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NCT00851994 | ALL | ADULT, OLDER_ADULT | Surgery | null | Changes in urine proteins after surgery., Pre-op, intraoperative, post operatively (1-6 months) | The investigators are measuring novel proteins in the urine of patients having surgery. |
NCT01216696 | ALL | ADULT, OLDER_ADULT | Metastatic Melanoma | DRUG: ipilimumab | Disease Control Rate according to immune-related response criteria, To determine the efficacy of ipilimumab in patients with stage III and stage IV malignant melanoma and spontaneous preexisting immune response to NY-ESO-1., 1 year | This is an Open-label, single-arm, phase II study of ipilimumab in patients with spontaneous preexisting immune response to NY-ESO-1.
Preclinical data suggest, that CTLA-4 blockade enhances polyfunctional T cell responses in patients with melanoma. Thus patients with immunological response to NY-ESO-1 might benefit from an anti CTLA-4 treatment.
Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit (partial response, complete response or stable disease according to the immune-related response criteria) will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression,toxicities requiring discontinuation |
NCT00174993 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus | DRUG: Pioglitazone|DRUG: Placebo | Time to the Composite of All Cause Mortality, Non-Fatal Myocardial Infarction, Stroke, Acute Coronary Syndrome, Major Leg Amputation, Cardiac Intervention, Bypass Surgery or Leg Revascularization., At First Occurrence | The purpose of this study is to determine whether pioglitazone, once daily (QD), can delay the time to death, heart attack, acute coronary syndrome, heart bypass surgery, stroke, leg bypass surgery or amputation in patients with type 2 diabetes. |
NCT01816971 | ALL | ADULT, OLDER_ADULT | Stage I Multiple Myeloma|Stage II Multiple Myeloma|Stage III Multiple Myeloma | DRUG: dexamethasone|DRUG: carfilzomib|DRUG: lenalidomide|PROCEDURE: autologous hematopoietic stem cell transplantation|OTHER: laboratory biomarker analysis | Percentage of Patients Achieving sCR, The percentage of stringent complete response (CR) (sCR) will be reported along with 95% confidence intervals, adjusted for the two-stage nature of the trial design., Day 224 | This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant may kill more cancer cells |
NCT01457521 | FEMALE | CHILD, ADULT, OLDER_ADULT | Pain | DRUG: Ibuprofen | 11-point Visual Analog Scale for Pain, Participant pain was assessed using an 11-point Visual Analog Scale for Pain. Scores ranged from 0 (no pain) to 10 (worst pain possible), 1-2 weeks | This trial will compare two oral analgesic regimens in women undergoing first trimester medical abortion with mifepristone and misoprostol. The primary study outcome is pain. |
NCT03300336 | ALL | ADULT, OLDER_ADULT | Early Ambulation | BEHAVIORAL: STRIDE | Proportion of Patients Discharged to Skilled Nursing Facility, Discharge to skilled nursing facility (versus home) will be assessed via administrative data pulls and chart review (not patient report)., Assessed at hospital discharge, an average of 7 days|Hospital Length of Stay (Days), Hospital length of stay will be assessed via administrative data pulls (not patient report), Assessed at hospital discharge, an average of 7 days | Optimizing Function and Independence Through STRIDE aims to implement the STRIDE inpatient hospital mobility program at 8 VAMC sites in a stepped-wedge design and evaluate patient outcomes before and after the program is implemented, as well as the efficacy of a usual vs enhanced implementation design. |
NCT01389934 | FEMALE | ADULT, OLDER_ADULT | Local Anesthetic | DRUG: levo-bupicaine|DRUG: Placebo | effectiveness of administering levo-bupicaine to control postoperative pain., the control postoperative pain will be measured by a a patient satisfaction scale (very good, good, fair, bad, very bad), 48 hours | Background: The use of local anesthetics as a supplement to conventional techniques in breast surgery is widely reported in the literature. Currently there is controversy regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. The aim of this study demonstrate the efficacy of administering a local anesthetic into the surgical bed of women operated radical mastectomy for breast cancer for the control of postoperative pain.
Material and methods: double-blind randomized clinical trial. The investigators recruited patients who underwent modified radical mastectomy that met inclusion and exclusion criteria. The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours, and saline control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local anesthetic and rescue medication was identical in both groups.
Statistical analysis: The baseline patient characteristics of the patients were analyzed by Chi square or Student t always meet criteria of normality, otherwise it will use the Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse events will be held on chi-square test. |
NCT01842412 | ALL | ADULT, OLDER_ADULT | Intermittent Claudication | BEHAVIORAL: exercise | Mitochondrial function, respirometry, One day | The hypothesis of this study is that one bout of leg exercise gives acute qualitative changes in mitochondrial function in claudication. Final purpose is to determine the optimal exercise frequency in treatment of claudication. |
NCT03032003 | FEMALE | ADULT, OLDER_ADULT | Recurrent Urinary Tract Infections in Women | OTHER: Cysticlean|OTHER: Placebo | Effectiveness of the use of Cranberries in the prevention of the recurrent UTIs is women., Follow up with urinary cultures will be evaluated for Cranberries affection in UTIs, 12 months | To investigate if oral administration of 240mg PAC of cranberries can reduce the number of episodes of acute bacterial cystitis and improve general QoL in women with recurrent bacterial cystitis. In addition, the effect on vagina and rectal flora will studied and the adverse effect profile of the drug will be reported.
Women with ≥3 symptomatic episodes of lower UTIs at the previous year will be recruited from the outpatient population who present to their family physician or specialist with symptomatic recurrent UTI. Informed consent will be obtained from all patients and they will be divided in groups according to their age. Urinary culture, vaginal and rectal swab will be taken from all the patients. Antibiotic treatment will be prescribed (using the drug of choice according to the urine culture and the treating physician choice). Subsequently, they will be randomized to receive combined antibiotic treatment with one capsule of Cysticlean 240mg PAC two times per day or antibiotic treatment with placebo. At 14th day post treatment and after a negative urinary culture patients will continue to receive per os, daily, one capsule of Cysticlean 240mg at bed time for 12 months or placebo respectively.
Study visits will occur at 3rd, 6th , 9th and 12th month treatment phase. A urine collection, vaginal swabs and rectal swab will be taken at study entry and at the month 3, 6, 9 and 12 visits.
Participants will be asked about medication usage, any side effects they may be experiencing at each study visit. If participants develop a UTI at any time during the study, they will be asked to visit the study site within 24 hours. |
NCT02319525 | FEMALE | ADULT, OLDER_ADULT | Systemic Lupus Erythematosus | OTHER: Computerized patient decision-aid|OTHER: Usual care (lupus pamphlet) | Change From Baseline in Decisional Conflict Scale Scores, Patient self-administered, validated measure of decisional conflict, most commonly used as the primary outcome in RCTs of decision aids (change score). The score ranges from 0 (no decisional conflict) to 100 (extreme decisional conflict). Decisional conflict represents a state of uncertainty about a choice or course of action and is more likely in situations involving high-stakes choices with important potential gains and losses, value tradeoffs in selecting a choice or a course of action (vs. the alternative) or uncertain outcomes., Baseline and after viewing the decision-aid or the standard hand-out (pamphlet) on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week)|Informed Choice (Validated Instruments for Values Regarding Immunosuppressives, Knowledge About Immunosuppressives, and Treatment Decision-making), Concordance between values related (for or against starting) immunosuppressive drugs with patients' decision (to start or not start) immunosuppressive drugs, in those with adequate knowledge about benefits/harms of immunosuppressive drugs, assessed using validated instruments for values regarding immunosuppressive drugs, knowledge about immunosuppressive drugs, and treatment decision-making (patient's decision to start immunosuppressive drug)., After viewing the guide or standard hand-out on the same visit as the intervention (preferred) but before treatment decision-making (usually within 1 week) | The study will compare the efficacy of the usual education materials to individualized computerized decision guide on decision conflict of patients with lupus nephritis making treatment decisions regarding immunosuppressive therapies. |
NCT00501215 | ALL | ADULT, OLDER_ADULT | Hyperparathyroidism | PROCEDURE: Parathyroid Surgery|BEHAVIORAL: Telephone Interview|PROCEDURE: Parathyroid Surgery|BEHAVIORAL: Polysomnography (PSG) | Total sleep time, Before and After Intervention | Primary hyperparathyroidism (PHPT) is an endocrine disorder that disrupts calcium metabolism and has a broad range of clinical manifestations. With respect to the nonclassic, subjective symptoms that have been reported to be associated with PHPT, such as sleep disturbance, neurocognitive dysfunction, mood disturbance, fatigue, and decreased quality of life, there is a lack of objective data on the extent to which these symptoms are affected by parathyroidectomy.
There have been reports of improvements in sleep in patients following parathyroidectomy, but these have been based solely on subjective sleep surveys. To date, there are no published studies on objective sleep evaluations of patients with PHPT. The overall goals of this protocol are to ascertain the feasibility of performing sleep studies on patients with PHPT, and to obtain pilot data on the effects of parathyroidectomy on those sleep studies.
It is hypothesized that it will be feasible to evaluate sleep parameters in patients with PHPT in the M. D. Anderson Sleep Center. Towards testing this hypothesis, the specific aims are:
Specific Aim 1: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the primary outcome measure of total sleep time.
Specific Aim 2: To assess the feasibility of using nocturnal polysomnography (PSG) to evaluate the secondary outcome measures of sleep architecture, arousal index, sleep efficiency, wake after sleep onset, and sleep onset latency in patients with PHPT.
Specific Aim 3: To assess the feasibility of evaluating the secondary outcome measures of subjective sleepiness as tested with the Epworth Sleepiness Scale (ESS), and of sleep quality as tested with the Brief Sleep Disturbance Scale (BSDS) in patients with PHPT.
Specific Aim 4: To assess the feasibility using a randomized "wait-list"-control design to assess the effects of parathyroidectomy on sleep measures obtained with nocturnal PSG. |
NCT04614545 | ALL | ADULT, OLDER_ADULT | Obesity | DRUG: Phentermine 37.5 Mg|BEHAVIORAL: Dietary program|BEHAVIORAL: Exercise program | Change in Body Weight (Percentage), The primary endpoint is mean change in body weight (%) from baseline (visit 1) to 12 weeks (visit 4) in body weight., 12 weeks | This study will study the effects associated with the prescription of phentermine in a virtual setting, comparing with prescription of phentermine via a standard face-to-face visit for patients with obesity or overweight. |
NCT00513916 | FEMALE | ADULT | Breast Cancer|Healthy, no Evidence of Disease | DIETARY_SUPPLEMENT: soy isoflavones | Effect of two daily servings of soy on estrogen levels in nipple aspirate fluid (NAF) and serum|Cytologic patterns of epithelial breast cells obtained from NAF|Effect of two daily servings of soy on cytochrome alterations of estrogen metabolism as expressed in the formation of urinary 2-, 16α-, and 4-hydroxy estrogen metabolites|Comparison of estrogen levels in NAF and serum measured at the same time during luteal phase | RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Eating a diet high in isoflavones, compounds found in soy foods, may keep cancer from forming.
