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NCT01900743 | ALL | ADULT, OLDER_ADULT | Sarcoma | DRUG: Regorafenib|DRUG: Placebo | Progression-free survival (PFS), Progression-Free Survival will be measured from the date of randomization until the date of radiological progression or death (if death occurs before progression).
Progression-free rate at 3 and 6 months (PFR-3 and PFR-6), time to progression, response rate and duration of response, overall survival according to RECIST 1.1 criteria, Up to 2 years | This is an international (France, Austria and Germany), randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of regorafenib in patients with histologically proven metastatic and/or unresectable Soft Tissue Sarcoma (STS) after failure or intolerance to doxorubicin (or other anthracycline).
Five cohorts will be defined:
Cohort A: Liposarcoma Cohort B: Leiomyosarcoma Cohort C: Synovial sarcoma Cohort D: other sarcomas (see Appendix C) Cohort E: Leiomyosarcoma, Synovial sarcoma and other sarcomas listed in Appendix C previously treated with pazopanib Approximately 226 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment groups. |
NCT01981148 | ALL | ADULT, OLDER_ADULT | Autofluorescence Imaging|Neuroimaging | DEVICE: Fluorescence lifetime ophthalmoscope | Fluorescence lifetime measured by a fluorescence lifetime imaging ophthalmoscope, Measured by fluorescence lifetime variable (TAU). Measured once; in some patients, up to 4 measurements within 2 years will be done, at baseline | Fluorescent lifetime microscopy has emerged as a useful tool to study fluorescent lifetimes in vitro. Fluorescence lifetime represents the average amount of time a fluorophore remains in the excited state following excitation and depends on the fluorophores molecular environment. Fluorescence lifetime ophthalmoscopy (FLIO) is a technique which can quantify fluorescence lifetimes in the human retina in vivo. The purpose of this study is to investigate fluorescence lifetime characteristics in the human retina by using a FLIO. The investigators hypothesize that FLIO will allow to identify areas of retinal metabolic stress such as ischemia by detecting changes in fluorescence lifetimes. |
NCT02674490 | ALL | ADULT, OLDER_ADULT | Stroke | DEVICE: A-tDCS (1 mA)|BEHAVIORAL: SALT|DEVICE: Sham | Change in Accuracy of Naming Untrained Pictures (Philadelphia Naming Test (PNT)) Pre-treatment to 1 Week Post-treatment, The purpose of this measure was to determine whether A-tDCS coupled with SALT will improve naming performance of participants with post stroke aphasia more effectively than SALT alone (i.e., the sham condition).
The PNT is a 175-item picture naming test where a person earns one point per each correct answer. Scores range from 0-175 with higher scores associated with better performance.
The outcome measure was the difference between the average of administrations on two consecutive days immediately before treatment and administrations on two consecutive days within 1 week after the end of treatment., 2 consecutive days immediately before treatment and 2 consecutive days within 1 week after the end of treatment | The investigators will study the effects of transcranial direct current (tDCS) stimulation during language therapy for naming in individuals with aphasia in the acute and subacute post stroke period. Naming difficulties are a persistent and common symptom in aphasia after left-hemisphere (LH) stroke. Behavioral therapy (speech and language therapy; SALT) is the mainstay treatment for post stroke aphasia. Transcranial direct cortical stimulation (tDCS) is a promising adjunct to traditional SALT. tDCS is a safe, non-invasive, non-painful electrical stimulation of the brain which modulates cortical excitability by application of weak electrical currents in the form of direct current brain polarization. It is usually administered via saline-soaked surface sponge electrodes attached to the scalp and connected to a direct current stimulator with low intensities. Most studies are conducted in the chronic phase after stroke. Because neuroplasticity is greatest early after stroke, there is reason to believe tDCS might be most effective in the acute-subacute period. However, only two studies have evaluated tDCS paired with language therapy in group studies of acute to subacute aphasic stroke patients and only one of these was sham-controlled. Furthermore, no studies (of which we are aware) have combined tDCS with therapy to facilitate naming in post stroke aphasia, as shown to be effective in studies of chronic stroke. In this study, the investigators will evaluate whether tDCS combined with SALT improves naming in individuals with aphasia in the acute and subacute post stroke period, more than SALT alone in a randomized, double-blind, sham-controlled trial. The investigators will test the hypothesis that anodal tDCS (A-tDCS) over a targeted region and computer-delivered SALT is associated with greater gains in accuracy in naming pictures, compared to sham combined with the same computer-delivered SALT in post stroke aphasia. |
NCT02781727 | ALL | CHILD | Growth Hormone Deficiency, Pediatric|hGH (Human Growth Hormone)|Endocrine System Diseases|Hormones|Pituitary Diseases | DRUG: Once weekly subcutaneous injection of TransCon hGH|DRUG: Once daily subcutaneous injection of Genotropin | Annualized Height Velocity at 52 Weeks for Weekly Lonapegsomatropin and Daily hGH Treatment Groups, Annualized height velocity (AHV) at 52 weeks for weekly lonapegsomatropin (TransCon hGH) and daily hGH treatment groups, 52 weeks | A 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females) with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH : Genotropin). This is a global trial that will be conducted in Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and the United States. |
NCT01631552 | ALL | ADULT, OLDER_ADULT | Gastric Adenocarcinoma|Esophageal Cancer|Hepatocellular Carcinoma|Non-small Cell Lung Cancer|Small Cell Lung Cancer|Ovarian Epithelial Cancer|Carcinoma Breast Stage IV|Hormone-refractory Prostate Cancer|Head and Neck Cancers- Squamous Cell|Renal Cell Cancer|Urinary Bladder Neoplasms|Cervical Cancer|Endometrial Cancer|Glioblastoma Multiforme|Triple Negative Breast Cancer|Pancreatic Cancer | DRUG: Sacituzumab Govitecan-hziy (SG) | Percentage of Participants Experiencing Any Treatment Emergent Adverse Events and Serious Treatment Emergent Adverse Events, Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) that begin or worsen on or after the start of study drug through 30 days after the last dose of study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 4.03. An AE that met one or more of the following outcomes was classified as serious:
* Fatal
* Life-threatening
* Disabling/incapacitating
* Results in hospitalization or prolongs a hospital stay
* A congenital abnormality
* Other important medical events may also be considered serious AEs if they may require medical or surgical intervention to prevent one of the outcomes listed above
Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population., First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months) plus 30 days|Percentage of Participants Who Permanently Discontinued Sacituzumab Govitecan-hziy (SG) Due to Any Adverse Events, Excluding Adverse Events Leading to Death, Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP)., First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)|Percentage of Participants Who Required Dose Interruption Due to Any Adverse Events, Per planned analysis, populations to be used for evaluation of this outcome measure were as follows: Triple Negative Breast Cancer (TNBC) Target Population, HR+/HER2- Metastatic Breast Cancer (mBC) Population, Metastatic Urothelial Cancer (mUC) Population, and Overall Safety Population (OSP)., First dose date up to last dose for data cutoff date of 01 March 2019 (maximum duration: 55.2 months)|Objective Response Rate (ORR) by Independent Central Review (ICR), ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by ICR assessment according to RECIST1.1. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥ 30% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by ICR was assessed for the TNBC Target Population only., Up to data cutoff date of 01 March 2019 (maximum duration: 74 months)|Objective Response Rate by Local Assessment, ORR was defined as the rate an overall best response of either complete response (CR) or partial response (PR) by local assessment. CR was defined as the disappearance of all target lesions and reduction in short axis of any pathologic lymphnode to \<10 mm. PR was defined as ≥3 0% decrease in the sum of diameters of target lesions, taking the baseline sum diameters. Per planned analysis, ORR by Local Assessment was assessed for TNBC Target Population, HR+/HER2-mBC Population, and mUC Population., Up to data cutoff date of 01 March 2019 (maximum duration: 74 months) | The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I.
Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC). |
NCT00157066 | ALL | ADULT, OLDER_ADULT | Tuberculosis | DRUG: Ergocalciferol | Bacillus Calmette-Guerin (BCG) lux whole blood assay | The purpose of this study is to determine how vitamin D supplementation (ergocalciferol) affects the immune response to mycobacterial infection. |
NCT01102777 | ALL | ADULT, OLDER_ADULT | Chronic Obstructive Pulmonary Disease (COPD) | BEHAVIORAL: automated internet-mediated walking program|OTHER: Usual Care | Self-Reported Respiratory-Specific Quality of Life, Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to four months. (Scores range from 0 to 100, with higher scores indicating more limitations.), four months from randomization|Self-Reported Respiratory-Specific Quality of Life, Change in St. George's Respiratory Questionnaire (SGRQ) Total Score from Baseline to twelve months. (Scores range from 0 to 100, with higher scores indicating more limitations.), twelve months from randomization | The purpose of this study is to assess the efficacy of an internet-mediated pedometer based intervention that is designed to increase walking and improve function among veterans with chronic obstructive pulmonary disease (COPD). The Specific Aims are: 1) to test the effectiveness of an automated internet-mediated walking program for veterans with COPD with a primary outcome of improvement in health-related quality of life at four-months and at one year in a randomized controlled trial (RCT) with a wait list control. 2) to estimate the effect of internet-mediated walking program for veterans with COPD on all cause days of hospitalization over one year following randomization. 3) to compare intervention reach, participation and satisfaction outcomes between rural and urban veterans among those randomized to the intervention arm. The long-term objective of this research is to develop, evaluate and disseminate effective, low-cost interventions that improve quality of life for veterans, particularly rural veterans, managing complex chronic conditions. |
NCT02066948 | ALL | ADULT | Body Composition, Beneficial|Paresis|Impaired Glucose Tolerance | OTHER: wt loss|OTHER: Meal Pattern|OTHER: meal pattern|DIETARY_SUPPLEMENT: even|DIETARY_SUPPLEMENT: skew | Body composition, Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry (DXA, GE Healthcare LUNAR iDXA™ with EnCORE software version 5.60, Madison, WI)., 20 weeks|Body composition, Fasting-state body weight and waist and hip circumferences will be measured. Body composition (fat mass, lean body mass, and bone mass) will also be determined using Dual Energy X-ray Absorptiometry, 20 weeks | About two-thirds of adults in the United States are overweight or obese with likely adverse health consequences. A Moderate weight loss by dieting and exercise is recommended to improve health. We are interested to know whether eating dietary protein at different times of the day influences changes in body composition, muscle and indices of health. The purpose of this study is to examine the effects of within-day patterning of dietary protein intake (even vs. skewed) on energy-restriction and resistance training-induced changes in body composition, muscle size, appetite, and clinical health (including blood glucose and blood pressure). |
NCT03036124 | ALL | ADULT, OLDER_ADULT | Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) | DRUG: Dapagliflozin|DRUG: Placebo | Subjects Included in the Composite Endpoint of CV Death, Hospitalization Due to Heart Failure or Urgent Visit Due to Heart Failure., Primary efficacy, Up to 27.8 months. | The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction |
NCT01331564 | FEMALE | ADULT | Gestational Weight Gain|Postpartum Weight Retention | BEHAVIORAL: electronic intervention during pregnancy and postpartum|BEHAVIORAL: electronic intervention during pregnancy|BEHAVIORAL: Control | Proportion of women whose gestational gain is within the recommended gestational weight gain Institute of Medicine Guidelines in kilograms, Gestational weight gain is the result of the last predelivery weight minus the prepregnancy weight (or early pregnancy weight)., 40 weeks|Postpartum weight retention in kg at 12 months postpartum, The difference between the weight at 12 months postpartum and the pre-pregnancy weight (or early pregnancy weight. Participants will be followed for a maximum of 2 years from recruitment in early pregnancy to 18 months postpartum. The final outcome in the postpartum period is postpartum weight retention at 18 months. Interim measure of postpartum weight will be collected at 6 and 12 months for analyses. The primary hypothesis for the postpartum period is weight retention at 12 months postpartum., 1.5 years | The project aims to develop, implement and evaluate electronically-mediated behavioral intervention programs for pregnant and postpartum women in order to prevent excessive weight gain during pregnancy and postpartum weight retention. |
NCT01470092 | FEMALE | ADULT, OLDER_ADULT | Menopausal Depression | DRUG: Tibolone | Montgomery and Asberg Depression Rating Scale, A 10-item clinician rated scale validated to be most strongly sensitive to change in depression associated with treatment. This scale will be used to measure change in depression associated with treatment at weeks 2, 4, 8 and 12 compared to baseline., Baseline, then at weeks 2,4, 8 and 12 | Longitudinal epidemiological studies have shown that many women experience significant physical and psychological changes as they approach menopause and for a long time following. Vasomotor symptoms (such as hot flushes, night sweats), sleep disturbances and changes in libido are common, and impact significantly on the quality of life, social and personal well-being. However, the major reason that many women seek help from menopause clinics or their doctors, is for depression and anxiety symptoms. As such, treatment commonly draws on traditional approaches for the management of major depression including the use of antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or Selective Norepinephrine Reuptake Inhibitors (SNRIs) as the first line response. However, standard treatment of menopausal depression using antidepressants has only shown small improvements at best and at worst, is associated with severe side effects. Some SSRIs have been shown to be less effective in postmenopausal women compared to child bearing age women.
