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Sample records for clinical trial comparing

  1. Clinical Trial Of Glimepiride Compared With Glibenclamide For ...

    African Journals Online (AJOL)

    Objective: The study was undertaken to compare the efficacy and safety of Glimepiride against Glibenclamide in the management of patients with type 2 DM in Jos, Nigeria. Study design: An open, randomised controlled trial. Setting: Diabetes Clinic of the Jos University Teaching Hospital, Jos, Nigeria. Subjects: Seventy four ...

  2. A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety ...

    African Journals Online (AJOL)

    A Randomized, Controlled Clinical Trial Comparing Efficacy, Safety and Cost Effectiveness of Lornoxicam with Diclofenac Sodium in Patients of Osteoarthritis Knee. ... All patients were assessed with visual analogue scale and 100 meter walking test before starting of therapy, at 15 days and at 1, 2 and 3 months of therapy.

  3. Clinical Trials

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    Full Text Available ... healthy people to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants ... DSMBs for large trials comparing alternative strategies for diagnosis or treatment. In addition, the NIH requires DSMBs ...

  4. Clinical Trials

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... humans. What Are Clinical Trials? Clinical trials are research studies that explore whether a medical strategy, treatment, or ...

  5. Clinical Trials

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    Full Text Available ... questions and clinical trials. Optimizing our Clinical Trials Enterprise NHLBI has a strong tradition of supporting clinical ... multi-pronged approach to Optimize our Clinical Trials Enterprise that will make our clinical trials enterprise even ...

  6. Clinical Trials

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    Full Text Available ... clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a ... will be done during the clinical trial and why. Each medical center that does the study uses ...

  7. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ...

  8. Clinical Trials

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    Full Text Available ... Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, or ... and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance ...

  9. Clinical Trials

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    Full Text Available ... take part in a clinical trial. When researchers think that a trial's potential risks are greater than ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  10. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are ... earlier than they would be in general medical practice. This is because late-phase trials have large ...

  11. Clinical trial of osteoarthritis jamu formula compare to piroxicam

    Directory of Open Access Journals (Sweden)

    Danang Ardiyanto

    2016-12-01

    is a lack of evidence of its efficacy and safety. The objectives of study were to investigate the efficacy and safety of  a traditional formula for OA. Methods: Design of the study was a randomized clinical trial (RCT involved 123 patients (subjects for 28 days intervention. This study was conducted between March - December 2014 with 30 physicians were participated at 20 regencies in Indonesia. The variables measured were VAS score, PGAP functional status assessment (FSA, and Short Form (SF-36 to assess jamu efficacy in comparison to piroxicam. To evaluate the safety of jamu formula using values of SGOT, SGPT, BUN, and creatinine. Result: The jamu formula administration effects can reduce VAS significantly  (p<0.05  if it was compared to baseline. FSA score of jamu formula group was decreased significantly (p=0.000 when compared to the start of intervention. Short Form (SF-36 of jamu formula group were significantly improved when compared with baseline value. The result of the three parameters between jamu group and piroxicam group should not significantly different. There was no difference in those parameters between both groups (p>0.05. In biological parameters, SGPT, SGOT, BUN, and creatinine level, showed normal range in both groups. Conclusion: This study showed that the efficacy and safety of jamu formula was clinically comparable to piroxicam after 28 days of treatment. Keywords: efficacy, safety, RCT, jamu formula  

  12. Clinical Trials

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    Full Text Available ... and compare new treatments with other available treatments. Steps To Avoid Bias The researchers doing clinical trials take steps to avoid bias. "Bias" means that human choices ...

  13. Clinical Trials

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    Full Text Available ... sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; ... age and frequency for doing screening tests, such as mammography; and compare two or more screening tests ...

  14. Clinical Trials

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    Full Text Available ... small groups of people for safety and side effects. Phase II clinical trials look at how well ... confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ...

  15. Comparing the Effectiveness of a Clinical Registry and a Clinical Data Warehouse for Supporting Clinical Trial Recruitment: A Case Study

    Science.gov (United States)

    Weng, Chunhua; Bigger, J Thomas; Busacca, Linda; Wilcox, Adam; Getaneh, Asqual

    2010-01-01

    This paper reports a case study comparing the relative efficiency of using a Diabetes Registry or a Clinical Data Warehouse to recruit participants for a diabetes clinical trial, TECOS. The Clinical Data Warehouse generated higher positive predictive accuracy (31% vs. 6.6%) and higher participant recruitment than the Registry (30 vs. 14 participants) in a shorter time period (59 vs. 74 working days). We identify important factors that increase clinical trial recruitment efficiency and lower cost. PMID:21347102

  16. Clinical Trials

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    Full Text Available ... to-kol). This plan explains how the trial will work. The trial is led by a principal ... for the clinical trial. The protocol outlines what will be done during the clinical trial and why. ...

  17. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... kol). This plan explains how the trial will work. The trial is led by a principal investigator ( ...

  18. Clinical Trials

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    Full Text Available ... Trial Protocol Each clinical trial has a master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The trial ... clinical trial; and detailed information about the treatment plan. Eligibility Criteria A clinical trial's protocol describes what ...

  19. Clinical Trials

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    Full Text Available ... clinical trials are vital to the process of improving medical care. Many people volunteer because they want ... care costs for clinical trials. If you're thinking about taking part in a clinical trial, find ...

  20. Clinical Trials

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    Full Text Available ... or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  1. Clinical Trials

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    Full Text Available ... Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human ...

  2. Clinical Trials

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    Full Text Available ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research studies ... parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, ...

  3. Decision on performing interim analysis for comparative clinical trials.

    Science.gov (United States)

    Pak, Kyongsun; Jacobus, Susanna; Uno, Hajime

    2017-09-01

    In randomized-controlled trials, interim analyses are often planned for possible early trial termination to claim superiority or futility of a new therapy. While unblinding is necessary to conduct the formal interim analysis in blinded studies, blinded data also have information about the potential treatment difference between the groups. We developed a blinded data monitoring tool that enables investigators to predict whether they observe such an unblinded interim analysis results that supports early termination of the trial. Investigators may skip some of the planned interim analyses if an early termination is unlikely. We specifically focused on blinded, randomized-controlled studies to compare binary endpoints of a new treatment with a control. Assuming one interim analysis is planned for early termination for superiority or futility, we conducted extensive simulation studies to assess the impact of the implementation of our tool on the size, power, expected number of interim analyses, and bias in the treatment effect. The numerical study showed the proposed monitoring tool does not affect size or power, but dramatically reduces the expected number of interim analyses when the effect of the treatment difference is small. The tool serves as a useful reference when interpreting the summary of the blinded data throughout the course of the trial, without losing integrity of the study. This tool could potentially save the study resources and budget by avoiding unnecessary interim analyses.

  4. Clinical trial comparing excision and primary closure with modified ...

    African Journals Online (AJOL)

    Walid Galal Elshazly

    2011-12-03

    Dec 3, 2011 ... sure, advancement flap (Karydakis procedure), local advance- ment flap (V-Y advancement flap), and rotational flap. (Limberg flap, modified Limberg flap, gluteus maximus myo- cutaneous flap).5,6. However, there have been few clinical studies to compare the rhomboid fasciocutaneous transposition flap ...

  5. Clinical Trials

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    Full Text Available ... protocol affect the trial's results. Comparison Groups In most clinical trials, researchers use comparison groups. This means ... study before you agree to take part. Randomization Most clinical trials that have comparison groups use randomization. ...

  6. Clinical Trials

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    Full Text Available ... more information about eligibility criteria, go to "How Do Clinical Trials Work?" Some trials enroll people who ... for adults. For more information, go to "How Do Clinical Trials Protect Participants?" For more information about ...

  7. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  8. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  9. Clinical Trials

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    Full Text Available ... need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in ... Maryland, runs clinical trials. Many other clinical trials take place in medical centers and ... trial can have many benefits. For example, you may gain access to new treatments before ...

  10. Clinical Trials

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    Full Text Available ... of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key ... Enterprise NHLBI has a strong tradition of supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  11. Clinical trial to compare tinnitus masking and tinnitus retraining therapy.

    Science.gov (United States)

    Henry, J A; Schechter, M A; Zaugg, T L; Griest, S; Jastreboff, P J; Vernon, J A; Kaelin, C; Meikle, M B; Lyons, K S; Stewart, B J

    2006-12-01

    Both tinnitus masking (TM) and tinnitus retraining therapy (TRT) can be effective therapies for amelioration of tinnitus. TM may be more effective for patients in the short term, but with continued treatment TRT may produce the greatest effects. Although TM and TRT have been used for many years, research has not documented definitively the efficacy of these methods. The present study was a controlled clinical trial to prospectively evaluate the clinical efficacy of these two methods for US military veterans with severe tinnitus. Over 800 veterans were screened to ensure that enrolled patients had tinnitus of sufficient severity to justify 18 months of individualized treatment. Qualifying patients (n=123) were placed quasi-randomly (alternating placement) into treatment with either TM or TRT. Treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated primarily using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index). Findings are presented from the three written questionnaires with respect to three categories of patients: describing tinnitus as a 'moderate,' 'big,' and 'very big' problem at baseline. Based on effect sizes, both groups showed considerable improvement overall. In general, TM effects remained fairly constant over time while TRT effects improved incrementally. For the patients with a 'moderate' and 'big' problem, TM provided the greatest benefit at 3 and 6 months; benefit to these TRT patients was slightly greater at 12 months, and much greater at 18 months. For patients with a 'very big' problem, TM provided the greatest benefit at 3 months. For these latter patients, results were about the same between groups at 6 months, and improvement for TRT was much greater at 12 months, with further gains at 18 months.

  12. Clinical Trials

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    Full Text Available ... Working at the NHLBI Contact and FAQs Accessible Search Form Search the NHLBI, use the drop down list to ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  13. Clinical Trials

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    Full Text Available ... comparison groups by chance, rather than choice. This method helps ensure that any differences observed during a ... to learn more about clinical research and to search for clinical trials: NHLBI Clinical Trials Browse a ...

  14. Clinical Trials

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    Full Text Available ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ... All types of clinical trials contribute to medical knowledge and practice. Why Clinical Trials Are Important Clinical ...

  15. Clinical Trials

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    Full Text Available ... clinical trials. If you're thinking about taking part in a clinical trial, find out ahead of time about costs and coverage. You should learn about the risks and benefits of any clinical trial before you agree to take part in the trial. Talk with your doctor about ...

  16. Clinical Trials

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    Full Text Available ... treatments produce better results for certain illnesses or groups of people; look at the best age and frequency for doing screening tests, such as mammography; and compare two or more screening tests to see which test ... Some companies and groups sponsor clinical trials that test the safety of ...

  17. Clinical Trials

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    Full Text Available ... resources to the strategies and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking part in a clinical trial is different ...

  18. Clinical Trials

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    Full Text Available ... Health Topics / About Clinical Trials About Clinical Trials Clinical trials are research studies that explore whether a medical strategy, treatment, ... tool for advancing medical knowledge and patient care. Clinical research is done only if doctors don't know ...

  19. Clinical Trials

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    Full Text Available ... about your health or fill out forms about how you feel. Some people will need to travel or stay in hospitals to take part in clinical trials. For example, the National Institutes of Health Clinical Center in Bethesda, Maryland, runs clinical trials. Many other clinical trials take place ...

  20. Clinical Trials

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    Full Text Available ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Clinical trials for children have the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ...

  1. Clinical Trials

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    Full Text Available ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment options. Together, you can make the ... more about, or taking part in, clinical trials, talk with your doctor. He or she may know about ... clinical trials. NIH Clinical Research Studies ...

  2. Clinical Trials

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    Full Text Available ... you agree to take part in the trial. Talk with your doctor about specific trials you're ... part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  3. Clinical Trials

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    Full Text Available ... any clinical trial before you agree to take part in the trial. Talk with your doctor about specific trials you're interested in. For a list of questions to ask your doctor and the ...

  4. Clinical Trials

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    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results ...

  5. Clinical Trials

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    Full Text Available ... Entire Site NHLBI Entire Site Health Topics News & Resources Intramural Research ... or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ...

  6. Clinical Trials

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    Full Text Available ... sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, ... and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually ...

  7. Clinical Trials

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    Full Text Available ... decisionmaking. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ... otherwise. The purpose of clinical trials is research, so the studies follow strict scientific standards. These standards ...

  8. Clinical Trials

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    Full Text Available ... medical strategy, treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials ... medical strategy, treatment, or device is safe and effective for humans. These studies also may show which ...

  9. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... care providers might be part of your treatment team. They will monitor your health closely. You may ...

  10. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

  11. Clinical Trials

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    Full Text Available ... to main content U.S. Department of Health & Human ... of people. Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ...

  12. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  13. Clinical Trials

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    Full Text Available ... needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ... phase I clinical trials test new treatments in small groups of people for safety and side effects. ...

  14. Clinical Trials

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    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ...

  15. Clinical Trials

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    Full Text Available ... risks that outweigh any possible benefits. Clinical Trial Phases Clinical trials of new medicines or medical devices are done in phases. These phases have different purposes and help researchers ...

  16. Clinical Trials

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    Full Text Available ... clinical trials. An IRB is an independent committee created by the institution that sponsors a clinical trial. ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  17. Clinical Trials

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    Full Text Available ... and Centers sponsor clinical trials. Many other groups, companies, and organizations also sponsor clinical trials. Examples include ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers ( ...

  18. Clinical Trials

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    Full Text Available ... at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ... in a clinical trial, find out ahead of time about costs and coverage. You should learn about ...

  19. Clinical Trials

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    Full Text Available ... Clinical trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... and advance medical care. They also can help health care decisionmakers direct resources to the strategies and treatments ...

  20. Clinical Trials

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    Full Text Available ... whether a new approach causes any harm. In later phases of clinical trials, researchers learn more about ... other National Institutes of Health (NIH) Institutes and Centers sponsor clinical trials. Many other groups, companies, and ...

  1. Clinical Trials

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    Full Text Available ... are research studies that explore whether a medical strategy, treatment, or device is safe and effective for ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  2. Clinical Trials

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    Full Text Available ... treatment, or device is safe and effective for humans. What Are Clinical Trials? Clinical trials are research ... are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and ...

  3. Clinical Trials

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    Full Text Available ... best data available for health care decisionmaking. The purpose of clinical trials is research, so the studies ... Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients ...

  4. Clinical Trials

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  5. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Customer Service/Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute ...

  6. Clinical Trials

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    Full Text Available ... Some companies and groups sponsor clinical trials that test the safety of products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ...

  7. Clinical Trials

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    Full Text Available ... What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might ... enroll in a clinical trial, a doctor or nurse will give you an informed consent form that ...

  8. Clinical Trials

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    Full Text Available ... and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial ... volunteer because they want to help others. Possible Risks Clinical trials do have risks and some downsides, ...

  9. Clinical Trials

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    Full Text Available ... providers don't always cover all patient care costs for clinical trials. If you're thinking about ... clinical trial, find out ahead of time about costs and coverage. You should learn about the risks ...

  10. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... Learn More Connect With Us Contact Us Directly Policies Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

  11. Clinical Trials

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    Full Text Available ... and treatments that work best. How Clinical Trials Work If you take part in a clinical trial, ... your doctor about all of your treatment options. Together, you can make the best choice for you. ...

  12. Clinical Trials

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    Full Text Available ... medical knowledge and practice. Why Clinical Trials Are Important Clinical trials are a key research tool for ... and Usage No FEAR Act Grants and Funding Customer Service/Center for Health Information Email Alerts Jobs ...

  13. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ... Customer Service/Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute ...

  14. Clinical Trials

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    Full Text Available ... give permission for their child to enroll. Also, children aged 7 and older often must agree (assent) to take part in clinical trials. Find a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, ...

  15. Clinical Trials

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    Full Text Available ... more screening tests to see which test produces the best results. Some companies and groups sponsor clinical trials that test the ... and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  16. Clinical Trials

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    Full Text Available ... you to explore NIH Clinical Center for patient recruitment and clinical trial information. For more information, please email the NIH Clinical Center Office of Patient Recruitment at cc-prpl@cc.nih.gov or call ...

  17. Clinical Trials

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    Full Text Available ... the same scientific safeguards as clinical trials for adults. For more information, go to "How Do Clinical ... based on what is known to work in adults. To improve clinical care of children, more studies ...

  18. Clinical Trials

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    Full Text Available ... groups, companies, and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments ... sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the benefits of ...

  19. Clinical Trials

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    Full Text Available ... Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including ... our campus or trials NIH has sponsored at universities, medical centers, and hospitals. ClinicalTrials.gov View a ...

  20. Clinical Trials

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    Full Text Available ... identified earlier than they would be in general medical practice. This is because late-phase trials have large ... supporting clinical trials that have not only shaped medical practice around the world, but have improved the health ...

  1. Clinical Trials

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    Full Text Available ... the past, clinical trial participants often were White men. Researchers assumed that trial results were valid for ... different ethnic groups sometimes respond differently than White men to the same medical approach. As a result, ...

  2. Clinical Trials

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    Full Text Available ... or strategies work best for certain illnesses or groups of people. Some clinical trials show a positive result. For example, the National Heart, Lung, and Blood Institute (NHLBI) sponsored a trial of two different ...

  3. Clinical Trials

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    Full Text Available ... well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. The NIH may partner with these companies or groups to help sponsor some trials. All ...

  4. Clinical Trials

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    Full Text Available ... trials produce the best data available for health care decisionmaking. The purpose of clinical trials is research, ... they advance medical knowledge and help improve patient care. Sponsorship and Funding The National Heart, Lung, and ...

  5. Clinical Trials

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    Full Text Available ... including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored ... risks. Other examples of clinical trials that test principles or strategies include studies that explore whether surgery ...

  6. Clinical trial comparing excision and primary closure with modified ...

    African Journals Online (AJOL)

    The aim of this study was to compare modified Limberg flap procedure with excision and primary closure in the treatment of uncomplicated pilonidal disease. Methods: This study was conducted on 120 patients with uncomplicated sacrococcygeal pilonidal disease that were randomly allocated into two groups: group I ...

  7. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to ... as clinical trials for adults. For more information, go to "How Do Clinical ...

  8. The efficacy of maggot debridement therapy - a review of comparative clinical trials

    DEFF Research Database (Denmark)

    Zarchi, K.; Jemec, G.B.

    2012-01-01

    in a variety of ulcers. However, comparative clinical trials and in particular randomized controlled trials investigating the efficacy of MDT are sparse. A systematic search in the literature showed three randomized clinical trials and five non randomized studies evaluating the efficacy of sterile Lucilia......, including hydrocolloid, hydrogel and saline moistened gauze. However, the design of the studies was suboptimal, with important differences in the use of other therapies, such as compression, that may influence both debridement and healing between the compared groups, as well as inappropriately short follow...

  9. Clinical Trials

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    Full Text Available ... part. Randomization Most clinical trials that have comparison groups use randomization. This involves assigning patients to different comparison groups by chance, rather than choice. This ...

  10. Clinical Trials

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    Full Text Available ... Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in ... Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain ...

  11. Clinical Trials

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    Full Text Available ... you may get tests or treatments in a hospital, clinic, or doctor's office. In some ways, taking ... people will need to travel or stay in hospitals to take part in clinical trials. For example, ...

  12. Clinical Trials

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    Full Text Available ... the clinical trial you take part in, the information gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

  13. Clinical Trials

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative ... safe a treatment is or how well it works. Children (aged 18 and younger) get ... legal consent for their child to take part in a clinical trial. When ...

  14. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... clinical trials are vital to the process of improving medical care. Many people ... participants, it may not work for you. A new treatment may have side ...

  15. Clinical Trials

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    Full Text Available ... Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ... phase II clinical trials. The risk of side effects might be even greater for ... treatments. Health insurance and health care providers don't always ...

  16. Clinical Trials

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    Full Text Available ... a Clinical Trial If you're interested in learning more about, or taking part in, clinical trials, talk with your doctor. He or she may know about studies going on in your area. You can visit the following website to learn more about ...

  17. Clinical Trials

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    Full Text Available ... products, such as medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these clinical trials. ... cancer also increased. As a result, the U.S. Food and Drug Administration now recommends never using HT ... Clinical Trials Work If you take ...

  18. Clinical Trials

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    Full Text Available ... trial found that one of the combinations worked much better than the other for moderate persistent asthma. The results provided important treatment information for doctors and patients. The results from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI ...

  19. Clinical Trials

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    Full Text Available ... other expenses (for example, travel and child care)? Who will be in charge of my care? What will happen after the trial? Taking part in a clinical trial is your decision. Talk with your doctor about all of your treatment ...

  20. Clinical Trials

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    Full Text Available ... strict scientific standards. These standards protect patients and help produce reliable study results. Clinical trials are one ... are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding The National ...

  1. Clinical Trials

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    Full Text Available ... patients to find out whether a new approach causes any harm. In later phases of clinical trials, ... device improves patient outcomes; offers no benefit; or causes unexpected harm All of these results are important ...

  2. Clinical Trials

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    Full Text Available ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are vital to the process of improving medical care. Many people volunteer because they want to help others. ...

  3. Clinical Trials

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    Full Text Available ... materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of Health ( ... III clinical trial is required to have a Data and Safety Monitoring Board (DSMB). This board consists ...

  4. Clinical Trials

    Science.gov (United States)

    ... of Personal Stories Peers Celebrating Art Peers Celebrating Music Be Vocal Support Locator DBSA In-Person Support ... by participating in a clinical trial is to science first and to the patient second. More About ...

  5. Clinical Trials

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    Full Text Available ... to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be ... the new approach. You also will have the support of a team of health care providers, who ...

  6. Clinical Trials

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    Full Text Available ... final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists ... part in clinical trials are vital to the process of improving medical care. Many people volunteer because ...

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    Full Text Available ... as gene therapy) or vulnerable patients (such as children). A DSMB's role is to review data from a clinical trial for safety problems or differences in results among different groups. The DSMB also reviews research results ...

  8. Clinical Trials

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    Full Text Available ... medical centers and doctors' offices around the country. Benefits and Risks Possible Benefits Taking part in a clinical trial can have many benefits. For example, you may gain access to new ...

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    Full Text Available ... or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that ...

  10. Clinical Trials

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    Full Text Available ... Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling the clinical trial participants which treatment they're getting. Masking, or "blinding," helps avoid bias. For this reason, ...

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    Full Text Available ... organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and ... how you feel. Some people will need to travel or stay in hospitals to take part in ...

  12. Clinical Trials

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    Full Text Available ... clinical trials are required to have an IRB. Office for Human Research Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees all research ...

  13. Clinical Trials

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    Full Text Available ... clinical trial. IRB members are doctors, statisticians, and community members. The IRB's purpose is to ensure that ... lung, and blood disorders. By engaging the research community and a broad group of stakeholders and advisory ...

  14. Clinical Trials

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    Full Text Available ... successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, ... gathered can help others and add to scientific knowledge. People who take part in clinical trials are ...

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    Full Text Available ... studies. View funding information for clinical trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn ... and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn ...

  16. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and ...

  17. Clinical Trials

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    Full Text Available ... results. Clinical trials are one of the final stages of a long and careful research process. The ... a patient's age and gender, the type and stage of disease, and whether the patient has had ...

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ...

  19. Clinical Trials

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    Full Text Available ... issues arise. Participation and Eligibility Each clinical trial defines who is eligible to take part in the ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the ...

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ...

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    Full Text Available ... A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders ... to fill an important gap in information and education for parents, clinicians, researchers, children, and the general ...

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    Full Text Available ... clinical care of children, more studies are needed focusing on children's health with the goal to develop ... study? How might this trial affect my daily life? Will I have to be in the hospital? ...

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    Full Text Available ... work best for certain illnesses or groups of people. Clinical trials produce the best data available for ... or animals doesn't always work well in people. Thus, research in humans is needed. For safety ...

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    Full Text Available ... harm. In later phases of clinical trials, researchers learn more about the new approach's risks and benefits. ... explore whether surgery or other medical treatments produce better results for certain illnesses or groups of people; ...

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    Full Text Available ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ... Center for Health Information Email Alerts Jobs and Careers Site Index About NHLBI National Institute of Health ...

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    Full Text Available ... patients. Usually, a computer program makes the group assignments. Masking The term "masking" refers to not telling ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ...

  7. Clinical Trials

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    Full Text Available ... study explored whether the benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials that test principles or strategies include studies that explore whether ...

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical trials that are ...

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    Full Text Available ... questions to ask your doctor and the research staff, go to "How Do Clinical Trials Protect Participants?" ... in Bethesda, Maryland. The physicians, nurses, scientists and staff of the NHLBI encourage you to explore NIH ...

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    Full Text Available ... Science Science Home Blood Disorders and Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ...

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    Full Text Available ... and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, ...

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    Full Text Available ... Events About NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory ... offer a variety of funding mechanisms tailored to planning and conducting clinical trials at all phases, including ...

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    Full Text Available ... NHLBI About NHLBI Home Mission and Strategic Vision Leadership Scientific Divisions Operations and Administration Advisory Committees Budget ... always, parents must give legal consent for their child to take part in a clinical trial. When ...

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    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and ...

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    Full Text Available ... records can quickly show this information if safety issues arise. Participation and Eligibility Each clinical trial defines ... and materials, and offer advice on research-related issues. Data Safety Monitoring Board Every National Institutes of ...

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    Full Text Available ... women and that are ethnically diverse. Children also need clinical trials that focus on them, as medical ... often differ for children. For example, children may need lower doses of certain medicines or smaller medical ...

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    Full Text Available ... care providers might be part of your treatment team. They will monitor your health closely. You may ... taking part in a clinical trial. Your treatment team also may ask you to do other tasks. ...

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    Full Text Available ... new treatments in small groups of people for safety and side effects. Phase II clinical trials look at how well treatments work and further review these treatments for safety. Phase ...

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    Full Text Available ... Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood ... these results are important because they advance medical knowledge and help improve patient care. Sponsorship and Funding ...

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    Full Text Available ... and organizations also sponsor clinical trials. Examples include Government Agencies, such as the U.S. Departments of Defense ... FOIA) Accessibility Copyright and Usage No FEAR Act Grants and Funding Building 31 31 Center Drive Bethesda, ...

  1. Clinical Trials

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    Full Text Available ... as the U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes ... for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  2. Clinical Trials

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    Full Text Available ... combination of estrogen and progestin, the risk of breast cancer also increased. As a result, the U.S. Food ... to test new approaches to prevention, diagnosis, or screening. In the past, clinical trial participants often were ...

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    Full Text Available ... from other clinical trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. ( ...

  4. Clinical Trials

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    Full Text Available ... always, parents must give legal consent for their child to take part in a clinical trial. When ... minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

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    Full Text Available ... Wide Range of Audiences The Children and Clinical Studies Program has been successfully developed and evaluated to fill an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, ...

  6. A comparative analysis of quality management standards for contract research organisations in clinical trials.

    Science.gov (United States)

    Murray, Elizabeth; McAdam, Rodney

    2007-01-01

    This article compares and contrasts the main quality standards in the highly regulated pharmaceutical industry with specific focus on Good Clinical Practice (GCP), the standard for designing, conducting, recording and reporting clinical trials involving human participants. Comparison is made to ISO quality standards, which can be applied to all industries and types of organisation. The study is then narrowed to that of contract research organisations (CROs) involved in the conduct of clinical trials. The paper concludes that the ISO 9000 series of quality standards can act as a company-wide framework for quality management within such organisations by helping to direct quality efforts on a long-term basis without any loss of compliance. This study is valuable because comparative analysis in this domain is uncommon.

  7. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment team. ...

  8. Clinical Trials

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    Full Text Available Skip to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ...

  9. Clinical Trials

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    Full Text Available ... patient has had certain treatments or has other health problems. Eligibility criteria ensure that new approaches are tested ... public. What to Expect During a clinical trial, doctors, nurses, social workers, and other health care providers might be part of your treatment ...

  10. Clinical Trials

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    Full Text Available ... This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start ...

  11. Clinical Trials

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    Full Text Available ... to main content U.S. Department of Health & Human Services Health Topics Health Topics A-Z Clinical Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep Science and ...

  12. Clinical Trials

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    Full Text Available ... protect patients and help produce reliable study results. Clinical trials are one of the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ...

  13. Clinical Trials

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    Full Text Available ... benefits of lowering high blood pressure in the elderly outweighed the risks. Other examples of clinical trials ... child to enroll. Also, children aged 7 and older often must agree (assent) to take part ... about how you feel. Some people will need to travel or stay in hospitals ...

  14. Clinical Trials

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    Full Text Available ... safe a treatment is or how well it works. Children (aged 18 and younger) get special protection as research subjects. Almost always, parents must give legal consent for their child to take part in a clinical trial. When ...

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    Full Text Available ... As a result, the U.S. Food and Drug Administration now recommends never using HT to prevent heart disease. When HT is used for menopausal symptoms, it should be taken only at the smallest dose and for the shortest time possible. Clinical trials, like the two described above, ...

  16. Clinical Trials

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    Full Text Available ... approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical trials start with small groups of patients to find out whether a ...

  17. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials

    OpenAIRE

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2010-01-01

    ABSTRACT Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of kn...

  18. Comparing Amazon Mechanical Turk with unpaid internet resources in online clinical trials

    Directory of Open Access Journals (Sweden)

    Eduardo Bunge

    2018-06-01

    Full Text Available Internet interventions face significant challenges in recruitment and attrition rates are typically high and problematic. Finding innovative yet scientifically valid avenues for attaining and retaining participants is therefore of considerable importance. The main goal of this study was to compare recruitment process and participants characteristics between two similar randomized control trials of mood management interventions. One of the trials (Bunge et al., 2016 was conducted with participants recruited from Amazon's Mechanical Turk (AMT, and the other trial recruited via Unpaid Internet Resources (UIR. Methods: The AMT sample (Bunge et al., 2016 consisted of 765 adults, and the UIR sample (recruited specifically for this study consisted of 329 adult US residents. Participants' levels of depression, anxiety, confidence, motivation, and perceived usefulness of the intervention were assessed. The AMT sample was financially compensated whereas the UIR was not. Results: AMT yielded higher recruitment rates per month (p < .05. At baseline, the AMT sample reported significantly lower depression and anxiety scores (p < .001 and p < .005, respectively and significantly higher mood, motivation, and confidence (all p < .001 compared to the UIR sample. AMT participants spent significantly less time on the site (p < .05 and were more likely to complete follow-ups than the UIR sample (p < .05. Both samples reported a significant increase in their level of confidence and motivation from pre- to post-intervention. AMT participants showed a significant increase in perceived usefulness of the intervention (p < .0001, whereas the UIR sample did not (p = .1642. Conclusions: By using AMT, researchers can recruit very rapidly and obtain higher retention rates; however, these participants may not be representative of the general online population interested in clinical interventions. Considering that AMT and UIR participants

  19. Iohexol and iopamidol myelography in the dog: a clinical trial comparing adverse effects and myelographic quality

    International Nuclear Information System (INIS)

    Widmer, W.R.; Blevins, W.E.; Jakovljevic, S.; Teclaw, R.F.; Han, C.M.; Hurd, C.D.

    1992-01-01

    In a blind clinical trial, adverse effects after iohexol and iopamidol myelography were evaluated in 151 dogs. Eighty-one dogs were given iohexol (240 mgI/ml) and 70 dogs were given iopamidol (200 mgI/ml) by pre-determined assignment. Each dog was evaluated postmyelographically for seizures, hyperthermia, prolonged recovery from anesthesia and intensification of pre-existing neural signs. Myelographic quality was evaluated with a subjective scoring method. In comparing iohexol and iopamidol groups, there was not a statistically significant difference in the incidence of adverse effects or in myelographic quality. Iopamidol and iohexol appeared to be equally efficacious for routine canine myelography

  20. Textbook of clinical trials

    National Research Council Canada - National Science Library

    Day, Simon; Machin, David; Green, Sylvan B

    2006-01-01

    ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . xix INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 1 The Development of Clinical Trials Simon...

  1. Clinical Trials

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    Full Text Available ... criteria differ from trial to trial. They include factors such as a patient's age and gender, the ... bias. "Bias" means that human choices or other factors not related to the protocol affect the trial's ...

  2. Clinical Trials

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    Full Text Available ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ... stop a trial, or part of a trial, early if the strategy or treatment is having harmful ...

  3. Comparing methods to combine functional loss and mortality in clinical trials for amyotrophic lateral sclerosis

    Directory of Open Access Journals (Sweden)

    van Eijk RPA

    2018-03-01

    Full Text Available Ruben PA van Eijk,1 Marinus JC Eijkemans,2 Dimitris Rizopoulos,3 Leonard H van den Berg,4,* Stavros Nikolakopoulos5,* 1Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 2Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands; 3Department of Biostatistics, Erasmus University Medical Center, Rotterdam, the Netherlands; 4Department of Neurology, University Medical Center Utrecht, Utrecht, the Netherlands; 5Department of Biostatistics, University Medical Center Utrecht, Utrecht, the Netherlands *These authors contributed equally to this work Objective: Amyotrophic lateral sclerosis (ALS clinical trials based on single end points only partially capture the full treatment effect when both function and mortality are affected, and may falsely dismiss efficacious drugs as futile. We aimed to investigate the statistical properties of several strategies for the simultaneous analysis of function and mortality in ALS clinical trials. Methods: Based on the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT database, we simulated longitudinal patterns of functional decline, defined by the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R and conditional survival time. Different treatment scenarios with varying effect sizes were simulated with follow-up ranging from 12 to 18 months. We considered the following analytical strategies: 1 Cox model; 2 linear mixed effects (LME model; 3 omnibus test based on Cox and LME models; 4 composite time-to-6-point decrease or death; 5 combined assessment of function and survival (CAFS; and 6 test based on joint modeling framework. For each analytical strategy, we calculated the empirical power and sample size. Results: Both Cox and LME models have increased false-negative rates when treatment exclusively affects either function or survival. The joint model has superior power compared to other strategies. The composite end point

  4. A Bayesian Analysis of a Randomized Clinical Trial Comparing Antimetabolite Therapies for Non-Infectious Uveitis.

    Science.gov (United States)

    Browne, Erica N; Rathinam, Sivakumar R; Kanakath, Anuradha; Thundikandy, Radhika; Babu, Manohar; Lietman, Thomas M; Acharya, Nisha R

    2017-02-01

    To conduct a Bayesian analysis of a randomized clinical trial (RCT) for non-infectious uveitis using expert opinion as a subjective prior belief. A RCT was conducted to determine which antimetabolite, methotrexate or mycophenolate mofetil, is more effective as an initial corticosteroid-sparing agent for the treatment of intermediate, posterior, and pan-uveitis. Before the release of trial results, expert opinion on the relative effectiveness of these two medications was collected via online survey. Members of the American Uveitis Society executive committee were invited to provide an estimate for the relative decrease in efficacy with a 95% credible interval (CrI). A prior probability distribution was created from experts' estimates. A Bayesian analysis was performed using the constructed expert prior probability distribution and the trial's primary outcome. A total of 11 of the 12 invited uveitis specialists provided estimates. Eight of 11 experts (73%) believed mycophenolate mofetil is more effective. The group prior belief was that the odds of treatment success for patients taking mycophenolate mofetil were 1.4-fold the odds of those taking methotrexate (95% CrI 0.03-45.0). The odds of treatment success with mycophenolate mofetil compared to methotrexate was 0.4 from the RCT (95% confidence interval 0.1-1.2) and 0.7 (95% CrI 0.2-1.7) from the Bayesian analysis. A Bayesian analysis combining expert belief with the trial's result did not indicate preference for one drug. However, the wide credible interval leaves open the possibility of a substantial treatment effect. This suggests clinical equipoise necessary to allow a larger, more definitive RCT.

  5. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    Science.gov (United States)

    Pagnoux, Christian; Carette, Simon; Khalidi, Nader A.; Walsh, Michael; Hiemstra, Thomas F.; Cuthbertson, David; Langford, Carol; Hoffman, Gary S.; Koening, Curry L.; Monach, Paul A.; Moreland, Larry; Mouthon, Luc; Seo, Phil; Specks, Ulrich; Ytterberg, Steven; Westman, Kerstin; Hoglund, Peter; Harper, Lorraine; Flossmann, Oliver; Luqmani, Raashid; Savage, Caroline; Rasmussen, Niels; de Groot, Kirstin; Tesar, Vladimir; Jayne, David; Merkel, Pater A.; Guillevin, Loic

    2015-01-01

    Objective To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods The main characteristics and outcomes of patients with generalised and/or severe GPA or MPA with a five-factor score ≥1 enrolled in the French Vasculitis Study Group (FVSG) or the US-Canadian-based Vasculitis Clinical Research Consortium cohorts were compared to those enrolled in one of 2 FVSG clinical RCTs (WEG91, WEGENT) or 3 European Vasculitis Society clinical trials (CYCLOPS, CYCAZAREM, IMPROVE). Results 657 patients (65.3% with GPA) in RCTs were compared to 437 in cohorts (90.6% with GPA). RCT patients were older at diagnosis than the cohort patients (56.6±13.9 vs. 46.8±17.3 years), had higher Birmingham vasculitis activity score (19.5±9.1 vs. 16.9±7.4), and more frequent kidney disease (84.0% vs. 54.9%) but fewer ear, nose, and throat symptoms (56.8% vs. 72.2%). At 56 months post-diagnosis, mortality and relapse rates, adjusted for age and renal function, were higher for patients with GPA in RCTs vs. cohorts (10.7% vs. 2.5% [p=0.001] and 22.5% vs. 15.6% [p=0.03], respectively) but similar for patients with MPA (6.2% vs. 6.6% [p=0.92] and 16.6% vs. 10.1% [p=0.39], respectively). Conclusion Patients with GPA or MPA in RCTs and those in observational cohorts show important differences that should be remembered when interpreting results based on these study populations. PMID:26016754

  6. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...... of antiandrogen (flutamide, Anandron, or cyproterone acetate) added to castration. This paper reviews the different types of heterogeneity that might exist among trials that are involved in the overview: study design, randomization procedure, treatment evaluation, statistical evaluation, and data maturity....... In order to overcome these various types of heterogeneity and to compare like with like, the treatment comparison should be stratified a posteriori by question (i.e., type of castration or type of anti-androgen studied) and by study. In this way, one may draw valid conclusions. Of course, those trials...

  7. Comparability of patients with ANCA-associated vasculitis enrolled in clinical trials or in observational cohorts

    NARCIS (Netherlands)

    Pagnoux, C.; Carette, S.; Khalidi, N. A.; Walsh, M.; Hiemstra, T. F.; Cuthbertson, D.; Langford, C.; Hoffman, G.; Koening, C. L.; Monach, P. A.; Moreland, L.; Mouthon, L.; Seo, P.; Specks, U.; Ytterbere, S.; Westman, K.; Hoglund, P.; Harper, L.; Flossmann, O.; Luqmani, R.; Savage, C.; Rasmussen, N.; de Groot, K.; Tesar, V.; Jayne, D.; Merkel, P. A.; Guillevin, L.; Stegeman, C. A.

    2015-01-01

    Objective. To analyse the differences between patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) entered into randomised clinical trials (RCTs) and those followed in large observational cohorts. Methods. The main characteristics and outcomes of patients with

  8. Clinical Trials

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    Full Text Available ... people who fit the patient traits for that study (the eligibility criteria). Eligibility criteria differ from trial to trial. They include factors such as a patient's age and gender, the type and stage of disease, and whether ...

  9. Clinical Trials

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    Full Text Available ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ... trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective ...

  10. Clinical Trials

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    Full Text Available ... trials show what doesn't work or may cause harm. For example, the NHLBI Women's Health Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  11. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A ...

  12. Clinical Trials

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    Full Text Available ... sponsored a trial of two different combinations of asthma treatments. The trial found that one of the ... much better than the other for moderate persistent asthma. The results provided important treatment information for doctors ...

  13. Clinical Trials

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    Full Text Available ... Sponsors also may stop a trial, or part of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ...

  14. Comparative randomised active drug controlled clinical trial of a herbal eye drop in computer vision syndrome.

    Science.gov (United States)

    Chatterjee, Pranab Kr; Bairagi, Debasis; Roy, Sudipta; Majumder, Nilay Kr; Paul, Ratish Ch; Bagchi, Sunil Ch

    2005-07-01

    A comparative double-blind placebo-controlled clinical trial of a herbal eye drop (itone) was conducted to find out its efficacy and safety in 120 patients with computer vision syndrome. Patients using computers for more than 3 hours continuously per day having symptoms of watering, redness, asthenia, irritation, foreign body sensation and signs of conjunctival hyperaemia, corneal filaments and mucus were studied. One hundred and twenty patients were randomly given either placebo, tears substitute (tears plus) or itone in identical vials with specific code number and were instructed to put one drop four times daily for 6 weeks. Subjective and objective assessments were done at bi-weekly intervals. In computer vision syndrome both subjective and objective improvements were noticed with itone drops. Itone drop was found significantly better than placebo (pcomputer vision syndrome.

  15. Randomized clinical trial to comparing efficacy of daily, weekly and monthly administration of vitamin D3.

    Science.gov (United States)

    Takács, István; Tóth, Béla E; Szekeres, László; Szabó, Boglárka; Bakos, Bence; Lakatos, Péter

    2017-01-01

    The comparative efficacy and safety profiles of selected daily 1000 IU, weekly 7000 IU and monthly 30,000 IU vitamin D 3 -not previously investigated-will be evaluated. Here, a prospective, randomized clinical trial, comparing efficacy and safety of a daily single dose of 1000 IU (group A) to a once-weekly 7000 IU dose (group B), or monthly 30,000 IU dose (group C) of vitamin D 3 . The present study is a controlled, randomized, open-label, multicenter clinical trial, 3  months in duration. Sixty-four adult subjects with vitamin D deficiency (25OHD<20 ng/ml), were included according to the inclusion and exclusion criteria. Dose-responses for increases in serum vitamin 25OHD were statistically equivalent for each of the three groups: A, B and C. Outcomes were 13.0 ± 1.5; 12.6 ± 1.1 and 12.9 ± 0.9 ng/ml increases in serum 25OHD per 1000 IU, daily, weekly and monthly, respectively. The treatment of subjects with selected doses restored 25OHD values to levels above 20 ng/ml in all groups. Treatment with distinct administration frequency of vitamin D 3 did not exhibit any differences in safety parameters. The daily, weekly and monthly administrations of daily equivalent of 1000 IU of vitamin D 3 provide equal efficacy and safety profiles.

  16. Clinical Trials

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    Full Text Available ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often had to ...

  17. Clinical Trials

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... participants. Children and Clinical Studies Learn about the importance of children in clinical studies and get answers ...

  18. Clinical Trials

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    Full Text Available ... for trials with cutting-edge approaches, such as gene therapy or new biological treatments. Health insurance and health ... trials that involve high-risk procedures (such as gene therapy) or vulnerable patients (such as children). A DSMB's ...

  19. Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

    Science.gov (United States)

    Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

    2016-05-01

    ). This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

  20. Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures.

    Science.gov (United States)

    Bueno, Letícia Rossi; Binda, Marcia; Monego, Heleusa; Scherer, Roberta Luísa; Rolim, Karen Machado; Bottini, Alessandra Leal; Fregnani, José H T G; dos Reis, Ricardo

    2015-06-01

    Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries. Randomized clinical trial. Hospital de Clínicas de Porto Alegre (HCPA). 102 patients that underwent cold knife conization. Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures. blood loss measured in grams. operative time and postoperative intervention. Only the participants were blinded to group assignment. From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082). Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

  1. Clinical trials of homoeopathy.

    Science.gov (United States)

    Kleijnen, J; Knipschild, P; ter Riet, G

    1991-01-01

    OBJECTIVE--To establish whether there is evidence of the efficacy of homoeopathy from controlled trials in humans. DESIGN--Criteria based meta-analysis. Assessment of the methodological quality of 107 controlled trials in 96 published reports found after an extensive search. Trials were scored using a list of predefined criteria of good methodology, and the outcome of the trials was interpreted in relation to their quality. SETTING--Controlled trials published world wide. MAIN OUTCOME MEASURES--Results of the trials with the best methodological quality. Trials of classical homoeopathy and several modern varieties were considered separately. RESULTS--In 14 trials some form of classical homoeopathy was tested and in 58 trials the same single homoeopathic treatment was given to patients with comparable conventional diagnosis. Combinations of several homoeopathic treatments were tested in 26 trials; isopathy was tested in nine trials. Most trials seemed to be of very low quality, but there were many exceptions. The results showed a positive trend regardless of the quality of the trial or the variety of homeopathy used. Overall, of the 105 trials with interpretable results, 81 trials indicated positive results whereas in 24 trials no positive effects of homoeopathy were found. The results of the review may be complicated by publication bias, especially in such a controversial subject as homoeopathy. CONCLUSIONS--At the moment the evidence of clinical trials is positive but not sufficient to draw definitive conclusions because most trials are of low methodological quality and because of the unknown role of publication bias. This indicates that there is a legitimate case for further evaluation of homoeopathy, but only by means of well performed trials. PMID:1825800

  2. Clinical Trials

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    Full Text Available ... include factors such as a patient's age and gender, the type and stage of disease, and whether ... How long will the trial last? Who will pay for the tests and treatments I receive? Will ...

  3. Clinical Trials

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    Full Text Available ... medicines, and how well they work. The U.S. Food and Drug Administration (FDA) oversees these ... trials are a key research tool for advancing medical knowledge and patient care. ...

  4. Clinical Trials

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    Full Text Available ... Masking, or "blinding," helps avoid bias. For this reason, researchers also may not be told which treatments ... from a study at any time, for any reason. Also, during the trial, you have the right ...

  5. Clinical Trials

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    Full Text Available ... get special protection as research subjects. Almost always, parents must give legal consent for their child to ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. ...

  6. Clinical Trials

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... a safety measure. They ensure a trial excludes any people for whom the protocol has known risks ...

  7. Clinical Trials

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    Full Text Available ... Initiative tested whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT was already in common use for the treatment of menopausal symptoms. It also ...

  8. Clinical Trials

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    Full Text Available ... risk of heart disease in the first few years, and HT also increased the risk of stroke ... master plan called a protocol (PRO-to-kol). This plan explains how the trial will work. The ...

  9. Clinical Trials

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    Full Text Available ... treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug ... life? Will I have to be in the hospital? How long will the trial last? Who will ...

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    Full Text Available ... procedures painful? What are the possible risks, side effects, and benefits of taking part in the study? How might this trial affect my daily life? Will I have to be in the hospital? ...

  11. Clinical Trials

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    Full Text Available ... Blood Safety Sleep Science and Sleep Disorders Lung Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ...

  12. Clinical Trials

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    Full Text Available ... are ethical and that the participants' rights are protected. The IRB reviews the trial's protocol before the ... may know about studies going on in your area. You can visit the following website to learn ...

  13. Clinical Trials

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    Full Text Available ... a laboratory (lab), where scientists first develop and test new ideas. If an approach seems promising, the ... Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study ...

  14. Clinical Trials

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    Full Text Available ... whether hormone therapy (HT) reduced the risk of heart disease in postmenopausal women. (When the trial began, HT ... also was increasingly being used for prevention of heart disease.) The study found that HT increased the risk ...

  15. Clinical Trials

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    Full Text Available ... trials optimization . Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Get ... and Funding Building 31 31 Center Drive Bethesda, MD 20892 Learn more about getting to NIH Connect ...

  16. Clinical Trials

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    Full Text Available ... that the participants' rights are protected. The IRB reviews the trial's protocol before the study begins. An IRB will only approve research that deals with medically important questions ...

  17. Clinical Trials

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    Full Text Available ... to preexisting differences between the patients. Usually, a computer program makes the group assignments. Masking The term " ... under way. For example, some trials are stopped early if benefits from a strategy or treatment are ...

  18. Clinical Trials

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    Full Text Available ... treatment of menopausal symptoms. It also was increasingly being used for prevention of heart disease.) The study ... a trial are due to the different strategies being used, not to preexisting differences between the patients. ...

  19. Clinical Trials

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    Full Text Available ... Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies Women’s Health All Science A- ... assumed that trial results were valid for other populations as well. Researchers now realize that women and ...

  20. Examination of Individual Differences in Outcomes from a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

    Science.gov (United States)

    Smith, Sherri L.; Saunders, Gabrielle H.; Chisolm, Theresa H.; Frederick, Melissa; Bailey, Beth A.

    2016-01-01

    Purpose: The purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training. Method: A retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home…

  1. Understanding Clinical Trials

    Science.gov (United States)

    Watch these videos to learn about some basic aspects of cancer clinical trials such as the different phases of clinical trials, methods used to protect patient safety, and how the costs of clinical trials are covered.

  2. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about Children and ...

  3. Clinical Trials

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    Full Text Available ... go to the NHLBI's Children and Clinical Studies Web page. Children and Clinical Studies Learn more about ... Protections The U.S. Department of Health and Human Services’ (HHS’) Office for Human Research Protections (OHRP) oversees ...

  4. Clinical Trials

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    Full Text Available ... Studies Learn more about Children and Clinical Studies Importance of Children in Clinical Studies Children have often ... rights that help protect them. Scientific Oversight Institutional Review Board Institutional review boards (IRBs) help provide scientific ...

  5. Clinical Trials

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    Full Text Available ... taking the same treatment the same way. These patients are closely watched by Data and Safety Monitoring Boards. Even if you don't directly ... risk procedures (such as gene therapy) or vulnerable patients (such as ... trial for safety problems or differences in results among different groups. ...

  6. Clinical Trials

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    Full Text Available ... edge approaches, such as gene therapy or new biological treatments. Health insurance and health care providers don't ... of a trial, early if the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and ...

  7. Clinical Trials

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    Full Text Available ... U.S. Departments of Defense and Veterans Affairs; private companies; universities; and nonprofit organizations. NIH Institutes and Centers (including the NHLBI) usually sponsor trials that test principles or strategies. For example, one NHLBI study explored whether the ...

  8. Clinical Trials

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    Full Text Available ... Trials Publications and Resources Health Education and Awareness The Science Science Home Blood Disorders and Blood Safety Sleep ... Activity Population and Epidemiology Studies Women’s Health All Science A-Z Grants ... in the Press Research Features All Events Past Events Upcoming ...