PURPOSE: This randomized phase III trial is studying the effects of dietary soy on estrogens in breast fluid, blood, and urine samples from healthy women. |
NCT02454023 | ALL | CHILD, ADULT, OLDER_ADULT | Stroke|Transient Ischemic Attack|Obstructive Sleep Apnea | DEVICE: Portable sleep monitor (ApneaLink Air)|DEVICE: In-laboratory polysomnography | Proportion of patients diagnosed with treatable OSA, Proportion of patients diagnosed with treatable OSA by 6 \& 12 months, 6 & 12 months | Obstructive sleep apnea (OSA) is common after stroke/TIA and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. Despite its high prevalence, OSA often remains underdiagnosed after stroke. The purpose of this study is to evaluate portable sleep monitors (PSMs) as a broad screening tool for OSA after stroke/TIA. The study investigators hypothesize that the screening with PSMs will lead to an increase in the diagnosis of treatable OSA after stroke/TIA and an improvement in sleep-related and functional outcomes. |
NCT00346138 | ALL | ADULT, OLDER_ADULT | Fuchs Dystrophy|Corneal Edema | PROCEDURE: Corneal transplantation | Visual acuity. | The objectives of this study are to compare the visual and refractive outcomes of deep lamellar endothelial keratoplasty (DLEK) with penetrating keratoplasty as treatment for certain cases of corneal edema due to endothelial decompensation. Additionally, data will be collected to compare corneal shape, corneal thickness, endothelial cell density, keratocyte density, corneal sensitivity, light scatter, and subjective visual function between the two procedures. |
NCT00234429 | ALL | ADULT, OLDER_ADULT | Colorectal Cancer | DRUG: Gefitinib, raltitrexed | Determine the progression free survival | The primary objective of this study is to compare the activity of raltitrexed and ZD1839 versus raltitrexed alone as second line chemotherapy in subjects with colorectal carcinoma by estimating progression free survival (PFS) in each treatment arm. |
NCT00684060 | ALL | ADULT, OLDER_ADULT | Left Ventricular Dysfunction | BIOLOGICAL: Adult stem cells|BIOLOGICAL: Placebo | Global Left Ventricular Function, Left ventricular ejection fraction (global) as assessed via cardiac MRI. Values reported represent the change in Global EF from baseline to six months., Measured at Baseline and Month 6|Regional Left Ventricular Function (Infarct Zone Wall Motion), One of two calculated values of regional left ventricular function as assessed via cardiac MRI. The infarct zone is defined as the cMRI segments with the largest 2 signal intensity enhancement measures with gadolinium (using a 17-segment model).Values reported represent the change in wall motion over time in the infarct zone from baseline to six months., Measured at Baseline and Month 6|Regional Left Ventricular Function (Border Zone Wall Motion), Two of two calculated values of regional left ventricular function assessed via cardiac MRI. The border zone is defined as those regions adjacent to the infarct zone in which the cMRI signal intensity enhancement were in the 10%-75% range. Values reported represent the change in wall motion over time in the border zone of the infarct from baseline to six months., Measured at Baseline and Month 6 | More than 1 million Americans suffer heart attacks each year. Although current treatments are able to stabilize the condition of the heart, none is able to restore heart function as it was prior to the heart attack. Adult stem cells, which are immature cells that can become many different types of cells, may offer a potential means of reversing or preventing permanent damage caused by a heart attack. Recent studies have shown promise in using adult stem cells from bone marrow to reverse damage to the heart muscle caused by a heart attack, but more research is needed to assess the safety and effectiveness of stem cell use and to discover the best time to administer treatment. This study will evaluate the safety and effectiveness of using adult stem cell infusions 2 to 3 weeks after a heart attack for improving heart function in people who have had a recent heart attack and a common procedure called a percutaneous coronary intervention (PCI). |
NCT04527640 | ALL | ADULT, OLDER_ADULT | Constipation|End Stage Renal Disease on Dialysis | DIETARY_SUPPLEMENT: Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg|OTHER: Placebo | Indoxyl Sulfate concentration, Concentration of indoxyl sulfates in the subjects' blood samples, Through study completion, an average of 60 days | This is a double-blind, placebo-controlled, randomized clinical trial conducted to evaluate the effects of synbiotics supplementation on the level of the uremic toxin indoxyl sulfate, symptoms of constipation, and constipation-related quality of life in end-stage renal disease patients undergoing hemodialysis. |
NCT00224770 | ALL | ADULT, OLDER_ADULT | Intracerebral Hemorrhage | DRUG: MIS+Cathflo Activase (drug)|PROCEDURE: Intraoperative stereotactic CT-Guided Endoscopic Surgery | Safety Outcome Number 1: Rate of Mortality, Percentage of participants who died during the first 30 days after randomization., 30 days from randomization|Safety Outcome Number 2: Rate of Procedure-related Mortality, Percentage of participants who died during the first 7 days after randomization., 7 days from randomization|Safety Outcome Number 3: Rate of Cerebritis, Meningitis, Bacterial Ventriculitis, Percentage of participants who had a bacterial brain infection (cerebritis, meningitis, ventriculitis) within 30 days of randomization., 30 days from randomization|Safety Outcome Number 4: Rate of Symptomatic Rebleeding, The difference in the rate of symptomatic rebleeding 72 hours post last dose., 72 hours post last dose|Efficacy Outcome Number 1: Dichotomized Modified Rankin Scale (mRS) at Day 180, Percentage of participants with dichotomized mRS score in 0-3 range. The mRS measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale ranges from 0-6: (0) no symptoms at all, (1) no significant disability despite symptoms; able to carry out all usual duties and activities, (2) slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance, (3) moderate disability; requiring some help, but able to walk without assistance, (4) moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance, (5) severe disability; bedridden, incontinent and requiring constant nursing care and attention, (6) dead, 180 days from randomization | The purpose of this trial is to determine the safety of using a combination of minimally invasive surgery and clot lysis with rt-PA to remove intracerebral hemorrhage (ICH). The ICES arm of the trial will determine the safety of endoscopic surgery to remove ICH. All MISTIE intention to treat subjects represent the hypothesized test group. The ICES cohort is to be analyzed separately. |
NCT02684240 | ALL | ADULT, OLDER_ADULT | Tuberculosis | DRUG: Nitazoxanide|OTHER: Control | time to positivity (TTP), To assess the change in time in hours to positive (TTP) signal in an automated liquid media culture system (BACTEC MGIT 960, Becton Dickinson) in participants receiving NTZ over 14 days, first 14 days of anti-tuberculosis therapy | This research is being done to determine if Nitazoxanide (NTZ) will cause a significant decrease in the number of M. tuberculosis bacteria in sputum after 14 days of treatment. The study is being conducted at the GHESKIO Centers in Port au Prince Haiti |
NCT03084367 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease|Coronary Stenosis|Angina, Unstable|Angina, Stable | DIAGNOSTIC_TEST: iFR pullback | Number of Participants With Residual Ischemia (iFR <0.90), Residual ischemia is defined as iFR measurement \<0.90 after operator-assessed angiographically successful PCI (residual diameter stenosis \<50% in any treated lesion in the target vessel) This outcome describes the number of participants that had a residual ischemia (defined as iFR\<0.90) after a PCI that appeared to be successful based on angiography., end of procedure/intervention | This is a pilot study designed to assess the relationship between iFR (instantaneous wave-free ratio) pullback and the distribution of coronary atheroma/stenoses as assessed by Quantitative Coronary Angiography (QCA) post angiographically successful PCI (Percutaneous Coronary Intervention). |
NCT01507506 | ALL | ADULT, OLDER_ADULT | Glioblastoma | RADIATION: Radiotherapy|RADIATION: Experimental arm | Overall survival defined as the time from randomization to the date of death or date of last follow-up news (censured data), 8 years | This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up.
Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or surgical specimen) and who meet all eligibility criteria will be randomized in one chemoradiotherapy arm :
* Conventional arm: 3-dimensional conformational radiotherapy + Temozolomide
* Experimental arm : simultaneous-integrated boost with intensity-modulated radiotherapy guided by magnetic resonance spectroscopic imaging + Temozolomide The patient monitoring will be regular and standardized. The main objective of this study is to improve overall survival of patients treated in experimental group (with simultaneous integrated boost). |
NCT01534234 | ALL | ADULT, OLDER_ADULT | Heart Failure NYHA Class III and Ambulatory IV | DEVICE: PARADYM RF SONR|DEVICE: PARADYM RF SONR | Evaluation of SonR CRT Optimization Effectiveness in terms of proportion of responders at 12 months. The investigational(SonR)and control groups(ECHO)will be compared in a non-inferiority context employing a clinically meaningful difference of 10%., The analysis will be done on all patients implanted with the entire system who have been followed out to 12 months. The patients will be classified as improved, unchanged or worsened based on composite criteria(death/heart failure (HF) events,New York Heart association(NYHA) class), Quality of life (QOL).
In the event that the non-inferiority test is met, a test of superiority will be conducted comparing the treatment and control groups., 12 months|Evaluation of Lead Safety: Acute SonRTipLead Complication-Free Rate (at 3 months), SonRtip acute lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead within 3 months post-implant, relative to the total number of patients implanted with the lead.All patients who are successfully implanted with SonRtip lead will be included., 3 months|Evaluation of Lead Safety: Chronic SonRTipLead Complication-Free Rate (from 3 months to 12 months), SonRtip lead-related complication-free rate is defined as the proportion of patients not experiencing any complication related to the SonRtip lead from 3 to 12 months post-implant.All patients who are successfully implanted with SonRtip lead will be included., 12 months | The objective of this study is to assess the safety and effectiveness of the automatic atrioventricular (AV) delay and interventricular (VV) delay optimization algorithm used in the PARADYM RF SONR Cardiac Resynchronization Therapy with Defibrillation (CRT-D) device (Model 9770) in combination with the SonRtip Lead, which includes a SonR sensor in the tip of the atrial pacing lead, and compatible SmartView programming software.
This study will evaluate the effectiveness of the automatic optimization algorithm in increasing the rate of patients responding to the therapy as compared to an echocardiographic optimization method.
This study will also evaluate the safety and effectiveness of the SonRtip atrial pacing lead. |
NCT05048667 | MALE | ADULT, OLDER_ADULT | Erectile Dysfunction | DEVICE: Shock Wave therapy (SWT)|DRUG: Platelet Rich Plasma (PRP)|OTHER: Sham SWT|OTHER: Placebo Saline | Change in IIEF-EF Scores, International Index of Erectile Function - Erectile Function Subdomain Score (IIEF-EF) is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function., Baseline, Month 3, Month 6|Percentage of participants achieving MCID in IIEF-EF, IIEF-EF is a 5-item subdomain self- evaluation questionnaire of erectile function with a total score ranging from 0-25 with the higher score indicating better erectile function. Mild Clinically Important Difference (MCID) is attained via an increase of 2 points in IIEF-EF score for participants with mild ED and an increase of 5 points for participants with moderate ED., Baseline, Month 3, Month 6|Penile Blood Flow, Penile Blood Flow will be reported as Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV), both assessed in cm/sec, via Penile Doppler ultrasonography, Baseline, Month 6|Circulating Angiogenic Factor levels, Circulating angiogenic factor levels including Vascular Endothelial Growth Factor (VEGF), Stromal Cell Derived Factor-1 (SDF-1 alpha) and Stem cell Factor (SCF), all reported in pg/mL, will be assessed via blood samples, Baseline, Month 3, Month 6 | The purpose of this research study is to evaluate whether the combination of Shock Wave Therapy (SWT) with Platelet Rich Plasma (PRP) is synergistic and can reverse the pathology of microvascular Erectile Dysfunction (ED) and enhance erectile function by improving vasodilation, and endothelial function |
NCT01510769 | ALL | ADULT, OLDER_ADULT | Tophaceous Gout | DRUG: Lesinurad|DRUG: Lesinurad|DRUG: Placebo|DRUG: Febuxostat | Subjects With a Serum Urate (sUA) Level That is < 5.0 mg/dL by Month 6, Proportion of subjects with an sUA level that is \< 5.0 mg/dL by Month 6, 6 months, analysis after all subjects complete 12 months | This study will compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with febuxostat to febuxostat alone in patients with tophaceaous gout. |
NCT01062295 | ALL | ADULT, OLDER_ADULT | Sleep | DEVICE: Siesta-System|DEVICE: Standard headrest | null | NTRODUCTION: The investigators have developed a new device to help passengers of vehicles to rest, sleep, and to avoid cervical injuries due to sleepiness postures while travelling. The device is attached to the headrest and is based in a new concept called "dynamic vertical holding of the head and neck". It could also provide some help in avoiding accidents by allowing a sleeping time for a secondary driver while the main one is driving. Several studies have shown that up to 30% of car crashes are related to sleepiness.
AIM: To estimate the efficacy and safety of a new device in "patent pending" phase to facilitate the sleep and rest in the passenger.
METODOLOGY: DESIGN: Prospective, cross-over and open clinical assay, comparing the results of 40 different passengers during a journey after using both systems, that is the new device and the standard headrest.
MEASUREMENTS: A) Standard polysomnography for 3 and a half hours during the night; B) Anthropometric and clinical variables; C) Sleepiness scale and Epworth sleepiness; D) Questionnaires of sleep, health and quality of life. E) Evaluation of the neck posture in recorded images.
