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NCT00488735 | ALL | ADULT | Back Pain|Neck Pain | BEHAVIORAL: Cognitive-behavioral rehabilitation|BEHAVIORAL: Traditional primary care | Return-to-work=the proportion of patients who during 1-18 months regained a degree of work ability>0 for at least 30 days in succession., 18 months. | BACKGROUND
Non-specific back and neck pain (BNP) dominates sick-listing. A program of cognitive-behavioral rehabilitation for subacute and chronic BNP was compared, with 18-month follow-up, with traditional primary care concerning sick-listing and health-care visits.
METHODS
After stratification to age (44 (years) and younger/45 and older) and subacute/chronic BNP (= full-time sick-listed 43-84/85-730 days respectively), 125 primary-care patients were randomized to a rehabilitation center or continued health-center care. Outcome measures were Return-to-work (=the proportion who regained work ability for at least 30 consecutive days), the proportion with Work ability at different time points, Total sick-listing (expressed in whole days) and the total number of Visits (to physicians, physiotherapists etc.) 1-18 months and corresponding six-month periods. For the analyses were used t-test, z-test, generalized estimating equations and a mixed, linear model. |
NCT02460198 | ALL | ADULT, OLDER_ADULT | Colorectal Carcinoma | BIOLOGICAL: Pembrolizumab | Objective Response Rate (ORR) - Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) Assessed by Central Imaging Vendor, Objective response rate was defined as the percentage of the participants in the analysis population who had a complete response (CR) or partial response (PR). Complete Response: disappearance of all target lesions. Partial Response: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Responses were based upon blinded central imaging vendor per RECIST 1.1. The point estimate and 95% confidence interval for the ORR, were provided using an exact binomial distribution (Clopper and Pearson method). Participants without response data were counted as nonresponders. The data cutoff date was 09-SEPT-2019., Up to approximately 48 months | In this study, participants with previously-treated locally-advanced unresectable or metastatic mismatched repair (MMR) deficient or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) will be treated with pembrolizumab (MK-3475, KEYTRUDA®) monotherapy.
There will be two cohorts in this study: Cohort A and Cohort B. For Cohort A, participants are required to have been previously treated with standard therapies, which must include fluoropyrimidine, oxaliplatin, and irinotecan. Enrollment into Cohort A has been completed. For Cohort B, participants are required to have been previously treated with at least one line of systemic standard of care therapy: fluoropyrimidine + oxaliplatin or fluoropyrimidine + irinotecan +/ - anti-vascular endothelial growth factor (VEGF)/ epidermal growth factor regulator (EGFR) monoclonal antibody.
The primary hypothesis is that Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor in participants with locally advanced unresectable or metastatic MMR deficient or MSI high CRC is greater than 15%. |
NCT00067522 | ALL | CHILD, ADULT | Pregnancy|HIV Infections | BEHAVIORAL: User-independent contraception program|BEHAVIORAL: Future Planning Perspectives program | pregnancy | Prevention of unplanned pregnancies among HIV infected couples decreases the rate of maternal-child virus transmission and the number of children orphaned when parents die of AIDS. This study will evaluate two programs for reducing the number of unplanned pregnancies among HIV infected couples in Zambia. |
NCT00608764 | ALL | ADULT, OLDER_ADULT | Pulmonary Disease, Chronic Obstructive|Emphysema|Bronchitis, Chronic | null | Forced expiratory volume in 1 second (FEV1), Measured at baseline|Emphysema, as shown on chest CT scan, Measured at baseline|Airway wall thickness on chest CT scan, Measured at baseline|COPD status (COPD participants versus control group participants), Measured at baseline | Chronic obstructive pulmonary disease (COPD) is a long-term lung disease that is often caused by cigarette smoking. The purpose of this study is to evaluate whether certain genetic factors predispose some smokers to develop COPD more than others. |
NCT00950326 | ALL | ADULT, OLDER_ADULT | Osteoarthritis of the Hip or Knee | PROCEDURE: Physiotherapy|PROCEDURE: Affusion|PROCEDURE: Affusion/ Physiotherapy | The primary outcome measure will be the pain intensity of the affected joint during inpatient care, as assessed by the patient and the investigator, 2 Years | The study design consists of a prospective randomised controlled three-armed clinical trial, which will be carried out at a specialist clinic for integrative medicine, to investigate the clinical effects of hydrotherapy on osteoarthritis of the knee or hip joint, in comparison with conventional physiotherapy. |
NCT00671099 | ALL | ADULT, OLDER_ADULT | Trauma|Posttraumatic Stress Disorder | DIETARY_SUPPLEMENT: Omega-3 Polyunsaturated Fatty Acid|DIETARY_SUPPLEMENT: Placebo | Total score of Clinician-Administrated PTSD Scale, Three month | The purpose of this study is to evaluate efficacy and safety of Polyunsaturated Fatty Acid for the prevention of Posttraumatic Stress Disorder (PTSD) in patients with accidental injuries. |
NCT01554358 | FEMALE | ADULT | Gestational Diabetes Mellitus (GDM) | BEHAVIORAL: Lifestyle intervention | incident type 2 diabetes, during 4-year follow-up|Cardiovascular risk factors, Patients with newly diagnosed diabetes in Aim 3, 9 month|cardimetablic risk, Children in Aim 4, During 4-year follow-up | A total of 1,180 women diagnosed with Gestational Diabetes Mellitus (GDM) from 2005 to 2009 and their children have and continues to be randomly assigned to either the intervention group or the control group. A total of 83 women with prior GDM and newly diagnosed diabetes at baseline survey have the nine-month lifestyle intervention program. GDM women in the intervention group will have five consulting sessions with a dietician during the first year and two sessions during the second year. The intervention group are given detailed advice about how to achieve the five goals of the intervention. The primary aim will test whether lifestyle intervention can reduce incident Type 2 Diabetes (T2D) in women with prior GDM. The second aim will test gene-intervention interactions through fine-mapping established genes for glucose, IR, lipids, obesity and T2D in relation to metabolic traits for T2D in GDM women. The third aim will evaluate the effects of the nine-month lifestyle intervention program on cardiovascular risk factors in women with prior GDM and newly diagnosed diabetes. The forth aim will assess if a lifestyle intervention targeting both GDM mothers and their offspring can greatly improve offspring's cardimetablic risk (body weight, glucose and lipid metabolism). |
NCT02081846 | ALL | CHILD, ADULT | Focus: Hospitalized Patients | OTHER: Nurse Home Visit|OTHER: Standard of Care | Number of Participants With Any Occurrence of Unplanned Re-hospitalization and/or Any Emergency/Urgent Care Visits Within 30 Days of Hospital Discharge, The dependent variable will be a dichotomized indicator of any occurrence of unplanned rehospitalization and/or any emergency department/urgent care visit within 30-days post-discharge (i.e. unplanned reutilization). Differences in this outcome between intervention and control groups will be evaluated using logistic regression with the stratification variables (neighborhood poverty and complex versus noncomplex teams) included in the model., 30 days post-discharge | Home Nurse Visit post discharge. |
NCT00228956 | FEMALE | ADULT, OLDER_ADULT | Breast Cancer | DRUG: pharmacodynamic analysis | null | You are invited to participate in a research study looking at metabolism (breakdown) and effects of aromatase inhibitors. The purpose of this research is to try to identify which women who take an aromatase inhibitor are more likely to have certain benefits or side effects from the drug. We will do so by determining whether there are differences that normally occur in genes that you have inherited from your parents that might influence the way individuals respond to medications. If you agree to participate in this study, you will be asked to sign this informed consent form. |
NCT02239198 | ALL | ADULT, OLDER_ADULT | Cardiovascular Disease Prevention | OTHER: Nutrition bar | High density lipoprotein, 1 year | There are prevalent micronutrient and fiber deficiencies in a significant proportion of US population, particularly among the overweight or obese. Intensive lifestyle counseling results in modest, measurable dietary improvements and weight stabilization, yet falls short of restoring optimal nutritional status and metabolism. A carefully formulated nutritional supplement bar (referred to as the CHORIBAR) delivered in a whole food matrix may correct micronutrient deficiencies in overweight or obese adults and children. This may have a beneficial impact on traditional indices of insulin dysregulation and the metabolic syndrome, gut inflammation, redox status, immune function and DNA integrity, and may favorably influence weight change and fat distribution.
The investigators believe that the improvements seen with CHORIBAR trials will be mediated at the level of generalized enhancement in cellular metabolism that are not readily achieved with lifestyle counseling alone. The investigators suspect this is due to many nutritional barriers, some of which are disproportionately borne by inner city populations, such as cost and access to healthy food. The investigators hypothesize that a nutritional supplement like the CHORIBAR will facilitate restoration of optimal nutritional status and improve metabolic and weight outcomes. |
NCT01732822 | ALL | ADULT, OLDER_ADULT | Peripheral Artery Disease | DRUG: Ticagrelor|DRUG: Clopidogrel | Composite of Cardiovascular (CV) Death/MI/Ischemic Stroke, Participants with CV death, myocardial infarction (MI) or ischemic stroke. If no event, censoring occurs at the minimum of (primary analysis censoring date (PACD), last endpoint assessment date, non-CV death date), From randomization to PACD, an average of 2.5 years | The purpose of this study is to compare the effects of ticagrelor and clopidogrel in patients with Peripheral Artery Disease. |
NCT03884660 | ALL | ADULT, OLDER_ADULT | Central Sleep Apnea | DEVICE: remede System | Evaluate safety of the remedē System at implant and protocol required follow up by assessment of serious adverse events (SAEs) related to procedure, device, or delivered therapy, Proportion of subjects with peri-operative and long-term serious adverse events (SAEs) related to the remedē System implant procedure, device or delivered therapy, 5 years|Evaluate changes in sleep disordered breathing metrics after 12 months of therapy, Change from baseline to 12-month visit for the following sleep metrics measured during in-lab polysomnogram (PSG): apnea hypopnea index (AHI), central apnea index (CAI), oxygen desaturation index 4% (ODI4) and percent of sleep with oxygen saturation \<90%, 12 months | The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting. |
NCT02311699 | ALL | ADULT | HIV | BEHAVIORAL: Intervention to reduce IPV and HIV | Experience of physical violence by an intimate partner in the previous 12 months (among married or co-habitating women), 12 months|Experience of sexual violence by an intimate partner in the previous 12 months (among married or co-habitating women), 12 months | Violence against women (VAW), the most extreme manifestation of the unequal power balance between women and men, is a major global public health concern. One of the most common forms of VAW is that perpetrated by a husband or other intimate partner. In Ethiopia, 70.9% of women reported having experienced physical and/or sexual intimate partner violence (IPV) in their lifetime, demonstrating the pervasiveness of the problem. A growing body of evidence has also linked IPV and HIV risk.
