to better define predictors of response to such treatment. Inclusion Criteria:- Patient inclusion criteria consisted of the following: age 18-65 years old, diagnosisof DCM according to the European Society of Cardiology position statement (9),optimal medical management for at least 6 months, left ventricular ejection fraction(LVEF) <40%, and New York Heart Association functional Class III on stable medicaltherapy for at least 3 months before referral.Exclusion Criteria:- Patients with acute multi-organ failure or a history of hematologic neoplasms werenot included.
|
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 age of either sex and any race- Have a positive history of ocular allergies and a positive skin test reaction to aperennial allergen- Have a calculated best-corrected visual acuity of 0.7 logMAR or better in each eye asmeasured using an ETDRS chartExclusion Criteria:- Have known contraindications or sensitivities to the use of any of theinvestigational product medication or components- Have had a history of refractive surgery, including LASIK procedures
|
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 observed and documented prior to and followinginjection at week 0 and at follow up visits at 2, 10 and 16 weeks. Evaluations will be donevia photographic analysis at week 0,2,10 and 16 weeks and half of the patients will undergomagnetic resonance imaging at week zero and at week 16. The dominant wrist will serve as acontrol and will receive no injection. Analysis includes volume retention, tissue analysis,local skin changes and adverse events, if any. Inclusion Criteria:- Female,- Between 35 and 75 years of age,- Well controlled blood pressure,- Able to sign an informed consentExclusion Criteria:- Patients with active infection,- Patients with a body weight change of greater than 5% throughout the 16 weeks oftheir participation,- Patients with a BMI of greater than 30,- Patients with a collagen vascular disease,- Patients with end-stage organ failure (advanced COPD, CRF, CHF),- Patients with lymphedema or mastectomy or axillary lymph node dissection, Patientswho smoke,- Patients that have undergone deep chemical peels, lasers, Ultherapy, Thermage, otherlight or energy based procedures to the dorsum of the hands one year prior,- Patients who have taken any medication or oral supplements for the previous 4 weeksthat could prolong bleeding time (e.g; Aspirin, Plavix, nutritional supplementsstarting with G, omega-3 , fish oil, etc)
|
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. The intervention regimen is a loading dose of cefuroxime followed bya continuous infusion of cefuroxime until the end of surgery. The intervention regimendosing will be calculated using a patient's renal function and body weight. The interventionregimen will target a free serum drug concentration of 64mg/L. This serum level is 4x theMIC90 for colonising Enterobacteriaceae. The rational for this dosing regimen is summarisedbelow. The primary objective of the study is to reduce by 50% the rate of surgical woundinfections after colorectal surgery. Inclusion criteria- Undergoing colorectal surgery (incision, excision or anastomosis of the large bowel,including anastomosis of small to large bowel)- Age >18.- Expected duration of surgery > 2hours- Creatinine clearance > 40 ml/min- Cefuroxime/metronidazole are appropriate antibiotic prophylaxis regimens.- Patient capable of giving informed consent- Patients undergoing colorectal surgery plus additional surgery e.g. plastic surgery,urological surgery, gynaecological surgery.- If it is not possible to obtain intra-operative blood samples e.g. difficult vascularaccess, or pre-operative swabs e.g. anatomy makes it difficult to obtain, patientswill be included and this information treated as missing data. Patients on antibiotictreatment for an existing infection (except SSIs) can be included in the studyExclusion Criteria:- Unable to consent- Pregnancy- Expected duration of surgery <2hours- Creatinine clearance <40ml/min- Individual level microbiological advice for non cefuroxime based prophylaxis- Cephalosporin allergy- Penicillin allergy (hypersensitivity reaction only)- Coumarin (warfarin and acenocoumarol) treatment- Active blood borne virus infection e.g. HIV, hepatitis.- Seizure history- Concurrent use of probenecid- Current participation in a research project aimed at reducing SSIs- Antibiotics for treatment of a systemic Gram negative infection within 2 hours ofinitiation of surgery (Vancomycin, Teicoplanin, Daptomycin, Linezolid,Flucloxacillin. Nitrofurantoin and Clarithromycin would be permissible antibioticswithout systemic Gram negative antibiotics).- A current diagnosis of a SSI at the time of study entry.
|
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 patients Inclusion Criteria:- documented chronic lymphocytic leukemia (CLL) requiring treatment according toInternational Working Group on CLL (iwCLL) criteria- adequate hematologic function: platelets 25.000/l, neutrophils 1.000/l andhemoglobin 8.0 g/dL, unless directly attributable to the patients CLL (e.g. bonemarrow infiltration)- adequate renal function: a creatinine clearance 30ml/min calculated according to themodified formula of Cockcroft and Gault or directly measured with 24 hr. urinecollection- adequate liver function: total bilirubin 1,5x, aspartate aminotransferase (AST) /alanin aminotransferase (ALT) 2.5x the institutional upper limit of normal (ULN)value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome- negative serological testing for hepatitis B, negative testing for hepatitis-C RNAand negative HIV test within 6 weeks prior to registration- age 18 years- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2, ECOG 3 is onlypermitted if related to CLL- life expectancy 6 months- ability and willingness to provide written informed consent and to adhere to thestudy visit schedule and other protocol requirementsExclusion Criteria:- transformation of CLL (i.e. Richter's transformation, prolymphocytic leukemia)- known central nervous system (CNS) involvement- confirmed progressive multifocal leukoencephalopathy (PML)- malignancies other than CLL currently requiring systemic therapies- uncontrolled infection requiring systemic treatment- any comorbidity or organ system impairment rated with a cumulative illness ratingscale (CIRS) score of 4, excluding the eyes/ears/nose/throat/larynx organ system orany other life-threatening illness, medical condition or organ system dysfunctionthat - in the investigators opinion - could compromise the patients safety orinterfere with the absorption or metabolism of the study drugs (e.g, inability toswallow tablets or impaired resorption in the gastrointestinal tract)- ongoing inflammatory bowel disease- ongoing drug induced pneumonitis- use of investigational agents which would interfere with the study drug 28 daysprior to registration- known hypersensitivity to GA101 (obinutuzumab), CAL-101 (idelalisib) or any of theexcipients- pregnant women and nursing mothers- fertile men or women of childbearing potential unless surgically sterile or 2 yearsafter the onset of menopause, or willing to use two methods of reliable contraceptionincluding one highly effective (Pearl Index <1) and one additional effective(barrier) method during study treatment and for 18 months after end of studytreatment- vaccination with a live vaccine 28 days prior to registration- legal incapacity- prisoners or subjects who are institutionalized by regulatory or court order- persons who are in dependence to the sponsor or an investigator
|
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 select patients for clinical trials with anti-targeted agentsaccording to molecular criteria are generally limited to the analysis of a few biomarkers.Recent studies have shown how this strategy is inappropriate in case of infrequent molecularalterations and that the ideal strategy would consist in simultaneous examination of largenumbers of actionable genomic alterations.This is the first genomic screening platform ever attempted in Spain. By this molecularplatform SOLTI aims to increase the likelihood of a patient being included in a trialdesigned specifically for her molecular tumor type. Thus, the primary objective of thispilot study is to determine the Platform's effectiveness to include patients in clinicaltrials with targeted agents based on the tumor molecular profiling. Inclusion Criteria:- Female or Male patients- Between 18 and 70 years of age- Signed informed consent prior to any screening procedure- Advanced or Metastatic breast cancer of any subtype confirmed both pathologically andradiologically (stage IIIb- IV disease)- The patient may present with a responding, stable or progressive disease- The subjects must be about to receive, or receiving, or will have completed treatmentfor their metastatic disease with any line of treatment in either a clinical trial orthe healthcare setting- Availability of one archived initial or metastatic tumor sample. If archived materialwere not available, a biopsy of the metastatic cancer should be performed to obtainsuch material.- Measurable or non-measurable disease- Quality of life score according to ECOG scale 2- Minimal life expectancy of 3 monthsExclusion Criteria:- Presence of progressive disease at the time of inclusion requiring treatmentinitiation before genomic profile results are obtained- LVEF<50% (MUGA)- Inadequate bone marrow reserve or organ dysfunction shown by any of the followinglaboratory values:- Absolute neutrophil count- Platelet count< 100 x 109/L- Hemoglobin < 90 g/dL- AST/ALT > 2.5 times the upper limit of normality if no demonstrable hepaticmetastases, or > 5 times the upper limit of normality in the presence of hepaticmetastases- Total bilirubin > 1.5 times the upper limit of normality- Creatinine>1.5 times the upper limit of normal- Corrected calcium > upper limit of normality- Phosphate > upper limit of normality- Presence of any other type of cancer, except suitably
|
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 parkinsonism (VP). Each of these diseases has a singularphysiopathological origin, course and prognosis. Numerous imaging studies consequently aimedat finding markers to early make the distinction between the different types ofparkinsonism, in order to identify patients who could benefit from dopaminergic agonisttherapy.Excessive iron deposition in the subcortical and brainstem nuclei has been described innumerous neurodegenerative disorders including Parkinson's disease. Increased iron levelsare more frequent in area that are rich in dopaminergic neurons and have been implicated inthe development of movement disorders, the distribution of areas with increased irondeposition however varying according to parkinsonism types. Iron deposition quantificationcould thus potentially help in differentiating parkinsonism types and could improve therapyguidance. Quantitative susceptibility mapping (QSM) locally estimates the magneticsusceptibility of brain tissues based on gradient-echo signal phase. The localsusceptibility being sensitive to the presence of paramagnetic susbtances, QSM allows thenon-invasive evaluation of iron distribution and quantification in the brain with high imagequality (Liu et al., 2013). However, since iron deposition followed an exponential curveduring normal aging in most of the basal ganglia the potential of QSM to distinguish betweenhealthy and parkinsonian subjects in elderly remains unclear.The aim of this study was thus to determine susceptibility values in the basal ganglia ofelderly patients with parkinsonian syndromes, to compare these values to healthyaged-matched controls and between parkinsonian syndrome types. Secondly, investigators aimedto evaluate microstructural changes in the basal ganglia using diffusion tensor imaging(DTI) in the same population and to determine whether susceptibility and DTI parameterchanges are correlated. Finally investigators sought to assess the relation betweensusceptibility/DTI parameter values in the basal ganglia and behavioral measures of motorand cognitive abilities. Inclusion Criteria:- For Both patients and healthy volunteers :- Age limits 70 et 90 years- Subject able to understand the nature, the aim and the methodology of the study.- Collection of the infomed consent- Affiliation or recipient with the mode of social security.- For the patients :Parkinsonian Syndrome began after 65 years defined as Parkinson's disease Multiple SystemAtrophy (AMS), Progressive Supranuclear Palsy, Vascular Parkinson- For the healthy volunteers :The healthy volunteers will be selected according to the age and the of the study'spatients.Exclusion Criteria:- For Both patients and healthy volunteers :- Person with majority age protected by the law (supervision or trusteeship).- Loss of liberty per court order or administative- Subject presenting contraindications in MRI (valve of ventricular diversion,Ferromagnetic foreign bodies, pace-maker, Implantable defibrillator (ICD),Cochlear hearing implant, Claustrophobia, .)- Antecedent of serious cranial trauma (according to classification) of ischeamicstroke ou intracranial hematoma.- For the patients :Patient treated by neuroleptics- For the healthy volunteers :- Antecedent of neurological desease- Antecedent of psychiatric trouble de trouble psychiatrique (Exceptanxio-depressive disorder)- In period of exclusion relative to another protocol or which the annual amountof the allowances maximum of 4500 was reached.