  9. Clinical Trials

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    Full Text Available ... Diseases Heart and Vascular Diseases Precision Medicine Activities Obesity, Nutrition, and Physical Activity Population and Epidemiology Studies ... include factors such as a patient's age and gender, the type and stage of disease, ... helps ensure that any differences observed during a trial are due to the ...

  10. Clinical Trials

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    Full Text Available ... an important gap in information and education for parents, clinicians, researchers, children, and the general public. What to Expect During ... trial's potential risks are greater than minimal, both parents must give permission for their child to enroll. Also, children aged 7 and older ...

  11. A clinical trial comparing Lanconone® with ibuprofen for rapid relief in acute joint pain.

    Science.gov (United States)

    Girandola, Robert N; Srivastava, Shalini; Loullis, Costas C

    2016-04-06

    To study the effect of Lanconone® (1000 mg) on acute pain on exertion as compared to the standard of care, Ibuprofen (400 mg). The study recruited 72 subjects diagnosed with mild to moderate knee joint pain on exertion. Subjects with Pain Visual Analogue Scale of more than 40 mm were included. Uphill walking was provided as the stressor using Naughton's protocol on a treadmill. The subjects walked for 10 minutes continuously followed by a rest period and baseline pain score for index knee joint was recorded. Subjects were administered a single dose of Lanconone® (1000 mg)/Ibuprofen (400 mg). Thereafter the same stressor was provided at 0.5, 1, 2, 3, 4, and 6 hours, subsequently, pain scores were recorded on a visual analogue scale. Double stopwatch method was used to evaluate the onset of pain relief and time taken to meaningful pain relief. Both Lanconone® and Ibuprofen showed the first perceived pain relief at 65.31 ± 35.57 mins as compared to 60.82 ± 32.56 mins respectively. The mean time taken to experience meaningful pain relief in Lanconone® group was 196.59 ± 70.85 mins compared to 167.13 ± 71.41 mins amongst Ibuprofen group. The meaningful pain relief continued for 6 hours. The current study successfully demonstrated rapid pain-relieving potential of Lanconone® which was comparable to Ibuprofen. No adverse event related to the interventions was reported in the study. Clinical trials.gov NCT02417506 . 21 January 2015.

  12. Comparative costs and activity from a sample of UK clinical trials units.

    Science.gov (United States)

    Hind, Daniel; Reeves, Barnaby C; Bathers, Sarah; Bray, Christopher; Corkhill, Andrea; Hayward, Christopher; Harper, Lynda; Napp, Vicky; Norrie, John; Speed, Chris; Tremain, Liz; Keat, Nicola; Bradburn, Mike

    2017-05-02

    The costs of medical research are a concern. Clinical Trials Units (CTUs) need to better understand variations in the costs of their activities. Representatives of ten CTUs and two grant-awarding bodies pooled their experiences in discussions over 1.5 years. Five of the CTUs provided estimates of, and written justification for, costs associated with CTU activities required to implement an identical protocol. The protocol described a 5.5-year, nonpharmacological randomized controlled trial (RCT) conducted at 20 centres. Direct and indirect costs, the number of full time equivalents (FTEs) and the FTEs attracting overheads were compared and qualitative methods (unstructured interviews and thematic analysis) were used to interpret the results. Four members of the group (funding-body representatives or award panel members) reviewed the justification statements for transparency and information content. Separately, 163 activities common to trials were assigned to roles used by nine CTUs; the consistency of role delineation was assessed by Cohen's κ. Median full economic cost of CTU activities was £769,637 (range: £661,112 to £1,383,323). Indirect costs varied considerably, accounting for between 15% and 59% (median 35%) of the full economic cost of the grant. Excluding one CTU, which used external statisticians, the total number of FTEs ranged from 2.0 to 3.0; total FTEs attracting overheads ranged from 0.3 to 2.0. Variation in directly incurred staff costs depended on whether CTUs: supported particular roles from core funding rather than grants; opted not to cost certain activities into the grant; assigned clerical or data management tasks to research or administrative staff; employed extensive on-site monitoring strategies (also the main source of variation in non-staff costs). Funders preferred written justifications of costs that described both FTEs and indicative tasks for funded roles, with itemised non-staff costs. Consistency in role delineation was fair (κ

  13. Clinical Trials

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    Full Text Available ... and useful results, which in turn will improve public health. We offer a variety of funding mechanisms tailored to planning and conducting clinical ... Privacy Policy Freedom of Information Act (FOIA) Accessibility ...

  14. Clinical Trials

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    Full Text Available ... and devices specific to children. Resources for a Wide Range of Audiences The Children and Clinical Studies ... have not only shaped medical practice around the world, but have improved the health of millions of ...

  15. Clinical Trials

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    Full Text Available ... the strategy or treatment is having harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight for clinical ...

  16. Clinical Trials

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    Full Text Available ... harmful effects. Food and Drug Administration In the United States, the Food and Drug Administration (FDA) provides oversight ... of research studies at the NIH Clinical Center, America's research hospital, located on the NIH campus in ...

  17. Randomized clinical trial comparing control of maxillary anchorage with 2 retraction techniques.

    Science.gov (United States)

    Xu, Tian-Min; Zhang, Xiaoyun; Oh, Hee Soo; Boyd, Robert L; Korn, Edward L; Baumrind, Sheldon

    2010-11-01

    The objective of this pilot randomized clinical trial was to investigate the relative effectiveness of anchorage conservation of en-masse and 2-step retraction techniques during maximum anchorage treatment in patients with Angle Class I and Class II malocclusions. Sixty-four growing subjects (25 boys, 39 girls; 10.2-15.9 years old) who required maximum anchorage were randomized to 2 treatment techniques: en-masse retraction (n = 32) and 2-step retraction (n = 32); the groups were stratified by sex and starting age. Each patient was treated by a full-time clinic instructor experienced in the use of both retraction techniques at the orthodontic clinic of Peking University School of Stomatology in China. All patients used headgear, and most had transpalatal appliances. Lateral cephalograms taken before treatment and at the end of treatment were used to evaluate treatment-associated changes. Differences in maxillary molar mesial displacement and maxillary incisor retraction were measured with the before and after treatment tracings superimposed on the anatomic best fit of the palatal structures. Differences in mesial displacement of the maxillary first molar were compared between the 2 treatment techniques, between sexes, and between different starting-age groups. Average mesial displacement of the maxillary first molar was slightly less in the en-masse group than in the 2-step group (mean, -0.36 mm; 95% CI, -1.42 to 0.71 mm). The average mesial displacement of the maxillary first molar for both treatment groups pooled (n = 63, because 1 patient was lost to follow-up) was 4.3 ± 2.1 mm (mean ± standard deviation). Boys had significantly more mesial displacement than girls (mean difference, 1.3 mm; P <0.03). Younger adolescents had significantly more mesial displacement than older adolescents (mean difference, 1.3 mm; P <0.02). Average mesial displacement of the maxillary first molar with 2-step retraction was slightly greater than that for en-masse retraction, but the

  18. Comparative Clinical Study of Conventional Dental Implants and Mini Dental Implants for Mandibular Overdentures: A Randomized Clinical Trial.

    Science.gov (United States)

    Aunmeungtong, Weerapan; Kumchai, Thongnard; Strietzel, Frank P; Reichart, Peter A; Khongkhunthian, Pathawee

    2017-04-01

    Dental implant-retained overdentures have been chosen as the treatment of choice for complete mandibular removable dentures. Dental implants, such as mini dental implants, and components for retaining overdentures, are commercially available. However, comparative clinical studies comparing mini dental implants and conventional dental implants using different attachment for implant-retained overdentures have not been well documented. To compare the clinical outcomes of using two mini dental implants with Equator ® attachments, four mini dental implants with Equator attachments, or two conventional dental implants with ball attachments, by means of a randomized clinical trial. Sixty patients received implant-retained mandibular overdentures in the interforaminal region. The patients were divided into three groups. In Groups 1 and 2, two and four mini dental implants, respectively, were placed and immediately loaded by overdentures, using Equator ® attachments. In Group 3, conventional implants were placed. After osseointegration, the implants were loaded by overdentures, using ball attachments. The study distribution was randomized and double-blinded. Outcome measures included changes in radiological peri-implant bone level from surgery to 12 months postinsertion, prosthodontic complications and patient satisfaction. The cumulative survival rate in the three clinical groups after one year was 100%. There was no significant difference (p < 0.05) in clinical results regarding the number (two or four) of mini dental implants with Equator attachments. However, there was a significant difference in marginal bone loss and patient satisfaction between those receiving mini dental implants with Equator attachments and conventional dental implants with ball attachments. The marginal bone resorption in Group 3 was significantly higher than in Groups 1 and 2 (p < 0.05); there were no significant differences between Groups 1 and 2. There was no significant difference in

  19. Treatment of secondary hyperparathyroidism in haemodialysis patients: a randomised clinical trial comparing paricalcitol and alfacalcidol

    DEFF Research Database (Denmark)

    Hansen, Ditte; Brandi, Lisbet; Rasmussen, Knud

    2009-01-01

    BACKGROUND: Secondary hyperparathyroidism is a common feature in patients with chronic kidney disease. Its serious clinical consequences include renal osteodystrophy, calcific uremic arteriolopathy, and vascular calcifications that increase morbidity and mortality.Reduced synthesis of active vita...... in the risk of cardiovascular mortality depending on which vitamin D analog that are used. This has potential major importance for this group of patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT00469599....... vitamin D contributes to secondary hyperparathyroidism. Therefore, this condition is managed with activated vitamin D. However, hypercalcemia and hyperphosphatemia limit the use of activated vitamin D.In Denmark alfacalcidol is the primary choice of vitamin D analog.A new vitamin D analog, paricalcitol...... and hyperphosphatemia are associated with increased cardiovascular mortality in patients with chronic kidney disease.If there is any difference in the ability of these two vitamin D analogs to decrease the secondary hyperparathyroidism without causing hypercalcemia and hyperphosphatemia, there may also be a difference...

  20. CYberinfrastructure for COmparative effectiveness REsearch (CYCORE): improving data from cancer clinical trials.

    Science.gov (United States)

    Patrick, Kevin; Wolszon, Laura; Basen-Engquist, Karen M; Demark-Wahnefried, Wendy; Prokhorov, Alex V; Barrera, Stephanie; Baru, Chaitan; Farcas, Emilia; Krueger, Ingolf; Palmer, Doug; Raab, Fred; Rios, Phil; Ziftci, Celal; Peterson, Susan

    2011-03-01

    Improved approaches and methodologies are needed to conduct comparative effectiveness research (CER) in oncology. While cancer therapies continue to emerge at a rapid pace, the review, synthesis, and dissemination of evidence-based interventions across clinical trials lag in comparison. Rigorous and systematic testing of competing therapies has been clouded by age-old problems: poor patient adherence, inability to objectively measure the environmental influences on health, lack of knowledge about patients' lifestyle behaviors that may affect cancer's progression and recurrence, and limited ability to compile and interpret the wide range of variables that must be considered in the cancer treatment. This lack of data integration limits the potential for patients and clinicians to engage in fully informed decision-making regarding cancer prevention, treatment, and survivorship care, and the translation of research results into mainstream medical care. Particularly important, as noted in a 2009 report on CER to the President and Congress, the limited focus on health behavior-change interventions was a major hindrance in this research landscape (DHHS 2009). This paper describes an initiative to improve CER for cancer by addressing several of these limitations. The Cyberinfrastructure for Comparative Effectiveness Research (CYCORE) project, informed by the National Science Foundation's 2007 report "Cyberinfrastructure Vision for 21(st) Century Discovery" has, as its central aim, the creation of a prototype for a user-friendly, open-source cyberinfrastructure (CI) that supports acquisition, storage, visualization, analysis, and sharing of data important for cancer-related CER. Although still under development, the process of gathering requirements for CYCORE has revealed new ways in which CI design can significantly improve the collection and analysis of a wide variety of data types, and has resulted in new and important partnerships among cancer researchers engaged in

  1. Clinical Trials

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    Full Text Available ... seems promising, the next step may involve animal testing. This shows how the approach affects a living body and whether it's harmful. However, an approach that works well in the lab or animals doesn't always work well in people. Thus, research in humans is needed. For safety purposes, clinical ...

  2. Clinical Trials

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    Full Text Available ... the final stages of a long and careful research process. The process often begins in a laboratory (lab), where scientists first develop and test new ideas. If an approach seems ... Thus, research in humans is needed. For safety purposes, clinical ...

  3. Clinical Trials

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    Full Text Available ... help improve and advance medical care. They also can help health care decisionmakers direct resources to the ... while another group gets a new treatment. Researchers can then compare the results to see whether one ...

  4. Conservative treatment of a mandibular condyle fracture: comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  5. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial

    NARCIS (Netherlands)

    van den Bergh, B.; Blankestijn, J.; van der Ploeg, T.; Tuinzing, D.B.; Forouzanfar, T.

    2015-01-01

    Introduction A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of

  6. Clinical Trials

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    Full Text Available ... groups of people to confirm how well treatments work, further examine side effects, and compare new treatments with other available treatments. ... new approach benefits some participants, it may not work for you. A new treatment may have side effects or risks that doctors don't know about ...

  7. Randomized clinical trial comparing an oral carbohydrate beverage with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, T; Kristiansen, V B; Hjortsø, N C

    2004-01-01

    BACKGROUND: Preoperative oral carbohydrate can attenuate postoperative insulin resistance and catabolism, and may have the potential to improve postoperative recovery. There are no data from randomized studies on postoperative clinical outcome after specific surgical procedures. This study...... evaluated the clinical effects of a preoperative carbohydrate beverage in patients undergoing laparoscopic cholecystectomy. METHODS: Ninety-four patients undergoing laparoscopic cholecystectomy were included in a randomized clinical trial. Patients were randomized to receive 800 ml of an iso-osmolar 12.......5 per cent carbohydrate-rich beverage the evening before operation (100 g carbohydrate) and another 400 ml (50 g carbohydrate) 2 h before initiation of anaesthesia, or the same volume of a placebo beverage. The primary endpoint was general well-being the day after operation. Patients were evaluated from...

  8. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  9. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    ... in the pharmaceutical industry, Clinical trial methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research...

  10. Comparability of prostate trials

    DEFF Research Database (Denmark)

    Suciu, S; Sylvester, R; Iversen, P

    1993-01-01

    The present overview of advanced prostate cancer required the identification of randomized clinical trials studying the question of maximal androgen blockade versus the classic castration therapy. The heterogeneity of the trials concerned the type of castration (surgical or chemical) and the type...

  11. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  12. A Randomized Clinical Trial Comparing Methotrexate and Mycophenolate Mofetil for Non-Infectious Uveitis

    Science.gov (United States)

    Rathinam, Sivakumar R; Babu, Manohar; Thundikandy, Radhika; Kanakath, Anuradha; Nardone, Natalie; Esterberg, Elizabeth; Lee, Salena M; Enanoria, Wayne TA; Porco, Travis C; Browne, Erica N; Weinrib, Rachel; Acharya, Nisha R

    2014-01-01

    Objective To compare the relative effectiveness of methotrexate and mycophenolate mofetil for non-infectious intermediate uveitis, posterior uveitis, or panuveitis. Design Multicenter, block-randomized, observer-masked clinical trial Participants Eighty patients with non-infectious intermediate, posterior or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India. Intervention Patients were randomized to receive 25mg weekly oral methotrexate or 1g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered. Main Outcome Measures Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤ 10 mg of prednisone and ≤ 2 drops of prednisolone acetate 1% a day and (3) no declaration of treatment failure due to intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence. Results Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (p=0.09). Treatment failure due to adverse events or tolerability was not significantly different by treatment arm (p=0.99). There were no statistically significant differences between treatment groups in time to corticosteroid-sparing control of inflammation (p=0.44), change in best spectacle-corrected visual acuity (p=0.68), and resolution of macular

  13. A randomized clinical trial comparing methotrexate and mycophenolate mofetil for noninfectious uveitis.

    Science.gov (United States)

    Rathinam, Sivakumar R; Babu, Manohar; Thundikandy, Radhika; Kanakath, Anuradha; Nardone, Natalie; Esterberg, Elizabeth; Lee, Salena M; Enanoria, Wayne T A; Porco, Travis C; Browne, Erica N; Weinrib, Rachel; Acharya, Nisha R

    2014-10-01

    To compare the relative effectiveness of methotrexate and mycophenolate mofetil for noninfectious intermediate uveitis, posterior uveitis, or panuveitis. Multicenter, block-randomized, observer-masked clinical trial. Eighty patients with noninfectious intermediate, posterior, or panuveitis requiring corticosteroid-sparing therapy at Aravind Eye Hospitals in Madurai and Coimbatore, India. Patients were randomized to receive 25 mg weekly oral methotrexate or 1 g twice daily oral mycophenolate mofetil and were monitored monthly for 6 months. Oral prednisone and topical corticosteroids were tapered. Masked examiners assessed the primary outcome of treatment success, defined by achieving the following at 5 and 6 months: (1) ≤0.5+ anterior chamber cells, ≤0.5+ vitreous cells, ≤0.5+ vitreous haze and no active retinal/choroidal lesions in both eyes, (2) ≤10 mg of prednisone and ≤2 drops of prednisolone acetate 1% a day, and (3) no declaration of treatment failure because of intolerability or safety. Additional outcomes included time to sustained corticosteroid-sparing control of inflammation, change in best spectacle-corrected visual acuity, resolution of macular edema, adverse events, subgroup analysis by anatomic location, and medication adherence. Forty-one patients were randomized to methotrexate and 39 to mycophenolate mofetil. A total of 67 patients (35 methotrexate, 32 mycophenolate mofetil) contributed to the primary outcome. Sixty-nine percent of patients achieved treatment success with methotrexate and 47% with mycophenolate mofetil (P = 0.09). Treatment failure from adverse events or tolerability was not different by treatment arm (P = 0.99). There were no differences between treatment groups in time to corticosteroid-sparing control of inflammation (P = 0.44), change in best spectacle-corrected visual acuity (P = 0.68), or resolution of macular edema (P = 0.31). There was no statistically significant difference in corticosteroid-sparing control of

  14. The first clinical experience on efficacy of topical flutamide on melasma compared with topical hydroquinone: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Adalatkhah H

    2015-08-01

    Full Text Available Hassan Adalatkhah,1 Homayoun Sadeghi-Bazargani2,3 1Department of Dermatology, Ardabil University of Medical Sciences, Ardabil, Iran; 2Road Traffic Injury Research Center, Department of Statistics and Epidemiology, Tabriz University of Medical Sciences, Tabriz, Iran; 3Department of Public Health Sciences, Karolinska Institute, Stockholm, Sweden Background: Treatment of melasma is unsatisfactory most of the times. Hormonal role is shown to exist in pathogenesis of the melasma, and sex-hormone related drugs may have an effect on melasma.Aim: To investigate efficacy of 1% flutamide cream versus 4% hydroquinone cream on melasma.Methods: In a parallel randomized clinical trial, 74 women with melasma were allocated to receive a sunscreen along with 4% hydroquinone cream or 1% flutamide cream. Melasma Area and Severity Index (MASI, mexameter melanin assay, and patient satisfaction were investigated.Results: Mean age of the participants was 33.8 years. Mean length of time suffering from Melasma was 96.3 months. The subjects reported in average 1.1 hours per day of exposure to sunlight. Mean standardized total patient satisfaction score was 28.8 (standard deviation [SD] 17.2 in flutamide group patients versus 18 (SD 15.5 in control group (P<0.01. Regardless of treatment group, the skin darkness assessed upon MASI scales was reduced over the treatment course (P<0.001. Using mixed effects, longitudinal modeling showed better treatment efficacy based on MASI scale for flutamide group compared to the hydroquinone group (P<0.05. However, longitudinal analysis of mexameter scores did not reveal any significant difference in melanin measurements between flutamide and hydroquinone.Conclusion: Topical flutamide appeared as effective as topical hydroquinone in treating melasma using mexameter assessment but with a better MASI improvement trend and higher patient satisfaction in flutamide treatment versus topical hydroquinone. As the present study is possibly the

  15. Research Areas - Clinical Trials

    Science.gov (United States)

    Information about NCI programs and initiatives that sponsor, conduct, develop, or support clinical trials, including NCI’s Clinical Trial Network (NCTN) and NCI Community Oncology Research Program (NCORP) initiatives.

  16. Clinical trial methodology

    National Research Council Canada - National Science Library

    Peace, Karl E; Chen, Ding-Geng

    2011-01-01

    "Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide...

  17. Is a comparative clinical trial for breast cancer tumor markers to monitor disease recurrence warranted? A value of information analysis.

    Science.gov (United States)

    Thariani, Rahber; Henry, Norah Lynn; Ramsey, Scott D; Blough, David K; Barlow, Bill; Gralow, Julie R; Veenstra, David L

    2013-05-01

    Breast cancer tumor markers are used by some clinicians to screen for disease recurrence risk. Since there is limited evidence of benefit, additional research may be warranted. To assess the potential value of a randomized clinical trial of breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors. We developed a decision-analytic model of tumor marker testing plus standard surveillance every 3-6 months for 5 years. The expected value of sample information was calculated using probabilistic simulations and was a function of: the probability of selecting the optimal monitoring strategy with current versus future information; the impact of choosing the nonoptimal strategy; and the size of the population affected. The value of information for a randomized clinical trial involving 9000 women was US$214 million compared with a cost of US$30-60 million to conduct such a trial. The probability of making an alternate, nonoptimal decision and choosing testing versus no testing was 32% with current versus future information from the trial. The impact of a nonoptimal decision was US$2150 and size of population impacted over 10 years was 308,000. The value of improved information on overall survival was US$105 million, quality of life US$37 million and test performance US$71 million. Conducting a randomized clinical trial of breast cancer tumor markers appears to offer a good societal return on investment. Retrospective analyses to assess test performance and evaluation of patient quality of life using tumor markers may also offer valuable areas of research. However, alternative investments may offer even better returns in investments and, as such, the trial concept deserves further study as part of an overall research-portfolio evaluation.

  18. Comparative clinical trial of castor oil and diclofenac sodium in patients with osteoarthritis.

    Science.gov (United States)

    Medhi, B; Kishore, K; Singh, U; Seth, S D

    2009-10-01

    A randomized, double-blind, comparative clinical study was conducted to compare the safety and efficacy of castor oil with diclofenac sodium in patients with knee osteoarthritis. Subjects with symptoms of knee osteoarthritis were given a castor oil capsule 0.9 mL (n = 50) thrice daily for 4 weeks or a capsule of diclofenac sodium (n = 50), 50 mg thrice daily for 4 weeks. The subjects completed an overall evaluation of symptom relief at 2 weeks and 4 weeks of completed treatment. The subjects were evaluated by clinical, routine laboratory and radiographic investigations for improvement of disease conditions and also for adverse drug reaction. On completion of 4 weeks treatment it was observed that both drugs were significantly effective in the treatment of knee osteoarthritis (p castor oil there were no adverse effects reported. The present study indicates that castor oil can be used as an effective therapy in primary knee osteoarthritis. (c) 2009 John Wiley & Sons, Ltd.

  19. Metformin compared with insulin in the management of gestational diabetes mellitus: a randomized clinical trial.

    Science.gov (United States)

    Niromanesh, Shirin; Alavi, Azin; Sharbaf, Fatemeh Rahimi; Amjadi, Nooshin; Moosavi, Sanaz; Akbari, Soheila

    2012-12-01

    To evaluate the effect of metformin and insulin in glycemic control and compare pregnancy outcome in women with gestational diabetes mellitus (GDM). This randomized controlled trial was conducted in GDM women with singleton pregnancy and gestational age between 20 and 34 weeks who did not achieve glycemic control on diet were assigned randomly to receive either metformin (n=80) or insulin (n=80). The primary outcomes were maternal glycemic control and birth weight. The secondary outcomes were neonatal and obstetric complications. Two groups were comparable regarding the maternal characteristics. Two groups were similar in mean FBS (P=0.68) and postprandial measurements (P=0.87) throughout GDM treatment. The neonates of metformin group had less rate of birth weight centile >90 than insulin group (RR: 0.5, 95% CI: 0.3-0.9, P=0.012). Maternal weight gain was reduced in the metformin group (P0.05). In metformin group 14% of women needed to supplemental insulin to achieve euglycemia. Metformin is an effective and safe alternative treatment to insulin for women with GDM. This study does not show significant risk of maternal or neonatal adverse outcome with the use of metformin. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

  20. Randomized clinical trial comparing oral prednisone (50 mg) with placebo before laparoscopic cholecystectomy

    DEFF Research Database (Denmark)

    Bisgaard, Thue; Schulze, S.; Hjortso, N.C.

    2008-01-01

    cholecystectomy. Methods In a double-blind placebo-controlled study, 200 patients were randomized to oral administration of prednisone (50 mg) or placebo 2 h before laparoscopic cholecystectomy. Patients received a similar standardized anaesthetic, surgical, and analgesic treatment. The primary outcome was pain......-h pain, fatigue or malaise scores or any other variables were found (P > 0.05). Conclusion There is no important clinical gain of preoperative oral steroid administration compared with placebo in patients undergoing laparoscopic cholecystectomy Udgivelsesdato: 2008/2...

  1. Hepatitis C: Clinical Trials

    Science.gov (United States)

    ... and Public Home » Hepatitis C » Treatment Decisions Viral Hepatitis Menu Menu Viral Hepatitis Viral Hepatitis Home For ... can I find out about participating in a hepatitis C clinical trial? Many trials are being conducted ...

  2. Effects of Letrozole Compared with Danazol on Patients with Confirmed Endometriosis: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Navid Koleini

    2010-01-01

    Full Text Available Background: Letrozole is an aromatase inhibitor which can decrease estrogen production inperipheral tissues and endometriosis. Danazol, as an androgen, inhibits estrogen production inovaries and recently has been introduced as an aromatase inhibitor. This study was designed tocompare the effects of Danazol with Letrozole on endometriosis symptom relief.Materials and Methods: This study was a randomized clinical trial in which 105 patients withconfirmed endometriosis were randomly assigned to one of three groups. Group 1 received Letrozoletablets (2.5 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 2 received Danazoltablets (600 mg/day, calcium (1000 mg/day and vitamin D (800 IU/day. Group 3 (placebo groupwere assigned to take two calcium tablets daily (500 mg/tablet and vitamin D (800 IU/day. Pelvicpain, dysmenorrhea and dyspareunia were assessed in participants at baseline and monthly duringthe study for a total of six months. Data were analyzed via SPSS version 15 software with Freidmanand Wilcoxon tests.Results: Mean age in three groups has no significant difference. Of the 105 participants who wereenrolled in this study, 38 patients were assigned to group 1 (Letrozole group, 37 patients in group 2(Danazol group and 31 patients were placed in group 3 (placebo group. This study showed that themean scores for chronic pelvic pain, dysmenorrhea and dyspareunia for the Letrozole group wereless than the Danazol and placebo groups.Conclusion: This study showed that Letrozole can be more effective than Danazol for reducingchronic pelvic pain, dyspareunia and dysmenorrhea in patients suffering from recurrent endometriosis(Registeration Number: IRCT138812043414N1.

  3. Managing clinical trials

    Directory of Open Access Journals (Sweden)

    Kenyon Sara

    2010-07-01

    Full Text Available Abstract Managing clinical trials, of whatever size and complexity, requires efficient trial management. Trials fail because tried and tested systems handed down through apprenticeships have not been documented, evaluated or published to guide new trialists starting out in this important field. For the past three decades, trialists have invented and reinvented the trial management wheel. We suggest that to improve the successful, timely delivery of important clinical trials for patient benefit, it is time to produce standard trial management guidelines and develop robust methods of evaluation.

  4. Polyetheretherketone (PEEK) Spacers for Anterior Cervical Fusion: A Retrospective Comparative Effectiveness Clinical Trial.

    Science.gov (United States)

    Lemcke, Johannes; Al-Zain, Ferass; Meier, Ullrich; Suess, Olaf

    2011-01-01

    Anterior cervical decompression and fusion (ACDF) is the standard surgical treatment for radiculopathy and myelopathy. Polyetheretherketone (PEEK) has an elasticity similar to bone and thus appears well suited for use as the implant in ACDF procedures. The aim of this study is to examine the clinical and radiographic outcome of patients treated with standing alone PEEK spacers without bone morphogenic protein (BMP) or plating and to examine the influence of the different design of the two spacers on the rate of subsidence and dislocation. This retrospective comparative study reviewed 335 patients treated by ACDF in a specialized urban hospital for radiculopathy or myelopathy due to degenerative pathologies. The Intromed PEEK spacer was used in 181 patients from 3/2002 to 11/2004, and the AMT SHELL spacer was implanted in 154 patients from 4/2004 to 12/2007. The follow-up rate was 100% at three months post-op and 82.7% (277 patients) at one year. The patients were assessed with the Japanese Orthopedic Association (JOA) questionnaire and radiographically. At the one-year follow-up there were 118/277 patients with an excellent clinical outcome on the JOA, 112/277 with a good outcome, 20/277 with a fair outcome, and 27/277 with a poor outcome. Subsidence was observed in 13.3% of patients with the Intromed spacer vs 8.4% of the patients with the AMT SHELL. Dislocation of the spacer was observed in 10 of the 181 patients with Intromed spacers but in none of the 154 patients with Shell spacers. The study demonstrates that ACDF with standing alone PEEK cages leads to excellent and good clinical outcomes. The differences we observed in the subsidence rate between the two spacers were not significant and cannot be related to a single design feature of the spacers.

  5. Treatment of helicobacter pylori infection; a controlled randomized comparative clinical trial

    International Nuclear Information System (INIS)

    Mehmood, A.; Usmanghani, K.; Mohiuddin, E.; Akram, M.

    2010-01-01

    Helicobacter pylori induces chronic inflammation of the underlying gastric mucosa and is strongly linked to the development of duodenal and gastric carcinoma. A study was conducted to evaluate the efficacy of Pylorex, a herbal formulation, for treatment of H. pylori infection as compared to triple allopathic therapy (Omeprazole, Amoxicillin, Metronidazole). The therapeutic evaluations of these medicines were conducted on 97 clinically and immunologically diagnosed cases of H. pylori infection. H. pylori was eradicated in 16 (32.6%) out of 49 patients by the use of triple allopathic therapy (Control drugs), and in 9 (18.7%) out of 48 patients by the use of Pylorex (Test drug). Pylorex possesses a therapeutic value for the treatment of H. pylori associated symptoms but the eradication rate is superior in triple allopathic therapy. (author)

  6. Types of Cancer Clinical Trials

    Science.gov (United States)

    Information about the several types of cancer clinical trials, including treatment trials, prevention trials, screening trials, supportive and palliative care trials. Each type of trial is designed to answer different research questions.

  7. Randomized controlled clinical trial comparing two dental implants with different neck configurations.

    Science.gov (United States)

    Sanz-Martín, Ignacio; Sanz-Sánchez, Ignacio; Noguerol, Fernando; Cok, Susy; Ortiz-Vigón, Alberto; Sanz, Mariano

    2017-06-01

    Peri-implant bone levels can vary according to the implant neck macro-design and the implant-abutment interface. To compare the changes in soft and hard tissues when using a one-piece implant with a machined collar (TG) versus a two-piece implant with a progressive platform widening and a platform switching connection (SP). Partially edentulous patients willing to receive one or two implants in the posterior maxilla or mandible were randomized to the control (TG) or to the test group (SP). Final prostheses were delivered after 12 months. Radiographic measurements of interproximal bone levels (primary outcome) were assessed at implant loading and 1-year postloading. Clinical, patient related outcomes and adverse events were assessed at loading and after 6 and 12 months. Sixty-one implants were placed in 47 patients, 37 patients (18 in the TG group and 19 in the SP group), and 47 implants (23 TG and 24 SP) completed the 24-months follow up. At the patient level, a significantly greater bone resorption from baseline to implant loading was observed in the SP group (-0.42 ± 0.45 vs -0.07 ± 0.45; P = .001*), while from loading to the final visit, the TG group had significantly greater bone loss than the SP group (-0.26 ± 0.22 vs -0.11 ± 0.2; P = .020*). At 24 months after surgery, there were no significant differences between both groups (control: 0.33 ± 0.49 vs test: 0.53 ± 0.53; P = .230). Similarly, no significant differences were observed for the secondary outcomes. Both types of implant reported high survival rates and similar bone level changes, clinical parameters, and patient related outcomes after 12 months of loading. © 2017 Wiley Periodicals, Inc.

  8. A proposed framework for evaluating and comparing efficacy estimates in clinical trials of new rotavirus vaccines.

    Science.gov (United States)

    Neuzil, Kathleen M; Zaman, K; Victor, John C

    2014-08-11

    Oral rotavirus vaccines have yielded different point estimates of efficacy when tested in different populations. While population and environmental factors may account for these differences, study design characteristics should also be considered. We review the study design elements of rotavirus vaccine trials that may affect point estimates of efficacy, and propose a framework for evaluating new rotavirus vaccines. Copyright © 2014. Published by Elsevier Ltd.

  9. Results of a clinical trial comparing conservative and modified radical mastectomy for early breast cancer

    International Nuclear Information System (INIS)

    Du Xianghui; Wang Yuezhen; Wu Lie; Zhu Yuan; Yang Hongjian; Zou Dehong

    2005-01-01

    Objective: The influence of conservative mastectomy plus postoperative radiation (CM + RT) in local control, distant failure, cosmetic and psychological outcome for early stage breast cancer was evaluated comparing with modified radical mastectomy. Methods: Between January 1998 and December 2003, 68 early stage breast cancer patients underwent CM + RT. During the save period, 76 similar patients were treated by modified radical mastectomy (MRM + RT). The cosmetic results evaluated as 'excellent', 'fair' or 'poor' using specific guide lines together with their psychological changes. Sex life and marital stability were also recorded. All patients were female with median age of 44.5 years (range, 28-62 years). Guidelines for patient selection reported by National Breast Cancer Cooperative Group was adhered to. In general, CM consisted of wide local excision with the breast conserved and postoperative radiotherapy to the entire breast with tangential fields followed by a boost to the tumor bed. All patients also received adjuvant chemotherapy with CAF. Patients with positive ER or PR assay results received tamoxifen for 5 years. In the 76 MRM + RT patients, the post operative radiotherapy and chemotherapy were given as clinically indicated. Results: There was no failure locally in all. In CM + RT group, the cause of failure was bone metastasis in 1 and mutiple metastasis in 2. In the MRM + RT group, the cause of failure was bone metastasis in 2, brain metastasis in 1 and mutiple metastases in 1. The cosmetic scores were 91.2% excellent, 5.6% fair and 2.9% poor. Conclusions: Breast preservation by conservative mastectomy is preferable to mastectomy in appropriately selected patients as it provides equivalent survival but giving good cosmetic results. (authors)

  10. HALF-DOSE DEPOT TRIPTORELIN COMPARABLE TO REDUCED DAILY BUSERELIN: A RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L. Safdarian

    2007-09-01

    Full Text Available Pituitary suppression by depot GnRH agonist may be excessive for ovarian stimulation. This study compares the efficacy of a single half-dose depot triptorelin and reduced-dose daily buserelin in a long protocol ICSI/ET. METHODS: A total of 182 patients were randomized into two groups using sealed envelopes. Pituitary desensitization was obtained in group 1 (91 patients with half-dose (1.87 mg depot triptorelin in the mid-luteal phase of their menstrual cycle, and in group 2 (91 patients with standard daily dose (0.5 mg buserelin, which was then reduced to 0.25 mg at the start of human menopausal gonadotropin (HMG stimulation. RESULTS: No significant differences were found among those who received HCG in terms of clinical pregnancy rate (34.4% in both groups, implantation rate (14.8% in group 1 versus 11.1% in group 2, fertilization rate (93.3 versus 95.6%, poor response rate (11.1 versus 6.7%, and miscarriage rate (11.1 versus 7.8%. No significant differences were seen in number of HMG ampoules used, follicles at HCG administration, and oocytes retrieved. The number of days of stimulation was significantly reduced in group 2 (11.2 +/- 1.8 in group 1 versus 10.6 +/- 1.9, p = 0.030. CONCLUSION: A half-dose of depot triptorelin can be successfully used in ovarian stimulation instead of reduced-dose daily buserelin, with more patient comfort and reduced stress and cost of injections.

  11. A Comparative Clinical Trial of Topical Triamcinolone (Adcortyle and a Herbal Solution for the Treatment of Minor Aphthous Stomatitis

    Directory of Open Access Journals (Sweden)

    F Rad

    2010-10-01

    The aim of this study was to compare the therapeutic effect of topical Myrtus communis (myrtle solution with topical triamcinolone (Adcortyle in the treatment of minor apotheosis. Materials & Methods: This clinical-trial study was conducted at Kurdistan University of Medical Sciences in 2009. 100 patients were randomly assigned into 2 groups. The 1st group received topical myrtle solution. The 2nd group received topical trimcinolone (Adcortyle. After one week, patients' declaration about time of the recovery of the pain and deterioration of oral lesion was recorded. The gathered data was then analyzed using the SPSS statistical software using t-test and chi-square. Results: After treatment, both groups showed response to topical medications with no significant difference between them (p>0.05. Conclusion: results of this study showed that topical myrtle solution is effective in the treatment of minor aphthous stomatitis and its therapeutic effect is comparable with topical triamcinolone (Adcortyle.

  12. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed trials.

    Directory of Open Access Journals (Sweden)

    Melissa Paoloni

    Full Text Available Molecularly-guided trials (i.e. PMed now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting.A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77% successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days. Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type.Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (<1 week. Clustering data show robust signatures by cancer type but also showed patient-to-patient heterogeneity in drug predictions. This lends further support to the inclusion of a heterogeneous population of dogs with cancer into the preclinical

  13. To compare PubMed Clinical Queries and UpToDate in teaching information mastery to clinical residents: a crossover randomized controlled trial.

    Science.gov (United States)

    Sayyah Ensan, Ladan; Faghankhani, Masoomeh; Javanbakht, Anna; Ahmadi, Seyed-Foad; Baradaran, Hamid Reza

    2011-01-01

    To compare PubMed Clinical Queries and UpToDate regarding the amount and speed of information retrieval and users' satisfaction. A cross-over randomized trial was conducted in February 2009 in Tehran University of Medical Sciences that included 44 year-one or two residents who participated in an information mastery workshop. A one-hour lecture on the principles of information mastery was organized followed by self learning slide shows before using each database. Subsequently, participants were randomly assigned to answer 2 clinical scenarios using either UpToDate or PubMed Clinical Queries then crossed to use the other database to answer 2 different clinical scenarios. The proportion of relevantly answered clinical scenarios, time to answer retrieval, and users' satisfaction were measured in each database. Based on intention-to-treat analysis, participants retrieved the answer of 67 (76%) questions using UpToDate and 38 (43%) questions using PubMed Clinical Queries (PPubMed Clinical Queries (PPubMed Clinical Queries users (PPubmed Clinical Queries can lead to not only a higher proportion of relevant answer retrieval within a shorter time, but also a higher users' satisfaction. So, addition of tutoring pre-appraised sources such as UpToDate to the information mastery curricula seems to be highly efficient.

  14. Fundamentals of clinical trials

    CERN Document Server

    Friedman, Lawrence M; DeMets, David L; Reboussin, David M; Granger, Christopher B

    2015-01-01

    This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise.  Most chapters have been revised considerably from the fourth edition.  A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded.  Many contemporary clinical trial examples have been added.  There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials.  This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of ...

  15. Clinical benefit of intra-articular saline as a comparator in clinical trials of knee osteoarthritis treatments

    DEFF Research Database (Denmark)

    Altman, Roy D; Devji, Tahira; Bhandari, Mohit

    2016-01-01

    August 14th, 2014. Two reviewers assessed the eligibility of potential reports and the risk of bias of included trials. We analyzed short (≤3 months) and long-term (6-12 months) pain reduction of the saline arm of included trials using standardized mean differences (SMDs; estimated assuming a null effect...... in the meta-analysis. Based on data with moderate inconsistency IA saline was found to significantly improve short-term knee pain in 32 studies involving 1705 patients (SMD = -0.68; 95% CI: -0.78 to -0.57; P ... with saline in 19 studies involving 1445 patients (SMD = -0.61; 95% CI: -0.76 to -0.45; P

  16. ClinicalTrials.gov

    Data.gov (United States)

    U.S. Department of Health & Human Services — Provides patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases...

  17. Cancer clinical trials

    International Nuclear Information System (INIS)

    Scheurlen, A.; Kay, R.; Baum, M.

    1988-01-01

    This book contains the proceedings on Cancer clinical trials: A critical appraisal. Topics covered include: Scientific fundamentals; Heterogeneous treatment effects; On combining information: Historical controls, overviews, and comprehensive cohort studies; and assessment of quality of life

  18. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia

    NARCIS (Netherlands)

    van Santen, Marijke; Bolwijn, Paulien; Verstappen, Frans; Bakker, Carla; Hidding, Alita; Houben, Harry; van der Heijde, Desiree; Landewé, Robert; van der Linden, Sjef

    2002-01-01

    To compare the therapeutic effects of physical fitness training or biofeedback training with the results of usual care in patients with fibromyalgia (FM). One hundred forty-three female patients with FM (American College of Rheumatology criteria) were randomized into 3 groups: a fitness program (n =

  19. Comparative randomised controlled clinical trial of a herbal eye drop with artificial tear and placebo in computer vision syndrome.

    Science.gov (United States)

    Biswas, N R; Nainiwal, S K; Das, G K; Langan, U; Dadeya, S C; Mongre, P K; Ravi, A K; Baidya, P

    2003-03-01

    A comparative randomised double masked multicentric clinical trial has been conducted to find out the efficacy and safety of a herbal eye drop preparation, itone eye drops with artificial tear and placebo in 120 patients with computer vision syndrome. Patients using computer for at least 2 hours continuosly per day having symptoms of irritation, foreign body sensation, watering, redness, headache, eyeache and signs of conjunctival congestion, mucous/debris, corneal filaments, corneal staining or lacrimal lake were included in this study. Every patient was instructed to put two drops of either herbal drugs or placebo or artificial tear in the eyes regularly four times for 6 weeks. Objective and subjective findings were recorded at bi-weekly intervals up to six weeks. Side-effects, if any, were also noted. In computer vision syndrome the herbal eye drop preparation was found significantly better than artificial tear (p computer vision syndrome.

  20. Prospective molecular profiling of canine cancers provides a clinically relevant comparative model for evaluating personalized medicine (PMed) trials.

    Science.gov (United States)

    Paoloni, Melissa; Webb, Craig; Mazcko, Christina; Cherba, David; Hendricks, William; Lana, Susan; Ehrhart, E J; Charles, Brad; Fehling, Heather; Kumar, Leena; Vail, David; Henson, Michael; Childress, Michael; Kitchell, Barbara; Kingsley, Christopher; Kim, Seungchan; Neff, Mark; Davis, Barbara; Khanna, Chand; Trent, Jeffrey

    2014-01-01

    Molecularly-guided trials (i.e. PMed) now seek to aid clinical decision-making by matching cancer targets with therapeutic options. Progress has been hampered by the lack of cancer models that account for individual-to-individual heterogeneity within and across cancer types. Naturally occurring cancers in pet animals are heterogeneous and thus provide an opportunity to answer questions about these PMed strategies and optimize translation to human patients. In order to realize this opportunity, it is now necessary to demonstrate the feasibility of conducting molecularly-guided analysis of tumors from dogs with naturally occurring cancer in a clinically relevant setting. A proof-of-concept study was conducted by the Comparative Oncology Trials Consortium (COTC) to determine if tumor collection, prospective molecular profiling, and PMed report generation within 1 week was feasible in dogs. Thirty-one dogs with cancers of varying histologies were enrolled. Twenty-four of 31 samples (77%) successfully met all predefined QA/QC criteria and were analyzed via Affymetrix gene expression profiling. A subsequent bioinformatics workflow transformed genomic data into a personalized drug report. Average turnaround from biopsy to report generation was 116 hours (4.8 days). Unsupervised clustering of canine tumor expression data clustered by cancer type, but supervised clustering of tumors based on the personalized drug report clustered by drug class rather than cancer type. Collection and turnaround of high quality canine tumor samples, centralized pathology, analyte generation, array hybridization, and bioinformatic analyses matching gene expression to therapeutic options is achievable in a practical clinical window (strategies may aid cancer drug development.

  1. Falsificationism and clinical trials.

    Science.gov (United States)

    Senn, S J

    1991-11-01

    The relevance of the philosophy of Sir Karl Popper to the planning, conduct and analysis of clinical trials is examined. It is shown that blinding and randomization can only be regarded as valuable for the purpose of refuting universal hypotheses. The purpose of inclusion criteria is also examined. It is concluded that a misplaced belief in induction is responsible for many false notions regarding clinical trials.

  2. Open Clinical Trial on Using Nifuroxazide Compared to Probiotics in Treating Acute Diarrhoeas in Adults.

    Science.gov (United States)

    Begovic, Begler; Ahmedtagic, Sead; Calkic, Lejla; Vehabović, Midhat; Kovacevic, Sanela Bakić; Catic, Tarik; Mehic, Meliha

    2016-12-01

    Nifuroxazide is well known and often used anti-diarrhoeal medicine which has been pushed back from routine practice in recent years and often replaced with probiotics. Even probiotics are accepted and placed in some therapeutic guidelines for diarrhoea treatment, there are no enough evidence for its effectiveness and no comparative efficacy data with nifuroxazide in treatment of acute diarrhea. In open, prospective observational study, the efficacy and safety of nifuroxazide were compared with a probiotic containing lactic acid bacteria in the treatment of acute diarrhoea. A total number of 169 adult patients were included in this study, who administered nifuroxazide in the dose of 200 mg/4 times a day, while they took preparation containing lactic acid bacteria (1,2 x 10 7 live lyophilised lactic-acid bacteria) three times a day for three days. Mean time to last unformed stool (TLUS) in a group which was treated with nifuroxazide was two days, while it took five days for the stool normalisation in the group using probiotic (p=0.0001). Orally administered nifuroxazide has demonstrated better efficiency as compared to probiotic in treating acute diarrhoea, and both medicines have shown the same safety and tolerance in this study.

  3. Informed consent for clinical trials: a comparative study of standard versus simplified forms.

    Science.gov (United States)

    Davis, T C; Holcombe, R F; Berkel, H J; Pramanik, S; Divers, S G

    1998-05-06

    A high level of reading skill and comprehension is necessary to understand and complete most consent forms that are required for participation in clinical research studies. This study was conducted to test the hypothesis that a simplified consent form would be less intimidating and more easily understood by individuals with low-to-marginal reading skills. During July 1996, 183 adults (53 patients with cancer or another medical condition and 130 apparently healthy participants) were tested for reading ability and then asked to read either the standard Southwestern Oncology Group (SWOG) consent form (16th grade level) or a simplified form (7th grade level) developed at Louisiana State University Medical Center-Shreveport (LSU). Participants were interviewed to assess their attitudes toward and comprehension of the form read. Then they were given the alternate consent form and asked which one they preferred and why. Overall, participants preferred the LSU form (62%; 95% confidence interval [CI] = 54.8%-69.2%) over the SWOG form (38%; 95% CI = 30.8%-45.2%) (P = .0033). Nearly all participants thought that the LSU form was easier to read (97%; 95% CI = 93.1%-99.9%) than the SWOG form (75%; 95% CI = 65.1%-85.7%) (Pinformed consent documents for the substantial proportion of Americans with low-to-marginal literacy skills.

  4. A randomized clinical trial comparing mandibular incisor proclination produced by fixed labial appliances and clear aligners.

    Science.gov (United States)

    Hennessy, Joe; Garvey, Thérèse; Al-Awadhi, Ebrahim A

    2016-09-01

    To compare the mandibular incisor proclination produced by fixed labial appliances and third generation clear aligners. Patients underwent a course of orthodontic treatment using either fixed labial appliances or clear aligners (Invisalign). Mandibular incisor proclination was measured by comparing pretreatment and near-end treatment lateral cephalograms. Eligibility criteria included adult patients with mild mandibular incisor crowding (clear aligner group. Baseline characteristics were similar for both groups: Fixed appliance mean crowding was 2.1 ± 1.3 mm vs clear aligner mean crowding, 2.5 ± 1.3 mm; pretreatment mean mandibular incisor inclination for the fixed appliance group was 90.8 ± 5.4° vs 91.6 ± 6.4° for the clear aligner group. Fixed appliances produced 5.3 ± 4.3° of mandibular incisor proclination. Clear aligners proclined the mandibular incisors by 3.4 ± 3.2°. The difference between the two groups was not statistically significant (P > .05). There was no difference in the amount of mandibular incisor proclination produced by clear aligners and fixed labial appliances in mild crowding cases.

  5. Quality Assurance for Clinical Trials

    Science.gov (United States)

    Ibbott, Geoffrey S.; Haworth, Annette; Followill, David S.

    2013-01-01

    Cooperative groups, of which the Radiation Therapy Oncology Group is one example, conduct national clinical trials that often involve the use of radiation therapy. In preparation for such a trial, the cooperative group prepares a protocol to define the goals of the trial, the rationale for its design, and the details of the treatment procedure to be followed. The Radiological Physics Center (RPC) is one of several quality assurance (QA) offices that is charged with assuring that participating institutions deliver doses that are clinically consistent and comparable. The RPC does this by conducting a variety of independent audits and credentialing processes. The RPC has compiled data showing that credentialing can help institutions comply with the requirements of a cooperative group clinical protocol. Phantom irradiations have been demonstrated to exercise an institution’s procedures for planning and delivering advanced external beam techniques (1–3). Similarly, RPC data indicate that a rapid review of patient treatment records or planning procedures can improve compliance with clinical trials (4). The experiences of the RPC are presented as examples of the contributions that a national clinical trials QA center can make to cooperative group trials. These experiences illustrate the critical need for comprehensive QA to assure that clinical trials are successful and cost-effective. The RPC is supported by grants CA 10953 and CA 81647 from the National Cancer Institute, NIH, DHHS. PMID:24392352

  6. Effect of lactic acid suppositories compared with oral metronidazole and placebo in bacterial vaginosis: a randomised clinical trial.