This study is a cluster randomized controlled trial assessing the impact of a community-based intervention focused on Intimate Partner Violence and HIV delivered in the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion and conflict resolution. Villages will be randomly assigned to one of 4 study arms (3 intervention and one control arm): 1) Women only participate in the intervention, 2) Men only participate, 3) Both men and women (couples) participate, 4) Women and men receive the control intervention comprising a short informational session on violence reduction. |
NCT01856205 | ALL | CHILD | Japanese Encephalitis | DRUG: Intravenous immunoglobulin [ImmunoRel™ (batch 20081217)] | Evidence of side effects of study drug such as infusion site reaction, diarrhea, rise in blood pressure and change in urinary output, Patients will be monitored for side effects such as infusion site reaction, diarrhea, rise in blood pressure (in mm Hg) and change in urinary output (in ml/Kg/hour) every 12 hours from first day of commencing treatment until until death or discharge. Patient on average are administered the study drug on the first day of admission. The study drug is administered daily for 5 days. Patients are discharged on an average on eighth day (192 hours) of hospital admission., Every 12 hours after administration of study drug upto discharge, which is on average eigth day (192 hours) of hospital admission | Japanese encephalitis is caused by a viral infection of the brain transmitted by the bite of an infected mosquito. Patients with Japanese encephalitis can rapidly develop worsening conscious level and seizures. Around a third will die from the infection and half of survivors have serious long-term neurological disability. The majority of those affected are children. There are many causes of viral encephalitis, however Japanese encephalitis virus is the most common cause worldwide with over 60,000 cases annually. It occurs over much of Asia and the geographical range is expanding. There is no specific treatment for Japanese encephalitis virus, although several have been trialed. In this study we examined the effect of a new treatment, called intravenous immunoglobulin, on children with Japanese encephalitis in Nepal. Prior studies have suggested intravenous immunoglobulin may neutralize Japanese encephalitis virus and suppress damaging inflammation in the brain. It has previously been used in individual cases but never examined in a randomized trial. There was recently a trial of IVIG in West Nile encephalitis in the United States, in which Professor Solomon was on the Scientific Advisory Committee. In this study we will look if intravenous immunoglobulin is safe in this context, and that this treatment may alter the way the immune system manages the infection. Therefore, in this pilot study we will test the hypothesis that IVIG can be safely given to children with suspected JE, with no increased risk of serious adverse events compared with placebo. The aim of this proposal is to conduct a pilot safety and tolerability randomized placebo controlled trial of intravenous immunoglobulin (IVIG) in patients with Japanese encephalitis, to explore the relationship between JEV viral load, pro-inflammatory markers called cytokines and blood brain barrier markers, and the effect of IVIG on these relationships. |
NCT02067468 | FEMALE | ADULT, OLDER_ADULT | Cervical Abnormalities|Cervical Intraepithelial Neoplasia Grade 2/3|Cervical Cancer | DEVICE: HPV test|PROCEDURE: COLPOSCOPY|DEVICE: cytology | Cumulative Number of Participants Diagnosed by the Community Pathologist With Cervical Intraepithelial Neoplasia Grade 2 or Higher (CIN2+): "Community-based CIN2+", Cumulative Cervical Intraepithelial Neoplasia Grade 2 or higher (CIN2+) diagnosed by the community pathologists during the two years of follow-up. The first community-based CIN2+ diagnosis was adjudicated to the participant (including the exit visit if none community-based CIN2+ during the two years of follow-up). This outcome is used for the effectiveness analysis of the three strategies., Two years since the enrolment to the exit visit (inclusive) | Cervical cancer as well cervical preneoplastic abnormalities (CIN2+) are cause by human papillomavirus (HPV) infection. These abnormalities have been historically detected by cervical cytology, but recent evidence shows that HPV testing is superior to cytology to detect cervical lesions that eventually will progress to cancer. Despite evidence, conventional cytology (Pap) remains as a primary screening test in Colombia and HPV test is recommended as a triage test for women with atypical squamous cells of undetermined significance (ASC-US) in settings around the world. Women with ASC-US have low risk to CIN2+ but higher than healthy population, and therefore it is important to provide appropriate clinical management. However, there is no consensus of how to deal women with ASC-US and therefore there are still three strategies for this purpose: 1) immediate colposcopy, 2) repeat conventional cytology at 6 and 12 months and 3) HPV testing. The main objective of this study is to compare the effectiveness and the efficient among the strategies as well as to evaluate the acceptability of the HPV testing in a real-life setting. |
NCT01814683 | ALL | CHILD, ADULT, OLDER_ADULT | Uncomplicated Vivax Malaria | DRUG: Primaquine|DRUG: Primaquine|DRUG: Placebo | Incidence rate (per person-year) of symptomatic recurrent P. vivax, The incidence rate (i.e. per person-year) of symptomatic recurrent P. vivax parasitaemia (detected by microscopy) over 12 months of follow-up in the 7 versus 14-day primaquine groups for all sites combined and stratified by site., 12 months | The main determinant of primaquine efficacy is the total dose of primaquine administered, rather than the dosing schedule. Previous trials have demonstrated that the standard low dose regimen of primaquine (3.5 mg/kg total) fails to prevent relapses in many different endemic locations. For this reason the 2010 WHO antimalarial guidelines now recommend a high dose regimen of 7 mg/kg (equivalent to an adult dose of 30mg per day), although many countries still recommend lower doses for fear of causing more serious harm to unscreened G6PDd patients.
Shorter courses of higher daily doses of primaquine have the potential to improve adherence and thus effectiveness without compromising efficacy. Primaquine also has relatively weak but clinically relevant asexual stage activity against P. vivax so larger daily doses may substantially augment chloroquine's blood stage activity at low levels of resistance. In Thailand directly observed primaquine (1mg/kg/day) administered over 7 days was well tolerated and reduced relapses by day 28 to 4%. This is encouraging but not definitive since many relapses present after one month. Longer follow-up is needed to distinguish whether relapse was prevented or deferred. If the efficacy, tolerability and safety of short-course, high-dose primaquine regimens can be assured across the range of endemic settings, along with reliable point-of-care G6PDd diagnostics, then this new primaquine regimen would be a major advance in malaria treatment improving adherence to and thus the effectiveness of anti-relapse therapy.
Due to the long duration of standard primaquine treatment regimens, courses are difficult to supervise, are poorly adhered to and lack effectiveness. This proposed multicentre randomised clinical trial will provide evidence across a variety of endemic settings on the safety and efficacy of high dose-short course primaquine in G6PD normal patients. In a parallel single arm study the investigators will also gather safety data on the use of weekly primaquine in patients with G6PDd. This study aims to generate evidence that will directly inform global public health policy for the radical cure of P. vivax. A better understanding of the risks and benefits of primaquine is crucial in persuading policy makers and clinicians of the importance of the radical cure of vivax malaria that will reduce the parasite reservoir and decrease transmission.
The funder is Medical Research Council, UK. Grant number: MRC Reference: MR/K007424/1 |
NCT01612520 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes Mellitus|Telenursing | BEHAVIORAL: telecoaching | the absolute change in HbA1c, baseline; 6 months and 18 months | The objective of the study is to analyze the effectiveness and the cost-effectiveness of telecoching in improving glyceamic control and other modifiable risk factors in patients with type 2 diabetes compared to usual care only. |
NCT02693535 | ALL | CHILD, ADULT, OLDER_ADULT | Lymphoma, Non-Hodgkin|Multiple Myeloma|Advanced Solid Tumors | DRUG: Palbociclib|DRUG: Sunitinib|DRUG: Temsirolimus|DRUG: Trastuzumab and Pertuzumab|DRUG: Vemurafenib and Cobimetinib|DRUG: Regorafenib|DRUG: Olaparib|DRUG: Pembrolizumab|DRUG: Nivolumab and Ipilimumab|DRUG: Abemaciclib|DRUG: Talazoparib|DRUG: Atezolizumab and PHESGO|DRUG: Atezolizumab and Talazoparib|DRUG: Entrectinib|DRUG: Larotrectinib|DRUG: Tucatinib plus Trastuzumab Subcutaneous (SC)|DRUG: Futibatinib | Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria, Each cohort includes participants with the same tumor type, genomic variant and study drug. For solid tumors, the Response Evaluation Criteria for Solid Tumors (RECIST) criteria will be used, for non-Hodgkin Lymphoma, the Lugano Criteria will be used, and for multiple myeloma, the International Uniform Response Criteria for Multiple Myeloma will be used., Assessed at 16 weeks of treatment | The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
NOTE: Due to character limits, the arms section does NOT include all TAPUR Study relevant biomarkers. For additional information, contact TAPUR@asco.org, or if a patient, your nearest participating TAPUR site (see participating centers).
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Results in publication or poster presentation format are posted as they become available for individual cohorts at www.tapur.org/news. The results may be accessed at any time. All results will be made available on clinicaltrials.gov at the end of the study. Indexing of available results on PubMed is in progress.