ANALYSIS: To compare the results of questionnaires of sleep quality, comfort and safety as well as the images recorded and polysomnographic variables of objective sleep variables obtained by the device Siesta-SystemTM and the conventional headrest. |
NCT04171999 | ALL | CHILD, ADULT, OLDER_ADULT | Food Insecurity | OTHER: Community Rx-Hunger (CRx-H) | (Aim 1) Change in caregiver self-efficacy at 12 months from baseline, Self-efficacy is measured by Bandura's Self-Efficacy Scale which asks, "How confident are you in your ability to find resources in your community that help you manage your health?" Responses will be assessed on a 5-point Likert scale ranging from "not at all confident" to "completely confident.", Baseline, 12 months|(Aim 2) Caregiver satisfaction with hospital care, Satisfaction with hospital care is measured by the Hospital Consumer Assessment of Healthcare Providers Survey (HCAHPS); "Child HCAHPS" which includes 8 items plus one item added by the research team for a total of 9 items. Response options are "Yes, definitely," "Yes, somewhat" and "No." The items ask about the child and the hospital related to their recent stay., 7 days post discharge from the hospital | CommunityRx-Hunger (CRx-H) is a hospital-based intervention that addresses food insecurity and other health-related social needs such as transportation, housing, utilities, and safety. Study team members are recruiting caregivers at the time of their child's hospital admission at a large urban children's hospital. For Aim 1, the primary outcome is self-efficacy among food insecure caregivers compared to those who receive the usual standard of care. For Aim 2, the primary outcome is satisfaction with care compared between food secure and food insecure caregivers. |
NCT03047772 | ALL | ADULT, OLDER_ADULT | Myocardial Infarction|Stem Cell Transplantation|Angioplasty, Transluminal, Percutaneous Coronary | DRUG: Atorvastatin|DRUG: Intensive Atorvastatin|DRUG: Low dose BMMSC|DRUG: Middle dose BMMSC|DRUG: High dose BMMSC|DRUG: Transplantation | Changes in left ventricular ejection fraction from baseline to 12 months', Changes in left ventricular ejection fraction from baseline to 12 months' by MRI, 12 months | The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after acute myocardial infarction who underwent intracoronary transfer of autologous bone marrow mesenchymal stem cells. |
NCT00825929 | FEMALE | ADULT, OLDER_ADULT | HIV Infections | null | Plasma concentrations of the compounds during pregnancy compared to the concentrations after delivery, PK curve in Week 33 of pregnancy and 4-6 weeks after delivery | Due to the potential for pregnancy-induced changes in the pharmacokinetics of medication, one cannot assume that the currently licensed doses of the medication to be tested under this protocol lead to adequate exposure in an HIV-infected pregnant woman. For the agents under study no or limited pharmacokinetic data during pregnancy are available. As the changes in pharmacokinetics during pregnancy are most prominent in the third trimester a pharmacokinetic curve will be recorded in the third trimester after attaining steady state. |
NCT00868231 | ALL | ADULT, OLDER_ADULT | Chronic Obstructive Pulmonary Disease (COPD) | DRUG: Aclidinium bromide 400 μg bid|DRUG: Tiotropium 18 μg once-daily|DRUG: Placebo | Change From Baseline in Normalised Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 hr at Day 15 on Treatment., Day 15 | The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients. |
NCT02344290 | ALL | ADULT, OLDER_ADULT | HIV Infections|Cardiovascular Diseases | DRUG: Pitavastatin|DRUG: Placebo | Time to the first event of a composite of major cardiovascular events, Includes atherosclerotic or other CVD death, nonfatal myocardial infarction, unstable angina hospitalization, coronary, carotid or peripheral arterial revascularization, nonfatal stroke or transient ischemic attack (TIA), peripheral arterial ischemia, Measured through participants' final study visit, at approximately Month 36 to 96 | People infected with HIV are at risk for cardiovascular disease (CVD). This study will evaluate the use of pitavastatin to reduce the risk of CVD in adults infected with HIV who are on antiretroviral therapy (ART).
The REPRIEVE trial consists of two parallel identical protocols:
* REPRIEVE (A5332) is funded by the NHLBI, with additional infrastructure support provided by the NIAID, and is conducted in U.S and select international sites (approximately 120 sites in 11 countries).
* REPRIEVE (EU5332) is co-sponsored by NEAT ID and MGH, and is conducted at 13 sites in Spain. |
NCT01991769 | ALL | ADULT, OLDER_ADULT | Diabetes Mellitus, Type 2 | BEHAVIORAL: 47 min moderate intensity training|BEHAVIORAL: exercise healthy volunteers|BEHAVIORAL: control; no exercise training | endothelial function, measured as flow mediated dilatation (FMD) of the brachial artery using high resolution vascular ultrasound according to current guidelines, 24 hours | The purpose of this study is to examine whether exercise reduces the postprandial effects of an unhealthy meal on heart function and endothelial function.
Both healthy people and type 2 diabetes subjects will during three days either carry out two different sessions of exercise training or not before ingesting an unhealthy meal high in saturated fat and fast carbohydrates. The two different exercise training modes used are high intensity interval training (HIIT) and moderate intensity training (MIT) Hypothesis: Exercise training in advance of an unhealthy meal will improve endothelial- and cardiac function in healthy and type 2 diabetes individuals. HIIT will reduce the negative postprandial effects on the endothelium more than MIT. |
NCT02191579 | ALL | ADULT, OLDER_ADULT | Migraine Disorders | BIOLOGICAL: onabotulinumtoxinA|DRUG: Topiramate | Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days, Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported., Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 | This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine. |
NCT00098137 | ALL | ADULT, OLDER_ADULT | Heart Disease|Arrhythmia|Atrial Fibrillation | DRUG: Olmesartan | Percentage of days with documented episodes of paroxysmal atrial fibrillation (number of days with paroxysmal atrial fibrillation/number of days with at least one readable Tele-ECG recording), 12 months follow-up | Hypothesis:
Blocking the angiotensin (AT) II type 1 receptor (Olmesartan) reduces the incidence of episodes of atrial fibrillation in patients with paroxysmal atrial fibrillation during 12 months by more than 25% compared to standard medication without angiotensin II type 1 receptor.
A total of 422 subjects will be included in the two study groups. The treatment arm will receive 40mg Olmesartan per day, the remaining patients will receive placebo. Follow-up is 12 months. Daily Tele-ECG recordings will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation (AF) every day. Concomitant therapy with AV-nodal blocking drugs are allowed during the study. In case of severe AF-induced symptoms, an antiarrhythmic "recovery medication" (amiodarone) is allowed during follow-up. |
NCT04390698 | FEMALE | ADULT, OLDER_ADULT | Opioid Free Anesthesia | PROCEDURE: paravertebral block|DRUG: opioid free anesthesia|PROCEDURE: sham block|PROCEDURE: opioid general anesthesia | quality of recovery, 15-item 15-item 15-item quality of recovery questionnaire, 24 hours after surgery | A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia. |
NCT02696213 | ALL | ADULT, OLDER_ADULT | Mobility Scooter Skills Training | OTHER: Systematic, Comprehensive, One to One Training (SCOOT)|OTHER: Six Week Delay | Change in scooter skills capacity, The WST-ScQ measures the participant's subjective scooter skills (capacity), and inquires on the frequency the skill is performed, and whether or not improvement of the skill is a personal goal., Change from baseline skill level at 6 weeks, 12 weeks, 6 months, and 1 year | Systematic, Comprehensive, One-to-One Training (SCOOT) for Scooter Skills, is a novel, community-based, client-centred intervention where skills training is incorporated into social activities that users want to perform. The trainer also offers problem solving strategies to help manage environmental barriers and to promote social participation. This intervention is different from customary scooter training in that customary training is often very limited and focuses on learning discrete skills outside of the user's normal environment. The purpose of this study is to explore the feasibility of conducting a mixed-methods, rater-blinded, randomized controlled trial (RCT) for new scooter users, which will evaluate the efficacy of SCOOT. We anticipate that the feasibility outcomes will be strong enough to support the conduct of a subsequent multi-site trial with a sufficient sample size to enable us to quantify definitive outcomes such as adverse events (e.g., injuries and abandonment). |
NCT00057681 | ALL | CHILD | Bipolar Disorder | DRUG: Lithium carbonate|DRUG: Valproate|DRUG: Risperidone | Clinical Global Impressions-Bipolar Mania Improvement, The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse., Measured at Week 8 | This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania. |
NCT02725359 | ALL | ADULT, OLDER_ADULT | Thyroidectomy | DRUG: Placebo|DRUG: Tizanidine|DRUG: Bupivacaine|DRUG: Saline | Visual analog pain score, Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively., postoperative first hour|Visual analog pain score, Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively., postoperative second hour|Visual analog pain score, Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively., postoperative 4th hour|Visual analog pain score, Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively., postoperative 8th hour|Visual analog pain score, Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively., postoperative 12th hour|Visual analog pain score, Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively., postoperative 24th hour | Thyroid surgery is a quite painful procedure performed in a sensitive skin area of the human body. Unless pain is treated adequately thyroid surgery may cause severe postoperative pain and discomfort for the patients.
a2-Agonists are sympatholytic and centrally acting antihypertensive agents. In addition to their hypotensive effect, a2-agonists are also used in anesthetic practice for their sedative and analgesic effects. Tizanidine is a centrally acting a2-agonist with muscle relaxant, sedative and anxiolytic properties. This drug is widely used for the treatment of spasticity and has recently been used to treat musculoskeletal pain conditions.
Ultrasound (US) guidance during regional anesthesia practices has been a revolutionary advancement to improve success and safety of regional anesthesia. Analgesic effect of US guidance superficial cervical plexus block (SCPB) in patients undergoing thyroid surgery has not been reported yet.
The aim of this study was to evaluate the analgesic effect of preemptive oral single dose tizanidine and US guidance SCPB in patients undergoing elective thyroid surgery. The investigators hypothesis that: Tizanidine and US guided SCPB can reduce the pain scores, analgesic consumption, analgesic related side effects. |
NCT01777828 | ALL | CHILD, ADULT, OLDER_ADULT | Transcatheter Aortic Valve Implantation | null | 1-year survival, After leaving the hospital, the doctor responsible for the register in each center will contact the patient or his family and referring physicians by phone to take new or fix an appointment for consultation. The study is purely observational, it does not require special monitoring visits but involves collecting data obtained during routine follow-up visits., 1 year | Register multicenter, prospective, open, non-randomized implantation of percutaneous aortic bioprostheses through for the treatment of severe degenerative aortic stenosis Epidemiological data and the 1-year survival of aortic bioprostheses implanted by percutaneous. |
NCT02111577 | MALE | ADULT, OLDER_ADULT | Metastatic Castration-resistant Prostate Cancer | BIOLOGICAL: DCVAC/PCa|BIOLOGICAL: Placebo | Overall Survival, Intention-to-treat Population, Overall survival is defined as the time from randomization until death due to any cause., From randomization to death due to any cause, up to 58 months | The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer. |
NCT01264406 | ALL | ADULT, OLDER_ADULT | Exercise|Energy|Body Weight | null | A Comparison of the effects of energy balance with three groups., A comparison of three groups for the effects of energy balance: 1. Healthy Living, 2. Recommended dose exercise, and 3. High dose exercise. Random assignment is determined by chance.
Healthy Living Group: Information tips on a variety of topics, including stress management, the benefits of eating fruits and vegetables, and other health related matters. This information is sent directly to your cell phone or email address throughout the study. Encouragements are sent to attend monthly seminars on various health topics at Pennington. Maintain a baseline level of exercise throughout the study.
Recommended Dose Exercise: 3 t0 4 low-intensity sessions per week, each lasting about 30 minutes, at Pennington Fitness and Wellness Center. All exercise will be done on a treadmill.
High Dose Exercise: 4 to 5 high-intensity session s per week, each lasting about 50-70 minutes, at Pennington Fitness and wellness center. All exercise will be done on the treadmill., 6 months after screening | This study will compare the effect of two doses of exercise on energy intake and body weight. The comparison will be between three groups; two exercise groups and a control group. The exercise groups will not be provided with a dietary intervention and the study design also includes a non-exercise control group. E-Mechanic trial can make important contributions to understanding of the role of exercise dose in weight management. While it is accepted that regular exercise plays an important role in general health, the exact role of exercise in prevention of weight gain, weight loss and prevention of weight regain remains poorly understood despite exercise being widely prescribed for these purposes. The idea that current weight management exercise recommendations may produce increased energy intake (or other forms on compensation) resulting in disappointing weight loss is an important public health issue. The finding of this study could help shape future exercise and weight loss recommendations and treatment plans. |
NCT04081779 | ALL | ADULT, OLDER_ADULT | Breast Carcinoma|Colorectal Carcinoma|Lung Carcinoma|Lymphoma|Prostate Carcinoma | OTHER: Survivorship Care Plan|OTHER: Educational Intervention|OTHER: Questionnaire Administration | Initial participation rate of cancer survivors identified from community-based practices, Up to 8 weeks|Accuracy of survivors' self-generated survivorship care plans (SCPs) in relation to those based on medical record abstraction, Will measure the accuracy of participants' SCPs by comparing their self-reported medical history collected via questionnaire, with data abstracted from medical records. Accuracy will be reported by percentage of missing data in the self-generated SCP compared to medical records, and percentage of incorrect data in the self-generated SCP compared to medical records., Up to 8 weeks|Proportion of survivors who receive the phone-based education session within the study time period, Up to 8 weeks|Proportion of survivors who complete the follow-up questionnaire within the study time period, Up to 8 weeks|Response rate among primary care providers (PCPs) to the PCP survey, Up to 8 weeks | This trial studies how well self-generated survivorship care plans and telehealth education works in improving knowledge and self-efficacy in cancer survivors living in rural areas. Patients living in rural areas often face barriers to survivorship care and report unmet needs. A survivorship care plan created by the patient (self-generated) may help them to better transition from oncology to primary care and improve communication between care teams in order to meet these needs and create better health outcomes. Telehealth is a way of delivering health care services from a distance, including patient education. Combining a self-generated survivorship care plan with telehealth education may help to improve knowledge and self-efficacy in cancer survivors. |
NCT04494867 | ALL | ADULT, OLDER_ADULT | Covid19 | DEVICE: Core Warming|OTHER: Standard of Care | PaO2/FiO2 Ratio, Determine the change in PaO2/FiO2 ratio at 0, 24, 48, and 72 hours after implementation of core warming of ventilated patients, and compare this change to patients undergoing standard care., 0, 24, 48, and 72 hours after initiation of core warming | The purpose of the proposed pilot study is to determine if core warming improves respiratory physiology of mechanically ventilated patients with COVID-19, allowing earlier weaning from ventilation, and greater overall survival. |
NCT01813435 | ALL | ADULT, OLDER_ADULT | Coronary Artery Disease (CAD) | DRUG: Ticagrelor|DRUG: Acetylsalicylic Acid|DRUG: Clopidogrel | Number of Participants With a Composite of All-cause Mortality or Non-fatal New Q-wave Myocardial Infarction (MI), Number of Participants with a composite of all-cause mortality or non-fatal new Q-wave MI up to 2 years post randomisation., 2 year | After a stent procedure, it is common practice to prescribe anti-platelet medication to prevent the blood from clotting. The main objective of this study is to determine if there is a better medication strategy to prevent blood from clotting and at the same time minimising the number of complications.