    Science.gov (United States)

    Boeke, A J; Dekker, J H; van Eijk, J T; Kostense, P J; Bezemer, P D

    1993-01-01

    OBJECTIVE--To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN--Randomised clinical trial. SETTING--30 general practices in the Netherlands. PATIENTS--125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES--Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS--Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS--Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication. PMID:8244360

  7. Spirulina platensis versus silymarin in the treatment of chronic hepatitis C virus infection. A pilot randomized, comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Yakoot Mostafa

    2012-04-01

    Full Text Available Abstract Background Spirulina platensis, a cynobacterium used frequently as a dietary supplement had been found to exhibit many immune-stimulating and antiviral activities. It had been found to activate macrophages, NK cells, T cells, B cells, and to stimulate the production of Interferon gamma (IFN-γ and other cytokines. Natural substances isolated from Spirulina platensis had been found to be potent inhibitors against several enveloped viruses by blocking viral absorption/penetration and some replication stages of progeny viruses after penetration into cells. We aimed to study whether this dietary supplement possesses any therapeutically feasible activity worthy of further larger controlled clinical evaluation. Methods Sixty six patients with chronic hepatitis C virus infection and eligible for inclusion had been randomized to either Spirulina or Silymarin treated groups for a period of six months treatment. The two groups were followed up and blindly compared for early (after 3 months and end of 6 months treatment virological response. The effects of both treatments on each of alanine aminotransferase (ALT, Chronic Liver Disease Questionnaire scores (CLDQ, Arizona Sexual Experience Scale scores (ASEX and the occurrence of any attributable adverse events were also compared. Results Among the 30 patients who had been treated with Spirulina and completed the 6 months protocol, 4 patients (13.3% had a complete end of treatment virological response and 2 patients (6.7% had a partial end of treatment response defined as significant decrease of virus load of at least 2-logs10. Though the proportion of responders in Spirulina group was greater than in the Silymarin group, the difference was not statistically significant at the end of both 6 months (p = 0.12 and 3 months treatment (p = 0.22 by Exact test. Alanine aminotransferase as well as CLDQ and ASEX scores were found to be more significantly improved in Spirulina than in Silymarin treated group

  8. Clinical trial comparing autogenous fascia lata sling and Gore-Tex suspension in bilateral congenital ptosis

    Directory of Open Access Journals (Sweden)

    Elsamkary MA

    2016-03-01

    Full Text Available Mahmoud Ahmed Elsamkary,1 Maged Maher Salib Roshdy1,2 1Ophthalmology Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt; 2Pediatric Ophthalmology Department, Al Watany Eye Hospital, Cairo, Egypt Purpose: To study the effect of autogenous fascia lata sling (AFLS versus Gore-Tex suspension (GTS regarding the functional and aesthetic outcomes in patients with bilateral congenital ptosis. Patients and methods: A prospective comparative randomized single-center study enrolled 110 patients with bilateral congenital ptosis. One group (n=55 underwent AFLS and the second group (n=55 underwent GTS. Exclusion criteria were good levator function, absent Bell’s phenomenon, and abnormal ocular motility. Follow-up period was 2 years. Functional outcome was measured from digital photos by analysis of upper eyelid margin position relative to the superior limbus and classified as very good (<3 mm, good (3–5 mm, poor (>5 mm, and recurrent. Aesthetic outcome was assessed in terms of lid contour, symmetry of eyelid height, and lid crease presence. Complications were also reported. Results: Failure rate (recurrence and complications was less in AFLS (P=0.035. Symmetrical lid height and good contour were more frequently attained by AFLS (P=0.007 and 0.047, respectively. However, the frequency of very good, good, poor, recurrence, lagopthalmos, ectropion, infection, and formed lid crease individually showed no statistically significant difference (P=0.252, 0.482, 1, 0.489, 0.438, 1, 0.618, and 0.506, respectively. Conclusion: AFLS is a better choice in surgery for patients with bilateral congenital ptosis because it has fewer complications and a lesser recurrence rate than GTS. Keywords: ptosis surgery, surgical outcomes, ptosis recurrence, lagophthalmos

  9. Prospectively randomized clinical trial to compare in situ and reversed saphenous vein grafts for femoropopliteal bypass.

    Science.gov (United States)

    Harris, P L; How, T V; Jones, D R

    1987-04-01

    Two hundred and fifteen femoropopliteal bypass procedures using autologous saphenous vein grafts were randomly allocated to either the reversed or in situ technique. Eleven veins (5 per cent) were rejected at operation on the basis of their small size, nine in the reversed group and two in the in situ group, and there were two (2 per cent) perioperative deaths in each group, leaving 102 reversed and 98 in situ grafts for further study. The cumulative patency at 3 years of the reversed grafts was 77 per cent and that of the in situ grafts was 68 per cent (n.s.). The patency of all grafts was affected adversely by small veins (P less than 0.005), long grafts (P less than 0.05), low volume of blood flow in the grafts (P less than 0.001) and poor run-off (P less than 0.05). These factors influenced the outcome of the in situ and reversed operations to a similar degree and there was no statistically significant difference between them within any subgroup. The mean compliance of the in situ grafts measured 3 months or more after operation with an ultrasonic echo-tracking system was 0.024 +/- 0.01 per cent/mmHg (+/- s.d.) compared with 0.017 +/- 0.01 per cent/mmHg for the reversed grafts (t = 2.43, P less than 0.02). The incidence of fibrous stricture formation as shown by intravenous digital subtraction angiography was 29 per cent in both the reversed and the in situ grafts. The results of the study to date indicate that reversed and in situ vein grafts are equally effective for femoropopliteal bypass.

  10. A randomized clinical trial to compare three methods of orthodontic space closure.

    Science.gov (United States)

    Dixon, V; Read, M J F; O'Brien, K D; Worthington, H V; Mandall, N A

    2002-03-01

    To compare the rates of orthodontic space closure for: Active ligatures, polyurethane powerchain (Rocky Mountain Orthodontics, RMO Europe, Parc d'Innovation, Rue Geiler de Kaysersberg, 67400 Illkirch-Graffenstaden, Strasbourg, France) and nickel titanium springs. Patients entering the space closure phase of fixed orthodontic treatment attending six orthodontic providers. Twelve patients received active ligatures (48 quadrants), 10 patients received powerchain (40 quadrants) and 11 patients, nickel-titanium springs (44 quadrants). Patients were randomly allocated for treatment with active ligatures, powerchain or nickel titanium springs. Upper and lower study models were collected at the start of space closure (T(o)) and 4 months later (T(1)). We recorded whether the patient wore Class II or Class III elastics. Space present in all four quadrants was measured, by a calibrated examiner, using Vernier callipers at T(o) and T(1.) The rate of space closure, in millimetres per month (4 weeks) and a 4-monthly rate, was then calculated. Examiner reliability was assessed at least 2 weeks later. Mean rates of space closure were 0.35 mm/month for active ligatures, 0.58 mm/month for powerchain, and 0.81 mm/month for NiTi springs. No statistically significant differences were found between any methods with the exception of NiTi springs showing more rapid space closure than active ligatures (P space closure. NiTi springs gave the most rapid rate of space closure and may be considered the treatment of choice. However, powerchain provides a cheaper treatment option that is as effective. The use of inter-arch elastics does not appear to influence rate of space closure.

  11. Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).

    Science.gov (United States)

    Noguera, José F; Cuadrado, Angel; Dolz, Carlos; Olea, José M; García, Juan C

    2012-12-01

    Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

  12. A virtual clinical trial comparing static versus dynamic PET imaging in measuring response to breast cancer therapy

    Science.gov (United States)

    Wangerin, Kristen A.; Muzi, Mark; Peterson, Lanell M.; Linden, Hannah M.; Novakova, Alena; Mankoff, David A.; E Kinahan, Paul

    2017-05-01

    We developed a method to evaluate variations in the PET imaging process in order to characterize the relative ability of static and dynamic metrics to measure breast cancer response to therapy in a clinical trial setting. We performed a virtual clinical trial by generating 540 independent and identically distributed PET imaging study realizations for each of 22 original dynamic fluorodeoxyglucose (18F-FDG) breast cancer patient studies pre- and post-therapy. Each noise realization accounted for known sources of uncertainty in the imaging process, such as biological variability and SUV uptake time. Four definitions of SUV were analyzed, which were SUVmax, SUVmean, SUVpeak, and SUV50%. We performed a ROC analysis on the resulting SUV and kinetic parameter uncertainty distributions to assess the impact of the variability on the measurement capabilities of each metric. The kinetic macro parameter, K i , showed more variability than SUV (mean CV K i   =  17%, SUV  =  13%), but K i pre- and post-therapy distributions also showed increased separation compared to the SUV pre- and post-therapy distributions (mean normalized difference K i   =  0.54, SUV  =  0.27). For the patients who did not show perfect separation between the pre- and post-therapy parameter uncertainty distributions (ROC AUC  dynamic imaging outperformed SUV in distinguishing metabolic change in response to therapy, ranging from 12 to 14 of 16 patients over all SUV definitions and uptake time scenarios (p  PET imaging.

  13. Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema: Two-Year Results from a Comparative Effectiveness Randomized Clinical Trial.

    Science.gov (United States)

    Wells, John A; Glassman, Adam R; Ayala, Allison R; Jampol, Lee M; Bressler, Neil M; Bressler, Susan B; Brucker, Alexander J; Ferris, Frederick L; Hampton, G Robert; Jhaveri, Chirag; Melia, Michele; Beck, Roy W

    2016-06-01

    To provide 2-year results comparing anti-vascular endothelial growth factor (VEGF) agents for center-involved diabetic macular edema (DME) using a standardized follow-up and retreatment regimen. Randomized clinical trial. Six hundred sixty participants with visual acuity (VA) impairment from DME. Randomization to 2.0-mg aflibercept, 1.25-mg repackaged (compounded) bevacizumab, or 0.3-mg ranibizumab intravitreous injections performed up to monthly using a protocol-specific follow-up and retreatment regimen. Focal/grid laser photocoagulation was added after 6 months if DME persisted. Visits occurred every 4 weeks during year 1 and were extended up to every 4 months thereafter when VA and macular thickness were stable. Change in VA, adverse events, and retreatment frequency. Median numbers of injections were 5, 6, and 6 in year 2 and 15, 16, and 15 over 2 years in the aflibercept, bevacizumab, and ranibizumab groups, respectively (global P = 0.08). Focal/grid laser photocoagulation was administered in 41%, 64%, and 52%, respectively (aflibercept vs. bevacizumab, P 0.10, for pairwise comparisons). Anti-Platelet Trialists' Collaboration (APTC) events occurred in 5% with aflibercept, 8% with bevacizumab, and 12% with ranibizumab (global P = 0.047; aflibercept vs. bevacizumab, P = 0.34; aflibercept vs. ranibizumab, P = 0.047; ranibizumab vs. bevacizumab, P = 0.20; global P = 0.09 adjusted for potential confounders). All 3 anti-VEGF groups showed VA improvement from baseline to 2 years with a decreased number of injections in year 2. Visual acuity outcomes were similar for eyes with better baseline VA. Among eyes with worse baseline VA, aflibercept had superior 2-year VA outcomes compared with bevacizumab, but superiority of aflibercept over ranibizumab, noted at 1 year, was no longer identified. Higher APTC event rates with ranibizumab over 2 years warrants continued evaluation in future trials. Copyright © 2016 American Academy of Ophthalmology. All rights

  14. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation

    International Nuclear Information System (INIS)

    Fisher, B.; Redmond, C.; Fisher, E.R.

    1985-01-01

    In 1971 a randomized trial was begun to compare alternative local and regional treatments of breast cancer, all of which employ breast removal. Life-table estimates were obtained for 1665 women enrolled in the study for a mean of 126 months. There were no significant differences among three groups of patients with clinically negative auxillary nodes, with respect to disease-free survival, distant-disease-free survival, or overall survival (about 57%) at 10 years. The patients were treated by radical mastectomy, total (simple) mastectomy without auxillary dissection but with regional irradiation, or total mastectomy without irradiation plus auxillary dissection only if nodes were subsequently positive. Similarly, no differences, were observed between patients with clinically positive nodes treated by radical mastectomy or by total mastectomy without auxillary dissection but with regional irradiation. Survival at 10 years was about 38% in both groups. Our findings indicate that the location of a breast tumor does not influence the prognosis and that irradiation of internal mammary nodes in patients with inner-quadrant lesions does not improve survival. The data also demonstrate that the results obtained at five years accurately predict the outcome at 10 years. It was concluded that the variations of local and regional treatment used in this study are not important in determining survival of patients with breast cancer. 25 references, 6 figures, 1 table

  15. Conducting clinical trials in Singapore.

    Science.gov (United States)

    Woo, K T

    1999-04-01

    All clinical trials in Singapore will now have to conform to the Medicines (Clinical Trials) Amended Regulations 1998 and the Singapore Good Clinical Practice (GCP) Guidelines 1998. The Medical Clinical Research Committee (MCRC) has been established to oversee the conduct of clinical drug trials in Singapore and together with the legislations in place, these will ensure that clinical trials conducted in Singapore are properly controlled and the well-being of trial subjects are safe guarded. All clinical drug trials require a Clinical Trial Certificate from the MCRC before the trial can proceed. The hospital ethics committee (EC) vets the application for a trial certificate before it is sent to MCRC. The drug company sponsoring the trial has to indemnify the trial investigators and the hospital for negligence arising from the trial. The MCRC, apart from ensuring the safety of trial subjects, has to provide continuing review of the clinical trial and monitors adverse events in the course of the trial. The EC will conduct continuing review of clinical trials. When a non-drug clinical trial is carried out, the EC will ensure that the proposed protocol addresses ethical concerns and meets regulatory requirements for such trials. There is great potential for pharmaceutical Research & Development (R&D) in Singapore. We must develop our skills and infrastructure in clinical trials to enable Singapore to be a regional hub for R&D of drugs in Asia.

  16. Comparing Efficacy and Costs of Four Facial Fillers in Human Immunodeficiency Virus-Associated Lipodystrophy: A Clinical Trial.

    Science.gov (United States)

    Vallejo, Alfonso; Garcia-Ruano, Angela A; Pinilla, Carmen; Castellano, Michele; Deleyto, Esther; Perez-Cano, Rosa

    2018-03-01

    The objective of this study was to evaluate and compare the safety and effectiveness of four different dermal fillers in the treatment of facial lipoatrophy secondary to human immunodeficiency virus. The authors conducted a clinical trial including 147 patients suffering from human immunodeficiency virus-induced lipoatrophy treated with Sculptra (poly-L-lactic acid), Radiesse (calcium hydroxylapatite), Aquamid (polyacrylamide), or autologous fat. Objective and subjective changes were evaluated during a 24-month follow-up. Number of sessions, total volume injected, and overall costs of treatment were also analyzed. A comparative cost-effectiveness analysis of the treatment options was performed. Objective improvement in facial lipoatrophy, assessed by the surgeon in terms of changes from baseline using the published classification of Fontdevila, was reported in 53 percent of the cases. Patient self-evaluation showed a general improvement after the use of facial fillers. Patients reported being satisfied with the treatment and with the reduced impact of lipodystrophy on their quality of life. Despite the nonsignificant differences observed in the number of sessions and volume, autologous fat showed significantly lower costs than all synthetic fillers (p < 0.05). Surgical treatment of human immunodeficiency virus-associated facial lipoatrophy using dermal fillers is a safe and effective procedure that improves the aesthetic appearance and the quality of life of patients. Permanent fillers and autologous fat achieve the most consistent results over time, with lipofilling being the most cost-effective procedure.

  17. Neonatal outcomes in women with gestational diabetes mellitus treated with metformin in compare with insulin: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Safura Ruholamin

    2014-01-01

    Full Text Available Background: The objective of this study was to compare neonatal outcomes in women with gestational diabetes mellitus (GDM treated with either metformin or insulin. Materials and Methods: A randomized clinical trial carried out on year 2011 on 109 women with GDM who did not adequately control by dietary measures. They received metformin 500 mg once or twice daily or insulin 0.2 IU/kg/day initially. The dose was titrated to achieve target blood glucose values. Neonatal outcomes such as hypoglycemia, birth weight, Apgar score, umbilical artery pH, and hyperbilirubinemia in the 50 women who remained exclusively on metformin were compared with 50 women who treated with insulin. Results: Two groups were similar in mean fasting blood sugar (P = 0.7 and postprandial measurements (P = 0.8 throughout GDM treatment. Pregnancy complications or preterm labor were not different significantly between two groups. Considering neonatal outcomes between insulin and metformin groups, such as hypoglycemia (2 [4%] and 0 [0%], respectively, birth weight (3342 ± 506 mg and 3176 ± 438 mg, respectively, 5 th min Apgar score <7 (no one in either group, umbilical artery pH <7.05 (no one in either group and hyperbilirubinemia (1 [2%] and 0 [0%], respectively, no significant statistical differences were seen. Conclusion: Based on these preliminary data, considering neonatal outcomes, metformin appears to be a safe as insulin in the treatment of GDM.

  18. Randomized noninferiority trial comparing 2 commercial intramammary antibiotics for the treatment of nonsevere clinical mastitis in dairy cows.

    Science.gov (United States)

    Vasquez, A K; Nydam, D V; Capel, M B; Ceglowski, B; Rauch, B J; Thomas, M J; Tikofsky, L; Watters, R D; Zuidhof, S; Zurakowski, M J

    2016-10-01

    The purpose was to evaluate 2 intramammary treatments for mild-to-moderate cases of clinical mastitis in a noninferiority comparison. Noninferiority trials are intended to show whether a given treatment, hetacillin potassium, has at least comparable efficacy as the reference treatment, ceftiofur hydrochloride. Treatments can be deemed inferior to the reference treatment by an amount less than the margin of noninferiority, or inconclusive if the confidence interval crosses the margin of noninferiority. Cows with clinical mastitis from 6 farms were considered for enrollment. Using a randomized design, cows with mild or moderate mastitis in 1 quarter were assigned to on-label treatment with either ceftiofur or hetacillin. A total of 596 cows met the criteria needed for continued enrollment. Treatment distribution resulted in 309 cows in the ceftiofur group and 287 cows in the hetacillin group. Mixed regression analysis was performed for the following outcomes: bacteriological cure, pathogen cure, clinical cure, postevent milk production and linear score, and survival to d 30 and 60. Cox proportional hazards analysis was used to describe treatment effect on survival and mastitis risks. Bacteriological cure, defined as absence of causative organism in samples retrieved at d 14 and 21 postmastitis, was similar between groups. No significant statistical differences were found in cure risk, and noninferiority of hetacillin relative to ceftiofur for bacteriological cure was conclusive (hetacillin=67%, ceftiofur=72%). Absence of a pathogen on both follow-up samples designated a cow as a pathogen cure. Pathogen cure was similar between treatment groups and noninferiority of hetacillin relative to ceftiofur was shown (hetacillin=35%, ceftiofur=32%). Clinical cure (hetacillin=68%, ceftiofur=64%), postevent milk production (hetacillin=37.0kg, ceftiofur=38.2kg), and linear scores (hetacillin=3.4, ceftiofur=3.1) were also not statistically different between treatment groups

  19. Clinical efficacy and tolerability of praziquantel for intestinal and urinary schistosomiasis-a meta-analysis of comparative and non-comparative clinical trials.

    Directory of Open Access Journals (Sweden)

    Julien Zwang

    Full Text Available Extensive use of praziquantel for treatment and control of schistosomiasis requires a comprehensive understanding of efficacy and safety of various doses for different Schistosoma species.A systematic review and meta-analysis of comparative and non-comparative trials of praziquantel at any dose for any Schistosoma species assessed within two months post-treatment. Of 273 studies identified, 55 were eligible (19,499 subjects treated with praziquantel, control treatment or placebo. Most studied were in school-aged children (64%, S. mansoni (58%, and the 40 mg/kg dose (56%; 68% of subjects were in Africa. Efficacy was assessed as cure rate (CR, n=17,017 and egg reduction rate (ERR, n=13,007; safety as adverse events (AE incidence. The WHO-recommended dose of praziquantel 40 mg/kg achieved CRs of 94.7% (95%CI 92.2-98.0 for S. japonicum, 77.1% (68.4-85.1 for S. haematobium, 76.7% (95%CI 71.9-81.2 for S. mansoni, and 63.5% (95%CI 48.2-77.0 for mixed S. haematobium/S. mansoni infections. Using a random-effect meta-analysis regression model, a dose-effect for CR was found up to 40 mg/kg for S. mansoni and 30 mg/kg for S. haematobium. The mean ERR was 95% for S. japonicum, 94.1% for S. haematobium, and 86.3% for S. mansoni. No significant relationship between dose and ERR was detected. Tolerability was assessed in 40 studies (12,435 subjects. On average, 56.9% (95%CI 47.4-67.9 of the subjects receiving praziquantel 40 mg/kg experienced an AE. The incidence of AEs ranged from 2.3% for urticaria to 31.1% for abdominal pain.The large number of subjects allows generalizable conclusions despite the inherent limitations of aggregated-data meta-analyses. The choice of praziquantel dose of 40 mg/kg is justified as a reasonable compromise for all species and ages, although in a proportion of sites efficacy may be lower than expected and age effects could not be fully explored.

  20. Comparing Different Epinephrine Concentrations for Spinal Anesthesia in Cesarean Section: A Double-Blind Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Arash Hamzei

    2015-07-01

    Full Text Available Background: Although various anesthetic techniques can be used in different kinds of surgeries, spinal anesthesia has received considerable attention for the lower abdomen and lower extremities surgeries and cesarean section. This study aimed at comparing the effect of adding epinephrine 1:1000 and 1:10000 to lidocaine and fentanyl in spinal anesthesia on the prolongation of paralysis, analgesia and hemodynamic changes in pregnant women candidate for cesarean section. Methods: A double blind randomized clinical trial was carried out on 66 pregnant women (equally sized control and treatment groups of 33 in 2011. After randomizing the participants into two groups of recipients of epinephrine 1:1000 plus lidocaine 5% and fentanyl (control group and recipients of epinephrine 1:10000 with lidocaine 5% and fentanyl, (treatment group, the participants’ systolic and diastolic blood pressure and heart rate were recorded before and 1, 3, 5, 10, 15 minutes after procedure. Besides the prolongation of paralysis and analgesia, the presence of postoperative nausea and vomiting were evaluated. The outcome of the study was analyzed using SPSS software and via t test, χ2 test and RMANOVA. Results: The mean age (standard deviation of the participants was 29.3 (4.4 and 28.2 (4.5 in the treatment and control groups, respectively. There were no statistical significance between the participants’ prolongation of paralysis, analgesia, the frequency of nausea and vomiting, and the average values of hemodynamic variables between the two groups. Conclusion: The use of epinephrine 1:10000 along with lidocaine and fentanyl is recommended in spinal anesthesia in pregnant women candidate for cesarean section. Trial Registration Number: IRCT201012225445N1.

  1. Anti-Vascular Endothelial Growth Factor Comparative Effectiveness Trial for Diabetic Macular Edema: Additional Efficacy Post Hoc Analyses of a Randomized Clinical Trial.

    Science.gov (United States)

    Jampol, Lee M; Glassman, Adam R; Bressler, Neil M; Wells, John A; Ayala, Allison R

    2016-12-01

    Post hoc analyses from the Diabetic Retinopathy Clinical Research Network randomized clinical trial comparing aflibercept, bevacizumab, and ranibizumab for diabetic macular edema (DME) might influence interpretation of study results. To provide additional outcomes comparing 3 anti-vascular endothelial growth factor (VEGF) agents for DME. Post hoc analyses performed from May 3, 2016, to June 21, 2016, of a randomized clinical trial performed from August 22, 2012, to September 23, 2015, of 660 participants comparing 3 anti-VEGF treatments in eyes with center-involved DME causing vision impairment. Randomization to intravitreous aflibercept (2.0 mg), bevacizumab (1.25 mg), or ranibizumab (0.3 mg) administered up to monthly based on a structured retreatment regimen. Focal/grid laser treatment was added after 6 months for the treatment of persistent DME. Change in visual acuity (VA) area under the curve and change in central subfield thickness (CST) within subgroups based on whether an eye received laser treatment for DME during the study. Post hoc analyses were performed for 660 participants (mean [SD] age, 61 [10] years; 47% female, 65% white, 16% black or African American, 16% Hispanic, and 3% other). For eyes with an initial VA of 20/50 or worse, VA improvement was greater with aflibercept than the other agents at 1 year but superior only to bevacizumab at 2 years. Mean (SD) letter change in VA over 2 years (area under curve) was greater with aflibercept (+17.1 [9.7]) than with bevacizumab (+12.1 [9.4]; 95% CI, +1.6 to +7.3; P grid laser treatment was performed for DME, the only participants to have a substantial reduction in mean CST between 1 and 2 years were those with a baseline VA of 20/50 or worse receiving bevacizumab and laser treatment (mean [SD], -55 [108] µm; 95% CI, -82 to -28 µm; P grid laser treatment, ceiling and floor effects, or both may account for mean thickness reductions noted only in bevacizumab-treated eyes between 1 and 2 years

  2. Conservative treatment of a mandibular condyle fracture: Comparing intermaxillary fixation with screws or arch bar. A randomised clinical trial.

    Science.gov (United States)

    van den Bergh, B; Blankestijn, J; van der Ploeg, T; Tuinzing, D B; Forouzanfar, T

    2015-06-01

    A mandibular condyle fracture can be treated conservatively by intermaxillary fixation (IMF) or by open reposition and internal fixation (ORIF). Many IMF-modalities can be chosen, including IMF-screws (IMFS). This prospective multi-centre randomised clinical trial compared the use of IMFS with the use of arch bars in the treatment of mandibular condyle fractures. The study population consisted of 50 patients (mean age: 31.8 years). Twenty-four (48%) patients were allocated in the IMFS group. Twenty-six (52%) patients were assigned to the arch bars group. In total 188 IMF-screws were used (5-12 screws per patient, mean 7.83 screws per patient). All pain scores were lower in the IMFS group. Three patients developed a malocclusion (IFMS-group: one patient, arch bars-group: two patients). Mean surgical time was significantly shorter in the IMFS group (59 vs. 126 min; pfractured on insertion (0.53%), one (0.53%) screw was inserted into a root. Six (3.2%) screws loosened spontaneously in four patients. Mucosal disturbances were seen in 22 patients, equally divided over both groups. Considering the advantages and the disadvantages of IMFS, and observing the results of this study, the authors conclude that IMFS provide a superior method for IMF. IMFS are safer for the patients and surgeons. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  3. Failure Rates of Orthodontic Fixed Lingual Retainers bonded with Two Flowable Light-cured Adhesives: A Comparative Prospective Clinical Trial.

    Science.gov (United States)

    Talic, Nabeel F

    2016-08-01

    This comparative prospective randomized clinical trial examined the in vivo failure rates of fixed mandibular and maxillary lingual retainers bonded with two light-cured flowable composites over 6 months. Consecutive patients were divided into two groups on a 1:1 basis. Two hundred fixed lingual retainers were included, and their failures were followed for 6 months. One group (n = 50) received retainers bonded with a nano-hybrid composite based on nano-optimized technology (Tetric-N-Flow, Ivoclar Vivadent). Another group (n = 50) received retainers bonded with a low viscosity (LV) composite (Transbond Supreme LV, 3M Unitek). There was no significant difference between the overall failure rates of mandibular retainers bonded with Transbond (8%) and those bonded with Tetric-N-Flow (18%). However, the odds ratio for failure using Tetric-N-flow was 2.52-fold greater than that of Transbond. The failure rate of maxillary retainers bonded with Transbond was higher (14%), but not significantly different, than that of maxillary retainers bonded with Tetric-N-flow (10%). There was no significant difference in the estimated mean survival times of the maxillary and mandibular retainers bonded with the two composites. Both types of composites tested in the current study can be used to bond fixed maxillary and mandibular lingual retainers, with low failure rates.

  4. Comparing the Effects of Reflexology and Footbath on Sleep Quality in the Elderly: A Controlled Clinical Trial.

    Science.gov (United States)

    Valizadeh, Leila; Seyyedrasooli, Alehe; Zamanazadeh, Vahid; Nasiri, Khadijeh

    2015-11-01

    Sleep disorders are common mental disorders reported among the elderly in all countries, and with nonpharmacological interventions, they could be helped to improve their sleep quality. The aim of this study was to compare the effects of two interventions, foot reflexology and foot bath, on sleep quality in elderly people. This three-group randomized clinical trial (two experimental groups and a control group) was conducted on 69 elderly men. The two experimental groups had reflexology (n = 23) and foot bath (n = 23) interventions for 6 weeks. The reflexology intervention was done in the mornings, once a week for ten minutes on each foot. The participants in the foot bath group were asked to soak their feet in 41°C to 42°C water one hour before sleeping. The pittsburgh sleep quality index (PSQI) was completed before and after the intervention through an interview process. The results showed that the PSQI scores after intervention compared to before it in the reflexology and foot bath groups were statistically significant (P = 0.01 , P = 0.001); however, in the control group did not show a statistically significant difference (P = 0.14). In addition, the total score changes among the three groups were statistically significant (P = 0.01). Comparing the score changes of quality of sleep between the reflexology and foot bath groups showed that there was no significant difference in none of the components and the total score (P = 0.09). The two interventions had the same impact on the quality of sleep. It is suggested that the training of nonpharmacological methods to improve sleep quality such as reflexology and foot bath be included in the elderly health programs. In addition, it is recommended that the impact of these interventions on subjective sleep quality using polysomnographic recordings be explored in future research.

  5. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Kraus, V B; Blanco, F J; Englund, M

    2015-01-01

    The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from...

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    McAlindon, T. E.; Driban, J. B.; Henrotin, Y.

    2015-01-01

    The goal of this document is to update the original OARSI recommendations specifically for the design, conduct, and reporting of clinical trials that target symptom or structure modification among individuals with knee osteoarthritis (OA). To develop recommendations for the design, conduct...

  7. Dropout Rates in Randomized Clinical Trials of Antipsychotics: A Meta-analysis Comparing First- and Second-Generation Drugs and an Examination of the Role of Trial Design Features

    OpenAIRE

    Rabinowitz, Jonathan; Levine, Stephen Z.; Barkai, Orna; Davidov, Ori

    2008-01-01

    Dropout is often used as an outcome measure in clinical trials of antipsychotic medication. Previous research is inconclusive regarding (a) differences in dropout rates between first- and second-generation antipsychotic medications and (b) how trial design features reduce dropout. Meta-analysis of randomized controlled trials (RCTs) of antipsychotic medication was conducted to compare dropout rates for first- and second-generation antipsychotic drugs and to examine how a broad range of design...

  8. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone.

    Science.gov (United States)

    Wiehle, Ronald D; Fontenot, Gregory K; Wike, Jenny; Hsu, Kuang; Nydell, Jennifer; Lipshultz, Larry

    2014-09-01

    To determine the effect of enclomiphene citrate in men with secondary hypogonadism. Phase II clinical trial. Community dwelling men making visits to physician offices. Men with secondary hypogonadism. Oral administration of enclomiphene citrate or 1% topical T gel. Luteinizing hormone, FSH, T, and semen analysis. Treatment with enclomiphene citrate resulted in increased morning serum T, E2, and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism. Follicle-stimulating hormone and LH were increased with enclomiphene, and sperm counts were conserved. Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism, namely, low serum total T and low or inappropriately normal LH while preserving sperm production. NCT01270841 (ClinicalTrials.gov Identifier NCT01270841). Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  9. Interpreting the improved outcome of patients with central nervous system metastases managed in clinical trials compared with standard hospital practice

    International Nuclear Information System (INIS)

    Tang, J.I; Back, M.; Shakespeare, T.; Lu, J.J.; Mukherjee, R.; Wynne, C.

    2005-01-01

    The aims were to determine the median survival and prognostic factors of patients with central nervous system (CNS) metastases managed with whole-brain radiation therapy (WBRT), and to explore selection criteria in recently published clinical trials using aggressive interventions in CNS metastases. A retrospective audit was performed on patients managed with WBRT for CNS metastases. Potential prognostic factors were recorded and analysed for their association with survival duration. The proportion of patients with these factors was also compared with those of patients managed under three recently reported studies investigating aggressive interventions, such as radiosurgery and chemotherapy for CNS metastases. Seventy-three patients were treated with WBRT for cerebral metastases over a 12-month period. The median survival of the population was 3.4 months (95% confidence interval: 2.7-4.1), with 6- and 12-month survival rates of 30 and 18%, respectively. Significant prognostic factors for prolonged median survival were Eastern Cooperative Oncology Group status 0-2 (P = 0.015), Medical Research Council neurological functional status 0-1 (P = 0.006), and Recursive Partitioning Analysis Class 2 versus Class 3 (P = 0.020). On multivariate analysis, younger patient age (P = 0.02) and better performance status (P<0.01) were associated with improved outcome. When comparing these characteristics with selected published studies, our study cohort demonstrated a higher proportion of patients with poor performance status, a greater number of metastases per patient and a higher incidence of extracranial disease. This reflects the selected nature of patients in these published studies. Central nervous system metastases confer a poor prognosis and, for the majority of patients, aggressive interventions are unlikely to improve survival. The use of potentially toxic and expensive treatments should be reserved for those few in whom these studies have shown a potential benefit

  10. Cavity disinfection in minimally invasive dentistry - comparative evaluation of Aloe vera and propolis: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    A R Prabhakar

    2015-01-01

    Full Text Available Context: The survival of atraumatic restorative treatment (ART restorations would probably increase if near total elimination of cariogenic microorganisms could be done in the process of cavity cleaning before going ahead with the restoration. Thus, use of naturally occurring disinfecting agents for achieving this goal could herald a new beginning in the field of contemporary minimum intervention dentistry. Aims: To evaluate the efficacy of hand instruments in excavating dental caries and comparatively evaluate the roles of Aloe vera and propolis as potential cavity disinfecting agents after minimally invasive hand excavation of dental caries. Settings and Designs: Experimental, in vivo intergroup split mouth, randomized clinical trial. Subjects and Methods: The study included Group I (Control, Group II (A. vera and Group III (propolis. Ten patients with three teeth each have occlusal/occlusoproximal lesions suitable for ART were selected. Dentinal samples were collected three times from each tooth viz., preexcavation, postexcavation and postdisinfection of the cavities. These dentinal samples were subjected to microbiological analyses for total viable count. Statistical Analysis Used: Repeated measures of analysis of variance (ANOVA with Bonferroni post-hoc test and one-way ANOVA with Tukey post-hoc test. Results: In all the three groups, significant amount of bacteria were left behind after hand excavation. Group II and Group III, in which cavities were treated with A. vera and propolis extracts respectively, showed a significant reduction in the bacterial counts when compared to control the group. Conclusions: Hand excavation alone does not completely eliminate bacteria, which may predispose treated teeth to secondary caries. Both propolis and A. vera extracts can be used as potential natural disinfecting agents, thereby embracing the concept of phytotherapy in minimum intervention dentistry.

  11. Ethics of clinical trials.

    Science.gov (United States)

    Palter, S F

    1996-05-01

    The modern clinical trial is a form of human experimentation. There is a long history of disregard for individual rights of the patient in this context, and special attention must be paid to ethical guidelines for these studies. Clinical trials differ in basic ways from clinical practice. Foremost is the introduction of outside interests, beyond those of the patient's health, into the doctor-patient therapeutic alliance. Steps must be taken to protect the interests of the patient when such outside influence exists. Kantian moral theory and the Hippocratic oath dictate that the physician must respect the individual patient's rights and hold such interests paramount. These principles are the basis for informed consent. Randomization of patients is justified when a condition of equipoise exists. The changing nature of health care delivery in the United States introduces new outside interests into the doctor-patient relationship.

  12. Five-year extension of a clinical trial comparing the EX-PRESS glaucoma filtration device and trabeculectomy in primary open-angle glaucoma

    NARCIS (Netherlands)

    de Jong, Leo; Lafuma, Antoine; Aguadé, Anne-Sophie; Berdeaux, Gilles

    2011-01-01

    This study compared the efficacy of the EX-PRESS(®) glaucoma filtration device and trabeculectomy in primary open-angle glaucoma up to five years after surgery. Patients from a previously reported randomized, open-label, parallel-arm clinical trial in which 78 patients received either the EX-PRESS

  13. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent : 4-year results of the PROTECT randomized trial

    NARCIS (Netherlands)

    Wijns, William; Steg, Ph. Gabriel; Mauri, Laura; Kurowski, Volkhard; Parikh, Keyur; Gao, Runlin; Bode, Christoph; Greenwood, John P.; Lipsic, Erik; Alamgir, Farqad; Rademaker-Havinga, Tessa; Boersma, Eric; Radke, Peter; van Leeuwen, Frank; Camenzind, Edoardo

    2014-01-01

    Aims To compare the long-term clinical safety between two drug-eluting stents with different healing characteristics in the Patient Related Outcomes with Endeavour (E-ZES) vs. Cypher (C-SES) Stenting Trial (PROTECT). At 3 years, there was no difference in the primary outcome of definite or probable

  14. The Effect of Oxygen Inhalation Plus Oxytocin Compared with Oxytocin Only on Postpartum Haemorrhage: A Randomized Clinical Trial.

    Science.gov (United States)

    Suhrabi, Zainab; Taghinejad, Hamid; Direkvand-Moghadam, Ashraf; Akbari, Malihe

    2016-09-01

    Post Partum Haemorrhage (PPH) is the leading cause of maternal mortality across the world, mainly in the developing countries. The present study was conducted with the aim to investigate effect of oxygen inhalation plus oxytocin compared with oxytocin only on PPH. This study was a clinical trial which was performed in Shahid Mustafa Khomieni Teaching Hospital of Ilam (western Iran) from April 2012 to Nov 2013. One hundred and twenty pregnant women who were referred to delivery ward for normal vaginal delivery were selected with convenience sampling method and they were randomly assigned into two groups. For both groups management of the third stage of labour was done using 1000CC Ringer and 20 units of Oxytocin. In the intervention group, in addition to the routine administration, 8 liters of oxygen via face mask was used continuously until 2 hours after delivery. Blood loss was determined by regular weighing of the buttocks that were previously weighted. The difference was calculated before and after weighing (1 gram increasing of weight was considered to be equivalent to 1CC blood loss). Data were analysed by SPSS 16 version using Student- t and Chi-square tests. The two groups were homogenous in regard to all the base line variables. The study results indicated that the mean of blood loss were (256.16±97) ml at two hours after delivery in the control group and (149.5±46.49) ml in the intervention group. There was a significant difference between PPH of the two groups (poxytocin infusion during 2hours later resulted in a significant decreasing in the amount of bleeding after normal vaginal delivery.

  15. A randomized clinical trial comparing an acceptance-based behavior therapy to applied relaxation for generalized anxiety disorder.

    Science.gov (United States)

    Hayes-Skelton, Sarah A; Roemer, Lizabeth; Orsillo, Susan M

    2013-10-01

    To examine whether an empirically and theoretically derived treatment combining mindfulness- and acceptance-based strategies with behavioral approaches would improve outcomes in generalized anxiety disorder (GAD) over an empirically supported treatment. This trial randomized 81 individuals (65.4% female, 80.2% identified as White, average age 32.92) diagnosed with GAD to receive 16 sessions of either an acceptance-based behavior therapy (ABBT) or applied relaxation (AR). Assessments at pretreatment, posttreatment, and 6-month follow-up included the following primary outcome measures: GAD clinician severity rating, Structured Interview Guide for the Hamilton Anxiety Rating Scale, Penn State Worry Questionnaire, Depression Anxiety Stress Scale, and the State-Trait Anxiety Inventory. Secondary outcomes included the Beck Depression Inventory-II, Quality of Life Inventory, and number of comorbid diagnoses. Mixed effect regression models showed significant, large effects for time for all primary outcome measures (ds = 1.27 to 1.61) but nonsignificant, small effects for condition and Condition × Time (ds = 0.002 to 0.20), indicating that clients in the 2 treatments improved comparably over treatment. For secondary outcomes, time was significant (ds = 0.74 to 1.38), but condition and Condition × Time effects were not (ds = 0.004 to 0.31). No significant differences emerged over follow-up (ds = 0.03 to 0.39), indicating maintenance of gains. Between 63.3 and 80.0% of clients in ABBT and 60.6 and 78.8% of clients in AR experienced clinically significant change across 5 calculations of change at posttreatment and follow-up. ABBT is a viable alternative for treating GAD. (PsycINFO Database Record (c) 2013 APA, all rights reserved).

  16. COMPARATIVE STUDY OF 4 WEEKS OF DYNAMIC B ALANCE TRAINING PROGRAM IN COLLEGIATE FOOTBALL PLAYERS: RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    Nisha

    2015-03-01

    Full Text Available BACKGROUND: Balance is highly integrative dynamic process involving coordination of multiple neurological pathways that allows for the maintenance of the COG over BOS . Football players often perform lower extremity passing , shooting , twisting , cutting and dribbling skills while wearing shoes , these actions require body to be in the equilibrium position to perform the task . This leads to t he conclusion of the great importance of the ability of balance in football . AIMS: 1 . To study the effect of 4 week multidirectional balance board training on dynamic balance in football players . 2 . To study the effect of 4 week Both Sides Up ball training on dynamic balance in football players . 3 . To compare the effect of multidirectional balance board training program and BOSU ball training program on dynamic balance in football players . STUDY DESIGN: Randomized Clinical trial . METHODS: Total of 60 competitive badminton players with age group between18 - 25 were recruited in this study . The participants were allocated into 2 groups viz ., Group A (multidirectional balance board training and Group B (BOSU ball Training for a period of 4 we eks . Participants were test for SEBT and vertical jump test on first day and after 4 weeks of balance training . STATISTICAL ANALYSIS: Student t test , Chi - Square Test . RESULTS: The data analysis and statistical inference showed that , after 4 weeks of balanc e training there was improvement in dynamic balance in both the groups but there was no significant difference in dynamic balance between two groups . As seen by difference in the SEBT and VJT scores pre and post training with p<0 . 001 . CONCLUSION: 4 weeks balance training using BOSU and multidirectional balance board is effective in improving dynamic balance and vertical jump performance in football players and also can be used as a component of multifaceted training to improve dynamic balance and game skills

  17. A non-inferiority randomized controlled clinical trial comparing Unani formulation & psoralen plus ultraviolet A sol in chronic plaque psoriasis.

    Science.gov (United States)

    Khanna, Neena; Nazli, Tamanna; Siddiqui, Khalid Mahmud; Kalaivani, Mani

    2018-01-01

    Though Unani medications have been used for centuries to treat psoriasis, there is paucity of published studies which have systematically evaluated their efficacy and safety. This study was conducted to establish non-inferiority of Unani medications (oral UNIM-401 and topical UNIM-403) vs psoralen plus ultraviolet A (PUVA) sol in treatment of moderate-severe chronic plaque psoriasis (CPP) in achieving psoriasis area severity index (PASI) 75 at 12 wk and to estimate proportion of patients who relapsed in follow up period of 12 weeks, after having achieved PASI 50. In this randomized, controlled trial patients with CPP were block randomized to receive either Unani treatment (147 patients) or PUVA sol (140 patients) for 12 weeks. Percentage reduction in PASI was determined in each patient at 12 wk to calculate number of patients who achieved PASI 75 as also to estimate median of percentage reduction in PASI in each group. All patients who achieved PASI 50 at 12 weeks were followed up for another 12 wk to determine proportion of patients who relapsed. Of the 287 patients randomized, 84 of 147 in Unani group and 67 of 140 in PUVA sol group completed 12 weeks of treatment. On intention-to-treat (ITT) analysis, the response in patients on Unani medication was not inferior to those receiving PUVA sol, in attaining PASI 75 (16.3% in Unani group vs 15.7% in the PUVA sol group). Median of percentage reduction of PASI at 12 wk from baseline in Unani group (68.2%; -60, 100) and PUVA sol group (63%; -15.7, 100) was comparable. Proportion of patients who relapsed at 24 wk was comparable in both groups. However, frequency of clinical side effects was significantly higher (P =0.001) in PUVA sol group (16.4%) compared to Unani group (2%). The findings of the present study indicated that oral UNIM-401 and topical UNIM-403 were effective and well tolerated therapeutic options in patients with moderate-severe CPP.

  18. THE ROLE OF INTERFERON PREPARATIONS IN THE TREATMENT OF ACUTE VIRAL RESPIRATORY INFECTIONS IN INFANTS, BABIES AND TODDLERS (RESULTS OF A MULTICENTER COMPARATIVE RANDOMIZED CLINICAL TRIAL)

    OpenAIRE

    L.V. Feklisova; A.V. Gorelov; V.P. Drinevskii; A.A. Ploskireva; E.V. Tselipanova; E.Yu. Shvets; E.V. Kanner; Yu.N. Lin'kova; E.V. Chernyaeva

    2011-01-01

    The paper analyzes the results of a comparative clinical trial of drugs recombinant human interferon alpha-2b in the dosage form of suppositories for their use in the treatment of ARVI in infants, babies and toddlers age. In accordance to the selection criteria 100 children who were hospitalized, aged from 6 months to 3 years with clinically diagnosed ARVI were included in the study. Two study groups were formed: basic, which patients within 5 days received suppositories containing taurine an...

  19. Randomized Clinical Trial Comparing Proton Beam Radiation Therapy with Transarterial Chemoembolization for Hepatocellular Carcinoma: Results of an Interim Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Bush, David A., E-mail: dbush@llu.edu [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Smith, Jason C. [Department of Diagnostic Radiology, Loma Linda University Medical Center, Loma Linda, California (United States); Slater, Jerry D. [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Volk, Michael L. [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Reeves, Mark E. [VA Loma Linda Health Care System, Loma Linda, California (United States); Cheng, Jason [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States); Grove, Roger [Department of Radiation Medicine, Loma Linda University Medical Center, Loma Linda, California (United States); Vera, Michael E. de [Transplantation Institute and Liver Center, Loma Linda University Medical Center, Loma Linda, California (United States)

    2016-05-01

    Purpose: To describe results of a planned interim analysis of a prospective, randomized clinical trial developed to compare treatment outcomes among patients with newly diagnosed hepatocellular carcinoma (HCC). Methods and Materials: Eligible subjects had either clinical or pathologic diagnosis of HCC and met either Milan or San Francisco transplant criteria. Patients were randomly assigned to transarterial chemoembolization (TACE) or to proton beam radiation therapy. Patients randomized to TACE received at least 1 TACE with additional TACE for persistent disease. Proton beam radiation therapy was delivered to all areas of gross disease to a total dose of 70.2 Gy in 15 daily fractions over 3 weeks. The primary endpoint was progression-free survival, with secondary endpoints of overall survival, local tumor control, and treatment-related toxicities as represented by posttreatment days of hospitalization. Results: At the time of this analysis 69 subjects were available for analysis. Of these, 36 were randomized to TACE and 33 to proton. Total days of hospitalization within 30 days of TACE/proton was 166 and 24 days, respectively (P<.001). Ten TACE and 12 proton patients underwent liver transplantation after treatment. Viable tumor identified in the explanted livers after TACE/proton averaged 2.4 and 0.9 cm, respectively. Pathologic complete response after TACE/proton was 10%/25% (P=.38). The 2-year overall survival for all patients was 59%, with no difference between treatment groups. Median survival time was 30 months (95% confidence interval 20.7-39.3 months). There was a trend toward improved 2-year local tumor control (88% vs 45%, P=.06) and progression-free survival (48% vs 31%, P=.06) favoring the proton beam treatment group. Conclusions: This interim analysis indicates similar overall survival rates for proton beam radiation therapy and TACE. There is a trend toward improved local tumor control and progression-free survival with proton beam. There are

  20. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2007-12-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Intergrity, the drug discovery and development portal, http://integrity.prous.com. This issue focuses on the following selection of drugs: 249553, 2-Methoxyestradiol; Abatacept, Adalimumab, Adefovir dipivoxil, Agalsidase beta, Albinterferon alfa-2b, Aliskiren fumarate, Alovudine, Amdoxovir, Amlodipine besylate/atorvastatin calcium, Amrubicin hydrochloride, Anakinra, AQ-13, Aripiprazole, AS-1404, Asoprisnil, Atacicept, Atrasentan; Belimumab, Bevacizumab, Bortezomib, Bosentan, Botulinum toxin type B, Brivaracetam; Catumaxomab, Cediranib, Cetuximab, cG250, Ciclesonide, Cinacalcet hydrochloride, Curcumin, Cypher; Darbepoetin alfa, Denosumab, Dihydrexidine; Eicosapentaenoic acid/docosahexaenoic acid, Entecavir, Erlotinib hydrochloride, Escitalopram oxalate, Etoricoxib, Everolimus, Ezetimibe; Febuxostat, Fenspiride hydrochloride, Fondaparinux sodium; Gefitinib, Ghrelin (human), GSK-1562902A; HSV-tk/GCV; Iclaprim, Imatinib mesylate, Imexon, Indacaterol, Insulinotropin, ISIS-112989; L-Alanosine, Lapatinib ditosylate, Laropiprant; Methoxy polyethylene glycol-epoetin-beta, Mipomersen sodium, Motexafin gadolinium; Natalizumab, Nimotuzumab; OSC, Ozarelix; PACAP-38, Paclitaxel nanoparticles, Parathyroid Hormone-Related Protein-(1-36), Pasireotide, Pegfilgrastim, Peginterferon alfa-2a, Peginterferon alfa-2b, Pemetrexed disodium, Pertuzumab, Picoplatin, Pimecrolimus, Pitavastatin calcium, Plitidepsin; Ranelic acid distrontium salt, Ranolazine, Recombinant human relaxin H2, Regadenoson, RFB4(dsFv)-PE38, RO-3300074, Rosuvastatin calcium; SIR-Spheres, Solifenacin succinate, Sorafenib, Sunitinib malate; Tadalafil, Talabostat, Taribavirin hydrochloride, Taxus, Temsirolimus, Teriparatide, Tiotropium bromide, Tipifarnib, Tirapazamine, Tocilizumab; UCN-01, Ularitide

  1. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2005-04-01

    Gateways to Clinical Trials is a guide to the most recent clinical trials in current literature and congresses. The data in the following tables has been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity. prous.com. This issue focuses on the following selection of drugs: ABX-IL-8, Acclaim, adalimumab, AGI-1067, alagebrium chloride, alemtuzumab, Alequel, Androgel, anti-IL-12 MAb, AOD-9604, aripiprazole, atomoxetine hydrochloride; Biphasic insulin aspart, bosentan, botulinum toxin type B, bovine lactoferrin, brivudine; Cantuzumab mertansine, CB-1954, CDB-4124, CEA-TRICOM, choriogonadotropin alfa, cilansetron, CpG-10101, CpG-7909, CTL-102, CTL-102/CB-1954; DAC:GRF, darbepoetin alfa, davanat-1, decitabine, del-1 Genemedicine, dexanabinol, dextofisopam, dnaJP1, dronedarone hydrochloride, dutasteride; Ecogramostim, eletriptan, emtricitabine, EPI-hNE-4, eplerenone, eplivanserin fumarate, erlotinib hydrochloride, ertapenem sodium, escitalopram oxalate, esomeprazole magnesium, etoricoxib, ezetimibe; Falecalcitriol, fingolimod hydrochloride; Gepirone hydrochloride; HBV-ISS, HSV-2 theracine, human insulin; Imatinib mesylate, Indiplon, insulin glargine, ISAtx-247; L612 HuMAb, levodopa/carbidopa/entacapone, lidocaine/prilocaine, LL-2113AD, lucinactant, LY-156735; Meclinertant, metelimumab, morphine hydrochloride, morphine-6-glucuronide; Natalizumab, nimotuzumab, NX-1207, NYVAC-HIV C; Omalizumab, onercept, osanetant; PABA, palosuran sulfate, parathyroid hormone (human recombinant), parecoxib sodium, PBI-1402, PCK-3145, peginterferon alfa-2a, peginterferon alfa-2b, peginterferon alfa-2b/ribavirin, pemetrexed disodium, pimecrolimus, PINC, pregabalin; Ramelteon, rasagiline mesilate, rasburicase, rimonabant hydrochloride, RO-0098557, rofecoxib, rosiglitazone maleate/metformin hydrochloride; Safinamide mesilate, SHL-749, sitaxsentan sodium, sparfosic acid, SprayGel, squalamine, St. John's Wort

  2. Clinical trials in India.

    Science.gov (United States)

    Maiti, Rituparna; M, Raghavendra

    2007-07-01

    The concept of outsourcing for the development and global studies on new drugs has become widely accepted in the pharmaceutical industry due to its cost and uncertainty. India is going to be the most preferred location for contract pharma research and development due to its huge treatment naïve population, human resources, technical skills, adoption/amendment/implementation of rules/laws by regulatory authorities, and changing economic environment. But still 'miles to go' to fulfill the pre-requisites to ensure India's success. In spite of all the pitfalls, the country is ambitious and optimist to attract multinational pharmaceutical companies to conduct their clinical trials in India.