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NCT01173718 | ALL | ADULT, OLDER_ADULT | End Stage Renal Disease | DEVICE: GORE® ACUSEAL Vascular Graft | Cumulative Patency at 6 Months, Percentage of subjects free from loss of access for hemodialysis at the study access site, assessed at 6 month., 6 Months|Freedom From Bleeding at 6 Months, Percentage of subjects free from both major and minor bleeding events, assessed at 6-months, 6 Months | This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving or expected to require hemodialysis through a prosthetic vascular graft within 30 days. Gore proposes to demonstrate that the 6 month cumulative patency of the GORE® ACUSEAL Vascular Graft is similar to that of other arteriovenous grafts (AVGs). \> \>\>
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\>\> A total of 138 Subjects will be enrolled. Once the study procedure has been successfully completed, cannulation may occur at any time at the Investigator's discretion. \>
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\>\> Subjects will be selected from up to 20 Investigational Sites. |
NCT01849926 | FEMALE | ADULT | Acute Cystitis (Excl in Pregnancy) | DRUG: Ibuprofen|DRUG: Mecillinam | Number of patients who are symptom free by day four, Both symptom load with regard to specific symptoms and when feeling completely symptom free will be registered in the patient diary., Four days | Although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. Antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days. The aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women. Our main objective is to see whether symptomatic treatment with ibuprofen is equally efficient as treatment with mecillinam in this group. |
NCT04697147 | ALL | CHILD | Zika Virus Infection|Neurocognitive Deficit|Development, Child|Neurodevelopmental Abnormality | BEHAVIORAL: Conscious Discipline-Based Environmental Enrichment Intervention | The INTERGROWTH 21st Neurodevelopmental Assessment (INTER-NDA), The INTER-NDA is a measure of cognition, motor skills (fine and gross motor), language (expressive and receptive), behavior, executive function, attention and social-emotional reactivity for 2-year-olds. The measure is comprised of 30 items scored across a spectrum, with higher scores indicating better outcomes., 22-30 months | Implement a randomized controlled trial, evidence-based, culturally adapted, environmental enrichment intervention for the purpose of enhancing neurocognitive outcomes among Zika Exposed Children. |
NCT03057795 | ALL | ADULT, OLDER_ADULT | Classic Hodgkin Lymphoma|Recurrent Hodgkin Lymphoma|Refractory Hodgkin Lymphoma | DRUG: Brentuximab Vedotin|OTHER: Laboratory Biomarker Analysis|BIOLOGICAL: Nivolumab | Progression-free Survival at 18 Months, Progression-free survival will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error. When there is no censoring in progression-free survival prior to 18 months after the first dose of study treatment, the observed 18-month progression-free survival will be compared to the baseline of 65% by one-sided exact test of binomial proportion. In case of censoring in progression-free survival prior to 18 months after the first dose of study treatment, the Kaplan-Meier estimate for 18-month progression-free survival along with the Greenwood standard error estimator will be used for the testing of null hypothesis at 65%. Hodgkin Lymphoma(HL) response/progression was evaluated using 2014 Lugano Classification \[Cheson, Journal of Clinical Oncology 2014 Sep 20;32(27):3059-68\]., From the first dose of study treatment to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed at 18 months. | This phase II trial studies how well nivolumab and brentuximab vedotin work after stem cell transplant in treating patients with high-risk classical Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as nivolumab and brentuximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. |
NCT02272426 | ALL | ADULT, OLDER_ADULT | Cerebral Stroke | BEHAVIORAL: CARET|BEHAVIORAL: CTI|BEHAVIORAL: Sham CARET|BEHAVIORAL: Sham CTI | Number of participants with treatment emergent serious adverse events, To assess the number of participants with serious adverse events related to the interventions, comparing active groups versus the sham group., At 12 weeks visit (post-intervention)|Adherence to a 12-week combined exercise and cognitive training protocol versus a sham group, To assess participant adherence in the intervention group versus the sham group, comparing time on study., At 12 weeks visit (post-intervention) | It is estimated that 2 out of 3 patients with a stroke have some problems with their memory, difficulties performing certain tasks, making decisions and learning new things. In addition, many stroke patients do not get regular exercise and are often sedentary. Both physical and cognitive exercise have the potential to improve quality of life, cognition, and overall health, but the safety and tolerability of such interventions is not clear in stroke patients. The investigators will examine these outcomes by allocating stroke survivor participants to one of two groups: a combined exercise and cognitive training program and a sham control group. |
NCT01022580 | ALL | CHILD | Bronchopulmonary Dysplasia | DRUG: Infasurf surfactant (ONY, Inc.)|DRUG: Sham (No Treatment) | Survival Without BPD at 36 Weeks Post Menstrual Age., BPD was diagnosed as need for respiratory support with either positive pressure and/or oxygen as evaluated by physiological oxygen/flow reduction., 36 weeks post menstrual age +/- 1 week | The purpose of this study is to determine if late doses of Infasurf surfactant given when patients are receiving inhaled nitric oxide will interact to improve surfactant function and increase survival without BPD in treated infants. |
NCT02776176 | ALL | CHILD | Hirschsprung Disease | PROCEDURE: Enhanced Recovery After Surgery Program|PROCEDURE: Traditional Program | median length of postoperative hospital day, 30days | The study is designed to determine if enhanced recovery after surgery (ERAS) principles could provide benefit for pediatric patients undergoing radical surgery for Hirschsprung's Disease (HD). Half of patients will receive the ERAS program, while the other half will receive the traditional program. |
NCT02480855 | ALL | ADULT | Occupation-related Stress Disorder | OTHER: Questionnaire and feedback | Number of sick-leave days., Differences in number of sick-leave days between intervention group and control group., 12 months after inclusion|Number of periods of sick-leave, full-time or part-time., Differences in number of sick-leave periods, full-time or part-time between intervention group and control group., 12 months after inclusion | A vital question for society in general and primary health care in particular is early identification of persons at risk of sickness absence due to work-related stress. Even though both the individual and society can gain a lot from the prevention of absence, not the least since return to work is costly once a person is sick-listed. There is, surprisingly enough, no established method to do this. This project is a randomized controlled study of people with mental disorders and physical complaints consulting primary care. The purpose is to evaluate if a systematic use of early identification of work-related stress, combined with feedback at consultation, at the primary health care centers can prevent sickness absence among employed women and men with common mental disorders and subjective physical health complaints. |
NCT02959658 | ALL | ADULT, OLDER_ADULT | Primary Progressive Multiple Sclerosis | DRUG: Dimethyl fumarate|DRUG: Placebo | Neurofilament light chain in the cerebrospinal fluid (CSF), CSF Neurofilament Light Chain (NFL) is measured twice over a course of 48 weeks. Patients will have a spinal tap performed at baseline and again at week 48., 0-48 weeks | This study aims to evaluate safety and efficacy of dimethyl fumarate treatment in patients with primary progressive multiple sclerosis (PPMS).
Half of the patients will receive dimethyl fumarate and the other half will receive placebo. |
NCT03141073 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Type 2 | DRUG: HMS5552|DRUG: Placebo | Change from baseline in HbA1c, The change of HbA1c from baseline by comparing HMS5552 75 mg BID in combination with Metformin with Placebo BID in combination with Metformin in T2DM subjects after 24-week double-blind treatment, 24 weeks | This study evaluates the efficacy and safety and population PK of HMS5552 add-on to Metformin in adult type 2 diabetic subjects. There will be 2 groups in the first 24 weeks, one group will receive HMS5552 plus Metformin, while the other group will receive placebo plus Metformin; after 24 weeks, all subjects will receive HMS5552 plus Metformin for 28 weeks. |
NCT02507986 | ALL | ADULT, OLDER_ADULT | Atrial Fibrillation|Ischemic Stroke|Transient Ischemic Attack | DEVICE: Single lead ECG device|DEVICE: 7-Day Holter monitor. | Percentage of detected atrial fibrillation, 1 year of follow-up | The main objective of this study is to compare the incidence of detected atrial fibrillation (AF) in cryptogenic stroke patients by a single lead ECG device with the incidence of detected AF by a 7-Day Holter ECG. |
NCT02436655 | ALL | ADULT, OLDER_ADULT | Aortic Stenosis | PROCEDURE: surgical aortic valve replacement | all cause death, Major Adverse Cardiac Event (MACE) including: ( Acute Myocardial Infarction - AMI, Stroke - CVI, unplanned hospitalization for Heart failure (HF) needing intravenous treatment, 36 months|all cause death, Major Adverse Cardiac Event (MACE) including: ( Acute Myocardial Infarction - AMI, Stroke - CVI, unplanned hospitalization for Heart failure (HF) needing intravenous treatment, 5 years | Whether to intervene in asymptomatic patients with severe aortic stenosis and normal left ventricular ejection fraction remains controversial. The investigators therefore try to compare clinical outcomes of elective aortic valve replacement to conventional treatment and watchful waiting strategy in a prospective randomized trial. |
NCT02957058 | ALL | ADULT, OLDER_ADULT | Colonic Adenoma|Colonic Polyp | PROCEDURE: SCAR technique | Adenoma recurrence, Recurrence of adenoma at first and second surveillance colonoscopy, Variable dependent on SERT score | To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with thermal treatment applied to the defect margin. The primary aim of the study will be to ensure the safety of this approach and there will be constant monitoring to ensure that this is the case. |
NCT02519309 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Type 2|Pre-diabetes|Metabolic Syndrome | OTHER: Virta Program | Change from Baseline Type-2 Diabetes Status, Type-2 diabetes status will be evaluated by measuring Hemoglobin A1c (HbA1c), 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)|Change from Baseline Metabolic Syndrome Status, Metabolic syndrome status will be evaluated by standard markers. Metabolic syndrome is defined as having at least three of the following:
* Waist circumference: ≥40 inches (men) or ≥35 inches (women)
* Fasting triglycerides: ≥150 mg/dL
* HDL-C: \<40 mg/dL (men) or \<50 mg/dL (women)
* Blood pressure: ≥130/85 mm Hg or use of hypertensive medication
* Fasting glucose: ≥ 100 mg/dL or use of hyperglycemia medication, 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms)|Change from Baseline Body Weight, Body weight will be evaluated on a calibrated scale, 3 Months (intervention arms only), 12 and 24 Months (intervention and usual care arms) | The primary purpose of this research is to demonstrate the therapeutic effects of implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients with type 2 diabetes, pre-diabetes, and metabolic syndrome. |
NCT01114737 | ALL | CHILD, ADULT, OLDER_ADULT | Phenylketonuria | DRUG: Sapropterin dihydrochloride|DRUG: Placebo | Change in Attention-Deficit Hyperactivity Disorder Rating Scale-IV (ADHD-RS) / Adult ADHD Self-Report Scale (ASRS) Total Score From Baseline to Week 13, Effects of 6R-BH4 on symptoms of ADHD in PKU subjects who had symptoms of ADHD at screening in the subjects that had a blood Phe level reduction after treatment with 6R-BH4.
The total ADHD-RS score and the corrected total ARS score range from 0 to 54, with higher scores corresponding to worse severity of ADHD symptoms., Baseline to Week 13|Number of Participants With a Score of 1 or 2 in Global Function Evaluation (CGI-I) From Baseline to Week 13., Effects of 6R-BH4 on global function in PKU subjects in subjects that had a blood Phe level reduction after treatment with 6R-BH4 at screening.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse., 13 weeks | This double-blind, placebo-controlled, randomized study is designed to evaluate the safety and therapeutic effects of sapropterin dihydrochloride on neuropsychiatric symptoms in subjects with PKU. |
NCT04143802 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Type 2 | DRUG: LY3437943|DRUG: Dulaglutide|DRUG: Placebo | Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration, A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module, Baseline through Day 106 | The main purpose of this study is to learn about the side effects of LY3437943 when given to participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center. |
NCT00994292 | ALL | ADULT, OLDER_ADULT | Acute Coronary Syndrome | DRUG: YM150|DRUG: Placebo | Incidence of Major and Clinically Relevant Non Major bleeding events according to International Society of Thrombosis and Hemostasis (ISTH) definition, 6 Months | The purpose of this study is to evaluate the safety and efficacy of various doses of YM150 (the experimental drug) in the prevention of ischemic vascular events in subjects with recent acute coronary syndromes. |
NCT00164736 | ALL | CHILD, ADULT, OLDER_ADULT | HIV Infections | DRUG: Maternal zidovudine/lamivudine/lopinavir-ritonavir|DRUG: Infant nevirapine|DIETARY_SUPPLEMENT: Maternal protein and calorie supplement | Postpartum weight loss between delivery and 28 weeks, between delivery and 28 weeks|Infant HIV status at 28 weeks. (Infants found to have HIV at birth or 2 weeks after delivery will have been disenrolled.), birth to 28 weeks|Exclusive breastfeeding and breastfeeding cessation by 28 weeks, birth to 28 weeks | This is a comparative clinical trial among HIV-infected women and their infants to determine:
1. the benefit of nutritional supplementation given to women during breastfeeding
2. the benefit and safety of antiretroviral (ARV) medications given either to infants or to their mothers to prevent HIV transmission during breastfeeding
3. the feasibility of exclusive breastfeeding followed by early, rapid breastfeeding cessation |
NCT03130062 | FEMALE | ADULT, OLDER_ADULT | Primary Sjögren Syndrome | OTHER: Exercise | Change in functional fitness, The protocol consists of a sequence of 7 tests that aim to mimic the neuromotor and cardiorespiratory needs involved in the daily life activities. This battrey test was designed and validated to evaluate the elderly without a ceiling effect, ensuring that the physical aspect measured represents the maximum of the individual.
