Abstract TMP46: Fostering Eating After Stroke (FEAST) Trial: A Randomized Controlled Trial of Non-Invasive Brain Stimulation for Improving Dysphagia After Stroke

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Sandeep Kumar ◽  
Sarah Marchina ◽  
Susan Langmore ◽  
Jessica Pisegna ◽  
Na Wang ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Group Differences ◽  
High Dose ◽  
Phase 2 ◽  
Double Blind ◽  
Aspiration Risk ◽  
Subacute Stroke ◽  
Safety Outcomes ◽  
Swallowing Exercises

Background: Effective therapy for dysphagia recovery after stroke is currently lacking. We conducted a phase-2 RCT to investigate the effects of anodal transcranial direct current stimulation (atDCS) in reducing aspiration risk, improving diet, and analyzed its safety in the acute-subacute stroke phase. Hypothesis: Since swallowing has bi-hemispheric representation targeted atDCS to the unaffected hemisphere combined with swallowing exercises may improve dysphagia from a unilateral hemispheric infarction [UHI]. Methods: This phase-2, double-blind, RCT enrolled subjects with dysphagia [penetration and aspiration (PAS) score ≥ 4], from an acute-subacute UHI [day 2-day 6 after stroke onset] and randomized them into 3 groups: low-dose atDCS [2 mA atDCS alternating with sham twice daily], high-dose atDCS [2 mA atDCS twice daily] or sham [twice daily]. All sessions were performed with standardized swallowing exercises for 20 minutes over 5 days. Major safety outcomes were incidence of seizures, worsening of neurological and swallowing functions and mortality; primary efficacy outcome was a change in PAS scores between day 1 and 5 of intervention; main dietary outcome was a change in dietary intake at 1 month using the Functional Oral Intake scale (FOIS). Results: Of the planned 99 subjects, 42 could be enrolled in the funding period. No group differences in pre-defined safety outcomes were observed. Mean (SD) change in PAS score from baseline to final session was -0.8 (±1.6) in sham, -0.8 (±1.5) in low-dose and -0.4 (±1.2) in high dose groups. Adjusting for baseline PAS, NIHSS scores and age, means (SE) were -0.96 (0.33) in sham, -0.81 (0.36) in low-dose and -0.34 (0.35) in high dose; there were no significant pairwise differences (p>0.40). Mean (SD) changes in FOIS scores from baseline to 1 month were: 2.1 (±1.7) in sham, 2.5 (±1.7) in low-dose and 2.9 (±1.2) in high dose. Adjusted means (SE) were 2.07 (0.35) in sham, 2.46 (0.38) in low dose and 3.05 (0.38) in high dose (pairwise p > 0.15). Conclusion: Application of atDCS to the unaffected hemisphere is safe in the acute-subacute stroke phase but did not decrease aspiration risk in this phase-2 RCT. Higher doses of atDCS were associated with better dietary scores but group differences were not statistically significant.

scholarly journals Double-Blind, Randomized, Three-Armed, Placebo-Controlled, Clinical Investigation to Evaluate the Benefit and Tolerability of Two Dosages of IQP-AE-103 in Reducing Body Weight in Overweight and Moderately Obese Subjects

2019 ◽  
Vol 2019 ◽  
pp. 1-12 ◽  
Author(s):  
Ralf Uebelhack ◽  
Udo Bongartz ◽  
Stephanie Seibt ◽  
Gordana Bothe ◽  
Pee Win Chong ◽  
...  
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Placebo Group ◽  
Body Fat ◽  
Dose Group ◽  
Low Dose ◽  
Clinical Investigation ◽  
Controlled Trial ◽  
High Dose ◽  
Double Blind

