scholarly journals Improved survival in amyotrophic lateral sclerosis patients following autologous bone marrow mononuclear cell therapy: a long term 10-year retrospective study

2021 ◽  
Vol 9 (2) ◽  
pp. 117-136
Author(s):  
Alok Sharma ◽  
Hemangi Sane ◽  
Amruta Paranjape ◽  
Ritu Varghese ◽  
Vivek Nair ◽  
...  
Keyword(s):  
Cell Therapy ◽  
Standard Treatment ◽  
Intervention Group ◽  
Premenopausal Women ◽  
Survival Duration ◽  
Control Group ◽  
Kaplan Meier ◽  
Lateral Sclerosis ◽  
Limb Onset

Background:Promising results from previous studies using cell therapy have paved the way for an innovative treatment option for amyotrophic lateral sclerosis (ALS). There is considerable evidence of immune and inflammatory abnormalities in ALS. Bone marrow mononuclear cells (BMMNCs) possess immunomodulatory properties and could contribute to slowing of disease progression.Objective:Aim of our study was to evaluate the long-term effect of autologous BMMNCs combined with standard treatment on survival duration in a large population and to evaluate effect of type of onset and hormonal status on survival duration in the intervention group.Methods:This controlled, retrospective study spanned over 10 years, 5 months; included 216 patients with probable or definite ALS, 150 in intervention group receiving autologous BMMNCs and standard treatment, and 66 in control group receiving only standard treatment. The estimated survival duration of control group and intervention group was computed and compared using Kaplan Meier analysis. Survival duration of patients with different types of onset and hormonal status was compared within the intervention group.Results:None of the patients reported any major adverse events related to cell administration or the procedure. Kaplan Meier analysis estimated survival duration in the intervention group to be 91.7 months while 49.7 months in the control group (p = 0.008). Within the intervention group, estimated survival was significantly higher (p = 0.013) in patients with limb onset (102.3 months) vs. bulbar onset (49.9 months); premenopausal women (93.1 months) vs. postmenopausal women (57.6 months) (p = 0.002); and preandropausal men (153.7 months) vs. postandropausal males (56.5 months) (p = 0.006).Conclusion:Cell therapy using autologous BMMNCs along with standard treatment offers a promising and safe option for ALS with the potential of long term beneficial effect and increased survival. Limb onset patients, premenopausal women and men ≤ 40 years of age demonstrated better treatment efficacy.

scholarly journals Improved Long-Term Survival with Edaravone Therapy in Patients with Amyotrophic Lateral Sclerosis: A Retrospective Single-Center Study in Japan

2021 ◽  
Vol 14 (8) ◽  
pp. 705
Author(s):  
Hideki Houzen ◽  
Takahiro Kano ◽  
Kazuhiro Horiuchi ◽  
Masahiro Wakita ◽  
Azusa Nagai ◽  
...  
Keyword(s):  
Amyotrophic Lateral Sclerosis ◽  
Rank Test ◽  
Positive Pressure ◽  
Control Group ◽  
Single Center ◽  
Term Survival ◽  
Long Term Survival ◽  
Kaplan Meier ◽  
Lateral Sclerosis

Reports on the long-term survival effect of edaravone, which was approved for the treatment of amyotrophic lateral sclerosis (ALS) in 2015 in Japan, are rare. Herein, we report our retrospective analysis of 45 consecutive patients with ALS who initially visited our hospital between 2013 and 2018. Of these, 22 patients were treated with edaravone for an average duration of 26.6 (range, 2–64) months, whereas the remaining patients were not treated with edaravone and comprised the control group. There were no differences in baseline demographics between the two groups. The primary endpoint was tracheostomy positive-pressure ventilation (TPPV) or death, and the follow-up period ended in December 2020. The survival rate was significantly better in the edaravone group than in the control group based on the Kaplan–Meier analysis, which revealed that the median survival durations were 49 (9–88) and 25 (8–41) months in the edaravone and control groups, respectively (p = 0.001, log-rank test). There were no serious edaravone-associated adverse effects during the study period. Overall, the findings of this single-center retrospective study suggest that edaravone might prolong survival in patients with ALS.