  3. A clinical trial comparing the responses of animal tumors receiving heat sensitizing drugs prior to whole body hyperthermia

    International Nuclear Information System (INIS)

    Klein, M.K.; Forsyth, K.; Dewhirst, M.W.; Fuller, D.J.M.

    1984-01-01

    Whole body hyperthermia (WBH) has rarely been found effective in inducing complete tumor responses. Recent in vitro studies showing that heat sensitizion is possible have renewed interest in this field. In this protocol, WBH is induced via a commercially available inductive device and maintained at 42 0 C for thirty minutes. The heat sensitizing drugs, difluoromethylornithine (DFMO) methylglyoxal bis (guanylhydrazone) (MGBG) are administered 48 hours before, in accordance with in vitro studies. Goals of the study include evaluation of normal tissue toxicity and tumor response. Two normal dogs were treated to study acute toxicities before inception of the clinical trial. The gastrointestinal and hematopoietic systems were used to monitor toxicities using systems review and serial bloodwork. These studies and preliminary clinical results of observed tumor regression in dogs with lymphomas are discussed. Consistent changes in all patients included elevations in liver enzymes, creatine phosphokinase (CPK), and white blood cell counts, as well as, decreases in platelet counts. All changes were transient and clinical signs were not associated with them. Tumor volume reductions from 25% to 74% have been documented

  4. Randomized clinical trial comparing 5% and 1% topical minoxidil for the treatment of androgenetic alopecia in Japanese men.

    Science.gov (United States)

    Tsuboi, Ryoji; Arano, Osamu; Nishikawa, Tooru; Yamada, Hidekazu; Katsuoka, Kensei

    2009-08-01

    Minoxidil is efficacious in inducing hair growth in patients with androgenetic alopecia by inducing hair follicles to undergo transition from the early to late anagen phase. Although the efficacy of 1% topical minoxidil has been confirmed in Japan, no controlled study of 5% topical minoxidil has been conducted using male Japanese subjects. The objective of this trial was to verify the superiority in clinical efficacy of 5% topical minoxidil to 1% topical minoxidil in a double-blind controlled study with male, Japanese androgenetic alopecia patients as the subjects. The trial included 300 Japanese male patients aged 20 years or older with androgenetic alopecia who were administered either 5% topical minoxidil (n = 150) or 1% topical minoxidil (n = 150) for 24 weeks. The mean change from the baseline in non-vellus hair/cm(2), the primary efficacy variable, was 26.4 (n = 142) in the 5% topical minoxidil group and 21.2 (n = 144) in the 1% topical minoxidil group at 16 weeks, the main time point for the evaluation. The difference between the groups was significant (P = 0.020). The incidence of adverse events was 8.7% (13/150) in the 5% group and 5.3% (8/150) in the 1% group, with no significant difference between the groups (chi(2)-test: P = 0.258). Our findings confirmed the superiority of 5% topical minoxidil to 1% topical minoxidil in treating Japanese men with androgenetic alopecia.

  5. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    Energy Technology Data Exchange (ETDEWEB)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon [College of Medicine, Yonsei Univ., Seoul (Korea, Republic of)

    2001-06-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9{+-} 11.2 in group M, 46.5{+-}9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of

  6. A prospective randomized comparative clinical trial comparing the efficacy between ondansetron and metoclopramide for prevention of nausea and vomiting in patients undergoing fractionated radiotherapy to the abdominal region

    International Nuclear Information System (INIS)

    Park, Hee Chul; Suh, Chang Ok; Seong, Jin Sil; Cho, Jae Ho; Lim, John Jihoon; Park, Won; Song, Jae Seok; Kim, Gwi Eon

    2001-01-01

    This study is a prospective randomized clinical trial comparing the efficacy and complication of anti-emetic drugs for prevention of nausea and vomiting after radiotherapy which has moderate emetogenic potential. The aim of this study was to investigate whether the anti-emetic efficacy at ondansetron(Zofran) 8 mg bid dose (Group O) is better than the efficacy of metoclopramide 5 mg tid dose (Group M) in patients undergoing fractionated radiotherapy to the abdominal region. Study entry was restricted to those patients who met the following eligibility criteria: histologically confirmed malignant disease; no distant metastasis; performance status of not more than ECOG grade 2; no previous chemotherapy and radiotherapy. Between March 1997 and February 1998, 60 patients enrolled in this study. All patients signed a written statement of informed consent prior to enrollment. Blinding was maintained by dosing identical number of tables including one dose of matching placebo for Group O. The extent of nausea, appetite loss, and the number of emetic episodes were recorded everyday using diary card. The mean score of nausea, appetite loss and the mean number of emetic episodes were obtained in a weekly interval. Prescription error occurred in one patient. And diary cards have not returned in 3 patients due to premature refusal of treatment. Card from one patient was excluded from the analysis because she had a history of treatment for neurosis. As a result, the analysis consisted of 55 patients. Patient characteristics and radiotherapy characteristics were similar except mean age was 52.9± 11.2 in group M, 46.5±9.6 in group O. The difference of age was statistically significant. The mean score of nausea, appetite loss and emetic episodes in a weekly interval was higher in group M than O. In group M, the symptoms were most significant at 5th week. In a panel data analysis using mixed procedure, treatment group was only significant factor detecting the difference of weekly

  7. [Maraviroc: clinical trials results].

    Science.gov (United States)

    Chidiac, C; Katlama, C; Yeni, P

    2008-03-01

    Just over a decade after identification of chemokine receptors CCR5 and CXCR4 as coreceptors for HIV, maraviroc (Celsentri), the first CCR5 antagonist, has recently obtained its Marketing Authorization in the United States and Europe, for treatment of treatment-experienced adult patients infected with only CCR5-tropic HIV-1 detectable. CCR5 antagonists, after fusion inhibitor enfuvirtide available since 2003, also belong to entry inhibitors. These molecules, unlike previous antiretrovirals, do not target the virus but its target cell by blocking viral penetration. Maraviroc has shown its clinical efficacy in patients failing other antiretroviral classes. Its safety profile was similar to placebo in two large phase III trials. However, careful assessment of both hepatic and immunologic safety of this new therapeutic class is needed. Viral tropism testing has to be investigated before using maraviroc in the clinic, because CCR5 antagonists are not active against CXCR4 viruses. For the moment indicated for the treatment-experienced patient population, maraviroc could in the future benefit to other types of patients, depending on ongoing trials results.

  8. Improvdent: Improving dentures for patient benefit. A crossover randomised clinical trial comparing impression materials for complete dentures

    Directory of Open Access Journals (Sweden)

    Gray Janine C

    2012-08-01

    Full Text Available Abstract Background According to the UK Adult Dental Health Survey (2009 15% of adults aged 65–74, 30% aged 75–84 and 47% aged >85 years are edentulous and require complete dentures. Patients’ quality of life and nutrition status are affected by poor dentures. The quality of the dental impression is the most important issue for improving the fit and comfort of new dentures. There is paucity of RCT evidence for which impression material is best for complete dentures construction. This study aims to compare two impression materials for effectiveness and cost effectiveness. Methods/Design IMPROVDENT is a double-blind crossover trial comparing the use of alginate and silicone, two commonly used denture impression materials, in terms of patient preference and cost-effectiveness. Eighty five edentulous patients will be recruited and provided with two sets of dentures, similar in all aspects except for the impression material used (alginate or silicone. Patients will try both sets of dentures for a two-week period, unadjusted, to become accustomed to the feel of the new dentures (habituation period. Patients will then wear each set of dentures for a period of 8 weeks (in random order during which time the dentures will be adjusted for optimum comfort. Finally, patients will be given both sets of dentures for a further two weeks to wear whichever denture they prefer (confirmation period. Patients will be asked about quality of life and to rate dentures on function and comfort at the end of each trial period and asked which set they prefer at the end of the habituation period (unadjusted denture preference and confirmation period (adjusted denture preference. A health economic evaluation will estimate incremental cost-effectiveness ratios of producing dentures from the two materials. A qualitative study will investigate the impact of dentures on behaviour and quality of life. Funding: IMPROVDENT is funded by NIHR RfPB (PB-PG-0408-16300. Discussion

  9. [Clinical trials in nursing journals].

    Science.gov (United States)

    Di Giulio, Paola; Campagna, Sara; Dimonte, Valerio

    2014-01-01

    Clinical trials are pivotal for the development of nursing knowledge. To describe the clinical trials published in nursing journals in the last two years and propose some general reflections on nursing research. A search with the key-word trial was done on PubMed (2009-2013) on Cancer Nursing, European Journal of Oncology Nursing, International Journal of Nursing Studies, Journal of Advanced Nursing, Journal of Clinical Nursing and Nursing Research. Of 228 trials identified, 104 (45.8%) were published in the last 2 years. Nurses from Asian countries published the larger number of trials. Educational and supportive interventions were the most studied (61/104 trials), followed by clinical interventions (33/104). Samples were limited and most trials are monocentric. A growing number of trials is published, on issues relevant for the nursing profession, however larger samples and multicentric studies would be necessary.

  10. Comparing Two Methods of Cryotherapy and Intense Pulsed Light with Triamcinolone Injection in the Treatment of Keloid and Hypertrophic Scars: A Clinical Trial

    OpenAIRE

    Meymandi, Simin Shamsi; Moosazadeh, Mahmood; Rezazadeh, Azadeh

    2016-01-01

    Objectives Keloid and hypertrophic scars are abnormal manifestations of wounds that occur following skin injuries in the form of local proliferation of fibroblasts and increased production of collagen. There are several ways to cure these scars; treatment must be selected based on the nature of the scars. In this clinical trial, two methods?cryotherapy and intense pulsed light (IPL)?are compared in the treatment of scars, and the results are presented in terms of improvement level, complicati...

  11. Randomized clinical trial comparing manual suture and different models of mechanical suture in the mimicking of bariatric surgery in swine

    Directory of Open Access Journals (Sweden)

    Fernandes MA

    2014-02-01

    analysis included the formation of foreign body granuloma in the gastroenteroanastomosis and enteroanastomosis in 88.9% of the swine that underwent manual suture and in none of the swine that underwent stapling. There was also a significant statistical difference among swine from Group A, and those from groups B, C and D regarding the degree of inflammation, being more intense in those swine that underwent manual suture. Conclusion: This study shows that both types of suture promoted proper healing of gastroenteroanastomosis and enteroanastomosis, although there was a higher degree of inflammation and an increased occurrence of foreign body granuloma in swine subjected to manual suture, although there have been similarities in safety, efficiency, and effectiveness between the models of linear mechanical staplers tested during the performance of these anastomoses on swine. Keywords: linear mechanical stapler, stapler, manual suture, surgery, gastroenteroanastomosis, enteroanastomosis, swine, randomized clinical trial

  12. Gateways to clinical trials.

    Science.gov (United States)

    Bayés, M; Rabasseda, X; Prous, J R

    2006-10-01

    Gateways to Clinical Trials are a guide to the most recent clinical trials in current literature and congresses. The data the following tables have been retrieved from the Clinical Trials Knowledge Area of Prous Science Integrity, the drug discovery and development portal, http://integrity.prous.com. This issues focuses on the following selection of drugs: (-)-Epigallocatechin gallate, (-)-gossypol, 2-deoxyglucose, 3,4-DAP, 7-monohydroxyethylrutoside; Ad5CMV-p53, adalimumab, adefovir dipivoxil, ADH-1, alemtuzumab, aliskiren fumarate, alvocidib hydrochloride, aminolevulinic acid hydrochloride, aminolevulinic acid methyl ester, amrubicin hydrochloride, AN-152, anakinra, anecortave acetate, antiasthma herbal medicine intervention, AP-12009, AP-23573, apaziquone, aprinocarsen sodium, AR-C126532, AR-H065522, aripiprazole, armodafinil, arzoxifene hydrochloride, atazanavir sulfate, atilmotin, atomoxetine hydrochloride, atorvastatin, avanafil, azimilide hydrochloride; Bevacizumab, biphasic insulin aspart, BMS-214662, BN-83495, bortezomib, bosentan, botulinum toxin type B; Caspofungin acetate, cetuximab, chrysin, ciclesonide, clevudine, clofarabine, clopidogrel, CNF-1010, CNTO-328, CP-751871, CX-717, Cypher; Dapoxetine hydrochloride, darifenacin hydrobromide, dasatinib, deferasirox, dextofisopam, dextromethorphan/quinidine sulfate, diclofenac, dronedarone hydrochloride, drotrecogin alfa (activated), duloxetine hydrochloride, dutasteride; Edaravone, efaproxiral sodium, emtricitabine, entecavir, eplerenone, epratuzumab, erlotinib hydrochloride, escitalopram oxalate, etoricoxib, ezetimibe, ezetimibe/simvastatin; Finrozole, fipamezole hydrochloride, fondaparinux sodium, fulvestrant; Gabapentin enacarbil, gaboxadol, gefitinib, gestodene, ghrelin (human); Human insulin, human papillomavirus vaccine; Imatinib mesylate, immunoglobulin intravenous (human), indiplon, insulin detemir, insulin glargine, insulin glulisine, intranasal insulin, istradefylline, i.v. gamma

  13. Comparative effectiveness of individualised homeopathy and antibiotics in the treatment of bovine clinical mastitis: randomised controlled trial.

    Science.gov (United States)

    Keller, Diana; Sundrum, Albert

    2018-04-07

    Based on the widespread use of homeopathy in dairy farm practice when treating mastitis, a blind randomised controlled trial (RCT) was conducted to assess the effectiveness of homeopathic treatment of clinical mastitis on four dairy farms. The study considered specific guidelines for RCTs as well as the basic principles of individualised homeopathy and involved 180 lactating dairy cows. Evaluation of cure rates was based on clinical investigation of the udder and on laboratory analysis of milk samples. In culture-positive cases, the antibiotic treatment provided suboptimal bacteriological cures (60-81 per cent) but was more effective than individualised homeopathy (33-43 per cent) whose effects appeared little different to those of placebos (45-47 per cent) (P≤0.05). On the cytological cure level, all three treatment methods were similarly ineffective: antibiotic being 2-21 per cent, individualised homeopathy 0-8 per cent and placebo 3-13 per cent (P≤0.05; P=0.13). Antibiotics, individualised homeopathy and placebo had similar effects on bacteriological and cytological cure in cases of culture-negative milk samples (P>0.4) and Escherichia coli infections (P=1.0). The study results implied that the effectiveness of individualised homeopathy does not go beyond a placebo effect and successful treatment is highly dependent on the specific mastitis pathogen. Thus, antimicrobial or alternative remedies used should be based on the bacterial culture of the milk sample. NTP-ID: 00008011-1-9, Pre-results. © British Veterinary Association (unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  14. Racemic epinephrine compared to salbutamol in hospitalized young children with bronchiolitis; a randomized controlled clinical trial [ISRCTN46561076

    Directory of Open Access Journals (Sweden)

    LeBlanc John C

    2005-05-01

    Full Text Available Abstract Background Bronchiolitis is the most common cause of lower respiratory tract illness in infancy, and hospital admission rates appear to be increasing in Canada and the United States. Inhaled beta agonists offer only modest short-term improvement. Trials of racemic epinephrine have shown conflicting results. We sought to determine if administration of racemic epinephrine during hospital stay for bronchiolitis improved respiratory distress, was safe, and shortened length of stay. Methods The study was a randomized, double-blind controlled trial of aerosolized racemic epinephrine compared to salbutamol every one to 4 hours in previously well children aged 6 weeks to ≤ 2 years of age hospitalized with bronchiolitis. The primary outcome was symptom improvement as measured by the Respiratory Distress Assessment Instrument (RDAI; secondary outcomes were length of stay in hospital, adverse events, and report of symptoms by structured parental telephone interview one week after discharge. Results 62 children with a mean age of 6.4 months were enrolled; 80% of children had Respiratory Syncytial Virus (RSV. Racemic epinephrine resulted in significant improvement in wheezing and the total RDAI score on day 2 and over the entire stay (p 0.05. Adverse events were not significantly different in the two arms. At one week post-discharge, over half of parents reported that their child still had a respiratory symptom and 40% had less than normal feeding. Conclusion Racemic epinephrine relieves respiratory distress in hospitalized infants with bronchiolitis and is safe but does not abbreviate hospital stay. Morbidity associated with bronchiolitis as identified by parents persists for at least one week after hospital discharge in most infants.

  15. Time-Efficiency Analysis Comparing Digital and Conventional Workflows for Implant Crowns: A Prospective Clinical Crossover Trial.

    Science.gov (United States)

    Joda, Tim; Brägger, Urs

    2015-01-01

    To compare time-efficiency in the production of implant crowns using a digital workflow versus the conventional pathway. This prospective clinical study used a crossover design that included 20 study participants receiving single-tooth replacements in posterior sites. Each patient received a customized titanium abutment plus a computer-aided design/computer-assisted manufacture (CAD/CAM) zirconia suprastructure (for those in the test group, using digital workflow) and a standardized titanium abutment plus a porcelain-fused-to-metal crown (for those in the control group, using a conventional pathway). The start of the implant prosthetic treatment was established as the baseline. Time-efficiency analysis was defined as the primary outcome, and was measured for every single clinical and laboratory work step in minutes. Statistical analysis was calculated with the Wilcoxon rank sum test. All crowns could be provided within two clinical appointments, independent of the manufacturing process. The mean total production time, as the sum of clinical plus laboratory work steps, was significantly different. The mean ± standard deviation (SD) time was 185.4 ± 17.9 minutes for the digital workflow process and 223.0 ± 26.2 minutes for the conventional pathway (P = .0001). Therefore, digital processing for overall treatment was 16% faster. Detailed analysis for the clinical treatment revealed a significantly reduced mean ± SD chair time of 27.3 ± 3.4 minutes for the test group compared with 33.2 ± 4.9 minutes for the control group (P = .0001). Similar results were found for the mean laboratory work time, with a significant decrease of 158.1 ± 17.2 minutes for the test group vs 189.8 ± 25.3 minutes for the control group (P = .0001). Only a few studies have investigated efficiency parameters of digital workflows compared with conventional pathways in implant dental medicine. This investigation shows that the digital workflow seems to be more time-efficient than the

  16. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial: rationale and design

    Directory of Open Access Journals (Sweden)

    Schuler Gerhard

    2011-02-01

    Full Text Available Abstract Background Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO, but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. Methods The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age ( Discussion patients were randomized in 29 centers of Europe, Canada, and Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011. Trial Registration Trial listed in ClinicalTrials.gov as NCT00166257 and sponsored by AGA Medical, Plymouth, MN, USA

  17. Comparative effectiveness of family problem-solving therapy (F-PST for adolescents after traumatic brain injury: Protocol for a randomized, multicenter, clinical trial

    Directory of Open Access Journals (Sweden)

    Brad G. Kurowski

    2018-06-01

    Full Text Available Introduction: The objective of this manuscript is to describe the methodology that will be used to test the comparative effectiveness, feasibility, and acceptability of three formats of family problem solving therapy (F-PST for improving functional outcomes of complicated mild to severe adolescent TBI. Methods: Three-arm comparative effectiveness, randomized clinical trial (RCT design. We describe the protocol of a three-arm RCT comparing the effectiveness of three modalities of F-PST to reduce executive dysfunction and behavior problems following TBI in adolescence. The RCT will compare the relative effectiveness among face-to-face; online and self-directed; and therapist-supported online modes of treatment. Ethics and dissemination: It is anticipated that findings from this work will inform future clinical care practices, with implications for treatment of other patient populations of youth with psychological symptoms arising from neurological conditions. Institutional review board approval will be obtained from all sites prior to commencement of the study. Clinical Trials Registration: NCT:02368366, Keywords: Pediatric traumatic brain injury, Telehealth, Problem solving, Behavior, Executive function

  18. Spine device clinical trials: design and sponsorship.

    Science.gov (United States)

    Cher, Daniel J; Capobianco, Robyn A

    2015-05-01

    Multicenter prospective randomized clinical trials represent the best evidence to support the safety and effectiveness of medical devices. Industry sponsorship of multicenter clinical trials is purported to lead to bias. To determine what proportion of spine device-related trials are industry-sponsored and the effect of industry sponsorship on trial design. Analysis of data from a publicly available clinical trials database. Clinical trials of spine devices registered on ClinicalTrials.gov, a publicly accessible trial database, were evaluated in terms of design, number and location of study centers, and sample size. The relationship between trial design characteristics and study sponsorship was evaluated using logistic regression and general linear models. One thousand six hundred thrity-eight studies were retrieved from ClinicalTrials.gov using the search term "spine." Of the 367 trials that focused on spine surgery, 200 (54.5%) specifically studied devices for spine surgery and 167 (45.5%) focused on other issues related to spine surgery. Compared with nondevice trials, device trials were far more likely to be sponsored by the industry (74% vs. 22.2%, odds ratio (OR) 9.9 [95% confidence interval 6.1-16.3]). Industry-sponsored device trials were more likely multicenter (80% vs. 29%, OR 9.8 [4.8-21.1]) and had approximately four times as many participating study centers (pdevices not sponsored by the industry. Most device-related spine research is industry-sponsored. Multicenter trials are more likely to be industry-sponsored. These findings suggest that previously published studies showing larger effect sizes in industry-sponsored vs. nonindustry-sponsored studies may be biased as a result of failure to take into account the marked differences in design and purpose. Copyright © 2015 Elsevier Inc. All rights reserved.

  19. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    International Nuclear Information System (INIS)

    Babaei Jandaghi, Ali; Lebady, Mohammadkazem; Zamani, Athar-Alsadat; Heidarzadeh, Abtin; Monfared, Ali; Pourghorban, Ramin

    2017-01-01

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  20. A Randomised Clinical Trial to Compare Coaxial and Noncoaxial Techniques in Percutaneous Core Needle Biopsy of Renal Parenchyma

    Energy Technology Data Exchange (ETDEWEB)

    Babaei Jandaghi, Ali [Guilan University of Medical Sciences, Department of Radiology, Poursina Hospital (Iran, Islamic Republic of); Lebady, Mohammadkazem; Zamani, Athar-Alsadat [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Heidarzadeh, Abtin [Guilan University of Medical Sciences, Department of Community Medicine (Iran, Islamic Republic of); Monfared, Ali [Guilan University of Medical Sciences, Urology Research Center, Razi Hospital (Iran, Islamic Republic of); Pourghorban, Ramin, E-mail: ramin-p2005@yahoo.com [Tehran University of Medical Sciences, Department of Radiology, Imam Khomeini Hospital Complex (Iran, Islamic Republic of)

    2017-01-15

    PurposeTo compare the coaxial and noncoaxial techniques of renal parenchymal core needle biopsy.Materials and MethodsThis is an institutional review board-approved randomised controlled trial comparing 83 patients (male, n = 49) who underwent renal parenchymal core biopsy with coaxial method and 83 patients (male, n = 40) with noncoaxial method. The rate of complications, the number of glomerular profiles, and the procedural time were evaluated in a comparison of the two methods. Correlation between the presence of renal parenchymal disease and the rate of complication was also evaluated.ResultsThe procedural time was significantly shorter in the coaxial technique (coaxial group, 5 ± 1 min; noncoaxial group, 14 ± 2 min; p < 0.001). The rates of complications for the coaxial method was significantly lower than the noncoaxial method (coaxial group, 10.8 %; noncoaxial group, 24.1 %; p = 0.025). There was no significant correlation between gender and the rate of complication. The number of glomerular profiles was significantly higher in patents who underwent renal biopsy with the coaxial method (coaxial group, 18.2 ± 9.1; noncoaxial group, 8.6 ± 5.5; p < 0.001). In the whole study population, the rate of complications was significantly higher in patients with a pathologic renal parenchyma compared to those with a normal parenchyma (19/71 vs. 10/95; p = 0.006).ConclusionsRenal parenchymal biopsy using a coaxial needle is a faster and safer method with a lower rate of complications.

  1. [Principles of controlled clinical trials].

    Science.gov (United States)

    Martini, P

    1962-01-01

    The recovery of the patient should be facilitated as the result of therapeutic research. The basic rule for every therapeutic-clinical trial mist involve a comparison of therapeutic approaches. In acute conditions, such as acute infectious diseases, infarcts, etc., comparisons should be made between two or more groups: the collective therapeutic comparison = the between patients trial. The formation of groups, to be compared one with the other can be justified only if one is reasonably sure that a pathogenic condition indeed exists. In chronic diseases, which extend essentially unchanged over a lengthy period but are nevertheless reversible, therapeutic comparisons may be made between two or more time intervals within the course of the disease in the same individual. This type of therapeutic trial rests primarily upon a (refined!) type of specious reasoning and secondarily, upon modified statistics: the individual therapeutic comparison = the within patient trial. The collective therapeutic comparison, on the one hand, and the individual therapeutic comparison on the other, overlap somewhat in scope. The immediate therapeutic effect is not always an indication of its true value, which may become evident only upon long-term treatment. The short-term trials of therapeutic regimens in an individual must, therefore, be frequently supplemented by long-term trials which can only be carried out by comparing two groups. For many clinical investigations, therefore, the joint efforts of numerous hospitals are absolutely necessary. The second basic rule of therapeutic research is the elimination of secondary causes. The difficulties introduced by these secondary considerations are far greater in therapeutic trials carried out on ambulatory patients than has been hitherto realized. In order to remove subjective secondary causes, the author demanded, in 1931, the use of hidden or illusory media (placebos, dummies) that is, unconscious causative agents. The double blind

  2. How does routinely delivered cognitive-behavioural therapy for gambling disorder compare to "gold standard" clinical trial?

    Science.gov (United States)

    Smith, David P; Fairweather-Schmidt, A Kate; Harvey, Peter W; Battersby, Malcolm W

    2018-03-01

    Currently, it is unknown whether treatment outcomes derived from randomized controlled trials (RCTs) of cognitive-behavioural therapy (CBT) for problem gamblers still hold when applied to patients seen in routine practice. Thus, data from an RCT of cognitive therapy versus exposure therapy for problem gambling versus patients of a gambling help service were compared. Assessments of problem gambling severity, psychosocial impairment, and alcohol use were undertaken at baseline and post-treatment and evaluated within a counterfactual framework. Findings showed that the contrast between routine CBT for pokies and horse betting had a significant effect, indicative of a 62% lower gambling urge score if routine CBT recipients had all been horse/track betters opposed to gambling with "pokies." However, the majority of contrasts indicated therapeutic outcomes achieved in routine CBT treatments were of equivalent robustness relative to RCT conditions. The present findings infer routine practice treatment outcomes are as efficacious as those generated in RCT contexts. Copyright © 2017 John Wiley & Sons, Ltd.

  3. Cross-Over Clinical Trials?

    Directory of Open Access Journals (Sweden)

    Latif Gachkar

    2017-01-01

    Full Text Available Abstract Cross-Over Clinical Trials in comparison with Parallel groups clinical trials have some advantages such as control of confounding variables, small sample size, and short time to implement the research project. But this type of research has few essential limitations that discusses in this monogram.

  4. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

    Directory of Open Access Journals (Sweden)

    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  5. Accrual to Cancer Clinical Trials

    LENUS (Irish Health Repository)

    Kelly, C

    2016-07-01

    Accrual to cancer clinical trials (CCT) is imperative to safeguard continued improvement in cancer outcomes. A retrospective chart review was performed of patients (n=140) starting a new anti-cancer agent in a north Dublin cancer centre. This review was performed over a four-month period, beginning in November 2015. Only 29% (n=41) had a CCT option. The overall accrual rate to CCT was 5% (n=7), which is comparable to internationally reported figures. The main reasons for failure to recruit to CCT included the lack of a CCT option for cancer type (n=30, 23%), stage (n=25, 19%), and line of treatment (n=23, 17%). Over the last decade, the rate of accrual to CCTs has in fact doubled and the number of trials open to recruitment has tripled. Ongoing governmental and philanthropic support is necessary to continue this trend to further expand CCT patient options with a target accrual rate of 10%.

  6. A randomized clinical trial comparing hydrocolloid, phenytoin and simple dressings for the treatment of pressure ulcers [ISRCTN33429693

    Directory of Open Access Journals (Sweden)

    Khedmat Hossein

    2004-12-01

    Full Text Available Abstract Background Pressure sores are important and common complications of spinal cord injury. Many preventive and therapeutic approaches have been tried and new trials are evolving. One relatively recent method is application of a hydrocolloid dressing (HD. In this study we compared the therapeutic effects of HD on pressure ulcer healing with two other topical applications, phenytoin cream (PC and simple dressing (SD. Methods Ninety-one stage I and stage II pressure ulcers of 83 paraplegic male victims of the Iran-Iraq war were randomly allocated to three treatment groups. Mean age and weight of the participants were 36.64 ± 6.04 years and 61.12 ± 5.08 kg, respectively. All the patients were managed in long term care units or in their homes for 8 weeks by a team of general practitioners and nurses, and the ulcer status was recorded as "Complete healing", "Partial healing", "Without improvement" and "Worsening". Results Complete healing of ulcers, regardless of location and stage, was better in the HD group than the PC [23/31(74.19% vs 12/30(40%; difference: 34.19%, 95% CI = 10.85–57.52, (P 0.05]. We performed a second analysis considering only one ulcer per patient (i.e. 83 ulcers in 83 patients. This "per patient" analysis showed that complete ulcer healing in the HD group was better than in the PC [20/28(71.4% vs 11/28 (39.3%; difference: 32.1%, 95% CI = 7.4–56.7, (P Conclusion We deduced that HD is the most effective method investigated for treating stage I and II pressure ulcers in young paraplegic men.

  7. A Randomized Clinical Trial Comparing the Effectiveness of Electroacupuncture versus Medium-Frequency Electrotherapy for Discogenic Sciatica

    Directory of Open Access Journals (Sweden)

    Xue Zhang

    2017-01-01

    Full Text Available Objective. To investigate the short- and long-term effects of electroacupuncture (EA compared with medium-frequency electrotherapy (MFE on chronic discogenic sciatica. Methods. One hundred participants were randomized into two groups to receive EA (n=50 or MFE (n=50 for 4 weeks. A 28-week follow-up of the two groups was performed. The primary outcome measure was the average leg pain intensity. The secondary outcome measures were the low back pain intensity, Oswestry Disability Index (ODI, patient global impression (PGI, drug use frequency, and EA acceptance. Results. The mean changes in the average leg pain numerical rating scale (NRS scores were 2.30 (1.86–2.57 and 1.06 (0.62–1.51 in the EA and MFE groups at week 4, respectively. The difference was significant (P<0.001. The long-term follow-up resulted in significant differences. The average leg pain NRS scores decreased by 2.12 (1.70–2.53 and 0.36 (−0.05–0.78 from baseline in the EA and MFE groups, respectively, at week 28. However, low back pain intensity and PGI did not differ significantly at week 4. No serious adverse events occurred. Conclusions. EA showed greater short-term and long-term benefits for chronic discogenic sciatica than MFE, and the effect of EA was superior to that of MFE. The study findings warrant verification. This trial was registered under identifier ChiCTR-IPR-15006370.

  8. Oral Chloral Hydrate Compare with Rectal Thiopental in Pediatric Procedural Sedation and Analgesia; a Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Reza Azizkhani

    2014-03-01

    Full Text Available Introduction: The increasing use of diagnostic imaging in pediatric medicine has resulted in growing need for procedural sedation and analgesia (PSA to minimize motion artifacts during procedures. The drug of choice in pediatric PSA was not introduced till now. The aim of the present study was comparison of oral chloral hydrate (OCH and rectal sodium thiopental (RST in pediatric PSA.Methods: In the present randomized clinical trial, 2-6 years old pediatrics who referred for performing brain computed tomography scan was enrolled and were randomly divided in to two groups. OCH (50mg/kg and RST (25mg/kg were prescribed and a trained nurse recorded the time from drug prescription to receiving the conscious sedation (onset of action, the total time period which the patient has the Ramsay score≥4 (duration of action, and adverse effect of agents. Mann-Whitney U test and chi-squared test, and Non-parametric analysis of covariance (ANCOVA were used for comparisons. Results: One hundred and forty children were entered to two groups of OCH and RST, randomly. The patients of two groups had similar age, sex, weight, and baseline vital signs except for diastolic blood pressure (p<0.001. The onset of action in OCH and RST groups were 24.5±6.1and 28.7±5.2 minutes, respectively (p<0.001. Duration of action in OCH and RST groups were 12.9±2.8 minutes and 13.7±2.6 minutes, respectively (p=0.085. Non parametric ANCOVA revealed that only diastolic blood pressure was affected by drug prescription (p=0.001. In 11(15.7% patients in RST group, diarrhea was observed during 24 hours (p=0.001. Oxygen desaturation was observed only in two patients, both in OCH group. Conclusion: Each of the sedative has advantages and disadvantages that should be considered when selecting one for inducing short-term sedation. It seems that rectal sodium thiopental and oral chloral hydrate are equally effective in pediatric PSA and based on patient’s condition we can administrate

  9. The suitability of EIT to estimate EELV in a clinical trial compared to oxygen wash-in/wash-out technique.

    Science.gov (United States)

    Karsten, Jan; Meier, Torsten; Iblher, Peter; Schindler, Angela; Paarmann, Hauke; Heinze, Hermann

    2014-02-01

    Open endotracheal suctioning procedure (OSP) and recruitment manoeuvre (RM) are known to induce severe alterations of end-expiratory lung volume (EELV). We hypothesised that EIT lung volumes lack clinical validity. We studied the suitability of EIT to estimate EELV compared to oxygen wash-in/wash-out technique. Fifty-four postoperative cardiac surgery patients were enrolled and received standardized ventilation and OSP. Patients were randomized into two groups receiving either RM after suctioning (group RM) or no RM (group NRM). Measurements were conducted at the following time points: Baseline (T1), after suctioning (T2), after RM or NRM (T3), and 15 and 30 min after T3 (T4 and T5). We measured EELV using the oxygen wash-in/wash-out technique (EELVO2) and computed EELV from EIT (EELVEIT) by the following formula: EELVEITTx,y…=EELVO2+ΔEELI×VT/ΔZ. EELVEIT values were compared with EELVO2 using Bland-Altman analysis and Pearson correlation. Limits of agreement ranged from -0.83 to 1.31 l. Pearson correlation revealed significant results. There was no significant impact of RM or NRM on EELVO2-EELVEIT relationship (p=0.21; p=0.23). During typical routine respiratory manoeuvres like endotracheal suctioning or alveolar recruitment, EELV cannot be estimated by EIT with reasonable accuracy.

  10. Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

    Science.gov (United States)

    Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

    2015-02-01

    Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

  11. Methodology series module 4: Clinical trials

    Directory of Open Access Journals (Sweden)

    Maninder Singh Setia

    2016-01-01

    Full Text Available In a clinical trial, study participants are (usually divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care. We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1 parallel study design, (2 cross-over design, (3 factorial design, and (4 withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials. Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  12. Methodology Series Module 4: Clinical Trials.

    Science.gov (United States)

    Setia, Maninder Singh

    2016-01-01

    In a clinical trial, study participants are (usually) divided into two groups. One group is then given the intervention and the other group is not given the intervention (or may be given some existing standard of care). We compare the outcomes in these groups and assess the role of intervention. Some of the trial designs are (1) parallel study design, (2) cross-over design, (3) factorial design, and (4) withdrawal group design. The trials can also be classified according to the stage of the trial (Phase I, II, III, and IV) or the nature of the trial (efficacy vs. effectiveness trials, superiority vs. equivalence trials). Randomization is one of the procedures by which we allocate different interventions to the groups. It ensures that all the included participants have a specified probability of being allocated to either of the groups in the intervention study. If participants and the investigator know about the allocation of the intervention, then it is called an "open trial." However, many of the trials are not open - they are blinded. Blinding is useful to minimize bias in clinical trials. The researcher should familiarize themselves with the CONSORT statement and the appropriate Clinical Trials Registry of India.

  13. Social media in clinical trials.

    Science.gov (United States)

    Thompson, Michael A

    2014-01-01

    Social media has potential in clinical trials for pointing out trial issues, addressing barriers, educating, and engaging multiple groups involved in cancer clinical research. Social media is being used in clinical trials to highlight issues such as poor accrual and barriers; educate potential participants and physicians about clinical trial options; and is a potential indirect or direct method to improve accrual. We are moving from a passive "push" of information to patients to a "pull" of patients requesting information. Patients and advocates are often driving an otherwise reluctant health care system into communication. Online patient communities are creating new information repositories. Potential clinical trial participants are using the Twittersphere and other sources to learn about potential clinical trial options. We are seeing more organized patient-centric and patient-engaged forums with the potential to crowd source to improve clinical trial accrual and design. This is an evolving process that will meet many individual, institutional, and regulatory obstacles as we move forward in a changed research landscape.

  14. Comparative Evaluation of Liposomal Albendazole and Tablet-Albendazole Against Hepatic Cystic Echinococcosis: A Non-Randomized Clinical Trial.

    Science.gov (United States)

    Li, Haitao; Song, Tao; Shao, Yingmei; Aili, Tuergan; Ahan, Ayifuhan; Wen, Hao

    2016-01-01

    In this study, we aimed to compare the clinical efficacy of liposomal albendazole (L-ABZ) and tablet-albendazole (T-ABZ) for the treatment of human hepatic cystic echinococcosis (CE). Sixty patients with single cyst (CE1) or daughter cyst (CE2) were included in this study and were nonrandomly divided into the L-ABZ group (n = 30, 10  mg/kg per day, p.o., b.i.d.) and T-ABZ group (n = 30, 12-20 mg/kg per day, p.o., b.i.d.), respectively. The treatment duration lasted for 6 months, during which dynamic follow-up was carried out to evaluate the clinical efficacy through calculating the total effective rates (TERs). Measurement data and numerous data were analyzed by the chi-square test. Two-sided tests were performed for all the statistical tests. In our study, 2 patients were lost in the follow-up in the L-ABZ group. One patient was lost in the follow-up in the T-ABZ group, and 1 patient was withdrawal from the study due to receiving surgery. Significant difference was identified in the 3-month TERs of L-ABZ group and T-ABZ group (33.3% vs 76.7%, P  0.05). Based on our study, both T-ABZ and L-ABZ are effective for treating human CE. The TER in the L-ABZ group is superior to that of T-ABZ.

  15. Effectiveness of individualized physiotherapy on pain and functioning compared to a standard exercise protocol in patients presenting with clinical signs of subacromial impingement syndrome. A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    de Bie Rob A

    2010-06-01

    Full Text Available Abstract Background Shoulder impingement syndrome is a common musculoskeletal complaint leading to significant reduction of health and disability. Physiotherapy is often the first choice of treatment although its effectiveness is still under debate. Systematic reviews in this field highlight the need for more high quality trials to investigate the effectiveness of physiotherapy interventions in patients with subacromial impingement syndrome. Methods/Design This randomized controlled trial will investigate the effectiveness of individualized physiotherapy in patients presenting with clinical signs and symptoms of subacromial impingement, involving 90 participants aged 18-75. Participants are recruited from outpatient physiotherapy clinics, general practitioners, and orthopaedic surgeons in Germany. Eligible participants will be randomly allocated to either individualized physiotherapy or to a standard exercise protocol using central randomization. The control group will perform the standard exercise protocol aiming to restore muscular deficits in strength, mobility, and coordination of the rotator cuff and the shoulder girdle muscles to unload the subacromial space during active movements. Participants of the intervention group will perform the standard exercise protocol as a home program, and will additionally be treated with individualized physiotherapy based on clinical examination results, and guided by a decision tree. After the intervention phase both groups will continue their home program for another 7 weeks. Outcome will be measured at 5 weeks and at 3 and 12 months after inclusion using the shoulder pain and disability index and patients' global impression of change, the generic patient-specific scale, the average weekly pain score, and patient satisfaction with treatment. Additionally, the fear avoidance beliefs questionnaire, the pain catastrophizing scale, and patients' expectancies of treatment effect are assessed. Participants

  16. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma

    NARCIS (Netherlands)

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A.; Punt, Cornelis J. A.; Haanen, John B.; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L.; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A.; Dreno, Brigitte; Nathan, Paul D.; Mackiewicz, Jacek; Kirkwood, John M.; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-01-01

    In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with

  17. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

    NARCIS (Netherlands)

    Ribas, A.; Kefford, R.; Marshall, Martin; Punt, C.J.A.; Haanen, J.B.; Marmol, M.; Garbe, C.; Gogas, H.; Schachter, J.; Linette, G.; Lorigan, P.; Kendra, K.L.; Maio, M.; Trefzer, U.; Smylie, M.; McArthur, G.A.; Dreno, B.; Nathan, P.D.; Mackiewicz, J.; Kirkwood, J.M.; Gomez-Navarro, J.; Huang, B.; Pavlov, D.; Hauschild, A.

    2013-01-01

    PURPOSE: In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients

  18. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Katz, J N; Losina, E; Lohmander, L S

    2015-01-01

    To highlight methodological challenges in the design and conduct of randomized trials of surgical interventions and to propose strategies for addressing these challenges. This paper focuses on three broad areas: enrollment; intervention; and assessment including implications for analysis. For eac...

  19. Mobilization with movement and kinesiotaping compared with a supervised exercise program for painful shoulder: results of a clinical trial.

    Science.gov (United States)

    Djordjevic, Olivera C; Vukicevic, Danijela; Katunac, Ljiljana; Jovic, Stevan

    2012-07-01

    The purpose of this study was to compare the efficacy of Mobilization with Movement (MWM) and kinesiotaping (KT) techniques with a supervised exercise program in participants with patients with shoulder pain. Twenty subjects with shoulder pain were included if subjects were diagnosed by the referring physician with either rotator cuff lesion with impingement syndrome or impingement shoulder syndrome. Participants were randomly assigned to 1 of 2 groups after clinical and radiologic assessment: group 1 was treated with MWM and KT techniques, whereas group 2 was treated with a supervised exercise program. The main outcome measures were active pain-free shoulder abduction and flexion tested on days 0, 5, and 10. Improvement in active pain-free shoulder range of motion was significantly higher in the group treated with MWM and KT. Repeated-measures analysis of variance indicated significant effects of treatment, time, and treatment×time interaction. This study suggests that MWM and KT may be an effective and useful treatment in range of motion augmentation of subjects with rotator cuff lesion and impingement syndrome or impingement shoulder syndrome. Copyright © 2012 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

  20. Clinical evaluation of a dressing with poly absorbent fibres and a silver matrix for managing chronic wounds at risk of infection: a non comparative trial.

    Science.gov (United States)

    Dalac, S; Sigal, L; Addala, A; Chahim, M; Faivre-Carrere, C; Lemdjadi, Z; Bohbot, S

    2016-09-01

    To assess the efficacy, safety and acceptability of a new silver poly absorbent dressing (UrgoCleanAg) in the local management of exudative chronic wounds at risk of infection, with inflammatory signs suggesting heavy bacterial load. This prospective, multicentre, non-comparative clinical trial was conducted in French hospital wards (dermatology and vascular medicine) or specialised private-practice physicians. Patients were considered at high-risk of infection when presenting with at least three of five selected inflammatory clinical signs, suggesting a heavy bacterial load (pain between two dressing changes, erythema, oedema, malodorous wound and presence of a heavy exudate). They were treated for a maximum period of four weeks, and followed by the physician on a weekly basis, including a clinical examination, area tracings and photographs. The primary efficacy criterion of the trial was the relative wound surface area reduction at the end of the four weeks of treatment. Acceptability was documented by the nursing staff at each dressing change between the weekly evaluations. We recruited 37 patients with chronic wounds. Wound surface area, mostly covered by sloughy tissue, was reduced by 32.5% at the end of the treatment (median value), while the clinical score (maximum value of 5, based on inflammatory clinical signs) decreased from 4.0 to 2.0. Effective debridement properties were documented (62.5% relative reduction of sloughy tissue at week 4; 58.8% of debrided wounds at week 4) and improvement of the periwound skin status was noted (healthy for 28.6% of the patients at week 4 versus 2.7% at baseline). In addition, the tested wound dressing presented a good safety profile associated to a high level of acceptability, noted by both patients and nursing staff. These clinical data support that the tested dressing is a credible therapeutic alternative for the management of chronic wounds at risk of infection with inflammatory signs suggesting heavy bacterial load.

  1. Palm Oil Consumption Increases LDL Cholesterol Compared with Vegetable Oils Low in Saturated Fat in a Meta-Analysis of Clinical Trials.

    Science.gov (United States)

    Sun, Ye; Neelakantan, Nithya; Wu, Yi; Lote-Oke, Rashmi; Pan, An; van Dam, Rob M

    2015-07-01

    Palm oil contains a high amount of saturated fat compared with most other vegetable oils, but studies have reported inconsistent effects of palm oil on blood lipids. We systematically reviewed the effect of palm oil consumption on blood lipids compared with other cooking oils using data from clinical trials. We searched PubMed and the Cochrane Library for trials of at least 2 wk duration that compared the effects of palm oil consumption with any of the predefined comparison oils: vegetable oils low in saturated fat, trans fat-containing partially hydrogenated vegetable oils, and animal fats. Data were pooled by using random-effects meta-analysis. Palm oil significantly increased LDL cholesterol by 0.24 mmol/L (95% CI: 0.13, 0.35 mmol/L; I(2) = 83.2%) compared with vegetable oils low in saturated fat. This effect was observed in randomized trials (0.31 mmol/L; 95% CI: 0.20, 0.42 mmol/L) but not in nonrandomized trials (0.03 mmol/L; 95% CI: -0.15, 0.20 mmol/L; P-difference = 0.02). Among randomized trials, only modest heterogeneity in study results remained after considering the test oil dose and the comparison oil type (I(2) = 27.5%). Palm oil increased HDL cholesterol by 0.02 mmol/L (95% CI: 0.01, 0.04 mmol/L; I(2) = 49.8%) compared with vegetable oils low in saturated fat and by 0.09 mmol/L (95% CI: 0.06, 0.11 mmol/L; I(2) = 47.8%) compared with trans fat-containing oils. Palm oil consumption results in higher LDL cholesterol than do vegetable oils low in saturated fat and higher HDL cholesterol than do trans fat-containing oils in humans. The effects of palm oil on blood lipids are as expected on the basis of its high saturated fat content, which supports the reduction in palm oil use by replacement with vegetable oils low in saturated and trans fat. This systematic review was registered with the PROSPERO registry at http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42012002601#.VU3wvSGeDRZ as CRD42012002601. © 2015 American Society for Nutrition.

  2. Spontaneous improvement in randomised clinical trials: meta-analysis of three-armed trials comparing no treatment, placebo and active intervention

    DEFF Research Database (Denmark)

    Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C

    2009-01-01

    were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... uncertainty, as indicated by the confidence intervals for the three SMDs. The conditions that had the most pronounced spontaneous improvement were nausea (45%), smoking (40%), depression (35%), phobia (34%) and acute pain (25%). CONCLUSION: Spontaneous improvement and effect of placebo contributed importantly...

  3. Limited Amount of Formula May Facilitate Breastfeeding: Randomized, Controlled Trial to Compare Standard Clinical Practice versus Limited Supplemental Feeding.