There are two medication strategies:
* Study group: Dual anti-platelet therapy (ticagrelor combined with aspirin) for 1 month, and then ticagrelor alone for another 23 months OR
* Control group: Standard treatment, being dual anti-platelet therapy (ticagrelor or clopidogrel combined with aspirin) for 12 months, and then aspirin alone indefinitely |
NCT00425776 | FEMALE | ADULT, OLDER_ADULT | Breast Cancer|Postmenopause | DEVICE: acupuncture|DEVICE: Sham acupuncture | using a hot flushes rating scale., 12 weeks|Sleep disturbances yes or no, 12 weeks | In a randomized 3-group clinical study acupuncture is used for the relief of menopausal hot flushes and sleep disturbances in women treated for breastcancer.
The three groups consists of 35 women given acupuncture once a week five times and 35 women given shamacupuncture once a week five times and 35 women with no kind of treatment. Se-estradiol and endorphin is measured before and after the acupuncture.
We want to state that acupuncture given five times once a week has a significant better effect on hot flushes and sleeping disturbances than shamacupuncture or no treatment at all.
We also want to measure if there are any changes in se-estradiol and endorphine |
NCT01518933 | ALL | ADULT, OLDER_ADULT | Hepatitis C Virus Recurrence | DRUG: Silibinin (Legalon-SIL)|DRUG: Saline | Viral load, To determine the effect of post-transplant treatment with Legalon SIL on HCV viral load 30 days after the beginning of treatment., 30 days after the beginning of treatment | Hepatitis C virus (HCV)-related liver disease is the most common indication for liver transplantation (LT). However, LT does not cure the infection, and therapeutic strategies resulted in very limited efficacy and tolerability in LT recipients. In view of its postulated safety profile, Silibinin seems an ideal drug to be used in the setting of HCV recurrent patients after liver transplantation. |
NCT02659059 | ALL | ADULT, OLDER_ADULT | Non-Small-Cell Lung Cancer | BIOLOGICAL: Nivolumab|BIOLOGICAL: Ipilimumab|DRUG: Platinum Doublet Chemotherapy | Objective Response Rate (ORR) by PD-L1 Positive and Negative Levels - Part 1, Objective response rate (ORR) in PD-L1 positive (PD-L1 ≥1%) and PD-L1 negative (PD-L1 \<1%) participants was defined as the percentage of treated participants with confirmed complete response (CR) or partial response (PR) per RECIST 1.1 based on Blinded Independent Central Review (BICR) assessment., From first dose to database lock (Up to 18 months)|Number of Participants With Dose Limiting Toxicities (DLTs) - Part 2, Dose limiting toxicities (DLTs) were defined as any of the items listed below.
1. Any Grade 2 drug-related uveitis or eye pain that does not respond to topical therapy and does not improve to Grade 1 severity within the re-treatment period OR requires systemic treatment.
2. Any Grade 2 drug-related pneumonitis or interstitial lung disease that does not resolve to dose delay and systemic steroids in 14 days.
3. Any Grade 3 non-skin drug-related adverse event with the exception of laboratory abnormalities that cannot be alleviated or controlled by appropriate care within 14 days.
4. Any Grade 4 drug-related adverse event including laboratory abnormalities except Grade 4 leukopenia or neutropenia lasting \< 14 days and asymptomatic amylase/lipase elevation.
5. Drug-related hepatic function laboratory abnormalities., 9 weeks after first dose|Number of Participants With Adverse Events (AEs) - Part 2, Number of participants with adverse events (AEs) including serious adverse events (SAEs) and deaths graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy., Deaths are from first dose to database lock (Up to 24 months). AEs and SAEs are from first dose to 30 days post last dose|Number of Participants With Laboratory Abnormalities in Hepatic Tests - Part 2, Number of participant with specific liver laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy., From first dose to 30 days post last dose|Number of Participants With Laboratory Abnormalities in Thyroid Tests - Part 2, Number of participants with specific thyroid laboratory abnormalities graded by Common Terminology Criteria for Adverse Events (CTCAE v4.0) to determine the safety and tolerability of Nivolumab and Ipilimumab combined with chemotherapy., From first dose to 30 days post last dose | The purpose of part 1 of this study is to determine the objective response rate (ORR) in stage IV NSCLC subjects treated with nivolumab in combination with ipilimumab as first line therapy.
The purpose of part 2 of this study is to determine the safety and tolerability of nivolumab and ipilimumab combined with a short course of chemotherapy in first line stage IV NSCLC. |
NCT00913302 | ALL | ADULT, OLDER_ADULT | Ankylosing Spondylitis | BEHAVIORAL: Cardiovascular Training | Cardiovascular Fitness, Baseline and post-intervention | To test the effects of a cardiovascular training compared to attention control in a group of AS-patients participating in classic spinal mobility exercise groups (randomized controlled trial) |
NCT01406106 | ALL | ADULT, OLDER_ADULT | Hypercholesterolemia | DIETARY_SUPPLEMENT: Plant stanol esters | Change in lipid profile, Lipid levels will be measured in both plasma and capillary blood at the initial visit. The validity of the capillary blood lipid levels can be checked with the Cardiochek analyser (by total cholesterol, HDL-cholesterol and triglyceride strips, and subsequent calculation of LDL-cholesterol using the Friedewald formula). The measurements at 3, 12 and 24 months will be in plasma. At 1, 6 and 18 months they will only be in capillary blood., At 1, 3, 6, 12, 18 and 24 months | Background information Studies have been conducted on supplementing the daily diet with plant sterol ester-enriched milk derivatives in order to reduce LDL-cholesterol levels and, consequently, cardiovascular risk. However, clinical practice guidelines on hypercholesterolaemia state that there is not sufficient evidence to recommend their use in subjects with hypercholesterolaemia. The null hypothesis establishes that there is no relationship between the decrease in blood LDL-cholesterol levels and the consumption of stanol ester enriched liquid yoghurt. The alternative hypothesis establishes a relationship between such consumption and the incidence of the primary variable.
The main objective of this study is to determine the efficacy of the intake of 2 g of plant sterol esters a day in lowering LDL-cholesterol levels in patients diagnosed with hypercholesterolaemia. The specific objectives are: 1) to quantify the efficacy of the daily intake of plant sterol esters in lowering LDL-cholesterol, total cholesterol and cardiovascular risk in patients with hypercholesterolaemia; 2) to evaluate the occurrence of adverse effects of the daily intake of plant sterol esters; 3) to identify the factors that determine a greater reduction in lipid levels in subjects receiving plant sterol ester supplements.
Study design Randomised, double-blind, placebo controlled experimental trial carried out at family doctors' surgeries at three health centres in the Health Area of Albacete (Spain). The study subjects will be adults diagnosed with "limit" or "defined" hypercholesterolaemia and who have LDL cholesterol levels of 130 mg/dl or over. A dairy product in the form of liquid yoghurt containing 2 g of plant sterol ester per container will be administered daily after the main meal, for a period of 24 months. The control group will receive a daily unit of yogurt not supplemented with plant sterol esters that has a similar appearance to the enriched yoghurt. The primary variable is the change in lipid profile at 1, 3, 6, 12, 18 and 24 months. The secondary variables are: change in cardiovascular risk, adherence to the dairy product, adverse effects, adherence to dietary recommendations, frequency of food consumption, basic physical examination data, health problems, lipid-lowering medication, physical activity, smoking habits and socio-demographic variables. |
NCT01260350 | ALL | ADULT, OLDER_ADULT | Chronic Hepatitis C Infection | DRUG: SOF|DRUG: RBV|DRUG: PEG|DRUG: LDV|DRUG: GS-9669|DRUG: LDV/SOF | Percentage of Participants Who Experienced Adverse Events, Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event., Up to 12 weeks plus 30 days | This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection. |
NCT03029169 | ALL | CHILD, ADULT, OLDER_ADULT | Supraventricular Arrhythmia|Septic Shock | DRUG: Propafenone i.v.|DRUG: Amiodarone i.v. | Efficacy of propafenone, cardioversion rate, 1 year|ICU mortality of septic shock patients on propafenone for a SV arrhythmia, ICU mortality, 1 year|28-day mortality of septic shock patients on propafenone for a SV arrhythmia, 28-day mortality, 2 years|12-month mortality of septic shock patients on propafenone for a SV arrhythmia, 12-month mortality, 2 years | Arrhythmias accompany septic shock in increased rates than in other ICU cohorts and their presence and management are related to patient´s prognosis. 1c class antiarrhythmics are seldom administered in intensive care due to a dose dependent toxicity published in case reports and unfavourable outcome reported in a few prospective trials done on cardiology patients. The papers on 1c class antiarrhythmics do not take into consideration a complex haemodynamic assessment using echocardiography. The authors have recently presented a retrospective study on SV arrhythmias in septic shock patients demonstrating favourable effect and safety of propafenone which showed higher antiarrhythmic efficacy than amiodarone. |
NCT00917618 | ALL | ADULT, OLDER_ADULT | Knee Osteoarthritis | OTHER: Exercise|OTHER: Control | Preferred gait speed, 12 weeks | Hypothesis: Group cycling classes (Spinning®) will improve pain and functional outcomes in patients with knee osteoarthritis
Methods: Patients with symptomatic knee OA will be randomized to active Spinning® classes 2-3 per week or control group for 3 months. Outcomes including gait speed, WOMAC, KOOS, KOS, and VAS pain at rest and after 6 min walk will be performed at baseline and at 12 weeks. |
NCT00713648 | ALL | CHILD, ADULT, OLDER_ADULT | Congenital Bleeding Disorder|Congenital FXIII Deficiency | DRUG: catridecacog | Rate (Number Per Subject Year) of Bleeding Episodes Requiring Treatment With a FXIII Containing Product During the Treatment Period, It represents the incidence of bleeding episodes requiring treatment with a FXIII-containing product., For a period of 322 days (approximately one year) comprised of a screening visit (Visit 1), treatment period (Visits 2-15), unscheduled visit and end-of-trial visit (Visit 16). | The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes. |
NCT03468478 | ALL | ADULT, OLDER_ADULT | Kidney Transplant Infection | DRUG: Sirolimus|DRUG: Everolimus|DRUG: Mycophenolic acid | Incidence of Cytomegalovirus Infection or Disease, Incidence of CMV infection/disease in three study groups (SRL, EVR anda MPS)., 12 months follow up | This study was designed to compare 3 immunosuppression regimens: sirolimus and tacrolimus versus everolimus and tacrolimus versus mycophenolate and tacrolimus.