Objective. This study was performed to determine the efficacy and tolerability/safety of IQP-AE-103 on body weight reduction in overweight to moderately obese adults. Methods. A double-blind, randomized, placebo-controlled trial involved one hundred and eight subjects (BMI between 25 and 35 kg/m2) that were randomly assigned to either the low-dose or the high-dose IQP-AE-103 group, or the placebo group. Following a 2-week run-in period, subjects received two capsules of investigational product after three daily main meals for 12 weeks. Subjects were instructed to maintain a nutritionally balanced hypocaloric diet according to the individual’s energy requirement. Body weight, body fat, and waist and hip circumference were measured at baseline, and after 2, 4, 8, and 12 weeks. Subjects also rated their feelings of hunger and fullness using visual analogue scales, and food craving on a 5-point scale at the same time intervals. Blood samplings for safety laboratory parameters were taken before and at the end of the study. Results. After 12 weeks of intake, the high-dose IQP-AE-103 group had a significantly greater weight loss compared with the placebo (5.03 ± 2.50 kg vs. 0.98 ± 2.06 kg, respectively; p<0.001) and the low-dose group (3.01 ± 2.19 kg; p=0.001). The high-dose group experienced a decrease in body fat of 3.15 ± 2.41 kg compared with a decrease of 0.23 ± 2.74 kg for the placebo group (p<0.001). High-dose IQP-AE-103 also decreased the feeling of hunger in 66% subjects. A beneficial effect of IQP-AE-103 on the lipid metabolism was also demonstrated in the subgroup of subjects with baseline total cholesterol levels above 6.2 mmol/L. No side effects related to the intake of IQP-AE-103 were reported. Conclusions. These findings indicate that IQP-AE-103 could be an effective and safe weight loss intervention. This trial is registered with NCT03058367.

scholarly journals Safety and immunogenicity of a new inactivated polio vaccine made from Sabin strains: a randomized, double-blind, active-controlled, phase 2/3 seamless study

2020 ◽  
Author(s):  
Maria Rosario Capeding ◽  
Grace Devota Gomez-Go ◽  
Peninnah Oberdorfer ◽  
Charissa Borja-Tabora ◽  
Lulu Bravo ◽  
...  
Keyword(s):  
Low Dose ◽  
Seroconversion Rate ◽  
Optimal Dose ◽  
Stage I ◽  
Stage Ii ◽  
High Dose ◽  
Phase 2 ◽  
Double Blind ◽  
Inactivated Polio Vaccine ◽  
Polio Vaccine

Abstract Background A new inactivated polio vaccine made from Sabin strains (sIPV) was developed as part of the global polio eradication initiative. Methods This randomized, double-blind, active-controlled, phase 2/3 seamless study was conducted in two stages. Healthy infants aged 6 weeks were randomly assigned to receive three doses of one of four study vaccines at 6, 10, and 14 weeks of age (336 received low-, middle-, or high-dose sIPV, or conventional IPV [cIPV] in Stage I, and 1086 received lot A, B, or C of the selected sIPV dose, or cIPV in Stage II). The primary outcome was the seroconversion rate 4 weeks after the third vaccination. Results In Stage I, low-dose sIPV was selected as the optimal dose. In Stage II, consistency among the three manufacturing lots of sIPV was demonstrated. The seroconversion rates for Sabin and wild strains of the 3 serotypes after the three-dose primary series were 95.8% to 99.2% in the lot-combined sIPV group and 94.8% to 100% in the cIPV group, proving the non-inferiority of sIPV compared to cIPV. No notable safety risks associated with sIPV were observed. Conclusions Low-dose sIPV administered as a three-dose vaccination was safe and immunogenic compared to cIPV.

scholarly journals A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of High-Dose Rebamipide Treatment for Low-Dose Aspirin-Induced Moderate-to-Severe Small Intestinal Damage