Newer therapies directly targeting the disrupted hormonal systems (in particular estrogen) through the administration of such compounds as tibolone, have shown significant potential to treat depression with the added benefit of fewer adverse side effects. With growing evidence supporting the use of tibolone as a viable and improved treatment for menopausal depression, the investigators propose to investigate the potential of tibolone, a selective Hormone Replacement Therapy (HRT), to ameliorate de-novo or first onset depression occurring in the menopausal period. |
NCT03859141 | ALL | CHILD | Seasonal Influenza | BIOLOGICAL: Quadrivalent influenza vaccine|BIOLOGICAL: Quadrivalent influenza vaccine|BIOLOGICAL: Trivalent influenza vaccine (contains B/Victoria strain)|BIOLOGICAL: Trivalent influenza vaccine (contains B/Yamagata strain) | The lower limit of 95% confidence intervals (95%CI) of geometric mean titer (GMT) ratio (experimental group/control group) of hemagglutination inhibition (HI) antibody titer≥2/3., Immunogenicity index, One of the standard to evaluate the experimental vaccine is non-inferior to the control vaccines., 28 days after two doses immunization|The lower limit of 95% CI of the seroconversion rate difference (experimental group-control group)≥-10%., Immunogenicity index, Another standard to evaluate the experimental vaccine is non-inferior to the control vaccines., 28 days after two doses immunization | The purpose of this study is to evaluate the safety and immunogenicity of quadrivalent influenza vaccine in healthy children aged 6-35 months. |
NCT00892047 | ALL | ADULT, OLDER_ADULT | Depression | DRUG: venlafaxine XR plus aripiprazole|DRUG: venlafaxine plus placebo | Percentage of Subjects Who Met Criteria for Remission Based on the Montgomery-Asberg Depression Rating Scale (MADRS), The Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician rated ten item instrument assessing depression symptoms. Possible scores range from 0-60; higher scores indicate greater severity of depression. Remission defined as score of 10 or less based on the MADRS., 12 weeks|Akathisia, Percentage of participants who developed clinically significant akathisia., 12 weeks|Weight, Weight change in kilograms, Baseline through12 weeks|Parkinsonism, Percentage of participants who develop signs of parkinsonism, 12weeks | The primary aims of this study are to:
1. Assess the efficacy of aripiprazole augmentation for the acute and continuation treatment of TRLLD.
Hypothesis 1: Patients with TRLLD (defined as those who do not remit after 12 weeks of acute treatment with venlafaxine XR) will have a higher rate of remission with aripiprazole than with placebo augmentation (primary outcome) and greater improvement in depressive symptoms and stability of remission (secondary outcomes).
2. Assess the tolerability of aripiprazole in TRLLD with a focus on adiposity and akathisia/restlessness.
Hypothesis 2: Aripiprazole will be associated with a higher rate of clinically significant akathisia and increased adiposity than placebo.
The Secondary/exploratory aims of this study are to:
1. Examine anxiety, medical burden, and executive impairment as moderators of aripiprazole augmentation efficacy in TRLLD.
Hypothesis 3: Pre-levels of anxiety symptoms, medical burden, and executive impairment will be treatment-specific factors: they will moderate the efficacy of aripiprazole augmentation. The aripiprazole-placebo difference will be greater in individuals with these variables, compared to those without these variables because these three factors will be associated with a decreased likelihood that "staying the course" with venlafaxine monotherapy will achieve remission.
2. Examine genetic predictors (phase 1) and moderators (phase 2-3) of treatment outcomes, while controlling for drug exposure.
Hypothesis 4: Selected polymorphisms will reduce remission rate with venlafaxine and will reduce efficacy and tolerability with aripiprazole. |
NCT02215408 | ALL | ADULT, OLDER_ADULT | Diabetes|Hyperlipidemia|Hypertension|Cardiovascular Disease | BEHAVIORAL: CVRS Intervention | The mean percent of applicable Guideline Advantage standards of care that are met at 12 months, Of the 53 specific standards of care listed in the Guideline Advantage criteria, the mean percent of those standards applicable to each subject that are met at the 12 month time point, 12 months | The study tested whether a pharmacist-run cardiovascular risk service (CVRS) at the University of Iowa can increase use of national standards of care in clinics |
NCT03135535 | ALL | ADULT, OLDER_ADULT | Diabetes|PAD|Lower Extremity Edema|Neuropathy;Peripheral|Foot Ulcer, Diabetic|Lymphatic Diseases | DEVICE: Avex Footbeat | Change in Balance From Baseline to 4 Weeks, Balance will be quantified by measuring body sway in medial-lateral direction using a validated wearable sensors technology (Balansens, Biosensics LLC) and body sway change after 4-weeks of daily use of AVEX Footbeat will be assessed compare to baseline. Th unit of measurement is cm., baseline and 4 weeks.|Change in Skin Perfusion From Baseline to 4 Weeks, Skin perfusion was quantified using Skin Perfusion Pressure Test (SPP) at the lower extremities at baseline and at 4-week (end point). The measurement of SPP was done using a device called Sensilase PAD-IQ (VASAMED). The unit of measurement is mmHg., Baseline and 4 weeks | Diabetic foot ulceration (DFU) is a common and largely preventable complication. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb.Prevention by identifying people at higher risk is the key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene.
A novel micro-mobile foot compression device named Footbeat (AVEX, Inc.) offers alternative means providing lower extremity compression. This device is portable and can be used in a standard diabetic shoes on daily basis, which in turn may improve venous blood and relief from concomitant lower extremity edema. In addition, potential improvement in lower extremity blood flow in response to regular foot compression, could improve balance, gait, skin perfusion, plantar sensation, and overall daily physical activities (e.g. number of taken steps per day, duration of standing, etc).
The purpose of this study is to conduct an observational study with N=30 ambulatory patients with diabetes and loss of protective sensation to assess whether this micro-mobile foot compression device can help improving motor function, lower extremity perfusion, and vascular health. |
NCT02154334 | ALL | ADULT | Allergic Rhinitis | DRUG: Esketamine|DRUG: Mometasone|DRUG: Oxymetazoline | Maximum Plasma Concentration (Cmax), The Cmax is the maximum plasma concentration., 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18, 24 and 30 hours after study drug administration|Time to Reach Maximum Concentration (tmax), The tmax is time to reach the maximum observed plasma concentration., 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18, 24 and 30 hours after study drug administration|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]), The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(0-last) and C(0-last)/lambda(z), wherein AUC(0-last) is area under the plasma concentration time curve from time zero to last quantifiable time; C(0-last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant., 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18, 24 and 30 hours after study drug administration|Elimination Half-Life (t [1/2] Lambda), Elimination half-life (t \[1/2\] Lambda) is associated with the terminal slope (lambda \[z\]) of the semi logarithmic drug concentration-time curve, calculated as 0.693/lambda(z)., 0 (pre-dose), 7, 12, 22, 32, 40, 50 minutes; 1, 1.25, 1.5, 2, 3, 4, 6, 9, 12, 18, 24 and 30 hours after study drug administration|Number of participants with adverse events (AEs) and serious adverse events (SAEs), An AE is any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product and does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that meets any of the following conditions: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect., Screening Up to 10 days after last study drug administration in Cohort 1 and Cohort 2 | The purpose of this study is to evaluate the effects of allergic rhinitis (group of symptoms affecting the nose) and co-administration of mometasone or oxymetazoline on the pharmacokinetics (explores what the body does to the drug), safety, and tolerability of intranasal (administered through the nose) esketamine. |
NCT03107793 | ALL | ADULT, OLDER_ADULT | Crohn Disease | DRUG: Ustekinumab | Percentage of Participants With Endoscopic Response at Week 48, Endoscopic response defined as showing a reduction from baseline in simple endoscopic score for Crohn's disease (SES-CD) of greater than or equal to (\>=) 50 percent (%). SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. Randomized participants who stopped treatment before reaching Week 48 due to any reason, or participants without endoscopic data at Week 48 were analyzed as nonresponders., Week 48 | The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response. |
NCT02366390 | ALL | CHILD, ADULT, OLDER_ADULT | Chronic Obstructive Pulmonary Disease|Anxiety | BEHAVIORAL: Psychoeducative intervention | Change in HADS-A score from baseline to three months follow-up, The Hospital Anxiety and Depression Scale (HADS), subscale for anxiety HADS-A is a self-completed questionnaire that measure symptoms of general anxiety, Three months | The purpose of this trial is to determine whether a minimal homebased psychoeducative intervention is effective in management of anxiety and dyspnea in patients with severe chronic obstructive pulmonary disease. |
NCT01581515 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease | DEVICE: Promus Element everolimus eluting coronary stent|DEVICE: Xience Prime everolimus eluting coronary stent | the ratio of the malapposed strut, The ratio of the malapposed strut, on an immediate OCT after nominal stent pressure and at a final post-procedure between two different DES; ANCHOR-I, Participants will be followed from first OCT invervention to 3month OCT following intervention | The purpose of this study is to compare the degree of stent malapposition on an immediate optical coherence tomography (OCT) after nominal stent pressure and at a final post-procedure OCT (ANCHOR-I) and the neointimal coverage on 3-months OCT following the intervention with the randomly assigned two drug-eluting stents (DES), PromusTMElementTM stents versus Xience PRIME® stents. |
NCT00090584 | FEMALE | ADULT, OLDER_ADULT | Urinary Incontinence (UI) | DRUG: Tolterodine|BEHAVIORAL: Behavioral training | Proportion of Women Who Meet Definition of Success, Proportion of women who meet definition of success: not taking drug or receiving other urge UI therapy (i.e., neuromodulation, botox injections, myomectomy, electrical stimulation, or any intravesical therapy) and not taking a tricyclic antidepressant or duloxetine at 8 months; and a \>70% reduction in number of incontinence episodes as compared to baseline., 8 months | The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence. |
NCT00072995 | ALL | ADULT, OLDER_ADULT | Cardiovascular Diseases|Heart Diseases|Obesity | BEHAVIORAL: Four Diets Differing in Macronutrient Composition|BEHAVIORAL: Diets Low in Saturated Fat | Change in body weight (measured at Year 2) | The purpose of this study is to test the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40 percent energy) with two different protein levels (15 percent and 25 percent), and low in fat (20 percent energy), also with 15 percent and 25 percent protein levels. The study is only accepting participants in the Boston, Massachusetts or Baton Rouge, Louisiana area. For further enrollment information in Boston or Baton Rouge, see Eligibility Criteria or Design Narrative. |
NCT02669706 | ALL | ADULT, OLDER_ADULT | Hematologic Malignancy | DRUG: Pentamidine | Safety of IV pentamidine for PJP prophylaxis, Safety will be assessed via analyzing the number of patients experiencing adverse effects, with their severity graded using CTCAE v4.0., 1 year | The main objective of this study is to assess the safety of administering intravenous (IV) pentamidine for Pneumocystis jirovecii pneumonia (PJP) prophylaxis in adult inpatients with hematologic malignancies and stem cell transplant recipients. There will also be an assessment of patient satisfaction associated with intravenous pentamidine PJP prophylactic therapy. |
NCT01537289 | ALL | ADULT, OLDER_ADULT | Traumatic Pneumothorax | DEVICE: Pigtail catheter insertion (Cook)|DEVICE: chest tube (28-French) | Change in Tube-site pain, pain medication requirement, day 0, 1, 2 | A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.
There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT. |
NCT01898455 | ALL | ADULT, OLDER_ADULT | Migraine|Cluster Headache | DEVICE: RhinoChill intranasal cooling | • Reduction of pain score and overall symptoms from baseline in Migraine/cluster headache sufferers, When a participant presents with headache, baseline assessments will be performed for pain, nausea and other recognised symptoms of migraine/cluster headache. The Rhinochill device will be used to provide transnasal cooling for a period of 20 minutes then reassessment of pain and other symptoms will be undertaken., 20 minutes | This study will be looking at the clinical efficacy of using a intranasal evaporative cooling device in providing relief of the symptoms of migraine and cluster headache. It will involve using a nasal catheter to spray a liquid coolant into the nasal cavity where it evaporates and removes heat from the tissue, thereby cooling the tissue and the blood vessels which supply blood to the brain. This cooling effect will cause the blood vessels to constrict and it is thought that this may provide symptomatic relief in both these forms of headache. 10 migraine patients and 5 cluster headache patients will be enrolled in the study and will receive 10 treatments each, for a maximum of 20 minutes at a time. They will be monitored during the treatment and for two hours afterwards to assess headache severity and side effects. There will be a further follow up 2 months after the last treatment to assess for longer term side effects from the treatment. |
NCT02785237 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease | DEVICE: Coroflex® ISAR Drug-eluting stent|DEVICE: Ultimaster® Drug-eluting stent | Percentage of early coating on the struts of the Coroflex® ISAR Drug-eluting stent versus Ultimaster® - Drug eluting stent at 3 months OCT after stent implantation., 3 months|Percentage of covered struts at 3 months OCT after stent implantation., 3 months|Percentage of stents with ≥3% of uncovered struts at 3 months OCT after stent implantation., 3 months|Percentage of uncovered struts ≥3% at 3 months OCT after stent implantation., 3 months|Number of transversal sections with a percentage (rate of uncovered struts/ total number of struts) > 30 % at 3 months OCT after stent implantation., 3 months | The objective of the study is to evaluate the process of early re-endothelialization of the Coroflex® ISAR Drug-eluting stent compared with the Ultimaster® Drug-eluting stent |
NCT03518021 | ALL | ADULT, OLDER_ADULT | Overdose|Drug Abuse | DRUG: Naloxone, intranasal|DRUG: placebo, intranasal|DRUG: Naloxone, intramuscular|DRUG: placebo, intramuscular | Proportion of patients with return of spontaneous respiration (above or equal to 10 breaths per minute) within 10 minutes of naloxone administration in pre-hospital opioid overdose, 40 minutes | This trial will compare the clinical response to intramuscular and intranasal naloxone in pre-hospital opioid overdoses. Objective of the study is to measure and evaluate clinical response (return of spontaneous respiration within 10 minutes of naloxone administration) to a new nasal naloxone formulation in real opioid overdoses in the pre-hospital environment. The aim is to demonstrate that intranasal administration of naloxone is not clinically inferior to intramuscular administration, which is now standard treatment of care. |
NCT02411448 | ALL | ADULT, OLDER_ADULT | Metastatic Non-Small Cell Lung Cancer | DRUG: Ramucirumab|DRUG: Placebo|DRUG: Erlotinib|DRUG: Gefitinib|DRUG: Osimertinib | Part B: Progression Free Survival (PFS), PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of 1 or more new lesions is also considered progression., Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months)|Number of Participants With Treatment-Emergent Adverse Events, A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section., Cycle 1 Day 1 through End of Study (Up To 3 Years) | The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B.