scholarly journals Efficacy of implementing intermittent STOP THE BLEED® reviews on long term retention of hemorrhage control skills of first year medical students

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Enkhtsogt Sainbayar ◽  
Nathan Holt ◽  
Amber Jacobson ◽  
Shalini Bhatia ◽  
Christina Weaver
Keyword(s):  
Medical Students ◽  
Intervention Group ◽  
Training Session ◽  
Likert Scale ◽  
Control Group ◽  
First Year ◽  
Hemorrhage Control ◽  
Term Retention ◽  
Long Term Retention

Abstract Context Some medical schools integrate STOP THE BLEED® training into their curricula to teach students how to identify and stop life threatening bleeds; these classes that are taught as single day didactic and hands-on training sessions without posttraining reviews. To improve retention and confidence in hemorrhage control, additional review opportunities are necessary. Objectives To investigate whether intermittent STOP THE BLEED® reviews were effective for long term retention of hemorrhage control skills and improving perceived confidence. Methods First year osteopathic medical students were asked to complete an eight item survey (five Likert scale and three quiz format questions) before (pretraining) and after (posttraining) completing a STOP THE BLEED® training session. After the surveys were collected, students were randomly assigned to one of two study groups. Over a 12 week intervention period, each group watched a 4 min STOP THE BLEED® review video (intervention group) or a “distractor” video (control group) at 4 week intervals. After the 12 weeks, the students were asked to complete an 11 item survey. Results Scores on the posttraining survey were higher than the pretraining survey. The median score on the five Likert scale items was 23 points for the posttraining survey and 14 points for the pretraining survey. Two of the three knowledge based quiz format questions significantly improved from pretraining to posttraining (both p<0.001). On the 11 item postintervention survey, both groups performed similarly on the three quiz questions (all p>0.18), but the intervention group had much higher scores on the Likert scale items than the control group regarding their confidence in their ability to identify and control bleeding (intervention group median = 21.4 points vs. control group median = 16.8 points). Conclusions Intermittent review videos for STOP THE BLEED® training improved medical students’ confidence in their hemorrhage control skills, but the videos did not improve their ability to correctly answer quiz-format questions compared with the control group.

Impact of a 12-month web and smartphone-based intervention initiated during spa therapy to improve long-term physical activity of patients with chronic diseases: randomized controlled trial. (Preprint)

2021 ◽  
Author(s):  
Florie FILLOL ◽  
Ludivine PARIS ◽  
Sébastien PASCAL ◽  
Aurélien MULLIEZ ◽  
Christian-François ROQUES ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Waist Circumference ◽  
Controlled Trial ◽  
Intervention Group ◽  
Group Versus ◽  
Control Group ◽  
Spa Therapy