The physiological components evaluated, based on the physical abilities performed in the daily activities are: upper and lower limb strength, aerobic capacity, upper and lower limb flexibility, as well as motor agility / dynamic balance. In addition, the authors added the body mass index (BMI), to estimate the body composition., The subjects were assessed in 2 moments: before entering the resistance training program and after 16 weeks of intervention.|Change in daily motor activity index, To verify the daily movement index of the subjects we used a device called an actigraphy or actimeter., The subjects were assessed for 15 consecutive days belonging to the habitual routine of the volunteers. It was used in 2 moments: before entering the resistance training program and after 16 weeks of intervention. | To analyze the effectiveness of 16-week resistance exercise in daily motor behavior and functional fitness in women with Primary Sjögren's Syndrome. The present study presents as hypothesis that a supervised resistance exercise program is effective and safe in improving the functional fitness and quality of life of patients with Primary Sjögren's Syndrome, making them more physically active, contributing positively to the capacity to perform daily life activities as household and / or professional tasks. |
NCT00853957 | ALL | ADULT, OLDER_ADULT | Hypertension | DRUG: Aliskiren/Amlodipine|DRUG: Amlodipine | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP), To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension., Baseline, 8 weeks | The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension. |
NCT02979964 | ALL | CHILD, ADULT, OLDER_ADULT | High-risk Prescribing in Nursing Homes | BEHAVIORAL: Audit and Feedback | CNS-active medication prescribing, monthly number of CNS-active medications per resident (antipsychotics, opioids, benzodiazepines or antidepressants (including TCAs and trazodone)), 6 months | Health Quality Ontario (HQO) is the provincial advisor on quality in health care. HQO currently conducts audit and feedback as a key quality improvement strategy. For example, it offers physicians working in long-term care homes with access to practice reports detailing rates of high-risk prescribing in comparison with others in Ontario and suggested change ideas. Research shows that providing this kind of feedback can lead to improvements in care. However, the size of these improvements depends how the feedback is presented. For instance, prior research suggests that how the results are 'framed' and what sort of benchmark the recipient is compared to may each affect how the physician will respond. This factorial trial tests each of these aspects of feedback design in the context of practice reports that nursing home physicians have already signed up to receive quarterly. |
NCT00512473 | MALE | ADULT | Intracellular Signaling Peptides and Proteins | DRUG: Saline infusion|DRUG: Human Growth Hormone|DRUG: Pegvisomant | GH-receptor signaling, hours | Objective: GH induces insulin resistance in muscle and fat and in vitro data indicate that this may involve crosstalk between the signaling pathways of the two hormones.
Aim: To investigate GH and insulin signaling in vivo in human muscle and fat tissue in response to GH, GH receptor blockade and insulin stimulation.. |
NCT01688778 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes|Poor Glycemic Control|Medication Adherence | BEHAVIORAL: Telemedicine | Changes in HbA1c, Baseline, 16 weeks, 32 weeks, 6 months after intervention | The aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine. |
NCT01380808 | FEMALE | ADULT, OLDER_ADULT | Metastatic Breast Cancer | DRUG: capecitabine and pseudomonas aeruginosa combination | progression free survival, 1 year | The progression free survival could be prolonged adding pseudomonas aeruginosa to monotherapy capecitabine. |
NCT00210925 | ALL | ADULT, OLDER_ADULT | Alcoholism | DRUG: topiramate | The change in percentage of heavy drinking days (5 or more standard drinking units per day for men and 4 or more standard drinking units per day for women) from baseline at 12 weeks or final visit. | The purpose of this study is to evaluate the safety and effectiveness of topiramate compared to placebo in patients with alcohol dependence. |
NCT01444430 | ALL | CHILD, ADULT, OLDER_ADULT | Asthma | DRUG: Symbicort pMDI|DRUG: budesonide pMDI | Number of Participants Experiencing an Event in the Composite Endpoint (Asthma-related Death, Asthma-related Intubation or Asthma-related Hospitalization), Number of participants experiencing an event in the composite endpoint (asthma-related death, asthma-related intubation or asthma-related hospitalization), using events adjudicated and confirmed by the Joint Adjudication Committee. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated., Up to 27 weeks|Number of Participants Experiencing an Event Included in the Definition of Asthma Exacerbation, Number of participants experiencing an event included in the definition of asthma exacerbation. An asthma exacerbation was defined as a deterioration of asthma requiring systemic corticosteroids for at least 3 days or an inpatient hospitalization or emergency room visit due to asthma that required systemic corticosteroids. Cox proportional hazards model with terms for randomized treatment and strata for incoming control/asthma treatment was used to compare Symbicort and budesonide. Hazard ratios and 95% confidence intervals were estimated., Up to 26 weeks | The purpose of the study is to evaluate the safety of Symbicort compared to inhaled corticosteroid alone during 6 months in adult and adolescent patients with asthma |
NCT03519685 | FEMALE | ADULT | Contraception | BEHAVIORAL: Contraceptive Training and Education|BEHAVIORAL: Placebo Nutrition Education | Change in student knowledge of full range of contraceptive methods (questionnaire), The outcome is measured by whether student knows of reversible methods including male condom, female condom, oral contraceptive pill, transdermal patch, vaginal ring, Depo-provera injectable, intrauterine device, subdermal implant, and emergency contraception., Baseline, immediate post educational intervention session | The purpose of this study is to measure whether a training and education intervention for clinic staff and young women aged 18-25 on contraceptive methods, including intrauterine devices (IUDs) and the implant, will result in greater contraceptive knowledge and access among students in community colleges. |
NCT00571844 | ALL | ADULT, OLDER_ADULT | Hypertension | BEHAVIORAL: DASH diet|BEHAVIORAL: DASH diet plus Weight loss | Blood pressure, 4 months | This study is an NIH-funded clinical trial conducted at Duke Medical Center evaluating the effects of the DASH diet alone and combined with a behavioral weight loss program on blood pressure and various vascular measures. Eligible patients must be unmedicated with blood pressure values ranging from approximately 130/85 to 159/99. Our primary hypothesis are as follows: (1) The DASH diet alone and combined with a behavioral weight management program will result in greater BP reductions than Usual Care controls at the end of the 4 month treatment period; (2) The DASH diet in combination with a behavioral weight management program will be more effective in lowering BP than the DASH diet alone; (3) The DASH diet alone and the DASH diet combined with the behavioral weight management program will result in greater improvements in cardiac, metabolic, and vascular function compared to the control condition; and (4) The combined DASH diet and weight management intervention also will be the most effective treatment in maintaining BP reductions at 1-year follow-up. |
NCT02079103 | ALL | ADULT, OLDER_ADULT | Stroke | DEVICE: Virtual Reality|BEHAVIORAL: Conventional arm training | Change in Action Research Arm Test score from baseline, Assessment of changes in arm motor function from baseline to 3 months follow up, Baseline, after 4 weeks and at 3 months follow-up | Background: High intensity training of challenging tasks with many repetitions is a key factor for regaining motor function after stroke. Novel virtual reality (VR) rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of VR systems has not been demonstrated yet in sufficiently powered studies.
Methods: In 5 participating rehabilitation centers patients in the subacute phase after stroke will be randomized to either a group receiving 4 weeks of VR training in addition to conventional arm training or a group receiving dose-matched and therapist attention-matched conventional arm-training.
Hypothesis: VR training is more effective in improving arm motor function than conventional arm training in the subacute phase after stroke. |
NCT02129595 | MALE | ADULT, OLDER_ADULT | Pre-diabetes | DIETARY_SUPPLEMENT: placebo|DIETARY_SUPPLEMENT: resveratrol | insulin sensitivity: overall, muscle- and liver specific, Hyperinsulinemic euglycemic clamp combined with indirect calorimetry: Glucose infusion rate (GIR), rate of appearance and disappearance of glucose (Ra, Rd), endogenous glucose production (EGP), oxidative and non-oxidative glucose disposal, carbohydrate and lipid oxidation, energy expenditure., 30 days after supplementation | The main objective of the study is to investigate if resveratrol supplementation can improve overall and muscle-specific insulin sensitivity in first-degree relatives of type 2 diabetic patients.
As a secondary objective the investigators want to investigate whether the improved insulin sensitivity can be attributed to improved muscle mitochondrial oxidative capacity and a reduced intrahepatic and cardiac lipid content. Furthermore, in a subset of the participants the investigators want to investigate the effect of resveratrol on glucose uptake in brown adipose tissue. |
NCT02394119 | ALL | CHILD, ADULT | Nephrotic Syndrome | DRUG: Ofatumumab|DRUG: Rituximab | Risk of relapse, The primary endpoints will be risk of relapse at 12 months without steroid or calcineurin-inhibitors. Relapse is defined by uPCR ≥2000 mg/g (≥ 200 mg/mmol) or \> 3+ protein on urine dipstick for 3 consecutive days (KDIGO Clinical Practice Guideline for Glomerulonephritis, Kidney International Supplement, 2012 2, 163-171)., 12 months | Open-label, two-parallel-arm, controlled randomized clinical trial testing the superiority of Ofatumumab over Rituximab in maintaining steroid- and calcineurin-inhibitor-free disease remission in SD-INS.
Eligible participants will enter a 1-month run-in period, during which instruction on urine collection and dipstick readings will be carefully reviewed, compliance assessed, and therapy with RAS inhibitors withdrawn and, in hypertensive children replaced by other anti-hypertensive drug.
After run-in period, children will be randomized to either the intervention arm (Ofatumumab) or the comparator arm (Rituximab).
After infusion of intervention or comparator, steroids will be maintained at initial dose for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.
One week after the steroid withdrawal calcineurin inhibitors will be decreased by 50% and withdrawn within 2 additional weeks.
All patients will be followed for up to 24 months. In case of relapses during the study (see outcome section for definition) patients will be treated with 60 mg/m2of prednisone p.o. in order to achieve remission. At remission, patients will be treated with another infusion of either Oftumumab or Rituximab, according to the initial randomization.
After infusion of intervention or comparator, steroids will be maintained at initial dose for 30 days and then tapered off by 0.3 mg/kg per week until complete withdrawal.
One week after the steroid withdrawal calcineurin-inhibitors will be decreased by 50% and withdrawn within 2 additional weeks. This strategy will be repeated to treat full relapses during the study. |
NCT00232180 | ALL | ADULT, OLDER_ADULT | Heart Failure | DRUG: Eplerenone | Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated): Up to Cut-off Date, CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator., Baseline (30 March 2006) up to 50 months (cut-off date: 25 May 2010)|Number of Participants With First Occurrence of Cardiovascular (CV) Mortality or Hospitalization Due to Heart Failure (HF) (Adjudicated), CV mortality is defined as death due to heart failure, myocardial infarction, cardiac arrhythmia, stroke or cerebral vascular accident (CVA), other CV cause (such as aneurysm or pulmonary embolism). Hospitalization due to HF is defined as an overnight stay, or longer, in a hospital environment (emergency room, observation unit or in-patient care, or similar facility including admission to a day care facility) due to HF as the primary reason for hospitalization as determined by the endpoint committee adjudicator., Baseline (30 March 2006) up to 59.5 months (complete DB phase: 18 March 2011) | In an earlier study, eplerenone was shown to improve survival in patients who had heart failure immediately following a heart attack. However, it is not known how patients with established mild-to-moderate heart failure (NYHA Class II), who have the additional risk of sudden death, will respond if treated with eplerenone. In this trial, eplerenone plus standard heart failure medicines is being compared to placebo plus standard heart failure medicines in terms of an additional ability to prolong life and prevent re-hospitalizations for worsening heart failure in these patients.