The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC. |
NCT02234726 | ALL | CHILD | Stunting|Child Development | BEHAVIORAL: Early Childhood Development Program | Stunting, Heights of all study children will be measured. Height-for-age z-scores will be calculated using standard WHO criteria. Stunting will be defined as having a height-for-age z-score \< -2. The difference in the prevalence of stunting between children in the intervention and comparison areas will be determined., One year starting with baseline (August-September 2014) and finishing with end line (September 2015); Amendment: also measured at year two (extension) endline|Cognitive function, Study children will be assessed at end line using the INTERGROWTH 21st century instrument. Scores will be standardized within the study sample for analysis. Scores of children in intervention health zones will be compared with children in comparison areas to determine differences.
Amendment: at year two (extension) endline, children are assessed using the Bayley Scale for Infant and Toddler Development (BSID-III). Scores are standardized within the study sample for analysis., End line (after one year); Amendment: BSID-III at year two (extension) endline | The purpose of this study is to evaluate the impact of a community-based early childhood development (ECD) program on children's physical and cognitive development. Under the program, targeted communities will be assigned a trained Child Development Agent (CDA) who will have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases including malaria, diarrhea, and pneumonia and referral for diagnosis and treatment; and 4) organization and mentoring of biweekly caregiver meetings to discuss parenting and promote early childhood cognitive stimulation. The investigators will enroll at baseline around 600 children ages 6 - 12 months and their caregivers, and randomize them at the community-level to receive the ECD program or to remain in the control group. The study period will be one year. At end line, the investigators will collect important indicators of child physical and cognitive development to assess program impact. If the program shows both feasibility and impact, there is the potential to integrate program interventions into existing national community-based health initiatives.
Amendment: the study period has been extended for a second year. After a five month gap when no intervention was provided, biweekly (i.e., fortnightly) community-based parenting groups were restarted in intervention clusters. In the second year of the intervention, CDAs no longer visit households. |
NCT03129438 | ALL | ADULT, OLDER_ADULT | EEG With Periodic Abnormalities|EEG With Abnormally Slow Frequencies|Coma|Outcome, Fatal | DIAGNOSTIC_TEST: continuous EEG (cEEG)|DIAGNOSTIC_TEST: routine EEG (rEEG) | Mortality, Fatality rate, 6 months | Continuous video-EEG monitoring (cEEG) significantly improves seizure or status epilepticus detection in patients in intensive care units (ICUs), and is recommended for patients with consciousness impairment. cEEG is time- and resource consuming as compared to routine EEG (rEEG, lasting 20-30 minutes). While centers in North America have been using it increasingly, most European hospitals still do not have resources to comply with these guidelines. In addition, only one population-based study based on discharge diagnoses suggested that cEEG may improve patients' outcome. Current guidelines are thus based upon weak evidence and expert opinions.
Aim of the study is to assess if cEEG in adults with consciousness impairment is related to an improvement of functional outcome, and to address the prognostic role of quantitative network EEG analyses.
In this multicenter randomized controlled trial, adults with GCS inferior or equal to 11 or FOUR score inferior or equal to 12 will be randomized 1:1 to cEEG for 30-48 hours or two rEEG within 48 hours. The primary outcome will be mortality at 6 months. Secondary outcomes will blindly assess functional outcome, seizure/status epilepticus detection rate, duration of ICU stay, change in patient management (antiepileptic drug introduced, increased, or stopped, brain imaging), and reimbursement. Additionally, quantitative EEG will be assessed towards the primary outcome. 350 patients are planned to be included. |
NCT01270139 | ALL | ADULT, OLDER_ADULT | Stable Angina|Heart Failure|Atherosclerosis|Multivessel Coronary Artery Disease | PROCEDURE: Transplantation of nanoparticles|PROCEDURE: Transplantation of iron-bearing nanoparticles|DEVICE: Stenting | Total Atheroma Volume, Total atheroma volume (TAV, plaque-media volume, mm3) at 12 months. Quantitative coronary angiography (QCA) and Intravascular Ultrasound (IVUS) were performed pre-, post-procedure and at 12-month follow-up after a bolus infusion of i.c. nitrate. QCA was undergone with the CAAS II analysis system (Pie Medical B.V., Maastricht, The Netherlands) with analysis of different QCA parameters such as minimal lumen diameter, maximum lumen diameter, reference diameter, diameter stenosis, lesion length, percent atheroma volume (PAV), total atheroma volume (TAV), and lumen volume., at 12-month follow-up|MACE (Major Adverse Cardiovascular Events)-Free Survival, MACE (major adverse cardiovascular events)-free survival reflects per cent of survived patients without MACE. An amendment to the protocol was approved on August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively., at 60 months follow-up | The investigators hypothesize that the nanoburning is a very challenging technique to demolish and reverse the plaque especially in combination with stem cell technologies promising the functional restoration of the vessel wall.
The completed (in July 2012) interventional three arms (n=180) first-in-man trial (the NANOM-FIM trial) assessed (NCT01270139) the safety and feasibility of two delivery techniques for nanoparticles (NP), and plasmonic photothermal therapy (PPTT) of atherosclerotic lesions. Patients were assigned in a 1:1:1 ratio to receive either (1) nano-intervention with delivery of silica-gold NP in mini-surgery implanted bioengineered on-artery patch (n=60), or (2) nano-intervention with delivery of silica-gold iron-bearing NP with targeted micro-bubbles or stem cells in hands of magnetic navigation system (n=60) versus (3) stent implantation (n=60). The primary outcome was TAV at 12 months.
The observational prospective cohort analysis (an amendment to the protocol of August 29th 2012 with a decision to extend a 1-year study for another 4 years with the assessment of the 5-year clinical outcomes both retro- and prospectively) of the long-term clinical outcomes at the intention-to-treat population of 180 patients with CAD and angiographic SYNTAX score ≤22 enrolled initially to NANOM-FIM trial will be performed at 5 years after the intervention. The primary outcome will be a MACE-free survival. The secondary outcomes will be MACE, cardiac death, TLR (target lesion revascularization) and TVR (target vessel revascularization). Imaging endpoints will be assessed pre-, post- procedure and at 12-month follow-up. Clinical endpoints will be analyzed at the baseline and at 12 and 60-month follow-up (the release of results is expected after October 2016). Parameters of nanotoxicity will be assessed. The independent adjudication analysis of the clinical outcomes is scheduled in 2017-2019.
The subset post-hoc analysis will be conducted at 1- and 5-year follow-up (by the Amendment of August 29th 2012). At the first subset, patients underwent stenting with XIENCE V stent proximal to the site of nano-intervention (n=13). Subjects in the second subset were undergone drug-coated balloon pre-dilation with further nano-technique (n=20). Lesions in patients of the third subset were not prepared for the nano-approach (n=147) (neither stenting nor balloon angioplasty). The analysis will be performed and results will be released after 2018 with the same clinical outcomes.
This project and related manuscripts were not prepared or funded in any part by a commercial organization. Nanoparticles and biomedical equipment were supplied free for the study by the non-profit Agiko and De Haar Research Task Force (Rotterdam-Amsterdam, the Netherlands). All rights of the authors are reserved. The access of the international academic or governmental organizations to the essential and primary data of the trial is restricted by the Russian governmental authorities due to the interest of the Russian Federal Security Service (FSB). |
NCT00045968 | ALL | ADULT, OLDER_ADULT | Glioblastoma Multiforme|Glioblastoma|GBM|Grade IV Astrocytoma|Glioma|Brain Cancer|Brain Tumor | DRUG: Dendritic cell immunotherapy | The primary objective of this study is to compare overall survival (OS) between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in newly diagnosed glioblastoma., Until death | The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain) |
NCT01536574 | ALL | ADULT, OLDER_ADULT | Parkinson Disease | DRUG: Requip PR | Number of Participants With the Indicated Types of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the On-Treatment Phase (Comprised of the Open-label Treatment Phase and the Down-titration Phase), AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition., From the start of treatment (Baseline) up to Week 25|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the On-treatment Phase, An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. The On-Treatment Phase is comprised of the Open-label Treatment Phase and the Down-titration Phase., From the start of treatment (Baseline) up to Week 25|Number of Participants With an Adverse Event During the Follow-up Phase, AE=any untoward medical occurrence (UMO), temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. SAE=any UMO that, at any dose, results in death, is life threatening, requires hospitalization/prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomoly/birth defect. The Investigator determined if an AE/SAE was related to investigational product. Medical/scientific judgment was used to determine whether SAE reporting was appropriate in situations in which an event may not have met the SAE definition., 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Number of Participants With the Indicated Adverse Events During the Follow-up Phase, An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase., 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27)|Number of Participants With the Indicated Adverse Events Related to Investigational Product During the Follow-up Phase, An adverse event is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. The Investigator determined if an AE/SAE was related to investigational product. In addition to the data recorded at the follow-up visit, SAEs occurring up to and including 2 days after the last dose of down-titration medication are included in the Follow-up Phase., 4- to 14-day Follow-up Phase, beginning after the date of the last dose of down-titration medication (up to and during Study Weeks 26 and 27) | This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.
Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.
Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication. |
NCT00924222 | ALL | ADULT, OLDER_ADULT | Cardiac On-pump Surgery | DRUG: Sevoflurane|DRUG: Propofol | Myocardial injury markers (myoglobin, creatine kinase, myocard specific creatine kinase, and troponin T), Start and end of ICU stay | Organ protection, volatile anesthetics, postconditioning.
Sedation of patients on ICU after cardiac surgery with cardiopulmonary bypass with either propofol or sevoflurane. Evaluation of organ function and inflammatory mediators in the blood. |
NCT04147598 | ALL | ADULT, OLDER_ADULT | Ulcerative Colitis | OTHER: LFD|OTHER: SAD | Change in quality of life as measured by the Short Inflammatory Bowel Disease Questionnaire (sIBDQ)., sIBDQ is a 10-item shortened version of the original IBDQ assessing quality of life (QOL) with total scores ranging from 1 to 7 with a higher score indicating a better QOL., Baseline, 4 weeks|Change in quality of life as measured by the Food-Related Quality of Life (FR-QoL-29) Questionnaire., FR-QoL-29 is a 29-item questionnaire assessing quality of life (QOL) with total scores ranging from 29 to 145 with a score less than 90 suggesting poor food related QoL., Baseline, 4 weeks|Change in quality of life as measured by the Medical Outcomes Short Form-36 (SF-36) Questionnaire., SF-36 is a 36-item questionnaire assessing quality of life (QOL) with total scores ranging from 0 to 100 with a higher score indicating a better QOL., Baseline, 4 weeks|Change in the expression of inflammatory markers in the colon., Change in the expression of interleukin (IL)-1β, IL-6 and Tumor Necrosis Factor alpha (TNFa) evaluated in pg/mL., Baseline, 4 weeks|Change in the expression of cytokine in the colon., Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluted in mg/L., Baseline, 4 weeks|Change in intestinal microbiota, Change in relative abundance of the microbial communities evaluated as a percentage., Baseline, 4 weeks | The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies. |
NCT01719835 | ALL | ADULT, OLDER_ADULT | Peripheral T-cell Lymphoma NOS|Anaplastic Large Cell Lymphoma, ALK-Negative|Angioimmunoblastic T-cell Lymphoma|Hepatosplenic Gamma/ Delta T-cell Lymphoma|Enteropathy-Associated T-Cell Lymphoma | DRUG: Cyclophosphamide|DRUG: Gemcitabine|DRUG: Doxorubicin|DRUG: Vincristine|DRUG: Prednisolone|DRUG: methylprednisolone|DRUG: Cisplatin | complete response rate (CR/CRu), approximately 20 weeks after randomisation | This is a randomised, open-label phase II study comparing GEM-P chemotherapy (experimental arm) with CHOP (control arm) in previously untreated T-cell lymphoma. Eligible patients will be randomised 1:1 between 4-weekly GEM-P or 3-weekly CHOP chemotherapy. |
NCT01149538 | ALL | CHILD | Fetal Alcohol Spectrum Disorders|Fetal Alcohol Syndrome|Partial Fetal Alcohol Syndrome|Alcohol Related Neurodevelopmental Disorder|Prenatal Alcohol Exposure | DRUG: Choline bitartrate|DIETARY_SUPPLEMENT: Placebo for choline bitartrate | Side Effects of Choline Bitartrate, Side effects of choline bitartrate will be monitored by the study physician and the P.I. with physical examinations and telephone contact., Baseline, 6 months, & 9 months|Mullen Scales of Early Learning - Early Learning Composite, The Mullen Scales of Early Learning is a measure of global cognitive development and is a primary outcome measure. The Early Learning Composite is the total score for this measure. It is a scaled score with a mean of 100 and a standard deviation of 15 (higher scores indicate better global cognitive status; average range is 85-115; Impaired range is 70 or below; full range is typically 50 - 150, although minimum and maximum scores are dependent on age). See the Mullen Scales reference manual for more psychometric details., Baseline and 9 months | The purpose of this study is to determine if choline bitartrate can be administered daily to children with prenatal alcohol exposure, ages 2.5 to 5, as a potential treatment for brain development and cognitive functioning. |
NCT02132494 | ALL | CHILD | Academic Performance; Primary Prevention; Physical Activity | BEHAVIORAL: Physical activity | Academic performance, Academic performance will be measured by Norwegian "national tests" in Numeracy, Norwegian and English, October 2014 - June 2015 (8 months) | The relationship between physical activity and academic performance has received widespread attention owing to the pressure on schools to graduate pupils who meet accepted academic standards. As important, there are global concerns regarding the increased prevalence of lifestyle-related non-communicable diseases (NCDs). First, Norway has a history of mediocre scores on international comparative academic performance tests such as Trends in International Mathematics and Science Study (TIMSS) and the Programme for International Student Assessment (PISA) \[1\]. It is therefore important to develop and evaluate strategic programs that may enhance pupil's academic performance. It is increasingly evident that a physical activity strategy that brings about enhanced cognitive function, better blood flow, and more, plays a key role in this effort \[2\]. Second, the prevalence of NCDs, such as diabetes mellitus type 2, is increasing worldwide, and such NCDs affect people of all ages \[3\]. Hence, healthcare costs are escalating to unaffordable levels. The best means to deal with this immense problem is through primary prevention, and physical activity is a powerful common denominator known to play a key role in preventing a host of NCDs \[4\].
