Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial

Background.Suicide is a devastating public health problem and very few biological treatments have been found to be effective for quickly reducing the intensity of suicidal ideation (SI). We have previously shown that a single dose of ketamine, a glutamate N-methyl-d-aspartate (NMDA) receptor antagonist, is associated with a rapid reduction in depressive symptom severity and SI in patients with treatment-resistant depression.Method.We conducted a randomized, controlled trial of ketamine in patients with mood and anxiety spectrum disorders who presented with clinically significant SI (n = 24). Patients received a single infusion of ketamine or midazolam (as an active placebo) in addition to standard of care. SI measured using the Beck Scale for Suicidal Ideation (BSI) 24 h post-treatment represented the primary outcome. Secondary outcomes included the Montgomery–Asberg Depression Rating Scale – Suicidal Ideation (MADRS-SI) score at 24 h and additional measures beyond the 24-h time-point.Results.The intervention was well tolerated and no dropouts occurred during the primary 7-day assessment period. BSI score was not different between the treatment groups at 24 h (p = 0.32); however, a significant difference emerged at 48 h (p = 0.047). MADRS-SI score was lower in the ketamine group compared to midazolam group at 24 h (p = 0.05). The treatment effect was no longer significant at the end of the 7-day assessment period.Conclusions.The current findings provide initial support for the safety and tolerability of ketamine as an intervention for SI in patients who are at elevated risk for suicidal behavior. Larger, well-powered studies are warranted.

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Open release versus radiofrequency microtenotomy in the treatment of lateral epicondylitis: a prospective randomized controlled trial

Shoulder & Elbow ◽

10.1177/1758573217715255 ◽

2017 ◽

Vol 10 (1) ◽

pp. 45-51 ◽

Cited By ~ 5

Author(s):

Katharine Hamlin ◽

Christopher Munro ◽

Scott L. Barker ◽

Sean McKenna ◽

Kapil Kumar

Keyword(s):

Randomized Controlled Trial ◽

Grip Strength ◽

Rating Scale ◽

Numerical Rating Scale ◽

Controlled Trial ◽

Lateral Epicondylitis ◽

Open Release ◽

Randomized Controlled ◽

Prospective Randomized Controlled Trial ◽

Significant Difference

Background Optimal surgical treatment of lateral epicondylitis remains uncertain. Recently, radiofrequency microtenotomy (RFMT) has been proposed as a suitable treatment. We compared RFMT with standard open release (OR) in this prospective randomized controlled trial. Methods In total, 41 patients with symptoms for at least 6 months were randomized into two groups: 23 patients had RFMT and 18 had OR. Two patients from RFMT withdrew. Each patient underwent Numerical Rating Scale (NRS) pain score, grip strength and Disabilities of the Arm, Shoulder and Hand (DASH) scores pre-operatively and at 6 weeks. Pain and DASH scores were repeated at 6 months and 12 months. Results NRS pain scores improved by 4.8 points for RFMT and by 3.9 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Grip strength improved by 31% in the RFMT group compared to 38% in OR. There was no significant difference between the initial and 6 weeks scores or between treatments. At 1 year, DASH was 39.8 points for RFMT and 24.4 points for OR. There was a significant improvement in both groups from pre-operative scores, although there was no statistically significant difference between the groups at 1 year. Conclusions Both groups showed significant improvements and similar benefit to the patient. The results of the present study do not show any benefit of RFMT over the standard OR. As a result of the extra expense of RFMT, we therefore recommend that OR is offered as the standard surgical management.