PLoS ONE ◽  
2015 ◽  
Vol 10 (4) ◽  
pp. e0122330 ◽  
Author(s):  
Toshio Watanabe ◽  
Toshihisa Takeuchi ◽  
Osamu Handa ◽  
Yasuhisa Sakata ◽  
Tetsuya Tanigawa ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
High Dose ◽  
Intestinal Damage ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Dose Aspirin ◽  
Low Dose Aspirin ◽  
Small Intestinal

scholarly journals Immunoprotective effects of oral intake of heat-killed Lactobacillus pentosus strain b240 in elderly adults: a randomised, double-blind, placebo-controlled trial

2012 ◽  
Vol 109 (10) ◽  
pp. 1856-1865 ◽  
Author(s):  
Shoji Shinkai ◽  
Masamichi Toba ◽  
Takao Saito ◽  
Ikutaro Sato ◽  
Mina Tsubouchi ◽  
...  
Keyword(s):  
Common Cold ◽  
Low Dose ◽  
Controlled Trial ◽  
Oral Intake ◽  
High Dose ◽  
Elderly Adults ◽  
Double Blind ◽  
Lactobacillus Pentosus ◽  
Sf 36 ◽  
The Common

Oral intake of Lactobacillus pentosus strain b240 (b240) has been shown to enhance the secretion of salivary secretory IgA in elderly adults. However, its clinical benefits remain to be determined. We tested the hypothesis that b240 exerts a protective effect against the common cold in elderly adults. The design of the present study was a randomised, double-blind, placebo-controlled trial (RCT) with parallel three-group comparison. For this purpose, 300 eligible elderly adults were randomly allocated to one of three groups, namely a placebo, low-dose or high-dose b240 group. Participants in the low-dose and high-dose b240 groups were given tablets containing 2 × 109 or 2 × 1010 cells, respectively, of heat-killed b240, while those in the placebo group were given tablets without b240. Each group consumed their respective tablets once daily for 20 weeks. The common cold was assessed on the basis of a diary. Change in quality of life was evaluated using the SF-36®. Of the total participants, 280 completed the 20-week RCT. The accumulated incidence rate of the common cold was 47·3, 34·8 and 29·0 % for the placebo, low-dose b240 and high-dose b240 groups, respectively (P for trend = 0·012). Lower incidence rates were consistently observed throughout the experimental period in the b240 groups (log-rank test, P= 0·034). General health perception, as determined by the SF-36®, dose-dependently increased in the b240 groups (P for trend = 0·016). In conclusion, oral intake of b240 significantly reduced the incidence rate of the common cold in elderly adults, indicating that b240 might be useful in improving resistance against infection through mucosal immunity.

scholarly journals Safety and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older: two single-center, randomised, double-blind, placebo-controlled, phase 1 and phase 2 trials

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Fan-Yue Meng ◽  
Fan Gao ◽  
Si-Yue Jia ◽  
Xiang-Hong Wu ◽  
Jing-Xin Li ◽  
...  
Keyword(s):  
Dose Group ◽  
Low Dose ◽  
Phase 1 ◽  
High Dose ◽  
Healthy Population ◽  
Phase 2 ◽  
Double Blind ◽  
Double Blind Placebo ◽  
To Receive ◽  
Dose Vaccine

AbstractCOVID-19 vaccines from multiple manufacturers are needed to cope with the problem of insufficient supply. We did two single-center, randomised, double-blind, placebo-controlled phase 1 and phase 2 trials to assess the safety, tolerability and immunogenicity of a recombinant COVID-19 vaccine (Sf9 cells) in healthy population aged 18 years or older in China. Eligible participants were enrolled, the ratio of candidate vaccine and placebo within each dose group was 3:1 (phase 1) or 5:1 (phase 2). From August 28, 2020, 168 participants were sequentially enrolled and randomly assigned to receive the low dose vaccine, high dose vaccine or placebo with the schedule of 0, 28 days or 0, 14, 28 days in phase 1 trial. From November 18, 2020, 960 participants were randomly assigned to receive the low dose vaccine, high dose vaccine or placebo with the schedule of 0, 21 days or 0, 14, 28 days in phase 2 trial. The most common solicited injection site adverse reaction within 7 days in both trials was pain. The most common solicited systematic adverse reactions within 7 days were fatigue, cough, sore throat, fever and headache. ELISA antibodies and neutralising antibodies increased at 14 days, and peaked at 28 days (phase 1) or 30 days (phase 2) after the last dose vaccination. The GMTs of neutralising antibody against live SARS-CoV-2 at 28 days or 30 days after the last dose vaccination were highest in the adult high dose group (0, 14, 28 days), with 102.9 (95% CI 61.9–171.2) and 102.6 (95% CI 75.2–140.1) in phase 1 and phase 2 trials, respectively. Specific T-cell response peaked at 14 days after the last dose vaccination in phase 1 trial. This vaccine is safe, and induced significant immune responses after three doses of vaccination.