Consequently, both World Health Organization (WHO) and the Norwegian health authorities call for effective primary prevention strategies to promote physical activity in children and adolescents \[5, 6\]. Prop. 90 L (2010-2011) Act on public health work \[6\] emphasizes that physical activity in school can benefit both the learning process and public health prevention.
Therefore, the objective of the ASK-study is to investigate the effects on academic performance of 60 minutes of daily physical activity during one school year. Furthermore, due to the complexity in the relationship between physical activity and academic performance, it is necessary to identify possible mediating and moderating variables as cognitive performance, quality of life (QoL), classroom behavior, motor skills and motivation. Also, we aim to investigate changes in risk factors related to NCDs and factors that influence NSDs, such as physical activity, sedentary behavior and health-related fitness.
In addition a qualitative part of the ASK-Study will be conducted to get an in-depth understanding of the children's embodied experiences and the meaning of the social learning culture in school physical activity (PA). This will give us an in-depth description of the intervention context, offer insight in how the intervention possibly influences children's overall development and enables us to estimate potential long term effects of the intervention.
If successful, the ASK cluster-randomized controlled trial (RCT) could provide much needed solutions to enhancing schoolchildren's academic performance and position the school as an effective setting for a massive public health intervention concerning the prevention of NCDs. |
NCT02796963 | MALE | CHILD, ADULT, OLDER_ADULT | HIV | BEHAVIORAL: Crowdsourced intervention|BEHAVIORAL: Traditional intervention campaign | Number of Men Who Have Sex With Men (MSM) Reporting HIV Testing in the Past Three Months, This will be assessed by self-report during a follow-up survey, From implementation roll-out to three months after implementation of crowdsourced intervention | The purpose of this stepped wedge randomized controlled trial is to evaluate the effectiveness of a crowdsourced intervention on promoting HIV testing among young Chinese men who have sex with men (MSM). The crowdsourced intervention will include an open contest, judging to determine finalists and prizes, a designathon, and contest-based MSM engagement. The hypothesis is that a crowdsourced intervention will be superior to conventional HIV test uptake campaigns in eliciting HIV test uptake. |
NCT05143931 | ALL | CHILD, ADULT, OLDER_ADULT | Obesity|Overweight | BEHAVIORAL: Home food environment and grocery delivery (AVOID)|BEHAVIORAL: Inhibitory control training (RESIST)|BEHAVIORAL: WW | Change in BMI from baseline to 12 months., BMI will be calculated by aggregating participants' self-reported height in meters and weight in kilograms at baseline, 6- and 12-months., Baseline, 6-month, 12-month | The proposed randomized controlled trial tests two self-regulatory approaches to improve intentional weight loss and diet quality in individuals with overweight or obesity: (1) an environmental control strategy (AVOID) and (2) an impulse control training strategy (RESIST). |
NCT04259229 | ALL | ADULT, OLDER_ADULT | Diet, Healthy | OTHER: Mediterranean Diet -- Mushrooms|OTHER: Mediterranean Diet -- Control | Change in perceived depression from baseline to post-intervention, Beck's Depression Inventory questionnaire, 8 weeks|Change in perceived depression from baseline to post-intervention, Patient Health Questionnaire-9, 8 weeks|Change in perceived anxiety from baseline to post-intervention, General Anxiety Disorder-7 questionnaire, 8 weeks|Change in cognitive function from baseline to post-intervention, Repeatable Battery for the Assessment of Neuropsychological Status, 8 weeks|Change in perceived daily mood from baseline to post-intervention, Profile of Mood States, 8 weeks|Change in perceived quality of life from baseline to post-intervention, Medical Outcomes Study 36-Item Short Form Health Survey Version 2, 8 weeks|Risk factors for cardiovascular disease, Blood pressure, 8 weeks|Risk factors for cardiovascular disease, Complete metabolic panel, 8 weeks|Risk factors for cardiovascular disease, Lipoprotein Particle Plus (LPP+) Panel, 8 weeks|Risk factors for type 2 diabetes, Complete metabolic panel, 8 weeks|Change in immunity/inflammation markers, Complete Cytokine 13 Panel -- all outcomes reported as pg/mL, 8 weeks|Change in immunity/inflammation markers, Complete Immunoglobulin Panel -- all outcomes reported as mg/dL, 8 weeks | The investigators propose to assess the effects of including mushrooms as part of a healthy eating pattern on indices of perceived mental health/anxiety/depression, along with risk factors for cardiovascular disease and type 2 diabetes. |
NCT02074839 | ALL | ADULT, OLDER_ADULT | Relapsed or Refractory Acute Myeloid Leukemia (AML)|Untreated AML|Other IDH1-mutated Positive Hematologic Malignancies|Myelodysplastic Syndromes | DRUG: AG-120 | Safety/tolerability: incidence of adverse events., up to 26 weeks, on average|Maximum Tolerated Dose and/or the recommended Phase II dose of AG-120 in subjects with advanced hematologic malignancies., up to 26 weeks, on average|Assess clinical activity of AG-120 in subjects with relapsed or refractory AML who are enrolled in the Expansion Phase., up to 26 weeks, on average|Safety/tolerability of treatment with AG-120 in subjects with relapsed or refractory myelodysplastic syndrome., up to 26 weeks, on average|Assess clinical activity of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome., up to 26 weeks, on average | The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. |
NCT04994691 | ALL | CHILD | Health Care Utilization | OTHER: No Message|OTHER: Standard message|OTHER: Tailored message | Appointment completed, Appointment completed (yes or no) based on electronic health record documentation, Within 8 weeks of receiving intervention | Our objective is to determine the effectiveness of varied outreach methods (e.g. standard versus tailored MyChart messaging) to children age 6-17 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling and appointment completion. |
NCT01985126 | ALL | ADULT, OLDER_ADULT | Multiple Myeloma | DRUG: Daratumumab 16 mg/kg (Part 1)|DRUG: Daratumumab 8 mg/kg (Part 1)|DRUG: Methylprednisolone|DRUG: Acetaminophen|DRUG: Diphenhydramine|DRUG: Daratumumab (Part 2) | Percentage of Participants With Overall Response, Overall response defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). Per IMWG criteria, sCR: is defined as normal free light chain (FLC) ratio, and absence of clonal plasma cells (PCs) by immunohistochemistry, immunofluorescence or 2- to 4-color flow cytometry; CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5 % plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>= 90% reduction in serum M-protein plus urine M-protein level \< 100mg/24 hours; PR: \>= 50 % reduction of serum M-protein and reduction in 24 hour urinary M-protein by \>= 90% or to \<200 mg/24 hours; if the serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria., Up to 14.4 Months | The purpose of this study is to evaluate the efficacy and safety of 2 daratumumab treatment regimens in participants with multiple myeloma who have received at least 3 prior lines of therapy (including a proteasome inhibitor \[PI\] and immunomodulatory drug \[IMiD\]) or are double refractory to a PI and an IMiD. |
NCT00000150 | ALL | ADULT, OLDER_ADULT | Macular Degeneration|Histoplasmosis | PROCEDURE: Subfoveal Choroidal Neovascularization Removal | null | To determine whether surgical removal of subfoveal choroidal neovascularization (CNV) and associated hemorrhage in patients with age-related macular degeneration (AMD), the ocular histoplasmosis syndrome (OHS), or idiopathic CNV stabilizes or improves vision more often than observation.
To determine how surgical removal compared to observation of subfoveal CNV due to AMD, OHS, or idiopathic causes changes the patient's perception of health- and vision-related "quality of life," as measured by telephone interview using the Medical Outcomes Survey Short Form-36 (MOS SF-36) instrument, the Hospital Anxiety and Depression Scale, and the National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
To determine whether randomized trials of surgery are warranted for patients with subfoveal CNV associated with age-related macular degeneration not suitable for laser treatment. |
NCT00363922 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease | BEHAVIORAL: Rehabilitation in institution|BEHAVIORAL: Rehabilitation at home|BEHAVIORAL: Out-patient rehabilitation at the hospital | Maximal oxygen consumption, At baseline and after 6 months | The purpose of this study is to compare different types of rehabilitation after coronary bypass surgery. The investigators wish to compare rehabilitation in an institution for four weeks with a home based rehabilitation. They also wish to compare rehabilitation in an institution for four weeks with a rehabilitation program were the patients live at home but visit the hospital twice a week for twelve week. The investigators will measure the patients' physical capacity by measuring their maximal oxygen consumption. The investigators will also analyze their blood and their endothelian function (how well their arteries dilate). |
NCT00672932 | ALL | ADULT, OLDER_ADULT | HIV Infections | DRUG: raltegravir | Change in CSF Concentrations of Neopterin After 12 Weeks, CSF markers of immuno¬activation and inflammation after 12 weeks compared to baseline., three months (Rollover subjects were assessed for a second baseline after the initial 12 week period) | This pilot study focuses on the persistence of central nervous system (CNS) immune activation that has been observed in the presence of 'effective' combination antiretroviral therapy (cART). Attention to this issue is based on the fear that chronic CNS immunoactivation can cause indolent brain injury that will eventually compromise brain function as patients survive for years on treatment. A leading hypothesis explaining this continued immunoactivation is that viral replication continues within the brain at a level too low for detection in cerebrospinal fluid (CSF), yet sufficient to stimulate local immunoactivation. Based on this hypothesis, we propose to use augmented treatment with raltegravir to test whether additional suppression of this hypothesized CNS HIV-1 replication will reduce continued CNS immunoactivation. |
NCT01954966 | ALL | ADULT | Nicotine Dependence|Nicotine Withdrawal | DRUG: Progesterone|DRUG: Placebo | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]), GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex \[DACC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan).
Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA., Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.|GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]), GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex \[DLPFC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan).
Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA., Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months. | Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo. |
NCT00254683 | ALL | ADULT, OLDER_ADULT | Rectal Cancer | DEVICE: PET/CT with FDG | PET/CT specificity and sensitivity for tumor response, Response assesment at 6 and 8 weeks following neoadjuvant therapy | Preoperative chemoradiation therapy is the preferred initial treatment option for distal rectal cancers. However, assessing tumor response to preoperative chemoradiation therapy remains a challenge to the colorectal surgeon, especially when determining if there is a complete response, observed in more than 10% of cases. The purpose of this study is to evaluate the use of the PET/CT in assessing distal rectal tumor response to preoperative chemoradiation therapy. |
NCT03724721 | ALL | ADULT, OLDER_ADULT | Iatrogenic Pneumothorax|Vacuum Bottle Assisted Needle Aspiration | PROCEDURE: vacuum bottle | Intrapleural pressure during vacuum bottle air drainage, The investigator will measure the intrapleural pressure during air drainage at 5 seconds, 10 seconds, 15 seconds, 20 seconds, 25 seconds, 30 seconds, 1 minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes and until finished (the remaining with 5 minutes interval). It is proposed in previous studies that it is safe if the intrapleural pressure is less than 20 cmH2O during the procedure., Within 1 hour | The use of vacuum bottle in drainage of pneumothorax was seldom reported. This study aims to investigate the safety of vacuum bottle plus non-tunneled catheter for drainage of iatrogenic pneumothorax. |
NCT03382964 | ALL | ADULT | Chikungunya | BIOLOGICAL: VLA1553 | Frequency of solicited injection site reactions, Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling., up to Day 14 after single vaccination|Severity of solicited injection site reactions, Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling. They will be rated according to the Severity Grading Scale of Injection Site Reactions (FDA Guidance on Toxicity Grading Scales for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA 2007), up to Day 14 after single vaccination|Frequency of solicited systemic reactions, Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner, up to Day 14 after single vaccination|Severity of solicited systemic reactions, Systemic reactions including fever, nausea/vomiting, headache, fatigue, myalgia (muscle pain), arthralgia (joint pain) and rash will be reported in a standardized manner. They will be rated according to the FDA Guidance on Toxicity Grading Scales, up to Day 14 after single vaccination | Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization.
120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms.
A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia.
Study participants will be followed up until 13 months after initial vaccination. |
NCT01683617 | ALL | ADULT | Psychological Stress | BEHAVIORAL: Coping skills and relaxation training with new technologies|BEHAVIORAL: Traditional coping skills and relaxation training | Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI), Treatment duration is 5 weeks. Outcome measures are assessed before and after treatment and at follow-up (18-month)., five weeks|quality of life questionnaire, 5 weeks|psychophysiological measures (heart rate and heart rate variability indexes), 5 weeks | Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. In this view, stressful experiences are conceptualized as person-environment transactions, whose result is dependent on the impact of the external stimulus. This is mediated by the person's appraisal of the significance of the stimulus, of the personal, social and cultural resources available and of the efficacy of the coping efforts.
Extreme levels of stress can have a negative influence on one's professional life and can disrupt both the social and personal life of an individual. Stress can also cause different physiological and psychological disorders such as anxiety, chronic headaches, depression, withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.
Stress Management Therapy can help to overcome counter effects of stress. Usually various techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated approach covering both stress management and stress treatment is the Cognitive Behavioral Therapy (CBT) approach.
The trouble with stress is that it is very personal. Thus, stress-related disorders depend a great deal on how the person experiencing a stressor is put together -psychologically and physically. So the focus for assessment, prediction and treatment has to be the person's situated experience.