    Directory of Open Access Journals (Sweden)

    Zbyněk Straňák

    Full Text Available Breastfeeding is known to reduce infant morbidity and improve well-being. Nevertheless, breastfeeding rates remain low despite public health efforts. Our study aims to investigate the effect of controlled limited formula usage during birth hospitalisation on breastfeeding, using the primary hypothesis that early limited formula feeds in infants with early weight loss will not adversely affect the rate of exclusive or any breastfeeding as measured at discharge, 3 and 6 months of age.We randomly assigned 104 healthy term infants, 24 to 48 hours old, with ≥ 5% loss of birth weight to controlled limited formula (CLF intervention (10 ml formula by syringe after each breastfeeding, discontinued at onset of lactation or control group (standard approach, SA. Groups were compared for demographic data and breastfeeding rates at discharge, 3 months and 6 months of age (p-values adjusted for multiple testing.Fifty newborns were analysed in CLF and 50 in SA group. There were no differences in demographic data or clinical characteristics between groups. We found no evidence of difference between treatment groups in the rates of exclusive as well as any breastfeeding at discharge (p-value 0.2 and >0.99 respectively, 3 months (p-value 0.12 and 0.10 and 6 months of infants' age (p-value 0.45 and 0.34 respectively. The percentage weight loss during hospitalisation was significantly higher in the SA group (7.3% in CLF group, 8.4% in SA group, p = 0.002.The study shows that controlled limited formula use does not have an adverse effect on rates of breastfeeding in the short and long term. Larger studies are needed to confirm a possible potential in controlled limited formula use to support establishing breastfeeding and to help to improve the rates of breastfeeding overall.ISRCTN registry ISRCTN61915183.

  4. An open-label, pragmatic, randomized controlled clinical trial to evaluate the comparative effectiveness of daptomycin versus vancomycin for the treatment of complicated skin and skin structure infection.

    Science.gov (United States)

    Kauf, Teresa L; McKinnon, Peggy; Corey, G Ralph; Bedolla, John; Riska, Paul F; Sims, Matthew; Jauregui-Peredo, Luis; Friedman, Bruce; Hoehns, James D; Mercier, Renée-Claude; Garcia-Diaz, Julia; Brenneman, Susan K; Ng, David; Lodise, Thomas

    2015-11-07

    Treatment of complicated skin and skin structure infection (cSSSI) places a tremendous burden on the health care system. Understanding relative resource utilization associated with different antimicrobials is important for decision making by patients, health care providers, and payers. The authors conducted an open-label, pragmatic, randomized (1:1) clinical study (N = 250) to compare the effectiveness of daptomycin with that of vancomycin for treatment of patients hospitalized with cSSSI caused by suspected or documented methicillin-resistant Staphylococcus aureus infection. The primary study end point was infection-related length of stay (IRLOS). Secondary end points included health care resource utilization, cost, clinical response, and patient-reported outcomes. Patient assessments were performed daily until the end of antibiotic therapy or until hospital discharge, and at 14 days and 30 days after discharge. No difference was found for IRLOS, total LOS, and total inpatient cost between cohorts. Hospital LOS contributed 85.9% to the total hospitalization cost, compared with 6.4% for drug costs. Daptomycin showed a nonsignificant trend toward a higher clinical success rate, compared with vancomycin, at treatment days 2 and 3. In the multivariate analyses, vancomycin was associated with a lower likelihood of day 2 clinical success (odds ratio [OR] = 0.498, 95% confidence interval [CI], 0.249-0.997; P < 0.05). This study did not provide conclusive evidence of the superiority of one treatment over the other in terms of clinical, economic, or patient outcomes. The data suggest that physician and patient preference, rather than drug acquisition cost, should be the primary driver of initial antibiotic selection for hospitalized patients with cSSSI. ClinicalTrials.gov: NCT01419184 (Date: August 16, 2011).

  5. Randomised clinical trial

    DEFF Research Database (Denmark)

    Reimer, C; Lødrup, A; Smith, G

    2016-01-01

    of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. MethodsThis was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using...

  6. Comparison of surgical treatment with direct repair versus conservative treatment in young patients with spondylolysis: a prospective, comparative, clinical trial.

    Science.gov (United States)

    Lee, Gun Woo; Lee, Sun-Mi; Ahn, Myun-Whan; Kim, Ho-Joong; Yeom, Jin S

    2015-07-01

    Although direct repair (DR) with screw fixation at the pars defect is a common surgical treatment for lumbar spondylolysis, it is unknown whether DR leads to better outcomes for young patients with spondylolysis than traditional nonsurgical treatment. The purpose of the study was to investigate whether DR was associated with better outcomes for lumbar spondylolysis in young patients than traditional conservative treatment. This is a prospective cohort study. Of 1,784 patients with low back pain in the reference period, 149 young patients with spondylolysis who followed up for at least 1 year were enrolled in the study. The primary outcome was pain intensity at the lower back measured with a Visual Analog Scale. Secondary outcomes included the functional outcome as measured with the Oswestry disability index (ODI) and the 12-item short-form health survey (SF-12) consisting of the physical component summary (PCS) and mental component summary (MCS) scores, the radiologic outcome as measured with lumbar spine radiographs and computed tomography scans, and complications of treatment. This was a prospective comparative study between two groups of patients who were treated with either conservative treatment or surgery for lumbar spondylolysis. Enrolled patients self-selected their own treatment and were allocated to either the traditional care group with conservative treatment (87 patients) or the surgery group (62 patients). All patients were followed up for at least 1 year. Pain intensity at the lower back did not differ significantly between groups at the final follow-up. Likewise, the ODI and SF-12 (PCS and MCS) scores did not differ significantly between groups (p=.13, .71, and .68, respectively). The change in the gap distance of the pars defect at the final follow-up was significantly different between groups (traditional care group: +0.8±0.4 mm; surgery group: -0.7±0.5; p=.01). The union rate at 1 year after surgical treatment was 52% (32/61). The rate of

  7. Systemic Review and Meta-analysis of Randomized Clinical Trials Comparing Primary vs Delayed Primary Skin Closure in Contaminated and Dirty Abdominal Incisions

    Science.gov (United States)

    2013-06-26

    Trials. 1986;7(3):177-188. 14. ChatwiriyacharoenW. Surgical wound infection post surgery in perforated appendicitis in children. J Med Assoc Thai ...randomized clinical trial. Anesth Analg. 2012;115(4):849-854. 36. Dharan S, Pittet D. Environmental controls in operating theatres . J Hosp Infect

  8. Comparing Two Methods of Cryotherapy and Intense Pulsed Light with Triamcinolone Injection in the Treatment of Keloid and Hypertrophic Scars: A Clinical Trial.

    Science.gov (United States)

    Meymandi, Simin Shamsi; Moosazadeh, Mahmood; Rezazadeh, Azadeh

    2016-10-01

    Keloid and hypertrophic scars are abnormal manifestations of wounds that occur following skin injuries in the form of local proliferation of fibroblasts and increased production of collagen. There are several ways to cure these scars; treatment must be selected based on the nature of the scars. In this clinical trial, two methods-cryotherapy and intense pulsed light (IPL)-are compared in the treatment of scars, and the results are presented in terms of improvement level, complications, and patient satisfaction. This clinical trial was conducted in southeastern Iran. The intervention group included scars that underwent the IPL method and the control group, which consisted of scars that were subjected to cryotherapy. In both methods, intralesional corticosteroid injection was administered. To select samples, the easy sampling method was used. To determine the expected outcomes, the criteria determined in the Vancouver scar scale were used. Data were analyzed using the Mix Model, chi-square test, and t test. In this study, 166 samples of keloid and hypertrophic scars were cured using two methods (Cryotherapy, 83; IPL, 83). The recovery rate was higher in the Cryotherapy group than in the IPL group ( p  > 0.05), and the incidence of complications was also higher in the Cryotherapy group (14.5% vs. 12%). Moreover, patients were more satisfied, although not significantly so, with the cryotherapy method ( p  = 0.09). Both methods were highly successful in curing scars; participants were totally satisfied with both methods.

  9. Effects of kinesiotaping versus non-steroidal anti-inflammatory drugs and physical therapy for treatment of pes anserinus tendino-bursitis: A randomized comparative clinical trial.

    Science.gov (United States)

    Homayouni, Kaynoosh; Foruzi, Shima; Kalhori, Fereshte

    2016-09-01

    Pes anserinus tendino-bursitis is a condition caused by repetitive friction over the bursa or direct trauma to knee joint and it presents with proximal medial tibial pain and swelling. The aim of this study is to determine the effects of kinesiotaping in comparison with naproxen and physical therapy in treatment of pes anserinus tendino-bursitis. In a randomized comparative clinical trial 56 patients with clinical diagnosis of pes anserinus tendino-bursitis were randomly assigned to kinesiotaping and naproxen/physical therapy (28 patients in each group). Kinesiotaping on the tender area in the form of space-correction (lifting) technique was used and repeated for three times with a one-week interval. Another group received naproxen (250mg TID for 10 days) and ten sessions of daily physical therapy. The visual analog scale (VAS) was used for evaluation of pain. The depth of swelling of the area was measured with sonography before and after treatment. Wilcoxon signed ranks test has been used for determining the influence of interventions on pain (VAS) and swelling scores in each group. The ANCOVA (Analysis of covariance) test was applied for comparing the influence of interventions on VAS and swelling scores after adjustment for co-variables. At end of the study, 27 patients remained in the kinesiotaping group and 19 patients in naproxen/physical therapy group. Treatment with kinesiotaping significantly decreased the pain (P=0.0001) and swelling scores (P=0.0001) in comparison with naproxen/physical therapy after adjustment for baseline characteristics. Kinesiotaping was safe without any complications except for a mild local skin irritation in one patient. Kinesiotaping is more effective than naproxen plus physical therapy in reduction of pain and swelling in patients with pes anserinus tendino-bursitis. www.ClinicalTrials.gov identifier is NCT01680263.

  10. A randomized clinical trial comparing embryo culture in a conventional incubator with a time-lapse incubator

    DEFF Research Database (Denmark)

    Kirkegaard, Kirstine; Hindkjaer, Johnny Juhl; Grøndahl, Marie Louise

    2012-01-01

    Time-lapse monitoring allows for a flexible embryo evaluation and potentially provides new dynamic markers of embryo competence. Before introducing time-lapse monitoring in a clinical setting, the safety of the instrument must be properly documented. Accordingly, the aim of this study...

  11. Routine resite of peripheral intravenous devices every 3 days did not reduce complications compared with clinically indicated resite: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Rickard Claire M

    2010-09-01

    Full Text Available Abstract Background Peripheral intravenous device (IVD complications were traditionally thought to be reduced by limiting dwell time. Current recommendations are to resite IVDs by 96 hours with the exception of children and patients with poor veins. Recent evidence suggests routine resite is unnecessary, at least if devices are inserted by a specialised IV team. The aim of this study was to compare the impact of peripheral IVD 'routine resite' with 'removal on clinical indication' on IVD complications in a general hospital without an IV team. Methods A randomised, controlled trial was conducted in a regional teaching hospital. After ethics approval, 362 patients (603 IVDs were randomised to have IVDs replaced on clinical indication (185 patients or routine change every 3 days (177 patients. IVDs were inserted and managed by the general hospital medical and nursing staff; there was no IV team. The primary endpoint was a composite of IVD complications: phlebitis, infiltration, occlusion, accidental removal, local infection, and device-related bloodstream infection. Results IVD complication rates were 68 per 1,000 IVD days (clinically indicated and 66 per 1,000 IVD days (routine replacement (P = 0.86; HR 1.03; 95% CI, 0.74-1.43. Time to first complication per patient did not differ between groups (KM with log rank, P = 0.53. There were no local infections or IVD-related bloodstream infections in either group. IV therapy duration did not differ between groups (P = 0.22, but more (P = 0.004 IVDs were placed per patient in the routine replacement (mean, 1.8 than the clinical indication group (mean, 1.5, with significantly higher hospital costs per patient (P Conclusions Resite on clinical indication would allow one in two patients to have a single cannula per course of IV treatment, as opposed to one in five patients managed with routine resite; overall complication rates appear similar. Clinically indicated resite would achieve savings in equipment

  12. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Dekker Joost

    2009-02-01

    Full Text Available Abstract Background Patients with Chronic Tension Type Headache (CTTH report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles. We present the design of a randomised clinical trial (RCT evaluating the effectiveness of manual therapy (MT compared to usual care by the general practitioner (GP in patients with CTTH. Methods and design Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS. Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques, exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks. Discussion This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible. The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache.

  13. An analysis of registered clinical trials in otolaryngology from 2007 to 2010: ClinicalTrials.gov.

    Science.gov (United States)

    Witsell, David L; Schulz, Kristine A; Lee, Walter T; Chiswell, Karen

    2013-11-01

    To describe the conditions studied, interventions used, study characteristics, and funding sources of otolaryngology clinical trials from the ClinicalTrials.gov database; compare this otolaryngology cohort of interventional studies to clinical visits in a health care system; and assess agreement between clinical trials and clinical activity. Database analysis. Trial registration data downloaded from ClinicalTrials.gov and administrative data from the Duke University Medical Center from October 1, 2007 to September 27, 2010. Data extraction from ClinicalTrials.gov was done using MeSH and non-MeSH disease condition terms. Studies were subcategorized to create the following groupings for descriptive analysis: ear, nose, allergy, voice, sleep, head and neck cancer, thyroid, and throat. Duke Health System visits were queried by using selected ICD-9 codes for otolaryngology and non-otolaryngology providers. Visits were grouped similarly to ClinicalTrials.gov for further analysis. Chi-square tests were used to explore differences between groups. A total of 1115 of 40,970 registered interventional trials were assigned to otolaryngology. Head and neck cancer trials predominated. Study models most frequently incorporated parallel design (54.6%), 2 study groups (46.6%), and randomization (69.1%). Phase 2 or 3 studies constituted 46.4% of the cohort. Comparison of the ClinicalTrials.gov database with administrative health system visit data by disease condition showed discordance between national research activity and clinical visit volume for patients with otolaryngology complaints. Analysis of otolaryngology-related clinical research as listed in ClinicalTrials.gov can inform patients, physicians, and policy makers about research focus areas. The relative burden of otolaryngology-associated conditions in our tertiary health system exceeds research activity within the field.

  14. Does prolonged β-lactam infusions improve clinical outcomes compared to intermittent infusions? A meta-analysis and systematic review of randomized, controlled trials

    Directory of Open Access Journals (Sweden)

    Van Arendonk Kyle J

    2011-06-01

    Full Text Available Abstract Background The emergence of multi-drug resistant Gram-negatives (MDRGNs coupled with an alarming scarcity of new antibiotics has forced the optimization of the therapeutic potential of available antibiotics. To exploit the time above the minimum inhibitory concentration mechanism of β-lactams, prolonging their infusion may improve outcomes. The primary objective of this meta-analysis was to determine if prolonged β-lactam infusion resulted in decreased mortality and improved clinical cure compared to intermittent β-lactam infusion. Methods Relevant studies were identified from searches of MEDLINE, EMBASE, and CENTRAL. Heterogeneity was assessed qualitatively, in addition to I2 and Chi-square statistics. Pooled relative risks (RR and 95% confidence intervals (CI were calculated using Mantel-Haenszel random-effects models. Results Fourteen randomized controlled trials (RCTs were included. Prolonged infusion β-lactams were not associated with decreased mortality (n= 982; RR 0.92; 95% CI:0.61-1.37 or clinical cure (n = 1380; RR 1.00 95% CI:0.94-1.06 compared to intermittent infusions. Subgroup analysis for β-lactam subclasses and equivalent total daily β-lactam doses yielded similar results. Most studies had notable methodological flaws. Conclusions No clinical advantage was observed for prolonged infusion β-lactams. The limited number of studies with MDRGNs precluded evaluation of prolonged infusion of β-lactams for this subgroup. A large, multicenter RCT with critically ill patients infected with MDRGNs is needed.

  15. Comparative evaluation of pregnancy outcome in gonadotrophin-clomiphene combination vs clomiphene alone in polycystic ovarian syndrome and unexplained infertility-A prospective clinical trial

    Directory of Open Access Journals (Sweden)

    Shiuli Mukherjee

    2010-01-01

    Full Text Available Objectives: A large prospective clinical trial was conducted to compare the efficacy of single dose uFSH and clomiphene citrate combination with clomiphene citrate alone for ovulation induction to improve the pregnancy rate. Materials and Methods: The study was a randomized, prospective clinical trial. Totally, 1527 infertile women (4381 cycles with polycystic ovarian syndrome (PCOS (n=911/2573 cycles and unexplained infertility (n=616/1808 cycles were randomized into two groups. Group A received single dose of uFSH on D 3 of menstrual cycle along with clomiphene. Group B received clomiphene only for ovulation induction. We compared the pregnancy rate and miscarriage rate between two groups. Results: Group A had a pregnancy rate of 17% compared to 8.3% of Group B which was significantly higher (P=0.0001. The miscarriage rate was 11% in Group A and 10% in Group B which was not significant (P=0.99. Pregnancy rates in PCOS women were 22% in Group A and 9.3% in Group B which shows significantly higher pregnancy rate (P=0.0001 in anovulatory infertility. But in unexplained infertility, there was no significant difference in pregnancy rate between Group A (11% and Group B(6.3%. Miscarriage rates were 8.8% and 9.5% in Group A and Group B, respectively, in PCOS women and 14% and 13% in women with unexplained infertility. Conclusion: Addition of single dose of uFSH improves pregnancy outcome particularly in anovulatory infertility (WHO II. Correction of unexplained infertility may need more than simple correction of possible subtle ovulatory effect.

  16. The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J; Brawer, Michael K; Barry, Michael J; Jones, Karen M; Kwon, Young; Gingrich, Jeffrey R; Aronson, William J; Nsouli, Imad; Iyer, Padmini; Cartagena, Ruben; Snider, Glenn; Roehrborn, Claus; Fox, Steven

    2009-01-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy versus watchful waiting conducted in Scandinavia. We screened 13,022 men with prostate cancer at 52 United States medical centers for potential enrollment. From these, 5023 met initial age, comorbidity and disease eligibility criteria and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African-American. Approximately 85% reported they were fully active. The median prostate specific antigen (PSA) was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason

  17. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    Science.gov (United States)

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  18. Amount of health care and self-care following a randomized clinical trial comparing flexion-distraction with exercise program for chronic low back pain

    Directory of Open Access Journals (Sweden)

    Keenum Michael

    2006-08-01

    Full Text Available Abstract Background Previous clinical trials have assessed the percentage of participants who utilized further health care after a period of conservative care for low back pain, however no chiropractic clinical trial has determined the total amount of care during this time and any differences based on assigned treatment group. The objective of this clinical trial follow-up was to assess if there was a difference in the total number of office visits for low back pain over one year after a four week clinical trial of either a form of physical therapy (Exercise Program or a form of chiropractic care (Flexion Distraction for chronic low back pain. Methods In this randomized clinical trial follow up study, 195 participants were followed for one year after a four-week period of either a form of chiropractic care (FD or a form of physical therapy (EP. Weekly structured telephone interview questions regarded visitation of various health care practitioners and the practice of self-care for low back pain. Results Participants in the physical therapy group demonstrated on average significantly more visits to any health care provider and to a general practitioner during the year after trial care (p Conclusion During a one-year follow-up, participants previously randomized to physical therapy attended significantly more health care visits than those participants who received chiropractic care.

  19. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial

    Science.gov (United States)

    Thow, Megan; Ferguson, Stuart G

    2016-01-01

    Background Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. Objectives (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Methods Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Results Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was

  20. Phase III Randomized Clinical Trial Comparing Tremelimumab With Standard-of-Care Chemotherapy in Patients With Advanced Melanoma

    Science.gov (United States)

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A.; Punt, Cornelis J.A.; Haanen, John B.; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L.; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A.; Dreno, Brigitte; Nathan, Paul D.; Mackiewicz, Jacek; Kirkwood, John M.; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-01-01

    Purpose In phase I/II trials, the cytotoxic T lymphocyte–associated antigen-4–blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients and Methods Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). Results In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. Conclusion This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma. PMID:23295794

  1. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma.

    Science.gov (United States)

    Ribas, Antoni; Kefford, Richard; Marshall, Margaret A; Punt, Cornelis J A; Haanen, John B; Marmol, Maribel; Garbe, Claus; Gogas, Helen; Schachter, Jacob; Linette, Gerald; Lorigan, Paul; Kendra, Kari L; Maio, Michele; Trefzer, Uwe; Smylie, Michael; McArthur, Grant A; Dreno, Brigitte; Nathan, Paul D; Mackiewicz, Jacek; Kirkwood, John M; Gomez-Navarro, Jesus; Huang, Bo; Pavlov, Dmitri; Hauschild, Axel

    2013-02-10

    In phase I/II trials, the cytotoxic T lymphocyte-associated antigen-4-blocking monoclonal antibody tremelimumab induced durable responses in a subset of patients with advanced melanoma. This phase III study evaluated overall survival (OS) and other safety and efficacy end points in patients with advanced melanoma treated with tremelimumab or standard-of-care chemotherapy. Patients with treatment-naive, unresectable stage IIIc or IV melanoma were randomly assigned at a ratio of one to one to tremelimumab (15 mg/kg once every 90 days) or physician's choice of standard-of-care chemotherapy (temozolomide or dacarbazine). In all, 655 patients were enrolled and randomly assigned. The test statistic crossed the prespecified futility boundary at second interim analysis after 340 deaths, but survival follow-up continued. At final analysis with 534 events, median OS by intent to treat was 12.6 months (95% CI, 10.8 to 14.3) for tremelimumab and 10.7 months (95% CI, 9.36 to 11.96) for chemotherapy (hazard ratio, 0.88; P = .127). Objective response rates were similar in the two arms: 10.7% in the tremelimumab arm and 9.8% in the chemotherapy arm. However, response duration (measured from date of random assignment) was significantly longer after tremelimumab (35.8 v 13.7 months; P = .0011). Diarrhea, pruritus, and rash were the most common treatment-related adverse events in the tremelimumab arm; 7.4% had endocrine toxicities. Seven deaths in the tremelimumab arm and one in the chemotherapy arm were considered treatment related by either investigators or sponsor. This study failed to demonstrate a statistically significant survival advantage of treatment with tremelimumab over standard-of-care chemotherapy in first-line treatment of patients with metastatic melanoma.

  2. Developments in statistical evaluation of clinical trials

    CERN Document Server

    Oud, Johan; Ghidey, Wendimagegn

    2014-01-01

    This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.

  3. Clinical trials. A pending subject.

    Science.gov (United States)

    Gil-Extremera, B; Jiménez-López, P; Mediavilla-García, J D

    2018-04-01

    Clinical trials are essential tools for the progress of clinical medicine in its diagnostic and therapeutic aspects. Since the first trial in 1948, which related tobacco use with lung cancer, there have been more than 150,000 clinical trials to date in various areas (paediatrics, cardiology, oncology, endocrinology, etc.). This article highlights the importance for all physicians to participate, over the course of their professional career, in a clinical trial, due to the inherent benefits for patients, the progress of medicine and for curricular prestige. The authors have created a synthesis of their experience with clinical trials on hypertension, diabetes, dyslipidaemia and ischaemic heart disease over the course of almost 3 decades. Furthermore, a brief reference has been made to the characteristics of a phase I unit, as well as to a number of research studies currently underway. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  4. A randomized clinical trial comparing the effect of basal insulin and inhaled mealtime insulin on glucose variability and oxidative stress

    NARCIS (Netherlands)

    Siegelaar, S. E.; Kulik, W.; van Lenthe, H.; Mukherjee, R.; Hoekstra, J. B. L.; DeVries, J. H.

    2009-01-01

    To assess the effect of three times daily mealtime inhaled insulin therapy compared with once daily basal insulin glargine therapy on 72-h glucose profiles, glucose variability and oxidative stress in type 2 diabetes patients. In an inpatient crossover study, 40 subjects with type 2 diabetes were

  5. Comparative effectiveness of lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain: randomized clinical trial.

    Science.gov (United States)

    Bhadauria, Esha A; Gurudut, Peeyoosha

    2017-08-01

    The aim of the present study was to compare three different forms of exercises namely lumbar stabilization, dynamic strengthening, and Pilates on chronic low back pain (LBP) in terms of pain, range of motion, core strength and function. In this study, 44 subjects suffering from non-specific LBP for more than 3 months were randomly allocated into the lumbar stabilization group, the dynamic strengthening group, and the Pilates group. Ten sessions of exercises for 3 weeks were prescribed along with interferential current and hot moist pack. Pain was assessed by visual analog scale, functional affection by modified Oswestry Disability Questionnaire, range of motion by assessing lumbar flexion and extension by modified Schober test and core strength was assessed by pressure biofeedback on day 1 and day 10 of the treatment. There was reduction of pain, improvement in range of motion, functional ability and core strength in all the 3 exercise groups. The improvement was significantly greater in the lumbar stabilization group for all the outcome measures, when compared the posttreatment after 10th session. Pairwise comparison showed that there was greater reduction of disability in the Pilates group than the dynamic strengthening group. It was concluded that the lumbar stabilization is more superior compared to the dynamic strengthening and Pilates in chronic nonspecific LBP. However, long-term benefits need to be assessed and compared with prospective follow-up studies.

  6. OARSI Clinical Trials Recommendations

    DEFF Research Database (Denmark)

    Emery, C. A.; Roos, Ewa M.; Verhagen, E.

    2015-01-01

    The risk of post-traumatic osteoarthritis (PTOA) substantially increases following joint injury. Research efforts should focus on investigating the efficacy of preventative strategies in high quality randomized controlled trials (RCT). The objective of these OARSI RCT recommendations is to inform...... the design, conduct and analytical approaches to RCTs evaluating the preventative effect of joint injury prevention strategies. Recommendations regarding the design, conduct, and reporting of RCTs evaluating injury prevention interventions were established based on the consensus of nine researchers...... internationally with expertise in epidemiology, injury prevention and/or osteoarthritis (OA). Input and resultant consensus was established through teleconference, face to face and email correspondence over a 1 year period. Recommendations for injury prevention RCTs include context specific considerations...

  7. Comparative study of amrutbhallataka and glucosamine sulphate in osteoarthritis: Six months open label randomized controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ashwinikumar Raut

    2013-01-01

    Full Text Available Background: AmrutBhallatak (ABFN02, a ′rasayana′ drug from Ayurveda is indicated in degenerative diseases and arthritis. Objective: To evaluate safety and efficacy of ABFN02 in osteoarthritis (OA and compare it with Glucosamine sulphate (GS Materials and Methods: This was a r andomized open comparative study. Ambulant OPD patients of OA knees (n = 112 were enrolled for 24 weeks. Tablets (750mg each of GS and ABFN02 were matched. Three groups of patients: (A GS, one tablet × twice/day × 24 weeks. (B ABFN02, incremental pulse dosage (one tablet x twice/day × two weeks, two tablets × twice/day × two weeks, three tablets × twice/day × two weeks, two such cycles of drug and non-drug phases alternately for six weeks each (C ABFN02 continuous dosage akin to GS. Pain visual analogue score (Pain-VAS and Western Ontario and Mc-Master University Osteoarthritis Index (WOMAC were the primary outcome measures. Secondary outcome measures were Health assessment questionnaire (HAQ, paracetamol consumption, 50 feet walking, physician and patient global assessment, knee stiffness, knee status, urinary CTX II, serum TNFa-SRI, SRII and MRI knee in randomly selected patients. Results: ABFNO2 and GS demonstrated, adherence to treatment 87.75% and 74.3%, reduction in Pain-VAS at rest 61.05% and 57.1%, reduction in pain-VAS on activity 57.4% and 59.8%, WOMAC score drop 62.8% and 59.1% respectively. Secondary outcome measures were comparable in all groups. Safety measures were also comparable. No serious adverse events reported. However, asymptomatic reversible rise in liver enzymes was noted in the ABFNO2 group. Conclusions: ABFN02 has significant activity in OA; the formulation needs further investigation.

  8. Evaluation of carboxytherapy and platelet-rich plasma in treatment of periorbital hyperpigmentation: A comparative clinical trial.

    Science.gov (United States)

    Nofal, Eman; Elkot, Reham; Nofal, Ahmad; Eldesoky, Fatma; Shehata, Shymaa; Sami, Maha

    2018-01-03

    Management of periorbital hyperpigmentation (POH) is still a therapeutic challenge. Although different therapeutic modalities are available, the outcomes of most of them are unsatisfactory. To investigate and compare the efficacy and safety of two new modalities in the treatment of POH; the platelet rich plasma (PRP) and the carboxytherapy. The study included 30 patients with POH. Every patient was subjected to seven intradermal injections of PRP on the left periorbital area with 2 week intervals between sessions and carboxytherapy on the right area with 1 week interval apart. Assessments were done by investigators' assessment, visual analogue scale by both patients and doctors, and patients' satisfaction. Side effects were reported. All patients completed the sessions in the carboxy-treated side. In the PRP-treated side, 10 patients refused to complete all sessions because of intolerable side effects. Significant improvement in POH was achieved in both sides (P ≤ .0001). The improvement was comparable with no statistically significant difference between both modalities. Side effects in the carboxy treated side were mild and well tolerated by all patients while they were relatively severe, and persisted for days after sessions in the PRP-treated side. Both PRP and carboxytherapy are relatively effective and their efficacy is comparable in treatment of POH. Carboxtherapy is simple and slightly more effective modality and well tolerated than PRP. We believe that both modalities are promising but not the ideal solutions of the POH problem which is caused by multifactorial etiology. © 2018 Wiley Periodicals, Inc.

  9. The effect of supervised Tai Chi intervention compared to a physiotherapy program on fall-related clinical outcomes: a randomized clinical trial.

    Science.gov (United States)

    Tousignant, Michel; Corriveau, Hélène; Roy, Pierre-Michel; Desrosiers, Johanne; Dubuc, Nicole; Hébert, Réjean; Tremblay-Boudreault, Valérie; Beaudoin, Audrée-Jeanne

    2012-01-01

    To assess some fall-related clinical variables (balance, gait, fear of falling, functional autonomy, self-actualization and self-efficacy) that might explain the fact that supervised Tai Chi has a better impact on preventing falls compared to a conventional physiotherapy program. The participants (152 older adults over 65 who were admitted to a geriatric day hospital program) were randomly assigned to either a supervised Tai Chi group or the usual physiotherapy. The presence of the clinical variables related to falls was evaluated before the intervention (T1), immediately after (T2), and 12 months after the end of the intervention (T3). Both exercise programs significantly improved fall-related outcomes but only the Tai Chi intervention group decreased the incidence of falls. For both groups, most variables followed the same pattern, i.e. showed significant improvement with the intervention between T1 and T2, and followed by a statistically significant decrease at the T3 evaluation. However, self-efficacy was the only variable that improved solely with the Tai Chi intervention (p = 0.001). The impact of supervised Tai Chi on fall prevention can not be explained by a differential effect on balance, gait and fear of falling. It appeared to be related to an increase of general self-efficacy, a phenomenon which is not seen in the conventional physiotherapy program.

  10. Randomized double blinded placebo controlled trial comparing diclofenac and piroxicam in management of acute renal colic and its clinical implications.

    Science.gov (United States)

    KandaSwamy, Gokul Vignesh; Dhanasekaran, Ananda Kumar; Elangovan, Aravindhan; John, Bobby; Viswaroop, Bobby; Vedanayagam, Kandasami Sangam

    2015-04-29

    To compare the efficacy of sublingual piroxicam 40 mg with intramuscular diclofenac 75 mg in treatment of acute renal colic. The secondary objective was to look for factors that can affect the severity of the pain and pain relief in acute renal colic. One hundred patients with acute renal colic were randomized into two groups. Group A (n = 50) received intramuscular diclofenac and sublingual methylcobalamin. Group B (n = 50) received sublingual piroxicam 40 mg and intramuscular distilled water. Pain severity was measured using Visual Analog Scale (VAS) and verbal and facial response scales. They were followed up for 3 h. Intramuscular injection of pentazocine 30 mg with promethazine 25 mg were used as rescue drugs. Both groups were comparable for age, sex distribution, body mass index (BMI), and pain duration before presentation. Significant pain relief was noticed in both groups. Sixteen percent in group A and 18% in group B had complete pain relief within 30 min (P = .75). Fifteen patients in group A and 13 patients in group B needed rescue drugs, 84% of group A and 76% of group B had complete pain relief at the end of 3 hours (P = .25). Decrease in pain by each scoring method was also comparable (P = .75). In multiple regression analysis, increasing age, positively affects the severity of pain and pain relief while increasing BMI negatively affect the initial pain relief. Acute renal colic seems to affect men more commonly than women, 81% of the study population were men. Patients with low initial pain score did not require any additional pain relief. Average pain duration before presenting to hospital is 260 min. Sixty percent of renal colics are due to stones below pelvic brim. The results show that sublingual piroxicam is as effective as intramuscular diclofenac. It can be easily self-administered and it overcomes the morbidity and time delay in getting intramuscular diclofenac.

  11. Randomized clinical trial comparing TVT Secur system and trans vaginal obturator tape for the surgical management of stress urinary incontinence.

    Science.gov (United States)

    Maslow, Ken; Gupta, Chander; Klippenstein, Peter; Girouard, Lise

    2014-07-01

    This prospective randomized study aimed to compare the safety and efficacy of the TVT-Secur (TVT-S) with the trans vaginal obturator tape (TVT-O) for the treatment of stress urinary incontinence. We set out to enroll 136 patients in our study. 106 patients with stress urinary incontinence were randomized to either the TVT-S (n = 56) or TVT-O (n = 50) procedure. Patients were evaluated postoperatively at 2 months and 1 year. Our primary outcome was objective cure measured by the cough test. Secondary outcomes of subjective symptoms, questionnaires, pain scores, complications, and urodynamic studies were also included. Statistical analysis was by Chi-squared, Kruskal-Wallis, Wilcoxon, and Fisher's exact tests as appropriate. P values of TVT-O compared with TVT-S at 1 year (86 % and 63 % respectively, p = 0.01). Subjective cure rates were 88 % for TVT-O and 63 % for TVT-S. Quality of life scores through questionnaires improved in both groups and were not statistically different. Initial post-operative groin pain was more prevalent in the TVT-O group; however, this resolved quickly with time. TVT-O was superior to TVT-S in the objective cure of stress urinary incontinence at 1-year follow-up.

  12. Comparing Two Exercise Programmes for the Management of Lateral Elbow Tendinopathy (Tennis Elbow/Lateral Epicondylitis—A Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Dimitrios Stasinopoulos

    2013-09-01

    Full Text Available Aim: To compare the effectiveness of supervised exercise programme as proposed by Stasinopoulos and colleagues with home exercise programme as proposed by Pienimaki and his coworkers in the treatment of lateral elbow tendinopathy. Design: Controlled clinical trial. Setting: Physiotherapy and rehabilitation centre. Participants: This trial was carried out with 60 patients, who had lateral elbow tendinopathy. Intervention: Group A (n = 30 had received supervised exercise programme, once per day for 4 weeks. Group B (n = 30 was treated with home exercise programme four to six times daily for 8 weeks. Outcome measures: pain, using a visual analogue scale, function, using a visual analogue scale for elbow function and the pain-free grip strength. Patients were evaluated at baseline, at the end of treatment (week 12, and 3 months (week 24 after the end of treatment. Results: Both the supervised and home exercise programme were found to be significantly effective in the reduction of pain and in the improvement of functional status. The supervised exercise programme resulted in significantly different improvement in comparison to those who received home exercise programme. Conclusion: A specific supervised exercise programme is superior to a specific home exercise programme in reducing pain and improving function in patients with LET at the end of the treatment and at the 3 month follow-up. Further research is needed to confirm our results.

  13. Comparative evaluation of photoablative efficacy of erbium: yttrium-aluminium-garnet and diode laser for the treatment of gingival hyperpigmentation. A randomized split-mouth clinical trial.

    Science.gov (United States)

    Giannelli, Marco; Formigli, Lucia; Bani, Daniele

    2014-04-01

    The use of lasers in periodontology is a matter of debate, mainly because of the lack of consensual therapeutic protocols. In this randomized, split-mouth trial, the clinical efficacy of two different photoablative dental lasers, erbium:yttrium-aluminum-garnet (Er:YAG) and diode, for the treatment of gingival hyperpigmentation is compared. Twenty-one patients requiring treatment for mild-to-severe gingival hyperpigmentation were enrolled. Maxillary or mandibular left or right quadrants were randomly subjected to photoablative deepithelialization with either Er:YAG or diode laser. Masked clinical assessments of each laser quadrant were made at admission and days 7, 30, and 180 postoperatively by an independent observer. Histologic examination was performed before and soon after treatment and 6 months after irradiation. Patients also compiled a subjective evaluation questionnaire. Both diode and Er:YAG lasers gave excellent results in gingival hyperpigmentation. However, Er:YAG laser induced deeper gingival tissue injury than diode laser, as judged by bleeding at surgery, delayed healing, and histopathologic analysis. The use of diode laser showed additional advantages compared to Er:YAG in terms of less postoperative discomfort and pain. This study highlights the efficacy of diode laser for photoablative deepithelialization of hyperpigmented gingiva. It is suggested that this laser can represent an effective and safe therapeutic option for gingival photoablation.

  14. Subjective vs. objective evaluation of gallbladder opacification during oral cholecystography in comparative clinical trials: implications for studies involving visual assessment

    International Nuclear Information System (INIS)

    Fon, G.T.; Hunter, T.B.; Berk, R.N.; Patton, D.D.; Capp, M.P.

    1982-01-01

    Radiographs and CT images taken during oral cholecystography in dogs were interpreted in an independent, blind fashion by three radiologists on two occasions and visual assessment of gallbladder density compared to the actual CT values. While there was significant intra- and inter-observer variation, the mean scores for the observers' interpretations of both radiographs and prints correlated well with the actual CT values (p > 0.05). In five out of six comparisons between first and second readings, the observers gave a lower score on the second reading. The considerable variation reflects the problems inherent in subjective evaluation of agents that produce small but measurable differences in radiographic density. Studies involving such subjective data have to be carefully designed in order to obtain meaningful results

  15. Midterm Clinical and First Reproductive Results of a Randomized Controlled Trial Comparing Uterine Fibroid Embolization and Myomectomy

    International Nuclear Information System (INIS)

    Mara, Michal; Maskova, Jana; Fucikova, Zuzana; Kuzel, David; Belsan, Tomas; Sosna, Ondrej

    2008-01-01

    The purpose of this study was to compare the midterm results of a radiological and surgical approach to uterine fibroids. One hundred twenty-one women with reproductive plans who presented with an intramural fibroid(s) larger than 4 cm were randomly selected for either uterine artery embolization (UAE) or myomectomy. We compared the efficacy and safety of the two procedures and their impact on patient fertility. Fifty-eight embolizations and 63 myomectomies (42 laparoscopic, 21 open) were performed. One hundred eighteen patients have finished at least a 12-month follow-up; the mean follow-up in the entire study population was 24.9 months. Embolized patients underwent a significantly shorter procedure and required a shorter hospital stay and recovery period. They also presented with a lower CRP concentration on the second day after the procedure (p < 0.0001 for all parameters). There were no significant differences between the two groups in the rate of technical success, symptomatic effectiveness, postprocedural follicle stimulating hormone levels, number of reinterventions for fibroid recurrence or regrowth, or complication rates. Forty women after myomectomy and 26 after UAE have tried to conceive, and of these we registered 50 gestations in 45 women. There were more pregnancies (33) and labors (19) and fewer abortions (6) after surgery than after embolization (17 pregnancies, 5 labors, 9 abortions) (p < 0.05). Obstetrical and perinatal results were similar in both groups, possibly due to the low number of labors after UAE to date. We conclude that UAE is less invasive and as symptomatically effective and safe as myomectomy, but myomectomy appears to have superior reproductive outcomes in the first 2 years after treatment

  16. The Effectiveness Of Social Media (Facebook) Compared With More Traditional Advertising Methods for Recruiting Eligible Participants To Health Research Studies: A Randomized, Controlled Clinical Trial.

    Science.gov (United States)

    Frandsen, Mai; Thow, Megan; Ferguson, Stuart G

    2016-08-10

    Recruiting participants for research studies can be difficult and costly. The popularity of social media platforms (eg, Facebook) has seen corresponding growth in the number of researchers turning to social networking sites and their embedded advertising frameworks to locate eligible participants for studies. Compared with traditional recruitment strategies such as print media, social media advertising has been shown to be favorable in terms of its reach (especially with hard-to-reach populations), cost effectiveness, and usability. However, to date, no studies have examined how participants recruited via social media progress through a study compared with those recruited using more traditional recruitment strategies. (1) Examine whether visiting the study website prior to being contacted by researchers creates self-screened participants who are more likely to progress through all study phases (eligible, enrolled, completed); (2) compare conversion percentages and cost effectiveness of each recruitment method at each study phase; and, (3) compare demographic and smoking characteristics of participants recruited through each strategy to determine if they attract similar samples. Participants recruited to a smoking cessation clinical trial were grouped by how they had become aware of the study: via social media (Facebook) or traditional media (eg, newspaper, flyers, radio, word of mouth). Groups were compared based on throughput data (conversion percentages and cost) as well as demographic and smoking characteristics. Visiting the study website did not result in individuals who were more likely to be eligible for (P=.24), enroll in (P=.20), or complete (P=.25) the study. While using social media was more cost effective than traditional methods when we examined earlier endpoints of the recruitment process (cost to obtain a screened respondent: AUD $22.73 vs $29.35; cost to obtain an eligible respondent: $37.56 vs $44.77), it was less cost effective in later endpoints

  17. [Random clinical comparative trial between free and directed exercise in post-operative complications of breast cancer].

    Science.gov (United States)

    Rezende, Laura Ferreira de; Beletti, Patricia Odila; Franco, Ricardo Laier; Moraes, Sirlei Siani; Gurgel, Maria Salete Costa

    2006-01-01

    The objective of this study was to evaluate the association among physiotherapy exercises performed--directed or free--in case of post-operative complications in women who underwent radical mastectomy or quadrantectomy with axillary dissection. Sixty women were randomized. The directed group performed physiotherapy following a regimen of 19 exercises. The free group performed the exercises following the biomechanical physiological movements of the shoulder without a previously defined sequence or number of repetitions, exercises were done to the rhythm of music. In the average, the directed group remained 12.17 + 2.96 days with the drain, while the free group remained 11.96 + 2.32 days, with no significant difference between groups. The amount of secretion drained during the permanence of the drain also revealed resemblance between groups, with an average of 1308.71 + 562.6 ml in the directed group and of 1391.62 + 644.65 ml in the group of free exercises. Incidences of seroma and dehiscence of the surgical wound did not seem to be influenced by the type of exercise at any of the times evaluated. In the directed group, 7.4% and 3.4% of the women presented with seroma on the 28th and 42nd days, respectively, while at the same moments of evaluation the free group presented respectively. 3.6% and 3.6%. Incidence of dehiscence of the surgical wound also was similar in the two groups, in the directed group it was of 20% on the 14th day, 31% on the 28th day and 10.3% on the 42nd day of postoperative. In the free group the incidence was of 23.3% on the 14th day, of 33.3% on the 28th day and of 22.2% on the 42nd day of postoperative. The statistical difference observed in the averages of the hand and arm circumferences does not translate into clinical differences. The complications were not influenced f by the physiotherapy exercises performed.

  18. A randomized controlled clinical trial to compare the safety and efficacy of edaravone in acute ischemic stroke

    Directory of Open Access Journals (Sweden)

    Sharma Pawan

    2011-01-01

    Full Text Available Background and Objective: Edaravone has potent antioxidant and free radical scavenger properties. Few Japanese studies had demonstrated its neuroprotective role in acute ischemic stroke (AIS. This study aims to evaluate the efficacy of edaravone in terms of functional outcome in a group of Indian patients of AIS. Materials and Methods: Fifty patients of AIS were randomly divided into two groups. The study group received 30 mg of edaravone twice daily for 14 days by infusion, while control group received normal saline infusion as placebo. Outcome assessment was done by the Modified Rankin Scale (MRS. MRS score ≤2 at 90 days was considered as a favorable outcome. Results: Of 25 patients, 18 (72% had favorable outcomes (MRS ≤2 at 90 days in edaravone group, while 10 (40% of 25 patients in placebo group had favorable outcome (P < 0.005. Two patients expired (one in each group during treatment. The mean Barthel index increased from 41.20 ± 32.70 at baseline to 82.40 ± 18.32 at day 90 in edaravone group as compared with placebo group in which scores were 44.20 ± 22.76 at baseline and 68.20 ± 21.30 at day 90 (P < 0.005. Conclusions: We therefore conclude that edaravone effectively improves functional outcome in AIS.

  19. One-year outcomes of a bilateral randomised prospective clinical trial comparing PRK with mitomycin C and LASIK.

    Science.gov (United States)

    Wallau, A D; Campos, M

    2009-12-01

    To compare 1-year follow-up results of photorefractive keratectomy (PRK) with mitomycin C (MMC) and laser in situ keratomileusis (LASIK) for custom correction of myopia. Eighty-eight eyes of 44 patients with moderate myopia were randomised to PRK with 0.002% MMC for 1 min in one eye and LASIK in the fellow eye. The 1-year follow-up was evaluated. There were no differences between LASIK and MMC-PRK eyes preoperatively. Forty-two patients completed the 1-year follow-up. MMC-PRK eyes achieved better uncorrected visual acuity (p = 0.03) and better best-spectacle-corrected visual acuity (pPRK eyes postoperatively. Excellent vision was reported in 64% of LASIK and 74% of MMC-PRK eyes 1 year after surgery. The corneal resistance factor and corneal hysteresis (ORA, Reichert) were higher in LASIK than in MMC-PRK eyes (pPRK with 0.002% MMC was more effective than wavefront-guided LASIK for correction of moderate myopia. Further research is necessary to determine the optimal concentration, exposure time and long-term corneal side effect of MMC.

  20. Intubating conditions and side effects of propofol, remifentanil and sevoflurane compared with propofol, remifentanil and rocuronium: a randomised, prospective, clinical trial

    Science.gov (United States)

    2014-01-01

    Background Tracheal intubation without muscle relaxants is usually performed with remifentanil and propofol or sevoflurane. Remifentanil 1.0 to 4.0 μg·kg-1 and propofol 2.0-3.0 mg·kg-1 or sevoflurane up to 8.0 Vol% provide acceptable, i.e. excellent or good intubating conditions. We hypothesized that sevoflurane 1.0 MAC would provide acceptable intubating conditions when combined with propofol and remifentanil. Methods Eighty-three patients to be intubated were randomised to two groups. The SEVO group received propofol 1.5 mg kg-1, remifentanil 0.30 μg kg min-1 and sevoflurane 1.0 MAC; the MR group received the same doses of propofol and remifentanil plus rocuronium 0.45 mg kg-1. We evaluated intubation and extubation conditions, mean arterial pressure (MAP), heart rate (HR) and bispectral index (BIS). The vocal cords were examined for injury by videolaryngoscopy before and 24 hours after surgery. Results Acceptable intubating conditions were seen more frequently with rocuronium than with sevoflurane: 97% versus 82%; p = 0.03; the subscore for vocal cords was comparable: 100% versus 98%. MAP before intubation decreased significantly compared with the MAP at baseline to the same extent in both groups; ephedrine IV was given in 15 (SEVO) versus 16 (MR) patients; p = 0.93. BIS at tracheal intubation was 27 (13-65) in the SEVO group, 29 (14-62) in the MR group; p = 0.07. Vocal cord injuries (oedema, haematoma) were similar: 4 patients in each group. Conclusions Overall intubating conditions were better when rocuronium was used; the subscore for vocal cords was comparable. The incidence of side effects was the same in the two groups. Trial registration ClinicalTrials.Gov: NCT 01591031. PMID:24860256

  1. Acute effects of transcutaneous electrical diaphragmatic stimulation on respiratory pattern in COPD patients: cross-sectional and comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Karina M. Cancelliero-Gaiad

    2013-12-01

    Full Text Available BACKGROUND: Transcutaneous electrical diaphragmatic stimulation (TEDS has been used to improve respiratory muscle strength in patients with respiratory muscle weakness. However, this physical therapy resource has not been studied in chronic obstructive pulmonary disease (COPD. OBJECTIVE: To evaluate the respiratory pattern during one session of TEDS in COPD patients. METHOD: Fifteen COPD patients participated in one TEDS session for plethysmographic analysis and assessment of peripheral oxygen saturation (SpO2 and heart rate (HR. After the session, patients were divided into two groups: Responder (R; n=9 and Non-Responder (NR; n=6 to TEDS. Statistic analysis was performed using the Shapiro-Wilk normality test and two-way ANOVA. For the parameters that showed interaction, the Student t test was used (P<0.05. RESULTS: R group consisted mainly of men, with lower SpO2 and higher HR than NR group. When time (before and during and groups (R and NR were compared (interaction, there were differences in the parameters minute ventilation (Vent, inspiratory tidal volume (ViVol, expiratory tidal volume (VeVol, and respiratory rate (Br/M. In the intergroup comparison, differences were observed in the parameters Vent, ViVol, and VeVol. A significant effect was also observed for time in change in end-expiratory lung volume level (qDEEL, phase relation during inspiration (PhRIB; phase relation during expiration (PhREB; phase relation of entire breath (PhRTB, and phase angle (PhAng. During TEDS, there was an increase in SpO2 and a reduction in HR in both groups. CONCLUSIONS: The most hypoxemic group with greater HR responded to TEDS and there was interaction between group and time of analysis for the pulmonary volumes. The time factor had an influence on the two groups with an increase in thoracoabdominal asynchrony.

  2. A double blind randomized clinical trial comparing lingualized and fully bilateral balanced posterior occlusion for conventional complete dentures.