|
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 group)Exclusion Criteria:- pregnant- have any medical comorbidities- considered unfit for participation by the principal investigator
|
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 is not done forIUI catheters. Therefore no data is available on applying the technique to IUI cathetersprior to insemination. Inclusion Criteria:- Infertile women age ranges from 18 to 40 years at the time of treatment at the MUHCreproductive centre.- Patients undergoing IUI.- Fresh and frozen sperm treatment cycles- Hormone induced and natural cycle (no hormonal stimulation).- Patients speaking English or/and French.- Patients able to consent.Exclusion Criteria:- Patients younger than 18 years or older than 40 years of age.- Patients undergoing ovarian stimulation without IUI.- Patients who have been recruited in our study in a previous IUI cycle.- Patients who don't speak English or French.- Patients who are not able or refuse to consent.- Patient who are recruited in a different IUI research study.
|
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. Group 1 Inclusion Criteria:- HIV infected- Age > 40 years old at enrollment- Minimum 2 years of antiretroviral therapyGroup 1 Exclusion Criteria:- Decline informed consentGroup 2 Inclusion Criteria:- Living in catchment area of Mbarara Regional Referral Hospital (greater Mbarara)- Age > 40 years old- Age and gender matched to a participant in group 1Group 2 Exclusion Criteria:- HIV infection (tested annually as part of study procedures)- Decline informed consent
|
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 transabdominal transducers (General Electric logic a500, logica200 City country). Thereafter, the mobile phone (type, in the dialing mode, was put on themother's abdomen for 10 minutes, concurrently with repeating the 15 minutes CTG trace. Theumbilical artery Doppler was repeated 5 minutes after hanging up to avoid the interferencewith the Doppler machine. The umbilical artery Doppler ultrasound and the recorded fetalheart rate (FHR) strips before and after the mobile phone use were blindly analyzed withrespect to umbilical artery resistance indices (RI) and CTG parameters in terms of number offetal kicks, absence of beat to beat variability, loss of accelerations and the appearanceof spontaneous decelerations. Inclusion Criteria:- aged 18 to 40 years pregnant between- singleton fetus- 32-38 weeks' gestation . They were classified into two groups. Group (A) included 120women with normally growing fetuses. Group (B) included 70 women withgrowth-restricted fetuses.Exclusion Criteria:- presence of medical disorders or obstetric complications (in group A), anomalousfetus and non-reactive fetal CTG in initial CTG trace severe oligohydramnios
|
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 investigators hypothesized that an educational videowould increase patients knowledge on osteoporosis and treatment at a two week follow up. Inclusion Criteria:- Scheduled for at DXA scan at the osteoporosis clinic- Currently on once-weekly alendronate treatment- Informed consentExclusion Criteria:- Patients that do not understand Danish- Patients having hearing impairments (unable to hear the video)- Patients having visual impairments (unable to watch the video)- Patients diagnosed with dementia- Patients unable to give written informed consent.
|
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 hundred and eighty five patients who were scheduled for primary unilateralMIS-TKA were enrolled in the study period.Exclusion Criteria:- Patients with condition/comorbidity that could compromise wound healing, includingvaricose eczema, peripheral vascular disease, receiving immunosuppressivemedications, corticosteroid abuse, chronic skin disease around the knee (e.g.psoriasis and chronic eczema) and having prior knee replacement, osteotomy orfracture of the ipsilateral knee.
|
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 relapse(by central pathology review beforeenrolment..- Relapsed or refractory disease after 2 lines of chemotherapy including rituximaband anthracycline and either having failed autologous Hematopoietic stem celltransplantation (ASCT), or being ineligible for or not consenting to ASCT- Measurable disease at time of enrollment- Life expectancy 12 weeks- Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 atscreening- Adequate organ function:- Renal function defined as:- A serum creatinine of 1.5 x Upper Limit of Normal ULN OR- Estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73 m2- Liver function defined as:- Alanine Aminotransferase (ALT) 5 times the Upper Limit of Normal (ULN)for age- Bilirubin 2.0 mg/dl with the exception of patients withGilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndromemay be included if their total bilirubin is 3.0 x ULN and directbilirubin 1.5 x ULN- Must have a minimum level of pulmonary reserve defined as Grade 1 dyspnea andpulse oxygenation > 91% on room air- Hemodynamically stable and Left Ventricle Ejection Fraction (LVEF) 45%confirmed by echocardiogram or Multigated Radionuclide Angiography (MUGA)- Adequate bone marrow reserve without transfusions defined as:- Absolute neutrophil count (ANC) > 1.000/mm3- Absolute lymphocyte count (ALC) 300/mm3- Platelets 50.000//mm3- Hemoglobin > 8.0 g/dl- Must have an apheresis product of non-mobilized cells accepted for manufacturing- Women of child-bearing potential (defined as all women physiologically capableof becoming pregnant) and all male participants must agree to use highlyeffective methods of contraception for at least 12 months following CTL019infusion and until CAR T cells are no longer present by PCR on two consecutivetestsExclusion Criteria:- Prior treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19therapy- Treatment with any prior gene therapy product- Active Central Nervous System (CNS) involvement by malignancy- Prior allogeneic HSCT- Eligible for and consenting to ASCT- Chemotherapy other than lymphodepleting chemotherapy within 2 weeks of infusion- Investigational medicinal product within the last 30 days prior to screening- The following medications are excluded:- Steroids: Therapeutic doses of steroids must be stopped > 72 hours prior toCTL019 infusion. However, the following physiological replacement doses ofsteroids are allowed: < 6 - 12 mg/m2/day hydrocortisone or equivalent- Immunosuppression: Any immunosuppressive medication must be stopped 4 weeksprior to enrollment- Antiproliferative therapies other than lymphodepleting chemotherapy within twoweeks of infusion- Antibody use including anti-CD20 therapy within 4 weeks prior to infusion or 5half-lives of the respected antibody, whichever is longer- CNS disease prophylaxis must be stopped > 1 week prior to CTL019 infusion (e.g.intrathecal methotrexate)- Prior radiation therapy within 2 weeks of infusion- Active replication of or prior infection with hepatitis B or active hepatitis C( HCVRNA positive )- HIV positive patients- Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. bloodculture positive 72 hours prior to infusion)- Unstable angina and/or myocardial infarction within 6 months prior to screening- Previous or concurrent malignancy with the following exceptions:- Adequately treated basal cell or squamous cell carcinoma (adequate wound healingis required prior to study entry)- In situ carcinoma of the cervix or breast, treated curatively and withoutevidence of recurrence for at least 3 years prior to the study- A primary malignancy which has been completely resected and in completeremission for 5 years- Investigational medicinal product within the last 30 days prior to screening- Pregnant or nursing (lactating) women- Intolerance to the excipients of the CTL019 cell product- Cardiac arrhythmia not controlled with medical management- Patients on oral anticoagulation therapy- Prior treatment with any adoptive T cell therapy- Patients with active neurological auto immune or inflammatory disorders(e.g. GuillainBarre Syndrome, Amyptrophic Lateral Sclerosis)Other protocol-related inclusion/exclusion may apply.