To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging physical and virtual world.
From the clinical point of view the INTERSTRESS solution may offer the following innovations to current traditional protocols for stress management:
* Objective and quantitative assessment of user's stress level using biosensors and behavioral analysis;
* Provision of warnings and motivating feedbacks to improve self awareness, compliance and long term outcome;
* Decision Support System (DSS) for treatment planning through data fusion and detection algorithms. |
NCT01699256 | ALL | ADULT, OLDER_ADULT | Low Back Pain | BEHAVIORAL: Guideline implementation as usual|BEHAVIORAL: Enhanced guideline implementation strategy | Referral of patients to a secondary care back centre, 12 weeks | The aim of this study is to evaluate whether an enhanced strategy of implementation of the new guideline will lower the number of patients getting referred to secondary care spine centres compared to a normal implementation strategy. |
NCT01191411 | ALL | ADULT | Colorectal Cancer | OTHER: Mailed invitations for FIT test kits|OTHER: Mailed invitations for a colonoscopy|OTHER: Visit Based Care | Colorectal Cancer Screening Participation, Defined as Completion of a Guaiac or Immunochemical Stool Occult Blood Test, Colonoscopy, Sigmoidoscopy, or Barium Enem., To compare participation rates for screening between those receiving (a) mailed invitation to screening (immunochemical stool blood test (MailFIT) or colonoscopy(MailColo)) and (b) traditional visit-based screening (VisitBased), rates for these groups will be contrasted via a Chi-squared test. A p value\<0.025 will be considered statistically significant., 1 year | Colon cancer (CRC) is a leading cause of cancer death in the United States. Screening can prevent CRC death, but screening rates are suboptimal, especially for vulnerable populations such as those with limited or no health insurance. This striking public health challenge demands urgent implementation of evidence-based strategies to reduce avoidable CRC death.
Prior research has shown that a direct-to-consumer strategy of inviting patients by mail to complete CRC screening may result in increased rates of screening completion. However, this approach has not been tested extensively in vulnerable populations, such as the under/uninsured, and minority populations often cared for by safety-net health systems. Further, it is unclear whether patients are more likely to participate in one CRC screening test versus another. Knowing this is important to designing programs for increasing screening. For example, the planning and resources required for a screening program with colonoscopy--which is a sensitive but invasive and expensive test--are very different from a program with that uses stool testing to detect microscopic blood such as an immunochemical stool blood test--which is a less sensitive, but non-invasive and cheap test.
Also, it is possible designing a program with a less sensitive, but more acceptable test could prevent more CRC death if participation in screening is test specific. For example, if many more patients participate in an immunochemical stool blood test based program than a colonoscopy based program, even though the immunochemical stool blood test is less sensitive, the program may save more lives because more patients are reached.
The aims of this trial are to:
Aim 1. Deliver CRC screening services (mailed invitation to screening, telephone reminders, and systematic clinical follow up) to uninsured, unscreened patients cared for by the safety-net health system serving Tarrant County, Texas. Patients will be invited to either:
1. Complete a free home-based, non-invasive immunochemical stool blood test
2. Complete a free colonoscopy
Aim 2. Evaluate program outcomes, including screening rates, cancers detected, and program costs.
The primary outcome is screening completion. |
NCT02417623 | ALL | ADULT | Obesity | BEHAVIORAL: Smartphone Application group | Body weight (Kg), Change in body weight at 12 months in the experimental group, compared with the control group. At each study visit, anthropometrics will be recorded by a primary care nurse or doctor. Body weight will be measured with the participant dressed in light clothing with shoes off on a calibrated balance., 12 months|Body mass index (Kg/m2), change in body mass index at 12 months in the experimental group, compared with the control group.. At each study visit, anthropometrics will be recorded by a primary care nurse or doctor. Body weight will be measured with the participant dressed in light clothing with shoes off on a calibrated balance., 12 months | AIM: To assess the efficacy of an intervention that includes the assistance of a weight loss smartphone application targeted to young people aged 18 to 40 years.
DESIGN: Randomisedclinical trial.
SETTING: Primary Health Care centres (PHCCs) in Catalonia.
PARTICIPANTS: Adults aged 18 to 40 years with criteria of obesity or overweight, consulting PHCCs for any reason and who provide written informed consent to participate in the trial.
INTERVENTION GROUP will receive a 12-month weight loss programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme.
CONTROL GROUP will receive the usual care. The outcome measure will be weight loss at 12 months.
EXPECTED RESULTS: The investigators expect a higher weight loss in the intervention group than in control group. |
NCT02310932 | ALL | ADULT, OLDER_ADULT | Chronic Disease|Depression|Anxiety | BEHAVIORAL: Healthy Living Intervention | incidence of dually diagnosed participants, incidence of patients presenting to Primary Health Clinic (PHC) with a dual diagnosis of depression or anxiety, and diabetes or cardiovascular disease in in the standard versus enhanced screening arms., 1 year|anxiety or depression, levels of anxiety or depression reported by participants, depending on initial diagnosis, 1 year|blood glucose control, for patients presenting with diabetes, 1 year|blood pressure, for patients presenting with hypertension, 1 year|cholesterol, for patients presenting with hypercholesterolemia, 1 year | This cluster Randomized Controlled Trial was designed to implement and evaluate the effects of a multi-level intervention designed to integrate mental health treatment into rural primary health clinics in South India using a collaborative care model. |
NCT01313676 | ALL | ADULT, OLDER_ADULT | Pulmonary Disease, Chronic Obstructive | DRUG: fluticasone furoate/vilanterol|DRUG: fluticasone furoate|DRUG: vilanterol|OTHER: Placebo | Number of Participants With Death (Both on and Off Treatment) Due to Any Cause, Time up to or on the Pre-determined Common End Date, Death from any cause: which occurred from the day of starting IP until the Commone End Date (CED). Common End Date (CED) is the study end date that was pre determined where approximately 1000 deaths would have occurred in the Intent-toTreat Efficacy (ITT-E) Population. Only deaths which occurred on or before the CED were used for the primary analysis. Those who had not died by CED, but who were known to be alive on or after the CED, were censored at the CED. Cox Proportional Hazards (PH) Model was adjusted for age, and gender, including all 4 arms. A hazard ratio of less than 1 indicates a lower death rate versus placebo or other arm. ITT-E Population consisted of all participants in the Safety Population (i.e. randomized to IP and who received at least one dose of IP), with the exception of those recruited at sites that were closed., From the date of randomization until date of death due to any cause (average of 2 study years) | The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease. |
NCT02655224 | FEMALE | ADULT, OLDER_ADULT | Uterine Fibroids | DRUG: Relugolix|DRUG: Relugolix placebo | Percentage of Participants With a Maximum NRS Score of 1 or Less During the 28 Days Before the Final Dose of Study Drug, Pain symptoms were evaluated using the NRS score. NRS score is a self-reported instrument assessing pain from 0 to 10. Higher scores reflect greater level of pain. The percentage of participants with a score of 1 or less is reported., For 28 days before the final dose of study drug (up to Week 12) | The purpose of this study is to evaluate the efficacy and safety of Relugolix (TAK-385) in patients having pain symptoms associated with uterine fibroids. |
NCT01340404 | ALL | CHILD | Sickle Cell Anemia|Cerebrovascular Accident | PROCEDURE: Stem cell transplantation|PROCEDURE: Transfusion program | Cerebral vasculopathy, velocity in the artery with highest velocity, 1 year | The aim of this study is to demonstrate that cerebral velocities assessed by transcranial doppler (TCD) are more significantly decreased by SCT than by long-term transfusion program A multicenter, national, non-randomized, prospective study of paired cohort will be conducted, with 2 groups of exposed (SCT) and non-exposed (TP) patients. |
NCT00926796 | ALL | CHILD, ADULT | Gonorrhoea | DRUG: Azithromycin|DRUG: Gentamicin|DRUG: Gemifloxacin | Microbiological Efficacy of Gentamicin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection, Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure), 10-17 days after treatment.|Microbiological Efficacy of Gemifloxacin and Azithromycin for the Treatment of Uncomplicated Gonococcal Infection, Percentage of enrollees negative by culture at cervix/urethra 10-17 days after treatment, regardless of history of re-exposure, among those with positive gonococcal cultures at enrollment (microbiological cure), 10-17 days after treatment. | The purpose of this study is to learn how to better treat gonorrhea infections. Gonorrhea is a sexually transmitted disease (STD) that is usually cured with a single antibiotic. However, some gonorrhea is not cured with a single antibiotic. The study will look at how well treating gonorrhea with 2 antibiotics works. Participants will be assigned to 1 of 2 treatment groups each receiving a combination of 2 antibiotics. Sites in the United States will recruit 500 male and female participants. Participants must be 15 to 60 years old, in good health and identified in participating sexually transmitted disease clinics as having uncomplicated cervical or urethral gonorrhea. Procedures include collection of current symptoms, medical and sexual history, sexual orientation, vital signs, height, weight, cervical/urethral cultures and clinical examinations. Volunteers will be involved for about 17 days. |
NCT00425100 | ALL | ADULT, OLDER_ADULT | Overactive Bladder | DRUG: fesoterodine fumarate | Mean Number of Micturition Episodes Per 24 Hours, The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit., Baseline and Week 12|Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours, The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine., Baseline and Week 12|Mean Number of Urgency Episodes Per 24 Hours, The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine., Baseline and Week 12|Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment, Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question., Week 12 | To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine. |
NCT02512445 | ALL | ADULT, OLDER_ADULT | Guilt|Shame|Post-traumatic Stress Disorders | BEHAVIORAL: Trauma Informed Guilt Reduction Therapy|BEHAVIORAL: Supportive Care Therapy | Change in Trauma Related Guilt Inventory - Guilt Severity, baseline to 8 months (for supplemental study of pandemic guilt in 2021, timeframe is baseline to 3 months) | The goal of this project is to determine if a 6-session psychotherapy intervention will help Veterans feel less deployment-related guilt and less distress related to their guilt. Half of the participants will receive the guilt focused intervention and half will receive a supportive intervention. A supplemental pilot study added in FY2021 will examine the intervention for pandemic-related guilt events. |
NCT00656747 | ALL | ADULT, OLDER_ADULT | Chronic Bronchitis | DRUG: Avelox (Moxifloxacin, BAY12-8039)|DRUG: Amoxicillin clavulanic acid | Clinical failure at 8 weeks post therapy, At day 63 | A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis. |
NCT02177058 | ALL | CHILD, ADULT, OLDER_ADULT | Unnecessary Hospitalizations of Nursing Home Residents | OTHER: INTERACT Quality improvement program|OTHER: Quarterly surveys/data reporting | Reductions in hospitalization, 1 year | This project directly addresses the national imperative for innovative strategies to improve care for Medicare beneficiaries and reduce health care costs. The overall objective of the proposed project is to improve the care of older individuals who reside in nursing homes (NHs), and at the same time reduce unnecessary Medicare expenditures. This goal will be accomplished by testing a quality improvement program designed to reduce the number of avoidable hospitalizations of NH residents in a randomized controlled trial.
The primary hypotheses to be tested are:
Hypothesis1: Interventions to Reduce Acute Care Transfers (INTERACT) implementation NHs will have a greater reduction in hospitalization rate than the control and monitoring only NHs during the 12-month implementation compared to a 12-month baseline period.
Hypothesis 2: Reductions in Medicare expenditures for hospitalizations in the INTERACT implementation NHs will be greater than the estimated costs of implementing the intervention.
Hypothesis 3: The effects of INTERACT on hospitalization rates will be greater among patients on the Medicare skilled benefit for post-acute care, than for long-stay patients.
Hypothesis 4: The effects of INTERACT on hospitalization rates will be greatest among those NHs with higher vs. lower intensity (fidelity) of implementing the program.
Hypothesis 5: There will be a greater reduction in measures of hospitalizations for conditions defined as "potentially preventable" than for other transfers and hospitalizations.
Hypothesis 6: Implementation of INTERACT will not be associated with worsening of relevant quality measures in the participating NHs. |
NCT00279370 | FEMALE | ADULT | Depression | null | SIGH-ADS, 20, 30, 36 weeks gestation and 2, 12, 28, 52, and 104 weeks postpartum|Bayley Scales of Infant Development, 12, 28, 52, and 104 weeks postpartum | This study will determine the safety of antidepressant use during pregnancy for both the mother and the child. |
NCT01560052 | ALL | ADULT, OLDER_ADULT | IgA Glomerulonephritis | DRUG: methylprednisolone|DRUG: Placebo | Progressive kidney failure, Progressive kidney failure, which is a composite of a 40% decrease in eGFR, the development of end stage kidney disease defined as a need for maintenance dialysis or kidney transplantation, and death due to kidney disease., 1-6 years|primary outcome for low dose cohort, Change in proteinuria from baseline at 6 and 12 months Mean change in eGFR at 6 and 12 months, 1 year | This study will evaluate the long-term efficacy and safety of low dose oral methylprednisolone compared to matching placebo, on a background of routine RAS inhibitor therapy, in preventing kidney events in patients with IgA nephropathy and features suggesting a high risk of progression. |
NCT01425853 | ALL | ADULT, OLDER_ADULT | Knee Osteoarthritis | DRUG: Chondroitin/Glucosamine (Droglican)|DRUG: Celecoxib | WOMAC Pain Subscale, Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing., 6 months | The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA). |
NCT04509973 | ALL | ADULT, OLDER_ADULT | Covid19|Hypoxia | DRUG: Dexamethasone | Days alive without life support at day 28, Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28, Day 28 after randomisation | We aim to assess the benefits and harms of higher (12 mg) vs lower doses (6 mg) of dexamethasone on patient-centered outcomes in patients with COVID-19 and severe hypoxia. |
NCT02102347 | ALL | ADULT, OLDER_ADULT | Osteoarthritis of the Knee | OTHER: exercise|OTHER: Phototherapy | physical function, Using the Western Ontario and McMaster Universities Arthritis Index, 9 months | The aim of the proposed study is to analyze the effect of the incorporation of phototherapy into a therapeutic exercise program on pain, functional capacity, range of motion, muscle strength in individuals with osteoarthritis of the knees. The participants will be allocated to different groups through a randomization process using opaque envelopes containing cards stipulating one of the three following groups: Group A (exercise protocol); Group B (exercise protocol + phototherapy protocol); and Group C (exercise protocol + placebo phototherapy protocol). Phototherapy will be performed on the knees diagnosed with osteoarthritis. |
NCT00828087 | ALL | CHILD, ADULT, OLDER_ADULT | Myocardial Infarction | DRUG: Everolimus Eluting Coronary Stent System|DEVICE: cobalt chromium balloon expandable stent ( non drug eluting stent Arm) | Composite endpoint of all-cause death, any myocardial infarction and any revascularization at 1 year., 1 year | This study is a prospective, randomized controlled, single blind, two-arm, multi center clinical evaluation. A total of 1500 patients will be enrolled in the study.
