scholarly journals Comparison of two tDCS protocols on pain and EEG alpha-2 oscillations in women with fibromyalgia

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Géssika Araújo de Melo ◽  
Eliane Araújo de Oliveira ◽  
Suellen Mary Marinho dos Santos Andrade ◽  
Bernardino Fernández-Calvo ◽  
Nelson Torro
Keyword(s):  
Frequency Band ◽  
Pain Reduction ◽  
Controlled Clinical Trial ◽  
Behavioral Measures ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Eeg Alpha ◽  
Group 1 ◽  
Anodic Stimulation

Abstract Transcranial Direct Current Stimulation (tDCS) has been used as an alternative treatment for pain reduction in fibromyalgia. In this study, in addition to behavioral measures, we analyzed oscillations in alpha 2 frequency band in the frontal, occipital, and parietal regions, in response to the application of two neuromodulation protocols in fibromyalgia. The study was a randomized, double-blind, placebo-controlled clinical trial with 31 women diagnosed with fibromyalgia. The participants were allocated to three groups with the anodic stimulation applied on the left motor cortex: Group 1, for five consecutive days; Group 2, for 10 consecutive days; and Group 3, sham stimulation for five consecutive days. Statistical analysis showed a reduction in pain intensity after treatment for groups in general [F (1.28) = 8.02; p = 0.008; η2 = 0.223], in addition to a reduction in alpha 2 in the frontal (p = 0.039; d = 0.384) and parietal (p = 0.021; d = 0.520) regions after the treatment on five consecutive days. We conclude that neuromodulation protocols produced similar effects on pain reduction, but differed with respect to the changes in the alpha 2 frequency band in the frontal and parietal regions.

scholarly journals Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study

2021 ◽  
Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Régis Josien ◽  
Karine Lacombe ◽  
...  
Keyword(s):  
Adverse Events ◽  
High Serum ◽  
Serum Concentrations ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Good Tolerability ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. To evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. Methods : In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5mg/kg at day 1 and day 5 (group 1), 2mg/kg at day 1 and day 5 (group 2), 2mg/kg at day 1 (group 3) or placebo. Results : Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at C max and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC 100 ]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions : Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384

scholarly journals EFFICACY OF MOUTH RINSE FORMULATION BASED ON CETYLPYRIDINIUM CHLORIDE 0.1% IN THE CONTROL OF DENTAL CALCULUS BUILDUP

2017 ◽  
Vol 9 ◽  
pp. 176 ◽  
Author(s):  
Diah Ayu Maharani ◽  
Alia Ramadhani ◽  
Melissa Adiatman ◽  
Yuniardini Septorini Wimardhani ◽  
Linda Kusdhany ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cetylpyridinium Chloride ◽  
Positive Control ◽  
Negative Control ◽  
Mouth Rinse ◽  
Dental Calculus ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: This study aimed at comparing the antiplaque, anticalculus, and antigingivitis potentials of a mouth rinse containing essential oil, alcohol,zinc, and fluoride with a mouth rinse containing cetylpyridinium chloride (CPC) 0.1% over 1-, 2-, and 3-month periods.Methods: This study was a double-blind, parallel randomized clinical trial with a 3-day run-in phase. Respondents were asked to gargle twice dailywith 15 ml of mouth rinse for 30 seconds after brushing teeth. Respondents were 80 females with a mean age of 21 years, and a single dental examinerwas employed throughout the study to decrease the variance. Prophylaxis was performed for all respondents before the intervention. Three mouthrinses were tested: Group 1 with the mouth rinse containing CPC 0.1%, Group 2 as the negative control, and Group 3 as the positive control with amouth rinse containing alcohol. Evaluations were conducted by plaque index, gingival index, calculus index, and CariScreen examinations.Results: The clinical trial showed that the mouth rinse with alcohol and the mouth rinse containing CPC 0.1% were effective in inhibiting bacterialbuildup (antiplaque) and have anticalculus properties, but with no statistically significant antigingivitis effect.Conclusion: It was found that the mouth rinse containing alcohol has similar effectiveness with CPC 0.1% mouth rinse, but side effects, such as aburning sensation, were reported in the alcohol-containing mouth rinse.

scholarly journals Prevention of Delayed Nausea: A University of Rochester Cancer Center Community Clinical Oncology Program Study of Patients Receiving Chemotherapy

2012 ◽  
Vol 30 (27) ◽  
pp. 3389-3395 ◽  
Author(s):  
Joseph A. Roscoe ◽  
Charles E. Heckler ◽  
Gary R. Morrow ◽  
Supriya G. Mohile ◽  
Shaker R. Dakhil ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Cancer Center ◽  
Double Blind ◽  
Group 4 ◽  
Community Clinical Oncology Program ◽  
Delayed Nausea ◽  
Group 3 ◽  
Group 2 ◽  
Mean Differences ◽  
Group 1