The Data Safety Monitoring Committee (DSMC) observed during its conduct of the protocol-specified second interim analysis on the 6th of May, 2010 that the efficacy of eplerenone had met the pre-specified stopping rules in the protocol. As a result of the discussion between the DSMC and the Executive Steering Committee (ESC), the ESC recommended that EMPHASIS-HF should be terminated, Based on the convincing efficacy and the consideration that it would be unethical not to offer this treatment to patients, the ESC recommended that all the patients in the trial should be transferred to open-label eplerenone. The Open Label Extension eplerenone arm will last for 12 months. Eplerenone is not currently approved for the indication studied in this patient population.
On May 26, 2010, further enrollment into EMPHASIS-HF was stopped. The amendment is considered to be the most appropriate way to ensure that all the subjects who participated in the double-blind phase of the EMPHASIS-HF trial can be offered treatment with eplerenone |
NCT04545060 | ALL | ADULT, OLDER_ADULT | Covid19 | BIOLOGICAL: VIR-7831 (sotrovimab)|DRUG: Placebo | Number of Participants Who Had Progression of COVID-19 Through Day 29, COVID-19 progression defined as hospitalization \>24 hours or death, Through Day 29 | This is a phase 2/3 study in which subjects with coronavirus disease 2019 (COVID-19) will receive VIR-7831 or placebo and will be assessed for safety, tolerability, efficacy, and pharmacokinetics. |
NCT00910689 | ALL | ADULT, OLDER_ADULT | Migraine Headache | DRUG: Propranolol or nadolol|DRUG: Placebo control|BEHAVIORAL: Behavioral Migraine Management (BMM)|DRUG: Optimal Acute Therapy | Change in Number of Migraine Episodes Per 30 Days at Month 10., Change in number of migraine episodes(with 24 hours pain free period required between episodes)per 30 days from OAT run-in (Month 1) to Month 10.Obtained from daily electronic diary., Change from Month 1 to Month 10 | The purpose of this study is to determine if the addition of preventive medication, behavior migraine management or the combination of preventive medication and behavior migraine management improves the outcome of optimal acute therapy for frequent migraines. |
NCT01619163 | ALL | OLDER_ADULT | Pain | DRUG: Placebo|DRUG: Prednisolone | Pain reduction, The primary outcome measure was pain reduction., 6 weeks | Background: Osteoarthritis (OA), a common disabling condition, is the commonest type of arthritis worldwide. Knee OA is the 4th leading cause of disability in women. Pain is the leading symptom and is often chronic in nature leading to significant morbidity and decreased quality of life. Synovitis is prevalent in knee OA and treatment to relieve this synovitis may reduce pain.
Objectives: A randomized double-blind placebo-controlled trial will be conducted to assess whether 6 weeks of daily low dose oral prednisolone will improve pain, mobility and systemic low-grade inflammation, in the short term and to determine if it sustained long term at 12 weeks in older adults with moderate to severe knee OA.
Methods: 125 community-dwelling older adults aged 65 years and above with primary knee OA diagnosed according to the ACR criteria for diagnosis of primary OA of the knee will berandomized 1:1. Sixty three will receive 7.5 mg/day of prednisolone and 62 will receive placebo together with their usual therapy for 6 weeks. The primary outcome measure will be pain reduction. Secondary outcome measures will be reduction in systemic inflammation and improvements in physical functioning scores. Alterations in dosage of analgesic/NSAID drugs used will be recorded. Safety and tolerability were also assessed. Data will be collected at baseline, 6 weeks and at 12 weeks to determine any change in results from those obtained at 6 weeks. Exclusion criteria will include any inflammatory or serious medical condition.
Knee OA will be documented by radiographic examination using the Kellgren-Lawrence scale. Symptomatic OA will be defined as the need to take NSAIDs daily and LequesneAlgofunctional Index (LFI)score \> 4. Clinical assessment will be include: Visual Analogue Pain Scale (VAS, 0-100), self-reported physical function as measured with the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), WOMAC pain and stiffness scores, and six-minute walk distance (6MWD). All patients will undergo a physical examination and will be questioned about the number of flares, pain and analgesic use. Blood samples will be collected and serum levels of IL-1, IL-6, TNF-alpha and hsCRP will be measured in all patients. |
NCT01049425 | FEMALE | ADULT, OLDER_ADULT | Primary Breast Cancer|Her2 Non-overexpressing | DRUG: Epirubicin|DRUG: Cyclophosphamide|DRUG: Docetaxel|DRUG: Cyclophosphamide|DRUG: Docetaxel | disease-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment, 5 years | The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy.
Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors. |
NCT03152188 | ALL | ADULT, OLDER_ADULT | Hepatic Encephalopathy|Cirrhosis, Liver | DRUG: FMT|OTHER: Placebo | Serious Adverse events related to FMT, Safety, 5 months | To evaluate the safety and tolerability of oral fecal transplant in patients with cirrhosis and hepatic encephalopathy |
NCT01725906 | ALL | ADULT, OLDER_ADULT | Self Efficacy | DRUG: empirical therapy|DRUG: Genotypic resistance guided therapy | Eradication rate after third line rescue therapy, Primary End Point: Eradication rate will be evaluated according to Intent-to-treat (ITT) and per-protocol (PP) analyses.
(genotypic resistance versus empirical therapy) Urea breath test will be used to determine the eradication status, 8 weeks | We aimed to compare the efficacy of genotypic resistance guided sequential therapy vs. empiric therapy in the third line therapy. Factors affecting the eradication rates, including the antibiotic resistance, CYP2C19 polymorphism, CagA and VacA status will also be assessed. |
NCT02974153 | ALL | ADULT, OLDER_ADULT | Migraine Disorders | BIOLOGICAL: ALD403 (Eptinezumab)|BIOLOGICAL: Placebo | Change From Baseline in Monthly Migraine Days, Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12, Week 1-12 | The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs. |
NCT00345371 | ALL | ADULT, OLDER_ADULT | Methamphetamine | DRUG: Topiramate|DRUG: Placebo Oral Tablet | Abstinence (Weeks 6 - 12), The number of participants who abstained from methamphetamine from weeks 6 through 12, weeks 6 through 12 | The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence. |
NCT00088478 | ALL | ADULT, OLDER_ADULT | Schizophrenia | DRUG: Intramuscular Olanzapine Depot|DRUG: Placebo | Demonstrate superiority of IM olanzapine depot 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks dosages compared with placebo in the treatment of patients with schizophrenia | Key objectives of this clinical study are to:
* Determine how well intramuscular (IM) olanzapine depot works compared to placebo
* Evaluate the safety and tolerability of IM olanzapine depot compared to placebo
* Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s). |
NCT03561675 | ALL | ADULT, OLDER_ADULT | Acute Mountain Sickness | DRUG: ACETAZOLAMIDE oral capsule|DRUG: Placebo oral capsule | Acute mountain sickness (AMS), incidence, Difference between acetazolamide and placebo group in the incidence of AMS during the stay at 3'100 m., Day 1 to 3 at 3'100m | Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing acute mountain sickness in lowlanders older than 40 years travelling from 760 m to 3'100 m. |
NCT04167254 | ALL | ADULT, OLDER_ADULT | Development, Child | BEHAVIORAL: Sit Down and Play | Parenting Behaviors that Promote Early Childhood developme, Key items from the UNICEF Multiple Indicator Cluster Surveys Early Childhood Development Module, 1 month after second immunization visit | To gather data essential to evaluate the acceptability and feasibility of a brief, health care-based program delivered in routine healthcare visits in low and low-middle income countries to promote positive parenting behaviors with the aim to support early child development. |
NCT02012803 | ALL | ADULT, OLDER_ADULT | Achilles Tendon Rupture | PROCEDURE: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture|OTHER: Conservative treatment of achilles tendon rupture | Subjective and objective results in conservative and operative treatment of Achilles tendon rupture., Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire. Objective results consists of calf muscle isokinetic strength measurements and MRI-findings., 18 months | The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.
Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol. |
NCT00514488 | ALL | ADULT, OLDER_ADULT | Chronic Myeloid Leukemia | DRUG: STI571 (400 mg/day; or 800 mg/day) | To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated high Sokal risk CML treated with imatinib at 2 different dose levels of 400 and 800 mg/daily. | This is a phase III multicenter, open-label study designed to investigate the efficacy (hematological response, cytogenetic response and molecular response) and feasibility (tolerance, compliance and safety) of the tyrosine kinase inhibitor imatinib mesylate (formerly STI 571, GLIVEC, Novartis Pharma) at conventional dose (400 mg/daily) if compared with high dose (800 mg/daily) (serial number protocol ICSG/CML/022) in patients with Ph+ chronic myeloid leukemia (CML) in chronic phase (CP) previously untreated, at high Sokal risk. |
NCT00860418 | ALL | CHILD | Asthma | BEHAVIORAL: Pediatric Asthma Alert (PAAL)|BEHAVIORAL: Standard asthma education | Number of primary care appointments kept over 12 months, 12 months | Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough.
The investigators hypothesize that:
1. Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group.
2. Children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group. |
NCT04027712 | ALL | ADULT, OLDER_ADULT | Diabetes|Clopidogrel Resistance|Amyloid|Insulin Resistance | null | mots-c predicts cardiovascular mortality in diabetic with coronary artery disease, mots-c concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality, 2 year follow up|b amyloid predicts cardiovascular mortality in diabetic with coronary artery disease, b amyloid concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality, 2 year follow up|b amyloid predicts cardiovascular mortality in diabetic with coronary artery, Resistance to clopidogrel as defined by Light Transmission Aggregometry in diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality., 2 year follow up | Increased circulating b-amyloid and decreased Mitochondrial-derived peptide (MOTS-c), a peptide improving tissue insulin sensitivity, are reported in diabetes. The investigators plan to investigate the association of both biofactors with high on-clopidogrel platelet reactivity and cardiovascular mortality in type 2 diabetic patients with Coronary artery disease |
NCT02256345 | ALL | ADULT, OLDER_ADULT | Heart Failure|Diastolic Heart Failure | DRUG: KNO3|DRUG: KCl | Change in Peak Oxygen Uptake (VO2) From Baseline Upto 1 Week of Administration for Each Dose, Peak oxygen uptake (VO2) defined as the average value obtained during the last 30 seconds of exercise., Baseline, end of week 1, end of week 2 | This study will be performed to determine the safety, tolerability, and dose-response to inorganic nitrate on exercise capacity in HFpEF. There are two primary goals for this study:
1. Determine the population-specific pharmacokinetics and dose of KNO3 that can be safely given to subjects with HFpEF.
2. Determine if there is a dose-response effect of nitrate supplementation on exercise capacity, evidenced by peak oxygen consumption (peak VO2), and physiologic adaptations to exercise. |
NCT03796923 | ALL | OLDER_ADULT | Frail Elderly Syndrome|Transitional Care|Frailty|Readmission|Aging|Elderly | OTHER: Early follow-up visit after discharge|OTHER: Comprehensive geriatric assessment (CGA)|OTHER: Continued geriatric care|OTHER: Possible follow-up visit from GP | Readmission, Readmission within 30 days after discharge, 30 days | In most Western countries the elderly population increases rapidly. In Denmark, the population of elderly aged 75 years or older may amount to nearly 15 % of the entire population in 2050 compared to 9 % today (2017). A large part of the elderly population is at high risk of hospitalization including more admissions and increased morbidity and mortality. The number of hospital beds is declining persistently, calling for shorter lengths of stay (LOS). Increasingly complex treatments now take place outside hospital. Presently, many Danish regional hospitals establish geriatric wards and other geriatric in-hospital and outpatient services to overcome these challenges. The aim of the present PhD-study is to investigate the effects of different models of transitional care among the frailest elderly patients. |
NCT02534987 | ALL | CHILD, ADULT, OLDER_ADULT | Strep Throat|Pneumonia | OTHER: iCPR2 | overall rate of antibiotic prescribing, overall rate of antibiotic prescribing for strep and pneumonia, 2 years | The study is a randomized controlled trial, with an Intervention Group and a Control Group at the University of Utah (U of U) and University of Wisconsin (UW). BU serves as the primary award and coordinating institution. The unit of randomization will be at the clinic level at each institution. UW will recruit all General Internal Medicine (GIM) Clinics and Department of Family Medicine (DFM) Clinics in Dane County as well as their East and West Urgent Care Clinics. U of U will recruit all affiliated primary care practices. The unit of randomization will be the clinic.