Patient randomization will be to one of the two treatment arms: Everolimus arm or Non drug eluting stent arm. The objective of this study is to assess the safety and performance of the Everolimus Eluting Coronary Stent System versus a modified cobalt chromium balloon expandable stent in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction. |
NCT01010841 | FEMALE | ADULT, OLDER_ADULT | Metabolic Syndrome|Overweight|Obesity|Hypercholesterolemia | DIETARY_SUPPLEMENT: UltraMealPlus 360 (Medical food)|OTHER: Low-glycemic-load diet | TG-to-HDL ratio, Baseline, 8 weeks, 12 weeks | The objective of this study was to investigate from 3 sites (University of Connecticut, University of Florida, and University of California, Irvine) whether enhancement of a modified Mediterranean-style, low glycemic load diet (MED) with specific phytochemicals (soy protein, phytosterols, rho iso-alpha acids and proanthocyanidins; PED) could improve cardiometabolic risk factors in women with metabolic syndrome. |
NCT00412607 | ALL | ADULT, OLDER_ADULT | Ventricular Tachycardia | DEVICE: NAVISTAR® THERMOCOOL® Catheter | The Percentage of Subjects That Expire From All-cause Mortality Within 12-months Post Ablation., The long-term primary safety endpoint is the percentage of subjects that expire from all-cause mortality within 12-months post ablation., 12-month post ablation|The Percentage of Subjects Who Experienced Cardiovascular-specific Adverse Events (CSAE) Within Seven Days of the Ablation Procedure., The acute primary safety endpoint is the percentage of subjects who experienced cardiovascular-specific adverse events (CSAE) within seven days of the ablation procedure., Seven days post ablation procedure | The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia. |
NCT02665364 | ALL | ADULT, OLDER_ADULT | Systemic Lupus Erythematosus | BIOLOGICAL: IFNα-Kinoid|OTHER: Placebo|OTHER: ISA 51 VG | Percent Change From Baseline in IFN Gene Signature at W36, The biological endpoint aimed at evaluating the neutralization of the IFN gene signature following treatment with IFN-K compared to placebo, as measured by the % change from baseline of the expression of IFN-induced genes., Baseline and Last Available Value (LVA) between week 24 and week 36|Number of Participants Who Achieved a British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) With Superimposed CS Tapering at Week 36, British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) responder was defined as a subject who had the following criteria at week 36:
* All BILAG A scores at baseline improve to B/C/D and all BILAG B scores improve to C/D at W36, and
* No BILAG worsening in other body systems: no new BILAG A or ≥ 2 new BILAG B scores at W36, and
* No worsening in SLEDAI-2K total score at W36 compared with baseline, and
* No deterioration in Physician Global Assessment (PGA) (\< 10% worsening) on Visual Analog Scale (VAS) 100 mm at W36 compared with baseline, and
* No addition or increased dose level of anti-malarial drugs or immunosuppressive drugs or CS\* between W24 and W36 (\*≤5 mg prednisolone or equivalent /day at W24 and no increase until W36)., At Week 36 | The safety and immunogenicity of the IFNα-Kinoid (IFN-K) have been evaluated in a phase I clinical study conducted in subjects with Systemic Lupus Erythematosus (SLE). Preliminary results showed acceptable safety profile and patients developped antibodies response.
The principal aim of the present study is to confirm the neutralization of the interferon gene signature and the clinical efficacy of IFN-K in subjects with SLE. In addition, the immune responses and the safety elicited by IFN-K will also be evaluated. |
NCT01685892 | ALL | ADULT, OLDER_ADULT | Lymphocytic Leukemia, Chronic | DRUG: Obinutuzumab|DRUG: Venetoclax | Percentage of Participants With Dose Limiting Toxicities (DLTs), Schedule (Sch) A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days)|Maximum Tolerated Dose (MTD) of Venetoclax in Combination with Obinutuzumab, Sch A (Cycle 1 Day 1 to Day 21), Sch B (Cycle 1 Day 22 to Cycle 2 Day 28) (1 Cycle=28 days) | This multi-center, open-label, dose-finding study will evaluate the safety and pharmacokinetics as well as the preliminary efficacy of venetoclax (GDC-0199; ABT-199) administered in combination with obinutuzumab to participants with relapsed/refractory or previously untreated chronic lymphocytic leukemia (CLL). The study is comprised of two stages for each participant population: a dose-finding stage and a safety-expansion stage. The dose-finding stage will explore multiple doses of venetoclax to be used in combination with a fixed dose of obinutuzumab. The dose-finding stage will also explore two schedules for drug administration, Schedule A (venetoclax introduced before obinutuzumab) and Schedule B (venetoclax introduced after obinutuzumab). |
NCT03941119 | ALL | OLDER_ADULT | Dementia|Delirium Superimposed on Dementia | OTHER: VR-therapy | Changes in Behavioural and Psychological Symptoms of Dementia (BPSD) during the hospital stay, BPSD recorded in the electronic medical record during the acute hospitalization, averaging 10.6 days, will be assessed for all participants. The E-BEHAVE-AD will be administered to all participants on days 1 and 4-7 of hospitalization, Throughout the acute hospitalization, an average of 10.6 days|Number of falls without injury during the hospital stay, All falls without injury that occurred during the current acute hospitalization that were recorded in the electronic medical record will be assessed for all participants, Throughout the acute hospitalization, an average of 10.6 days|Number of falls with injury during the hospital stay, All falls with injury that occurred during the acute hospitalization that were recorded in the electronic medical record will be assessed for all participants, Throughout the acute hospitalization, an average of 10.6 days|Number of pressure ulcers during the hospital stay, All pressure ulcers that developed during the acute hospitalization that were recorded in the electronic medical record will be assessed for all participants, Throughout the acute hospitalization, an average of 10.6 days|All-cause in-patient mortality during the hospital stay, If a participant expires during the acute hospitalization, all-cause in-patient mortality will be recorded as described in the electronic medical record including 24 hours after death, Throughout the acute hospitalization, an average of 10.6 days|Length of acute hospital stay, Number of days of acute hospitalization as recorded by the site staff, will be collected from the electronic medical record after patient's discharge from acute care for all study participants, At the end of the acute hospitalization, an average of 10.6 days|Discharge disposition, Discharge disposition - The disposition (also called Status) of the patient at time of hospital discharge (i.e., discharged to home, expired, etc.). For each participant, the discharge disposition, will be collected from the electronic medical record on the last day of acute hospitalization, At the end of the acute hospitalization, an average of 10.6 days|30-day readmission rate, The number of re-admissions to acute care at this hospital site in the 30 days following discharge will be collected for all participants., Within 30 days following the last day of acute hospitalization which is an average of 10.6 days | Behavioural and Psychological Symptoms of Dementia (BPSD) (such as aggression, restlessness, agitation, wandering, anxiety, depression) are common to most people with dementia at some point during their illness and represent an aspect of dementia particularly difficult to manage. There is growing attention to the therapeutic effects of natural environments on people's health. Exposure to natural environments (seeing greenery, hearing outside natural sounds) has been shown to enhance wellbeing, reduce depression, anxiety and stress levels, and decrease hospital length-of-stay for inpatients. Virtual Reality (VR) is a novel technology that uses a Head Mounted Display (HMD) to generate simulated immersive experiences that elicit perceptions and behaviors similar to those in real life and can make one feel as though they are truly present in another place. Based on scientific research, previous studies, and expert consultation, we created a library of VR experiences depicting calming nature scenes designed specifically for people with dementia.
The objectives of this RCT are 1) to evaluate the effects of VR-therapy on BPSD and the hospital care experience of in-patients with dementia and/or delirium admitted to an acute care hospital, 2) to determine the usability, tolerability, and safety of VR-therapy for patients with dementia and/or delirium admitted to acute care, 3) determine the effect of VR-therapy on quality of life for patients with dementia and/or delirium admitted to acute care and 4) to explore a framework for introducing non-pharmacological therapies in acute care hospitals.
Our hypotheses are 1) VR-therapy helps manage BPSD (e.g. decrease anxiety, aggression, depression, violent behaviors, incidents of wandering), and may decrease the amount and/or frequency of sedatives and anti-depressant medication administered and/or the number of incidents that require restraints, and the number of falls, in people with dementia and/or delirium admitted to an acute care hospital. 2) VR-therapy will improve the quality of life for individuals with dementia and/or delirium admitted to an acute care hospital (operationalized through conducting a validated instrument to measure quality of life for people with dementia). 3) VR-therapy is safe and feasible to administer to individuals with dementia and/or delirium admitted to an acute care hospital (with assistance from their circle of care members and/or caregivers). |
NCT00549757 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes Mellitus|Cardiovascular Disease | DRUG: Aliskiren|DRUG: Placebo | Percentage of Participants With Occurrence of Primary Composite Endpoint (Core : Active Treatment Phase), Occurrence was defined as the first event of the following composite primary endpoint:
* Cardiovascular (CV) death
* Resuscitated sudden death
* Non-fatal myocardial infarction (MI)
* Non-fatal stroke
* Unplanned hospitalization for heart failure (HF)
* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL., Time from randomization to the first event (Maximum 50 months)|Percentage of Participants With Cardiovascular (CV) Death (Core: Active Treatment Phase), Time from randomization to the first event (Maximum 50 months)|Percentage of Participants With Resuscitated Sudden Death (Core: Active Treatment Phase), Resuscitated sudden death was adjudicated when a subject experiences sudden death or cardiac arrest and is successfully resuscitated by cardioversion, defibrillation or cardiopulmonary resuscitation with a meaningful recovery of consciousness. This definition excludes known transient losses of consciousness such as seizure or vasovagal episodes that do not reflect significant cardiac dysfunction., Time from randomization to the first event (Maximum 50 Months)|Percentage of Participants With Fatal/Non-fatal Myocardial Infarction (MI) (Core: Active Treatment Phase), Time from randomization to the first event (Maximum 50 Months)|Percentage of Participants With Fatal/Non-fatal Stroke (Core: Active Treatment Phase), Time from randomization to the first event (Maximum 50 Months)|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Core: Active Treatment Phase), ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death, Time from randomization to the first event (Maximum 50 Months)|Percentage of Participants With Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Core: Active Treatment Phase), To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL., Time from randomization to the first event (Maximum 50 Months)|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Core: Active Treatment Phase), Time from randomization to the first event (Maximum 50 Months)|Percentage of Participants With All Cause Mortality (Core: Active Treatment Phase), Time from randomization to the first event (Maximum 50 months)|Percentage of Participants With Occurrence of Primary Composite Endpoint (Extension Phase), Occurrence was defined as the first event of the following composite primary endpoint:
* Cardiovascular (CV) death
* Resuscitated sudden death
* Non-fatal myocardial infarction (MI)
* Non-fatal stroke
* Unplanned hospitalization for heart failure (HF)
* Onset of end-stage renal disease (ESRD) or death due to renal failure. Onset of ESRD was defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 μmol/L), sustained for at least a month.
* Doubling of baseline serum creatinine concentration, sustained for at least one month. To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL., From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Percentage of Participants With Cardiovascular (CV) Death (Extension Phase), from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Percentage of Participants With Resuscitated Sudden Death (Extension Phase), From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Percentage of Participants Fatal/Non-fatal Myocardial Infarction (MI) (Extension Phase), From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 month in average)|Percentage of Participants With Fatal/Non-fatal Stroke (Extension Phase), From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Percentage of Participants With Onset of End-stage Renal Disease (ESRD) (Extension Phase), ESRD is defined as initiation of dialysis, renal transplantation, or a serum creatinine concentration above 6.0 mg/dL (530 µmol per liter) or renal death, From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Percentage of Participants Doubling of Baseline Serum Creatinine Concentration, Sustained for at Least One Month (Extension Phase), To fulfill the endpoint, the serum creatinine concentration had to be above the upper limit of normal for men and women according to the central laboratory. The upper limit of normal for men is 1.20 mg/dL and for women is 0.91 mg/dL., From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Percentage of Participants With Unplanned Hospitalization for Heart Failure (Extension Phase), From cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average)|Percentage of Participants With All Cause Mortality (Extension Phase), from cut-off date (20Dec2011/End of Treatment (EOT) ) to the first event after cut-off date (9 months in average) | The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.