    Science.gov (United States)

    Kawai, Yasuhiko; Ikeguchi, Nobuyuki; Suzuki, Asako; Kuwashima, Azusa; Sakamoto, Ryuji; Matsumaru, Yuichi; Kimoto, Suguru; Iijima, Morio; Feine, Jocelyne Sylvia

    2017-04-01

    A lingualized occlusion (LO) for complete dentures reduces lateral inferences and occlusal force contacts and direction; thus, LO is theorized to be more suitable for patients with compromised ridges than fully bilateral balanced articulation (FBBA). However, no studies have yet provided evidence to support LO in edentate patients with compromised alveolar ridges. The purpose of this study was to compare LO and FBBA in edentulous individuals with compromised ridges. Sixty edentulous individuals were randomly allocated into groups and received dentures with either LO or FBBA. Following delivery, several denture-related satisfaction variables were measured using 100mm visual analogue scales; oral health-related quality of life (OHRQoL) was also assessed using the Oral Health Impact Profile (OHIP). Sub-group analyses of the effect of moderate and severe mandibular bone loss were also carried out. No significant differences were detected between LO and FBBA with the primary outcome. At 6 months, participants with severely atrophied mandibles and FBBA rated their satisfaction with retention of mandibular dentures significantly lower than those with LO (median LO: 86, FBBA: 58.5, p=0.03). They also had significantly lower OHRQoL for the domain of Pain (median LO: 4, FBBA: 5, p=0.02). General satisfaction and total OHIP scores significantly improved between baseline and 6 months only for the LO subjects with severely atrophied mandibles (satisfaction: p=0.003, OHIP total score: p=0.0007). The results indicate that the LO occlusal scheme with hard resin artificial teeth is more efficient for patients with severely resorbed mandibular ridges. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Update on clinical trials in Dysphagia.

    Science.gov (United States)

    Logemann, Jeri A

    2006-04-01

    Randomized clinical trials (RCTs) are often known as the gold standard in treatment efficacy studies. This article defines the characteristics of RCTs and the factors that investigators must consider in designing clinical trials in dysphagia. Design issues unique to behavioral treatments often used in dysphagia are discussed. Ongoing RCTs in dysphagia are described including studies of (1) the effectiveness of the Shaker exercise versus standardized treatment in patients with severe dysphagia resulting from stroke or treatment for head and neck cancer who have been nonoral for at least three months; (2) the comparative effects of nectar- and honey-thickened liquids versus chin tuck posture and in patients with dementia or Parkinson's disease with or without dementia who aspirate on thin liquids; and (3) the comparative effects of muscle exercise versus sensory postural therapy for dysphagia resulting from treatment for head and neck cancer. Issues in generalizing from the results of clinical trials are also described.

  4. Adaptive designs in clinical trials

    Directory of Open Access Journals (Sweden)

    Suresh Bowalekar

    2011-01-01

    Full Text Available In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  5. Adaptive designs in clinical trials.

    Science.gov (United States)

    Bowalekar, Suresh

    2011-01-01

    In addition to the expensive and lengthy process of developing a new medicine, the attrition rate in clinical research was on the rise, resulting in stagnation in the development of new compounds. As a consequence to this, the US Food and Drug Administration released a critical path initiative document in 2004, highlighting the need for developing innovative trial designs. One of the innovations suggested the use of adaptive designs for clinical trials. Thus, post critical path initiative, there is a growing interest in using adaptive designs for the development of pharmaceutical products. Adaptive designs are expected to have great potential to reduce the number of patients and duration of trial and to have relatively less exposure to new drug. Adaptive designs are not new in the sense that the task of interim analysis (IA)/review of the accumulated data used in adaptive designs existed in the past too. However, such reviews/analyses of accumulated data were not necessarily planned at the stage of planning clinical trial and the methods used were not necessarily compliant with clinical trial process. The Bayesian approach commonly used in adaptive designs was developed by Thomas Bayes in the 18th century, about hundred years prior to the development of modern statistical methods by the father of modern statistics, Sir Ronald A. Fisher, but the complexity involved in Bayesian approach prevented its use in real life practice. The advances in the field of computer and information technology over the last three to four decades has changed the scenario and the Bayesian techniques are being used in adaptive designs in addition to other sequential methods used in IA. This paper attempts to describe the various adaptive designs in clinical trial and views of stakeholders about feasibility of using them, without going into mathematical complexities.

  6. Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design.

    Science.gov (United States)

    Khattab, Ahmed A; Windecker, Stephan; Jüni, Peter; Hildick-Smith, David; Dudek, Dariusz; Andersen, Henning R; Ibrahim, Reda; Schuler, Gerhard; Walton, Antony S; Wahl, Andreas; Mattle, Heinrich P; Meier, Bernhard

    2011-02-28

    Several studies have shown an association of cryptogenic stroke and embolism with patent foramen ovale (PFO), but the question how to prevent further events in such patients is unresolved. Options include antithrombotic treatment with warfarin or antiplatelet agents or surgical or endovascular closure of the PFO. The PC-Trial was set up to compare endovascular closure and best medical treatment for prevention of recurrent events. The PC-Trial is a randomized clinical trial comparing the efficacy of percutaneous closure of the PFO using the Amplatzer PFO occluder with best medical treatment in patients with cryptogenic embolism, i.e. mostly cryptogenic stroke. Warfarin for 6 months followed by antiplatelet agents is recommended as medical treatment. Randomization is stratified according to patients age (Australia. Randomization started February 2000. Enrollment of 414 patients was completed in February 2009. All patients will be followed-up longitudinally. Follow-up is maintained until the last enrolled patient is beyond 2.5 years of follow-up (expected in 2011).

  7. Treatment of forefoot problems in older people: study protocol for a randomised clinical trial comparing podiatric treatment to standardised shoe advice

    Directory of Open Access Journals (Sweden)

    Peeraer Louis

    2011-03-01

    Full Text Available Abstract Background Foot problems in general and forefoot problems in particular can lead to a decrease in mobility and a higher risk of falling. Forefoot problems increase with age and are more common in women than in men. Around 20% of people over 65 suffer from non-traumatic foot problems and 60% of these problems are localised in the forefoot. Little is known about the best way to treat forefoot problems in older people. The aim of this study is to compare the effects of two common modes of treatment in the Netherlands: shoe advice and podiatric treatment. This paper describes the design of this study. Methods The study is designed as a pragmatic randomised clinical trial (RCT with 2 parallel intervention groups. People aged 50 years and over who have visited their general practitioner (GP with non traumatic pain in the forefoot in the preceding year and those who will visit their GP during the recruitment period with a similar complaint will be recruited for this study. Participants must be able to walk unaided for 7 metres and be able to fill in questionnaires. Exclusion criteria are: rheumatoid arthritis, neuropathy of the foot or pain caused by skin problems (e.g. warts, eczema. Inclusion and exclusion criteria will be assessed by a screening questionnaire and baseline assessment. Those consenting to participation will be randomly assigned to either a group receiving a standardised shoe advice leaflet (n = 100 or a group receiving podiatric treatment (n = 100. Primary outcomes will be the severity of forefoot pain (0-10 on a numerical rating scale and foot function (Foot Function 5-pts Index and Manchester Foot Pain and Disability Index. Treatment adherence, social participation and quality of life will be the secondary outcomes. All outcomes will be obtained through self-administered questionnaires at the start of the study and after 3, 6, 9 and 12 months. Data will be analysed according to the "intention-to-treat" principle using

  8. Nutritional support of bone marrow transplant recipients: a prospective, randomized clinical trial comparing total parental nutrition to an enteral feeding program

    International Nuclear Information System (INIS)

    Szeluga, D.J.

    1985-01-01

    Allogeneic and autologous bone marrow transplantation (BMT) have been associated with nutritionally-depleting side effects. Total parental nutrition (TPN) has become the standard, but it has not been demonstrated that TPN is the appropriate method of nutritional support. Therefore, in a prospective, randomized clinical trial TPN and enteral feeding were compared for their effectiveness in maintaining the nutritional status of patients through the first 29 post-transplant days. Nutritional assessment included measurement of serum proteins, body weight, anthropometry and isotope dilution analysis of body composition. Total body water (TBW) and extracellular fluid (ECF) were quantified by standard radioisotope dilution techniques using tritiated water and 169 ytterbium-diethylenetriaminepentaacetate, respectively as the tracers. Consenting patients 10-58 years of age were stratified by type of BMT (autologous or allogeneic) and randomized to either TPN plus ad libitum oral feeding or the individualized enteral feeding program (EFP), which included one-on-one counseling, meal-by-meal menu selection, special snacks and tube feeding. There were no differences in the rate of hematologic recovery, incidence of graft-versus-host disease, organ toxicity, length of hospitalization or survival. Therefore, the observed changes in body composition were not clinically significant. Even allowing for increased dietary service, the EFP was only half as expensive as TPN. It was concluded that TPN is not superior to the EFP and therefore, TPN should be reserved for patients who demonstrate intolerance to enteral feeding

  9. THE ROLE OF INTERFERON PREPARATIONS IN THE TREATMENT OF ACUTE VIRAL RESPIRATORY INFECTIONS IN INFANTS, BABIES AND TODDLERS (RESULTS OF A MULTICENTER COMPARATIVE RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    L.V. Feklisova

    2011-01-01

    Full Text Available The paper analyzes the results of a comparative clinical trial of drugs recombinant human interferon alpha-2b in the dosage form of suppositories for their use in the treatment of ARVI in infants, babies and toddlers age. In accordance to the selection criteria 100 children who were hospitalized, aged from 6 months to 3 years with clinically diagnosed ARVI were included in the study. Two study groups were formed: basic, which patients within 5 days received suppositories containing taurine and interferon alpha (125,000 IU,  and the comparison group, where patients received suppositories with interferon (150,000 IU. The patients of both groups were subjects of medical observation for 5 days with an estimate of the effectiveness of treatment on the 6th day of therapy. The eliminating activity of the exploring drugs was determined using standard laboratory techniques (PCR or DFA scrapings from the nasopharynx. The study established the high effectiveness and wide safety profile of both drugs. No cases of the adverse events that have established link with the study medications. Key words: influenza, ARVI, recombinant human interferon alpha-2b, taurine, suppositories, children. (Pediatric Pharmacology. — 2011; 8 (5: 76–82.

  10. The effects of elastic tubing-based resistance training compared with conventional resistance training in patients with moderate chronic obstructive pulmonary disease: a randomized clinical trial.

    Science.gov (United States)

    Ramos, Ercy Mara Cipulo; de Toledo-Arruda, Alessandra Choqueta; Fosco, Luciana Cristina; Bonfim, Rafaela; Bertolini, Giovana Navarro; Guarnier, Flavia Alessandra; Cecchini, Rubens; Pastre, Carlos Marcelo; Langer, Daniel; Gosselink, Rik; Ramos, Dionei

    2014-11-01

    To investigate the effects of elastic tubing training compared with conventional resistance training on the improvement of functional exercise capacity, muscle strength, fat-free mass, and systemic inflammation in patients with chronic obstructive pulmonary disease. A prospective, randomized, eight-week clinical trial. The study was conducted in a university-based, outpatient, physical therapy clinic. A total of 49 patients with moderate chronic obstructive pulmonary disease. Participants were randomly assigned to perform elastic tubing training or conventional resistance training three times per week for eight weeks. The primary outcome measure was functional exercise capacity. The secondary outcome measures were peripheral muscle strength, health-related quality of life assessed by the Chronic Respiratory Disease Questionnaire (CRDQ), fat-free mass, and cytokine profile. After eight weeks, the mean distance covered during six minutes increased by 73 meters (±69) in the elastic tubing group and by 42 meters (±59) in the conventional group (p tubing training had a greater effect on functional exercise capacity than conventional resistance training. Both interventions were equally effective in improving muscle strength and quality of life. © The Author(s) 2014.

  11. Bright light in elderly subjects with nonseasonal major depressive disorder: a double blind randomised clinical trial using early morning bright blue light comparing dim red light treatment

    Directory of Open Access Journals (Sweden)

    van Someren Eus JW

    2008-07-01

    Full Text Available Abstract Background Depression frequently occurs in the elderly. Its cause is largely unknown, but several studies point to disturbances of biological rhythmicity. In both normal aging, and depression, the functioning of the suprachiasmatic nucleus (SCN is impaired, as evidenced by an increased prevalence of day-night rhythm perturbations, such as sleeping disorders. Moreover, the inhibitory SCN neurons on the hypothalamus-pituitary adrenocortical axis (HPA-axis have decreased activity and HPA-activity is enhanced, when compared to non-depressed elderly. Using bright light therapy (BLT the SCN can be stimulated. In addition, the beneficial effects of BLT on seasonal depression are well accepted. BLT is a potentially safe, nonexpensive and well accepted treatment option. But the current literature on BLT for depression is inconclusive. Methods/Design This study aims to show whether BLT can reduce non-seasonal major depression in elderly patients. Randomized double blind placebo controlled trial in 126 subjects of 60 years and older with a diagnosis of major depressive disorder (MDD, DSM-IV/SCID-I. Subjects are recruited through referrals of psychiatric outpatient clinics and from case finding from databases of general practitioners and old-people homes in the Amsterdam region. After inclusion subjects are randomly allocated to the active (bright blue light vs. placebo (dim red light condition using two Philips Bright Light Energy boxes type HF 3304 per subject, from which the light bulbs have been covered with bright blue- or dim red light- permitting filters. Patients will be stratified by use of antidepressants. Prior to treatment a one-week period without light treatment will be used. At three time points several endocrinological, psychophysiological, psychometrically, neuropsychological measures are performed: just before the start of light therapy, after completion of three weeks therapy period, and three weeks thereafter. Discussion If BLT

  12. Comparison of fractional microneedling radiofrequency and bipolar radiofrequency on acne and acne scar and investigation of mechanism: comparative randomized controlled clinical trial.

    Science.gov (United States)

    Min, Seonguk; Park, Seon Yong; Yoon, Ji Young; Suh, Dae Hun

    2015-12-01

    Fractional microneedling radiofrequency (FMR) is one of the promising methods in acne treatment. Moreover, bipolar radiofrequency (BR) generates heat thereby which induces neocollagenosis. FMR may have the potential to be a safe and effective treatment for the patients both with acne and acne scar. This study was performed to compare the efficacy and safety of FMR and BR in acne and acne scar treatment. Furthermore, mechanism of the FMR treatment was investigated through skin tissues obtained from subjects. Twenty subjects with mild-to-moderate acne and acne scars were treated in a split-face manner with FMR and BR. Two sessions of treatment was done 4 weeks apart in a total 12-week prospective single-blind, randomized clinical trial. Clinical assessment and sebum measurement were carried out for the evaluation of efficacy and safety. Skin tissues were acquired for investigation of molecular changes. FMR was more effective for acne scar especially in icepick and boxcar scar compared to BR. Both inflammatory and non-inflammatory acne lesions decreased by 80 and 65 % in the FMR-treated side at the final visit of 12 weeks, respectively. FMR treatment resulted in significant reduction of sebum excretion. Both treatments showed no severe adverse effects other than erythema. The FMR showed superior efficacy in acne and acne scar compared with BR. Increased expression of TGFβ and collagen I and decreased expression of NF-κB, IL-8 are suggested to involve in the improvement of acne scar and acne lesion by FMR.

  13. Pediatric Obstructive Uropathy: Clinical Trials

    International Nuclear Information System (INIS)

    Chan, C. M. C.; Scheinman, J. I.; Roth, K. S.

    2005-01-01

    As the powerful tools of molecular biology continue to delineate new concepts of pathogenesis of diseases, new molecular-level therapeutic modalities are certain to emerge. In order to design and execute clinical trials to evaluate outcomes of these new treatment modalities, we will soon need a new supply of investigators with training and experience in clinical research. The slowly-progressive nature of chronic pediatric kidney disease often results in diagnosis being made at a time remote from initial result, and the inherently slow rate of progression makes changes difficult to measure. Thus, development of molecular markers for both diagnosis and rate of progression will be critical to studies of new therapeutic modalities. We will review general aspects of clinical trials and will use current and past studies as examples to illustrate specific points, especially as these apply to chronic kidney disease associated with obstructive uropathy in children. (author)

  14. A randomized clinical trial to compare the immediate effects of seated thoracic manipulation and targeted supine thoracic manipulation on cervical spine flexion range of motion and pain.

    Science.gov (United States)

    Karas, Steve; Olson Hunt, Megan J

    2014-05-01

    Randomized clinical trial. To determine the effectiveness of seated thoracic manipulation versus targeted supine thoracic manipulation on cervical spine pain and flexion range of motion (ROM). There is evidence that thoracic spine manipulation is an effective treatment for patients with cervical spine pain. This evidence includes a variety of techniques to manipulate the thoracic spine. Although each of them is effective, no research has compared techniques to determine which produces the best outcomes. A total of 39 patients with cervical spine pain were randomly assigned to either a seated thoracic manipulation or targeted supine thoracic manipulation group. Pain and flexion ROM measures were taken before and after the intervention. Pain reduction (post-treatment-pre-treatment) was significantly greater in those patients receiving the targeted supine thoracic manipulation compared to the seated thoracic manipulation (Pmanipulation group. The results of this study indicate that a targeted supine thoracic manipulation may be more effective in reducing cervical spine pain and improving cervical flexion ROM than a seated thoracic manipulation. Future studies should include a variety of patients and physical therapists (PTs) to validate our findings.

  15. A randomized, multi-center, clinical trial to assess the efficacy and safety of alginate carboxymethylcellulose hyaluronic acid compared to carboxymethylcellulose hyaluronic acid to prevent postoperative intrauterine adhesion.

    Science.gov (United States)

    Kim, Tak; Ahn, Ki Hoon; Choi, Doo Seok; Hwang, Kyung Joo; Lee, Byoung Ick; Jung, Min Hyung; Kim, Jae Weon; Kim, Jong Hyuk; Cha, Sun Hee; Lee, Ki Hwan; Lee, Kyu Sup; Oh, Sung Tack; Cho, Chi Heum; Rhee, Jeong Ho

    2012-01-01

    To estimate the efficacy of alginate carboxymethylcellulose hyaluronic acid (ACH) gel to prevent intrauterine adhesions after hysteroscopic surgery in comparison with carboxymethylcellulose hyaluronic acid (CH) gel, which is known as an effective adhesion inhibitor. Randomized, multicenter, single-blind, clinical trial (Canadian Task Force classification I). Tertiary university hospital. One hundred eighty-seven patients with a surgically treatable intrauterine lesion (myomas, polyps, septa, intrauterine adhesion, dysfunctional uterine bleeding). Patients were randomized to 2 groups: hysteroscopic surgery plus intrauterine application of ACH or CH. The rate of adhesion formation and the adhesion severity score with type and extent were calculated 4 weeks after surgery. The ACH group had results that were comparable to the CH group in terms of the development of intrauterine adhesions at 4 weeks follow-up. The adhesion severities were not different between the 2 groups. In a subgroup without baseline intrauterine adhesion, the ACH group showed a lower intrauterine adhesion rate than the CH group (p = .016). ACH had a comparable efficacy to CH in terms of the adhesion rate and severity. In the case of no baseline intrauterine adhesion, intrauterine application of ACH after hysteroscopic surgery had a lower rate of intrauterine adhesion than application of CH. Copyright © 2012 AAGL. Published by Elsevier Inc. All rights reserved.

  16. The Effectiveness of the Comprehensive Voice Rehabilitation Program Compared With the Vocal Function Exercises Method in Behavioral Dysphonia: A Randomized Clinical Trial.

    Science.gov (United States)

    Pedrosa, Vanessa; Pontes, Antônio; Pontes, Paulo; Behlau, Mara; Peccin, Stella Maria

    2016-05-01

    To evaluate the effectiveness of the Comprehensive Voice Rehabilitation Program (CVRP) compared with Vocal Function Exercises (VFEs) to treat functional dysphonia. This is a randomized blinded clinical trial. Eighty voice professionals presented with voice complaints for more than 6 months with a functional dysphonia diagnosis. Subjects were randomized into two voice treatment groups: CVRP and VFE. The rehabilitation program consisted of six voice treatment sessions and three assessment sessions performed before, immediately after, and 1 month after treatment. The outcome measures were self-assessment protocols (Voice-Related Quality of Life [V-RQOL] and Voice Handicap Index [VHI]), perceptual evaluation of vocal quality, and a visual examination of the larynx, both blinded. The randomization process produced comparable groups in terms of age, gender, signs, and symptoms. Both groups had positive outcome measures. The CVRP effect size was 1.09 for the V-RQOL, 1.17 for the VHI, 0.79 for vocal perceptual evaluation, and 1.01 for larynx visual examination. The VFE effect size was 0.86 for the V-RQOL, 0.62 for the VHI, 0.48 for the vocal perceptual evaluation, and 0.51 for larynx visual examination. Only 10% of the patients were lost over the study. Both treatment programs were effective. The probability of a patient improving because of the CVRP treatment was similar to that of the VFE treatment. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  17. Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Hila Hajizadeh

    2017-07-01

    Full Text Available Objectives This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS after periodontal surgery. Materials and Methods Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil S3 Bond (Kuraray Dental, G2: Gluma Desensitizer (Heraeus Kulzer, and G3: placebo (water. The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0, 1 day after treatment (T1, after 1 week (T2, and after 1 month (T3 according to visual analog scale (VAS. Results Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Conclusions Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil S3 Bond can have some benefits.

  18. Tissue welding tonsillectomy provides an enhanced recovery compared to that after monopolar electrocautery technique in adults: a prospective randomized clinical trial.

    Science.gov (United States)

    Silvola, Juha; Salonen, Aarre; Nieminen, Jouko; Kokki, Hannu

    2011-02-01

    We have compared tonsillectomy (TE) with tissue welding (TW) technology using a specially designed forceps versus conventional monopolar electrocautery to evaluate whether this new technology may improve recovery after TE. This was a single-blind, randomized clinical trial with two parallel groups. Sixty healthy adult day-surgery patients were allocated into the TW-TE group (n = 31) and the monopolar electrocautery-TE group (n = 29). We recorded intraoperative events and short- and long-term recovery for 2 weeks postoperatively. The patients and study nurses evaluating patients during recovery were blinded to the operation method used. All patients in the TW-TE group completed the study as per protocol, but in the monopolar electrocautery-TE group, there was one drop-out in the hospital and another after discharge. There was no difference in the perioperative parameters and early recovery between the two groups. After discharge, recovery was significantly faster in the TW group than in the monopolar group: (1) the duration of postoperative pain was 2 days shorter, and (2) activities of normal daily living were less affected, and (3) the need for hospital contacts after discharge, and (4) the incidence of postoperative bleeding was less in the TW group than that in the monopolar group. No patients in the TW group developed secondary bleeding versus three patients in the monopolar group requiring electrocautery to control bleeding. In conclusion; our results indicate that, TW technique may provide reduced pain, faster recovery, and fewer complications compared to electrocautery TE.

  19. A self-controlled comparative clinical trial to explore the effectiveness of three topical hemostatic agents for stopping severe epistaxis in pediatrics with inherited coagulopathies.

    Science.gov (United States)

    Eshghi, P; Jenabzade, A; Habibpanah, B

    2014-09-01

    The aim of this study was to assess the effectiveness of localized treatments to persistently stop epistaxis in patients with inherited bleeding disorders. In a self-controlled comparative clinical trial, to offer the best solution to stop epistaxis at home (within 10 minutes), patients with inherited bleeding disorders were treated using three different topical hemostatic agents, including Tranexamic acid impregnated tampon, EpiCell tampon prepared from oxidized regenerated cellulose pad, and ChitoHem tampon (reinforced with chitosan). The results of using these different products on three groups of randomly selected patients were ultimately compared using the χ(2) and Fisher's exact test statistics. A total of 31 patients, 5 females and 26 males with a mean age of 5.6 years, were included in the study. Twenty-three patients had Glanzmann disease, four had von-Willebrand disease, two had Bernard soulier syndrome, two had activated factor VII deficiency, and one patient had impaired secretion of adenosine deaminase. The study exhibited that statistically there was no significant difference between EpiCell tampon and Tranexamic acid impregnated tampon treatments with respect to the hemostasis duration. However, ChitoHem tampon was more efficient than Tranexamic acid impregnated tampon (P value stop epistaxis. We recommend further research on the use of other hemostatic agents for localized bleeding in patients with inherited bleeding disorders.

  20. A preliminary randomized clinical trial comparing diode laser and scalpel periosteal incision during implant surgery: impact on postoperative morbidity and implant survival.

    Science.gov (United States)

    Shahnaz, Aysan; Jamali, Raika; Mohammadi, Farnush; Khorsand, Afshin; Moslemi, Neda; Fekrazad, Reza

    2018-01-01

    The aim of this preliminary randomized clinical trial was to compare: (1) post-operative morbidity after application of laser or scalpel incision for flap advancement during implant surgery and bone grafting and (2) implant survival rate following flap advancement with laser or scalpel incision after 6 months of loading. Eighteen patients who were scheduled for dental implant placement and simultaneous bone grafting were randomly assigned to test or control groups. Diode laser (810 nm, 2 W, pulse interval 200 μs; pulse length 100 μs, 400-μm initiated fiber tip), or scalpel (control) was used to sever the periosteum to create a tension-free flap. Visual analogue scale (VAS) pain score, rate of nonsteroid anti-inflammatory drug (NSAID) consumption, intensity of swelling, and ecchymosis were measured for the six postsurgical days. Six months after loading, implant survival was assessed. VAS pain score (during the first four postoperative days), rate of NSAID consumption (during the first three postoperative days), and intensity of swelling (during the first five postoperative days) were significantly lower in the test group compared to the control group (All P values laser for performing periosteal releasing incision reduced the incidence and severity of postoperative morbidity of the patients undergone implant surgery in conjunction with bone augmentation procedure. We did not find any detrimental effect of laser incision on the implant survival within 6 months of loading.

  1. Comparative clinical effectiveness and cost effectiveness of endovascular strategy v open repair for ruptured abdominal aortic aneurysm: three year results of the IMPROVE randomised trial.

    Science.gov (United States)

    2017-11-14

    gain in average quality adjusted life years (QALYs) at three years of 0.17 (95% confidence interval 0.00 to 0.33). The endovascular strategy group spent fewer days in hospital and had lower average costs of -£2605 (95% confidence interval -£5966 to £702) (about €2813; $3439). The probability that the endovascular strategy is cost effective was >90% at all levels of willingness to pay for a QALY gain. Conclusions  At three years, compared with open repair, an endovascular strategy for suspected ruptured abdominal aortic aneurysm was associated with a survival advantage, a gain in QALYs, similar levels of reintervention, and reduced costs, and this strategy was cost effective. These findings support the increasing use of an endovascular strategy, with wider availability of emergency endovascular repair. Trial registration  Current Controlled Trials ISRCTN48334791; ClinicalTrials NCT00746122. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  2. Comparative evaluation of effectiveness of intra-pocket anesthetic gel and injected local anesthesia during scaling and root planing – A split-mouth clinical trial

    Directory of Open Access Journals (Sweden)

    Kalyan Chintala

    2017-01-01

    Full Text Available Background and Aim: Pain control is an important outcome measure for successful periodontal therapy. Injected local anesthesia has been used to secure anesthesia for scaling and root planing (SRP and continues to be the anesthetic of choice for pain control. Alternatively, intra-pocket anesthetic gel has been used as an anesthetic during SRP. Hence, this clinical trial was done to compare the effectiveness of intra-pocket anesthetic gel and injected local anesthesia during SRP and also to assess the influence of intra-pocket anesthetic gel on treatment outcomes in chronic periodontitis patients. Materials and Methods: Fifteen systemically healthy chronic periodontitis patients were recruited. The dental quadrants on right side received either intra-pocket 20% benzocaine gel (Gel group or infiltration/block by 2% lidocaine with 1:80,000 adrenaline (injection group. Quadrants on the left side received the alternative. Pain perception and patients preference for the type of anesthesia was recorded. Clinical parameters: plaque index, modified gingival index, modified sulcular bleeding index, probing pocket depth, and clinical attachment level were recorded at baseline and 1 month after treatment. Results: No difference was observed in visual analog scale (P > 0.05 and verbal rating scale (P > 0.05 pain perception between gel group and injection group. A slightly increased preference to gel as anesthesia (53% vs. 47% was observed. The treatment outcome after SRP did not show a significant difference between gel and injection group (P > 0.05. Conclusion: Intra-pocket administration of 20% benzocaine gel may be effective for pain control during SRP and may offer an alternative to conventional injection anesthesia.

  3. A randomized, clinical trial of education or motivational-interviewing-based coaching compared to usual care to improve cancer pain management.

    Science.gov (United States)

    Thomas, Mary Laudon; Elliott, Janette E; Rao, Stephen M; Fahey, Kathleen F; Paul, Steven M; Miaskowski, Christine

    2012-01-01

    To test the effectiveness of two interventions compared to usual care in decreasing attitudinal barriers to cancer pain management, decreasing pain intensity, and improving functional status and quality of life (QOL). Randomized clinical trial. Six outpatient oncology clinics (three Veterans Affairs [VA] facilities, one county hospital, and one community-based practice in California, and one VA clinic in New Jersey)Sample: 318 adults with various types of cancer-related pain. Patients were randomly assigned to one of three groups: control, standardized education, or coaching. Patients in the education and coaching groups viewed a video and received a pamphlet on managing cancer pain. In addition, patients in the coaching group participated in four telephone sessions with an advanced practice nurse interventionist using motivational interviewing techniques to decrease attitudinal barriers to cancer pain management. Questionnaires were completed at baseline and six weeks after the final telephone calls. Analysis of covariance was used to evaluate for differences in study outcomes among the three groups. Pain intensity, pain relief, pain interference, attitudinal barriers, functional status, and QOL. Attitudinal barrier scores did not change over time among groups. Patients randomized to the coaching group reported significant improvement in their ratings of pain-related interference with function, as well as general health, vitality, and mental health. Although additional evaluation is needed, coaching may be a useful strategy to help patients decrease attitudinal barriers toward cancer pain management and to better manage their cancer pain. By using motivational interviewing techniques, advanced practice oncology nurses can help patients develop an appropriate plan of care to decrease pain and other symptoms.

  4. Implant Mandibular Overdentures Retained by Immediately Loaded Implants: A 1-Year Randomized Trial Comparing the Clinical and Radiographic Outcomes Between Mini Dental Implants and Standard-Sized Implants.

    Science.gov (United States)

    Zygogiannis, Kostas; Aartman, Irene Ha; Parsa, Azin; Tahmaseb, Ali; Wismeijer, Daniel

    The aim of this 1-year randomized trial was to evaluate and compare the clinical and radiographic performance of four immediately loaded mini dental implants (MDIs) and two immediately loaded standard-sized tissue-level (STL) implants, placed in the interforaminal region of the mandible and used to retain mandibular overdentures (IODs) in completely edentulous patients. A total of 50 completely edentulous patients wearing conventional maxillary dentures and complaining about insufficient retention of their mandibular dentures were divided into two groups; 25 patients received four MDIs and 25 patients received two STL implants. The marginal bone loss (MBL) at the mesial and distal sides of each implant was assessed by means of standardized intraoral radiographs after a period of 1 year. Implant success and survival rates were also calculated. Immediate loading was possible for all patients in the first group. In the second group, an immediate loading protocol could not be applied for 10 patients. These patients were treated with a delayed loading protocol. A mean MBL of 0.42 ± 0.56 mm for the MDIs and 0.54 ± 0.49 mm for the immediately loaded STL implants was recorded at the end of the evaluation period. There was no statistically significant difference between the MDIs and the immediately loaded STL implants. Two MDIs failed, resulting in a survival rate of 98%. The success rate was 91%. For the immediately loaded conventional implants, the survival rate was 100% and the success rate 96.7% after 1 year of function. However, in 10 patients, the immediate loading protocol could not be followed. Considering the limitations of this short-term clinical study, immediate loading of four unsplinted MDIs or two splinted STL implants to retain mandibular overdentures seems to be a feasible treatment option. The marginal bone level changes around the MDIs were well within the clinically acceptable range.

  5. Industry funded clinical trials: bias and quality.

    Science.gov (United States)

    Del Parigi, Angelo

    2012-01-01

    The quality of the clinical data supporting the development and ultimately the approval for medical use of new drugs is often challenged. Many share the perception that the business goals of the pharmaceutical industry overrule the best scientific efforts to accrue critical knowledge on a new molecule, in order to inform investment of resources, regulatory approvals and appropriate use by patients. Despite this common belief, few scientists have attempted to assess objectively the quality of industry funded (IF) clinical trials by measuring it and comparing it with non-industry funded (NIF) clinical trials in a data-driven fashion. Overall, the average quality of IF clinical research has been reported to be higher than the quality of NIF clinical research.

  6. A Phase III, Multicenter, Parallel-Design Clinical Trial to Compare the Efficacy and Safety of 5% Minoxidil Foam Versus Vehicle in Women With Female Pattern Hair Loss.

    Science.gov (United States)

    Bergfeld, Wilma; Washenik, Ken; Callender, Valerie; Zhang, Paul; Quiza, Carlos; Doshi, Uday; Blume-Peytavi, Ulrike

    2016-07-01

    BACKGROUND Female pattern hair loss (FPHL) is a common hair disorder that affects millions of women. A new 5% minoxidil topical foam (MTF) formulation, which does not contain propylene glycol, has been developed. To compare the efficacy and safety of once-daily 5% MTF with vehicle foam for the treatment of FPHL. This was a Phase III, randomized, double-blind, vehicle-controlled, parallel-group, international multicenter trial (17 sites) in women aged at least 18 years with FPHL (grade D3 to D6 on the Savin Density Scale), treated once daily with 5% MTF or vehicle foam for 24 weeks. The co-primary efficacy endpoints were the change from baseline at week 24 in target area hair count (TAHC) and subject assessment of scalp coverage. Also evaluated were TAHC at week 12, expert panel review of hair regrowth at week 24, and change from baseline in total unit area density (TUAD, sum of hair diameters/cm2) at weeks 12 and 24. A total of 404 women were enrolled. At 12 and 24 weeks, 5% MTF treatment resulted in regrowth of 10.9 hairs/cm2 and 9.1 hairs/cm2 more than vehicle foam, respectively (both P<.0001). Improved scalp coverage at week 24 was observed by both subject self-assessment (0.69-point improvement over vehicle foam; P<.0001) and expert panel review (0.36-point improvement over the vehicle foam; P<.0001). TUAD increased by 658 μm/cm2 and 644 μm/cm2 more with 5% MTF than with vehicle foam at weeks 12 and 24, respectively (both P<.0001). MTF was well tolerated. A low incidence of scalp irritation and facial hypertrichosis was observed, with no clinically significant differences between groups. Five percent MTF once daily for 24 weeks was well tolerated and promoted hair regrowth in women with FPHL, resulting in improved scalp coverage and increased hair density compared with vehicle foam. ClinicalTrials.gov identifier: nCT01226459J Drugs Dermatol. 2016;15(7):874-881.

  7. Results of a multicentric in silico clinical trial (ROCOCO): comparing radiotherapy with photons and protons for non-small cell lung cancer.

    Science.gov (United States)

    Roelofs, Erik; Engelsman, Martijn; Rasch, Coen; Persoon, Lucas; Qamhiyeh, Sima; de Ruysscher, Dirk; Verhaegen, Frank; Pijls-Johannesma, Madelon; Lambin, Philippe

    2012-01-01

    This multicentric in silico trial compares photon and proton radiotherapy for non-small cell lung cancer patients. The hypothesis is that proton radiotherapy decreases the dose and the volume of irradiated normal tissues even when escalating to the maximum tolerable dose of one or more of the organs at risk (OAR). Twenty-five patients, stage IA-IIIB, were prospectively included. On 4D F18-labeled fluorodeoxyglucose-positron emission tomography-computed tomography scans, the gross tumor, clinical and planning target volumes, and OAR were delineated. Three-dimensional conformal radiotherapy (3DCRT) and intensity-modulated radiotherapy (IMRT) photon and passive scattered conformal proton therapy (PSPT) plans were created to give 70 Gy to the tumor in 35 fractions. Dose (de-)escalation was performed by rescaling to the maximum tolerable dose. Protons resulted in the lowest dose to the OAR, while keeping the dose to the target at 70 Gy. The integral dose (ID) was higher for 3DCRT (59%) and IMRT (43%) than for PSPT. The mean lung dose reduced from 18.9 Gy for 3DCRT and 16.4 Gy for IMRT to 13.5 Gy for PSPT. For 10 patients, escalation to 87 Gy was possible for all 3 modalities. The mean lung dose and ID were 40 and 65% higher for photons than for protons, respectively. The treatment planning results of the Radiation Oncology Collaborative Comparison trial show a reduction of ID and the dose to the OAR when treating with protons instead of photons, even with dose escalation. This shows that PSPT is able to give a high tumor dose, while keeping the OAR dose lower than with the photon modalities.

  8. Omega-3 supplementation effects on body weight and depression among dieter women with co-morbidity of depression and obesity compared with the placebo: A randomized clinical trial.

    Science.gov (United States)

    Keshavarz, Seyed Ali; Mostafavi, Seyed-Ali; Akhondzadeh, Shahin; Mohammadi, Mohammad Reza; Hosseini, Saeed; Eshraghian, Mohammad Reza; Chamari, Maryam

    2018-06-01

    We aimed to evaluate the effects of the omega-3 supplementation on body weight and depression among women with co-morbidity of depression and obesity seeking weight reduction compared with the placebo. Sixty five patients with co-morbidity of depression and overweight/obesity (BMI ≥ 25) signed the informed consent form and enrolled into this 12-week double-blind, placebo-controlled randomized clinical Trial. Subsequently, participants randomly assigned into one of the two groups receiving daily 6 capsules of omega-3 (each capsule containing 180 mg EPA, and 120 mg DHA) or 6 capsules of placebo (two with each meal). We performed body composition assessments and Beck depression inventory at the baseline, and weeks 2, 4, 8, and 12 after the start of the study. One month after stopping the capsules at the follow-up visit, weight was measured to compare weight relapse between the two groups. Forty five patients finished the study. No significant differences were seen between groups regarding demographic and clinical variables at baseline. Using repeated measures ANOVA, omega-3 significantly reduced depression compared with the placebo (P = 0.05). Mean ± SD weight reduction in omega-3 group 3.07 ± 3.4 kg and in the placebo group was 1.16 ± 2.7 kg and the difference between groups was significant using independent sample t-test (p = 0.049). Patients in the omega-3 group did not show significantly more side effects compared to the placebo but they were not successful in preventing weight regain one month after the end of the study. Based on our findings omega-3 capsule as a safe over-the-counter supplement might be helpful in reducing the signs of depression and also body weight in patients with co-morbidity of depression and obesity. Copyright © 2018 European Society for Clinical Nutrition and Metabolism. Published by Elsevier Ltd. All rights reserved.

  9. A randomized clinical trial comparing cervical dysplasia treatment with cryotherapy vs loop electrosurgical excision procedure in HIV-seropositive women from Johannesburg, South Africa.

    Science.gov (United States)

    Smith, Jennifer S; Sanusi, Busola; Swarts, Avril; Faesen, Mark; Levin, Simon; Goeieman, Bridgette; Ramotshela, Sibongile; Rakhombe, Ntombiyenkosi; Williamson, Anna L; Michelow, Pam; Omar, Tanvier; Hudgens, Michael G; Firnhaber, Cynthia

    2017-08-01

    Mortality associated with cervical cancer is a public health concern for women, particularly in HIV-seropositive women in resource-limited countries. HIV-seropositive women are at a higher risk of high-grade cervical precancer, which can eventually progress to invasive carcinoma as compared to HIV-seronegative women. It is imperative to identify effective treatment methods for high-grade cervical precursors among HIV-seropositive women. Randomized controlled trial data are needed comparing cryotherapy vs loop electrosurgical excision procedure treatment efficacy in HIV-seropositive women. Our primary aim was to compare the difference in the efficacy of loop electrosurgical excision procedure vs cryotherapy for the treatment of high-grade cervical intraepithelial neoplasia (grade ≥2) among HIV-seropositive women by conducting a randomized clinical trial. HIV-seropositive women (n = 166) aged 18-65 years with histology-proven cervical intraepithelial neoplasia grade ≥2 were randomized (1:1) to cryotherapy or loop electrosurgical excision procedure treatment at a government hospital in Johannesburg. Treatment efficacy was compared using 6- and 12-month cumulative incidence posttreatment of: (1) cervical intraepithelial neoplasia grade ≥2; (2) secondary endpoints of histologic cervical intraepithelial neoplasia grade ≥3 and grade ≥1; and (3) high-grade and low-grade cervical cytology. The study was registered (ClinicalTrials.govNCT01723956). From January 2010 through August 2014, 166 participants were randomized (86 loop electrosurgical excision procedure; 80 cryotherapy). Cumulative cervical intraepithelial neoplasia grade ≥2 incidence was higher for cryotherapy (24.3%; 95% confidence interval, 16.1-35.8) than loop electrosurgical excision procedure at 6 months (10.8%; 95% confidence interval, 5.7-19.8) (P = .02), although by 12 months, the difference was not significant (27.2%; 95% confidence interval, 18.5-38.9 vs 18.5%; 95% confidence interval, 11

  10. Clinical Trials in Noninfectious Uveitis

    Science.gov (United States)

    Kim, Jane S.; Knickelbein, Jared E.; Nussenblatt, Robert B.; Sen, H. Nida

    2015-01-01

    The treatment of noninfectious uveitis continues to remain a challenge for many ophthalmologists. Historically, clinical trials in uveitis have been sparse, and thus, most treatment decisions have largely been based on clinical experience and consensus guidelines. The current treatment paradigm favors initiation then tapering of corticosteroids with addition of steroid-sparing immunosuppressive agents for persistence or recurrence of disease. Unfortunately, in spite of a multitude of highly unfavorable systemic effects, corticosteroids are still regarded as the mainstay of treatment for many patients with chronic and refractory noninfectious uveitis. However, with the success of other conventional and biologic immunomodulatory agents in treating systemic inflammatory and autoimmune conditions, interest in targeted treatment strategies for uveitis has been renewed. Multiple clinical trials on steroid-sparing immunosuppressive agents, biologic agents, intraocular corticosteroid implants, and topical ophthalmic solutions have already been completed, and many more are ongoing. This review discusses the results and implications of these clinical trials investigating both alternative and novel treatment options for noninfectious uveitis. PMID:26035763

  11. Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial.

    Science.gov (United States)

    Mackillop, Lucy; Hirst, Jane Elizabeth; Bartlett, Katy Jane; Birks, Jacqueline Susan; Clifton, Lei; Farmer, Andrew J; Gibson, Oliver; Kenworthy, Yvonne; Levy, Jonathan Cummings; Loerup, Lise; Rivero-Arias, Oliver; Ming, Wai-Kit; Velardo, Carmelo; Tarassenko, Lionel

    2018-03-20

    Treatment of hyperglycemia in women with gestational diabetes mellitus (GDM) is associated with improved maternal and neonatal outcomes and requires intensive clinical input. This is currently achieved by hospital clinic attendance every 2 to 4 weeks with limited opportunity for intervention between these visits. We conducted a randomized controlled trial to determine whether the use of a mobile phone-based real-time blood glucose management system to manage women with GDM remotely was as effective in controlling blood glucose as standard care through clinic attendance. Women with an abnormal oral glucose tolerance test before 34 completed weeks of gestation were individually randomized to a mobile phone-based blood glucose management solution (GDm-health, the intervention) or routine clinic care. The primary outcome was change in mean blood glucose in each group from recruitment to delivery, calculated with adjustments made for number of blood glucose measurements, proportion of preprandial and postprandial readings, baseline characteristics, and length of time in the study. A total of 203 women were randomized. Blood glucose data were available for 98 intervention and 85 control women. There was no significant difference in rate of change of blood glucose (-0.16 mmol/L in the intervention and -0.14 mmol/L in the control group per 28 days, P=.78). Women using the intervention had higher satisfaction with care (P=.049). Preterm birth was less common in the intervention group (5/101, 5.0% vs 13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01). There were fewer cesarean deliveries compared with vaginal deliveries in the intervention group (27/101, 26.7% vs 47/102, 46.1%, P=.005). Other glycemic, maternal, and neonatal outcomes were similar in both groups. The median time from recruitment to delivery was similar (intervention: 54 days; control: 49 days; P=.23). However, there were significantly more blood glucose readings in the intervention group (mean 3.80 [SD 1.80] and mean

  12. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial.

    Science.gov (United States)

    Hirshberg, Adi; Downes, Katheryne; Srinivas, Sindhu

    2018-04-27

    Monitoring blood pressure at 72 hours and 7-10 days post partum in women with hypertensive disorders is recommended to decrease morbidity. However, there are no recommendations as to how to achieve this. To compare the effectiveness of text-based blood pressure monitoring to in-person visits for women with hypertensive disorders of pregnancy in the immediate postpartum period. Randomised clinical trial among 206 postpartum women with pregnancy-related hypertension diagnosed during the delivery admission between August 2016 and January 2017. Women were randomised to 2 weeks of text-based surveillance using a home blood pressure cuff and previously tested automated platform or usual care blood pressure check at their prenatal clinic 4-6 days following discharge. The primary study outcome was a single recorded blood pressure in the first 10 days post partum. The ability to meet American Congress of Obstetricians and Gynecologists (ACOG) guidelines, defined as having a blood pressure recorded on postpartum days 3-4 and 7-10 was evaluated in the text message group. The study was powered to detect a 1.4-fold increase in a single recorded blood pressure using text messaging. All outcomes were analysed as intention to treat. 206 women were randomised (103 in each arm). Baseline characteristics were similar. There was a statistically significant increase in a single blood pressure obtained in the texting group in the first 10 days post partum as compared with the office group (92.2% vs 43.7%; adjusted OR 58.2 (16.2-208.1), p<0.001). Eighty-four per cent of patients undergoing text-based surveillance met ACOG criteria for blood pressures at both recommended points. Text-based monitoring is more effective in obtaining blood pressures and meeting current clinical guidelines in the immediate postdischarge period in women with pregnancy-related hypertension compared with traditional office-based follow-up. NCT03185455, Remote Surveillance of Postpartum Hypertension (Text

  13. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial.

    Science.gov (United States)

    Chanques, Gerald; Conseil, Matthieu; Roger, Claire; Constantin, Jean-Michel; Prades, Albert; Carr, Julie; Muller, Laurent; Jung, Boris; Belafia, Fouad; Cissé, Moussa; Delay, Jean-Marc; de Jong, Audrey; Lefrant, Jean-Yves; Futier, Emmanuel; Mercier, Grégoire; Molinari, Nicolas; Jaber, Samir

    2017-10-01

    Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared

  14. Comparing the effects of eccentric training with eccentric training and static stretching exercises in the treatment of patellar tendinopathy. A controlled clinical trial.

    Science.gov (United States)

    Dimitrios, Stasinopoulos; Pantelis, Manias; Kalliopi, Stasinopoulou

    2012-05-01

    The aim of the present study was to investigate the effectiveness of eccentric training and eccentric training with static stretching exercises in the management of patellar tendinopathy. Controlled clinical trial. Rheumatology and rehabilitation centre. Forty-three patients who had patellar tendinopathy for at least three months. They were allocated to two groups by alternative allocation. Group A (n = 22) was treated with eccentric training of patellar tendon and static stretching exercises of quadriceps and hamstrings and Group B (n = 21) received eccentric training of patellar tendon. All patients received five treatments per week for four weeks. Pain and function were evaluated using the VISA-P score at baseline, at the end of treatment (week 4), and six months (week 24) after the end of treatment. At the end of treatment, there was a rise in VISA-P score in both groups compared with baseline (Peccentric training and static stretching exercises produced the largest effect (PEccentric training and static stretching exercises is superior to eccentric training alone to reduce pain and improve function in patients with patellar tendinopathy at the end of the treatment and at follow-up.

  15. [A comparative study on efficacy of glucocorticoids, mineralocorticoids and vasoactive drugs on reversing hearing loss in patients suffering idiopathic sensorineural cochlear hypoacusis. A preliminary clinical trial].

    Science.gov (United States)

    Campos-Bañales, Eugenia María; López-Campos, Daniel; de Serdio-Arias, José Luis; Esteban-Rodriguez, J; García-Sáinz, Mar; Muñoz-Cortés, Álvaro; López-Aguado, Daniel

    2015-01-01

    Sensory neural hearing loss (SNHL) is a disorder characterised by an important deterioration of the auditory function. Re-establishing normal ion homeostasis of the endolymph could be related to hearing recovery and it might be mediated by mineralocorticoids. The main purpose of this preliminary, randomized controlled clinical trial was assessing the recovery of idiopathic sensory neural cochlear hearing loss (SNHL) by comparing the efficacy of 2 types of steroids versus vasodilators. The 3-month intervention involved 70 patients, allocated into 4 different groups: a control with no medication, consisting of 14 patients (8 men and 6 women); a vasodilator group of 21 patients (11 men and 10 women); a glucocorticoid group with 16 patients (10 men and 6 women); and a mineralocorticoid therapy group, consisting of 19 patients (11 men and 8 women). The level of hearing loss and its topography were estimated using Liminal Tone Audiometry (LTA) and Auditory Brainstem Response (ABR). Our research found overall greater efficacy of mineralocorticoids versus glucocorticoids and vasodilators. There was better response in women than in men and it was higher from the left ear, regardless of patient gender. The hearing gain was significantly superior in the mineralocorticoid group, followed by the glucocorticoid group. However, the responses to vasodilators were lesser and of low statistical significance. Copyright © 2014 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Patología Cérvico-Facial. All rights reserved.

  16. Long-term follow-up of a randomized clinical trial comparing Beger with pylorus-preserving Whipple procedure for chronic pancreatitis.

    Science.gov (United States)

    Müller, M W; Friess, H; Martin, D J; Hinz, U; Dahmen, R; Büchler, M W

    2008-03-01

    Duodenum-preserving pancreatic head resection according to Beger and the pylorus-preserving Whipple (ppWhipple) procedure were compared in patients with chronic pancreatitis (CP) in a randomized clinical trial. Perioperative data and short-term outcome have been reported previously. The present study evaluated long-term follow-up. Forty patients were enrolled originally, 20 in each group. Long-term follow-up included mortality, morbidity, pain status, occupational rehabilitation, quality of life (QoL), and endocrine and exocrine function at median follow-up of 7 and 14 years. One patient who had a ppWhipple procedure was lost to follow-up. There were five late deaths in each group. No differences were noted in pain status and exocrine pancreatic function. Loss of appetite was significantly worse in the ppWhipple group at 14 years' follow-up, but there were no other differences in QoL parameters examined. After 14 years, diabetes mellitus was present in seven of 15 patients who had the Beger procedure and 11 of 14 patients after ppWhipple resection (P = 0.128). After long-term follow-up of up to 14 years early advantages of the Beger procedure were no longer present. 2007 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd.