BACKGROUND Lack of physical activity (PA) and sedentary behaviors are leading risk factors for non-communicable diseases (NCD). Web-based interventions are effective in increasing PA in older adults and in NCD patients. In many countries a course of spa therapy is commonly prescribed to NCD patients and represents an ideal context to initiating lifestyle changes. OBJECTIVE The main objective of this study was to evaluate in NCD patients the effectiveness of an intervention combining an individual face-to-face coaching during spa therapy and, when returning home, a web- and smartphone-based PA program including a connected wrist pedometer and a connected weighing scale, on the achievement of physical activity guidelines (PAG) 12 months after the end of spa therapy. METHODS This was a 12-month, prospective, parallel-group, randomized controlled trial. Patients were enrolled during spa therapy and randomized 1:1 to intervention or control group who received usual advices about PA. From the end of spa therapy, PA, weight, waist circumference, and quality of life of the participants in both groups, were assessed by phone every 2 months. Primary outcome was meeting PAG (PA≥600 METs) at 12 months after the end of spa therapy. Secondary outcomes were: meeting current PAG at 6 months of follow-up; sedentary time, weight and waist circumference, PA and quality of life, at 6 and 12 months. Objective use data of the web-and smartphone-based PA program were collected. Analytic methods include intention-to-treat and constrained longitudinal data analyses. RESULTS The study sample was 228 patients (female : 77.2% (176/228), mean age: 62.4 years (SD 6.7), retired: 53.9% (123/228), mean BMI = 28.2 kg.m-2 (SD 4.2)). No group differences were found for any baseline variable. At 12 months, the proportion of patients achieving PAG was significantly higher in intervention group versus control group (81% vs 67% respectively, OR = 2.34 (95% CI 1.02- 5.38; P=.045). No difference between intervention and control group was found neither in achieving PAG at 6 months nor for sedentary time, weight and waist circumference, at 6 and 12 months. Regarding quality of life, the physical component subscale score was significantly higher at 12 months in intervention group versus control group (mean difference: 4.1 (95% CI 1.9-6.3; P<.001). The mean duration use of the program was 7.1 months (SD 4.5). Attrition rate during the first 2 months of the program was 20.4% (23/113) whereas 39.8% (45/113) of the participants used the program for at least 10 months. CONCLUSIONS The results showed significantly more participants meeting PAG at one year in the intervention group compared to controls. A course of spa therapy offers the ideal time and setting to implement education in PA. Digital coaching seems to be more efficient than usual coaching for increasing the level of PA and decreasing sedentariness on the long term. CLINICALTRIAL ClinicalTrials.gov NCT02694796; https://clinicaltrials.gov/ct2/show/NCT02694796.

scholarly journals Effects of 1 y of free school fruit on intake of fruits, vegetables, and unhealthy snacks: 14 y later

2018 ◽  
Vol 108 (6) ◽  
pp. 1309-1315 ◽  
Author(s):  
Tonje Holte Stea ◽  
Ingrid Marie Hovdenak ◽  
Jannike Rønnestad ◽  
Kjersti Rennestraum ◽  
Frøydis Nordgård Vik ◽  
...  
Keyword(s):  
Fruits And Vegetables ◽  
Intervention Group ◽  
Baseline Survey ◽  
Control Group ◽  
Intervention Period ◽  
Long Term Effects ◽  
Intervention Effects ◽  
Sample Mean ◽  
Unhealthy Snacks

ABSTRACT Background There are not many studies evaluating the long-term effects of fruit and vegetable interventions. Objective We examined the effects of 1 y of free fruit in elementary school on long-term consumption of fruit, vegetables, and unhealthy snacks, according to sex and educational attainment, 14 y after the intervention period. Design In 2001, the baseline survey of the longitudinal cohort, Fruits and Vegetables Make the Marks (FVMM), included 1950 children (mean age: 11.8 y) attending 38 randomly drawn elementary schools from 2 counties in Norway. In the following 10 mo, 9 schools served as intervention schools by participating in the Norwegian School Fruit Program for free, whereas 29 schools served as control schools. A follow-up survey conducted in 2016 included 982 participants (50%) from the original study sample (mean age: 26.5 y). The consumption of fruit and vegetables was measured by a 24-h recall (portions per day), and the consumption of unhealthy snacks was measured by food-frequency questions (portions per week). Linear mixed models were performed to test possible intervention effects on the consumption of fruit, vegetables, and unhealthy snacks 14 y after the intervention period. Results No overall intervention effects after 14 y due to the free-fruit scheme on the consumption of fruit, vegetables, and unhealthy snacks were observed, but significant interactions showed a sustained higher frequency of fruit consumption among females in the intervention group compared with the control group [mean difference (MD): 0.38 portions/d; P = 0.023] and that this effect was only significant among less-educated females (MD: 0.73 portions/d; P = 0.043). No significant long-term intervention effects were observed in the consumption of fruit among highly educated females and males nor in the consumption of vegetables or unhealthy snacks. Conclusion Results from the present study indicate that receiving free fruit at school for 1 y may have positive long-term effects for females without higher education.