The study biostatistician will receive a list of clinic sites that have agreed to participate in the study from the site PIs. Clinics will be randomized to either Intervention group or to a Control group stratified by clinic size. Both groups will receive a single 45 minute academic detailing session describing evidenced-based diagnosis and treatment for strep throat and pneumonia. The Intervention Group will also receive a demonstration of the iCPR tool during their academic detailing session. Providers and clinic staff will be invited to the academic detailing session. Any provider or staff that is unable to attend the session will receive written and electronic copies of the material. Individual providers will not be specifically recruited for participation and they will participate or not based on personal preferences as they would for any clinic quality improvement project. The iCPR tool will be "turned on" for providers in the Intervention group. This means that the best practice alerts will trigger for appropriate patients with suspected strep throat or pneumonia.
We will collect and analyze data about the use of each element of the iCPR tool during patient visits, including which elements of the tool were used and how often. We will also collect data from the site EHRs about antibiotic and diagnostic test orders for strep throat and pneumonia from all clinics participating in the trial, both Intervention and Control groups.
After one year of study implementation, we will run an Interim Primary Outcome Report comparing the antibiotic and diagnostic test orders between the Intervention and Control group clinics. This report will be in the aggregate and will not contain any personally-identifiable information. If there is a significant difference between the groups that meets our predetermined stopping end points, we will stop the randomized controlled trial. |
NCT01881399 | ALL | ADULT, OLDER_ADULT | Cholelithiasis|Gallbladder Polyps | DEVICE: Fluorescence cholangiography (da Vinci surgical system)|OTHER: Virtual cholangiography|PROCEDURE: Conventional IOC | To evaluate the ability of a ICG-fluorescence guidance in visualizing the biliary anatomy and to compare accuracy to conventional intraoperative cholangiography, Percentage of patients for whom fluorescence allows for cysticocholedochal junction with precision at least as good as intraoperative cholangiography (identification of anatomical details and information).
Independent aposteriori evaluation performed by a radiologist/surgeon team., Intra-operatively | The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.
Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:
1. ease of use
2. lack of invasiveness
3. absence of ionizing radiation to the patient and the operating staff
4. performed prior to any dissection (prior to "critical view of safety")
Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.
The study requires a 2-month patient participation. |
NCT00128804 | ALL | ADULT, OLDER_ADULT | Healthy|Ileostomy | BEHAVIORAL: absorption and conversion of beta-carotene in human gastrointestinal (GI) tract | levels of retinol and carotenoids and the degree of isotopic enrichment in serum (fasting blood sample) and in faeces (72 hour collection) at the start and at the end of each of the 2-week periods | A controlled dietary intervention study will be carried out based on the stable isotope method the investigators have developed to quantify both the absorption of beta-carotene and its bioconversion to retinol in oil and in a mixed diet. For 4 weeks the participants will consume 2 capsules/day, 7 days/week with each capsule containing 100-mg \[13C10\] beta-carotene and 100-mg \[13C10\] retinyl palmitate. For two weeks they will consume a diet with high levels of beta-carotene in vegetables and fruits and for the other 2 weeks they will consume a diet with low levels of beta-carotene in vegetables and fruits supplemented with an extra amount of beta-carotene in oil. Samples of blood and faeces will be taken. The study hypothesis is that the absorption of beta-carotene in oil in comparison with the absorption of beta-carotene in a mixed diet differs by a factor of 3 to 6. The investigators want to measure the influence of the food matrix of vegetables and fruits on the absorption of beta-carotene in ileostomy patients on a western diet. |
NCT02698319 | ALL | CHILD, ADULT, OLDER_ADULT | Triage | BEHAVIORAL: Copenhagen Triage Algorithm | All cause mortality, Time frame starts at the beginning of the index admission, defined as first admission in the study period. Patients will be followed using central registers., 30 days | Crowding in the emergency department (ED) is a well documented problem putting patients at risk of adverse outcomes. To combat this, most ED's use some form of triage. In the last two decades systematic triage or process triage has become the norm in most countries but this approach is supported by limited evidence. Our aim is to develop a faster triage model of only a few vital parameters, based on a data from a large cohort of unselected ED patients and evaluate if such a model combined with a clinical assessment by the ED nurse is inferior to existing triage models in a prospective cluster-randomized trial |
NCT01964430 | ALL | ADULT, OLDER_ADULT | Pancreatic Neoplasms|Digestive System Neoplasms|Neoplasms by Site|Neoplasms|Endocrine Gland Neoplasms|Pancreatic Diseases|Digestive System Diseases|Endocrine System Diseases|Gemcitabine|Antimetabolites, Antineoplastic | DRUG: nab-Paclitaxel|DRUG: Gemcitabine | Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee, Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date., Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone | The purpose of this study is to compare whether there is a delay or prevention of recurrence or death in participants with surgically removed pancreatic cancer who then take nab-Paclitaxel in combination with gemcitabine compared to those who take gemcitabine alone. |
NCT00604487 | FEMALE | ADULT, OLDER_ADULT | Unfavorable Cervix for Induction of Labor | DEVICE: ARD (Atad Ripener Device)|DEVICE: AID (Atad double balloon Instillation Device)|DEVICE: folly catheter | To evaluate and compare the efficacy of the Atad Ripening Device (ARD), of the double balloon instillation device (AID) with concomitant continuous extra-amniotic NS instillation - 50 Ml/hour and of the folly catheter combined with continuous extra-a, 2 years | Artificial ripening of the cervix and induction of labor remain as one of the therapeutic challenges in Obstetrics. The method widely used, the intravenous administration of Oxytocin, is associated with prolonged induction periods, a significant failure rate, and considerable patient discomfort. Therefore, over the years, a variety of locally applied pharmacological and physical ripening agents were evaluated. Currently, the commonly utilised local ripening agent is a Prostaglandin (PG) preparation. Although PG is being applied vaginally or extra-amniotically, systemic absorption of this agent is common, sometimes resulting in uterine hypertonicity, nausea and vomiting. In addition, both induction methods are associated with the initiation of uterine contractions, sometimes lasting for prolonged periods. Therefore a preferred induction method may be a mechanical one which will lead to cervical ripening without causing uterine contractions. Furthermore, there are additional potential advantages of mechanical methods compared to pharmacologic methods such as, ease of storage, low cost and less side effects. A folly catheter, inserted through the cervix, combined with continuous extra-amniotic NS instillation is being used for this purpose for many years. However this method although effective may cause uncomfortable traction of the balloon to the women's leg. Furthermore, dripping of saline through the cervix and vagina, occasionally occurs, may be annoying, and may be confused with rupture of membrane. We have recently introduced a newly developed balloon device (Atad Ripener Device), which was designed with one balloon located at the distal end of the device (the uterine balloon, U), while the other balloon is located 1.5 cm proximal to the first one (the cervicovaginal balloon, CV). Both balloons are expandable with Saline. The balloon inflated in the vagina provides the traction action and seals the cervix from saline leakage. Another balloon the AID (Atad double balloon Instillation Device) is identical to the ARD but has an additional long tip for instillation of normal to the extra-amniotic space. To the best of our knowledge, no comparison was performed between the use of the double balloon ripener device and folly catheter for induction of labor. Furthermore, there are no published data regarding the use of the double balloon instillation device (AID) combined with continuous extra-amniotic NS instillation. This study is designed to compare the efficacy, safety and side effects of mechanical methods of cervical ripening and labor induction by the double balloon device (ARD), the double balloon instillation device (AID) combined with continuous extra-amniotic instillation of normal saline and the folly catheter combined with continuous extra-amniotic normal saline instillation. The study aims at the accrual of 300 women (100 randomised in each arm). |
NCT02373319 | ALL | ADULT, OLDER_ADULT | Risk Factor, Cardiovascular | BEHAVIORAL: CV-screening-1 plus personalized|BEHAVIORAL: CV-screening-2 plus personalized|BEHAVIORAL: CV-screening-1 plus standard|BEHAVIORAL: CV-screening-2 plus standard | Pre-post changes in blood lipid levels, Pre-post changes in mean levels of blood lipid levels (total, HDL and LDL cholesterol). Blood samples will be obtained at baseline and 12 months after the intervention., [Time frame: From baseline to 12 months after the intervention] | The aims of this study are (1) to validate a self-screening method for cardiovascular (CV) risk that does not require the supervision of a health professional (including self-measurement of blood pressure, lipid profile evaluated by dry chemistry, and self-administered questionnaires on sex, age, diabetes, and tobacco consumption). (2) From these data, the investigators will generate personalized recommendations based on the best available evidence. The investigators will also analyze whether this innovative approach improves adherence to preventive recommendations for cardiovascular and other chronic diseases. |
NCT02314000 | ALL | ADULT, OLDER_ADULT | Chronic Pain | DEVICE: Precision or Precision Spectra Spinal Cord Stimulator System | Proportion of Subjects With 50% or Greater Reduction in Overall Pain Intensity From Baseline, Proportion of subjects with 50% or greater reduction in overall pain intensity from baseline with supra and sub perception amplitude with no increase in average daily medication intake to treat pain, 90 days post activation | To demonstrate sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Precision Spinal Cord Stimulator (SCS) System at sub-perception amplitude |
NCT01182948 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes | BEHAVIORAL: Aerobic Training|BEHAVIORAL: Resistance Training | Change in haemoglobin A1c (HbA1c) levels, The measurement of HbA1c is carried out with a DCCT (Diabetes Control and Complications Trial)-aligned method., 4 months | The purposes of this study are: a) to compare the effects of supervised programs of aerobic training or resistance training on the metabolic control of type 2 diabetes; b) to investigate some potential pathophysiologic and molecular mechanisms underlying these effects; c) to assess whether some changes may persist over time after termination of the supervised programs. |
NCT03008447 | ALL | ADULT, OLDER_ADULT | Healthy Subjects | DRUG: LEM5|DRUG: LEM10|DRUG: ZOL|DRUG: PBO | Change from time-matched baseline in postural stability for LEM5 and LEM10 compared to zolpidem (ZOL) at approximately 4 hours postdose, Magnitude of body sway upon being awakened at approximately 4 hours after receiving lemborexant 5 milligrams (mg) (LEM5), lemborexant 10 mg (LEM10), zolpidem 6.25 mg, or placebo., approximately 4 hours postdose at each of 4 single-dose treatment periods (up to 43 days) | E2006-A001-108 is a 4-period crossover study designed to demonstrate that the mean change from baseline in postural stability (worsening) when participants are awakened at approximately 4 hours postdose is significantly less after lemborexant than after zolpidem tartrate extended release following a single-dose administration at bedtime. |
NCT00298220 | ALL | CHILD, ADULT, OLDER_ADULT | Alcohol Drinking | BEHAVIORAL: Feedback about patients at risk|BEHAVIORAL: Dissemination guideline and patient information letters|BEHAVIORAL: Tailored educational training|BEHAVIORAL: Tailored outreach based facilitator support|BEHAVIORAL: Facilitation of co-operation with local addiction services|BEHAVIORAL: Patient directed interventions|BEHAVIORAL: Reminder-card for GP's desk|BEHAVIORAL: Personal feedback to patients | - Proportion of patients who, with an initial AUDIT score of 16 or more, have an AUDIT score at follow-up (= 18 months) of 15 or less.|- Proportion of patients who, with an initial AUDIT score of 16 or more, have been given advice by the general practitioner or by other staff (e.g. nurse practitioner, practice nurse). | The aim of the study is to test whether or not a tailored multi-component intervention program to increase the activity of general practice teams in the prevention of hazardous and harmful alcohol consumption results in increase advice giving rate to patient with hazardous and harmful alcohol consumption and a better patient outcome in terms of hazardous and harmful alcohol consumption.