Purpose We conducted a double-blind randomized clinical trial of the following four regimens for controlling delayed nausea (DN): group 1: palonosetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 2: granisetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 3: aprepitant + palonosetron + dexamethasone on day 1 with aprepitant + dexamethasone on days 2 and 3; and group 4: palonosetron + dexamethasone on day 1 with prochlorperazine + dexamethasone on days 2 and 3. Patients and Methods Chemotherapy-naive patients received doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin. The primary end point was average nausea assessed four times daily on days 2 and 3. Primary analyses were whether nausea control would be improved by using palonosetron versus granisetron on day 1 (group 1 v group 2); by adding dexamethasone on days 2 and 3 (group 1 v group 4); and by using aprepitant versus prochlorperazine (group 3 v group 4). Statistical significance was set at P = .017. Results Two hundred thirty-four, 234, 241, and 235 evaluable patients were accrued to groups 1, 2, 3, and 4, respectively. Adjusted mean differences for the three planned analyses were as follows: palonosetron versus granisetron: −0.01 (95% CI, −0.23 to 0.20; P = .72); adding dexamethasone on days 2 and 3: 0.20 (95% CI, −0.02 to 0.41; P = .01); and using aprepitant versus prochlorperazine: −0.03 (95% CI, −0.24 to 0.19; P = .56). Conclusion The addition of dexamethasone on days 2 and 3 reduced DN. Palonosetron and granisetron have similar effects on DN. The beneficial effect of adding aprepitant for control of DN was the same as adding prochlorperazine.

scholarly journals Comparison of Buccal Infiltration of 4% Articaine With 1 : 100,000 and 1 : 200,000 Epinephrine for Extraction of Maxillary Third Molars With Pericoronitis: A Pilot Study

2013 ◽  
Vol 60 (2) ◽  
pp. 42-45 ◽  
Author(s):  
José Lacet Lima ◽  
Eduardo Dias-Ribeiro ◽  
Julierme Ferreira-Rocha ◽  
Ramon Soares ◽  
Fábio Wildson Gurgel Costa ◽  
...  
Keyword(s):  
Third Molar ◽  
Controlled Clinical Trial ◽  
Third Molars ◽  
Double Blind ◽  
Experienced Pain ◽  
Group 2 ◽  
Upper Third ◽  
Buccal Infiltration ◽  
Palatal Mucosa ◽  
Group 1

Abstract We compared the buccal infiltration of 4% articaine with 1 : 100,000 or 1 : 200,000 epinephrine without a palatal injection for the extraction of impacted maxillary third molars with chronic pericoronitis. This prospective, double-blind, controlled clinical trial involved 30 patients between the ages of 15 and 46 years who desired extraction of a partially impacted upper third molar with pericoronitis. Group 1 (15 patients) received 4% articaine with 1 : 100,000 epinephrine and group 2 (15 patients) received 4% articaine with 1 : 200,000 epinephrine by buccal infiltration. None of the patients in group 1 reported pain, but 3 patients in group 2 reported pain, which indicated a need for a supplementary palatal injection. The palatal injections were all successful in eliminating the pain. Two additional patients in group 2 experienced pain when the suture needle penetrated their palatal mucosa. Based on these results, 4% articaine with 1 : 100,000 epinephrine was found to be more effective for the removal of upper third molars in the presence of pericoronitis than 4% articaine hydrochloride with 1 : 200,000 epinephrine when only a buccal infiltration was used.

scholarly journals Preemptive Analgesia in Total Knee Arthroplasty: Comparing the Effects of Single Dose Combining Celecoxib with Pregabalin and Repetition Dose Combining Celecoxib with Pregabalin: Double-Blind Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Andri M. T. Lubis ◽  
Rangga B. V. Rawung ◽  
Aida R. Tantri
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Knee Arthroplasty ◽  
Preemptive Analgesia ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Significant Difference ◽  
Total Knee ◽  
Group 2 ◽  
Group 1