|
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 the new "capsule-reserved" surgicalprocedure with conventional one on the effectiveness to prevent posterior capsuleopacification in age-related cataract patients. Inclusion Criteria:1. Aged 50 years or above2. Both eyes were diagnosed with age-related cataract3. Both eyes were planed to undergo the "Phacoemulsification and IOL implantation"surgery with 1 month4. Biocular BCVA improvement post surgery was feasible judged by the ophthalmologists.Exclusion Criteria:1. Other ocular diseases2. ACD<3CT3. Combined cataract surgery (trabeculoplasty, keratoplasty)4. Lens pseudoexfoliation syndrome combined with glaucoma or zonular abnormalities5. Previous intraocular surgery or trauma (laser not included)6. Uveitis7. Recent ocular infection8. Proliferative diabetic retinopathy9. Diabetes mellitus10. Congenital ocular abnormalities (aniridia, congenital cataract)11. Atrophy of iris12. Participants with previous clinical trials 30 days before surgery13. Using prostanoid eye drops14. Uncontrolled systematic diseases
|
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 with Nurse-driven Education and OutReach),a 4-facet, team-based intervention that re-engineers how surrogates are supported in ICUs,including: 1) changing care "defaults" to ensure clinician-family meetings within 48 hoursof enrollment and frequently thereafter; 2) protocolized, nurse-administered coaching andemotional support of surrogates before and during clinician-family meetings, 3) increaseduse of palliative care services for patients with a poor prognosis; and 4) structuredcommunication at care transitions about patient's health care preferences and goals. Theinvestigators propose to begin deployment of the PARTNERII program in the spring of 2015enrolling 690 patients and 690 surrogate decision makers in 5 ICUs using a stepped wedgedesign. The investigators expect to achieve the following project goals:1. To increase the patient-centeredness of end-of-life decisions, and to increase thequality of clinician-family communication.2. To decrease the psychological burden on family members acting as surrogates.3. Lower costs: To reduce total health care costs by increasing the use of palliative careand hospice services and decreasing unwanted readmissions near the end of life. Inclusion Criteria:- 18 years of age or older- Surrogate decision maker for ICU patient in one of 5 UPMC ICU'sExclusion Criteria:- Non-English Speaking- Surrogate's loved one is for organ transplantation- Not physically able to participate in family meeting
|
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. We will assess the bioenergetic profile of blood cells isolated mitochondria,and muscle fibers as well as the expression of mitochondrial proteins and regulators ofmitochondria biogenesis before and after supplementation. All participants will be givenvitamin D3 (4,000 IU/d) for 4 months. Inclusion Criteria:- SPPB score of 10 or less- initial serum 25(OH)D concentration of 12-17.9 ng/mL- not dependent on a walker- willing to provide informed consent and to adhere to the protocol- not involved in another behavioral, exercise, or investigational drug interventionstudy- self-reported physical performance difficulty- were screened for the EVIDENCE study within the last 2 monthsExclusion Criteria:- serious or uncontrolled chronic disease- evidence of impaired cognitive function (MoCA<18)- taking prescription vitamin D2 or taking >1000 IU/day of vitamin D3 from all sources;taking an oral corticosteroid; taking hormone replacement therapy- inability or contraindications to consume daily vitamin D supplements- knee or hip surgery within the last 6 months or planned knee or hip surgery withinthe next year- not willing or eligible to undergo a muscle biopsy (on blood thinners)- weight loss of greater than or equal to 5% in the past 3 months- BMI > 40kg/m2- eye surgery within the past month or planned within the next month- if the PI feels the participant is unlikely to follow the protocol
|
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 care visit at a study clinic- 18 years of age or older- Willing and able to provide informed consent for study participationExclusion Criteria:- Prior participation in the study
|
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 subacuteintervention in these patients. Inclusion Criteria:- Inclusion criteria:- Patients more than 18 years of age.- STEMI > 12 hours and < 36 hours.- Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP > 90)and Killip class < 3.Exclusion Criteria:- Clinical instability which requires an acute invasive strategy.- Left main occlusion or multivessel disease which requires CABG.- Previous Q-wave infarction in the current infarct related artery.- Left Bundle Branch Block (LBBB).- Severe renal insufficiency.- Pacemaker- Chronic atrial fibrillation.- Previous Coronary Artery Bypass Surgery (CABG).- Pregnancy.- Other severe illness with life expectancy less than 1 year
|
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 explore its effect on various health outcomes(healthcare utilization and engagement, expenditures, drinking and consequences, quality oflife) as well as the association of patient-level characteristics (e.g. sex, race, baselinedrinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness.Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase1) is essential before planning a large-scale effectiveness trial (phase 2). Inclusion CriteriaSubjects must meet all of the following criteria to be eligible for study enrollment:1. English or Spanish speaking**Non-English Spanish speaking patients will not be enrolled initially until studydocuments have been translated, back translated, and approved by the InstitutionalReview Board (IRB).2. Emergency Department patient3. Aged 18-804. Have had >4 emergency department visits within 12 months for 2 consecutive 12-monthperiods. Period of time can be extended by up to 6 months if incarcerated orinstitutionalized for 6 months.5. Meet Diagnostic and Statistical Manual version IV (DSM-IV) criteria for alcoholdependence or & DSM-V criteria for alcohol use disorder, severe.6. Have 2 days/week of heavy drinking (>4 drinks/day)7. Capable of giving informed consent.Exclusion CriteriaSubjects who meet any of the following criteria will be ineligible for study enrollment:1. Active opioid dependence2. Acute or chronic pain requiring opioid treatment3. Acute liver injury (liver aminotransferase concentrations >5 times the upper limit ofnormal)4. Health condition considered unsafe for inclusion (at discretion of PI and/orattending physician)5. Lack of capacity or willingness to consent6. Currently prescribed pharmacotherapy for alcohol dependence (not including treatmentof acute alcohol withdrawal syndrome)7. Previous significant adverse reaction to naltrexone or diluent8. Pregnant, nursing, or not using effective methods of birth control9. Prisoners (as defined by Office of Human Research Protection) at the time ofenrollment ARE NOT ELIGIBLE for study entry. However, subjects who become prisonersafter being enrolled will be included and not be withdrawn from the study. Patientson parole or probation are eligible for enrollment.
|
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 Patients between the ages of 18-50 planning to undergo cesarean section fordelivery.Exclusion Criteria:- Intra-operative findings suggestive of underlying cancerous condition- Known preoperative infectious disease.- Hysterectomy during cesarean section.
|
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 received hepatitis A vaccine before;- Completed hepatitis B vaccine full immunization schedule;- Written consent of the guardian of each participant;Exclusion Criteria of the First Injection:- History of allergy to vaccine(s), or history of serious adverse reaction tovaccination, such as urticaria, dyspnea, angioneurotic edema, or abdominal pain;- Autoimmune disease or immunodeficiency;- Any acute disease that made the conditions of the person unsuitable for vaccination- Administration of any live attenuated vaccine within 14 days prior to the injection;- Administration of any subunit vaccine or inactivated vaccine within 7 days prior tothe injection;- Administration of treatment of immunosuppressants (e.g., corticosteroid) within 1month prior to the injection, or planning for such treatment during this study;- Body temperature > 37.0 C before injection;- Based on the evaluation of the investigator, there was any other factor thatindicating the person was unsuitable for this study;Exclusion Criteria of the Second Injection:- Any acute infectious disease, body temperature > 38.5 C or acute attacks of chronicdiseases within 3 days prior to the second injection;- Administration of blood product or other investigational drug during this study;- Occurrence of adverse event at grade 3 or higher and the event was related to thefirst injection;- The investigator or the Ethic Committee decided that the subject should be excluded;
|
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 include twenty NSCLC patients confirmed by pathological examination ofbronchoalveolar examination (BAL), brush and/or biopsy. Inclusion Criteria:- Inclusion criteria for patients:Non small cell lung cancer patients recently diagnosed who did not receive chemotherapy,surgery or radiation therapy.Exclusion Criteria:- Exclusion criteria for patients:- Diagnosis of asthma or COPD.- Broncheiactasis.- upper/lower respiratory tract infection in the preceding 4 weeks.- Active pulmonary tuberculosis.- Associated cancer beside lung cancer.- Patients who received chemotherapy, surgery or radiation therapy previous to thesample collection.Exclusion criteria for control subjects:- Diagnosis of asthma or COPD.- Broncheiactasis.- Upper/lower respiratory tract infection in the preceding 4 weeks.- Active pulmonary tuberculosis- Smoking in group I.
|
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 previous participants will allow us to demonstrate the advancement of differenttechnologies, as well be used to allow comparisons between current technologies. Inclusion Criteria:- Normal, healthy participants and patients with AMDExclusion Criteria:1. Those suffering from head, neck or other injury which makes them unable to positionthemselves in head restraint for imaging2. Participants who are unable to maintain retinal fixation on a specified target3. Participants unable to achieve sufficient pupil dilation and alignment stability forimaging to take place4. Patients with media opacity which preclude high quality imaging will be excluded.5. Exclusion criteria include vulnerable patients patients under 18, pregnant,economically and educationally disadvantaged, decision impaired, or homeless people.We exclude pregnant women because pregnancy often can alter eye anatomy.