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Effects of Bupropion on Cognitive Function in Schizophrenia: A Double Blind Randomized Controlled Trial

Global Journal of Health Science ◽

10.5539/gjhs.v9n5p67 ◽

2016 ◽

Vol 9 (5) ◽

pp. 67

Author(s):

Mansoureh Mirzadeh ◽

Najmeh Shahini ◽

Masoud Kashani Lotf Abadi ◽

Maryam Tavakoli ◽

Arash Javanbakht ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Function ◽

Rating Scale ◽

Controlled Trial ◽

Control Group ◽

P Value ◽

Double Blind ◽

Randomized Controlled ◽

Significant Difference ◽

Schizophrenic Patients

Smoking habits are common in schizophrenic patients. Nicotine can suppress negative symptoms and cognitive impairments. The aim of this study was to determine the efficacy of bupropion on cognitive function in schizophrenic patients. This study is a double blind randomized controlled trial in a large referral psychiatric university hospital in Iran. Ninety smoker schizophrenic patients were randomly allocated (based on DSM -IV TR criteria) in two groups (46 patients for case group and 44 patients in control group). They get risperidone up to 6 mg/d and bupropion up to 400 mg/d .clinical assessment (Positive and Negative Syndrome Scale (PANSS), Brief psychiatric rating scale (BPRS) were taken in beginning of study, 14th and 28th days of study. Cognitive assessment (Stroop, Digit Span, and Wechsler, Wisconsin) were taken in begging of study, the days 2nd, 7th, 14th, 28th. All data were analyzed by SPSS Ver. 17 with analytic and descriptive tests. Mean age of patients was 37.66±1.01. Mean duration of disorder was 11.63±.98 years. The scores were significantly lower at the day 28th compared to the beginning of the study in both groups in Wechsler, Stroop color word , Stroop word , Stroop color , BPRS, PANSS p value ≤0.05 .The difference between the two treatments was not significant as indicated by the effect of group, the between-subjects factor p value ≥0.05. In this study, the side effects were examined and there was no significant difference between the two groups p value ≥0.05. Augmentation of bupropion to routine treatment improves cognitive symptoms of schizophrenia in abstinence of tobacco.

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Effects of Neuromuscular Electrical Stimulation Combined with Exercises versus an Exercise Program on the Pain and the Function in Patients with Knee Osteoarthritis: A Randomized Controlled Trial

BioMed Research International ◽

10.1155/2013/272018 ◽

2013 ◽

Vol 2013 ◽

pp. 1-7 ◽

Cited By ~ 6

Author(s):

Aline Mizusaki Imoto ◽

Stella Peccin ◽

Kelson Nonato Gomes da Silva ◽

Lucas Emmanuel Pedro de Paiva Teixeira ◽

Marcelo Ismael Abrahão ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Electrical Stimulation ◽

Knee Osteoarthritis ◽

Rating Scale ◽

Controlled Trial ◽

Neuromuscular Electrical Stimulation ◽

Functional Improvement ◽

Knee Oa ◽

Randomized Controlled ◽

Significant Difference

Objectives. To investigate the effect of 8 weeks of NMES + Ex (neuromuscular electrical stimulation combined with exercises) on pain and functional improvement in patients with knee osteoarthritis (OA) compared to exercise (Ex) alone.Design. Randomized controlled trial.Setting. A specialty outpatient clinic.Participants. Patients (N=100; women = 86, men = 14; age range, 50–75 years) with knee OA.Interventions. Participants were randomly assigned to NMES + Ex or Ex group.Outcome Measures. Numerical Rating Scale 0 to 10 (NRS) and the Timed Up and Go (TUG) test were the primary outcomes. The secondary outcomes used were the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).Results. Following the interventions, a statistically significant improvement in both groups was observed in all outcomes assessed. For the comparison between the groups, no statistically significant difference was found between the NMES + Ex and the Ex groups in NRS (P=0.52), TUG test (P=0.12), and aspects of WOMAC: pain (P=0.26), function (P=0.23), and stiffness (P=0.63).Conclusion. The addition of NMES to exercise did not improve the outcomes assessed in knee OA patients. This study was registered at the Australian Clinical Trials Registry (ACTRN012607000357459).

