Long-term outcome of childhood-onset complicated nephrotic syndrome after a multicenter, double-blind, randomized, placebo-controlled trial of rituximab

Background: The CHInese Medicine NeuroAiD Efficacy on Stroke recovery (CHIMES) study was an international randomized double-blind placebo-controlled trial of MLC601 (NeuroAiD) in subjects with cerebral infarction of intermediate severity within 72 h. CHIMES-E (Extension) aimed at evaluating the effects of the initial 3-month treatment with MLC601 on long-term outcome for up to 2 years. Methods: All subjects randomized in CHIMES were eligible for CHIMES-E. Inclusion criteria for CHIMES were age ≥18, baseline National Institute of Health Stroke Scale of 6-14, and pre-stroke modified Rankin Scale (mRS) ≤1. Initial CHIMES treatment allocation blinding was maintained, although no further study treatment was provided in CHIMES-E. Subjects received standard care and rehabilitation as prescribed by the treating physician. mRS, Barthel Index (BI), and occurrence of medical events were ascertained at months 6, 12, 18, and 24. The primary outcome was mRS at 24 months. Secondary outcomes were mRS and BI at other time points. Results: CHIMES-E included 880 subjects (mean age 61.8 ± 11.3; 36% women). Adjusted OR for mRS ordinal analysis was 1.08 (95% CI 0.85-1.37, p = 0.543) and mRS dichotomy ≤1 was 1.29 (95% CI 0.96-1.74, p = 0.093) at 24 months. However, the treatment effect was significantly in favor of MLC601 for mRS dichotomy ≤1 at 6 months (OR 1.49, 95% CI 1.11-2.01, p = 0.008), 12 months (OR 1.41, 95% CI 1.05-1.90, p = 0.023), and 18 months (OR 1.36, 95% CI 1.01-1.83, p = 0.045), and for BI dichotomy ≥95 at 6 months (OR 1.55, 95% CI 1.14-2.10, p = 0.005) but not at other time points. Subgroup analyses showed no treatment heterogeneity. Rates of death and occurrence of vascular and other medical events were similar between groups. Conclusions: While the benefits of a 3-month treatment with MLC601 did not reach statistical significance for the primary endpoint at 2 years, the odds of functional independence defined as mRS ≤1 was significantly increased at 6 months and persisted up to 18 months after a stroke.

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Ciclosporin and azathioprine treatment in severe ulcerative colitis: a double-blind controlled trial to evaluate short and long-term outcome

http://isrctn.org/> ◽

10.1186/isrctn56331683 ◽

2012 ◽

Author(s):

Christopher J Hawkey

Keyword(s):

Ulcerative Colitis ◽

Controlled Trial ◽

Double Blind ◽

Term Outcome ◽

Long Term Outcome ◽

Severe Ulcerative Colitis ◽

Azathioprine Treatment ◽

Short And Long Term

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A double-blind, placebo-controlled trial of triheptanoin in adult polyglucosan body disease and open-label, long-term outcome

Journal of Inherited Metabolic Disease ◽

10.1007/s10545-017-0103-x ◽

2017 ◽

Vol 41 (5) ◽

pp. 877-883 ◽

Cited By ~ 7

Author(s):

Raphael Schiffmann ◽

Mary E. Wallace ◽

Daisy Rinaldi ◽

Isabelle Ledoux ◽

Marie-Pierre Luton ◽

...