scholarly journals A CLINICAL STUDY TO ASSESS THE EFFICACY OF SHWASAHARA DASHEMANI GHANAVATI IN CARDIAC ASTHMA W.S.R L.V.F

2021 ◽  
Vol p6 (1) ◽  
pp. 3179-3185
Author(s):  
Roopa M.R ◽  
Vasudev A Chate ◽  
Shreevathsa Shreevathsa ◽  
Mohan Kumar G
Keyword(s):  
Standard Treatment ◽  
Intervention Group ◽  
Simple Random Sampling ◽  
Control Group ◽  
P Value ◽  
Common Symptom ◽  
Open Label ◽  
Post Test ◽  
Clinically Significant ◽  
Cardiac Asthma

Introduction: Shwasa is said as Shigrapranahara Roga. It occurs as the main disease and also a symptom in various diseases. Shwasakruchrata is a common symptom that occurs in Hrudroga. Acharya Charaka mentioned the unique classification of drugs based on their action. Shwasahara Dashemani is one among them. It is containing 10 herbal drugs which are specially indicated in Shwasa Roga. Hence to evaluate the efficacy of Shwasahara Dashemani in Lakshana Roopi Shwasa in L.V.F (Cardiac Asthma) has taken for the study. Aim and Objective: The objective is to assess the efficacy of Shwasahara Dashemani in L.V.F with dyspnea (Cardiac Asthma). Method: The present study is a controlled comparative, open-label, clinical trial with pre and post-test design. A total of 40 subjects of a diagnosed case of L.V.F with dyspnea (Cardiac Asthma) were selected by using a simple random sampling method. Control group subjects were intervened with standard treatment of L.V.F and intervention group subjects were intervened with standard treatment of L.V.F along with Shwasahara Dashemani Ghana Vati, for the duration of 30 days. Its efficacy was assessed before treatment (0th day) and after treatment (31st day) by using BDI (Baseline Dyspnea Index Scale). Results: The P-value of dyspnea of the control group is 1.000 and the P-value of dyspnea of the intervention group is 0.105. This shows that the results of both groups are statistically not significant. But as compared to the control group, the intervention group is clinically significant because after the intervention 35% of subjects had shown improvement in the intervention group. Conclusion: As compared to the control group, in the intervention group Shwasahara Dashemani Ghanavati is clinically significant in relieving cardiac asthma when used with standard treatment of L.V.F. Keyword: Shwasahara Dashemani. Cardiac Asthma, L.V.F, Dyspnea

Impact of a New Parent Behavioral-Schema Training on Children with ADHD: A Pragmatic Control Trial

2020 ◽  
pp. 108705472095971
Author(s):  
Maly Solan ◽  
Anat Brunstein Klomek ◽  
Galia Ankori ◽  
Asheda Bloch ◽  
Alan Apter ◽  
...  
Keyword(s):  
Intervention Group ◽  
Future Research ◽  
Control Group ◽  
Growth Curve Analysis ◽  
Long Term Effects ◽  
Hyperactivity Disorder ◽  
Behavioral Program ◽  
Symptom Relapse ◽  
Therapy Strategies

Objectives: To examine whether adding schema therapy strategies to the conventional parent behavioral program prevents symptom relapse in children with attention deficit hyperactivity disorder (ADHD). Method: The intervention was designed as an adaptive pragmatic control trial. The parent behavioral training and schema-enhanced parent behavior therapy (SPBT) protocols were delivered to the control group (40 parents of 23 children) and experimental group (97 parents of 54 children), respectively. Participants were assessed at baseline, mid-treatment, and termination. Parents and teachers indicated the severity of ADHD and comorbid symptoms through their responses to standardized questionnaires designed for this purpose. Results: A nested growth curve analysis demonstrated that participants in the schema-enhanced intervention group had a lower risk of symptom relapse than the control group. Conclusion: Participation in the SPBT program significantly reduced relapse rates by the end of the intervention. Future research may determine the long-term effects of the treatment.