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Lumbar Plexus Block versus Peri-capsular Injection for Hip Arthroscopy: A Single-Blinded Randomized Controlled Trial

Orthopaedic Journal of Sports Medicine ◽

10.1177/2325967120s00350 ◽

2020 ◽

Vol 8 (7_suppl6) ◽

pp. 2325967120S0035

Author(s):

Michael Polmear ◽

Daniel Christensen ◽

Catherine Salfiti ◽

Andrew Wolff ◽

John Scanaliato

Keyword(s):

Randomized Controlled Trial ◽

Hip Arthroscopy ◽

Rating Scale ◽

Controlled Trial ◽

Arthroscopic Surgery ◽

Lumbar Plexus ◽

Phone Call ◽

Randomized Controlled ◽

Post Operative Pain ◽

Significant Difference

Objectives: To perform a single-blinded, randomized controlled trial comparing pericapsular injection versus lumbar plexus blockade for post-operative pain control following arthroscopic surgery on the hip. Methods: 70 consecutive patients undergoing hip arthroscopy were prospectively assessed over a six-month period from 2017 to 2018. Patients were randomly allocated to 1 of 2 groups. 35 patients received a lumbar plexus blockade by a single anesthesiologist, while 35 patients received a pericapsular injection of 30cc of ropivacaine and 12mg of morphine. Post-operative pain in the post-anesthesia care unit (PACU) as measured by the numeric rating scale (NRS), time to discharge, PACU morphine equivalents and adverse effects were collected by PACU staff. Post-operative day (POD) 1 and POD 2 narcotic use was obtained through a phone call with the patient on post-operative day 2. Results: We found no statistically significant difference in PACU pain scores at all time-points, although there was a trend towards lower pain for patients receiving a pericapsular injection. PACU and short-term narcotic demand did not differ significantly between the two arms. Time to discharge from the PACU did not differ. There were no major adverse events reported for either intervention. Conclusion: Pericapsular injection provides equivalent analgesia when compared to lumbar plexus injection. It is a safe, time-saving intervention that allows for efficient post-operative analgesia for patients undergoing hip arthroscopy.

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Transdermal estrogen patches for aggressive behavior in male patients with dementia: a randomized, controlled trial

International Psychogeriatrics ◽

10.1017/s1041610205001535 ◽

2005 ◽

Vol 17 (2) ◽

pp. 165-178 ◽

Cited By ~ 21

Author(s):

Kathryn A. Hall ◽

Nicholas A. Keks ◽

Daniel W. O'Connor

Keyword(s):

Randomized Controlled Trial ◽

Aggressive Behavior ◽

Rating Scale ◽

Controlled Trial ◽

Advanced Dementia ◽

Randomized Controlled ◽

Significant Difference ◽

Multiple Variables ◽

Male Patients ◽

Transdermal Estrogen

Objectives: To investigate the efficacy and tolerability of transdermal estrogen patches for the adjunctive treatment of aggressive behavior in male patients with advanced dementia.Methods: The study was designed as an 8-week, randomized, controlled trial in acute aged psychiatry inpatient units and specialized nursing homes in Melbourne, Australia, between 1998 and 1999. The participants were 27 men with established dementia, identified as displaying aggressive behavior not responding to treatment for at least 2 weeks prior to referral. The instruments used to measure aggressive behavior were the Rating Scale for Aggressive Behavior in the Elderly (RAGE), the Cornell Scale for Depression in Dementia (CSDD) and the Mini-mental State Examination (MMSE). Physical examination was performed and biochemistry and serum hormone concentrations were measured at baseline and at 8 weeks. Concomitant psychotropic medication use was recorded and analyzed.Results: There was no significant difference in aggressive behavior at 8 weeks, but significant “rebound” in aggressive behavior (change in scores between week 8 and week 10, p<0.009) and benzodiazepine use in the estrogen group (p<0.03), following removal of the patches. Only behavioral items of the CSDD improved in the experimental group (p=0.031). The use of patches was associated with a significant rise in serum estrogen (p<0.001) but not with a significant decrease in serum testosterone (p=0.077). There were no adverse effects associated with their use.Conclusions: The use of transdermal estrogen yielding up to 100μg per day was not associated with discernable improvement in aggressive behavior in men with advanced dementia. Small subject numbers, multiple variables and a lack of statistical power impair interpretation of these results. However, the tolerability and apparent rebound effect on removal of patches indicate the need for larger studies in this area.

