scholarly journals A Pilot Study to Investigate the Efficacy of Nicotine Oral Soluble Film, Lozenge and Gum in Relief of Acute Smoking Cue-provoked Craving for Cigarette in Low Dependence Smokers

2014 ◽  
Vol 10 (2) ◽  
pp. 87-95 ◽  
Author(s):  
Daniel Du ◽  
James Borders ◽  
Alex Selmani ◽  
William Waverczak
Keyword(s):  
Pilot Study ◽  
Early Time ◽  
Controlled Study ◽  
Nicotine Gum ◽  
Open Label ◽  
Time Points ◽  
Smoking Cues ◽  
Significant Difference ◽  
Nicotine Lozenge

Introduction: A new nicotine film that releases nicotine quickly may lead to faster craving relief.Aims: This study compares the efficacy of 2.5 mg nicotine film with 2 mg nicotine lozenge and 2 mg nicotine gum on relieving provoked craving in low dependence smokers.Methods: A randomised, open-label, active comparators controlled study was conducted in 120 subjects. Subjects were abstinent from smoking for 4 hours prior to being provoked with smoking cues. After post-provocation craving assessment, subjects were administered one dose of the 3 treatments: nicotine film, lozenge, or gum. Craving intensity was then assessed at 50 seconds, 3, 5, 7, 15, 20, 25 and 30 minutes after administration.Results/Findings: Three treatments reduced craving with similar maximum effects. The effect was maintained up to 30 minutes. Nicotine film significantly reduced more craving than lozenge at 50 seconds, 3 and 5 minutes. It also significantly reduced more craving than gum at 50 seconds and 3 minutes. There was no significant difference between lozenge and gum.Conclusions: Nicotine film, lozenge and gum have similar maximum craving relief. Nicotine film significantly reduced more craving than lozenge and gum at early time points. Nicotine film may be particularly useful to provide acute craving relief.

Safety profile of a nicotine lozenge compared with thatof nicotine gum in adult smokers with underlying medical conditions: A 12-week, randomized, open-label study

2005 ◽  
Vol 27 (10) ◽  
pp. 1571-1587 ◽  
Author(s):  
Howard S. Marsh ◽  
Carolyn M. Dresler ◽  
Jae H. Choi ◽  
Darren A. Targett ◽  
Michael L. Gamble ◽  
...  
Keyword(s):  
Safety Profile ◽  
Nicotine Gum ◽  
Medical Conditions ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Nicotine Lozenge

scholarly journals Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: A Randomized controlled clinical studies

2021 ◽  
Author(s):  
Weilian Geng ◽  
Changxing Chen ◽  
Xingfeng Sun ◽  
Shaoqiang Huang
Keyword(s):  
Optic Nerve ◽  
Optic Nerve Sheath Diameter ◽  
Optic Nerve Sheath ◽  
Controlled Study ◽  
Anesthesia Induction ◽  
Gynecological Surgery ◽  
Time Points ◽  
Randomized Controlled ◽  
Nerve Sheath ◽  
Significant Difference

Abstract Background The results of studies on changes in intracranial pressure in patients undergoing laparoscopic surgery are inconsistent. Meanwhile, previous neurosurgery studies have suggested that propofol and sevoflurane have inconsistent effects on cerebral blood flow and cerebrovascular self-regulation. The purpose of this study is to compare changes in the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery under anesthetic maintenance with propofol versus sevoflurane. Methods This study included 110 patients undergoing laparoscopic gynecological surgery with an estimated operative time of more than 2 hours under general anesthesia. The study was a randomized controlled study. The optic nerve sheath diameter（ONSD）at various time points was measured by ultrasound, including when the patients entered the operating room (Tawake), after successful anesthesia induction and endotracheal intubation (Tinduction), when the body position was adjusted to the Trendelenburg position and the CO2 pneumoperitoneum pressure reached 14 mmHg, which was recorded as T0. Then, measurements were conducted every 15 minutes for the first 1 hour and then once every hour until the end of the surgery（T15,T30,T45 ,T1h ,T2h…）, after the end of surgery and the tracheal tube was removed (Tend), and before the patients were transferred to the ward (Tpacu).Results A significant difference in optic nerve sheath diameter was found between two groups at T15, T30, T45 (4.64±0.48mm and 4.50±0.29mm, respectively, p=0.031;4.77±0.45mm and 4.62±0.28mm, respectively, p=0.036;4.84±0.46mm and 4.65±0.30mm, respectively, p=0.012), while there was no significant difference at Tawake and other time points. Conclusion During laparoscopic gynecological surgery lasting more than 2 hours, the optic nerve sheath diameter was slightly larger in the propofol group than that in the sevoflurane group in the first 45 minutes. No significant difference was observed between the two groups 1 hour after surgery. Trial registration clinicaltrials.gov，NCT03498235. Retrospectively registered 1 March2018,https://register.clinicaltrials.gov/prs/app/action/SelectProtocol?sid=S0007UMM&selectaction=Edit&uid=U00040C5&ts=39&cx=c7i8icThe manuscript adheres to CONSORT guidelines.