scholarly journals Role of Human Recombinant Erythropoietin (rHuEPO) in Perinatal Asphyxia-a randomized controlled trial

2018 ◽  
Vol 10 (1) ◽  
pp. 330-334
Author(s):  
Syeda Mehnaz ◽  
MAK Azad Chowdhury ◽  
BH Nazma Yasmeen ◽  
Md Masudur Rahman ◽  
Rowshan Jahan Akter ◽  
...  
Keyword(s):  
Neurological Outcome ◽  
Seizure Control ◽  
Standard Treatment ◽  
Perinatal Asphyxia ◽  
Intervention Group ◽  
Treatment Protocol ◽  
Oral Feeding ◽  
Control Group ◽  
Term Neonates ◽  
And Control

Background : Perinatal asphyxia is an insult to the fetus or newborn infant due to lack of oxygen (hypoxia) and/or a lack of perfusion (ischemia) to various organs, which will manifest as difficulty in establishing spontaneous respiration evident by delayed cry after birth, at least after one minute. World-wide, perinatal asphyxia accounts for about 900,000 deaths each year. In Bangladesh it is a major cause of neonatal death. A substantial proportion of the children that survive suffer late effects such as cerebral palsy and epilepsy. Objective : To determine the efficacy of erythropoietin in improving the neurological outcome of term neonates with perinatal asphyxia (HIE stage II and III). Materials and methods : A Randomized Controll Trial was carried out in the Neonatal ward and NICU of Dhaka Shishu Hospital from 1st April 2014 to 30th Sep 2015. A total 68 neonates with perinatal asphyxia (both HIE stage II and III) who fulfill the inclusion criteria were enrolled and randomly assigned to intervention group (n=35) and control group (n=33). Intervention group received rHuEPO 300- 500 U/kg/dose daily subcutaneously for 5 days within first 48 hours of birth along with the standard treatment protocol and control group received standard treatment protocol only. Results : Baseline clinical characteristics, USG of brain during hospital stay were almost similar in both groups. Statistically significant effect was noted in seizure control, tolerance of oral feeding, hospital stay and neurological outcome at 3 months of age (p=008). USG of brain at 3 months of age also improved significantly (p=0.027). Conclusion : This study demonstrates the effectiveness of early administration of rHuEPO to term neonates with moderate to severe asphyxia, beneficial effect on short term outcomes like seizure control, tolerance of oral feeding and neurological outcome at 3 months of age. A large multicenter study would be done for further evaluation of these findings. Northern International Medical College Journal Vol.10(1) Jul 2018: 330-334

One Shot—No Hit? Evaluation of a Stress-Prevention Workshop for Adolescent Soccer Players in a Randomized Controlled Trial

2020 ◽  
Vol 34 (2) ◽  
pp. 132-142
Author(s):  
Johanna Belz ◽  
Jens Kleinert ◽  
Moritz Anderten
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Perceived Quality ◽  
Soccer Players ◽  
Control Group ◽  
Stress Coping ◽  
Quality Of Results ◽  
Stress Prevention

Adolescent soccer players experience many stressors and negative stress-related outcomes. Short-term stress-prevention programs are frequently implemented in youth sports, although there is limited evidence of their usefulness and effectiveness. Thus, the present study evaluated the usefulness and effectiveness of a stress-prevention workshop for adolescent soccer players. Ninety-two soccer players (age: M = 15.5 years, SD = 1.43; 31.5% female) were randomly allocated to either an intervention group or an intervention control group. To evaluate effectiveness, stress, coping, and depression were assessed at baseline (t1) and 4 weeks postworkshop (t2). To investigate usefulness, the perceived quality of results was assessed at t2. No intervention effects on stress, coping, and depression emerged, but both groups exhibited high values regarding perceived quality of results. Although one workshop might not be enough to modify stress-related parameters, it may be useful for adolescent soccer players and pave the way for long-term interventions.