Keyword(s):

Controlled Trial ◽

Open Label ◽

Double Blind ◽

Term Outcome ◽

Long Term Outcome ◽

Double Blind Placebo ◽

Polyglucosan Body ◽

Adult Polyglucosan Body Disease

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Faculty Opinions recommendation of Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.13489038.14866158 ◽

2012 ◽

Author(s):

Norman Hertzer

Keyword(s):

Deep Vein Thrombosis ◽

Standard Treatment ◽

Controlled Trial ◽

Term Outcome ◽

Long Term Outcome ◽

Vein Thrombosis ◽

Catheter Directed Thrombolysis ◽

Randomised Controlled ◽

Deep Vein

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Thirty-year outcome of anxiety and depressive disorders and personality status: comprehensive evaluation of mixed symptoms and the general neurotic syndrome in the follow-up of a randomised controlled trial

Psychological Medicine ◽

10.1017/s0033291721000878 ◽

2021 ◽

pp. 1-10

Author(s):

Peter Tyrer ◽

Helen Tyrer ◽

Tony Johnson ◽

Min Yang

Keyword(s):

Randomised Controlled Trial ◽

Panic Disorder ◽

Controlled Trial ◽

Anxiety And Depression ◽

Term Outcome ◽

Long Term Outcome ◽

Personality Dysfunction ◽

Randomised Controlled ◽

Anxiety Depression

Abstract Background Cohort studies of the long-term outcome of anxiety, depression and personality status rarely join together. Methods Two hundred and ten patients recruited with anxiety and depression to a randomised controlled trial between 1983 and 1987 (Nottingham Study of Neurotic Disorder) were followed up over 30 years. At trial entry personality status was assessed, together with the general neurotic syndrome, a combined diagnosis of mixed anxiety–depression (cothymia) linked to neurotic personality traits. Personality assessment used a procedure allowing conversion of data to the ICD-11 severity classification of personality disorder. After the original trial, seven further assessments were made. Observer and self-ratings of psychopathology and global outcome were also made. The primary outcome at 30 years was the proportion of those with no Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis. Data were analysed using multilevel repeated measures models that adjusted for age and gender. Missing data were assumed to be missing at random, and the models allowed all subjects to be included in the analysis with missing data automatically handled in the model estimation. Results At 30 years, 69% of those with a baseline diagnosis of panic disorder had no DSM diagnosis compared to 37–47% of those with generalised anxiety disorder, dysthymia or mixed symptoms (cothymia) (p = 0.027). Apart from those with no personality dysfunction at entry all patients had worse outcomes after 30 years with regard to total psychopathology, anxiety and depression, social function and global outcome. Conclusions The long-term outcome of disorders formerly called ‘neurotic’ is poor with the exception of panic disorder. Personality dysfunction accentuates poor recovery.

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Long-term outcome of two forms of randomised benzodiazepine discontinuation

The British Journal of Psychiatry ◽

10.1192/bjp.bp.105.012039 ◽

2006 ◽

Vol 188 (2) ◽

pp. 188-189 ◽

Cited By ~ 19

Author(s):

R. C. Oude Voshaar ◽

W. J. M. J. Gorgels ◽

A. J. J. Mol ◽

A. J. L. M. Van Balkom ◽

J. Mulder ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Controlled Trial ◽

Term Outcome ◽

Long Term Outcome ◽

Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

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LONG-TERM OUTCOME FOR CHILDREN WITH MINIMAL-CHANGE NEPHROTIC SYNDROME

The Lancet ◽

10.1016/s0140-6736(85)91387-x ◽

1985 ◽

Vol 325 (8425) ◽

pp. 368-370 ◽

Cited By ~ 117

Author(s):

R.S. Trompeter ◽

J. Hicks ◽

B.W. Lloyd ◽

R.H.R. White ◽

J.S. Cameron

Keyword(s):

Nephrotic Syndrome ◽

Minimal Change Nephrotic Syndrome ◽

Minimal Change ◽

Term Outcome ◽

Long Term Outcome

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Long term outcome of childhood onset headache: A prospective community study

Cephalalgia ◽

10.1177/0333102417727536 ◽

2017 ◽

Vol 38 (6) ◽

pp. 1159-1166 ◽

Cited By ~ 9

Author(s):

Matti Sillanpää ◽

Maiju M Saarinen

Keyword(s):