Efficacy and Tolerability of Celecoxib in the Treatment of Acute Gouty Arthritis: A Randomized Controlled Trial

2012 ◽  
Vol 39 (9) ◽  
pp. 1859-1866 ◽  
Author(s):  
H. RALPH SCHUMACHER ◽  
MANUELA F. BERGER ◽  
JULIE LI-YU ◽  
FERNANDO PEREZ-RUIZ ◽  
RUBÉN BURGOS-VARGAS ◽  
...  
Keyword(s):  
Adverse Events ◽  
Low Dose ◽  
Controlled Trial ◽  
Gouty Arthritis ◽  
Analgesic Efficacy ◽  
Mean Difference ◽  
High Dose ◽  
Double Blind ◽  
Acute Gouty Arthritis ◽  
Extreme Pain

Objective.To evaluate the analgesic efficacy of high-dose celecoxib in the treatment of moderate to extreme pain and inflammation associated with acute gouty arthritis.Methods.A multinational, randomized, double-blind, double-dummy, active-controlled trial was done with patients (aged ≥ 18 years) with acute gouty monoarthritis or oligoarthritis (onset of pain ≤ 48 h before enrollment). Patients were treated for 8 days with 1 week followup and were randomized 1:1:1:1 to receive celecoxib 50 mg bid, celecoxib 400 mg (followed by 200 mg later on Day 1 and then 200 mg bid for 7 days), celecoxib 800 mg (followed by 400 mg later on Day 1 and then 400 mg bid for 7 days), or indomethacin 50 mg tid.Results.Of 443 patients screened, 402 were randomized and 400 received treatment. Baseline demographics were comparable among treatments. Patients receiving high-dose celecoxib (800/400 mg) experienced a significantly greater reduction in pain intensity on Day 2 compared with low-dose celecoxib 50 mg bid [least squares (LS) mean difference −0.46; p = 0.0014]. For high-dose celecoxib 800/400 mg, the change in pain scores from baseline to Day 2 was comparable with indomethacin 50 mg tid (LS mean difference 0.11; p = 0.4331). There were significant differences in adverse events when the combined celecoxib groups (29.5%) were compared with patients taking indomethacin (43.1%; p = 0.0116). There was no change in median serum creatinine levels for any treatment. There were more discontinuations due to adverse events (8.8% vs 3%; p = 0.0147) with indomethacin than with the combined celecoxib groups.Conclusion.High-dose celecoxib (800/400 mg) was significantly more effective than low-dose celecoxib (50 mg bid) and comparable to indomethacin in the treatment of moderate to extreme pain in patients with acute gouty arthritis. Further, celecoxib was well tolerated.