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Hydroxychloroquine for the treatment of severe respiratory infection by COVID-19: A randomized controlled trial

PLoS ONE ◽

10.1371/journal.pone.0257238 ◽

2021 ◽

Vol 16 (9) ◽

pp. e0257238

Author(s):

Carmen Hernandez-Cardenas ◽

Ireri Thirion-Romero ◽

Sebastián Rodríguez-Llamazares ◽

Norma E. Rivera-Martinez ◽

Patricia Meza-Meneses ◽

...

Keyword(s):

Mechanical Ventilation ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Severe Disease ◽

Public Health Problem ◽

Major Public Health Problem ◽

Serious Adverse Events ◽

Randomized Controlled ◽

Significant Difference ◽

Secondary Outcomes

Introduction The novel coronavirus pandemic (COVID–19) represents a major public health problem and it is key to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo. Material and methods A double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes: days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events. Results A total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO2 of 65% ± 20, tachycardic (pulse rate 108±17 min-1) and tachypneic (32 ±10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51–1.53). In the surviving participants, no significant difference was found in secondary outcomes. Conclusion No beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19.

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HYDROXYCHLOROQUINE FOR THE TREATMENT OF SEVERE RESPIRATORY INFECTION BY COVID-19: A RANDOMIZED CONTROLLED TRIAL

10.1101/2021.02.01.21250371 ◽

2021 ◽

Author(s):

Carmen Hernandez-Cardenas ◽

Ireri Thirion-Romero ◽

Norma E. Rivera-Martinez ◽

Patricia Meza-Meneses ◽

Arantxa Remigio-Luna ◽

...

Keyword(s):

Mechanical Ventilation ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Severe Disease ◽

Public Health Problem ◽

Major Public Health Problem ◽

Serious Adverse Events ◽

Randomized Controlled ◽

Significant Difference ◽

Secondary Outcomes

ABSTRACTThe novel coronavirus pandemic (COVID–19) represents a major public health problem due to its rapid spread and its ability to generate severe pneumonia. Thus, it is essential to find a treatment that reduces mortality. Our objective was to estimate whether treatment with 400 mg/day of Hydroxychloroquine for 10 days reduces in-hospital mortality in subjects with severe respiratory disease due to COVID-19 compared with placebo.Material and methodsA double-blind, randomized, placebo-controlled trial to evaluate the safety and efficacy of Hydroxychloroquine for the treatment of severe disease by COVID-19 through an intention-to-treat analysis. Eligible for the study were adults aged more than 18 years with COVID-19 confirmed by RT-PCR and lung injury requiring hospitalization with or without mechanical ventilation. Primary outcome was 30-day mortality. Secondary outcomes: days of mechanical ventilation, days of hospitalization and cumulative incidence of serious adverse events.ResultsA total of 214 patients with COVID-19 were recruited, randomized and analyzed. They were hypoxemic with a mean SpO2 of 65% ± 20, tachycardic (pulse rate 108±17 min-1) and tachypneic (32 ±10 min-1); 162 were under mechanical ventilation at randomization. Thirty-day mortality was similar in both groups (38% in Hydroxychloroquine vs. 41% in placebo, hazard ratio [HR] 0.88, 95% Confidence Interval [95%CI] 0.51-1.53). In the surviving participants, no significant difference was found in secondary outcomes.ConclusionNo beneficial effect or significant harm could be demonstrated in our randomized controlled trial including 214 patients, using relatively low doses of Hydroxychloroquine compared with placebo in hospitalized patients with severe COVID-19.CONSORT GUIDELINES