|
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 patients suffering from pain.Objective: This study aims to determine if the analgesic effect induced by TENS can be usedto maximize the rehabilitation of elderly patients suffering from chronic pain. Morespecifically, the objectives are to: 1) compare functional outcomes of patients from the DayHospital receiving rehabilitation with either active TENS treatments or simulated TENStreatments, and 2) determine if there is an association between the analgesic effect of TENSand the clinical evolution of patients following their rehabilitation.Methods: In this RCT, patients will be assigned randomly to either the: 1) experimentalgroup receiving active TENS treatments or 2) the control group receiving simulated TENStreatments. Thirty-six patients will be recruited according to the following criteria: 1)will receive physiotherapy rehabilitation at the Day Hospital of the CSSS-IUGS, 2) be atleast 65 years of age, 3) suffering from chronic pain (pain lasting for more than 6 months),4) presenting pain during the rehabilitation at the Day hospital. For security reasons,patients with a cardiac simulator will be excluded from the present study (TENScontraindications). Patients with cognitive alterations (score of < 24/30 at the Folsteintest) will also be excluded. Sociodemographic information will be retrieved from medicalrecords by the research assistant at baseline (T1). Moreover, various questionnaires will beadministered at T1, after half of the rehabilitation period (i.e. 4 to 6 weeks) (T2), andafter the 8- to 12- week rehabilitation period (T3) to measure the qualitative aspects ofpain, mood, and physical function. Functional outcomes will as well be collected directlyfrom the medical record at each assessment times (T1, T2 and T3).The measures includeexercise tolerance, balance, mobility and balance, and functional ability.Anticipated results: We believe that: 1) use of active TENS during the rehabilitationsessions will potentiate rehabilitation of patients suffering from chronic pain at theCSSS-IUGS Day Hospital, and 2) there is a relationship between the analgesic effect inducedby TENS and the clinical evolution of patients. Inclusion Criteria:1. will receive physiotherapy rehabilitation at the Day Hospital of the Pavillond'Youville of the CSSS-IUGS,2. be at least 65 years of age,3. suffering from chronic pain (pain lasting for more than 6 months),4. presenting with pain during the rehabilitation session at the Day hospitalExclusion Criteria:1. Having a cardiac simulator (TENS contraindications).2. Having with cognitive alterations (score of < 24/30 at the Folstein test)
|
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 signs of autism and effective evidence-based practice withextensive video footage to rapidly build the capacity for early detection. The investigatorswill also conduct a multisite pragmatic randomized clinical trial to test the effectivenessof an evidence-based Family Engagement Intervention compared to Autism Navigator EnhancedPractice implemented by the 3 community service systems with children who have a positiveautism screen to increase the number of children who are screened, referred for evaluation,receive a diagnosis, and receive community-based EI between 18-27 months of age. This studywill impact family engagement in community screening and diagnosis by demonstrating theeffectiveness of brief manualized engagement interventions. Findings will advance science byproviding researchers with a method for recruiting a community sample, allowing for researchat younger ages, which could accelerate science. Inclusion Criteria:- community service providers will be recruited from the specific catchment areas ofthe 4 sites in Florida, Georgia, New York, and Pennsylvania from 3 differentcommunity service systems: 1) primary care including private, public, and militaryhealth care agencies and federally qualified health centers; 2) federal programsincluding Women, Infants, and Children (WIC) Food and Nutrition Service, Early HeadStart, and other social programs supporting low-income families; and 3) the NationalBlack Church Initiative (NBCI) and other religious networks serving minorities.- children screened between 9 and 18 months of age by these community service providerswho have agreed to be in this study and their families.
|
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 (PLA) for 12 weeks. Inclusion Criteria:- a body mass index between 18 and 27 kg/m2;- Diminished libido;- Sexual behavior complaints;- No evidence of severe clinical depression;- General good health based on history and physical examination.Exclusion Criteria:- a past history of neurological disorder;- Poor feelings for their partner;- Had received pharmacotherapy for depression within 8 weeks before screening- Taking medication known to interfere with normal sexual function (such as -blockersand -blockers);- Recent psychiatric or systemic illness;- Uncontrolled hypertension (blood pressure>160/95mmHg),- Unstable cardiovascular disease,- Genital bleeding;- Use of psychoactive medications, alcohol excess consumption or any other drug abuse;- Women who had under gone treatment for acne, depression, dyspareunia.
|
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 Consultation on Urological Diseases:- involuntary urine leakage on effort, exertion, sneezing or coughing whichstopped when the stress ends;- visible involuntary leakage from the urethra synchronous with increasedabdominal pressure, or a pad weight gain >1 g in 1-hour pad test;- without symptoms of urinary frequency and urgency.Exclusion Criteria:- Women were excluded from the study if they met any of the following criteria: *othertype of urinary incontinence (UI) (urge, mixed, or overflow UI, etc);- symptomatic urinary tract infection;- ever received UI or pelvic surgery;- a severity of pelvic organ prolapse degree 2;- residual urinary volume >30 ml;- maximum flow rate 20 ml/s;- limited in walking, stairs climbing and running;- receiving specialized treatment for SUI, or taking medicine affecting bladderfunction;- serious cardiovascular, cerebral, liver, kidney, or psychiatric disease,diabetes, multiple system atrophy, injury of cauda equina, or myeleterosis;- being pregnant or breastfeeding;- with cardiac pacemaker, metal allergy or severe needle phobia;- unlike to give written formed consent.
|
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 years old- Overweight or obese (BMI 25-35 kg/m2)- Post-menopausal (confirmed by clinical hormone levels assessed at screening if withinone year of last menses)- Plasma HDL cholesterol greater than or equal to 50 mg/dL.Exclusion Criteria:- Documented chronic diseases including diabetes, thyroid disease, metabolic syndrome,cancer (active), or previous cardiovascular events- Having 3 or more traits of Metabolic Syndrome- Egg allergy or multiple food allergies or food intolerances that would significantlylimit food intake- Smoker- Current consumption more than 1 alcoholic drink/ day- Extreme dietary or exercise patterns- Recent weight fluctuations (greater than 10% in the last six months)- Anemia- Taking prescription lipid medications or other supplements known to alter lipoproteinmetabolism such as isoflavones, red yeast rice, or > 1 g of fish oil/day.- Taking exogenous hormones (i.e. hormone replacement therapy)
|
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. Inclusion Criteria:- 100 thoracotomy patients who agreed to take part in our study and signed a consent- age 18-80 years- ASA I-III- men/women equally- thoracotomies are managed with using intratracheal double lumen tube- insertion of thoracic epidural cannula and during the operation administration of1mg/ml bucain, 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speedExclusion Criteria:- acute operation- diclofenac allergy in the anamnesis- the lack of thoracic epidural cannula
|
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 to assess optimal imaging technique, imagingquality, and subject tolerability. Inclusion Criteria:- Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject withprior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis ofGERD (18 years or older).- AND Subject must be able to give informed consent.- AND Subject must eat no solid foods for 8 hours before the procedure and only clearliquids for 2 hours before the procedure.Exclusion Criteria:- Subjects with any history of or known upper gastrointestinal strictures- OR Subjects with a history of Crohn's disease,- OR Subjects with difficulty swallow
|
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 accustomed to use. Fractionated ICED therapy is a therapy byadjusting the Original ICE regimen.This is how the capacity of Ifosfamide divided into threedays. (Fractionated ifosfamide).Original ICE therapy has been widely used as a salvagetherapy of patients with relapsed or refractory lymphoma for a long time, it has beenrecommended as part of primary therapy of T-cell lymphoma.But Fractionated ICED is added todexamethasone therapy in order to improve the effectiveness as a primary therapy.Therecurrent lymphoma in 75 patients with treatment after Fractionated ICE when the self-stemcell transplantation, showed a more than 40% progression-free survival.Thus treatment ofFractionated ICED targeting previously untreated patients, and if a combination of high-dosedexamethasone to expect to be able to induce a progression-free survival of 60% or more. Inclusion Criteria:1. Age 19-65 years2. Informed consent3. Subject able to adhere to the study visit schedule and other protocol requirements.4. Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for thetreatment of Peripheral T-cell Lymphoma It includes the following subtypes.- PTCL, not otherwise specified- Angioimmunoblastic T-cell lymphoma- Anaplastic large cell lymphoma, ALK-negative type- Enteropathy-associated T-cell lymphoma- Hepato-splenic T-cell lymphoma- Subcutaneous panniculitis-like T-cell lymphoma- Primary cutaneous gamma-delta T-cell lymphoma- Primary cutaneous CD8+ aggressive epidermotropic lymphoma- Other non classifiable T-cell Lymphoma5. Performance status (ECOG) 0,1 or 26. A negative pregnancy test prior to treatment must be available both forpre-menopausal women7. Female of childbearing potential (FCBP) must: contraceptive methods (oral,injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterinedevice; barrier contraceptive with spermicide; or vasectomized partner) while on IP;and for 3 months following the last dose of IP.Male subjects must practice trueabstinence or agree to use a condom during sexual contact with a pregnant female or afemale of childbearing potential while participating in the study, during doseinterruptions, and for 3 months following IP discontinuation.8. life expectancy90day(3months)Exclusion Criteria:1. Other serious medical illnesses or psychiatric disorders2. Any state that the confusion in the interpretation of test result.3. Other type lymphoma ex) B-cell lymphoma4. Other type T-cell lymphoma- Adult T-Cell Leukemia/Lymphoma- NK/T-cell Lymphoma, Nasal Type- ALK-Positive Anaplastic Large-Cell Lymphoma- Cutaneous Tcell lymphoma- primary cutaneous CD30+ lympho- proliferative disorder- primary cutaneous Anaplastic T cell lymphoma5. Priviously treated for PTCL(Except for a short period before randomization ofcorticosteroids (a period of not more than 8 days)6. Previous radiation therapy7. CNS involvement.8. If the contraindication to chemorherapy9. Subject has known historical or active infection with HIV.10. BM function: ANC < 1.5 109/L; Platelet count <100,000/mm2 (100 109/L), SGOT/ASTor SGPT/ALT 3.0 x ULN, Bilirubin> 2 x upper normal value11. serum creatinine level > 2.0 x ULN12. Any other malignancies within the past 3 years except curatively treated non-melanomaskin cancer or in situ carcinoma of cervix uteri13. MUGA scan <45%14. Those who administered doxorubicin exceeding 200 mg / m215. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiringsystemic therapy.16. Breast-feeding or pregnant female
|
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 the core protocol.- Able to understand and willing to sign the informed consent to participate in thefollow-up.- Treated with hESC-RPE cell transplant in the core protocol.- Previous participation in study.Exclusion Criteria:- Unwilling or unable to participate in the study
|
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. Inclusion Criteria:- Age 18 yo- Having on pump cardiac surgery at CHU of Lige between April 2013 and June 2014Exclusion Criteria:- Off pump surgery- Use of Blood or Albumin in the cardiopulmonary bypass priming solution- Preoperative dialysis
|
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 male or female, of any race who is at least 40 years of age and has clinical signsof CNV or exudative manifestations of AMD, has clinical signs of DR, or clinicalsigns of retinal occlusive disease.2. Patients with subfoveal, extrafoveal or juxtafoveal CNV, which is classic, minimallyclassic or occult and has dimensions less than 25.0 mm2 as measured on the sodiumfluorescein angiogram (SFA).3. Patient with recurrent CNV, where previous treatment never involved the fovealavascular zone (FAZ).4. Analysis of highspeed ICGA must show one or more welldefined feeder vessel.5. Patient must have best corrected visual acuity based on the ETDRS chart between 20/40and 20/320 in the study eye.6. Patient must be willing, be able to comply with the protocol and provide informedconsent.Exclusion Criteria:1. CNV secondary to any cause other than AMD or DR.2. Patient with significantly compromised visual acuity in the study eye due toconcomitant ocular conditions.3. Patient participating in any other investigational drug study.4. Patient with significant liver disease or uremia.5. Patient with known adverse reaction to indocyanine green or iodine.6. Patient is pregnant or nursing.