The primary objectives of the proposed study are:
1. to test the (cost) effectiveness of a tailored multi-component implementation program to engage general practices (i.e. GPs, nurse practitioners or practice nurses/assistants) in the prevention of hazardous or harmful alcohol consumption, changing both providers' advice giving behaviour and patients' alcohol consumption
2. to identify predictors of effect
3. to examine whether or not the implementation of a tailored multi-component implementation program to engage general practice in the prevention of hazardous or harmful alcohol consumption is feasible. |
NCT02216526 | ALL | OLDER_ADULT | Xerosis Cutis | OTHER: Cetaphil® Restoraderm|OTHER: Excipial | Change From Baseline in Overall Dry Skin Score (ODS), Clinical assessment of the presence or severity of skin dryness using a five point rating scale at right lower leg. The Overall Dry Skin score is a clinical assessment of the presence and severity of skin dryness using a five-point scale. A score of '0' indicates no skin dryness, whereas a score of '4' indicates advanced skin roughness, large scales, inflammation and cracks., Baseline; Day 56+/-4 | Residents of institutional long-term care facilities are at high risk for developing skin and tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis, candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant melanoma) but there are few epidemiological figures about the actual frequencies of these conditions in nursing homes. Therefore, in the first part of this study we aim at measuring key dermatological conditions and associated health and functional status, and the skin care practice of aged nursing home residents ("prevalence study").
Basic skin care interventions are believed to reduce skin dryness and to enhance skin health. Thus, the second aim of this study is to investigate the effectiveness of two structured skin care regimens compared to the routine standard skin care on skin health in nursing home residents ("intervention study").
The study will be conducted in a random sample of seven out of approximately 300 institutional long term care facilities of the federal state of Berlin. |
NCT03340493 | ALL | ADULT, OLDER_ADULT | Ischemic Stroke | DRUG: Tenecteplase | mTICI, Proportion of patients with substantial angiographic reperfusion (mTICI) score of 2b/3 (restoration of blood flow to \>50% of the affected arterial territory) or absence of retrievable thrombus at initial angiogram., Initial angiogram (day 0) | Patients presenting to the emergency department with acute ischemic stroke, who are eligible for standard intravenous thrombolysis within 4.5 hours of stroke onset will be assessed for major vessel occlusion to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using central computerised allocation to either 0.4mg/kg or 0.25mg/kg intravenous tenecteplase before all participants undergo endovascular thrombectomy. The trial is prospective, randomised, open-label, blinded endpoint (PROBE) design. |
NCT00106327 | ALL | CHILD, ADULT, OLDER_ADULT | Cardiovascular Diseases|Peripheral Vascular Diseases | BEHAVIORAL: Exercise|BEHAVIORAL: Diet | Six-minute walk distance, Measured at baseline and follow-up study visits|Summary performance score, Measured at baseline and follow-up study visits | The purpose of this study is to compare the effects of nutrition, a supervised treadmill exercise program, and supervised progressive resistance training program on peripheral arterial disease. |
NCT03410693 | ALL | ADULT, OLDER_ADULT | Carcinoma, Transitional Cell | DRUG: Rogaratinib (BAY1163877)|DRUG: Chemotherapy | Objective Response Rate (ORR) - Central Assessment, ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders., From start of treatment up to end of active follow-up, approximately 29 months | This is a randomized, open-label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy.
The primary objective is to demonstrate the superiority of rogaratinib over chemotherapy in terms of objective response rate (before: overall survivial) of urothelial carcinoma patients with FGFR positive tumors.
At randomization, patients will have locally advanced or metastatic urothelial carcinoma and have received at least one prior platinum-containing chemotherapy regimen. Only patients with FGFR1 or 3 positive tumors can be randomized into the study. Archival tumor tissue is adequate for testing of FGFR1 and 3 mRNA expressions, which will be determined centrally using an RNA in situ hybridization (RNA-ISH) test. Approximately 42 % of UC patients with locally advanced or metastatic UC are identified as FGFR-positive by the RNA-ISH cut-off applied. |
NCT01407094 | ALL | ADULT, OLDER_ADULT | Depression | DRUG: Sertraline|DRUG: Placebo|DRUG: BupropionXL | Hamilton Rating Scale for Depression, The Hamilton Rating Scale for depression is a measure of depressive severity (HAM-D17; HDRS)
* Scores range from 0-52
* Lower scores indicate less depressive symptomatology, and so are the more desirable., Week 8 | This study will examine multiple carefully selected clinical and biological markers, using both existing state-of-the-art technologies as well as pioneering, innovative approaches. The study is designed to identify moderators and mediators of treatment response for depression in order to specify a biosignature of treatment response for depression. Evaluation of the usefulness of these markers in a carefully conducted clinical trial comparing an antidepressant to placebo will assist in developing a Depression Treatment Response Index (DTRI) to help clinicians match treatments to patients with MDD, resulting in timely selection of treatments best suited for individual patients and thus approaching personalized treatment. The resulting index provides a truly novel means of synthesizing the contribution of key clinical and biological parameters in an easy to use tool for clinical care. |
NCT00811421 | FEMALE | CHILD, ADULT, OLDER_ADULT | Pregnancy|Malaria|HIV Infections | DRUG: Sulphadoxine-pyrimethamine|DRUG: Mefloquine (full dose)|DRUG: Mefloquine (split dose)|DRUG: placebo|DRUG: mefloquine | Trial 1 (IPTp MQ vs IPTp SP): Low birth weight., day 0, birth|Trial 2 (CTX+IPTp MQ vs. CTX+IPTp placebo): Peripheral parasitaemia., day 0, delivery | The study aims at comparing the safety, tolerability and efficacy of Mefloquine (MQ) to Sulfadoxine-Pyrimethamine (SP) as Interment Preventive Treatment in pregnancy (IPTp) for the prevention of malaria effects on the mother and her infant. |
NCT01528644 | ALL | ADULT, OLDER_ADULT | Iron Deficiency|Anaemia | DIETARY_SUPPLEMENT: alginate beads containing ferrous gluconate|DIETARY_SUPPLEMENT: ferrous gluconate in a capsule|DIETARY_SUPPLEMENT: ferrous gluconate in a capsule in presence of calcium|DIETARY_SUPPLEMENT: alginate beads with ferrous gluconate in presence of calcium | Change in iron absorption, Iron absorption (by measuring iron appearance in the serum)will be measured on four occasions with a week in between each measurement. Absorption will be assessed in response to four test meals as follows: unprotected ferrous gluconate, iron gluconate incorporated into alginate beads,ferrous gluconate incorporated into alginate beads given with calcium, and unprotected ferrous gluconate given with calcium., Four weekly measurements over a period of three weeks (6h Cannulation, baseline blood sample (t=0). Test meal 1, followed by blood sample collection at 20, 40, 60, 80, 100, 120, 150, 180, 240, 300 and 360 min. Removal of the cannula) | Iron deficiency anaemia affects around two billion people worldwide. Food fortification with iron is a realistic way to combat this problem. Water soluble forms of iron are considered to be more bioavailable than nonsoluble iron compounds. However, the former often cause sensory problems when added to foods, while the latter cause fewer problems but are not generally well absorbed and are therefore ineffective as fortificants. A potential strategy for overcoming this problem is the use of water soluble iron compounds protected by a water resistant barrier, which will prevent potential organoleptic changes within fortified foods and protect the iron (from oxidation) through the digestion process thus increasing its availability. The investigators will use alginate, in the form of alginate beads, as a protective barrier for soluble iron gluconate. It has been shown that alginates bind divalent and trivalent cations and therefore may be a useful vehicle for soluble iron compounds to fortify foods.
The aim of this project is to measure the effect of alginate on iron absorption from ferrous gluconate and assess the potential modulating effect of calcium on iron absorption in the presence and absence of alginate. |
NCT03577652 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease|Ticagrelor | DRUG: Ticagrelor | Platelet function assessments, The primary endpoint was the comparations between the three projects for the value changes of maximal platelet aggregation (MPA) measured by Light Transmittance Aggregometry (LTA) at 2 hours after switching strategies., 7 Days | The study is to further exploring the optimal switching strategy by evaluating the pharmacodynamic responses as well as adverse events in patients with complexity of coronary artery disease managed by percutaneous coronary intervention (PCI). All participants will be divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after the last dose of clopidogrel. |
NCT02552771 | ALL | CHILD, ADULT, OLDER_ADULT | Mitral Valve Prolapse | PROCEDURE: Mitral repair with leaflet preservation|PROCEDURE: Mitral repair with leaflet resection | Mean mitral valve gradient at peak exercise 12-months following repair, 12 months following repair | Multicentre, double-armed, randomized controlled trial designed to compare mitral valve leaflet resection versus leaflet preservation with regards to the development of functional mitral stenosis following surgical repair of mitral valve prolapse. Patients will be randomized (1:1) to receive: (1) mitral valve repair with a leaflet resection or (2) mitral valve repair with leaflet preservation (using polytetrafluoroethylene neochordae), followed by echocardiographic and clinical assessment at 12-months following surgery. |
NCT00339079 | ALL | ADULT, OLDER_ADULT | Hypochondriasis | DRUG: Fluoxetine|BEHAVIORAL: Cognitive Behavioral Therapy (CBT)|OTHER: Supportive Therapy|DRUG: Placebo | 25% Improvement on Both Whiteley Index and H-YBOCS-M, Whitley index is a self-report measure of hypochondriasis H-YBOCS-M is an independent evaluator structured assessment of hypochondriasis, Measured at Week 24 | This study will compare the effectiveness of cognitive behavioral therapy, antidepressant medication, and a combination of the two for treating hypochondriasis. |
NCT01212991 | MALE | ADULT, OLDER_ADULT | Prostate Cancer | DRUG: Enzalutamide|DRUG: Placebo | Overall Survival, Overall survival was defined as the time from randomization to death due to any cause. For patients who were alive at the time of the analysis data cutoff, overall survival was censored at the last date the patient was known to be alive or analysis data cutoff date, whichever was first. This included patients who were known to have died after the data analysis cutoff date. Patients with no post-baseline survival information were censored on the date of randomization., During study period (up to 3 years)|Radiographic Progression-free Survival (rPFS), Radiographic progression-free survival was defined as the time from randomization to the first objective evidence of radiographic disease progression assessed by independent central radiology review or death due to any cause within 168 days after treatment discontinuation, whichever was first. Radiographic disease progression was evaluated by CT scan or MRI and radionuclide bone scans at regularly scheduled visits. Radiographic disease progression in bone required a confirmatory scan. Radiographic disease progression in soft tissue did not require a confirmatory scan for purposes of analysis. Radiographic disease progression was evaluated by independent central radiology review using RECIST 1.1 for soft tissue disease and PCWG2 guidelines for bone disease. Patients who did not reach the endpoint were censored at their last assessment., During study period (up to 20 months) | The purpose of this study is to determine the benefit of enzalutamide versus placebo as assessed by overall survival and progression-free survival in patients with progressive metastatic prostate cancer who have failed androgen deprivation therapy but not yet received chemotherapy. |
NCT02070367 | ALL | CHILD, ADULT, OLDER_ADULT | Complex Regional Pain Syndrome|Peripheral Nerve Injuries|Hand Fractures | OTHER: Somatosensory rehabilitation|OTHER: Usual treatment: physiotherapy | McGill Pain Questionnaire, total number and intensity of sensory and affective pain descriptors selected by participant, baseline to 6 month follow-up | This pilot study will test a new therapy, somatosensory rehabilitation, for the painful sensitivity experienced by persons with nerve injuries and/or complex regional pain syndrome (CRPS). Several methods for measuring pain and sensitivity that emphasize the person's evaluation of their own symptoms and the impact of these symptoms on their daily activities will also be tested to make sure they are consistent and accurate.
