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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) a... |
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: disappearan... | 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 ... |
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 lifestyl... |
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-da... | 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 wh... |
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 metab... |
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 ... | 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... | 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/o... |
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 f... | 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 disabili... |
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 firs... | 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... |
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 anti... |
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: Entrectin... | 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 Tumo... | 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 rele... |
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... |
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 v... |
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... | 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... | 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,... |
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 prot... | 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 ... |
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 mo... | 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 i... |
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 recei... |
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, un... | 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 random... |
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 wi... |
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 marker... | 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 6... | 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, dula... |
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 br... |
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 repre... | 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 pat... |
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)... | 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... |
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 ev... | 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 ... | 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... |
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 demo... |
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... | 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 t... |
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 Supplemen... | 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... |
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... | 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 eplereno... |
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 ... |
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 ben... |
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 bo... |
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 d... |
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 ... |
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 ... | 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 dia... |
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 t... |
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 an... |
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 Gene... |
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 (identif... | 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 preven... |
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 ca... |
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. Ou... |
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 radi... | 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 yea... |
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 ... |
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... |
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., app... | 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 adminis... |
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 interventi... | - 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 p... |
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... | 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... |
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... |
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., F... | 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 t... |
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 treat... |
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 ... | 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 ... |
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 9... |
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 wi... |
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 ... | 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 t... |
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... |
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 calciu... |
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 HAAR... |
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 ... | 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 improv... |
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 imagin... | 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... |
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 Sale... | 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 k... |
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. |
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