|
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 specific web-based coaching, profiling and suggestiontool. Inclusion Criteria:- At least a bachelor level degree- Age over 18 years- Decreased psycho-physic state (own assessment)- Is in a relationship- Motivated to enhance own well-being and willing to change lifestyle, to do exercisesrelated on mental well-being and relationship- Willing to use technological wellness coaching tools, familiarity with technologyExclusion Criteria:- Work includes night shifts- Acute health conditions or serious diseases- Chronical pain affecting functionality- Long period(s) of absence from work during the coaching period (e.g. long vacation,alternation leave, parental leave, pension)- Participation in some other study
|
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 diabetes- Transmetatarsal amputation- Below-knee prosthetic user- 2-5 years from surgeryExclusion Criteria:- No diabetes- Other than transmetatarsal or below-knee amputation- Below-knee amputation but not a below-knee prosthetic user- Less than 2 years from the amputation- Over 5 years from amputation
|
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 complete daily and weekly questionnaires- be willing to wear a SenseWear Pro Armband (BodyMedia, Inc.) to monitor energyexpenditure and establish dietary energy needs- be willing to provide blood samples, stool samples, and urine samples throughout thecourse of the study- be willing to discontinue prebiotics, probiotics and/or any fiber supplements for theduration of the study- be willing to consume the provided diet for the designated 8 weeks of the study- are willing to report and maintain their usual alcohol intake throughout the study- are able to take foods, study fiber, probiotic, and placebo without the aid ofanother person- able to attend all scheduled study appointments for the duration of the study- have a usual protein intake consistent with United States' population as assessed bydietary analysis- have a usual fiber intake consistent with United States' population as assessed bydietary analysis- be willing to provide a social security number to receive study payment.Exclusion Criteria:To participate in the study you must NOT- have a physician-diagnosed gastrointestinal disease or condition (such as ulcerativecolitis, Crohn's disease, gastroparesis, peptic ulcer disease, cancer, celiacdisease, short bowel disease, ileostomy)- have had or are currently being treated for any known illnesses or conditions thatmay impact perceived health such as HIV/AIDS, immune modulating diseases (autoimmune,hepatitis, cancer, etc.), diabetes or chronic kidney disease- be a vegetarian- have any known food allergies or dietary restrictions- be currently taking medication for constipation or diarrhea- have taken antibiotics within the past 2 months- be a current smoker- be planning on loosing/gaining weight during the next 6 months- typically consume no more than one alcoholic beverage per day- have a BMI greater than 30
|
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 for prevention of metabolic syndrome or Cardiaccomplications- Having internet access.Exclusion Criteria:- No Internet access; Taking more than 3 antihypertensive drugs- Have Diabetes diagnosis; Meet the DSM-IV-TR of Eating Disorder- Submit a serious psychological disorder diagnosed (psychosis, bipolar disorder, majordepressive disorder, substance abuse)- Have a disability which prevents or hinders the exercise and physical activity- Be receiving any treatment for weight loss in another center.
|
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 continuous need to improve treatment as well as diagnostic and prognostictools.This study evaluates the clinical efficacy, tolerability and feasibility of remote ischemicconditioning (RIC) in patients with moderate active ulcerative colitis (UC). Theinvestigators hypothesize that RIC beyond the well known effect on reperfusion tissue damagehas a clinically relevant anti-inflammatory effect in UC. RIC constitute a repeated briefand non-harmful suppression of blood circulation in a limb. The mechanism of action of RICis likely to involve suppressed inflammation and cell death.Our study is a randomized clinical controlled study including 38 patients. Patients willreceive RIC or sham for 10 consecutive days.The effect of RIC on active UC is evaluated by changes patient's symptoms, endoscopyfindings, and various markers in the blood, faeces and the intestinal wall. Inclusion Criteria:- Age:18 years- Verified ulcerative colitis diagnosis according to clinical, endoscopic andhistological standard criteria.- Diagnosis of ulcerative colitis established for at least 6 months- Moderate active ulcerative colitis, total Mayo score > 6- Endoscopic subscore activity grade 1- Written informed consentExclusion Criteria:- Pancolitis or acute severe ulcerative colitis requiring immediate treatment- Need for admission due to active ulcerative colitis- Ulcerative colitis with systemic symptoms (abdominal pain, fever > 37.5 degrees,weight loss exceeding 3 kilograms).- Patient with anemia (Haemoglobin < 8.3 mmol/l for males and < 7.3 mmol/l forfemales).- Patient with ostomy or pouch.- The patient has had a bowel resection (except appendectomy)- The patient has constipation and/or another known bowel condition than ulcerativecolitis such as IBS.- The patient has diabetes.- Regular intake of acetylsalicylic acid or NSAIDs- The patient cannot understand the information material.- The patient has had colon cancer, dysplasia or adenomatous polyps in the colon duringthe recent 5 year- The patient is in a poor general condition.- The patient has had a food poisoning within the last three months.- The patient is pregnant at the time of inclusion or has planned pregnancy during theperiod of study.- The patient is in medical treatment with cyclosporine at the beginning of the run inperiod.- Treatment for ulcerative colitis treatment has been changed within two weeks beforethe first day in the run in period- The patient has commenced treatment with azathioprine, 6-mercaptopurine ormethotrexate within 12 weeks before the first day in the run in period.- The patient has commenced treatment with TNF- inhibitors within 12 weeks before thefirst day of the run in period.- The patient suffers from coeliac disease or lactose intolerance.- Antibiotic treatment within two weeks before the first day of the run in period.- Patient has any medical, surgical condition that excludes the use of RIC.