AMENDMENT 4 RATIONALE (MARCH 2012) :
Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation. |
NCT00159913 | ALL | CHILD | Pulmonary Arterial Hypertension, Children | DRUG: Sildenafil citrate|DRUG: Sildenafil citrate|DRUG: Placebo|DRUG: Sildenafil citrate | Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Intent To Treat Population, Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = \[(week 16 value minus baseline mean)/mean at baseline\]\*100%., Baseline, Week 16|Percent Change From Baseline in Peak Volume of Oxygen (VO2) Consumed : Per Protocol Population, Peak VO2 (normalized for body weight) at trough plasma levels assessed by CPX testing (bicycle ergometry)at the end of treatment (Week 16 for those who completed the study). Mean Percent change = \[(week 16 value minus baseline mean)/mean at baseline\]\*100%., Baseline, Week 16 | This is a clinical research study designed to evaluate sildenafil for the treatment of Pulmonary Arterial Hypertension in children, aged 1 to 17 years. The purpose of the study is to assess the efficacy, safety, and pharmacokinetics of 16 weeks of chronic treatment with oral sildenafil given in three different doses, compared to placebo (inactive treatment). Efficacy will be measured by exercise and hemodynamics. Patients who complete this trial may be eligible to take part in an extension study, in which all patients will receive active treatment of sildenafil. |
NCT05022576 | MALE | CHILD, ADULT, OLDER_ADULT | Prostate Cancer | DIAGNOSTIC_TEST: Robotic arm assisted PSMA PET/CT guided prostate biopsy | The diagnostic yield of the procedure, Obtaining a biopsy specimen from the PSMA expressing site of the prostate in patients with clinical suspicion of prostate cancer to establish a pathological diagnosis., three months|Safety of the procedure, The periprocedural and post procedural adverse effects were documented, Seven days | Gallium-68 prostate-specific-membrane-antigen (Ga-68 PSMA) PET/CT is being used in Prostate cancer imaging. In the present study, we aimed to evaluate the efficacy and safety of robotic arm-assisted Ga-68 PSMA PET/CT-guided transgluteal prostatic biopsy.
Seventy-eight participants with a clinical suspicion of PCa were recruited from January 2019 to September 2020. All the patients underwent whole-body Ga-68 PSMA PET/CT. The patients with PSMA-avid lesion in the prostate underwent robotic arm-assisted PET-guided transgluteal biopsies. The degree of pain during the procedure, procedure-related complications and histopathology were evaluated. |
NCT01414244 | ALL | ADULT, OLDER_ADULT | Diarrhea-Predominant Irritable Bowel Syndrome | DRUG: Glutamine | Change in the Irritable Bowel Symptom Severity Scale, The primary outcome measure will be a change in the Irritable Bowel Symptom Severity Scale (IBS-SS) from baseline to 8 weeks at the conclusion of therapy. The IBS-SS scale ranges from 0 to 500 (worst). A decrease in 50 or greater in the IBS-SS is considered a positive response., baseline and 8 weeks following therapy | New and effective treatments are needed for patients with post-infectious irritable bowel syndrome (PI-IBS). We conducted a randomized, placebo-controlled trial to assess the efficacy and safety of glutamine, an abundant amino acid in the body and the principal fuel for enterocytes, in patients who developed diarrhea-predominant irritable bowel syndrome with increased intestinal permeability following an enteric infection. |
NCT01072500 | ALL | OLDER_ADULT | Sedentary Lifestyle|Risk of Disability|Aging | BEHAVIORAL: Physical Activity|BEHAVIORAL: Successful Aging | Major Mobility Disability, Defined as Incapacity to Walk 400 Meters, The primary outcome of major mobility disability was defined as the inability to complete a 400-m walk test within 15 minutes without sitting and without the help of another person or walker. Use of a cane was acceptable. Participants were asked to walk 400 m at their usual pace, without overexerting, on a 20 meter course for 10 laps (40 meters/lap). Participants were allowed to stop for up to 1 minute for fatigue or related symptoms. When major mobility disability could not be objectively measured because of the inability of the participant to come to the clinic and absence of a suitable walking course at the participant's home, institution, or hospital, an alternative adjudication of the outcome was based on objective inability to walk 4 meters in less than 10 seconds, or self-, proxy-, or medical record-reported inability to walk across a room. If participants met these alternative criteria, they would not be able to complete the 400 meter walk within 15 minutes., Median 2.7 years/Average 2.6 years | Based upon promising results from a pilot study among 424 sedentary older adults who were randomized to a physical activity intervention or a successful aging health education intervention, a Phase 3 multi-center randomized controlled trial is being conducted to compare a moderate-intensity physical activity program to a successful aging health education program in 1,600 sedentary older adults who are followed for an average of 2.7 years.
The primary aim was to assess the long-term effects of the proposed interventions on the primary outcome of major mobility disability, defined as inability to walk 400 m. |
NCT02985047 | ALL | ADULT | Self-Injurious Behavior|Suicidal Ideation|Suicide, Attempted|Borderline Personality Disorder|Emergency Services, Psychiatric | OTHER: Brief Admission | Number of days with hospital admission, Number of days with Brief admission, general admission, forced (involuntary) admission, Change between the period from 12 month retrospectively to Baseline and the period from baseline to 12 months prospectively | The purpose of the study is to test a standardized version of brief admission (BA) through randomized controlled trial (RCT). The main objective is to evaluate if BA can serve as a crisis management model for individuals with recurrent self-harm, including suicide attempts and at least three symptoms of Borderline Personality disorder. Participants will be allocated to BA + Treatment as Usual (TAU) or TAU. |
NCT04330053 | ALL | OLDER_ADULT | Elderly|Accidental Falls|Prevention|Exercise | OTHER: Experimental|OTHER: Control | Changes in CONFbal - GREEK score questionnaire, The CONFbal questionnaire is a tool that assesses the self-esteem of an elderly person associated with the risk of falling. It consists of a 10-item scale, which are summed to give an index of balance confidence. The score ranges from 10 to 30. A higher score indicates lower balance confidence. Τhe questionnaire demonstrates excellent internal consistency and excellent test-retest reliability. The Greek version of the questionnaire CONFbal - GREEK (Billis, et al., 2011) will be used in this study., Pre-treatment, Month 6, 12|Changes in Short Falls Efficacy Scale International (Short FES-I) score questionnaire, Short FES-I is a measure of "fear of falling" or, more properly, "concerns about falling", which are suitable for use in research and clinical practice. It is the short version of the Falls Efficacy Scale International (FES-I), comprised of seven questions and is more applicable in clinical practice. The score ranges from 7 to 28. A higher score indicates greater fear of falling. The Greek version of the questioner (Billis, et al., 2011) will be used in this study, Pre-treatment, Month 6, 12|Changes in 4-Stage Balance Scale test, The 4-Stage Balance Test is an assessment of static balance in four different and increasingly challenging positions - feet together, instep of foot advanced to toe of other foot, foot in front of other foot (tandem), and single leg stance (Lajoie \& Gallagher, 2004). The participant must stand in each position for ten seconds, while the examiner tracks time using a stopwatch. Each of the first three positions is evaluated with the eyes open and closed, while the single leg stance is evaluated only with the eyes open, so each participant is evaluated in a total of seven tests. Each test is scored from four to zero (representing "able to stand for 10 seconds safely" and "needs help to keep from falling" respectively). The final score results from the sum of all seven tests and ranges from zero to 28. A higher score indicates greater static balance ability of the participant. The test has good validity (Marques et al., 2017)., Pre-treatment, Month 6, 12|Changes in Timed Up and Go test, It is a simple test used to assess a person's mobility. It requires both static and dynamic balance and is a valid and reliable indicator of the functional ability of an individual (Podsiadlo \& Richardson). The participant starts in a seated position. They then stand up following the instructions of the therapist, walk three meters, turn around, walk back to the chair and sit down. The examiner tracks time using a stopwatch. Time is calculated in seconds. A higher score indicates lower functional ability of the participant., Pre-treatment, Month 6, 12|Changes in number of falls, Changes in number of falls will be evaluated through a Falls diary which will be completed each month by the elderly, Pre-treatment, Month 6, 12|Changes in the 30-Second Chair Stand Test, The 30-Second Chair Stand Test is a test for assessing leg strength and endurance in elderly adults. It is part of the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit, which was created by the Centers for Disease Control and Prevention as a screening tool for seniors belonging in the high fall risk group (Stevens, 2013). The test measures the number of times an elderly person can get up from a chair with their arms crossed in front of their trunk (on the opposite shoulder crossed at the wrists) in 30sec. This test was developed to overcome the floor effect of the five or ten repetition sit to stand test in older adults. The test has been characterized by excellent test-retest reliability in a total number of participants: r = 0.89 (95% Confidence interval 0.79-0.93) (Rikli \& Jones, 1999)., Pre-treatment, Month 6, 12|Changes in Berg Balance scale Test, The Berg Balance Scale is a tool proposed by Berg (Berg et al., 1989; Berg et al., 1992) for assessing balance in the elderly. The test involves the execution of 14 tests of gradual increasing difficulty where in each one, the subject is asked to maintain a given position for a specific time or conduct specific tasks. Each of the 14 tests on the list is graded according to the balancing ability of the examinee from 0 to 4 points (with 0 indicating low balance ability, while 4 indicates high balance ability). According to Berg et al. (1992), a score of 56 indicates functional balance, whereas a score lower than 45 indicates notable balance deficits that have been related to increased fall risk. Studies have shown high intra-rater and inter-rater reliability in the elderly populations with intraclass correlation (ICC) ranging from .98 to .88 (Berg et al. 1992) and high content validity (Telenius et al., 2015)., Pre-treatment, Month 6, 12 | Due to the aging of the earth's population in the coming years, strategies for preventing falls in the elderly are of increasing research interest. Injuries due to falls have a direct impact on the quality of life of the elderly and are associated with very high costs for the healthcare system. However, few organized fall prevention interventions have been implemented in Greece, unlike other EU countries. The systematic recording of falls, the information and education of older people about injury prevention and the participation of older people in organized fall coping strategies in Greece are almost non-existent. Group exercise programs have proven to be effective in reducing falls. The OTAGO exercise program has shown that it can effectively reduce the number of falls in the elderly by up to 54%. However, its widespread implementation by a government agency in Greece such as the Elderly Day Care Centers (EDCC) has not yet been possible. |
NCT04447352 | ALL | ADULT, OLDER_ADULT | Gastric Cancer|Gastroesophageal Junction Adenocarcinoma | DRUG: 5-Fluorouracil|DRUG: Leucovorin|DRUG: Oxaliplatin|DRUG: Docetaxel|DRUG: Cisplatin | Comparison of progression-/disease-free survival (PFS/DFS) between arms, To compare PFS/DFS in patients with localized and advanced diffuse or mixed type adenocarcinoma of the stomach and Type II/III GEJ (i.e. ≥cT3 any N or any T N-positive) with exclusion of distant metastases and after receiving neoadjuvant FLOT- therapy will be included in this trial after a central review, receiving 3-6 cycles perioperative FLOT versus FLOT alone in the intent to treat population (ITT) and where PFS/DFS is defined as the time from randomization to disease progression or relapse after surgery or death from any cause., from randomization up to 5 years | This is a multicenter, randomized, controlled, open-label study evaluating efficacy and safety of perioperative FLOT chemotherapy plus intraoperative HIPEC versus FLOT chemotherapy alone in patients with resectable localized and locally advanced diffuse and mixed type adenocarcinoma of the stomach and Type II/III GEJ. |
NCT02027610 | ALL | CHILD | Vitamin A Deficiency | null | Naïve T-cells in peripheral blood, The concentration of naïve T-cells in peripheral blood will be measured once at 52 - 104 wk of age by flow cytometric analysis., measured once at 52 - 104 weeks of age | Vitamin A deficiency (VAD) increases the risk of death from infections in infants and young children. The World Health Organization (WHO) recommends high-dose vitamin A supplementation (VAS) from 6-59 months of age to reduce the risk of death in countries where VAD is common. Such countries include Bangladesh, where this study is being conducted. While providing VAS at 6 months is recommended, providing VAS at birth may also decrease the risk of death since newborn infants are also at risk of VAD. VAS presumably reduces infant mortality by improving the immune response to infection and immunization. Vitamin A particularly affects the development and function of T cells, which develop in the thymus and are a key component of the memory response to infection and immunization. Vitamin A is important for development of an important class of T cells, regulatory T-cells, in the intestine. Regulatory T-cells prevent over-reaction of the immune system to substances the immune system might otherwise treat as harmful such as food or the healthy bacteria in the intestine. VAD could disrupt the normal colonization of the infant's intestinal tract and cause a condition called "dysbiosis" where abnormal bacteria flourish and adversely affect the infant's immune system. Dysbiosis may disrupt the immune response to injectable and oral vaccines. VAS at birth may prevent dysbiosis and thus improve immune function, response to vaccines, and child survival. The investigators recently completed an intervention trial in Bangladeshi infants (NCT01583972) examining the effect of VAS at birth on immune function and response to vaccines administered from birth to 14 wk of age. The present study will recruit infants who completed NCT01583972 when they are from 12 to 24 m of age to determine if VAS at birth affects the responses to these same vaccines when they are measured during the second year of life. The investigators will examine the effect of VAS at birth on gut microbiota measured early in infancy and during the second year of life, and explore the association of the gut microbiota with vaccine response. Mothers of study infants will participate in the study because the breast milk oligosaccharide content strongly affects gut microbiota composition and the "secretor status" of the mother, which can be determined from maternal FUT2 genotype, strongly affects breast milk oligosaccharide content. |
NCT00391872 | ALL | ADULT, OLDER_ADULT | Acute Coronary Syndrome | DRUG: Ticagrelor|DRUG: Clopidogrel | Participants With Any Event From the Composite of Death From Vascular Causes, Myocardial Infarction (MI), and Stroke, Participants with death from vascular causes, MI, or stroke. If no event, censoring occurs at the earliest of patient withdrawal consent or date of scheduled withdrawal from therapy. Intention To Treat (ITT) analysis of whole population. Events were adjudicated by an endpoint committee., Randomization up to 12 months|Participants With Any Major Bleeding Event, Participants with major (fatal/life-threatening or other) bleed by a study protocol scale based on need for treatment, number of transfusions, hemoglobin decrease, and other factors. Events were adjudicated by an endpoint committee., First dosing up to 12 months | Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS. |
NCT02480582 | FEMALE | ADULT | Lack of Satiety|Hyperphagia | OTHER: Almonds|OTHER: Cheese Savouries | Test Meal Energy Intake, Measured reductions in ad-libitum energy intake following consumption of almonds as a mid-morning snack compared to control and comparator. Food will be weighed pre- and post-consumption to the nearest 0.1g to determine energy intake. Test meal energy intake will be measured on three occasions, on average a week apart., 3 Weeks | The current study will examine the effect of almond consumption (0.9g/kg dose) compared to an energy and weight matched comparator food or no food on measures of appetite control including appetite sensations, energy intake and food hedonics. |
NCT00017953 | ALL | ADULT, OLDER_ADULT | Diabetes|Myocardial Infarction|Stroke|Kidney Diseases|Bone Diseases|Dyslipidemia | BEHAVIORAL: Lifestyle Intervention|BEHAVIORAL: Diabetes Support and Education | First Occurrence of a Severe Cardiovascular Event, Number of participants with first on-study occurrence of one of the following major cardiovascular events: fatal and non-fatal myocardial infarctions and strokes, hospitalizations for angina, and cardiovascular deaths, up to 11 years | The Look AHEAD study is a multi-center, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese. |
NCT01306383 | ALL | CHILD | Dysentery|Diarrhoea | OTHER: SODIS Bottle | Dysentery disease rate, Incidence of occurrence of blood or mucous in diarrhoeal stools was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks., 12 month|Diarrhoea disease rate, Incidence of diarrhoea and numbers of diarrhoeal episodes was noted by caregivers and recorded in a pictorial diary which was collected every 2 weeks., 12 months | SODISWATER was a health impact assessment study investigating the effect of sunlight to inactivate microbial pathogens in drinking water. This study was carried out by observing whether children younger than 5 years old who drink solar disinfected water were healthier than those who did not. Health was measured by how often the children had diarrhoea or dysentery.