  17. Comparing Effectiveness of Mindfulness-Based Relapse Prevention with Treatment as Usual on Impulsivity and Relapse for Methadone-Treated Patients: A Randomized Clinical Trial.

    Science.gov (United States)

    Yaghubi, Mehdi; Zargar, Fatemeh; Akbari, Hossein

    2017-07-01

    Impulsivity is one of the causes of relapse that can affect treatment outcomes. Studies have shown that addiction treatments can reduce impulsivity in drug-dependent individuals. Studies also have suggested that mindfulness is associated with impulsivity. However, no study has investigated the effectiveness of the mindfulness-based intervention on impulsivity in opioid-dependent individuals. This study aimed to compare the effectiveness of mindfulness-based relapse prevention (MBRP) with treatment as usual (TAU) in terms of impulsivity and relapse for methadone-treated patients. The present randomized controlled clinical trial was performed in Kashan, Iran, in 2015. The study population was opioid-dependent patients referred to Maintenance Treatment Centers. Seventy patients were selected by random sampling and were assigned in two groups (MBRP and TAU) randomly. The participants of two groups filled out Barratt impulsivity scale (BIS-11) as a pre-test and 8 weeks later as post-test and 2 months later as a follow-up. Both groups received methadone-therapy. The MBRP group received 8 sessions of group therapy, while the control group did not receive any group psychotherapy session. Finally, data from 60 patients were analyzed statistically. The MBRP group had decreased impulsivity significantly (P relapse frequency (P relapse probability. These findings suggest that MBRP is useful for opioid-dependent individuals with high-level impulsivity, and relapse prevention.

  18. Comparing the effect of e-learning and educational booklet on the childbirth self-efficacy: a randomized controlled clinical trial.

    Science.gov (United States)

    Abbasi, Parastoo; Mohammad-Alizadeh Charandabi, Sakineh; Mirghafourvand, Mojgan

    2018-03-01

    This study aimed to compare the effect of e-learning and educational booklet on the childbirth self-efficacy (CBSE). This randomized controlled clinical trial was conducted on 153 pregnant women referred to health centers in the city of Miandoab, Iran in 2015-2016. Participants were assigned into two intervention groups (e-learning and educational booklet) and the control group. A single face-to-face session was held for intervention groups about the management of labor pain in 30-34 weeks of pregnancy and the booklet and software were provided. The CBSE questionnaire was filled out by the participants before intervention and active phase of labor at 4-5 cm dilatation of cervix. One-way ANOVA and ANCOVA test with adjusting the baseline scores were used to compare the mean score of self-efficacy among study groups respectively before and after the intervention. There was no significant difference between the three groups in terms of socio-demographic characteristics (p > 0.05). After the intervention, the mean score of the CBSE in the educational booklet group (adjusted mean difference: 113.4; confidence interval 95%: 100.7-126.1) and e-learning group (159.3; 146.5-172.0) was significantly higher than the control group. Also, the mean score of the CBSE in the e-learning group had a significant increase compared to the educational booklet group (45.9; 33.0-58.7). The results indicate that e-learning and educational booklet are effective in enhancing mothers' CBSE. Thus, the mothers are recommended to use these teaching methods.

  19. Gatekeepers for pragmatic clinical trials.

    Science.gov (United States)

    Whicher, Danielle M; Miller, Jennifer E; Dunham, Kelly M; Joffe, Steven

    2015-10-01

    To successfully implement a pragmatic clinical trial, investigators need access to numerous resources, including financial support, institutional infrastructure (e.g. clinics, facilities, staff), eligible patients, and patient data. Gatekeepers are people or entities who have the ability to allow or deny access to the resources required to support the conduct of clinical research. Based on this definition, gatekeepers relevant to the US clinical research enterprise include research sponsors, regulatory agencies, payers, health system and other organizational leadership, research team leadership, human research protections programs, advocacy and community groups, and clinicians. This article provides a framework to help guide gatekeepers' decision-making related to the use of resources for pragmatic clinical trials. Relevant ethical considerations for gatekeepers include (1) concern for the interests of individuals, groups, and communities affected by the gatekeepers' decisions, including protection from harm and maximization of benefits; (2) advancement of organizational mission and values; and (3) stewardship of financial, human, and other organizational resources. Separate from these ethical considerations, gatekeepers' actions will be guided by relevant federal, state, and local regulations. This framework also suggests that to further enhance the legitimacy of their decision-making, gatekeepers should adopt transparent processes that engage relevant stakeholders when feasible and appropriate. We apply this framework to the set of gatekeepers responsible for making decisions about resources necessary for pragmatic clinical trials in the United States, describing the relevance of the criteria in different situations and pointing out where conflicts among the criteria and relevant regulations may affect decision-making. Recognition of the complex set of considerations that should inform decision-making will guide gatekeepers in making justifiable choices regarding

  20. HIV/AIDS Clinical Trials Fact Sheet

    Science.gov (United States)

    ... AIDS Drugs Clinical Trials Apps skip to content HIV Overview Home Understanding HIV/AIDS Fact Sheets HIV/ ... 4 p.m. ET) Send us an email HIV/AIDS Clinical Trials Last Reviewed: August 25, 2017 ...

  1. NCI National Clinical Trials Network Structure

    Science.gov (United States)

    Learn about how the National Clinical Trials Network (NCTN) is structured. The NCTN is a program of the National Cancer Institute that gives funds and other support to cancer research organizations to conduct cancer clinical trials.

  2. Clinical trials in neurology: design, conduct, analysis

    National Research Council Canada - National Science Library

    Ravina, Bernard

    2012-01-01

    .... Clinical Trials in Neurology aims to improve the efficiency of clinical trials and the development of interventions in order to enhance the development of new treatments for neurologic diseases...

  3. Clinical and radiographic evaluation of Bio-Gen with biocollagen compared with Bio-Gen with connective tissue in the treatment of class II furcation defects: a randomized clinical trial

    Science.gov (United States)

    JENABIAN, Niloofar; HAGHANIFAR, Sina; MABOUDI, Avideh; BIJANI, Ali

    2013-01-01

    Objective Treatment of furcation defects are thought to be challenging. The purpose of this study was to evaluate the clinical and radiographic parameters of Bio-Gen with Biocollagen compared with Bio-Gen with connective tissue in the treatment of Class II furcation defects. Material and Methods In this clinical trial, 24 patients with Class II furcation defect on a buccal or lingual mandibular molar were recruited. After oral hygiene instruction, scaling and root planing and achievement of acceptable plaque control, the patients were randomly chosen to receive either connective tissue and Bio-Gen (case group) or Biocollagen and Bio-Gen (control group). The following parameters were recorded before the first and re-entry surgery (six months later): vertical clinical attachment level (VCAL), gingival index (GI), plaque index (PI), horizontal probing depth (HPD), vertical probing depth (VPD), gingival recession (GR), furcation vertical component (FVC), furcation to alveolar crest (FAC), fornix to base of defect (FBD), and furcation horizontal component (FHC) were calculated at the time of first surgery and during re-entry. A digital periapical radiograph was taken in parallel before first surgery and re-entry. The radiographs were then analyzed by digital subtraction. The differences with p value <0.05 were considered significant. Results Only the mean changes of FAC, FHC, mean of FHC, FBD in re-entry revealed statistically significant differences between the two groups. HPD, VPD, FBD, FAC, and FHC showed statistically significant differences after 6 months in the case group. However, in the control group, statistically significant differences were found in GR and HPD. We did not observe any significant difference in radiographic changes among the two groups. Conclusion The results of this trial indicate that better clinical outcomes can be obtained with connective tissue grafts in combination with bone material compared with a resorbable barrier with bone material

  4. Clinical and radiographic evaluation of Bio-Gen with biocollagen compared with Bio-Gen with connective tissue in the treatment of class II furcation defects: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Niloofar Jenabian

    2013-09-01

    Full Text Available OBJECTIVE: Treatment of furcation defects are thought to be challenging. The purpose of this study was to evaluate the clinical and radiographic parameters of Bio-Gen with Biocollagen compared with Bio-Gen with connective tissue in the treatment of Class II furcation defects. MATERIAL AND METHODS: In this clinical trial, 24 patients with Class II furcation defect on a buccal or lingual mandibular molar were recruited. After oral hygiene instruction, scaling and root planing and achievement of acceptable plaque control, the patients were randomly chosen to receive either connective tissue and Bio-Gen (case group or Biocollagen and Bio-Gen (control group. The following parameters were recorded before the first and re-entry surgery (six months later: vertical clinical attachment level (VCAL, gingival index (GI, plaque index (PI, horizontal probing depth (HPD, vertical probing depth (VPD, gingival recession (GR, furcation vertical component (FVC, furcation to alveolar crest (FAC, fornix to base of defect (FBD, and furcation horizontal component (FHC were calculated at the time of first surgery and during re-entry. A digital periapical radiograph was taken in parallel before first surgery and re-entry. The radiographs were then analyzed by digital subtraction. The differences with p value <0.05 were considered significant. RESULTS: Only the mean changes of FAC, FHC, mean of FHC, FBD in re-entry revealed statistically significant differences between the two groups. HPD, VPD, FBD, FAC, and FHC showed statistically significant differences after 6 months in the case group. However, in the control group, statistically significant differences were found in GR and HPD. We did not observe any significant difference in radiographic changes among the two groups. CONCLUSION: The results of this trial indicate that better clinical outcomes can be obtained with connective tissue grafts in combination with bone material compared with a resorbable barrier with bone

  5. Comparative trials in registration files of cardiovascular drugs : Comparator drugs and dosing schemes.

    NARCIS (Netherlands)

    Wieringa, NF; Vos, R; de Graeff, PA

    Registration files of 13 cardiovascular drugs were analysed with respect to the number of double-blind phase-III clinical trials, the use of placebo and active comparator drugs and their dosing schemes. Half of the 146 double-blind trials used active comparator drugs. The majority of files included

  6. Comparing Formation or Non-Formation of Bladder Flap at Cesarean Section on Perioperative and Postoperative Complications: Double-Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Farideh Akhlaghi

    2018-03-01

    Full Text Available Objective: To investigating formation or non-formation of bladder flap at Cesarean section on the complications during and after surgery.Materials and methods: This is a double-blind clinical trial study conducted during February 2014 to May 2015 on 64 pregnant women with gestational age of 36 weeks or more who were delivered by Cesarean section for the first time. They were randomly divided into two groups (intervention group: non-formation of bladder flap; control group: formation of bladder flap. The time to cut out the baby by Cesarean section, total duration of operation, bladder injury, intraoperative bleeding, hematocrit changes expected prior to during and following operation, postoperative pain, macroscopic and microscopic hematuria, postoperative complications and duration of  hospitalization were compared between two groups. The data were analyzed with SPSS version 16 using and statistics tests. p < 0.05 was considered significant.Results: Time to cut out the baby for the intervention group (124.9 ± 40.5 seconds and for control group 155.1 ± 42.9 seconds and total duration of the operation (intervention group: 27.7 ± 5.2 min and control group: 34 ± 4.73 min were significantly different (p = 0.000. Number of gauze consumption during operation and postoperative hematocrit drop in the intervention group was significantly lower in the intervention group compared the control group (p = 0.000. The postoperative pain score in the intervention group (4.8 ± 1.1 and in control group (6.3 ± 0.9 were significantly different (p = 0.000.Conclusion: Omission of the bladder flap at Cesarean section leads to short-term benefits such as reducing the time to cut out the fetus, duration of surgery, decreasing postoperative bleeding and lowering pain.

  7. Parahippocampectomy as a New Surgical Approach to Mesial Temporal Lobe Epilepsy Caused By Hippocampal Sclerosis: A Pilot Randomized Comparative Clinical Trial.

    Science.gov (United States)

    Alonso-Vanegas, Mario Arturo; Freire Carlier, Iván D; San-Juan, Daniel; Martínez, Alma Rosa; Trenado, Carlos

    2018-02-01

    The parahippocampal gyrus plays an important role in the epileptogenic pathways of mesial temporal lobe epilepsy caused by hippocampal sclerosis (mTLE-HS); its resection could prevent epileptic seizures with fewer complications. This study evaluates the initial efficacy and safety of anterior temporal lobectomy (ATL), selective amygdalohipppocampectomy (SAH), and parahippocampectomy (PHC) surgical approaches in mTLE-HS. A randomized comparative pilot clinical trial (2008-2011) was performed that included patients with mTLE-HS who underwent ATL, trans-T3 SAH, and trans-T3 PHC. Their sociodemographic characteristics, visual field profiles, verbal and visual memory profiles, and Engel scale outcome at baseline and at 1 and 5 years are described, using descriptive statistics along with parametric and nonparametric tests. Forty-three patients with a mean age of 35.2 years (18-56 years), 65% female, were analyzed: 14 underwent PHC, 14 ATL, and 15 SAH. The following percentages refer to those patients who were seizure free (Engel class IA) at 1-year and 5-year follow-up, respectively: 42.9% PHC, 71.4% ATL, and 60% SAH (P = 0.304); 28.6% PHC, 50% ATL, and 53.3% SAH (P = 0.353). Postoperative visual field deficits were 0% PHC, 85.7% ATL, and 46.7% SAH (P = 0.001). Verbal and/or visual memory worsening were present in 21.3% PHC, 42.8% ATL, and 33.4% SAH (P = 0.488) and preoperative and postoperative visual memory scores were significantly different in the SAH group only (P = 0.046). PHC, ALT, and SAH show a preliminary similar efficacy in short-term seizure-free rates in patients with mTLE-HS. However, PHC efficacy in the long-term decreases compared with the other surgical techniques. PHC does not produce postoperative visual field deficits. Copyright © 2017 Elsevier Inc. All rights reserved.

  8. Comparing the effects of aromatherapy massage and inhalation aromatherapy on anxiety and pain in burn patients: A single-blind randomized clinical trial.

    Science.gov (United States)

    Seyyed-Rasooli, Alehe; Salehi, Feridoon; Mohammadpoorasl, Asghar; Goljaryan, Sakineh; Seyyedi, Zahra; Thomson, Brian

    2016-12-01

    Anxiety and pain are recognized as major problems of burn patients; because pharmaceutical treatments for controlling anxiety and pain symptoms lead to complications and an increase in health costs, nonpharmacological nursing interventions were considered for this group of patients. This led to the present study aimed at comparing the effect of aromatherapy massage with inhalation aromatherapy for anxiety and pain in burn patients. This single-blind clinical trial was carried out on 90 patients with burns aromatherapy massage, inhalation aromatherapy, and control group. The patients assigned to the aromatherapy massage group received a massage for half an hour using a blend of lavender and almond oils, while a blend of rose and lavender aroma was used for the inhalation aromatherapy group. Spielberger State Anxiety Inventory was used for measuring anxiety and the visual analog scale (VAS) scale was used for measuring pain. The results showed that three groups were equal in terms of demographics, disease characteristics, and scores of anxiety and pain at the baseline. The mean decreases of anxiety scores were -0.04±5.08, 6.33±12.55, and 6.43±10.60 in the control group, aromatherapy massage group, and inhalation group, respectively (p=0.007). The mean decrease of pain scores were -0.10±0.96, 1.70±1.84, and 0.97±1.56 in the control group, aromatherapy massage group, and inhalation group, respectively (paromatherapy massage and inhalation aromatherapy compared with the control group in reducing both anxiety and pain of burn patients. Therefore, both interventions, which are inexpensive, and noninvasive nursing tasks can be proposed for alleviating anxiety and pain of burn patients. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

  9. Effect of inspiratory muscle training with load compared with sham training on blood pressure in individuals with hypertension: study protocol of a double-blind randomized clinical trial.

    Science.gov (United States)

    Posser, Simone Regina; Callegaro, Carine Cristina; Beltrami-Moreira, Marina; Moreira, Leila Beltrami

    2016-08-02

    Hypertension is a complex chronic condition characterized by elevated arterial blood pressure. Management of hypertension includes non-pharmacologic strategies, which may include techniques that effectively reduce autonomic sympathetic activity. Respiratory exercises improve autonomic control over cardiovascular system and attenuate muscle metaboreflex. Because of these effects, respiratory exercises may be useful to lower blood pressure in subjects with hypertension. This randomized, double-blind clinical trial will test the efficacy of inspiratory muscle training in reducing blood pressure in adults with essential hypertension. Subjects are randomly allocated to intervention or control groups. Intervention consists of inspiratory muscle training loaded with 40 % of maximum inspiratory pressure, readjusted weekly. Control sham intervention consists of unloaded exercises. Systolic and diastolic blood pressures are co-primary endpoint measures assessed with 24 h ambulatory blood pressure monitoring. Secondary outcome measures include cardiovascular autonomic control, inspiratory muscle metaboreflex, cardiopulmonary capacity, and inspiratory muscle strength and endurance. Previously published work suggests that inspiratory muscle training reduces blood pressure in persons with hypertension, but the effectiveness of this intervention is yet to be established. We propose an adequately sized randomized clinical trial to test this hypothesis rigorously. If an effect is found, this study will allow for the investigation of putative mechanisms to mediate this effect, including autonomic cardiovascular control and metaboreflex. ClinicalTrials.gov NCT02275377 . Registered on 30 September 2014.

  10. Sequential alternating deferiprone and deferoxamine treatment compared to deferiprone monotherapy: main findings and clinical follow-up of a large multicenter randomized clinical trial in -thalassemia major patients

    DEFF Research Database (Denmark)

    Pantalone, Gaetano Restivo; Maggio, Aurelio; Vitrano, Angela

    2011-01-01

    In β-thalassemia major (β-TM) patients, iron chelation therapy is mandatory to reduce iron overload secondary to transfusions. Recommended first line treatment is deferoxamine (DFO) from the age of 2 and second line treatment after the age of 6 is deferiprone (L1). A multicenter randomized open...... thalassemia patients were randomized and underwent intention-to-treat analysis. Statistically, a decrease of serum ferritin level was significantly higher in alternating sequential L1-DFO patients compared with L1 alone patients (p = 0.005). Kaplan-Meier survival analysis for the two chelation treatments did...

  11. A clinical trial comparing parenteral oxytetracyline and enrofloxacin on time to recovery in sheep lame with acute or chronic footrot in Kashmir, India

    Directory of Open Access Journals (Sweden)

    Kaler J

    2012-01-01

    Full Text Available Abstract Background No clinical trials have been conducted in India on the efficacy of parenteral antibacterials to treat footrot in sheep. In addition, there are no studies worldwide on the efficacy of parenteral antibacterials to treat chronic footrot. Sixty two sheep with acute footrot and 30 sheep with chronic footrot from 7 villages in Kashmir, India were recruited into two separate trials. Sheep with acute footrot were allocated to one of three treatments using stratified random sampling: long acting parenteral oxytetracycline, long acting parenteral enrofloxacin and topical application of potassium permanganate solution (a traditional treatment used by sheep farmers in India. In a quasi pre-post intervention design, sheep with chronic footrot that had not responded to treatment with potassium permanaganate were randomly allocated to treatment with one of the two parenteral antibacterials mentioned above. Sheep with acute footrot were treated on day 0 and those with chronic footrot on days 0, 3, 6 and 9. Sheep were monitored for up to 28 days after treatment. Time to recovery from lameness and initial healing of lesions was assessed using Kaplan-Meier survival curves, nonparametric log-rank and Wilcoxon sign-rank tests. Results There was significant correlation in recovery from lameness and presence of healing lesions in sheep with acute (r = 0.94 or chronic (r = 0.98 footrot. Sheep with acute footrot which were treated with parenteral antibacterials had a significantly more rapid recovery from lameness and had healing lesions (median = 7 days compared with those treated with topical potassium permanganate solution (less than 50% recovered in 28 days. The median time to recovery in sheep with chronic footrot treated with either antibacterial was 17 days; this was significantly lower than the median of 75 days lame before treatment with antibacterials. The median time to recovery for both acute and chronic footrot increased as the severity

  12. Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

    Science.gov (United States)

    Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

    2010-01-01

    To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (pattractiveness for biopharmaceutical industry-sponsored clinical trials.

  13. Where are clinical trials going? Society and clinical trials.

    Science.gov (United States)

    Sleight, P

    2004-02-01

    Clinical trials now increasingly impinge on society at large. First there is growing emphasis from health organizations on the need for unbiased evidence about the effectiveness of promoted remedies. Second, as most novel treatments accrue increased costs to society, these need to be evaluated in terms of value for money. Third, there has been confusion and concern about the resolution of conflicting evidence, especially the role of advertising and commercial pressures from a powerful pharmaceutical industry motivated by profit. Fourth, there is concern about research fraud and the ethics of clinical trials. Fifth, there is increasing suspicion of political advice, which sometimes has sought to reassure an anxious public on the basis of complex and possibly inadequate scientific information. Some of these issues are addressed by truly independent and properly constituted data and safety monitoring committees, which are of particular importance when academic investigators or universities have a large financial conflict of interest. This is now more problematic with the current encouragement of investigator-led spin-off companies. These issues are best resolved by independent financial support (from government or other institutions) rather than relying on the commercial sponsor.

  14. A safe-repositioning maneuver for the management of benign paroxysmal positional vertigo: Gans vs. Epley maneuver; a randomized comparative clinical trial.

    Science.gov (United States)

    Saberi, Alia; Nemati, Shadman; Sabnan, Salah; Mollahoseini, Fatemeh; Kazemnejad, Ehsan

    2017-08-01

    Benign paroxysmal positional vertigo (BPPV) is the most common cause of peripheral vertigo. Some repositioning maneuvers have been described for its management. The aim of this study was comparing the therapeutic effect of Epley and Gans maneuvers in BPPV. This randomized clinical trial was performed from September to December 2015. 73 patients with true vertigo diagnosed as BPPV enrolled the study. They randomly assigned in quadripartite blocks to modified Epley maneuver group (E) or Gans maneuver group (G). 1 day and 1 week after intervention, the objective and subjective responses to treatment were assessed. Statistical analysis was performed using the Chi-square test and regression model in the SPSS software version 21. Thirty patients enrolled each group with a mean age of 46.9 ± 13.4 (E group) and 46.7 ± 7.5 year (G group). 23.3 % of E group and 26.7 % of G group were men (p = 0.766). In E and G groups in the first day, subjective outcomes revealed 86.7 and 60 % rate of success (p = 0.02); and 86.7 and 56.7 % of patients exhibited objective improvement, respectively (p = 0.01). After 1 week, the subjective and objective outcomes revealed improvement among 70 % of E group and 46.7 % of G group (p = 0.067). The only complication with significant difference was cervical pain with a higher rate in E group (23.3 vs. 0.0 %, p = 0.005). These results revealed the similar long-term efficacy of Epley and Gans maneuver for the treatment of BPPV. Cervical pain was most frequent complication of Epley maneuver.

  15. Credentialing for participation in clinical trials

    International Nuclear Information System (INIS)

    Followill, David S.; Urie, Marcia; Galvin, James M.; Ulin, Kenneth; Xiao, Ying; FitzGerald, Thomas J.

    2012-01-01

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  16. Credentialing for participation in clinical trials

    Energy Technology Data Exchange (ETDEWEB)

    Followill, David S. [Radiological Physics Center, Department of Radiation Physics, University of Texas MD Anderson Cancer Center, Houston, TX (United States); Urie, Marcia [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Galvin, James M. [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); Ulin, Kenneth [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States); Xiao, Ying [Department of Radiation Oncology, Jefferson Medical College, Thomas Jefferson University, Philadelphia, PA (United States); Radiation Therapy Oncology Group, Philadelphia, PA (United States); FitzGerald, Thomas J., E-mail: dfollowi@mdanderson.org [Quality Assurance Review Center, Department of Radiation Oncology, University of Massachusetts Medical School, Lincoln, RI (United States); Department of Radiation Oncology, University of Massachusetts Medical School, Worcester, MA (United States)

    2012-12-26

    The National Cancer Institute (NCI) clinical cooperative groups have been instrumental over the past 50 years in developing clinical trials and evidence-based clinical trial processes for improvements in patient care. The cooperative groups are undergoing a transformation process to launch, conduct, and publish clinical trials more rapidly. Institutional participation in clinical trials can be made more efficient and include the expansion of relationships with international partners. This paper reviews the current processes that are in use in radiation therapy trials and the importance of maintaining effective credentialing strategies to assure the quality of the outcomes of clinical trials. The paper offers strategies to streamline and harmonize credentialing tools and processes moving forward as the NCI undergoes transformative change in the conduct of clinical trials.

  17. Clinical efficacy of Spasmofen® suppository in the emergency treatment of renal colic: a randomized, double-blind, double-dummy comparative trial

    Directory of Open Access Journals (Sweden)

    Yakoot M

    2014-05-01

    Full Text Available Mostafa Yakoot,1 Amel Salem,2 Sameh Yousef,2 Sherine Helmy31Green Clinic and Research Center, 2Alexandria Helmy Medical Center, 3Pharco Corporation, Alexandria, EgyptBackground: Renal colic is typically characterized by the sudden onset of severe pain radiating from the flank to the groin and its acute management in emergency departments essentially aims at rapid pain relief. Spasmofen® is a brand of Amriya Pharmaceutical Industries in the form of rectal suppositories containing ketoprofen 100 mg and hyoscine butylbromide 10 mg. This combination is intended for the rapid relief of severe colicky pain in the renal system, hepatobiliary system, or gastrointestinal tract. This trial aims to compare a single-dose of Spasmofen rectal suppository to a single intravenous (IV ketorolac tromethamine 30 mg/2 mL dose in patients with acute renal colic.Methods: A total of 80 eligible consecutive patients presenting to the emergency departments of two medical centers with acute renal colic were included in the study. Eligible patients who signed the informed consent were randomly assigned into two treatment groups: an experimental group (Spasmofen group who received one Spasmofen rectal suppository plus an IV injection of 2 mL of normal saline solution; and a control group (ketorolac group who received one ketorolac 30 mg/2 mL ampoule IV plus one placebo suppository. Treatment success, defined as a change in the verbal rating score from severe or moderate pain to none or mild at 60 minutes after the dose, was compared between groups using the chi-square/Fisher's exact test. Percentage reductions in visual pain analog scale (VPAS scores at 15 and 60 minutes after the dose were compared between groups using the Z-test for proportions.Results: Successful treatment at 60 minutes occurred in 35 of 40 (87.5% of Spasmofen-treated patients and in 33 of 40 (82.5% of ketorolac-treated patients. The difference was not statistically significant by Fisher's exact test

  18. Meta-Analysis of Randomized Clinical Trials Comparing Biodegradable Polymer Drug-Eluting Stent to Second-Generation Durable Polymer Drug-Eluting Stents.

    Science.gov (United States)

    El-Hayek, Georges; Bangalore, Sripal; Casso Dominguez, Abel; Devireddy, Chandan; Jaber, Wissam; Kumar, Gautam; Mavromatis, Kreton; Tamis-Holland, Jacqueline; Samady, Habib

    2017-03-13

    The authors sought to perform a meta-analysis of randomized clinical trials (RCTs) comparing the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DES) to second-generation durable polymer drug-eluting stents (DP-DES). Prior meta-analyses have established the superiority of BP-DES over bare-metal stents and first-generation DP-DES; however, their advantage compared with second-generation DP-DES remains controversial. The authors searched PubMed and Scopus databases for RCTs comparing BP-DES to the second-generation DP-DES. Outcomes included target vessel revascularization (TVR) as efficacy outcome and cardiac death, myocardial infarction (MI), and definite or probable stent thrombosis (ST) as safety outcomes. In addition, we performed landmark analysis for endpoints beyond 1 year of follow-up and a subgroup analysis based on the stent characteristics. The authors included 16 RCTs comprising 19,886 patients in the meta-analysis. At the longest available follow-up (mean duration 26 months), we observed no significant differences in TVR (p = 0.62), cardiac death (p = 0.46), MI (p = 0.98), or ST (risk ratio: 0.83, 95% confidence interval: 0.64 to 1.09; p = 0.19). Our landmark analysis showed that BP-DES were not associated with a reduction in the risk of very late ST (risk ratio: 0.87, 95% confidence interval: 0.49 to 1.53; p = 0.62). Similar outcomes were seen regardless of the eluting drug (biolimus vs. sirolimus), the stent platform (stainless steel vs. alloy), the kinetics of polymer degradation or drug release (6 months), the strut thickness of the BP-DES (thin 100 μm), or the DAPT duration (≥6 months vs. ≥12 months). BP-DES have similar safety and efficacy profiles to second-generation DP-DES. Published by Elsevier Inc.

  19. Combined oral contraceptives plus spironolactone compared with metformin in women with polycystic ovary syndrome: a one-year randomized clinical trial.

    Science.gov (United States)

    Alpañés, Macarena; Álvarez-Blasco, Francisco; Fernández-Durán, Elena; Luque-Ramírez, Manuel; Escobar-Morreale, Héctor F

    2017-11-01

    We aimed to compare a combined oral contraceptive (COC) plus the antiandrogen spironolactone with the insulin sensitizer metformin in women with polycystic ovary syndrome (PCOS). We conducted a randomized, parallel, open-label, clinical trial comparing COC (30 μg of ethinylestradiol and 150 μg of desogestrel) plus spironolactone (100 mg/day) with metformin (850 mg b.i.d.) for one year in women with PCOS (EudraCT2008-004531-38). The composite primary outcome included efficacy (amelioration of hirsutism, androgen excess and menstrual dysfunction) and cardiometabolic safety (changes in the frequencies of disorders of glucose tolerance, dyslipidemia and hypertension). A complete anthropometric, biochemical, hormonal and metabolic evaluation was conducted every three months and data were submitted to intention-to-treat analyses. Twenty-four patients were assigned to COC plus spironolactone and 22 patients to metformin. Compared with metformin, COC plus spironolactone caused larger decreases in hirsutism score (mean difference 4.6 points, 95% CI: 2.6-6.7), total testosterone (1.1 nmol/L, 0.4-1.7), free testosterone (25 pmol/L, 12-39), androstenedione (5.5 nmol/L, 1.8-9.2) and dehydroepiandrosterone sulfate (2.7 μmol/L, 1.4-4.0). Menstrual dysfunction was less frequent with COC plus spironolactone (OR: 0.06, 95% CI: 0.02-0.23). No differences were found in frequencies of abnormal glucose tolerance (OR: 1.7, 95% CI: 0.7-4.4), dyslipidemia (OR: 0.6, 95% CI: 0.2-1.8) or hypertension (OR: 0.3, 95% CI: 0.5-2.0). No major adverse events occurred and biochemical markers were similarly safe with both treatments. COC plus spironolactone was more effective than metformin for symptoms of PCOS showing similar safety and overall neutral effects on cardiometabolic risk factors. © 2017 European Society of Endocrinology.

  20. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte

    2015-01-01

    , either valve replacement or repair, remains the treatment of choice. However, post-surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesize that a comprehensive cardiac rehabilitation program can improve physical capacity and self-assessed mental health...... and reduce hospitalization and healthcare costs after heart valve surgery. METHODS: This randomized clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210...... patients 1:1 to an intervention or a control group, using central randomization, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise and a psycho-educational intervention comprising five consultations. The primary outcome is peak oxygen uptake...

  1. Clinical trials and gender medicine.

    Science.gov (United States)

    Cassese, Mariarita; Zuber, Veronica

    2011-01-01

    Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22%) which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa) which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  2. Clinical trials and gender medicine

    Directory of Open Access Journals (Sweden)

    Mariarita Cassese

    2011-01-01

    Full Text Available Women use more medicines than men because they fall ill more often and suffer more from chronic diseases, but also because women pay more attention to their health and have more consciousness and care about themselves. Although medicines can have different effects on women and men, women still represent a small percentage in the first phases of trials (22% which are essential to verify drugs dosage, side effects, and safety. Even though women are more present in trials, studies results are not presented with a gender approach. This situation is due to educational, social, ethical and economical factors. The scientific research must increase feminine presence in clinical trials in order to be equal and correct, and all the key stakeholder should be involved in this process. We still have a long way to cover and it doesn't concern only women but also children and old people. The aim is to have a medicine not only illness-focused but patient-focused: a medicine able to take into consideration all the patient characteristics and so to produce a really personalized therapy. What above described is part of the reasons why in 2005 was founded the National Observatory for Women's Health (Osservatorio Nazionale sulla Salute della Donna, ONDa which promotes a gender health awareness and culture in Italy, at all the levels of the civil and scientific society.

  3. CATCH: a randomised clinical trial comparing long-term tinzaparin versus warfarin for treatment of acute venous thromboembolism in cancer patients

    International Nuclear Information System (INIS)

    Lee, Agnes YY; Bauersachs, Rupert; Janas, Mette S; Jarner, Mikala F; Kamphuisen, Pieter W; Meyer, Guy; Khorana, Alok A

    2013-01-01

    Low-molecular-weight heparin (LMWH) is recommended and commonly used for extended treatment of cancer-associated thrombosis (CAT), but its superiority over warfarin has been demonstrated in only one randomised study. We report here the rationale, design and a priori analysis plans of Comparison of Acute Treatments in Cancer Haemostasis (CATCH; NCT01130025), a multinational, Phase III, open-label, randomised controlled trial comparing tinzaparin with warfarin for extended treatment of CAT. The primary objective is to assess the efficacy of tinzaparin in preventing recurrent venous thromboembolism (VTE) in patients with active cancer and acute, symptomatic proximal deep vein thrombosis and/or pulmonary embolism. The secondary objectives are to determine: safety of tinzaparin given over 6 months; clinical and laboratory markers for recurrent VTE and/or major bleeding; 6-month overall mortality; incidence and severity of post-thrombotic syndrome; patient-reported quality of life; and healthcare resource utilisation. Nine hundred patients are randomised to receive tinzaparin 175 IU/kg once daily for 6 months or initial tinzaparin 175 IU/kg once daily for 5–10 days and dose-adjusted warfarin (target INR 2.0–3.0) for 6 months. The primary composite outcome is time to recurrent VTE, including incidental VTE and fatal pulmonary embolism. All patients are followed up to 6 months or death, whichever comes sooner. Blinded adjudication will be performed for all reported VTE, bleeding events and causes of death. Efficacy will be analysed using centrally adjudicated results of all patients according to intention-to-treat analysis. An independent Data Safety Monitoring Board is reviewing data at regular intervals and an interim analysis is planned after 450 patients have completed the study. The results will add significantly to the knowledge of the efficacy, safety and cost effectiveness of tinzaparin in the prevention of recurrent VTE in patients with cancer and thrombosis

  4. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

  5. Efficacy and safety of sugammadex in the reversal of deep neuromuscular blockade induced by rocuronium in patients with end-stage renal disease: A comparative prospective clinical trial.

    Science.gov (United States)

    de Souza, Camila M; Tardelli, Maria A; Tedesco, Helio; Garcia, Natalia N; Caparros, Mario P; Alvarez-Gomez, Jose A; de Oliveira Junior, Itamar S

    2015-10-01

    Renal failure affects the pharmacology of nondepolarizing neuromuscular blockers making recovery of neuromuscular function unpredictable. Sugammadex antagonises rocuronium-induced neuromuscular blockade by encapsulating rocuronium, creating a stable complex molecule that is mainly excreted by the kidneys. Previous studies suggest that sugammadex is effective in reversing moderate neuromuscular block in the presence of renal failure, but no data are available regarding reversal of profound neuromuscular block in patients with renal failure. The objective of this study is to compare the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in patients with end-stage renal disease and those with normal renal function. A prospective clinical trial. Two university hospitals, from 1 October 2011 to 31 January 2012. Forty patients undergoing kidney transplant: 20 with renal failure [creatinine clearance (ClCr) 90 ml min). Neuromuscular monitoring was performed by acceleromyography and train-of-four (TOF) stimulation. Profound neuromuscular block (posttetanic count, one to three responses) was maintained during surgery. Sugammadex 4 mg kg was administered on completion of skin closure. Recovery of the TOF ratio to 0.9 was recorded. Monitoring of neuromuscular function continued in the postanesthesia care unit for a further 2 h. The efficacy of sugammadex was evaluated by the time taken for the TOF ratio to recover to 0.9. The safety of sugammadex was assessed by monitoring for recurrence of neuromuscular block every 15 min for 2 h. Secondary variables were time to recovery of TOF ratio to 0.7 and 0.8. After sugammadex administration, the mean time for recovery of the TOF ratio to 0.9 was prolonged in the renal failure group (5.6 ± 3.6 min) compared with the control group (2.7 ± 1.3 min, P = 0.003). No adverse events or evidence of recurrence of neuromuscular block were observed. In patients with

  6. NIH Clinical Research Trials and You

    Science.gov (United States)

    ... Info Lines Health Services Locator HealthCare.gov NIH Clinical Research Trials and You Talking to Your Doctor Science ... Labs & Clinics Training Opportunities Library Resources Research Resources Clinical Research Resources Safety, Regulation and Guidance More » Quick Links ...

  7. COMPARE CPM-RMI Trial: Intramyocardial Transplantation of Autologous Bone Marrow-Derived CD133+ Cells and MNCs during CABG in Patients with Recent MI: A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial.

    Science.gov (United States)

    Naseri, Mohammad Hassan; Madani, Hoda; Ahmadi Tafti, Seyed Hossein; Moshkani Farahani, Maryam; Kazemi Saleh, Davood; Hosseinnejad, Hossein; Hosseini, Saeid; Hekmat, Sepideh; Hossein Ahmadi, Zargham; Dehghani, Majid; Saadat, Alireza; Mardpour, Soura; Hosseini, Seyedeh Esmat; Esmaeilzadeh, Maryam; Sadeghian, Hakimeh; Bahoush, Gholamreza; Bassi, Ali; Amin, Ahmad; Fazeli, Roghayeh; Sharafi, Yaser; Arab, Leila; Movahhed, Mansour; Davaran, Saeid; Ramezanzadeh, Narges; Kouhkan, Azam; Hezavehei, Ali; Namiri, Mehrnaz; Kashfi, Fahimeh; Akhlaghi, Ali; Sotoodehnejadnematalahi, Fattah; Vosough Dizaji, Ahmad; Gourabi, Hamid; Syedi, Naeema; Shahverdi, Abdol Hosein; Baharvand, Hossein; Aghdami, Nasser

    2018-07-01

    The regenerative potential of bone marrow-derived mononuclear cells (MNCs) and CD133+ stem cells in the heart varies in terms of their pro-angiogenic effects. This phase II/III, multicenter and double-blind trial is designed to compare the functional effects of intramyocardial autologous transplantation of both cell types and placebo in patients with recent myocardial infarction (RMI) post-coronary artery bypass graft. This was a phase II/III, randomized, double-blind, placebo-controlled trial COMPARE CPM-RMI (CD133, Placebo, MNCs - recent myocardial infarction) conducted in accordance with the Declaration of Helsinki that assessed the safety and efficacy of CD133 and MNCs compared to placebo in patients with RMI. We randomly assigned 77 eligible RMI patients selected from 5 hospitals to receive CD133+ cells, MNC, or a placebo. Patients underwent gated single photon emission computed tomography assessments at 6 and 18 months post-intramyocardial transplantation. We tested the normally distributed efficacy outcomes with a mixed analysis of variance model that used the entire data set of baseline and between-group comparisons as well as within subject (time) and group×time interaction terms. There were no related serious adverse events reported. The intramyocardial transplantation of both cell types increased left ventricular ejection fraction by 9% [95% confidence intervals (CI): 2.14% to 15.78%, P=0.01] and improved decreased systolic wall thickening by -3.7 (95% CI: -7.07 to -0.42, P=0.03). The CD133 group showed significantly decreased non-viable segments by 75% (P=0.001) compared to the placebo and 60% (P=0.01) compared to the MNC group. We observed this improvement at both the 6- and 18-month time points. Intramyocardial injections of CD133+ cells or MNCs appeared to be safe and efficient with superiority of CD133+ cells for patients with RMI. Although the sample size precluded a definitive statement about clinical outcomes, these results have provided the

  8. A double blind randomised controlled clinical trial comparing a novel anti-stain and calculus reducing dentifrice with a standard fluoride dentifrice.

    Science.gov (United States)

    Jowett, Adrian K; Marlow, Ian; Rawlinson, Andrew

    2013-04-01

    This clinical trial tested the anti-stain efficacy at 3 and 6 months of a novel, sodium polyaspartate-containing, anti-stain dentifrice. In addition, the efficacy of the new dentifrice in controlling gingival inflammation and inhibition of calculus deposition was tested. Participants were recruited to this double blind randomised control clinical trial, and allocated to either test or control groups. The presence of stain and calculus were entry criteria. Measurements of stain, calculus and gingival inflammation were recorded using the Shaw and Murray Stain score, Volpe-Manhold Calculus score and the Modified Gingival Index respectively. Measurements were made at baseline, prior to the removal of stain and calculus, and after 3 and 6 months. Missing data were imputed by and the outcomes were analysed using univariate analysis. At three months, toothpaste containing sodium polyaspartate was better (difference of mean 1.13 with SEM 0.57) than control for the control of dental stain (p0.05). There was no difference between toothpastes with respect to calculus deposition or gingival inflammation. Toothpaste containing sodium polyaspartate was more effective than a control toothpaste at preventing deposition of dental stain for 3 months after professional tooth cleaning but showed no significant effect at 6 months. Sodium polyaspartate toothpaste was more effective than a control toothpaste at preventing dental stain formation and maybe helpful in controlling staining between episodes of scaling and polishing. Copyright © 2012 Elsevier Ltd. All rights reserved.

  9. Comparing Neonatal Outcome Following the Use of Ondansetron versus Vitamin B6 in Pregnant Females with Morning Sickness: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Shahraki

    2016-09-01

    Full Text Available Background Pregnancy-related nausea and vomiting or morning sickness with an overall prevalence rate of 80% is commonly appeared at the eighth week and frequently disappeared in most pregnant females at the 16th week of gestation. The severe form of the condition named hyperemesis occurs in one per 200 to 300 pregnancies; it is accompanied by dehydration, electrolyte instability and nutritional deficits and needs medical interventions. Limited data are available on harmful effects of common antiemetic medications used within pregnancy on human neonates. Objectives The current study aimed to compare the effects of ondansetron and vitamin B6 on neonatal outcome in pregnant females with pregnancy-related nausea and vomiting. Neonatal outcome included the probable difference in neonates’ gestational age, weight, height, head circumference and frequency of apparent congenital anomalies. Methods This randomized double-blinded clinical trial was conducted on 188 primipara singleton pregnant females with pregnancy-related nausea and vomiting who referred to state healthcare centers of Zabol, Iran, in 2014. The pregnant females were randomly assigned to receive drug packages including ondansetron tablets (4 mg or vitamin B6 tablets (40 mg and patients were instructed to take one tablet twice daily. Females were followed up until delivery and neonatal outcomes including any congenital anomaly, weight, height and head circumference at birth were assessed. Results There was no difference between the groups in the mean age of mother and the mean age of gestation. No differences were found between the groups regarding birth weight (3006.93 ± 441.86 versus 2949.65 ± 457.36 g, P= 0.67, height at birth (49.50 ± 1.45 versus 48.97 ± 1.47 cm, P= 0.75 and head circumference at birth (34.23 ± 1.22 versus 33.88 ± 1.26 cm, P = 0.56. No neonatal anomaly was observed in the two groups. Conclusions No significant differences were observed between the groups based

  10. Real-world cure rates for hepatitis C virus treatments that include simeprevir and/or sofosbuvir are comparable to clinical trial results.

    Science.gov (United States)

    Bichoupan, Kian; Tandon, Neeta; Crismale, James F; Hartman, Joshua; Del Bello, David; Patel, Neal; Chekuri, Sweta; Harty, Alyson; Ng, Michel; Sigel, Keith M; Bansal, Meena B; Grewal, Priya; Chang, Charissa Y; Leong, Jennifer; Im, Gene Y; Liu, Lawrence U; Odin, Joseph A; Bach, Nancy; Friedman, Scott L; Schiano, Thomas D; Perumalswami, Ponni V; Dieterich, Douglas T; Branch, Andrea D

    2017-11-12

    To assess the real-world effectiveness and cost of simeprevir (SMV), and/or sofosbuvir (SOF)-based therapy for chronic hepatitis C virus (HCV) infection. The real-world performance of patients treated with SMV/SOF ± ribavirin (RBV), SOF/RBV, and SOF/RBV with pegylated-interferon (PEG) were analyzed in a consecutive series of 508 patients with chronic HCV infection treated at a single academic medical center. Patients with genotypes 1 through 4 were included. Rates of sustained virological response - the absence of a detectable serum HCV RNA 12 wk after the end of treatment [sustained virological response (SVR) 12] - were calculated on an intention-to-treat basis. Costs were calculated from the payer's perspective using Medicare/Medicaid fees and Redbook Wholesale Acquisition Costs. Patient-related factors associated with SVR12 were identified using multivariable logistic regression. SVR12 rates were as follows: 86% (95%CI: 80%-91%) among 178 patients on SMV/SOF ± RBV; 62% (95%CI: 55%-68%) among 234 patients on SOF/RBV; and 78% (95%CI: 68%-86%) among 96 patients on SOF/PEG/RBV. Mean costs-per-SVR12 were $174442 (standard deviation: ± $18588) for SMV/SOF ± RBV; $223003 (± $77946) for SOF/RBV; and $126496 (± $31052) for SOF/PEG/RBV. Among patients on SMV/SOF ± RBV, SVR12 was less likely in patients previously treated with a protease inhibitor [odds ratio (OR): 0.20, 95%CI: 0.06-0.56]. Higher bilirubin (OR: 0.47, 95%CI: 0.30-0.69) reduced the likelihood of SVR12 among patients on SOF/RBV, while FIB-4 score ≥ 3.25 reduced the likelihood of SVR12 (OR: 0.18, 95%CI: 0.05-0.59) among those on SOF/PEG/RBV. SVR12 rates for SMV and/or SOF-based regimens in a diverse real-world population are comparable to those in clinical trials. Treatment failure accounts for 27% of costs.

  11. Pediatric Clinical Trials Conducted in South Korea from 2006 to 2015: An Analysis of the South Korean Clinical Research Information Service, US ClinicalTrials.gov and European Clinical Trials Registries.

    Science.gov (United States)

    Choi, Sheung-Nyoung; Lee, Ji-Hyun; Song, In-Kyung; Kim, Eun-Hee; Kim, Jin-Tae; Kim, Hee-Soo

    2017-12-01

    The status of pediatric clinical trials performed in South Korea in the last decade, including clinical trials of drugs with unapproved indications for children, has not been previously examined. The aim was to provide information regarding the current state of pediatric clinical trials and create a basis for future trials performed in South Korea by reviewing three databases of clinical trials registrations. We searched for pediatric clinical studies (participants South Korea between 2006 and 2015 registered on the Clinical Research Information Service (CRIS), ClinicalTrials.gov, and the European Clinical Trials Registry (EuCTR). Additionally, we reviewed whether unapproved indications were involved in each trial by comparing the trials with a list of authorized trials provided by the Ministry of Food and Drug Safety (MFDS). The primary and secondary outcomes were to determine the change in number of pediatric clinical trials with unapproved indications over time and to assess the status of unauthorized pediatric clinical trials from the MFDS and the publication of articles after these clinical trials, respectively. We identified 342 clinical studies registered in the CRIS (n = 81), ClinicalTrials.gov (n = 225), and EuCTR (n = 36), of which 306 were reviewed after excluding duplicate registrations. Among them, 181 studies were interventional trials dealing with drugs and biological agents, of which 129 (71.3%) involved unapproved drugs. Of these 129 trials, 107 (82.9%) were authorized by the MFDS. Pediatric clinical trials in South Korea aiming to establish the safety and efficacy of drugs in children are increasing; however, non-MFDS-authorized studies remain an issue.

  12. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis.

    Directory of Open Access Journals (Sweden)

    Joseph S Ross

    2009-09-01

    Full Text Available ClinicalTrials.gov is a publicly accessible, Internet-based registry of clinical trials managed by the US National Library of Medicine that has the potential to address selective trial publication. Our objectives were to examine completeness of registration within ClinicalTrials.gov and to determine the extent and correlates of selective publication.We examined reporting of registration information among a cross-section of trials that had been registered at ClinicalTrials.gov after December 31, 1999 and updated as having been completed by June 8, 2007, excluding phase I trials. We then determined publication status among a random 10% subsample by searching MEDLINE using a systematic protocol, after excluding trials completed after December 31, 2005 to allow at least 2 y for publication following completion. Among the full sample of completed trials (n = 7,515, nearly 100% reported all data elements mandated by ClinicalTrials.gov, such as intervention and sponsorship. Optional data element reporting varied, with 53% reporting trial end date, 66% reporting primary outcome, and 87% reporting trial start date. Among the 10% subsample, less than half (311 of 677, 46% of trials were published, among which 96 (31% provided a citation within ClinicalTrials.gov of a publication describing trial results. Trials primarily sponsored by industry (40%, 144 of 357 were less likely to be published when compared with nonindustry/nongovernment sponsored trials (56%, 110 of 198; p<0.001, but there was no significant difference when compared with government sponsored trials (47%, 57 of 122; p = 0.22. Among trials that reported an end date, 75 of 123 (61% completed prior to 2004, 50 of 96 (52% completed during 2004, and 62 of 149 (42% completed during 2005 were published (p = 0.006.Reporting of optional data elements varied and publication rates among completed trials registered within ClinicalTrials.gov were low. Without greater attention to reporting of all data

  13. Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.

    Science.gov (United States)

    Shepshelovich, D; Goldvaser, H; Wang, L; Abdul Razak, A R; Bedard, P L

    2017-12-01

    Background Data on completeness of reporting of phase I cancer clinical trials in publications are lacking. Methods The ClinicalTrials.gov database was searched for completed adult phase I cancer trials with reported results. PubMed was searched for matching primary publications published prior to November 1, 2016. Reporting in primary publications was compared with the ClinicalTrials.gov database using a 28-point score (2=complete; 1=partial; 0=no reporting) for 14 items related to study design, outcome measures and safety profile. Inconsistencies between primary publications and ClinicalTrials.gov were recorded. Linear regression was used to identify factors associated with incomplete reporting. Results After a review of 583 trials in ClinicalTrials.gov , 163 matching primary publications were identified. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were upgraded, downgraded or omitted in publications in 47% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Incompletely reported items in >25% publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Higher reporting scores were associated with phase I (vs phase I/II) trials (ppublication in journals with lower impact factor (p=0.004). Conclusions Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicalTrials.gov may provide more comprehensive data from new cancer drug trials.