scholarly journals Weight Reduction by the Low-Insulin-Method—A Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3004
Author(s):  
Martin Röhling ◽  
Katharina Martin ◽  
Sabine Ellinger ◽  
Michael Schreiber ◽  
Stephan Martin ◽  
...  
Keyword(s):  
Weight Reduction ◽  
Controlled Trial ◽  
Fasting Blood Glucose ◽  
Group Analysis ◽  
Intervention Group ◽  
Eating Behaviour ◽  
Control Group ◽  
Insulin Levels ◽  
Overweight Or Obesity

Continuous high insulin levels are associated with weight gain and lead to cardiometabolic diseases. Therefore, we have developed the Low-Insulin-Method and integrated it into the multi-component, occupational healthcare program SHAPE-AND-MOTION-Medical-Accompanied-Slimming (SAMMAS) to reduce daily insulin levels for long-term weight reduction in overweight or obesity. Employees were randomized into a starting intervention group (SI, n = 15) or waiting list control group (WL, n = 15). SAMMAS consisted of group-based seminars, low-carbohydrate nutrition including formula diet, continuous glucose monitoring, telemetric monitoring, and telemedical coaching. Both groups received telemetric devices at baseline. Intention-to-treat analyses were performed after 12, 26, and 52 weeks. The estimated treatment difference in weight reduction after 12 weeks, which is the primary endpoint of the study, showed a pronounced effect in favour of SI (−6.3 kg with (95% confidence interval) (−7.4; −4.5) (p < 0.001)) after 12 weeks. Furthermore, SI improved fasting blood glucose, HbA1c, quality of life, fasting insulin, blood pressure, and eating behaviour (all p < 0.05) in the within-group analysis, while WL did not. After 26 and 52 weeks, weight reduction could be maintained in the whole group (both groups together) by −6.7 kg (−9.5; −3.8) (p < 0.001) and −6.1 kg (−9.2; −2.7) (p < 0.01). SAMMAS supports clinically relevant weight reduction and long-term weight loss maintenance in individuals with overweight or obesity.

scholarly journals Objective Structured Assessment of Technical Skills to Teach and Study Retention of Fourth-Degree Laceration Repair Skills

2015 ◽  
Vol 7 (1) ◽  
pp. 32-35 ◽  
Author(s):  
Anjali Martinez ◽  
Caroline Cassling ◽  
Jennifer Keller
Keyword(s):  
Intervention Group ◽  
Technical Skills ◽  
Obstetrics And Gynecology ◽  
Control Group ◽  
Fourth Degree ◽  
Written Examination ◽  
Long Term Effect ◽  
Baseline Knowledge ◽  
Educational Workshop

Abstract Background Fourth-degree perineal lacerations are a serious but infrequent complication of childbirth. Objective We studied the long-term effect of an educational workshop on the knowledge and ability of obstetrics and gynecology residents to repair fourth-degree lacerations. Methods We assessed obstetrics and gynecology residents' baseline knowledge and skill of fourth-degree laceration repair by using a written examination and the Objective Structured Assessment of Technical Skills (OSATS). After the educational intervention (a lecture, a demonstrational video, and practice on a model), residents completed a written and OSATS posttest. Six months later, residents took the same posttests to determine their level of retention. Another group of residents who had not attended the workshop also took the tests at the 6-month mark and served as a control group. Results A total of 17 residents were in the intervention group and 11 residents in the control group. The pretest written examination mean was 6.1/10 and the OSATS mean was 10.9/18. After the workshop, the written mean increased to 9.1/10 and the OSATS to 16.6/18. This improvement was statistically significant (P &lt; .01). Compared to the pretest, the 6-month follow-up scores had a statistically significant increase (written mean, 8.0/10, P &lt; .01, and OSATS mean 15.5/18, P &lt; .01). Conclusions Residents improved on the written examination and OSATS after the educational workshop and maintained this improvement for 6 months. This intervention may prepare graduating residents for repairing future fourth-degree lacerations they may not have encountered during training.

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