|
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 has revealed results that mirror the investigators'own clinical experience. In their daily practice, the investigators have further advancedtheir treatment concept and routinely apply prophylactic augmentations with VP using analgorithm. Biomechanical studies support their approach, but clinical studies are rare sofar. Prophylactic augmentation with balloon kyphoplasty has not shown convincing effects ina small pilot study. Given the above mentioned methodological and clinical disputes and thecall for high-evidence studies about VP, the investigators aim at generating a reliablesample size calculation and preliminary results for a future multicenter RCT aboutprophylactic adjacent level augmentation with VP in single level osteoporotic compressionfractures. Inclusion Criteria:- Age 55 years- Written informed consent- Single level acute (< 6 weeks) vertebral compression fracture- Fracture due to diagnosed or presumed underlying primary or secondary osteoporosis- Patients with Association for the study of Osteosynthesis (AO) type A1.x fracturesand A3.1 fractures may be included in the study- Target Vertebral Compression Fracture (VCF) is between T10 and L4- Target VCF to be treated shows either: height change - an acute (< 6 weeks) change inVB height (>15% height loss) with height loss at the anterior or middle portion ofthe VB consistent with a worsening of 1 or more grades acc to Genant- OR positive MRI or bone scan - VB shows hyperintense signal on MRI-T2 or STIRsequence- OR target VB is positive on radionuclide bone scan- Back pain correlating with the location of the VCF- Treatment of target and adjacent VCFs is technically feasible by and clinicallyappropriate for vertebroplasty- No previous VCFs- No major surgery of the spine planned for at least 6 months following enrollment- Pre-treatment back pain by numerical rating scale (NRS) score > 4 (0-10 scale)- Subject is able to understand the risks and benefits of participating in the studyand is willing to provide written informed consent- Psychosocially, mentally and physically able to fully comply with the protocolrequirements for the duration of the study including adhering to scheduled visits,treatment plan, completing forms and other study procedures.Exclusion Criteria- VB morphology or configuration is such that vertebroplasty is not technicallyfeasible for the targeted and adjacent VCFs- Fracture due to high-energy trauma- Suspected OR proven cancer inside index vertebral body- Disabling back pain due to causes other than acute fracture (e.g., sacroiliacfracture, symptomatic degenerative disc disease, lumbar spinal stenosis)- Any painful VCF with fracture age > 6 weeks- Patients with primary tumors of the bone (e.g., osteosarcoma) or solitaryplasmacytoma at site of the index or adjacent VCF- Any objective evidence of neurologic compromise at baseline.- Previous balloon kyphoplasty, VBS or vertebroplasty for any VCF- Significant clinical comorbidity that may potentially interfere with follow-up (e.g.,dementia, severe comorbid illness)- Patients requiring the use of high-dose steroid (>= 100mg prednisone or 20 mgdexamethasone per day), IV pain medication, or nerve block to control chronic backpain unrelated to index VCF- Spinal cord compression or canal compromise requiring decompression- Patients with osteoblastic tumors at the site of the index VCF- MRI contraindication (e.g. cerebral aneurysm clips, pacemaker, implantedbiostimulators, cochlear implants, penile prosthesis)- Spinal instability as indicated by neurologic deficit, kyphosis >30, compression>50%, translation >4 mm, interspinous-process widening.- Pre-existing conditions contrary to vertebroplasty, such as: irreversiblecoagulopathy or bleeding disorder- Allergy to bone cement.- Any evidence of VB or systemic infection
|
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 eligible for this trial. This trial is open tothe accrual of women only.- Patients must be women- Patients must be at least 18 years of age- Patients must have an imaging abnormality that necessitated a core needle biopsy- The imaging abnormality must have been categorized as Breast Imaging-Reporting andData System (BIRADS) level 1-4 lesion- There is documented concordance* between the initial breast imaging finding and thecore biopsy pathology report. The core needle biopsy must contain FEA or IPWA,according to the local pathologist. (It is possible that the central pathology reviewwhich is done after the patient is registered on this protocol will have a diagnosisdiscrepant from that made by the original institution's pathologist. In that case,the study team will communicate this to the original institution's site investigatorwithin one week of the date of the central pathology review having been finalized).Patients may have a personal history of prior or concurrent fibroadenoma and a priorhistory of proliferative breast lesions with or without atypia.- Patients must be registered on study within 60 days after core needle biopsy.- Patients must have an ability to understand and the willingness to sign a writteninformed consent document. The patient is still eligible for this study even if shedeclines consent for her tissue to be used for any (or all) of the correlativestudies described in this document and/or if she declines consent for her tissue togo into a tissue bank for future unspecified research.- Concordance is a determination by the radiologist (or his or her coveringprovider) performing an image-guided core needle biopsy that the pathologyreport from this procedure corresponds to the imaging appearance of a givenlesion and that the said lesion's most representative portion has been sampled.Exclusion Criteria:- Personal history and/or concomitant diagnosis of invasive breast cancer or DCIS- Palpable abnormality diagnosed by core needle biopsy to be FEA or IPWA- Pathologic nipple discharge associated with IPWA (spontaneous bloody or clearpersistent single duct discharge)- A BIRADS 5 lesion- Discordance between the initial breast imaging finding and the core biopsy pathologyreport- The presence of atypical ductal hyperplasia (ADH) on core biopsy- Known current pregnancy. A pregnancy test is not required for this exclusioncriteria.- Women who are breastfeeding- Patient registered on study more than 60 days since the date of core needle biopsy.
|
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:- Histologically proven recurrent high grade serous ovarian/primary peritoneal orfallopian tube cancer.- Patients must have disease amenable to pre-operative biopsy.- Patients must have disease deemed suitable for surgical debulking.- Patients must have a progression free interval of at least 6 months prior toregistration.- Patients must have had at least one line of platinum based therapy.- Patients must have shown platinum sensitivity to their last line of platinum therapy- Age >=18 years- ECOG performance status 0-1 within 7 days of registration- Life expectancy of greater than 3 months- Patients must have normal organ and marrow function- Women of child-bearing potential must agree to use adequate contraception prior tostudy entry and for the duration of study participation.- Ability to understand and the willingness to sign a written informed consentdocument.- Subject's willingness and ability to comply with scheduled visits, treatment plans,laboratory tests, and other study procedures.Exclusion Criteria:- History of allergic reactions attributed to compounds of similar chemical or biologiccomposition to olaparib.- History of allergic reactions attributed to platinum precluding further use.- Radiation therapy within 4 weeks of registration- Use of any other systemic, targeted, immunotherapy, chemotherapy, or investigationalagents within 4 weeks of registration- Previously received a PARP inhibitor- Other malignancy within the last 2 years with exceptions- Patients considered a poor medical risk due to a serious, uncontrolled medicaldisorder, non-malignant systemic disease or active, uncontrolled infection.- Patients unable to swallow orally administered medication and patients withgastrointestinal disorders likely to interfere with absorption of the studymedication.- Concomitant use of known potent CYP3A4 inhibitors- Concomitant use of known potent CYP3A4 inducers- Other anti-cancer therapy including immunotherapy, hormonal therapy, biologicaltherapy, other novel agents or investigational agents- Persistent toxicities (CTCAE v 4.03 grade >2) caused by previous cancer therapy,excluding alopecia- Patients with myelodysplastic syndrome/acute myeloid leukemia- Patients with brain metastases- Immunocompromised patients, e.g., patients who are known to be serologically positivefor human immunodeficiency virus (HIV)- Patients with known active hepatitis (i.e., hepatitis B or C) due to risk oftransmitting the infection through blood or other body fluids- Pregnant or breastfeeding women- Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation or studydrug administration, or may interfere with the interpretation of study results, andin the judgment of the investigator would make the subject inappropriate for entryinto this study.
|
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 4 weeks.- Stable disease-modifying anti-rheumatic drugs, eg. sulphasalazine, methotrexate for 8weeks.- Stable anti-TNF biologics for 4 weeks.- Written informed consent.Exclusion Criteria:- Serum creatinine 3.0 mg/dl.- GPT5 times the laboratory's upper limit of normal.- Pregnant or breast-feeding women.
|
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 heart failure can reduce pressure on resources,particularly for conditions like chronic heart failure, which exert a large burden on healthservices. These are conclusions of the Cochrane Systematic Review from 2010.In Norway the costs for treatment of chronic heart failure are vast, both concerninghospital treatment, daily use of medication over years, and loss of quality of life forpatients and their family caregivers. Generally there is little knowledge about what isgained for the billions used. In Norway no telemonitoring services are established and henceno investigations have yet been published. Thus it seems that current evidence ofeffectiveness and quality is insufficient to recommend usage. The structure and fundingstreams in Norwegian health services are different from other countries and the conventionalservices that the intervention has been compared to in previous studies, are most likelyheterogeneous. It is thus important to investigate Norwegian conditions.Advanced telemonitoring technology with electronic transfer of physiological data such asblood pressure and weight is currently being used in research and established routineservices in several countries in Europe, amongst them the Netherlands, Germany and theUnited Kingdom.The proposed project intends to introduce such a strategy as an avenue for exploringpromising new services that would not otherwise be available in Norway. The service consistsof daily monitoring the patients' weight and blood pressure directly from their home;automatically and securely transmit the values to a server at the University Hospital ofNorth Norway (UNN); and monitor the values by a trained nurse at the Heart polyclinic.The primary objective of this study is thus to explore whether, as compared to current carefrom the Heart Polyclinic, the introduction of home telemonitoring will reduce hospitalreadmissions and will, in addition, be cost-effective. This is in line with currentdirections of European telemonitoring programmes for patients with chronic heart failure.This result may define if the telemonitoring of heart failure patients is feasible forNorway or not at all. Inclusion Criteria:Presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedemarequiring diuretic administration (New York Heart Association [NYHA] functional classII-IV); and ejection fraction (EF) under 40% combined or not with a left ventricularfilling pattern supporting the presence of diastolic dysfunction, according to theAmerican College of Cardiology/American Heart Association Guidelines for chronic heartfailure.Exclusion Criteria:Severe psychiatric disturbance diagnosed by DSM-IV-TR criteria. Any disability that mayprevent the subject from completing the informed consent form or other study requirements.Medication or drug dependency or abuse (except for nicotine). Inability to handle thetechnological devices included in the study, for some other reason.