Young Adulthood ◽

Childhood Onset ◽

Term Outcome ◽

Long Term Outcome ◽

Recurrent Headache ◽

Childhood Migraine ◽

Early School ◽

Increased Risk

Purpose To examine prevalence, course, and long-term outcome of childhood migraine and other headaches. Method Using questionnaires, 1185 children were followed for recurrent headaches at ages seven, 14 and 32 years, respectively. Results At age seven years, 4.0% of the 1185 children (girls 3.7%, boys 4.3%) had migraine and 24% (25%/23%) had nonmigrainous headache. In adulthood, 16% (22%/8%) had migraine and 60% (64%/54%) nonmigrainous headache. Childhood migraine persisted into adulthood in 65% of females and 21% of males, and nonmigrainous headache in 62% and 59%, respectively. After childhood, 17% of females and 7% of males started to have episodes of migraine. No recurrent headache during the follow-up was reported by 11% (6%/16%). In a multivariate analysis, compared with no childhood headache, childhood migraine increased the risk of adulthood migraine by 3.36-fold (95% CI 1.94–5.82) and that of nonmigrainous headache by 1.72-fold (1.14–2.60). Discussion and conclusions Headaches are generally as common in preschool girls as boys. From early school years, headaches steadily increase up to young adulthood, but among boys the prevalence levels off after adolescence. About two thirds of children experienced changes in their headache status during a 25-year follow-up. Any kind of recurrent headache at school entry predicts an increased risk of headache in young adulthood. Special attention should be paid to girls and particularly those girls who have recurrent headache when they start school.

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Hyperglycemia in the Posttransplant Period: NODAT vs Posttransplant Diabetes Mellitus

Journal of the Endocrine Society ◽

10.1210/js.2018-00227 ◽

2018 ◽

Vol 2 (11) ◽

pp. 1314-1319 ◽

Cited By ~ 2

Author(s):

Suruchi Gupta ◽

Teresa Pollack ◽

Candice Fulkerson ◽

Kathleen Schmidt ◽

Diana Johnson Oakes ◽

...

Keyword(s):

Insulin Resistance ◽

Liver Transplant ◽

Controlled Trial ◽

Organ Transplant ◽

Long Term Outcomes ◽

Term Outcome ◽

Long Term Outcome ◽

Persistent Hyperglycemia

Abstract Objective To characterize the types of hyperglycemia that occur up to 1 year following liver transplant and to clarify the nomenclature for posttransplant hyperglycemia. Design We analyzed 1-year glycemic follow-up data in 164 patients who underwent liver transplant and who had been enrolled in a randomized controlled trial comparing moderate to intensive insulin therapy to determine if patients had preexisting known diabetes, transient hyperglycemia, persistent hyperglycemia, or new-onset diabetes after transplantation (NODAT). Results Of 119 patients with posttransplant hyperglycemia following hospital discharge, 49 had preexisting diabetes, 5 had insufficient data for analysis, 48 had transient hyperglycemia (16 resolved within 30 days and 32 resolved between 30 days and 1 year), 13 remained persistently hyperglycemic out to 1 year and most likely had preexisting diabetes that had not been diagnosed or insulin resistance/insulinopenia prior to transplant, and 4 had NODAT (i.e., patients with transient hyperglycemia after transplant that resolved but then later truly developed sustained hyperglycemia, meeting criteria for diabetes). Conclusions Distinct categories of patients with hyperglycemia following organ transplant include known preexisting diabetes, persistent hyperglycemia (most likely unknown preexisting diabetes or insulin resistance/insulinopenia), transient hyperglycemia, and NODAT. Those with preexisting diabetes for many years prior to transplant may well have very different long-term outcomes compared with those with true NODAT. Therefore, it would be prudent to classify patients more carefully. Long-term outcome studies are needed to determine if patients with true NODAT have the same poor prognosis as patients with preexisting diabetes (diagnosed and undiagnosed) undergoing transplant.

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