Acute pain is the most common early complication after total knee arthroplasty causing delayed mobilization and increased demands of morphine, leading to higher operative cost. Several studies have assessed the effectiveness, side-effects, and ease of use of various analgesics. Preemptive analgesia with combined celecoxib and pregabalin has been reported to yield positive outcomes. In this randomized, double-blind controlled clinical trial, 30 subjects underwent surgery for total knee arthroplasty using 15-20mg bupivacaine 5% epidural anesthesia. All subjects were divided into three groups. Group 1 was given celecoxib 400mg and pregabalin 150mg 1 hour before the operation, Group 2 was given celecoxib 200mg and pregabalin 75mg twice daily starting from 3 days before the operation, and Group 3 was given a placebo. The outcome was measured with Visual Analog Scale, knee range of motion, and postoperative mobilization. There was a significant difference in postoperative morphine usage between the groups that were administered with preemptive analgesia and the placebo group, but no significant difference was found between Group 1 and Group 2 that were given preemptive analgesia at different doses. ROM and postoperative mobilization were not significantly different among the three groups. Two patients in the first group, one patient in the second group, and one patient in the third group developed nausea. Preemptive analgesia is proven to reduce postoperative usage of morphine independent of the dosage. We recommend the use of combined celecoxib and pregabalin as preemptive analgesia after the total knee arthroplasty procedure. This trial is registered with NCT03523832 (ClinicalTrials.gov).

Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion: A Randomized Double-Blind Clinical Trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Shaimaa G Helmy ◽  
Mohammed A El-Kadi ◽  
Mohamed E Elhodiby ◽  
Mohamed H Salama
Keyword(s):  
Controlled Trial ◽  
Secondary Outcome ◽  
Contraceptive Device ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Vaginal Misoprostol ◽  
Different Doses ◽  
Group 1

Abstract Objective This study aims to compare the efficacy and safety of different doses of vaginal misoprostol prior to IUCD insertion among women with nulliparous cervix “those who 29never delivered-vaginally”. Study design: The current study was a randomized, double-blind, placebo-controlled trial conducted in the Family Planning Clinic of Ain Shams University’s Maternity Hospital Egypt. It involved women who delivered only by elective CD (cesarean delivery). One hundred and eighty women were randomized into three groups, Group 1 received misoprostol 200 mcg. Group 2 received misoprostol 100 mcg. Group 3 received placebo. The primary outcome was pain scores which were measured using a visual analogue scale (VAS), the secondary outcome was the ease of insertion score (ES). Results VAS and ES were significantly lower in group 1 compared to group 2 and group 3 (P < 0.001).There was insignificant difference among the three groups as regards successful IUD insertion (P = 0.477). Duration of insertion was significantly lower in group 1 than group 2 (P < 0.001). Satisfaction was significantly higher in group 1 compared to group 2 and group 3 (P < 0.001) Conclusion The effect of misoprostol seems to be dose-dependent. Dose of 200mcg seems to be ideal with best efficacy and with no significant increase in the adverse effects Implications: The dose of 200mcg vaginal misoprostol prior to IUD insertion in women, who had never delivered vaginally before, seems to be the most effective dose. Trail to lower the dose to100mcg significantly compromises the efficacy without remarkable benefit on the side effect profile.

Fibrin gel versus papain gel in the healing of chronic venous ulcers: A double-blind randomized controlled trial

2016 ◽  
Vol 32 (7) ◽  
pp. 488-495 ◽  
Author(s):  
Illymack CF de Araújo ◽  
Elenice Defune ◽  
Luciana PF Abbade ◽  
Hélio A Miot ◽  
Matheus Bertanha ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Efficacy And Safety ◽  
Fibrin Gel ◽  
Double Blind ◽  
Randomized Controlled ◽  
Carbopol Gel ◽  
Venous Ulcers ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objectives Compare the efficacy and safety of fibrin gel to 8% papain gel for wound dressing of venous ulcers. Method Patients with chronic venous ulcers were randomly assigned to one in three groups: Group 1—fibrin gel; Group 2—8% papain gel; Group 3—carbopol gel (control). Patients were seen every 15 days during 2 months, verifying reduction of the ulcer area, local infection, exudation, and epithelization. All serious or nonserious adverse events were recorded. Results Fifty-five patients (total of 63 ulcers) were randomly distributed in three groups (G1 = 21; G2 = 19; G3 = 23). No patient was excluded or discontinued treatment throughout the study. The areas of the ulcers were similarly reduced in all groups (14.3%, 21.1%, and 30.4% in groups 1, 2, and 3, respectively), and all had significant reduction in exudation and contamination. Conclusion The data demonstrate that neither fibrin gel nor papain gel were able to improve the process of ulcer-healing, as compared to control.