|
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 capacity to give consent3. The patient is able to sit independentlyExclusion Criteria:1. Adults who have undertaken strenuous exercise within the last twenty-four hours2. Adults taking prescription medication with a known effect on the mechanicalproperties of muscle (e.g. benzodiazepines) or receiving antispasmodic medications(e.g. botulinum A toxin)3. Adults with poor mobility (unable to lie prone).4. Adults with a body mass index (BMI) >30 kg/m2 . Muscle measurements may be inaccuratewith excessive subcutaneous tissue
|
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 total activity of 18.5 GBq). Inclusion Criteria:- Patients must have histologically or cytologically confirmation of GEP -NETand Ki 67index <= 20%.- Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST1.1.criteria)- Advanced GEP-NET are eligible; patients must have progressive disease based on RECIST1.1. criteria- Diagnostic OctreoScan and/or PET/CT 68Ga-peptide images demonstrate a significantuptake in the tumour- FDG PET negative (SUV less than 2.5)- Concomitant somatostatin analogs assumption is allowed- Life expectancy greater than 6 months.- ECOG performance status <2- Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absoluteneutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin 1.5 Xupper normal limit (UNL) , Alanine transaminase (ALT) <2.5 X UNL (< 5 X UNL inpresence of liver metastases), creatinine < 2 mg/dL.- If female of childbearing potential, agreement to use adequate contraceptive methods(e.g., oral contraceptives, condoms, or other adequate barrier controls, intrauterinecontraceptive devices, or sterilization) beginning at the screening visit andcontinuing until 3 months following last treatment with study drug. Negative serumpregnancy test for females of childbearing potential within 14 days of startingtreatment.- Participant is willing and able to give informed consent for participation in thestudy.Exclusion Criteria:- Ki 67 index > 20 %- FDG PET positive at least in one documented lesion with a SUV more than 2.5- Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks andtreated within 2 weeks with palliative radiotherapy, hormonal or biological therapy).- Patients treated with previous radiometabolic therapy with an adsorbed dose to thekidney more than 25 Gy and 1,5 Gy for the bone marrow.- All acute toxic effects of any prior therapy (including surgery radiation therapy,chemotherapy) must have resolved to a grade <= 1 according to National CancerInstitute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE)- Participation in another clinical trial with any investigational agents within 30days prior to study screening.- Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance withstudy requirements.- History of allergic reactions attributed to compounds of similar chemical or biologiccomposition
|
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. Healthy female subjects ages 25 to 60 years of age4. Informed consent process completed and subject signed consent5. Willing to receive the proposed ePrime treatment and follow-up protocol6. Not pregnant or lactating and must be either post-menopausal, surgically sterilized,or using a medically acceptable form of birth control at least 3 months prior toenrollment (i.e., oral contraceptives, contraceptive implant, barrier methods withspermicide or abstinence)7. Willing to have photographs taken of the treated areas to be used de-identified inevaluations, publications and presentationsExclusion Criteria:1. Subject had surgery or any other procedure for cellulite in the last 6 months2. Pregnant or planning to become pregnant, having given birth less than 3 months ago,and/or breast feeding3. Known allergy to lidocaine or epinephrine or antibiotics4. Active malignancy or history of malignancy in the past 5 years5. Having any active electrical implant anywhere in the body, such as a pacemaker or aninternal defibrillator6. Suffering from significant concurrent illness, such as cardiac disorders, diabetes(type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. anydisease state that in the opinion of the Physician would interfere with theanesthesia, treatment, or healing process)7. Having a known anticoagulative or thromboembolic condition or taking anticoagulationmedications one week prior to and during the treatment course (to allow inclusion,temporary cessation of use as per the subject's physician discretion)8. History of immunosuppression/immune deficiency disorders (including HIV infection orAIDS) or currently using immunosuppressive medications9. Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen10. History of significant lymphatic drainage problems11. History of cancer which required lymph node biopsy or dissection12. Suffering from significant skin conditions in the treated areas or inflammatory skinconditions, including, but not limited to, open lacerations or abrasions,hidradenitis, or dermatitis of the treatment area prior to treatment (duration ofresolution as per the Investigator's discretion) or during the treatment course13. History of keloid scarring, abnormal wound healing and / or prone to bruising14. History of epidermal or dermal disorders (particularly if involving collagen ormicrovascularity), including collagen vascular disease or vasculitic disorders15. Use of isotretinoin (Accutane) within 6 months of treatment or during the study16. Subject on systemic corticosteroid therapy 6 months prior to and throughout thecourse of the study17. Dysplastic nevi in the area to be treated18. Participation in a study of another device or drug within 3 month prior to enrollmentor during this study, if treatments of cellulite were involved19. Subject has palpable lymphadenopathy at any visit. Standard palpation techniques willbe used20. Subjects with history of severe edema21. As per the Investigator's discretion, any physical or mental condition which mightmake it unsafe for the subject to participate in this study
|
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 standard therapies and to have disease progressionduring or within 3 months after the last administration of the last standard therapyor to have stopped standard therapy because of unacceptable toxic effects.- Standard therapies include as many of the following as were licensed: afluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab forpatients who had Her-2 positive tumours;- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;- Life expectancy of at least 3 months;- Have adequate bone-marrow, liver, and renal function at the start of the trial.- Prothrombin time international normalized ratio1.5Exclusion Criteria:- Patients with brain metastases.- Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy,radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.- Patients had evidence of clinically active interstitial lung disease or abnormalblood results by predefined criteria (serum bilirubin >1.5 times upper limit ofreference range, aspartate or alanine aminotransferase>2.5 times the upper limit ofnormal if no demonstrable liver disease).
|
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 endpoints are tumor response andprogression-free survival. Inclusion Criteria:- All patients provided written, informed consent.- Have histologically confirmed advanced oesophageal squamous-cell carcinoma, or typeI/II Siewert junctional tumours.- Have received up to two previous chemotherapy regimens( Platinum containing regimens& Paclitaxel / docetaxel containing regimens).- Have an Eastern Cooperative Oncology Group Performance status of 0-1.- Have ability to swallow tablets.- no contraindications to sorafenib or donafenib.- Have either measurable or evaluable lesion on CT.Exclusion Criteria:- Patients with brain metastases.- Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy,radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.- Patients had evidence of clinically active interstitial lung disease or abnormalblood results by predefined criteria (serum bilirubin >1.5 times upper limit ofreference range, aspartate or alanine aminotransferase>2.5 times the upper limit ofnormal if no demonstrable liver disease) .
|
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 enrolmentExclusion criteria:
|
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 who are naive to Spiriva Respimat and receive Spiriva Respimat for the firsttime for treatment of bronchial asthma on top of at least ICS (Inhaledcorticosteroids) treatment.Exclusion criteria:- Patients who have a contraindication to Spiriva Respimat defined in the packageinsert for Spiriva Respimat- Patients who have been enrolled this study before.
|
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 minutes. The aim of this regional study is to compareaspects of movement tasks measured using a mobile gait analysis system to those measuredusing laboratory based systems and to determine aspects of gait patterns relevant fordifferent orthopaedic conditions. Moreover, the researchers will investigate if theserelevant aspects can be altered using surgical treatment or manual therapy. Inclusion Criteria:- Age 40 years, for patients: diagnosed osteoarthritis at the ankle, knee or hip,lumbar spinal stenosis or limited range of motion at the kneeExclusion Criteria:- Body mass index > 35kg/m2- Use of walking aids- Inability to walk for 6 minutes- Neuromuscular disorders affecting gait- Cardiovascular disease- Inability to follow procedures due to psychological disorders or dementia
|
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 the highest risk for PSH (48%). PSH lead to recurrent pain,poor fitting appliance with leakage and therefore, skin irritation, and can also becomplicated by strangulation or occlusion. The literature reports that 30% of patients witha PSH will require surgery. There are many different surgical procedures to repair PSH:primary fascia repair, relocation of the stoma or repair with various type of mesh. Despitethe efforts done to improve the techniques, the incidence of recurrent PSH is up to 70%dependent of the used technique. Therefore, the idea of implanting a mesh at the time ofinitial stoma formation has lately been advocated. A new device, the KoringKM, which is astomaplasty ring made of propylene, flexible and non-absorbable, was created. This studywill try to prove that incorporation of the new stomaplasty ring at the time of stomacreation will diminish long-term PSH rate. This hypothesis will improve patient's quality oflife and reduce costs associated with PSH.All patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant diseaseand fulfilling the inclusion criteria are eligible to participate in the trial. The patientswill be randomized 24 to 48 hours prior to surgery after given written informed consent. Theimplantation of the Koring will be perfomed by experienced surgeons (expertise based, bestteam approach) who have already implanted the Koring (e.g. participated in the observationalstudy) and/or have reviewed the video documentation. The surgeon will fill out the firstform with the data of the patient and of the surgical procedure. The surgical wound will bedaily examined. A second form will be fill out during the 30 post-operative days visit. Thepatients will be asked to inform the surgeon and/or investigator if any side event orsuspicion of infection occurs after hospital discharge. The next follow-up visits will be atone and two years including a clinical examination and an abdominal CT. At this moment, the3rd and 4th forms will be documented. All data will be anonymised and included in an Exceldatabase. Inclusion Criteria:- Patients requiring permanent ostomy (ileo- or colostomy) for a malignant tumour withat least one year life expectancy- Patient is able to cooperate- Patient has given written informed consent- Age equal or greater than 18 yearsExclusion Criteria:- Life expectancy < 1 year- Palliative surgery- Benign disease- Factors impacting on the ability to cooperate- Mental disorders- Pregnant or breastfeeding women- Participation in another intervention trial with interference of intervention andoutcome of this study- BMI < 18
|
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, health eating and enforceability of human rightto adequate food. Inclusion Criteria:Quilombolas certified communities in Rio Grande do Sul, Brazil, with higher prevalence offood insecurity and obesity.Exclusion Criteria:Community leaders with no interest in study intervention.