The primary outcome is the incidence of cytomegalovirus infection / disease, a relevant medical need in the absence of pharmacological prophylaxis. |
NCT00992134 | ALL | ADULT, OLDER_ADULT | Lymphoma, Mantle-Cell | DRUG: Rituximab, Bendamustine, Cytarabine | The safety and tolerability of R-BAC treatment will be tested to determine the dose limiting toxicity (DLT) and maximum tolerated dose (MTD) of Ara-C when combined with Bendamustine and Rituximab., June 2011 | The objective of the study is to demonstrate the safety, tolerability, and activity of Rituximab-Bendamustine-Cytarabine(R-BAC) regimen in patients with mantle cell lymphoma (MCL) aged 65 years or more, as well as in younger patients who are not eligible for intensive regimens including/not including autologous transplantation. |
NCT02500043 | ALL | ADULT, OLDER_ADULT | Refractory Metastatic Gastric Cancer | DRUG: TAS-102|DRUG: Placebo | Overall Survival (OS), OS was defined as the time from the date of randomization to the date of death due to any cause. Participants without documented death were censored at last follow-up or cut-off date, whichever comes first. OS was estimated by Kaplan-Meier method., From the date of randomization to the data cut-off date (maximum duration: up to approximately 46 months) | The purpose of this trial is to compare the effects of TAS-102 and best supportive care (BSC) with Placebo (an inactive drug) and best supportive care on metastatic gastric cancer. |
NCT01443364 | ALL | ADULT, OLDER_ADULT | Rheumatoid Arthritis | BIOLOGICAL: Certolizumab pegol | The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52, Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system, From Baseline to Week 12 and Week 52|The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52, Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system, From Baseline to Week 8 and Week 52|The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52, Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system, From Baseline to Week 6 and Week 52|The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52, Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system, From Baseline to Week 4 and Week 52|The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52, Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system, From Baseline to Week 2 and Week 52|The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52, Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 \[Erythrocyte Sedimentation Rate\] (DAS28-ESR) scoring system, From Baseline to Week 1 and Week 52 | The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis. |
NCT02213601 | FEMALE | ADULT | Depression, Postpartum | BEHAVIORAL: Yoga | Change from baseline in depression on the 17-item Hamilton Depression Rating Scale (HDRS) at week 8, The Hamilton Depression Rating Scale (HDRS) is a validated and reliable measure of the severity of depressive symptoms, and is used extensively in depression treatment studies. The 17-item HDRS is sensitive to treatment change in the postpartum population, and is a valid indicator of depression severity in postpartum depression despite the overlap between somatic HDRS items and typical experiences of postpartum women., Baseline, Week 8 | The aim of this project is to compare the efficacy of an 8-week yoga intervention, relative to a wait-list control (WLC) condition, for improving psychological functioning and health-related quality of life in depressed postpartum women. It was hypothesized that the yoga intervention would be significantly more efficacious than the wait-list control condition in reducing symptoms of depression and anxiety, and improving health-related quality of life, at the end of the 8-week yoga intervention. |
NCT00671151 | MALE | ADULT, OLDER_ADULT | COPD | DRUG: Theophylline | HDAC activity in alveolar macrophages, 3 months | Molecular mechanisms of COPD exacerbations and the modulating effect of low dose theophylline on that inflammation are elucidated in this project. NF-kappa B-dependent pathway and acetylation status of nuclear histones are to be studied.Design: controlled, prospective and randomized study with or without theophylline, a potent HDAC activator.Objectives: 1) To determine NF-kB activation, histone deacetylase (HDAC) and histone acetyl-transferase (HAT) activity in sputum macrophages and blood monocytes during an episode of exacerbation and 3 months later, once stability is achieved. To correlate these measurements with inflammatory and oxidative stress markers and with pulmonary function and clinical variables. 2) To assess the effect of theophylline on previous molecular, functional and clinical data. Method: 25 patients with COPD will be recruited during an episode of exacerbation requiring hospitalization. NF-kB activation, HDAC and HAT activity, markers of inflammation and oxidative stress will be determined with specific assays. These determinations will be repeated once the patient is stable and compared with smokers and non smoker controls with normal lung function |
NCT00729937 | ALL | CHILD, ADULT, OLDER_ADULT | Staphylococcal Infection | DRUG: Cephalexin|DRUG: Clindamycin|OTHER: Placebo|DRUG: Trimethoprim-sulfamethoxazole | Number of Participants With Clinical Cure as of the Test-of-Cure (TOC) Visit in the Per Protocol Population, Clinical cure at TOC was defined as no failure on any previous visit up through the TOC, absence of fever, and resolution or minimal presence of all the following signs and symptoms from baseline based on clinician assessment of erythema, swelling, and tenderness. A participant would have been a clinical failure at the On Therapy (OTV) visit with presence of fever attributable to the infection being studied, increase in erythema by 25% or more, or worsening of both swelling and tenderness based on clinical assessment. A participant would have been a clinical failure at the End of Therapy (EOT) visit with presence of fever attributable to the infection being studied, increase or no improvement in erythema, or no improvement in either swelling or tenderness based on clinical assessment., Days 14-21 | The purpose of this study is to determine the optimal outpatient treatment strategy of uncomplicated skin and soft tissue infection (SSTI) in areas of the United States where the prevalence of Community-Acquired Methicillin-Resistant Staphylococcus (S.) aureus (CA-MRSA) is high. Infection with the S. aureus bacteria that is resistant to antibiotics is a cause of SSTIs. Three oral antibiotics will be tested for off patent treatment. Patients will receive Trimethoprim/Sulfamethoxazole (TMP/SMX), placebo (substance containing no medication), clindamycin, or cephalexin or some combination of these. The study population will include 2,235 volunteers, children 13 years of age and over and adults presenting to 5 large urban Emergency Departments. Therapy for acute uncomplicated SSTIs, including abscess, infected wound, and cellulitis will start on the day of enrollment. Participants may be involved in study related procedures for about 9 weeks. |
NCT02328079 | ALL | CHILD, ADULT | Facial Palsy | DRUG: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir) | Facial muscle function using clinical scale, Evaluations of facial muscle function using clinical scale were performed blindly by a neurologist who was unaware of the type of treatment of which the patient had received, 2 months | The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient was submitted to the following clinical evaluation using House and Brackmann 6 facial function scoring system and Synnybrook grading system. Neurophysiological assessment of facial nerve and muscles was done before and after the end of treatment, then after the end of first and second month of treatment. EMG was done for facial muscles of both sides beside measuring facial nerve excitability to determine the excitation threshold by recording the minimum electrical stimulus required to produce visible muscle contraction. A difference greater than 3.5 mA between the affected and unaffected side is considered significant in terms of poor prognosis. Nerve conduction study of facial nerves of both sides using concentric needle electrode. Trigeminal Blink reflex for both sides of the face. Facial functional recovery was defined as "good" or "complete" using the same criteria used in the 2001 practice guideline. An outcome of grade I or II was considered a good recovery using the House and Brackmann 6 facial function scoring system |
NCT00125502 | FEMALE | CHILD, ADULT | Cytomegalovirus Infections | BIOLOGICAL: CMV gB vaccine|DRUG: MF59 adjuvant|DRUG: Placebo | Time to CMV infection., From initial vaccine to final study visit. | The purpose of this study is to determine if a new cytomegalovirus (CMV) vaccine (CMV gB/MF59) can safely prevent mothers from catching CMV infection between pregnancies. This study includes 464 women, ages 14-40 years, who delivered a newborn infant within 12 months prior to the study. Participants must live within the Birmingham metropolitan area or the Tuscaloosa county area and they cannot have had CMV infection previously. CMV vaccine or placebo (substance containing no medication) will be given at 3 study visits. Participants fill out diary cards for 7 days after each vaccination. Blood samples will be collected. Urine samples will be collected several times and pregnancy tests will be performed. Participants who tested positive for CMV will have urine, vaginal swab, and saliva specimens collected. Each participant will be followed for 3 years after the third dose of vaccine. Infants born to participants in the study will be checked for CMV infection. |
NCT02491632 | ALL | ADULT, OLDER_ADULT | Advanced Malignant Neoplasm|Fatigue|Metastatic Malignant Neoplasm|Recurrent Malignant Neoplasm|Refractory Malignant Neoplasm | DRUG: Dexamethasone|BEHAVIORAL: Exercise Intervention|OTHER: Laboratory Biomarker Analysis|OTHER: Quality-of-Life Assessment|OTHER: Questionnaire Administration | Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29, FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test., Baseline, day 8, day 29 | This randomized phase II trial studies how well physical activity and dexamethasone work in reducing cancer-related fatigue in patients with cancer that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Dexamethasone is approved for the treatment of tiredness, pain, and nausea. Physical activity may help improve cancer-related fatigue by improvement in symptoms, distress, and overall well-being. It is not yet known whether high dose or low dose dexamethasone combined with physical activity works better in reducing fatigue in patients with advanced cancer. |
NCT01611883 | ALL | ADULT, OLDER_ADULT | Hypercholesterolemia | DRUG: Ezetimibe|DRUG: Placebo | Change in Glycated Hemoglobin (HbA1c) From Baseline, HbA1c is blood marker used to report average blood glucose levels over a prolonged period of time and is reported as a percentage (%). HbA1C was measured at baseline and after 24 weeks of study drug administration., Baseline and Week 24 | This study will examine the effect of ezetimibe on glucose metabolism in participants with Type 2 diabetes and hypercholesterolemia.The primary hypothesis is that change in glycated hemoglobin (HbA1c) from baseline in the ezetimibe treatment group will be non-inferior to the placebo control group. |
NCT02355210 | ALL | ADULT, OLDER_ADULT | Intestinal Microbiota and Barrier Function | DIETARY_SUPPLEMENT: Bifidobacteria adolescentis BD1|DIETARY_SUPPLEMENT: Bifidobacteria animalis subsp. lactis BB-12|DIETARY_SUPPLEMENT: Bifidobacteria adolescentis BD1 and galactooligosaccharide|DIETARY_SUPPLEMENT: Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide|DIETARY_SUPPLEMENT: galactooligosaccharide|DIETARY_SUPPLEMENT: Placebo | Change in Microbiota, as Measured by Change in Microbiota Composition, Including Presence of B. Adolescentis BD1 and B. Animalis Supsp Lactis BB-12, change in microbiota composition, including presence of B. adolescentis BD1 and B. animalis supsp lactis BB-12, baseline and three weeks|Change in Intestinal Permeability as Measured by Change in Percent Sugars in Urine, Change in intestinal permeability as measured by change in percent sugars in urine, baseline and three weeks | This study evaluates the effect of a dietary supplement to improve gut health. The participants will take one of six dietary treatments for three weeks, and the gut bacteria and the gut intestinal barrier will be assessed to determine if these dietary treatments beneficially change these markers of gut health. |
NCT01244698 | FEMALE | ADULT, OLDER_ADULT | Bacterial Infection|Anti-infective Agents|Breast Implantation | DRUG: Cefadroxil discontinued early|DRUG: Cefadroxil until drain removal | Surgical Site infection, One or more of the following:
1. Purulent drainage, with or without laboratory confirmation, from the superficial incision.
2. Organisms isolated from an aseptically obtained culture of fluid or tissue from the superficial incision.
3. At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately opened by surgeon, unless incision is culture-negative.
4. Diagnosis of superficial incisional SSI by the surgeon or attending physician., 365 days after the procedure | Antibiotics are used routinely in postoperative tissue expander based breast reconstruction (TE) and autologous flap (AF) breast reconstruction procedures. Closed suction drains are also used routinely in immediate breast reconstruction to prevent fluid accumulation and seroma formation at the surgical sites. Antibiotics are most often prescribed as a precaution since drains can be a source for infection by creating open channels to outside contaminants. Plastic surgery patients without closed suction drainage devices are usually not placed on prolonged postoperative antibiotics. Current preoperative surgical antibiotic prophylaxis is recommended for up to 24 hours only. These recommendations do not take into account the increased risk of indwelling closed suction drains. A recent survey of plastic surgeons, conducted by SBUMC investigators, (IRB# 129415) found that Plastic Surgeons are divided as to extended outpatient administration following TE breast reconstruction.
The study plans to prospectively enroll patients who will undergo immediate breast reconstruction with TE or AF based breast reconstruction. Using the above data and the current protocol, the investigators will investigate the optimal antibiotic discontinuation period for these patients. The investigators hypothesize that the use of 24-hour perioperative antibiotics in TE or AF based immediate breast reconstruction with closed suction drainage, does not result in an increased infection rate compared to prolonged postoperative antibiotic administration. |
NCT00326118 | ALL | CHILD | Haemophilus Influenzae Type b|Neisseria Meningitidis | BIOLOGICAL: Haemophilus influenzae type b and meningococcal serogroup C (vaccine)|BIOLOGICAL: Priorix™|BIOLOGICAL: Hiberix™|BIOLOGICAL: Meningitec™ | Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL), Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of short-term protection., 1 month after vaccination|Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titers Greater Than or Equal to 1:8 Titer, rSBA-MenC titers greater than or equal to 1:8 titer are indicative of seroprotection., 1 month after vaccination | The purpose of the primary phase of the study is to demonstrate the non-inferiority of a single dose of GSK Biologicals' Haemophilus influenzae type b and meningococcal C (Hib-MenC) conjugate vaccine when given in the second year of life to subjects primed in infancy with a Hib vaccine, but not with a meningococcal serogroup C vaccine, versus commercially available Hib and MenC vaccines.