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The The Effectiveness of Early Mobilization Time on Balance and Functional Ability after Ischemic Stroke

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2019.269 ◽

2019 ◽

Vol 7 (7) ◽

pp. 1088-1092

Author(s):

Umi Budi Rahayu ◽

Samekto Wibowo ◽

Ismail Setyopranoto

Keyword(s):

Randomized Controlled Trial ◽

Ischemic Stroke ◽

Functional Ability ◽

Controlled Trial ◽

Early Mobilization ◽

Berg Balance Scale ◽

Early Mobilisation ◽

Inclusion Criteria ◽

Randomized Controlled ◽

Significant Difference

BACKGROUND: Early mobilisation (EM) after-ischemic stroke is a motor learning intervention aimed to restore nerve cells and to improve balance and functional ability. Unfortunately, the study of when this intervention began has not been widely studied. AIM: On this study was compared the effect of EM started at 24 hours and 48 hours after an ischemic stroke on balance and functional ability. MATERIAL AND METHODS: Randomized controlled trial involving 40 patients on 2 groups meeting predefined inclusion criteria. The levels of balance were measured using the Berg Balance Scale, and the functional ability was measured using the Barthel Index, at 5th and 7th day. RESULTS: A significant difference was observed in both balance (p = 0.038) and functional ability (p = 0.021) obtained on the 7th day of assessment between both groups. A significant difference on the 5th day was observed only in the functional ability (p = 0.002) and not in the balance (p = 0.147), between the groups. CONCLUSION: EM started at 24 hours after the ischemic stroke has been found to have a better impact on balance and functional ability compared to that at 48 hours.

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Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

Journal of Nursing Education and Practice ◽

10.5430/jnep.v10n2p70 ◽

2019 ◽

Vol 10 (2) ◽

pp. 70

Author(s):

Samah Nasser Abd El-Aziz El-Shora ◽

Amina Mohamed Rashad El-Nemer

Keyword(s):

Randomized Controlled Trial ◽

Cesarean Section ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Control Group ◽

Induced Hypotension ◽

Randomized Controlled ◽

Significant Difference ◽

Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

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Boxing vs Sensory Exercise for Parkinson’s Disease: A Double-Blinded Randomized Controlled Trial

Neurorehabilitation and Neural Repair ◽

10.1177/15459683211023197 ◽

2021 ◽

pp. 154596832110231

Author(s):

Kishoree Sangarapillai ◽

Benjamin M. Norman ◽

Quincy J. Almeida

Keyword(s):

Parkinson’S Disease ◽

Parkinson's Disease ◽

Randomized Controlled Trial ◽

Repeated Measures ◽

Rating Scale ◽

Controlled Trial ◽

Motor Symptoms ◽

Post Intervention ◽

Randomized Controlled ◽

Double Blinded

Background. Exercise is increasingly becoming recognized as an important adjunct to medications in the clinical management of Parkinson’s disease (PD). Boxing and sensory exercise have shown immediate benefits, but whether they continue beyond program completion is unknown. This study aimed to investigate the effects of boxing and sensory training on motor symptoms of PD, and whether these benefits remain upon completion of the intervention. Methods. In this 20-week double-blinded randomized controlled trial, 40 participants with idiopathic PD were randomized into 2 treatment groups, (n = 20) boxing or (n = 20) sensory exercise. Participants completed 10 weeks of intervention. Motor symptoms were assessed at (week 0, 10, and 20) using the Unified Parkinson’s Disease Rating Scale (UPDRS-III). Data were analyzed using SPSS, and repeated-measures ANOVA was conducted. Results. A significant interaction effect between groups and time were observed F(1, 39) = 4.566, P = .036, where the sensory group improved in comparison to the boxing group. Post hoc analysis revealed that in comparison to boxing, the effects of exercise did not wear off at washout (week 20) P < .006. Conclusion. Future rehabilitation research should incorporate similar measures to explore whether effects of exercise wear off post intervention.

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