Risks of Alternate-Day Prednisone in Patients With Cystic Fibrosis

PEDIATRICS ◽  
1991 ◽  
Vol 87 (2) ◽  
pp. 245-246
Author(s):  
Beryl J. Rosenstein ◽  
Howard Eigen
Keyword(s):  
Cystic Fibrosis ◽  
Placebo Group ◽  
Interim Analysis ◽  
Inflammatory Process ◽  
Dose Group ◽  
Low Dose ◽  
Controlled Trial ◽  
The United States ◽  
High Dose ◽  
Double Blind

In recent years an immune-mediated inflammatory process has been implicated in the genesis of the pulmonary damage seen in patients with cystic fibrosis.1,2 A 4-year double-blind, placebo-controlled trial of alternate-day prednisone (2 mg/kg) was conducted in 45 cystic fibrosis patients with mild-to-moderate pulmonary disease to assess the effect of this drug on the pulmonary inflammatory process.3 The patients in the prednisone group showed better growth and pulmonary function and less morbidity compared with those in the placebo group. No complications were reported among the prednisone-treated patients. To extend these observations, the United States Cystic Fibrosis Foundation sponsored a multicenter double-blind, placebo-controlled trial of alternate-day prednisone. Since March 1986, 283 patients with cystic fibrosis, followed up at 15 centers in the United States and Canada, have been enrolled in this trial. Patients 5 through 14 years of age with mild-to-moderate pulmonary disease were randomly assigned to receive prednisone 2 mg/kg (high-dose) every other day, prednisone 1 mg/kg (low-dose) every other day, or placebo. On entry into the study, patients in the three groups were closely matched by a variety of clinical and laboratory parameters (Table 1). Patients are closely monitored at 3-month intervals for both efficacy and side effects. An interim analysis is carried out every 6 months and the results are reviewed by an unblinded study ombudsman. Initially, 95 patients were randomly assigned to the high-dose group, 94 to the low-dose group, and 94 to the placebo group. At the time of the most recent interim analysis, mean duration in the study was 33.9 months for the high-dose group, 35.3 months for the low-dose group, and 36.8 months for the placebo group.

Effect of IGF-I therapy on VLDL apolipoprotein B100 metabolism in type 1 diabetes mellitus

2002 ◽  
Vol 282 (5) ◽  
pp. E1154-E1162 ◽  
Author(s):  
Emanuel R. Christ ◽  
Paul V. Carroll ◽  
Elaine Albany ◽  
A. Margot Umpleby ◽  
Peter J. Lumb ◽  
...  
Keyword(s):  
Type 1 Diabetes ◽  
Low Dose ◽  
Controlled Trial ◽  
Density Lipoprotein ◽  
High Dose ◽  
Double Blind ◽  
Apolipoprotein B100 ◽  
Igf I ◽  
Vldl Triglyceride

Abnormal lipid metabolism may be related to the increased cardiovascular risk in type 1 diabetes. Secretion and clearance rates of very low density lipoprotein (VLDL) apolipoprotein B100 (apoB) determine plasma lipid concentrations. Type 1 diabetes is characterized by increased growth hormone (GH) secretion and decreased insulin-like growth factor (IGF) I concentrations. High-dose IGF-I therapy improves the lipid profile in type 1 diabetes. This study examined the effect of low-dose (40 μg · kg−1· day−1) IGF-I therapy on VLDL apoB metabolism, VLDL composition, and the GH-IGF-I axis during euglycemia in type 1 diabetes. Using a stable isotope technique, VLDL apoB kinetics were estimated before and after 1 wk of IGF-I therapy in 12 patients with type 1 diabetes in a double-blind, placebo-controlled trial. Fasting plasma triglyceride ( P < 0.03), VLDL-triglyceride concentrations ( P < 0.05), and the VLDL-triglyceride-to-VLDL apoB ratio ( P < 0.002) significantly decreased after IGF-I therapy, whereas VLDL apoB kinetics were not significantly affected by IGF-I therapy. IGF-I therapy resulted in a significant increase in IGF-I and a significant reduction in GH concentrations. The mean overnight insulin concentrations during euglycemia decreased by 25% after IGF-I therapy. These results indicate that low-dose IGF-I therapy restores the GH-IGF-I axis in type 1 diabetes. IGF-I therapy changes fasting triglyceride concentrations and VLDL composition probably because of an increase in insulin sensitivity.

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