In the extension phase, at Years 1, 2, 3, 4 \& 5, one blood sample is taken at each year to follow the antibody persistence up to 5 years after vaccination. No additional vaccine is administered during the extension phase. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. |
NCT02584816 | ALL | CHILD | Rotavirus Gastroenteritis | BIOLOGICAL: BRV-PV Lot A + DPT-HepB-Hib + OPV|BIOLOGICAL: BRV-PV Lot B + DPT-HepB-Hib + OPV|BIOLOGICAL: BRV-PV Lot C + DPT-HepB-Hib + OPV|BIOLOGICAL: ROTARIX + DPT-HepB-Hib + OPV | Rotavirus vaccine lots Immunogenicity, Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots., Four weeks after the third dose of vaccination|Immunogenicity of UIP vaccines, Four weeks after the third dose of vaccination | This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV). |
NCT00091949 | ALL | ADULT, OLDER_ADULT | Stroke|Myocardial Infarction|Diabetes | DRUG: pioglitazone|DRUG: placebo | Recurrent Fatal or Non-fatal Stroke, or Fatal or Non-fatal Myocardial Infarction, Up to 5 years | The purpose of this study is to determine if pioglitazone is effective in preventing future strokes or heart attacks among non-diabetic persons who have had a recent ischemic stroke. |
NCT01479972 | ALL | CHILD | Tuberculosis | BIOLOGICAL: VPM1002|BIOLOGICAL: BCG | Safety, Safety and tolerability as assessed by monitoring of adverse events (incidence, time profile, other profiles, and including local or regional reactions at the vaccination site), physical examination, vital signs, standard laboratory safety parameters, including haematology, clinical chemistry and urinalysis., Six months | Goal of VPM is the development of a recombinant urease C-deficient listeriolysin expressing BCG vaccine strain (VPM1002) as a safe, well tolerated and efficacious vaccine against tuberculosis (TB) for residents in endemic areas and persons at risk in non-endemic areas. The new vaccine should be at least as potent as the current strain and should be safer than BCG (Kaufmann, 2007a; Grode et al., 2005). The vaccine is formulated as live lyophilised bacteria to be re-suspended before intradermal injection. The preceding clinical trials in 80 volunteers in Germany and 24 volunteers in Bloemfontein, South Africa indicated immunogenicity and safety being sufficient for proceeding with the clinical development in newborn infants. Hence, the current study is commenced at Stellenbosch University, South Africa. This is the first investigation of VPM1002 in newborn infants. |
NCT03647072 | ALL | ADULT, OLDER_ADULT | Lymphoma | DRUG: CHOP|DRUG: CHOP Plus Lanzoprazole|DRUG: CHOP Plus Famotidine | Number of patients eith radiological and clinical improvement, Number of patients eith radiological and clinical improvement after cycles of chemotherapy, 6 months | The study is a Comparative Clinical and Biochemical Study Evaluating the effect of Proton Pump I nhibitors versus histamine 2 Receptor antagonists as an adjuvant with chemotherapy in patients with Non-hodgkin Lymphoma. |
NCT02586415 | ALL | ADULT, OLDER_ADULT | Stroke, Acute|Cerebral Infarction | PROCEDURE: Endovascular Thrombectomy|DEVICE: Trevo Retriever|DEVICE: Solitaire™ FR Revascularization Device|DEVICE: Penumbra thrombectomy system|DEVICE: Covidien MindFrame Capture Revascularization Device | The Distribution of Scores on the Modified Rankin Scale (mRS) at Day 90, The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The scale runs from 0-6 with "0" being perfect health without symptoms to "6" being death. 0 - No symptoms.
1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. - Moderate disability. Requires some help, but able to walk unassisted.
4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. - Dead., Day 90 | This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well. |
NCT04123951 | ALL | ADULT, OLDER_ADULT | Kidney Transplant; Complications | OTHER: Home-based Exercise | Change in Left ventricular mass (g/m), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in left/right ventricular volumes (ml), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in ejection fractions (%), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in native and post-contrast T1 mapping time (ms), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in Myocardial systolic-strain (%), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in peak early-diastolic strain rate (%s-1), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in Aortic pulse wave velocity (m/s), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in aortic distensibility (mmHg-1×10-3), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks|Change in Myocardial and hepatic triglyceride content (%), Measured using multi-parametric cardiac MRI (CMR), Baseline and 12 weeks | Although patients who have received a kidney transplant have better health than patients on dialysis, heart problems are still the commonest cause of death for kidney transplant recipients. This is because diseases like high blood pressure and diabetes are more common in patients with kidney transplants as well as factors related to having kidney disease itself and the medications transplant recipients have to take to stop them rejecting their transplanted kidney. Exercise is known to help with heart disease in lots of conditions and improves many of the risk factors known to cause heart disease in kidney transplant recipients. This study will investigate whether an individualised, home-based, exercise program improves heart disease in kidney transplant recipients. The study is a randomised controlled trial, with half the patients completing the 12 week exercise programme and the other half continuing with their normal care. The investigators will use detailed MRI scans to assess patient's hearts and blood vessels at the start and end of the study. The investigators will also assess changes in physical function, exercise capacity, blood markers of heart disease, changes in body type and quality of life measures assessed with questionnaires. |
NCT00923013 | ALL | ADULT, OLDER_ADULT | Hairy Cell Leukemia | DRUG: Cladribine|DRUG: Rituximab | Response Rate, Rate of minimal residual disease (MRD) identified in patients 6 months after beginning cladribine for treatment of HCL compared to patients treated with cladribine combined with rituximab, 6 months | Background:
Hairy cell leukemia (HCL) is highly responsive to but not curable by cladribine (CdA). HCL responds to rituximab, which is not yet standard therapy for HCL.
Patients with the CD25-negative variant (HCLv) respond poorly to initial cladribine but do respond to rituximab in anecdotal reports.
Deoxycytidine kinase phosphorylates cladribine to CdATP, which incorporates into DNA, leading to DNA strand breaks and inhibition of DNA synthesis. Rituximab is an anti-CD20 monoclonal antibody which induces apoptosis and either complement or antibody dependent cytotoxicity (ADCC or CDC).
Patients in complete remission (CR) to cladribine have minimal residual disease (MRD) by immunohistochemistry of the bone marrow biopsy (BMBx IHC), a risk for early relapse. Tests for HCL MRD in blood or marrow include flow cytometry (FACS) or PCR using consensus primers. The most sensitive HCL MRD test is real-time quantitative PCR using sequence-specific primers (RQ-PCR).
In studies with limited follow-up, MRD detected by tests other than RQ-PCR can be eliminated by rituximab after cladribine in greater than 90 percent of patients, but MRD rates after cladribine alone are unknown. Simultaneous cladribine and rituximab might be superior or inferior to delaying rituximab until detection of MRD.
Only 4 HCL-specific trials are listed on Cancer.gov: a phase II trial of cladribine followed 4 weeks later by 8 weekly doses of rituximab, and phase I-II trials of recombinant immunotoxins targeting CD22 (BL22, HA22) and CD25 (LMB-2).
Objectives:
Primary:
To determine if HCL MRD differs at 6 months after cladribine with or without rituximab administered concurrently with cladribine.
Secondary:
* To compare cladribine plus rituximab vs cladribine alone in terms of 1) initial MRD-free survival and disease-free survival, and 2) response to delayed rituximab for relapse, to determine if early rituximab compromises later response.
* To determine if MRD levels and tumor markers (soluble CD25 and CD22) after cladribine and/or rituximab correlate with response and clinical endpoints.
* To determine, using MRD and tumor marker data, when BMBx can be avoided.
* To compare response and MRD after the 1st and 2nd courses of cladribine.
* To evaluate the effects of cladribine and rituximab on normal T- and B-cells.
* To enhance the study of HCL biology by cloning, sequencing and characterizing monoclonal immunoglobulin rearrangements.
Eligibility:
HCL with 0-1 prior courses of cladribine and treatment indicated.
Design:
Cladribine 0.15 mg/Kg/day times 5 doses each by 2hr i.v. infusion (days 1-5)
Rituximab 375 mg/m2/week times 8 weeks, randomized half to begin day 1, then repeat for all patients with blood-MRD relapse at least 6 months after cladribine. Also may repeat for those with blood-MRD relapse at least 6 months after delayed rituximab.
MRD tests used for the primary objective will be limited to BMBx IHC, blood FACS or blood consensus PCR, all CLIA certified. Blood MRD relapse is defined as FACS positivity or low blood counts (ANC less than 1500/microl, Plt less than 100,000/microl, or Hgb less than 11).
Stratification: 68 patients with 0 and 62 with 1 prior course of cladribine.
Statistics: 80% power to discriminate rates of MRD of 5 vs 25%, or 10 vs 35%
Non-randomized arm: 20 with HCLv will begin rituximab with cladribine.