|
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. Subjects with Type 1 or Type 2 diabetes (enrolled in an approximate ratio of 1:1,respectively)3. Subjects with an HbA1c value within the range of 7.5% to 12% (or higher) for Group 1and <7.5% for Group 2Note: The study investigator or primary physician must be planning to institute, ormust be in the process of instituting, therapy to improve glycemic control forsubjects in Group 1; this therapy can include oral agents, insulin, or non-insulininjectable anti-diabetic medications.4. Willingness to complete the protocol requirements, including the use of SMBG andattendance at all scheduled study visits; if selected for CGM monitoring, awillingness to follow the additional requirements and to use only the CGM devicemodel provided for the study5. Satisfactory completion of home SMBG measurements during the screening period of thestudy prior to enrollment at Visit 2Exclusion Criteria:Subjects will be excluded from the study if they meet any of the following criteria:1. Any clinically significant disease, as determined by the investigator, that wouldinterfere with study evaluations including but not limited to the following currentor historical conditions/procedures (self-reported by the subject):1. End-stage renal disease2. Chronic kidney disease of Stage 3 or greater3. Liver cirrhosis4. Uncontrolled or untreated thyroid disease5. Any other acute or chronic conditions that, in the opinion of the investigator,may significantly influence albumin or glucose metabolism (Note: routine irondeficiencies and abnormal hemoglobin variants are not exclusions)2. History within the last 6 months of a blood transfusion3. Any other condition or factor that, in the opinion of the investigator, wouldcomplicate or compromise the study or the well-being of the subject
|
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 investigate the efficacy, safety and tolerability of the fixeddose combination (FDC) of empagliflozin 10 mg / linagliptin 5 mg compared with empagliflozin10 mg plus FDC matching placebo administered orally once daily for 24 weeks in Japanesepatients with T2DM who have insufficient glycaemic control after 16 weeks of treatment withempagliflozin 10 mg alone once daily. The study is designed to show superiority of the FDCof empagliflozin 10 mg / linagliptin 5 mg over empagliflozin 10 mg plus FDC matching placeboafter 24 weeks of treatment. The objective of Part B is to investigate the efficacy, safetyand tolerability of the FDC of empagliflozin 25 mg / linagliptin 5 mg compared withempagliflozin 25 mg plus FDC matching placebo administered orally once daily for 24 weeks inJapanese patients with T2DM who have insufficient glycaemic control after 16 weeks oftreatment with empagliflozin 25 mg alone once daily. The study is designed to showsuperiority of the FDC of empagliflozin 25 mg / linagliptin 5 mg over empagliflozin 25 mgplus FDC matching placebo after 24 weeks of treatment. The 24 week treatment period will befollowed by a 28 week extension treatment period to evaluate further efficacy and safety upto 52 weeks. Inclusion criteria:- Diagnosis of type 2 diabetes prior to informed consent- Male and female patients on diet and exercise regimen for at least 12 weeks prior toinformed consent who are:- drug-nave, defined as no antidiabetic drugs for at least 12 weeks prior toinformed consent or,- pre-treated with one oral antidiabetic drug (for sulfonylurea, with up to halfof the maximum approved dose) on stable dosage for at least 12 weeks prior tothe informed consent (for thiazolidinedione, therapy has to be unchanged for atleast 18 weeks prior to the informed consent). Individual antidiabetic drug willhave to be discontinued at Visit 1.- haemoglobin A1c (HbA1c) at Visit 1 (screening)- for patients without antidiabetic therapy : HbA1c >=8.0 to =<10.5%- for patients with one oral antidiabetic drug : HbA1c >=7.5 to =<10.5%- HbA1c >=7.5 to =<10.0% at Visit 4 for randomisation into the double blind treatmentperiodExclusion criteria:- Uncontrolled hyperglycaemia with a glucose level >270 mg/dL (>15.0 mmol/L) during theopen label stabilisation period and placebo run in period- Impaired renal function, defined as estimated glomerular filtration rate (eGFR) <45mL/min/1.73m2 (modification of diet in renal disease (MDRD) formula)- Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeksprior to informed consent- Indication of liver disease, defined by serum levels of either alanine transaminase(ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upperlimit of normal (ULN)
|
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 Disease (CAD) in CanadianCardiovascular Society (CCS)'s functional classification of angina Class I or II- patients who did not submit hospitalization for cardiovascular disease in the lastyearExclusion Criteria:- patients who were not followed up in the health service to at least one year- unstable patients requiring adjustments of medications or who are performing somediagnostic evaluation at discharge outpatient
|
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 (involving advance care planning-relatedcontent) or a control video (no advance care planning-related content) prior to surgery. Theinvestigators hypothesize that the video will lead to more and better preoperativediscussions between the patient and surgeon that are related to advance care planning. Theinvestigators also hypothesize that seeing the advance care planning-related video willdecrease perioperative anxiety and depression scores. Inclusion Criteria:- Patients aged 18 and older of study surgeons who are scheduled to have a surgicalprocedure identified by study surgeons to the study team.- Patients willing to give informed consent, ability to speak English, reasonably ableto read a newspaper or book (without sight impairment); reasonable able to listen toradio, television (without hearing impairment).Exclusion Criteria:- Age <18 years old, non-English speaking patients who are not identified byparticipating surgeons
|
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 effective and commonly used antibiotic in most cases is tobramycin. If this cannotbe used because of previous side effects, allergy or a resistant infection then colomycin oramikacin are usually used. Each of these antibiotics are known to be toxic to both thekidneys and ear. As patients are living longer (into their forties), the total amount ofthese antibiotics they are receiving over their lifetime is increasing. This is now leadingto increased complications such as kidney damage and hearing loss. Because of this, theinvestigators need to look at methods to accurately quantify damage and reduce potentialkidney and hearing damage.The investigators intend to quantify kidney damage by measuring new protein markers withinthe urine and blood that signify kidney damage before more conventional and currentlyavailable methods are able to.In those patients treated with intravenous tobramycin theinvestigators will also look at an alternative method used to calculate the most appropriatedose of antibiotic for each participant. This dosing method is called 'area under the curveor AUC' dose monitoring. This method currently in clinical use in other countries is thoughtto more accurately reflect the most appropriate dose for each participant and thus reducethe chance of kidney and hearing problems. This 'AUC' method requires two rather than onedose level to be checked each time a dose calculation is made. Participants receivingtobramycin will be randomised to receive dosing by this method or the investigators'currently used method of 'trough' monitoring. Inclusion Criteria:- Diagnosis of CF*- Able to give written informed consent- Pulmonary exacerbation requiring IV tobramycin, amikacin or colistin based on thedecision of the treating physicianExclusion Criteria:- Known allergy or adverse reaction to proposed antibiotic (tobramycin, amikacin orcolistin)- Pregnancy (if found to be pregnant during the study the participant will beimmediately withdrawn)- Continuation of nebulised aminoglycoside or colistin during IV treatment- Use or intended use of NSAIDS
|
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 prodrome in major depressive disorder (MDD). Inclusion Criteria:- Participants must have met Diagnostic and Statistical Manual of Mental Disorders-5thedition (DSM-5) criteria for diagnosis of nonpsychotic MDD within the past 2 years(that is, the start of the current major depressive episode (MDE) must be less thanor equal to 24 Months before screening), as confirmed using the MINI InternationalNeuropsychiatric Interview (MINI - DSM-5). MDD must be recurrent, rather than asingle episode- In the current MDE, participant must have responded to, and must be continuing toreceive and respond to, an oral antidepressant treatment regimen (given at anadequate dosage and duration based on the Massachusetts General HospitalAntidepressant Treatment Response Questionnaire), within the past 3 months. A changein the oral antidepressant treatment regimen since the time of achieving response inthe current episode will be allowed- Participants must have a Montgomery Asberg Depression Rating Scale total score lessthan or equal to 14- Participant must be willing and able to complete self-reported assessments via astudy-specific smartphone, and must be willing to wear an wrist actigraphy device forthe duration of the studyExclusion Criteria:- Participant has any of the following DSM-5 psychiatric diagnoses: MDD with psychoticfeatures (lifetime), bipolar disorder (including lifetime diagnosis), schizophrenia,or schizoaffective disorder- Participant has a history of drug or alcohol use, with a severity of at leastmoderate or severe, according to DSM-5 criteria, within 6 months before screening- Participant is currently receiving or has received vagal nerve stimulation (VNS),electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) or deepbrain stimulation (DBS) for the current MDE- Participant is currently receiving stimulants, anticonvulsants, or mood stabilizersfor treatment of his or her MDD- Participant is a woman who is pregnant, or planning to become pregnant, whileenrolled in this study
|
End of preview. Expand
in Data Studio
README.md exists but content is empty.
- Downloads last month
- 59