Previous research has suggested one of the assessments may also be used to assist in the identification of CRPS: this simple test will be evaluated to see if it can accurately identify persons with this disorder (for which there is currently no diagnostic test). Together, this will improve treatment of CRPS through early, accurate diagnosis and the ability to measure important changes in this painful condition, and set up future studies for this new rehabilitation treatment method. |
NCT02597257 | ALL | ADULT, OLDER_ADULT | Postherpetic Neuralgia|Diabetic Polyneuropathy|Peripheral Neuropathy | DRUG: Lidocaine HCl|DRUG: Normal saline | 11-point Numeric Rating Scale, Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain, 1 week after the end of intervention | The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain. |
NCT02836899 | ALL | ADULT, OLDER_ADULT | Acute Kidney Injury | DRUG: Nitric Oxide|OTHER: Placebo | Acute kidney injury, Incidence of Acute Kidney injury according to KDIGO criteria., 7 days | The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass. |
NCT00076232 | ALL | CHILD, ADULT, OLDER_ADULT | HIV Infections|HIV Seronegativity|Herpes Genitalis | DRUG: Acyclovir|DRUG: Acyclovir placebo | Serologically confirmed HIV infection, Throughout study | Genital herpes (HSV-2) is the most common cause of genital sores worldwide, and the presence of genital sores is a significant risk factor for becoming infected with HIV. This study will test the effectiveness of twice-daily dosing of acyclovir, a commonly prescribed anti-herpes drug, in preventing HIV infection in HSV-2 infected women who sleep with men (WSM) and men who sleep with men (MSM).
Study hypothesis: Given that genital herpes is a significant risk factor to HIV acquisition, twice-daily HSV-2 suppressive therapy - 400 mg of acyclovir - will prevent HIV infection among high risk, HSV-2 seropositive WSM and MSM. |
NCT01066806 | FEMALE | CHILD | Obesity | BEHAVIORAL: counseling on increasing calcium intake|OTHER: observation | percent change in body fat, 1 year | SPECIFIC AIM The aim of this study is to determine if increasing calcium intake to recommended levels with dairy foods in adolescent females with habitually low calcium intake and above-the-median body mass index (BMI) for sex and age will decrease body fat gain compared to similar females who continue their low calcium intake. .
HYPOTHESIS Post-menarcheal adolescent girls with habitually low calcium intake who consume dairy foods providing at least 1200 mg of calcium per day will have a smaller increase in percent body fat, as measured by dual energy absorptiometry, during one year than post-menarcheal adolescent girls on a usual diet of 600 mg of calcium per day or less. |
NCT01403051 | ALL | ADULT, OLDER_ADULT | HIV-1 Infection | DRUG: EFV/FTC/TDF|DRUG: Calcium Carbonate|DRUG: Vitamin D3|DRUG: Placebo for calcium carbonate|DRUG: Placebo for vitamin D3 | The Percent Change From Baseline in Bone Mineral Density (BMD) at Total Hip, The efficacy endpoint is the percent change from baseline to week 48 in bone mineral density (BMD) at total hip (as measured by DXA scan), Weeks 0 and 48 | This study was done with people who were infected with HIV and needed to start treatment for their HIV disease. The purpose of this study is to see if taking vitamin D and calcium will help prevent the bone loss that sometimes happens when people start HIV treatment. For this study, the following HIV treatment (or HAART) were provided in the form of a single tablet that contains three different drugs: efavirenz/emtricitabine/tenofovir (EFV/FTC/TDF). These drugs are approved by the FDA to treat HIV infection. The HIV treatment provided is common for people who are taking HIV drugs for the first time. The risks seen with this HIV treatment are the same that you would encounter when taking these drugs outside of the study. The lists of risks of this HIV treatment are included in this document because the drugs are provided by the study, not because the drugs are being tested. The purpose of the study is only to look at the impact of high doses of vitamin D and calcium in preventing bone loss. There are no study objectives related to HIV treatment (EFV/FTC/TDF). |
NCT01535001 | ALL | ADULT, OLDER_ADULT | Osteoarthritis of the Knee | OTHER: Neuromuscular training (NEMEX-TJR)|BEHAVIORAL: Information|DRUG: Paracetamol|DRUG: Burana|DRUG: Pantoprazole|BEHAVIORAL: Dietary counseling|BEHAVIORAL: Patient education|OTHER: Insoles | Change From Baseline in KOOS4 (Knee Injury and Osteoarthritis Outcome Score), The average score for four of the five KOOS subscales, covering pain, symptoms, difficulties in functions of daily living, and quality of life (KOOS4), with scores ranging from 0 (worst) to 100 (best).
Between group comparisons of treatment effect (change in KOOS4 from baseline to 1 year follow-up) will be dependent on data distribution. We expect the change to be normally distributed and analysis will be made using a mixed model ANOVA with subject being a random factor and visit (baseline, 3, 6 and 12 months), treatment arm (TKA + MEDIC, MEDIC) and site (Frederikshavn, Farsoe) being fixed factors. Baseline KOOS4 will be a covariate. Furthermore interactions between the fixed factors will be included in the model. P-values and 95% CI will be presented to assess superiority., Primary: 12months. | The purpose of this study is to test whether an algorithm for systematic non-surgical treatment consisting of corrective insoles, neuromuscular training, weight loss, patient education and pharmacological treatment with paracetamol, non steroidal anti inflammatory drugs (NSAIDs) and Pantoprazole provides further improvement in pain, function and quality of life than standard non-surgical treatment (information on the disease and how to treat it) in patients with knee osteoarthritis.
The H1-hypothesis is that the treatment algorithm results in a greater increase in quality of life and functional capacity and greater reduction in pain than standard treatment at the primary endpoint, which is follow-up 12months after the start of the treatment.
See statistical analysis plan available under "Links" for further description of the study. |
NCT02018107 | ALL | ADULT, OLDER_ADULT | Liver Tumor|Liver Neoplasms | DIAGNOSTIC_TEST: N-13 ammonia or F-18 fluorodeoxyglucose|DIAGNOSTIC_TEST: PET scan | Number and Percentage of Tumors With Complete, Circumferential Ablation Margin Visibility During FDG PET/CT-guided Liver Ablations (AP-PET-1 v. Contrast-enhanced MRI), For FDG-avid tumors, compare the rates of complete, circumferential ablation margin visibility during FDG PET/CT-guided liver ablations using two imaging techniques: intra-procedural AP-PET-1(research scan #1) and post-procedural contrast enhanced MRI . Discordance rates for complete ablation margin visibility between the two imaging techniques will be calculated., 2 Years | In this research study, the investigators are evaluating whether ammonia PET scans or FDG PET perfusion scans are more useful in helping radiologists determine whether liver tumors were successfully destroyed by the heating or freezing procedures (ablations) than other scans currently available to radiologists, such as CT scans and MRI scans.
The currently available scan (usually a CT scan with contrast dye) is not always effective in showing how completely the tumor has been destroyed. The ammonia PET scan is a different way of looking at how much tumor has been destroyed. This study will compare the standard scan (CT scan) with the ammonia PET scan. |
NCT02173509 | ALL | CHILD, ADULT, OLDER_ADULT | Antibiotics Misuse | OTHER: Multidisciplinary and multifaceted educational intervention. | Change From Baseline Antibiotic Consumption at 18 Months, in Primary Care, To quantify antibiotic drug consumption, we used monthly sales data sourced from IMS Health® and we used the quality indicators validated by Coenen S et al., (2007) to calculate monthly prescribing rates., up to 18 months|Antibiotic Monthly Sales Data and Quality Indicators Monthly Prescribing Rates., antibiotic monthly sales data, obtained from IMS and quality indicators monthly prescribing rates, according to the ESAC indicators., May 2012- September 2014 | This is a cluster randomised controlled trial covering all general practitioners working in the National Health System (SNS) and all pharmacists working in community pharmacies in the area covered by the Health Region Administration of Center (ARS-C) . A specific educative intervention, designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance, will be carried out on the intervention group. The control group will not receive any specific intervention.
Hypotheses:
1. The attitudes and knowledge towards antibiotics generate habits of prescription by physicians
2. The attitudes and knowledge towards to antibiotics generate propensity to dispense antibiotics without prescription by pharmacists
3. The identification of the attitudes, knowledge and factors that generate habits of inadequate prescription will allow the design of specific educative interventions to improve the use of antibiotics
4. The identification of the attitudes, knowledge and factors that generate propensity to dispense antibiotics without prescription will allow the design of specific educative interventions to antibiotic use
5. The interventions designed from gaps detected in knowledge and attitudes with respect to antibiotics and resistance will improve the prescription and dispensation of antibiotics by physicians and pharmacists, respectively.
6. The intervention will collaborate in the control of the bacterial resistance. |
NCT00272753 | ALL | ADULT | Asthma | DRUG: budesonide/formoterol Turbuhaler|DRUG: formoterol Turbuhaler|DRUG: salbutamol | The decrease in lung function (FEV1) after the third AMP provocation test. | The aim is to study whether the budesonide component within the budesonide/ formoterol combination inhaler has additive value in a model of "slow onset acute asthma" , namely three AMP provocation tests performed on one day |
NCT03241355 | ALL | CHILD | Infectious Disease|Children, Only|Diet Modification | DIETARY_SUPPLEMENT: prebiotic inulin-type fructan|DIETARY_SUPPLEMENT: Placebo maltodextrin | Frequency of infectious disease episodes, 24 weeks period | The study aims to explore whether prophylactic dietary supplementation with prebiotic inulin-type fructans is able to influence the intestinal microbiota and the frequency of infectious disease episodes in kindergarten children during a winter period. |