Caregivers for the participants were given plastic bottles to place in the sun, water samples were then collected from these plastic bottles to be analyzed. They were also requested to fill in diarrhea diaries.
TESTABLE RESEARCH HYPOTHESES:
Health Impact Assessment: Children who use solar disinfected water will have:
(a) lower morbidity due to non-bloody diarrhoea and bloody diarrhoea (c) increased growth rates (d) lower mortality (e) increased family productivity (f) decreased care-giver burden (g) increased school attendance |
NCT01546922 | ALL | ADULT, OLDER_ADULT | Adrenal Insufficiency | DRUG: Hydrocortisone | Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone., Cognitive domains to be tested: memory, executive functioning, attention and social cognition.
The psychological tests consist of oral and written questions or computer tasks.
Data is given as Z-scores based on normative data. Higher Z-scores represent a better performance., After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline). | The aim of this study is to investigate whether a physiologically low hydrocortisone (HC) dose is better for cognition as compared to a physiologically high HC dose. In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose. |
NCT00114517 | FEMALE | CHILD, ADULT, OLDER_ADULT | Atherosclerosis | DRUG: 17B-estradiol|OTHER: Placebo | Progression of Subclinical Atherosclerosis, Rate of change in distal common carotid artery (CCA) far wall intima-media thickness (mm per year) in computer image processed B-mode ultrasonograms that were obtained at two baseline examinations (averaged to obtain the baseline CIMT value) and every 6 months during trial follow-up., Baseline x 2 and then every 6 months up to 6.7 years | The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy postmenopausal women. |
NCT04080843 | ALL | ADULT, OLDER_ADULT | Colorectal Cancer|RAS and BRAF Wild-type|Colorectal Neoplasms|Intestinal Neoplasms|Gastrointestinal Neoplasms|Digestive System Neoplasms|Neoplasms by Site|Neoplasms|Digestive System Diseases|Gastrointestinal Diseases|Colonic Diseases|Intestinal Diseases|Rectal Diseases | DRUG: Anlotinib Hydrochloride|DRUG: Capecitabine|DRUG: Oxaliplatin | Objective response rate(ORR), using RECIST version 1.1, Every 2 weeks until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months | This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With CAPEOX in RAS and BRAF wild-type patients with Metastatic Colorectal Carcinoma(CRC) as 1st Therapy. After 6 cycles of combined therapy, patients will receive capecitabine and anlotinib as maintenance therapy until tumor progression.In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with CAPEOX in treatment of patients with mCRC. The patients who are pathologically confirmed as RAS and BRAF wild-type mCRC will be enrolled.
Condition or disease Invention/treatment Phase Colorectal Cancer Drug: Anlotinib Hydrochloride Drug: Capecitabine Drug: Oxaliplatin Phase 2 |
NCT01473381 | ALL | ADULT, OLDER_ADULT | Major Depressive Disorder | DRUG: Vilazodone|DRUG: Placebo to citalopram|DRUG: Placebo to vilazodone|DRUG: Citalopram | Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10, The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement., Baseline to Week 10 | The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder. |
NCT00699374 | ALL | ADULT, OLDER_ADULT | Carcinoma, Hepatocellular | DRUG: sunitinib malate|DRUG: sorafenib | Overall Survival (OS), Overall survival is the duration from randomization to death. For participants who are alive, overall survival was censored at the last contact., Baseline, every 4 weeks during treatment, every 8 weeks posttreatment up to Week 150 | The study will evaluate the efficacy and safety of sunitinib (Arm A), given at 37.5 mg orally once daily, compared to sorafenib (Arm B), given orally at 400 mg twice daily, in patients with inoperable liver cancer. A total number of 1200 patients will be enrolled, 600 on Arm A and 600 on Arm B. Study treatment may be adjusted based on patient tolerance. and will be given until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of study treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival. |
NCT00587639 | ALL | CHILD, ADULT | Depression | DEVICE: rTMS Treatment | Change in Cognitive Status as Measured by the Children's Auditory Verbal Learning Test 2 (CAVLT-2), The Children's Auditory Verbal Learning Test 2 (CAVLT-2) is a neuropsychological test that measures auditory verbal learning and memory. This test is designed for ages 6.6-17.11 years. Scores are reported as normalized standard scores. The minimum standard score is 60 and the maximum 140; a higher score indicates a better performance., Pre-treatment (baseline visit) and post treatment (approximately 6-8 weeks after baseline visit) | The objective of this investigation is to examine the safety and feasibility of a series of repetitive transcranial magnetic stimulation (rTMS) treatments (10 Hertz \[Hz\]; Left Dorsolateral Prefrontal Cortex), with a Neuronetics Model 2100 Therapy System as adjuvant treatment for depression in adolescent subjects. |
NCT01738100 | ALL | ADULT, OLDER_ADULT | ST-Segment Elevation Myocardial Infarction | DRUG: Ticagrelor|DRUG: Clopidogrel|DRUG: Morphine Sulfate|DRUG: Saline | Myocardial infarct size measured by magnetic resonance imaging (MRI) at 3-5 days after the index procedure, Post-PCI 3-5 days | A 2 by 2 factorial, multicenter, prospective, randomized, open-label, blinded endpoint trial. Patients undergoing primary PCI for STEMI will be eligible. Enrolled patients will be randomly assigned to the ticagrelor group or the clopidogrel group in a 1:1 ratio. After emergent coronary angiography, patients who have thrombolysis in myocardial infarction (TIMI) flow grade \<2 in coronary angiogram will be randomized again, to either bolus intracoronary injection of morphine sulfate or saline in a 1:1 ratio. Randomization will be stratified by infarct location (anterior vs. non-anterior), and morphine use for pain control before study enroll (for only intracoronary morphine). |
NCT00440947 | ALL | ADULT, OLDER_ADULT | Infection, Human Immunodeficiency Virus I|HIV Infection | DRUG: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) + ritonavir (/r)|DRUG: Abacavir (ABC)/lamivudine (3TC) + atazanavir (ATV) | Percentage of Participants (PAR) Who Achieved Plasma HIV-1 RNA <50 Copies (c) /Milliliter (ml) at the Week 84 Visit, The percentage of PAR with HIV-1 RNA virus \<50 c/ml determined from a blood sample drawn at Week 84 was tabulated by treatment arm with stratification by baseline HIV-1 RNA (\<100,000 c/ml and \>=100,000 c/ml). Per TLOVR algorithm, responders were PAR with confirmed viral load \<50 c/ml who had not met any non-responder criterion. Non-responders were PAR who never achieved confirmed HIV RNA \<50 c/ml, prematurely discontinued study or study medication for any reason, had confirmed rebound to at least 50 c/ml, or had an unconfirmed HIV RNA of at least 50 c/ml at last visit., Week 84 | This study was designed to test the efficacy, safety, tolerability and durability of the antiviral response between atazanavir (ATV) + ritonavir (/r) + abacavir/lamivudine(ABC/3TC) Fixed dose combination (FDC) each administered once daily (QD) for 36 weeks followed by randomization to either a simplification regimen of ATV or continuation of ATV +/r for an additional 48 weeks, each in combination with ABC/3TC in antiretroviral (ART)-naive, HIV-1 infected, HLA-B\*5701 negative subjects.
All subjects who complete the 84-week study will be eligible to enter the treatment extension phase and continue for an additional 60 weeks. The purpose of this extension is to obtain longer term treatment data in subjects who have completed the 84-week study. |
NCT01248637 | ALL | ADULT, OLDER_ADULT | Pancreatic Cancer | DRUG: Pimonidazole hydrochloride | characterization of intratumoral hypoxia in pancreatic cancer, estimation of tumoral hypoxic fraction by immunodetection of pimonidazole adducts., 5 Years|correlation of intratumoral hypoxia with patient survival rate, evaluation of correlation of tumoral hypoxia with disease-free survival using Cox proportional hazards analysis, 5 Years | This study involves the administration of a hypoxia marker, pimonidazole hydrochloride, taken orally approximately 24 hours before surgical resection of a pancreatic tumor in order to identify areas of lower oxygen content on tumor samples. |
NCT01192022 | ALL | CHILD, ADULT, OLDER_ADULT | Hemorrhage | BIOLOGICAL: TachoSil®|DEVICE: Surgicel® Original | Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes, 3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped., within 3 minutes | The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original. Hemostatic efficacy will be evaluated intraoperatively after application of randomized treatment. |
NCT02541695 | MALE | ADULT | Diarrhea|Gastroenteritis|Bacterial Infections|Escherichia Coli Infections | BIOLOGICAL: E. coli strain E1392-75-2A | Change in percentage of faecal dry weight from baseline, % of faecal dry weight determined by freeze-drying, Day 14-17 and Day 35-38 | Although the existing diarrhoeagenic Escherichia coli (E. coli) challenge model is already suitable for dietary interventions in its current form, further characterization of the working-mechanism of the attenuated strain and further optimization of the study design will enable the investigators to better select those ingredients that affect the key pathophysiological processes. The aim of the CORAL study is to further characterize and increase the discriminative power of the diarrhoeagenic E. coli challenge model. |
NCT00705445 | ALL | CHILD | Malnutrition|Diarrhea|Pneumonia|Growth | DIETARY_SUPPLEMENT: Micronutrient Supplementation without Zinc|DIETARY_SUPPLEMENT: Micronutrient Supplementation with Zinc|OTHER: Nutritional Counselling and Education | Episodes of Diarrhea and additional morbidity such as acute lower respiratory tract infection, pneumonia and days with severe illness., 2 years | Information on the mechanisms of zinc is still in developing phase. Ecological and biological implications of long term zinc supplementation at population level requires assessment. The trial aims to assess the impact of routine supplementation of zinc among young growing children and evaluate its impact on intestinal microbial flora and relationship with gut mucosa integrity and co-morbidities. |
NCT03113292 | ALL | ADULT | Chronic Low Back Pain | OTHER: Pilates|OTHER: Home Exercises | Pain Intensiy, Pain Intensity measured on a Visual Analog Scale (VAS, in centimeters), Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months)|Disability, Quebec Back Pain Disability Scale, scores ranging from 0 to 100, Change from Pre-Intervention (baseline) compared to Post-Intervention (6 weeks) and Follow-up (6 months) | The aim is to compare the effectiveness and cost-effectiveness of a Pilates program versus home-based exercises in individuals with chronic non-specific low back pain. This is a randomized controlled trial with economic evaluation. Participants will be sequentially enrolled and randomly allocated into two groups: 1) Pilates: Mat Pilates sessions, supervised by a physiotherapist (2x/week for 6 weeks); 2) Home-Based Exercise: face-to-face familiarization (two sessions), supervised by another physiotherapist. After familiarization, the exercises will be prescribed using a booklet containing descriptions of sets/repetitions, as well as guidelines and precautions, to be performed during 6 weeks (2x/week) and monitored in a diary. Participants will be supervised by the physiotherapist (telephone/text messaging). Participants will be evaluated in three different moments: 1) Baseline (pre-intervention); 2) At the end of the intervention (post-intervention, 6 weeks); and 3) After six months follow-up (from post-intervention). Primary outcomes: pain intensity and disability. Secondary outcomes: perception of recovery, postural balance, and quality of life. Concurrently, a cost-effectiveness study will be conducted comparing the Pilates vs Home-Based Exercise, from the perspectives of public healthcare and society. In the first perspective, only costs incurred by the public healthcare system will be included (direct costs related to consultations, medications, tests, hospitalizations, and professional fees). In the second perspective, private health care expenses, costs incurred by patients (transportation and support by caregivers, when applicable), as well as indirect costs (missed workdays and loss of productivity) will be included. The incremental cost-effectiveness ratios for the primary outcomes and cost-utility ratios will be calculated for both perspectives. The cost-utility ratio will express the incremental costs per quality-adjusted life year (QALY). In addition, the absolute and incremental net monetary benefit will be calculated. Sensitivity analyses will be conducted. Data normality assumptions will be evaluated using the Shapiro Wilk test. If confirmed, a mixed model will be used, for the comparisons between groups and moments. It is hypothesized that the Pilates will be more cost-effective compared to the home-based exercise program. |