Accrual Ceiling: 152 patients (130 HCL, 2 extra HCL if needed, and 20 HCLv.) |
NCT01740791 | ALL | ADULT, OLDER_ADULT | Chronic Hepatitis C Virus | DRUG: Velpatasvir|DRUG: Placebo | Percentage of Participants Experiencing Treatment Emergent Adverse Events, Treatment-emergent adverse events were defined as any new or worsening adverse event that began on or after the date of the first dose of study drug until the Day 17 study visit date + 2 (Day 19 if Day 17 visit missing)., First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)|Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities, A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline at any postbaseline visit up to the Day 17 visit date + 2 days (or Day 19 if Day 17 visit was missing). The criteria used to grade laboratory results were as follows: Grade 1 (mild), Grade 2 (moderate), or Grade 3 (severe). Graded laboratory abnormalities were defined using the grading scheme defined in protocol (Gilead Sciences, Inc. Grading Scale for Severity of Adverse Events and Laboratory Abnormalities) for analysis purpose., First dose date up to Day 17 + 2 (Day 19 if Day 17 visit missing)|Antiviral Activity of Velpatasvir as Measured by Change in Plasma HCV RNA From Baseline, Participants who were genotyped incorrectly but received appropriate treatment for that genotype were included in that treatment group for the efficacy analysis. Data were summarized by treatment and placebo., Baseline; Days 4, 5, 6, 7, 8, 10, and 17 | The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6. |
NCT00132691 | ALL | CHILD, ADULT, OLDER_ADULT | Uveitis | DRUG: fluocinolone acetonide intraocular implant|DRUG: oral corticosteroid with immunosuppressive agents as needed | Change in Best-corrected Visual Acuity (Change in the Numbers of Letters Read From a Standard ETDRS Eye Chart) From Baseline to 24 Months in Eyes With Uveitis, Best-corrected visual acuity was measured as the number of letters read from standard logarithmic visual acuity charts by study-certified examiners who were masked to treatment. Visual acuity was measured at all study visits. The primary outcome was eye-specific change in visual acuity from baseline to 2-year follow-up. Positive change values indicate improved vision while negative change values indicate vision has gotten worse. A change of 7.5 letters is considered clinically meaningful., 24 months | The purpose of this study is to compare the effectiveness of standardized systemic therapy versus fluocinolone acetonide implant therapy for the treatment of severe cases of non-infectious intermediate uveitis, posterior uveitis, or panuveitis. |
NCT05002738 | FEMALE | ADULT | Contraception | DRUG: Desogestrel and Ethinyl Estradiol Tablets | Serum etonogestrel concentrations, 12 serum measurements taken over the course of 24 hours, 24 hours|Serum ethinyl estradiol concentrations, 12 serum measurements taken over the course of 24 hours, 24 hours | This study aims to validate prior pharmacokinetic research with combined oral contraceptive pill users that supports utilizing a 24-hour trough concentration as an accurate proxy for the intensive pharmacokinetic parameter of area under the curve (gold standard pharmacokinetics). The original pharmacokinetic studies were performed with a levonorgestrel-containing oral contraceptive pill and we aim to duplicate those findings with a desogestrel-containing oral contraceptive pill. |
NCT02813343 | ALL | ADULT, OLDER_ADULT | Type 2 Diabetes | DEVICE: BlueStar app | Glucose control (HbA1c levels), Change in HbA1c from baseline to 6 months, Baseline, 3 months and 6 months | This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 300 participants that are randomized to an immediate treatment group or a delayed intervention group. The primary outcomes include changes in HbA1c and patient reported outcomes and experience measures. Qualitative interviews with various stakeholders will explore issues relating to successful implementation. |
NCT01316211 | ALL | ADULT, OLDER_ADULT | Spinal Stenosis | DEVICE: Implantation of coflex™ after surgical decompression|PROCEDURE: Surgical decompression | Change in ODI From Baseline to 24 Months, The ODI, also known as the Oswestry Low Back Pain Disability Questionnaire is a questionnaire providing information on back and leg pain and the affects on managing everyday life by dividing questions into 10 sections. For this study, the questions on sexual activity will not be asked. The total possible score for each section is 0-5. The scores are then converted percentages ranging from 0% (minimal disability) to 100% (maximum possible disability)., Baseline, 3, 12, and 24 months | A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology |
NCT01739686 | ALL | ADULT, OLDER_ADULT | Chronic Heart Failure | OTHER: CASA Intervention | Difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall score, The KCCQ is a self-administered questionnaire that measures heart failure-specific health status. The KCCQ is reliable, sensitive to clinical change, and predicts hospitalization and mortality. The study will test whether there is a difference in KCCQ overall score between the intervention and control groups at 6 months., 6 months | Chronic heart failure is an important public health problem as it is a leading cause of disability, hospitalization, death, and costs. People who live with advanced chronic heart failure suffer from numerous symptoms that affect their daily lives. The investigators are conducting a randomized clinical trial to evaluate a symptom management and psychosocial care intervention to improve health status (symptom burden, functioning, and quality of life). The results will be directly relevant to patients and families who suffer with this illness, as well as to providers, payers, and other researchers. |
NCT00988325 | ALL | CHILD | Influenza | DRUG: Tamiflu | Steady-state Area Under the Plasma Concentration Versus Time Curve From Time Zero to 12 Hours of Oseltamivir and Oseltamivir Carboxylate, Oseltamivir carboxylate is active metabolite of oseltamivir. AUC0-12 was estimated for oseltamivir and oseltamivir carboxylate by linear trapezoidal rule, 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Steady-state Maximum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate, Oseltamivir carboxylate is an active metabolite of oseltamivir. Cmax was estimated for both oseltamivir and Oseltamivir carboxylate by non-compartmental analysis., 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1|Steady-state Minimum Observed Plasma Concentration of Oseltamivir and Oseltamivir Carboxylate, Oseltamivir carboxylate is active metabolite of oseltamivir. Cmin was estimated for both oseltamivir and oseltamivir carboxylate by non-compartmental analysis, 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 3 if two doses taken on Day 1 or 15 minutes pre-dose; 1 hour +/- 15 minutes, 2-3, 5-7, 10-12 hours post-dose on Day 4 if one dose taken on Day 1 | This study will assess the pharmacokinetics/pharmacodynamics and safety of oseltamivir \[Tamiflu\] therapy in infants less than 1 year of age with influenza diagnosed in the 96 hours prior to the first dose. Patients age 3-12 months will receive 3 mg/kg, 1-3 months will receive 2.5 mg/kg, and birth to 1 month will receive 2 mg/kg twice a day for a total of 10 doses. Patients positive for influenza virus on Day 6 will be eligible to receive continued study treatment for an additional 10 doses (5 days). The anticipated time on study treatment is 4 weeks, and the target sample size is 65-85 male and female infants. |
NCT01966848 | ALL | ADULT, OLDER_ADULT | Osteoarthritis | DEVICE: Wich prosthesis is used | To compare the Vanguard CR and Vanguard XP prosthesis regarding migration/rotation over time, measured by RSA, Migration/rotation of the prosthesis measured in mm/degrees using RSA., 2 years | In the history of TKA several different types of prosthetic designs have been evolved in order to optimize knee function after total knee replacement. The most common difference between the prosthetic designs revolves around issues concerning the preservation of the cruciate ligaments. The most popular prostheses have been the posterior stabilized prosthesis (PS) in which both cruciate ligaments are resected and the posterior cruciate retaining prosthesis (CR) in which only ACL is resected and PCL is preserved. Both these prosthetic designs have shown excellent clinical results in the literature.
In the knee the role of the cruciate ligaments is to insure anterior/posterior stability, but studies have also shown, that the cruciate ligaments contain proprioceptive mechanisms which control joint kinematics essential for accurate knee function. One could therefore imagine that a prosthetic design that preserves both cruciate ligaments would be superior to prosthetic designs in which ACL or ACL/PCL is resected in achieving good clinical results and patient satisfaction.
Only a few prosthetic designs, which preserve both cruciate ligaments, have been available to the market. However studies based on fluoroscopic assays and gait analysis has shown that this prosthetic design is superior to cruciate sacrificing designs in preserving normal knee kinematics during activities of daily living after TKA. Studies, in which patients have received two different types of prosthesis in each knee, have also shown that bi-cruciate retaining TKA's is preferred, when compared to more constrained prosthetic designs.
The new Vanguard XP TKA system (Biomet®, Warsaw, Indiana, USA) is a further development of the Vanguard TKA system, which has shown good clinical results in earlier studies. With the new Vanguard XP system both cruciate ligaments are preserved. In theory this should result in a more natural feeling of the knee because the stability and proprioceptive signals from both cruciate ligaments are preserved. In order to investigate the potential benefits of this new prosthetic design, the clinical and radiological results of knees receiving a Vanguard XP and Vanguard CR prostheses are compared.
In this study we wish to investigate:
1. If the use of the Vanguard XP prosthesis will influence the migration of the femur- and tibial components measured by Radiostereometric Analysis (RSA) when compared to the Vanguard CR prosthesis.
2. If the use of the Vanguard XP prosthesis will result in increased participant knee function, satisfaction and quality of life when compared to the Vanguard CR prosthesis.
3. If the use of the Vanguard XP prosthesis will influence radiologic signs of osteolysis, complication rates and revision rates when compared to the Vanguard CR prosthesis.
This project is carried out as a randomized controlled double-blinded trial, in which the clinical and radiological outcomes after treatment of knee osteoarthritis with insertion of either a Vanguard XP or Vanguard CR prosthesis is compared. |
NCT03682302 | ALL | CHILD | Postoperative Pain Management | DRUG: Exparel|DRUG: 0.5% Bupivacaine HCl | Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Infinity, 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)|Maximum Plasma Concentration (Cmax), 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)|The Apparent Terminal Elimination Half-life (t1/2el), 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)|Apparent Clearance (CL/F), 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)|Apparent Volume of Distribution (Vd/F), 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery)|Area Under the Plasma Concentration-versus-time Curve (AUC) 0 to Tlast, 15, 30, 45 min, 1-1.25h, 2-4h, 10-18h, 24-36h, 42-60h (spine surgery) or 15, 30, 45 min, 1-1.25, 15-25, 20-40, 45-55, 64-72h (cardiac surgery) | Primary Objective: To evaluate the pharmacokinetics (PK) of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries.
Secondary Objective: To evaluate the safety of EXPAREL in pediatric subjects aged 6 to less than 17 years undergoing various types of surgeries. |
NCT03057977 | ALL | ADULT, OLDER_ADULT | Heart Failure | DRUG: Empagliflozin|DRUG: Placebo | Time to the First Event of Adjudicated Cardiovascular (CV) Death or Adjudicated Hospitalisation for Heart Failure (HHF), Time to the first event of adjudicated cardiovascular (CV) death or adjudicated hospitalisation for heart failure (HHF). The incidence rate per 100 patient years (100 \* number of patients with event /time at risk \[years\]) is presented. With time at risk \[year\] calculated as: Sum of time at risk \[days\] over all patients in a treatment group / 365.25.
Patients without a specific endpoint event were censored at the last date the patient was known to be free of the event or at the end of the planned treatment period, whichever was earlier.
Unit of Measure: Patients with events per 100 patient-years (pt-yrs) at risk., From randomisation until completion of the planned treatment period, up to 1040 days. | The aim of the study is to investigate the safety and efficacy of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with reduced ejection fraction. |
NCT00468676 | ALL | ADULT, OLDER_ADULT | Depression | BEHAVIORAL: Nurse-led case management|BEHAVIORAL: Treatment as usual | Combined Effect of Intervention on SCL-20, Systolic Blood Pressure, LDL and HbA1c, A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large., Baseline to 12 months|Symptom Checklist-20 Score at Baseline, 6 Months and 12 Months, SCL-20 is a 20 question checklist in which items are averaged to yield a potential score of 0 to 4 with higher scores indicating more severe depression symptoms.
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes., Measured at Baseline, 6 Months, 12 months|Systolic Blood Pressure at Baseline, 6 Months and 12 Months, Systolic Blood Pressure was measured at Baseline, 6 months and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes., Measured at Baseline, 6 Months, 12 months|LDL Cholesterol at Baseline and 12 Months, LDL Cholesterol was measured at Baseline and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes., Measured at Baseline and 12 months|Glycated Hemoglobin (HbA1c) at Baseline, 6 Months and 12 Months, Glycated hemoglobin (HbA1c) was measured at Baseline, 6 months and 12 months
For the Primary Outcome (Outcome Measure #1 above), a scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes., Measured at Baseline, 6 months and 12 months | This study will evaluate the effectiveness of a nurse-led case management intervention in improving disease control and depression symptoms in adults with diabetes and/or heart disease who are also depressed. |
NCT03809819 | null | CHILD, ADULT, OLDER_ADULT | Mayer-Rokitansky-Kuster Syndrome | PROCEDURE: laparoscopic Vecchietti vaginoplasty|DIAGNOSTIC_TEST: FSFI questionnaire|DIAGNOSTIC_TEST: UDI-6 questionnaire|DIAGNOSTIC_TEST: IIQ-7 questionnaire | sexual functions after Vecchietti operation, assessment of sexual functions after Vecchietti operation with the use of The Female Sexual Function Index (FSFI) questionnaire, 8 years|Urinary incontinence after Vecchietti operation, assessment of Urinary incontinence after Vecchietti operation with the use of the Urinary Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7), 8 years | The aim of this study was to establish the urogynecological and sexual functions after Vecchietti operation. |
NCT00867412 | ALL | ADULT, OLDER_ADULT | Non-Small Cell Lung Cancer|Thoracotomy | null | Number of futile thoracotomies, Within 1 year | Patients with possible operable non-small cell lung cancer are randomised to conventional staging, or conventional staging and PET/CT. According to, patients with operable tumor will be referred to surgery, and the number of thoracotomies and futile thoracotomies wil be compared with the two groups in order to asses the possible benefit of PET/CT. |