  14. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

    Directory of Open Access Journals (Sweden)

    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  15. Clinical trials in dentistry in India: Analysis from trial registry.

    Science.gov (United States)

    Gowri, S; Kannan, Sridharan

    2017-01-01

    Evidence-based practice requires clinical trials to be performed. In India, if any clinical trial has to be performed, it has to be registered with clinical trial registry of India. Studies have shown that the report of clinical trials is poor in dentistry. Hence, the present study has been conducted to assess the type and trends of clinical trials being undertaken in dentistry in India over a span of 6 years. All the clinical trials which were registered with the Central Trial Registry of India (CTRI) (www.ctri.nic.in) from January 1, 2007 to March 3, 2014 were evaluated using the keyword "dental." Following information were collected for each of the clinical trials obtained from the search; number of centres (single center/multicentric), type of the institution undertaking the research (government/private/combined), study (observational/interventional), study design (randomized/single blinded/double-blinded), type of health condition, type of participants (healthy/patients), sponsors (academia/commercial), phase of clinical trial (Phase 1/2/3/4), publication details (published/not published), whether it was a postgraduate thesis or not and prospective or retrospective registration of clinical trials, methodological quality (method of randomization, allocation concealment). Descriptive statistics was used for analysis of various categories. Trend analysis was done to assess the changes over a period of time. The search yielded a total of 84 trials of which majority of them were single centered. Considering the study design more than half of the registered clinical trials were double-blinded (47/84 [56%]). With regard to the place of conducting a trial, most of the trials were planned to be performed in private hospitals (56/84 [66.7%]). Most (79/84, 94.1%) of the clinical trials were interventional while only 5/84 (5.9%) were observational. Majority (65/84, 77.4%) of the registered clinical trials were recruiting patients while the rest were being done in healthy

  16. PIMS (Positioning In Macular hole Surgery) trial - a multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning, with an inactive face-forward position on the outcome of surgery for large macular holes: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pasu, Saruban; Bunce, Catey; Hooper, Richard; Thomson, Ann; Bainbridge, James

    2015-11-17

    Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery. This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery. This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery. UK CRN: 17966 (date of registration 26 November 2014).

  17. Comparative effects of carbohydrate versus fat restriction on metabolic profiles, biomarkers of inflammation and oxidative stress in overweight patients with Type 2 diabetic and coronary heart disease: a randomized clinical trialComparative effects of car

    Directory of Open Access Journals (Sweden)

    Fariba Raygan

    2017-02-01

    Full Text Available BACKGROUND: This study was conducted to establish the comparative effects of carbohydrate versus fat restriction on metabolic indices in Type 2 diabetic (T2D patients with coronary heart disease (CHD. METHODS: This randomized, clinical trial was done among 56 overweight persons with T2D and CHD aged 40-85 years old. The patients were randomly allocated to take either a high-carbohydrate (HC diet (60-65% carbohydrates and 20-25% fats (n = 28 or a restricted carbohydrate (RC diet (43-49% carbohydrate and 36-40% fats (n = 28 for 8 weeks to determine metabolic status. RESULTS: After 8 weeks of treatment, RC diet decreased fasting plasma glucose (FPG (−11.5 ± 28.3 vs. +7.0 ± 26.9 mg/dl, P = 0.010 and high-sensitivity C-reactive protein (hs-CRP (−564.3 ± 1280.1 vs. +286.1 ± 1789.2 ng/ml, P = 0.040 compared with a HC diet. Moreover, compared with a HC diet, RC diet increased total antioxidant capacity (TAC (+274.8 ± 111.5 vs. +20.2 ± 82.5 mmol/l, P < 0.001 and glutathione (GSH levels (+51.6 ± 111.5 vs. −32.6 ± 88.5 µmol/l, P = 0.003. No significant alterations between the two groups were found in terms of their effect on other metabolic profiles. CONCLUSION: RC diet in overweight T2D with CHD had beneficial effects on FPG, hs-CRP, TAC, and GSH values. 

  18. Comparing the Effects of Oral Contraceptives Containing Levonorgestrel With Products Containing Antiandrogenic Progestins on Clinical, Hormonal, and Metabolic Parameters and Quality of Life in Women With Polycystic Ovary Syndrome: Crossover Randomized Controlled Trial Protocol

    Science.gov (United States)

    Amiri, Mina; Nahidi, Fatemeh; Khalili, Davood; Bidhendi-Yarandi, Razieh

    2017-01-01

    Background Oral contraceptives (OCs) have been used as a first-line option for medical treatment in women with polycystic ovary syndrome (PCOS). Despite theoretical superiority of products containing antiandrogenic progestins compared to OCs containing levonorgestrel (LNG), the clinical advantage of these compounds remains unclear. Objective The aim of this study was to compare the effects of OCs containing LNG with products containing antiandrogenic progestins including cyproterone acetate, drospirenone, and desogestrel on clinical, hormonal, and metabolic parameters and quality of life in women with PCOS. Methods We conducted a 6-arm crossover randomized controlled trial with each arm including OCs containing LNG and one of those 3 OCs containing antiandrogenic progestins. The anthropometric and clinical manifestations and hormonal and biochemical parameters of participants were assessed at 6 time points including baseline, after washout period, and 3 and 6 months after intervention. Results The study is ongoing and follow-up of recruited women will continue until 2018. Conclusions This study will provide scientific evidence on comparability of OCs with the various progesterones that will assist in decision making taking into account cost effectiveness. Trial Registration Iranian Registry of Clinical Trials IRCT201702071281N2; http://www.irct.ir/searchresult.php? keyword=&id=1281&number=2&prt=12869&total=10&m=1 (Archived by WebCite at http://www.webcitation.org/6tSP8FNWo) PMID:28963092

  19. Opioid detoxification : from controlled clinical trial to clinical practice

    NARCIS (Netherlands)

    Dijkstra, Boukje A G; De Jong, Cor A J; Wensing, Michel; Krabbe, Paul F M; van der Staak, Cees P F

    2010-01-01

    Controlled clinical trials have high internal validity but suffer from difficulties in external validity. This study evaluates the generalizability of the results of a controlled clinical trial on rapid detoxification in the everyday clinical practice of two addiction treatment centers. The results

  20. Additive Complex Ayurvedic Treatment in Patients with Fibromyalgia Syndrome Compared to Conventional Standard Care Alone: A Nonrandomized Controlled Clinical Pilot Study (KAFA Trial

    Directory of Open Access Journals (Sweden)

    Christian S. Kessler

    2013-01-01

    Full Text Available Background. Fibromyalgia (FMS is a challenging condition for health care systems worldwide. Only limited trial data is available for FMS for outcomes of complex treatment interventions of complementary and integrative (CIM approaches. Methods. We conducted a controlled, nonrandomized feasibility study that compared outcomes in 21 patients treated with Ayurveda with those of 11 patients treated with a conventional approach at the end of a two-week inpatient hospital stay. Primary outcome was the impact of fibromyalgia on patients as assessed by the FIQ. Secondary outcomes included scores of pain intensity, pain perception, depression, anxiety, and quality of sleep. Follow-up assessments were done after 6 months. Results. At 2 weeks, there were comparable and significant improvements in the FIQ and for most of secondary outcomes in both groups with no significant in-between-group differences. The beneficial effects for both treatment groups were partly maintained for the main outcome and a number of secondary outcomes at the 6-month followup, again with no significant in-between-group differences. Discussion. The findings of this feasibility study suggest that Ayurvedic therapy is noninferior to conventional treatment in patients with severe FMS. Since Ayurveda was only used as add-on treatment, RCTs on Ayurveda alone are warranted to increase model validity. This trial is registered with NCT01389336.

  1. Ethics of clinical trials in Nigeria.

    Science.gov (United States)

    Okonta, Patrick I

    2014-05-01

    The conduct of clinical trials for the development and licensing of drugs is a very important aspect of healthcare. Drug research, development and promotion have grown to a multi-billion dollar global business. Like all areas of human endeavour involving generation and control of huge financial resources, it could be subject to deviant behaviour, sharp business practices and unethical practices. The main objective of this review is to highlight potential ethical challenges in the conduct of clinical trials in Nigeria and outline ways in which these can be avoided. Current international and national regulatory and ethical guidelines are reviewed to illustrate the requirements for ethical conduct of clinical trials. Past experiences of unethical conduct of clinical trials especially in developing countries along with the increasing globalisation of research makes it imperative that all players should be aware of the ethical challenges in clinical trials and the benchmarks for ethical conduct of clinical research in Nigeria.

  2. Inherited Retinal Degenerative Clinical Trial Network

    Science.gov (United States)

    2009-10-01

    clinical efforts that will impact the NEER network going forward and laid the ground work for the CTECs to participate in ongoing clinical trials for...Clinical Implications: • How will the proposed clinical trial have a significant impact on disease outcome? 34 • How will the clinical trial offer...was 0 041U>< for pat<t!nts NPtS and <H08, 0 4 1ux !01 Ct 110, 1nd 10.0 lux f01 < H13 OJ)Ilo •her on~tion are indiuttd AhtrNtor19 stimuli Wl’f1! pres

  3. Comparing two low-energy diets for the treatment of knee osteoarthritis symptoms in obese patients: a pragmatic randomized clinical trial.

    Science.gov (United States)

    Riecke, B F; Christensen, R; Christensen, P; Leeds, A R; Boesen, M; Lohmander, L S; Astrup, A; Bliddal, H

    2010-06-01

    To evaluate in a prospective, randomized clinical trial (RCT), symptom response among obese knee osteoarthritis (OA) patients following a feasible, intensive weight-loss program for 16 weeks. Eligible patients were obese [body mass index (BMI)>30 kg/m(2)]; >50 years old, with primary knee OA. Participants were randomized to either a very-low-energy diet (VLED) or a low-energy diet (LED) (415 kcal/day and 810 kcal/day, respectively), using commercially available formula foods - only for the first 8 weeks, managed by dieticians. The 8 weeks were followed by an additional 8-week period of a hypo-energetic diet consisting of normal food plus meal replacements (1200 kcal/day). The primary endpoint was the number of patients responding according to the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) responder criterion. The statistical analysis was based on a non-responder intention-to-treat (ITT) population (baseline observation carried forward). One hundred and ninety two patients (155 (80.7%) females) with a mean age 62.5 years [standard deviation (SD) 6.4; range 50-78 years]; average BMI 37.3 (SD 4.8) were included. At 16 weeks, similar proportions of the VLED and LED groups, 59 (61.5%), and 63 (65.6%) patients, respectively, met the OMERACT-OARSI responder criteria, with no statistical significant difference between the groups (P=0.55). Combining the groups the pooled estimate was 64% meeting the responder criteria [95% confidence interval (CI) 57%, 70%]. There was an overall reduction in pain, corresponding to an average pain reduction on the visual analogue scale (VAS) of 11.1 (95%CI 13.6, 8.5) in the combined groups. At week 16 weight loss in the combined groups was 12.8 kg (95%CI: 11.84-13.66; P or =10% body weight in both diet groups, with a pooled estimate of 74% (95%CI: 68-80%). No clinically significant differences were found between the 415 kcal/day and 810 kcal/day diets. A 16-week formula

  4. Construction of ethics in clinical research: clinical trials registration

    Directory of Open Access Journals (Sweden)

    C. A. Caramori

    2007-01-01

    Full Text Available Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials and scientific publications (selective, manipulated and with wrong conclusions led to an inappropriate clinical practice, favoring the involved economic aspect. In 2005, the International Committee of Medical Journal Editors (ICMJE, supported by the World Association of Medical Editors, started demanding as a requisite for publication that all clinical trials be registered at the database ClinicalTrials.gov. In 2006, the World Health Organization (WHO created the International Clinical Trial Registry Platform (ICTRP, which gathers several registry centers from all over the world, and required that all researchers and pharmaceutical industries register clinical trials. Such obligatory registration has progressed and will extend to all scientific journals indexed in all worldwide databases. Registration of clinical trials means another step of clinical research towards transparency, ethics and impartiality, resulting in real evidence to the forthcoming changes in clinical practice as well as in the health situation.

  5. Clinical and economic evaluation of laparoscopic surgery compared with medical management for gastro-oesophageal reflux disease: 5-year follow-up of multicentre randomised trial (the REFLUX trial).

    Science.gov (United States)

    Grant, A M; Boachie, C; Cotton, S C; Faria, R; Bojke, L; Epstein, D M; Ramsay, C R; Corbacho, B; Sculpher, M; Krukowski, Z H; Heading, R C; Campbell, M K

    2013-06-01

    Despite promising evidence that laparoscopic fundoplication provides better short-term relief of gastro-oesophageal reflux disease (GORD) than continued medical management, uncertainty remains about whether benefits are sustained and outweigh risks. To evaluate the long-term clinical effectiveness, cost-effectiveness and safety of laparoscopic surgery among people with GORD requiring long-term medication and suitable for both surgical and medical management. Five-year follow-up of a randomised trial (with parallel non-randomised preference groups) comparing a laparoscopic surgery-based policy with a continued medical management policy. Cost-effectiveness was assessed alongside the trial using a NHS perspective for costs and expressing health outcomes in terms of quality-adjusted life-years (QALYs). Follow-up was by annual postal questionnaire and selective hospital case notes review; initial recruitment in 21 UK hospitals. Questionnaire responders among the 810 original participants. At entry, all had documented evidence of GORD and symptoms for > 12 months. Questionnaire response rates (years 1-5) were from 89.5% to 68.9%. Three hundred and fifty-seven participants were recruited to the randomised comparison (178 randomised to surgical management and 179 randomised to continued medical management) and 453 to the preference groups (261 surgical management and 192 medical management). The surgeon chose the type of fundoplication. Primary: disease-specific outcome measure (the REFLUX questionnaire); secondary: Short Form questionnaire-36 items (SF-36), European Quality of Life-5 Dimensions (EQ-5D), NHS resource use, reflux medication, complications. The randomised groups were well balanced. By 5 years, 63% in the randomised surgical group and 13% in the randomised medical management group had received a total or partial wrap fundoplication (85% and 3% in the preference groups), with few perioperative complications and no associated deaths. At 1 year (and 5 years

  6. Clinical Trials Management | Division of Cancer Prevention

    Science.gov (United States)

    Information for researchers about developing, reporting, and managing NCI-funded cancer prevention clinical trials. Protocol Information Office The central clearinghouse for clinical trials management within the Division of Cancer Prevention.Read more about the Protocol Information Office. | Information for researchers about developing, reporting, and managing NCI-funded

  7. Inherited Retinal Degenerative Clinical Trial Network. Addendum

    Science.gov (United States)

    2013-10-01

    inherited orphan retinal degenerative diseases and dry age-related macular degeneration (AMD) through the conduct of clinical trials and other...design and conduct of effective and efficient clinical trials for inherited orphan retinal degenerative diseases and dry AMD; • Limited number and...linica l trial in the NEER network for autosomal dominant retinitis pigmentosa, and the ProgSTAR studies for Stargardt disease ) . As new interventions b

  8. Local Heat Application for the Treatment of Buruli Ulcer: Results of a Phase II Open Label Single Center Non Comparative Clinical Trial.

    Science.gov (United States)

    Vogel, Moritz; Bayi, Pierre F; Ruf, Marie-Thérèse; Bratschi, Martin W; Bolz, Miriam; Um Boock, Alphonse; Zwahlen, Marcel; Pluschke, Gerd; Junghanss, Thomas

    2016-02-01

    Buruli ulcer (BU) is a necrotizing skin disease most prevalent among West African children. The causative organism, Mycobacterium ulcerans, is sensitive to temperatures above 37°C. We investigated the safety and efficacy of a local heat application device based on phase change material. In a phase II open label single center noncomparative clinical trial (ISRCTN 72102977) under GCP standards in Cameroon, laboratory confirmed BU patients received up to 8 weeks of heat treatment. We assessed efficacy based on the endpoints 'absence of clinical BU specific features' or 'wound closure' within 6 months ("primary cure"), and 'absence of clinical recurrence within 24 month' ("definite cure"). Of 53 patients 51 (96%) had ulcerative disease. 62% were classified as World Health Organization category II, 19% each as category I and III. The average lesion size was 45 cm(2). Within 6 months after completion of heat treatment 92.4% (49 of 53, 95% confidence interval [CI], 81.8% to 98.0%) achieved cure of their primary lesion. At 24 months follow-up 83.7% (41 of 49, 95% CI, 70.3% to 92.7%) of patients with primary cure remained free of recurrence. Heat treatment was well tolerated; adverse effects were occasional mild local skin reactions. Local thermotherapy is a highly effective, simple, cheap and safe treatment for M. ulcerans disease. It has in particular potential as home-based remedy for BU suspicious lesions at community level where laboratory confirmation is not available. ISRCT 72102977. © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America.

  9. A Randomized, Controlled, Multicenter Clinical Trial Comparing Pemetrexed/Cisplatin and Gemcitabine/Cisplatin as First-line Treatment for Advanced Nonsquamous Non-small Cell Lung Cancer

    Directory of Open Access Journals (Sweden)

    Yan HUANG

    2012-10-01

    Full Text Available Background and objective Platinum-based doublet chemotherapy is still the standard first-line treatment for non-small cell lung cancer (NSCLC. Previous studies have demonstrated that pemetrexed combined with platinum had promising efficacy and safety profile in NSCLC, especially in patients with nonsquamous NSCLC. This trial was conducted to evaluate the efficacy and safety of pemetrexed made in China as first-line treatment. Methods The present study was a randomized, controlled, multicenter clinical trial. Patients were randomly assigned (1:1 to receive cisplatin plus pemetrexed chemotherapy (PC group or gemcitabine plus cisplatin (GC group every 3 weeks. The primary end point was progression free survival (PFS and the secondary end points included 1 year survival rate, objective response rate (ORR, survival without grade 3/4 toxicity (SWT3/4 and safety profile. Results A total of 288 patients from 20 institutions across China were enrolled into the study. Based on the Full Analyses Set (FAS, the PFS was 168 days (5.6 months vs 140 days (4.7 months (P=0.16, one year survival rate was 50.0% vs 54.9% (P=0.47, ORR was 24.4% vs 14.2% (P=0.06 in the PC group and the GC group, respectively; Survival without grade 3/4 toxicity was 11.3 months in GC group vs 8.1 months in PC group (P=0.23. In terms of the safety, side effects were less observed on the PC group (81.95% vs 93.75%, P=0.003. The main side effects included leukopenia, neutropenia, emesis, anemia, thrombopenia. Conclusion The both regimens have similar efficacy as the treatment for advanced nonsquamous NSCLC, but pemetrexed plus cisplatin regimen has better safety profile and seems to have longer PFS, which makes it a new option as the first line setting.

  10. Clinical Efficacy and Safety of Benjakul Remedy Extract for Treating Primary Osteoarthritis of Knee Compared with Diclofenac: Double Blind, Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Patamaporn Rachawat

    2017-01-01

    Full Text Available Background. The purpose of this study was to investigate the clinical efficacy and safety of Benjakul (BJK extract for treating primary osteoarthritis (OA of the knee compared with diclofenac. Methods. A phase 2, double blind, randomized, and controlled study was conducted. The BJK group received 300 mg of BJK extract per day, while another group received 75 mg of diclofenac per day. All patients were followed up at 14 and 28 days. The changing of visual analogue scale (VAS for pain, 100-meter walking times, the modified Thai WOMAC index scores, and the global assessment were evaluated for efficacy. For safety issue, clinical signs and symptoms, complete physical examination, and renal and liver function were evaluated. Results. 39 and 38 patients for BJK extract group and diclofenac group were evaluated. For efficacy, all patients from both groups reported a decrease in the VAS pain score and 100-meter walking times but only the diclofenac group showed significant reduction of both measurements when compared with day 0. The modified Thai WOMAC scores of both groups were significantly reduced from baseline. However, all efficacy outcomes were not significantly different for both groups. For safety outcomes, the patients from both groups had no severe adverse events reported and only BJK had no toxicity in renal and liver functions. Conclusions. The BJK remedy extract showed equal clinical efficacy in relieving symptoms of OA knee when compared with diclofenac.

  11. Construction of ethics in clinical research: clinical trials registration

    OpenAIRE

    C. A. Caramori

    2007-01-01

    Scientific development that has been achieved through decades finds in clinical research a great possibility of translating findings to human health application. Evidence given by clinical trials allows everyone to have access to the best health services. However, the millionaire world of pharmaceutical industries has stained clinical research with doubt and improbability. Study results (fruits of controlled clinical trials) and scientific publications (selective, manipulated and with wrong c...

  12. Best clinical trials reported in 2010.

    Science.gov (United States)

    Garner, John B; Grayburn, Paul A; Yancy, Clyde W

    2011-07-01

    Each year, a number of clinical trials emerge with data sufficient to change clinical practice. Determining which findings will result in practice change and which will provide only incremental benefit can be a dilemma for clinicians. The authors review selected clinical trials reported in 2010 in journals, at society meetings, and at conferences, focusing on those studies that have the potential to change clinical practice. This review offers 3 separate means of analysis: an abbreviated text summary, organized by subject area; a comprehensive table of relevant clinical trials that provides a schematic review of the hypotheses, interventions, methods, primary end points, results, and implications; and a complete bibliography for further reading as warranted. It is hoped that this compilation of relevant clinical trials and their important findings released in 2010 will be of benefit in the everyday practice of cardiovascular medicine. Copyright © 2011 Elsevier Inc. All rights reserved.

  13. Comparative Study Between the Effect of Myofascial Release Using M2T Blade and Kinesiotape on Recreational Badminton Shoulder Pain Subjects: A Randomised Clinical Trial

    Directory of Open Access Journals (Sweden)

    Varun Naik

    2017-05-01

    Full Text Available Background: Shoulder pain is one of the most common conditions seen in recreational badminton players. It is caused due to repeated movements at the shoulder joint which further limits the range of motion and hence hampers the activities of daily living. M2T helps to release the myofascial tightness which causes the pain. Kinesiotape also helps in increasing the range of motion. Patients and Methods: Thirty recreational shoulder pain subjects were assessed and treated between the age group of 18-30 years at the KLE University’s Indoor Stadium, Jawaharlal Nehru Medical College, Belagavi, Karnataka, India. Methods: The recreational shoulder pain subjects were divided into Group “A” and Group “B” by Randomized clinical trial. Outcome measures used were the visual analogue scale (VAS for pain and the Disability of Arm, Hand, and Shoulder (DASH. VAS and DASH were assessed pre-treatment and post-treatment. Results: Inter-group comparison for both the groups had differences but showed no statistical significance. Hence based on results it can be concluded that both the treatment techniques are effective in reducing pain and increasing ability at the shoulder joint.

  14. A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol

    Directory of Open Access Journals (Sweden)

    Enrique Gómez-Barrena

    2018-01-01

    Full Text Available ORTHOUNION is a multicentre, open, comparative, three-arm, randomized clinical trial (EudraCT number 2015-000431-32 to compare the efficacy, at one and two years, of autologous human bone marrow-derived expanded mesenchymal stromal cell (hBM-MSC treatments versus iliac crest autograft (ICA to enhance bone healing in patients with diaphyseal and/or metaphysodiaphyseal fracture (femur, tibia, and humerus status of atrophic or oligotrophic nonunion (more than 9 months after the acute fracture, including recalcitrant cases after failed treatments. The primary objective is to determine if the treatment with hBM-MSCs combined with biomaterial is superior to ICA in obtaining bone healing. If confirmed, a secondary objective is set to determine if the dose of 100 × 106 hBM-MSCs is noninferior to that of 200 × 106 hBM-MSCs. The participants (n=108 will be randomly assigned to either the experimental low dose (n=36, the experimental high dose (n=36, or the comparator arm (n=36 using a central randomization service. The trial will be conducted in 20 clinical centres in Spain, France, Germany, and Italy under the same clinical protocol. The confirmation of superiority for the proposed ATMP in nonunions may foster the future of bone regenerative medicine in this indication. On the contrary, absence of superiority may underline its limitations in clinical use.

  15. A Multicentric, Open-Label, Randomized, Comparative Clinical Trial of Two Different Doses of Expanded hBM-MSCs Plus Biomaterial versus Iliac Crest Autograft, for Bone Healing in Nonunions after Long Bone Fractures: Study Protocol.

    Science.gov (United States)

    Gómez-Barrena, Enrique; Padilla-Eguiluz, Norma G; Avendaño-Solá, Cristina; Payares-Herrera, Concepción; Velasco-Iglesias, Ana; Torres, Ferran; Rosset, Philippe; Gebhard, Florian; Baldini, Nicola; Rubio-Suarez, Juan C; García-Rey, Eduardo; Cordero-Ampuero, José; Vaquero-Martin, Javier; Chana, Francisco; Marco, Fernando; García-Coiradas, Javier; Caba-Dessoux, Pedro; de la Cuadra, Pablo; Hernigou, Philippe; Flouzat-Lachaniette, Charles-Henri; Gouin, François; Mainard, Didier; Laffosse, Jean Michel; Kalbitz, Miriam; Marzi, Ingo; Südkamp, Norbert; Stöckle, Ulrich; Ciapetti, Gabriela; Donati, Davide Maria; Zagra, Luigi; Pazzaglia, Ugo; Zarattini, Guido; Capanna, Rodolfo; Catani, Fabio

    2018-01-01

    ORTHOUNION is a multicentre, open, comparative, three-arm, randomized clinical trial (EudraCT number 2015-000431-32) to compare the efficacy, at one and two years, of autologous human bone marrow-derived expanded mesenchymal stromal cell (hBM-MSC) treatments versus iliac crest autograft (ICA) to enhance bone healing in patients with diaphyseal and/or metaphysodiaphyseal fracture (femur, tibia, and humerus) status of atrophic or oligotrophic nonunion (more than 9 months after the acute fracture, including recalcitrant cases after failed treatments). The primary objective is to determine if the treatment with hBM-MSCs combined with biomaterial is superior to ICA in obtaining bone healing. If confirmed, a secondary objective is set to determine if the dose of 100 × 10 6 hBM-MSCs is noninferior to that of 200 × 10 6 hBM-MSCs. The participants ( n = 108) will be randomly assigned to either the experimental low dose ( n = 36), the experimental high dose ( n = 36), or the comparator arm ( n = 36) using a central randomization service. The trial will be conducted in 20 clinical centres in Spain, France, Germany, and Italy under the same clinical protocol. The confirmation of superiority for the proposed ATMP in nonunions may foster the future of bone regenerative medicine in this indication. On the contrary, absence of superiority may underline its limitations in clinical use.

  16. Sample size determination in clinical trials with multiple endpoints

    CERN Document Server

    Sozu, Takashi; Hamasaki, Toshimitsu; Evans, Scott R

    2015-01-01

    This book integrates recent methodological developments for calculating the sample size and power in trials with more than one endpoint considered as multiple primary or co-primary, offering an important reference work for statisticians working in this area. The determination of sample size and the evaluation of power are fundamental and critical elements in the design of clinical trials. If the sample size is too small, important effects may go unnoticed; if the sample size is too large, it represents a waste of resources and unethically puts more participants at risk than necessary. Recently many clinical trials have been designed with more than one endpoint considered as multiple primary or co-primary, creating a need for new approaches to the design and analysis of these clinical trials. The book focuses on the evaluation of power and sample size determination when comparing the effects of two interventions in superiority clinical trials with multiple endpoints. Methods for sample size calculation in clin...

  17. Increase in Periodontal Interleukin-1β Gene Expression Following Osseous Resective Surgery Using Conventional Rotary Instruments Compared with Piezosurgery: A Split-Mouth Randomized Clinical Trial.

    Science.gov (United States)

    Aimetti, Mario; Ferrarotti, Francesco; Bergandi, Loredana; Saksing, Laura; Parducci, Francesca; Romano, Federica

    2016-01-01

    The purpose of this study was to evaluate the early inflammatory response following osseous resective surgery (ORS) with Piezosurgery compared to commonly used diamond burs. A sample was selected of 24 bilateral posterior sextants requiring ORS in 12 chronic periodontitis patients in a split-mouth design. In 12 sextants, bone recontouring was performed using a piezoelectric device. In the contralateral sextants, rotary instruments were used. Sextants treated with Piezosurgery obtained similar 12-month clinical results but lower postsurgical gene expression of interleukin-1β (IL-1β), a well-known proinflammatory cytokine, and lower patient morbidity compared with sextants treated with rotary instruments. In spite of the longer surgical time, the use of Piezosurgery for ORS seems to promote more favorable wound healing compared with rotary instruments, as the lower pain and the low levels of IL-1β mRNA at the surgical sites suggest a milder underlying inflammatory response.

  18. Evaluation of the physicians‘ of n hospital opinion on clinical trials of medicinal products

    OpenAIRE

    Videikaitė, Lina

    2014-01-01

    Aim of the research. To evaluate the physicians‘ of N Hospital opinion on clinical trials of medicinal products. Objectives. To evaluate the factors affecting physicians' motivation to perform clinical trials of medicinal products as well as those that prevent the physicians getting involved in the trials. To assess physicians' attitude towards clinical trials of medicinal products. To compare the opinions of physicians who have and have’nt participated in clinical trials. Methods of...

  19. Telemedicine is Cost Effective Compared with Standard Care in Type 2 Diabetes Mellitus - A Randomized Trial with an Economic Analysis in an Outpatient Clinic

    Directory of Open Access Journals (Sweden)

    Ole Winther Rasmussen

    2017-07-01

    Full Text Available Background New approaches on outpatient control are required and need testing to motivate and give feedback to the patients at home. Telemedicine has the capacity to achieve this, optimizing care through motivation and direct feedback adapted to milieu of the patient and at the same time to keep the total cost at a reasonable level. Objectives We evaluated the economic and short-time health effect of two different ways of outpatient treatment in patients with type 2 diabetes (T2DM. A health economist calculated the total cost of replacing the standard care with telemedicine. Methods Forty patients with T2DM in the outpatient department were prospectively randomized to either treatment at home by telemedicine with video conferences or the standard treatment with regular visits at the clinic over six months. The trial lasted for six months. HbA1c, blood glucose, 24-h blood pressure, cholesterol levels and albuminuria were measured. The telephone company, TDC, Denmark delivered and serviced a TandBerg E20 video telephone to the patients in the telemedicine group. The economic analysis was performed with a Danish hospital payer’s cost perspective. Cost data were based on the measured time consumption per home-based video telephone, consultations at out-patient clinic, telemedicine set-up equipment, and hospital operating cost. Sample size calculation concluded that 11 patients were needed in each group. Results The reductions in the two treatments resulted in differences between telemedicine vs. standard, in HbA1c (9.1 to 7.7 % vs. 8.1 to 7.2 %, mean blood glucose (12 to 9.9 mmol/L vs.10 to 8.7 mmol/L, and cholesterol (3.8 to 3.4 vs. 4.3 to 3.9 mmol/L. Total cholesterol was different at three and at six months between the two groups (P < 0.05. Similar values were found at all time points in the two groups in LDL, body weight, and diurnal blood pressure. At a six months follow-up, the standard care proved more costly (53.9 vs. 41.3€ per 1 % HbA1c

  20. The Scandinavian Propaten(®) trial - 1-year patency of PTFE vascular prostheses with heparin-bonded luminal surfaces compared to ordinary pure PTFE vascular prostheses - a randomised clinical controlled multi-centre trial

    DEFF Research Database (Denmark)

    Lindholt, J S; Gottschalksen, B; Johannesen, N

    2011-01-01

    To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study.......To compare 1-year potencies' of heparin-bonded PTFE [(Hb-PTFE) (Propaten(®))] grafts with those of ordinary polytetraflouroethylene (PTFE) grafts in a blinded, randomised, clinically controlled, multi-centre study....

  1. Microbicide clinical trial adherence: insights for introduction.

    Science.gov (United States)

    Woodsong, Cynthia; MacQueen, Kathleen; Amico, K Rivet; Friedland, Barbara; Gafos, Mitzy; Mansoor, Leila; Tolley, Elizabether; McCormack, Sheena

    2013-04-08

    After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants' adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.

  2. Comparing the Efficacy of CBASP with Two Versions of CBT for Depression in a Routine Care Center: A Randomized Clinical Trial.

    Science.gov (United States)

    Rief, Winfried; Bleichhardt, Gabi; Dannehl, Katharina; Euteneuer, Frank; Wambach, Katrin

    2018-04-12

    The cognitive-behavioral analysis system of psychotherapy (CBASP) was developed for the treatment of chronic, early-onset depression. However, it is unclear whether this approach can be recommended for depression in general (episodic and chronic), and no direct comparisons between CBASP with different versions of cognitive-behavioral therapy (CBT) exist. A randomized controlled trial compared 3 treatment conditions (all lasting 16 sessions) with a waiting list group (WL): CBASP, CBT with a focus on physical exercise (CBT-E), and CBT with a focus on pleasurable, low-energy and mindful activities (CBT-M). We included 173 patients and involved 41 therapists. Assessments were at baseline, after session 8, and at the end of treatment. Our primary outcome Beck Depression Inventory-II indicated a general advantage of the CBT arms compared to CBASP [F(6, 154.5) = 4.2, p = 0.001], with significant contrasts in particular in favor of CBT-E. Effect sizes against WL were d = 0.91 (CBT-E), 0.87 (CBT-M), and 0.47 (CBASP). A triple interaction with an additional factor "chronic versus episodic depression" [F(6, 142.7) = 2.2, p = 0.048] indicated that the treatments resulted in different outcomes, with best results again for CBT-E in particular in episodic depression. Responder rates indicated significant improvements (56% in both CBT arms, 34% in the CBASP arm, 3.4% in WL; intention-to-treat samples). As compared to CBASP, response rates were significantly higher for CBT-E (OR = 2.48; 95% CI = 1.02-6.00) and CBT-M (OR = 2.46; 95% CI = 1.01-6.01). CBASP was more effective than WL, but less effective than the 2 CBT arms. This was mainly caused by an advantage of CBT interventions in episodic depression. © 2018 S. Karger AG, Basel.

  3. Future clinical trials in DIPG: bringing epigenetics to the clinic

    Directory of Open Access Journals (Sweden)

    Andres E. Morales La Madrid

    2015-07-01

    Full Text Available In spite of major recent advances in DIPG molecular characterization, this body of knowledge has not yet translated into better treatments.To date,more than 250 clinical trials evaluating radiotherapy along with conventional cytotoxic chemotherapy as well as newer biologic agents,have failed to improve the dismal outcome when compared to palliative radiation alone.The biology of DIPG remained unknown until recently when the neurosurgical expertise along with the recognition by the scientific and clinical community of the importance of tissue sampling at diagnosis;ideally in the context of a clinical trial and by trained neurosurgical teams to maximize patient safety.These pre-treatment tumor samples,and others coming from tissue obtained post-mortem,have yielded new insights into DIPG molecular biology.We now know that DIPG comprises a heterogeneous disease with variable molecular phenotypes, different from adult high grade glioma,other non-pontine pediatric high grade gliomas and even between pontine gliomas.The discovery of histone H3.3 or H3.1 mutations has been an important step forward in understanding tumor formation,maintenance and progression.Pharmacologic reversal of DIPG histone demethylation therefore offers an important potential intervention strategy for the treatment of DIPG.To date,clinical trials of newly diagnosed or progressive DIPG with epigenetic modifiers have been unsuccessful.Whether this failure represents limited activity of the agents used,their CNS penetration,redundant pathways within the tumor,or the possibility that histone mutations are necessary only to initiate DIPGs but not maintain their growth,suggest that a great deal still needs to be elucidated in both the underlying biology of these pathways,and the drugs designed to target them.In this review, we discuss the role of both epigenetic and genetic mutations within DIPG and the development of treatment strategies directed against the unique abnormalities

  4. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

    Science.gov (United States)

    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  5. Clinical trials: bringing research to the bedside.

    Science.gov (United States)

    Arvay, C A

    1991-02-01

    Over the years, clinical trials with their structured treatment plans and multicenter involvement have been instrumental in developing new treatments and establishing standard of care therapy. While clinical trials strive to advance medical knowledge, they provide scientifically sound, state of the art care and their use should be increased. The Brain Tumor Cooperative Group, one such NCI-sponsored cooperative group, has been the primary group for the treatment of malignant gliomas. As the field of neuro-oncology expands, the neuroscience nurse needs to develop an understanding of clinical trials and their operation. The nurse is in an optimal position to support medical research and the research participant.

  6. clinical trials of Sutherlandia frutescens

    African Journals Online (AJOL)

    economic and political imperatives surrounding randomised controlled trials and the ambiguous, or even ..... the medicinal properties of the plant, as reported both in the book, and also in the .... London, UK: Harvard University Press. Latour, B.

  7. Efficacy of an electrically active sonic toothbrush and an oscillating/rotating powered toothbrush in the reduction of plaque and gingivitis: A comparative clinical trial

    Directory of Open Access Journals (Sweden)

    Himanshu Dadlani

    2010-01-01

    Full Text Available Objectives: The purpose of the present study was to clinically evaluate and compare the efficacy of an electrically active sonic toothbrush and an oscillating/rotating powered toothbrush in the reduction of plaque and gingivitis. Material and Methods: For this study, 40 healthy student volunteers (20 males, 20 females were selected. The subjects were randomly assigned into two groups by a second examiner; one group used a current producing sonic toothbrush and the other group used a battery powered toothbrush. Plaque Index, Modified Gingival Index and Gingival Bleeding Index were assessed at baseline, 15 th day, 30 th day, 45 th day and 60 th day. Results: All the baseline indices appeared to be well balanced. At the end of the study, reduction in plaque index, modified gingival index and gingival bleeding index were statistically highly significant during each interval for both the toothbrushes. The difference in reduction of clinical parameters between the two toothbrushes was statistically non significant. Conclusion: Both the toothbrushes used in this study were clinically effective in removing plaque and improving gingival health.

  8. Early rehabilitation after total knee replacement surgery: a multicenter, noninferiority, randomized clinical trial comparing a home exercise program with usual outpatient care.

    Science.gov (United States)

    Han, Annie S Y; Nairn, Lillias; Harmer, Alison R; Crosbie, Jack; March, Lyn; Parker, David; Crawford, Ross; Fransen, Marlene

    2015-02-01

    To determine, at 6 weeks postsurgery, if a monitored home exercise program (HEP) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement (TKR) surgery for osteoarthritis. We conducted a multicenter, randomized clinical trial. Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation (n = 196) or the HEP (n = 194). Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales, knee range of motion, and the 50-foot walk time. The upper bound of the 95% confidence interval (95% CI) mean difference favoring usual care was used to determine noninferiority. At 6 weeks after surgery there were no significant differences between usual care and HEP, respectively, for pain (7.4 and 7.2; 95% CI mean difference [MD] -0.7, 0.9), physical function (22.5 and 22.4; 95% CI MD -2.5, 2.6), knee flexion (96° and 97°; 95% CI MD -4°, 2°), knee extension (-7° and -6°; 95% CI MD -2°, 1°), or the 50-foot walk time (12.9 and 12.9 seconds; 95% CI MD -0.8, 0.7 seconds). At 6 weeks, 18 patients (9%) allocated to usual care and 11 (6%) to the HEP did not achieve 80° knee flexion. There was no difference between the treatment allocations in the number of hospital readmissions. The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR. Copyright © 2015 by the American College of Rheumatology.

  9. Comparative Efficacy of Aloe vera and Benzydamine Mouthwashes on Radiation-induced Oral Mucositis: A Triple-blind, Randomised, Controlled Clinical Trial.

    Science.gov (United States)

    Sahebjamee, Mahnaz; Mansourian, Arash; Hajimirzamohammad, Mohammad; Mohammad, Haji Mirza Mohammad; Zadeh, Mohsen Taghi; Bekhradi, Reza; Kazemian, Ali; Manifar, Soheila; Ashnagar, Sajjad; Doroudgar, Kiavash

    2015-01-01

    To compare the efficacy of an Aloe vera mouthwash with a benzydamine mouthwash in the alleviation of radiation- induced mucositis in head and neck cancer patients using a triple-blind, randomised controlled trial. Twenty-six eligible head and neck cancer patients who were to receive conventional radiation therapy at the radiation oncology department were randomised to receive an Aloe vera mouthwash or a benzydamine mouthwash. Mucositis severity was assessed during the course of radiation therapy using the WHO grading system. At baseline, there was no difference in the distribution of mucositis severity between the two groups. The mean interval between radiation therapy and onset of mucositis was similar for both groups (Aloe vera 15.69±7.77 days, benzydamine 15.85±12.96 days). The mean interval between the start of radiation therapy and the maximum severity of mucositis were was also similar in both the Aloe vera and benzydamine groups (Aloe vera 23.38±10.75 days, benzydamine 23.54±15.45 days). Mean changes of mucositis severity over time in both groups were statistically similar and the effect of both treatments did not change signficantly with time (p=0.09). Aloe vera mouthwash was as beneficial as benzydamine mouthwash in alleviating the severity of radiation-induced mucositis and showed no side effects. The Aloe vera mouthwash could be an alternative agent in the treatment of radiation-induced mucositis in patients with head and neck cancers.

  10. A Randomized Trial (Irish Clinical Oncology Research Group 97-01) Comparing Short Versus Protracted Neoadjuvant Hormonal Therapy Before Radiotherapy for Localized Prostate Cancer.

    LENUS (Irish Health Repository)

    Armstrong, John G

    2010-08-24

    PURPOSE: To examine the long-term outcomes of a randomized trial comparing short (4 months; Arm 1) and long (8 months; Arm 2) neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. METHODS AND MATERIALS: Between 1997 and 2001, 276 patients were enrolled and the data from 261 were analyzed. The stratification risk factors were prostate-specific antigen level >20 ng\\/mL, Gleason score >\\/=7, and Stage T3 or more. The intermediate-risk stratum had one factor and the high-risk stratum had two or more. Staging was done from the bone scan and computed tomography findings. The primary endpoint was biochemical failure-free survival. RESULTS: The median follow-up was 102 months. The overall survival, biochemical failure-free survival. and prostate cancer-specific survival did not differ significantly between the two treatment arms, overall or at 5 years. The cumulative probability of overall survival at 5 years was 90% (range, 87-92%) in Arm 1 and 83% (range, 80-86%) in Arm 2. The biochemical failure-free survival rate at 5 years was 66% (range, 62-71%) in Arm 1 and 63% (range, 58-67%) in Arm 2. CONCLUSION: No statistically significant difference was found in biochemical failure-free survival between 4 months and 8 months of neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer.

  11. TORPEDO: Prospective, double blind, randomized clinical trial comparing the use of Ketorolac verse placebo during live donor nephrectomy for kidney transplant

    Directory of Open Access Journals (Sweden)

    Jeffrey Campsen

    2017-06-01

    Full Text Available The aim of this pilot study was to determine if the use of Ketorolac for donor nephrectomies could decrease the use of narcotics. Methods: This is a prospective, double blind, randomized trial involving patients undergoing nephrectomy for live donor kidney transplantation. Three arms: 1. Ketorolac 30 mg IV×1 in the OR, then ketorolac 15 mg IV every 6 h for 7 doses. 2. Ketorolac 30 mg IV×1 in the OR, then placebo IV every 6 h for 7 doses. 3. Placebo IV×1 in the OR, then placebo IV every 6 h for 7 doses. Outcomes: blood loss, mortality, renal function, cumulative narcotic use, length of hospital stay (LOS, and urinary retention. Results: There were no patient deaths, blood transfusions or renal dysfunction in any study arm. Arm 1 had less narcotic use, reduced length of stay, and reduced urinary retention than Arm 3. Conclusion: There was reduced LOS, less narcotic use and less urinary retention in the Ketorolac group (Arm 1 versus the placebo group (Arm 3. Based on these results we will proceed with a larger study to compare the use of non-opioid analgesics in donor nephrectomies.

  12. Marketing and clinical trials: a case study

    Directory of Open Access Journals (Sweden)

    Entwistle Vikki A

    2007-11-01

    Full Text Available Abstract Background Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Methods Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. Results The case study demonstrates that trials need various categories of people to buy in – hence, to be successful, trialists must embrace marketing strategies to some extent. Conclusion The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  13. Marketing and clinical trials: a case study.

    Science.gov (United States)

    Francis, David; Roberts, Ian; Elbourne, Diana R; Shakur, Haleema; Knight, Rosemary C; Garcia, Jo; Snowdon, Claire; Entwistle, Vikki A; McDonald, Alison M; Grant, Adrian M; Campbell, Marion K

    2007-11-20

    Publicly funded clinical trials require a substantial commitment of time and money. To ensure that sufficient numbers of patients are recruited it is essential that they address important questions in a rigorous manner and are managed well, adopting effective marketing strategies. Using methods of analysis drawn from management studies, this paper presents a structured assessment framework or reference model, derived from a case analysis of the MRC's CRASH trial, of 12 factors that may affect the success of the marketing and sales activities associated with clinical trials. The case study demonstrates that trials need various categories of people to buy in - hence, to be successful, trialists must embrace marketing strategies to some extent. The performance of future clinical trials could be enhanced if trialists routinely considered these factors.

  14. OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of rehabilitation interventions for osteoarthritis.

    Science.gov (United States)

    Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L

    2015-05-01

    A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well. Copyright © 2015 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

  15. Moderate carbohydrate, moderate protein weight loss diet reduces cardiovascular disease risk compared to high carbohydrate, low protein diet in obese adults: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Evans Ellen M

    2008-11-01

    Full Text Available Abstract Background To evaluate the metabolic effects of two weight loss diets differing in macronutrient composition on features of dyslipidemia and post-prandial insulin (INS response to a meal challenge in overweight/obese individuals. Methods This study was a parallel-arm randomized 4 mo weight loss trial. Adults (n = 50, 47 ± 7 y matched on BMI (33.6 ± 0.6 kg/m2, P = 0.79 consumed energy restricted diets (deficit ~500 kcal/d: PRO (1.6 g.kg-1.d-1 protein and -1.d-1 protein and > 220 g/d carbohydrate for 4 mos. Meal challenges of respective diets were utilized for determination of blood lipids and post-prandial INS and glucose response at the beginning and end of the study. Results There was a trend for PRO to lose more weight (-9.1% vs. -7.3%, P = 0.07 with a significant reduction in percent fat mass compared to CHO (-8.7% vs. -5.7%; P = 0.03. PRO also favored reductions in triacylglycerol (-34% vs. -14%; P P = 0.05; however, CHO favored reduction in LDL-C (-7% vs. +2.5%; P P P Conclusion A weight loss diet with moderate carbohydrate, moderate protein results in more favorable changes in body composition, dyslipidemia, and post-prandial INS response compared to a high carbohydrate, low protein diet suggesting an additional benefit beyond weight management to include augmented risk reduction for metabolic disease.

  16. Problematic trial detection in ClinicalTrials.gov

    NARCIS (Netherlands)

    Hartgerink, C.H.J.; George, Stephen

    2015-01-01

    Clinical trials are crucial in determining the effectiveness of treatments and directly affect clinical and policy decisions. These decisions are undermined if the data are problematic due to data fabrication or other errors. Researchers have worked on developing statistical methods to detect

  17. Health literacy and usability of clinical trial search engines.

    Science.gov (United States)

    Utami, Dina; Bickmore, Timothy W; Barry, Barbara; Paasche-Orlow, Michael K

    2014-01-01

    Several web-based search engines have been developed to assist individuals to find clinical trials for which they may be interested in volunteering. However, these search engines may be difficult for individuals with low health and computer literacy to navigate. The authors present findings from a usability evaluation of clinical trial search tools with 41 participants across the health and computer literacy spectrum. The study consisted of 3 parts: (a) a usability study of an existing web-based clinical trial search tool; (b) a usability study of a keyword-based clinical trial search tool; and (c) an exploratory study investigating users' information needs when deciding among 2 or more candidate clinical trials. From the first 2 studies, the authors found that users with low health literacy have difficulty forming queries using keywords and have significantly more difficulty using a standard web-based clinical trial search tool compared with users with adequate health literacy. From the third study, the authors identified the search factors most important to individuals searching for clinical trials and how these varied by health literacy level.

  18. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    , in particular with respect to collaboration with the trial sponsor and to analytic pitfalls. The advantages of creating screening databases in conjunction with a given clinical trial are described; and finally, the potential for posttrial database studies to become a platform for training young scientists...

  19. Critical concepts in adaptive clinical trials

    Directory of Open Access Journals (Sweden)

    Park JJH

    2018-03-01

    Full Text Available Jay JH Park,1 Kristian Thorlund,2,3 Edward J Mills2,3 1Department of Medicine, University of British Columbia, Vancouver, BC, Canada; 2Department of Health Research Methods, Evidence, and Impact (HEI, McMaster University, Hamilton, ON, Canada; 3The Bill and Melinda Gates Foundation, Seattle, WA, USA Abstract: Adaptive clinical trials are an innovative trial design aimed at reducing resources, decreasing time to completion and number of patients exposed to inferior interventions, and improving the likelihood of detecting treatment effects. The last decade has seen an increasing use of adaptive designs, particularly in drug development. They frequently differ importantly from conventional clinical trials as they allow modifications to key trial design components during the trial, as data is being collected, using preplanned decision rules. Adaptive designs have increased likelihood of complexity and also potential bias, so it is important to understand the common types of adaptive designs. Many clinicians and investigators may be unfamiliar with the design considerations for adaptive designs. Given their complexities, adaptive trials require an understanding of design features and sources of bias. Herein, we introduce some common adaptive design elements and biases and specifically address response adaptive randomization, sample size reassessment, Bayesian methods for adaptive trials, seamless trials, and adaptive enrichment using real examples. Keywords: adaptive designs, response adaptive randomization, sample size reassessment, Bayesian adaptive trials, seamless trials, adaptive enrichment

  20. Clinical trial data analysis using R

    National Research Council Canada - National Science Library

    Chen, Ding-Geng; Peace, Karl E

    2011-01-01

    .... Case studies demonstrate how to select the appropriate clinical trial data. The authors introduce the corresponding biostatistical analysis methods, followed by the step-by-step data analysis using R...