scholarly journals Efficacy and safety of GV1001 in patients with moderate-to-severe Alzheimer’s disease already receiving donepezil: a phase 2 randomized, double-blind, placebo-controlled, multicenter clinical trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Seong-Ho Koh ◽  
Hyuk Sung Kwon ◽  
Seong Hye Choi ◽  
Jee Hyang Jeong ◽  
Hae Ri Na ◽  
...  
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trial ◽  
Adverse Events ◽  
Primary Endpoint ◽  
Phase 2 ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Abstract Background Our previous studies showed that GV1001 has various protective effects against β-amyloid and other stressors. Based on these findings, we hypothesized that GV1001 might have beneficial effects in patients with Alzheimer’s disease (AD). Methods A phase 2, double-blind, parallel-group, placebo-controlled, 6-month randomized clinical trial was performed to evaluate the safety and efficacy of subcutaneously administered GV1001. Between September 2017 and September 2019, 13 centers in South Korea recruited participants. A total of 106 patients were screened, and 96 patients with moderate-to-severe AD were randomized 1:1:1 to the placebo (group 1, n = 31), GV1001 0.56 mg (group 2, n = 33), and 1.12 mg (group 3, n = 32) groups. GV1001 was administered every week for 4 weeks (4 times), followed by every 2 weeks until week 24 (10 times). The primary endpoint was the change in the Severe Impairment Battery (SIB) score from baseline to week 24. The key secondary efficacy endpoints were the change in the Clinical Dementia Rating Sum of Box (CDR-SOB), Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI), Mini-Mental State Examination, and Global Deterioration Scale scores. The safety endpoints were also assessed based on adverse events, laboratory test results, vital signs, and other observations related to safety. Results Group 3 showed less decrease in the SIB score at 12 and 24 weeks compared with group 1 (P < 0.05). These were not significantly observed in group 2. Among the secondary endpoints, only the NPI score showed significantly better improvement in group 2 than in group 3 at week 12; however, there were no other significant differences between the groups. Although the ADCS-ADL and CDR-SOB scores showed a pattern similar to SIB scores, a statistically significant result was not found. Adverse events were similar across all three groups. Conclusions The results indicate that GV1001 1.12 mg met the primary endpoint of a statistically significant difference. GV1001 was well tolerated without safety concerns. This study warrants a larger clinical trial. Trial registration ClinicalTrials.gov NCT03184467. Registered on June 12, 2017.

scholarly journals THE USING OF POLYPRENOL-CONTAINING DRUG IN PATIENTS WITH ACUTE CORONARY SYNDROME

2018 ◽  
Vol 33 (2) ◽  
pp. 21-25
Author(s):  
E. I. Tsoi ◽  
E. V. Vyshlov ◽  
V. B. Trusov
Keyword(s):  
Acute Coronary Syndrome ◽  
Standard Therapy ◽  
Control Group ◽  
Study Group ◽  
Double Blind ◽  
Coronary Syndrome ◽  
Group 3 ◽  
Group 2 ◽  
The Right ◽  
Group 1

The article shows the results of the study using drug Ropren in the patients with acute coronary syndrome. Ropren is  a plant drug containing polyprenols — dolichol precursors which take part in dolichol phosphate pathway. The pathology in this pathway leads to disbalance and glycoprotein deficiency. This is the reason of large group of diseases. This study is randomized double blind placebo controlled (No. NCT03122340 at ClinicalTrials.gov). Patients (n=68) with ACS taking standard therapy including atorvastatin 40 mg/day were randomized into to 2 groups: group 1 (n=34) took Ropren  8 drops 3 times per day for 3 week, then 5 drops 3 times per day for 5 weeks; group 2 (n=34) took placebo in the same dose regimen. After two — month therapy there was a positive dynamic (decreasing) in the level of interleukin-6 in the study group whereas in the control group there was no statistically significant change: 4.36 (2.61, 8.95) and 5.5 (3.3; 8.4) pg/ml, respectively (p<0.05). In the group of patients taking Ropren the reduction or cessation of statin was required significantly less than in the placebo group: 3 (8.8%) vs 9 (26.5%), respectively. One patient from the first group had a side effect in the form of gravity in the right hypochondrium. That is why the administration of Ropren in addition to standard therapy is reasonable in patients with ACS.

scholarly journals Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study

2021 ◽  
Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Regis Josien ◽  
Karine Lacombe ◽  
...  
Keyword(s):  
Adverse Events ◽  
High Serum ◽  
Serum Concentrations ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Good Tolerability ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Background: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. In vitro, 100% neutralization activity is seen with XAV-19 concentrations above 5 microg/mL. Methods: In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5 mg/kg at day 1 and day 5 (group 1), 2 mg/kg at day 1 and day 5 (group 2), 2 mg/kg at day 1 (group 3) or placebo. Results: Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (microg/mL, median, range) at Cmax and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 microg/mL (tow fold the in vitro 100% inhibitory concentration [IC100]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions: Single intravenous dose of 2 mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability.

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