NCT00977574 | FEMALE | ADULT, OLDER_ADULT | Endometrial Adenocarcinoma|Endometrial Adenosquamous Carcinoma|Endometrial Clear Cell Adenocarcinoma|Endometrial Serous Adenocarcinoma|Recurrent Uterine Corpus Cancer|Stage IIIA Uterine Corpus Cancer AJCC v7|Stage IIIB Uterine Corpus Cancer AJCC v7|Stage IIIC Uterine Corpus Cancer AJCC v7|Stage IVA Uterine Corpus Cancer AJCC v7|Stage IVB Uterine Corpus Cancer AJCC v7 | BIOLOGICAL: Bevacizumab|DRUG: Carboplatin|DRUG: Ixabepilone|OTHER: Laboratory Biomarker Analysis|DRUG: Paclitaxel|DRUG: Temsirolimus | Number of Participants Who Progressed or Died by 25 Months From Enrollment, PFS (Progression free survival) is defined as the duration of time from date of study entry to time of progression or death, whichever occurs first. Patients with a status of alive, progression-free are censored at their date of last follow-up. To lessen the potential for bias in the progression evaluation times between treatment arms and historical controls, progression/death times will be grouped over 6 18-week time intervals. Progressions are carried forward to the end of the interval. All progressions or deaths occurring after the 6th 18-week interval are censored at 25 months for this analysis. Study NCT00977574, at 25 months | This randomized phase II trial studies paclitaxel, carboplatin, and bevacizumab or paclitaxel, carboplatin, and temsirolimus or ixabepilone, carboplatin, and bevacizumab to see how well they work in treating patients with stage III, stage IV, or recurrent endometrial cancer. Drugs used in chemotherapy, such as paclitaxel, carboplatin, and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which treatment regimen is most effective in treating patients with endometrial cancer. |
NCT03144583 | ALL | CHILD, ADULT, OLDER_ADULT | Leukemia|Lymphoma | BIOLOGICAL: Adult differentiated autologous T-cells | Procedure-related mortality (PRM), Any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event., Year 1|Procedure-related mortality (PRM), Any death not caused directly by leukemia / lymphoma. For the estimation of PRM, relapse or progression of the disease will be considered as a competitive event., Year 3|Assessment of toxicity, number of adverse events grade III-IV using CTC (common toxicity criteria), Month 3|Assessment of toxicity, number of adverse events grade III-IV using CTC (common toxicity criteria), Year 1 | To assess the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity \[A3B1\] conjugated with the co-stimulatory regions 4-1BB and CD3z ) safety on patients with leukemia or lymphoma CD19+ resistant or refractory to treatment and with a prognosis of less than 2 years. |
NCT00940797 | ALL | ADULT | Diabetes Type 2 | DRUG: DMMET-01|DRUG: Placebo | Insulin sensitivity, 2 months | The aim of this study is to determine the effect of DMMET-01 on insulin sensitivity by Glucose CLAMP technique in Mexican type 2 diabetes patients, after 2 months of treatment. |
NCT02331745 | ALL | CHILD, ADULT, OLDER_ADULT | Liver Failure|Hepatitis B|Alcoholic Liver Disease | DRUG: Granulocyte colony-stimulating factor|DRUG: standard treatment | Survival rates, 12 weeks | This study evaluates the Granulocyte colony-stimulating factor (G-CSF) in the treatment of Acute on Chronic Liver Failure in adult. Half participants will receive G-CSF and standard treatment in combination, while half participants will receive standard treatment. |
NCT00714090 | ALL | ADULT, OLDER_ADULT | Unipolar Depression | OTHER: active venlafaxine and active rTMS-repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed|OTHER: active rTMS -repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and sham venlafaxine|OTHER: sham rTMS- repetitive transcranial magnetic stimulator, Inomed and Alpine Biomed and active venlafaxine | The primary outcome measure is remission. It will be evaluated using the Hamilton Depression Rating Scale (HDRS-17 < 8)and Montgomery Asberg Depression Rating Scale (MADRS), 2 to 6 weeks | The purpose of this study is to assess the efficacy of add-on therapy with repetitive Transcranial Magnetic Stimulation (rTMS) and venlafaxine in the treatment of major depressive disorders compared to venlafaxine only (the optimal medication) and to rTMS only. |
NCT01405976 | ALL | CHILD, ADULT, OLDER_ADULT | Obesity Hypoventilation Syndrome | DEVICE: life style modification, noninvasive ventilation, CPAP | Days of hospitalization, Days of hospitalization, at least three years|PaCO2, PaCO2, at the end of first two months | Primary objectives: evaluate the efficacy of noninvasive ventilation (NIV) treatment versus continuous positive airway pressure (CPAP) and life style modification treatment in Obesity Hypoventilation Syndrome (OHS), with PCO2 (first phase) and days of hospitalization (second phase) analyzed as a primary variables and percentage of dropouts for medical reasons and mortality as operative variables. As secondary variables: Measure functional and clinical improvement during sleep and wakefulness, quality of life, echocardiography and the incidence and blood pressure and evolution of cardiovascular events. Objectives secondaries:role of apneogenic sleep events on molecular inflammation, endothelial damage and the genesis of diurnal hypercapnia. Methods:prospective, randomized controlled trial. Patients with OHS will be divided initially into two groups based on their apnea-hypopnea index (AHI) score, \>=30 and \< 30, using conventional polysomnography. The AHI \>=30 group will be randomized to CPAP, NIV or life style modification treatments. The AHI \<=30 groups will be randomized to NIV or life style modification treatments. Treatment efficacy at the medium- and long-term will be analyzed by comparing groups. The role of apneic events and leptin in the genesis of daytime alveolar hypoventilation will be analyzed by comparing the daytime PCO2/AHI coefficient between responders and non-responders to CPAP treatment, and the evolution of leptin levels in the four branches of the study. The role of apneic events in metabolic and biochemical alterations and endothelial dysfunction will be analyzed by comparing basal and post-treatment levels of related substances between groups, with and without significant AHI. |
NCT00640900 | FEMALE | ADULT, OLDER_ADULT | Overweight|Obesity | BEHAVIORAL: Usual care|BEHAVIORAL: Commercial weight loss program | weight loss, 2 year | This study will provide data on the response over 24 months to two commercial weight loss programs (center-based and telephone-based) compared to control conditions. |
NCT00995878 | FEMALE | ADULT, OLDER_ADULT | Symptomatic Uterine Leiomyomas|Fibroids|Uterine Fibroids|Myomas | PROCEDURE: Focused ultrasound (MRgFUS)|PROCEDURE: Uterine artery embolization (UAE) | Symptomatic outcomes measured by validated instruments, At baseline, 6 weeks and 6, 12, 24, and 36 months following treatment. | The primary goal of this study is to compare the safety and effectiveness of two standard fibroid treatments: MRI guided ultrasound surgery (MRgFUS) and uterine artery embolization (UAE). Both treatments are approved by the Food and Drug Administration (FDA) for women who do not plan to become pregnant.
A second goal of this study is to better understand which symptoms bother women with fibroids the most. Understanding and addressing the symptoms of clinically-significant uterine fibroids is important in order to optimize treatment outcomes and control health care costs.
Women who are eligible to participate in the study, are randomized to one of two treatment arms (UAE or MRgFUS). Women in both arms will receive treatment but will not be able to choose which treatment she will receive.
A comprehensive assessment of symptoms-including experienced pain- will take place at baseline, 6 weeks, and at 6, 12, 24, and 36 months following treatment with UAE and MRgFUS. |
NCT03439410 | ALL | ADULT, OLDER_ADULT | Multimorbidity|Health Knowledge, Attitudes, Practice | OTHER: Clinical Complexity Index | Validation of the Clinical Complexity Index (CCI), Validation of the Clinical Complexity Index (CCI) proposed in the project (see first Citation and Study Description for further details). This index should measure patients' clinical complexity, including biological, socioeconomic, cultural, behavioral, and envirnomental domains. The total score range is -25 to +25 (-5 to +5 per each domain). The investigators expect that a higher value is associated with a worse outcome (higher clinical complexity)., 2 years | The progressive rising of multimorbidity, which has been always considered the hallmark of clinical complexity (CC), has made management of the "complex" patient one of the most topical and challenging issues in medicine. However, patient-related factors (multimorbidity, age, frailty, disease severity) pertain only to the biological complexity, while CC is the result of the dynamic interaction between biological complexity and a number of other coexisting factors (socio-economic, cultural, behavioural, environmental). Starting from these premises, the investigators designed a five-year observational prospective longitudinal study that aims to validate and compare a CC score system on a large cohort of patients (n=1000) admitted in internal medicine wards. Clinicians, biostatisticians and epidemiologists will cooperate into the project. A questionnaire that encompasses the main biological and extra-biological factors was designed (Clinical Complexity Index, CCI) by a multiprofessional consensus. This questionnaire will be administered by the investigators to the patients and validated. Consecutive patients will be enrolled every other week for two years and followed-up for 5 years. The primary endpoint will be the validation of the CCI. Thereafter, the investigators will evaluate the correlation between the CCI and the length of stay of the index hospitalization, assuming that a higher CCI score is associated with longer length of stay. The secondary endpoints will be the demonstration of the association between higher CCI score and more health resources utilization (i.e., evaluating occurrence of hospital readmissions, number of accesses to the emergency room, visits at the outpatient clinic, different drugs prescribed and hospital reimbursement according to the local diagnosis-related group \[DRG\] system) along with worse prognosis (mortality at 1 and 5 years). |
NCT01283854 | FEMALE | ADULT | Gestational Diabetes Mellitus | BEHAVIORAL: Supervised home-based exercise | Diagnosis of gestational diabetes mellitus, After the 14 week intervention period (28 weeks gestation) | Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy and has serious health implications for both the pregnant woman and her child. In particular, offspring of mothers with GDM have an increased prevalence of obesity, diabetes and metabolic syndrome, perpetuating serious health consequences in subsequent generations.
Although regular exercise offers numerous benefits for both the mother and her child, its effectiveness in preventing GDM remains to be established. It has been recently shown that regular supervised home-based exercise may attenuate the decline in glucose tolerance in obese pregnant women. This study aims to conduct a single-centred, multi-sited, single-blinded randomised controlled trial examining the effect of 14 weeks of supervised home-based exercise (commenced at 14 weeks gestation) on the recurrence and severity of GDM, along with other aspects of maternal and fetal wellbeing.
Eligible participants (n = 200) will be randomly allocated to an exercise intervention (n = 100) or a control group (n = 100). The exercise intervention will involve three 60-minute home-based, supervised exercise sessions each week. This type of program overcomes many of the barriers to exercise in this population including transportation, child care issues and embarrassment associated with exercising in a public venue. The investigators have already shown this program to be both feasible and warmly accepted by obese pregnant women. |
NCT03255187 | ALL | ADULT | Oxidative Stress|Inflammation|Blood Pressure|Vasoconstriction|Coagulation|Pulmonary Function | DIETARY_SUPPLEMENT: Fish oil supplementation|DIETARY_SUPPLEMENT: Sunflower seed oil supplementation | Biomarkers of Antioxidant Activity-Total Antioxidant Capacity (TAC) and Superoxide Dismutase (SOD), Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure 2 biomarkers of antioxidant activity, including TAC and SOD. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Biomarkers of Inflammation-Interleukin-6 (IL-6) and Tumour Necrosis Factor-α (TNF-α), 2 inflammatory biomarkers in our study including IL-6 and TNF-α are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Cogulation Biomarker-von Willebrand Factor (vWF), We measure vWF level in serum, one of the measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Biomarkers of Endothelial Function and Stress Hormone, We measure endothelial function biomarkers, including E-selectin and endothelial nitric oxide synthase (eNOS), and 4 stress hormones, including corticotropin releasing hormone (CRH), adrenocorticotropic hormone (ACTH), cortisol and serotonin. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Endothelial Function Biomarker-Endothelin-1(ET-1), We measure ET-1 level in serum, an endothelial function biomarker. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Cogulation Biomarker-Fibrinogen, We measure the serum level of fibrinogen, one of the two measured cogulation biomarkers in our study. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|High-sensitivity C-reactive Protein (Hs-CRP)-an Inflammatory Biomarker, The serum levels of hs-CRP are measured. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Oxidized Low Density Lipoprotein (Ox-LDL)-an Oxidative Stress Biomarker, Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of ox-LDL. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Glutathione Peroxidase (GSH-Px)-a Biomarker of Antioxidant Activity, Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We also measure GSH-Px. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention.|Serum Level of Lipid Peroxidation (LPO)-a Biomarker of Oxdative Stress, Peripheral blood samples (5 ml) were drawn, separated into serum, and stored at -80 ℃ within 30 minutes. We measure the serum level of LPO. The values in the following Outcome Measure Data Table refer to the means of measurements at 4 follow-ups., Blood samples are obtained at the end of each round of 4 follow-ups with an interval of 2 weeks in the last 2 months of intervention. | This study aims to evaluate whether dietary supplementation with fish oil can protect against the cardiopulmonary alterations linked to air pollution |
NCT02663544 | ALL | ADULT, OLDER_ADULT | Insulin Resistance|Metabolic Syndrome|Obesity|Diabetes|NAFLD|Inflammation | OTHER: Limited dairy diet|OTHER: Low-fat dairy diet|OTHER: Full-fat dairy diet | Change in glucose tolerance, As measured by glucose area under the curve during a frequently sampled 3-hour oral glucose tolerance test (FS-OGTT)., Difference between pre- and post 12-week intervention period | This randomized controlled feeding trial aims to determine whether the consumption of different amounts and types of dairy products affects blood sugar regulation and cardiometabolic health in men and women with the metabolic syndrome. |
NCT01532869 | ALL | ADULT, OLDER_ADULT | Sclerosis, Systemic | DRUG: Placebo|DRUG: tocilizumab [RoActemra/Actemra]|DRUG: tocilizumab [RoActemra/Actemra] | Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24, Skin thickness was assessed by the mRSS. The mRSS was rated with scores ranging from 0 (normal) to 3 (severe skin thickening) across 17 different sites. The total score was the sum of the individual skin scores in the 17 body areas (e.g., face, hands, fingers; proximal area of the arms, distal area of the arms, thorax, abdomen; proximal area of the legs, and distal area of the legs, feet), giving a range of 0-51 units and had been validated for participants with systemic sclerosis (SSc). A negative change from baseline showed improvement., Baseline, Week 24|Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to Week 8 after last dose that were absent before treatment or that worsened relative to pretreatment state., Week 48 | This multicenter, randomized, double-blind, placebo-controlled, two-arm, parallel-group study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with systemic sclerosis. Participants will be randomized to receive either RoActemra/Actemra 162 mg subcutaneously weekly or placebo for 48 weeks. From Week 48 to Week 96, all participants will receive open-label RoActemra/Actemra 162 mg subcutaneously weekly. Anticipated time on study treatment is 96 weeks. |