scholarly journals A randomised controlled trial to evaluate a medication monitoring system for TB treatment

2022 ◽  
Vol 26 (1) ◽  
pp. 44-49
Author(s):  
J. Acosta ◽  
P. Flores ◽  
M. Alarcón ◽  
M. Grande-Ortiz ◽  
L. Moreno-Exebio ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Treatment Success ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Second Phase ◽  
Open Label ◽  
Pulmonary Tb ◽  
Tb Treatment ◽  
Significant Difference

BACKGROUND: Adherence to TB treatment and therefore treatment success could be improved using digital adherence technology.OBJECTIVE: To evaluate the effectiveness of a medication event reminder monitor system (MERM) on treatment success and treatment adherence in patients with drug-susceptible pulmonary TB in Perú.METHODS: This was an experimental, randomised, open-label, controlled study conducted among patients in the second phase of TB treatment. The intervention group received their medications through MERM with the support of a treatment monitor, whereas the control group used the usual strategy. Participants were followed until they completed the 54 doses of the second phase of treatment.RESULTS: The study included 53 patients in each group; four in the intervention group withdrew from the study. Treatment success was significantly more frequent in the MERM group (RR 1.15, 95% CI 1.02–1.30; P = 0.0322). There was no significant difference in the adherence outcomes; however, the percentage of patients who missed at least one dose and patients with more than 10% of total doses missed were lower in the intervention group.CONCLUSION: The use of MERM in the second phase of treatment showed a significant improvement in the treatment success rate in patients with drug-susceptible pulmonary TB.

scholarly journals Effects of Laser Acupuncture Therapy for Patients With Inadequate Recovery From Bell’s Palsy: Preliminary Results From Randomized, Double-Blind, Sham-Controlled Study

2021 ◽  
Vol 12 (1) ◽  
pp. e70-e70
Author(s):  
Gil Ton ◽  
Li-Wen Lee ◽  
Wen-Chao Ho ◽  
Cheng-Hao Tu ◽  
Yi-Hung Chen ◽  
...  
Keyword(s):  
Pilot Study ◽  
Acupuncture Therapy ◽  
Large Scale ◽  
Bell’S Palsy ◽  
Low Level Laser Therapy ◽  
Laser Acupuncture ◽  
Controlled Study ◽  
Clinical Effects ◽  
Bell's Palsy ◽  
Significant Difference

Introduction: Inadequate recovery from Bell’s palsy exists in a third of patients and results in physical and social impairments. The controversial nature of existing medical treatment options means that novel, alternative approaches are needed. In basic and clinical studies, low-level laser therapy (LLLT) has proven successful in regenerating peripheral nerves. Laser acupuncture therapy (LAT) is a rapidly growing treatment modality; however, its effectiveness for treating chronic Bell’s palsy is unknown. The feasibility of this innovative approach is the focus of this pilot study. Methods: A two-armed, parallel, randomized, investigator-subject-assessor-blinded, sham-controlled pilot study was conducted, and 17 eligible subjects were randomly allocated to either LAT (n=8) or sham LAT (n=9). The LAT group received three treatments each week for six weeks (18 sessions), while the sham LAT group received the same procedure but with a sham laser device. The change from baseline to week 6 in the social subscale of the Facial Disability Index (FDI) was the primary outcome. Secondary outcomes were changes in the House-Brackmann facial paralysis scale (HB), the Sunnybrook facial grading system (SB) and a stiffness scale at weeks 3 and 6. Results: A significant difference was shown in the HB score (P=0.0438) between baseline and week 3 and borderline significance was observed in both SB and stiffness scores from baseline to week 6 (P=0.0598 and P=0.0980 respectively). There was no significant difference in the FDI score between baseline and week 6. Conclusion: To the best of our knowledge, this clinical trial is the first such investigation on this topic. Our findings suggest that using LAT may have clinical effects on long-term complications of Bell’s palsy and justify further large-scale studies.

Donepezil for cancer-related fatigue: A double-blind, randomized, placebo-controlled study

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9003-9003
Author(s):  
E. Bruera ◽  
B. El Osta ◽  
V. Valero ◽  
L. Driver ◽  
J. Palmer ◽  
...  
Keyword(s):  
Advanced Cancer ◽  
Controlled Trial ◽  
Subscale Score ◽  
Assessment System ◽  
Phone Call ◽  
Controlled Study ◽  
Fatigue Improvement ◽  
Open Label ◽  
Double Blind ◽  
Significant Difference

9003 Background: Fatigue is the most frequent symptom in advanced cancer. No standard treatment is available. We previously found that open-label donepezil significantly improved fatigue by day 3 and 7 in patients (pts) on opioids for cancer pain (Fisch et al, ASCO 2003). The purpose of this study was to compare donepezil (D) with placebo (P) for fatigue in pts with advanced cancer. Methods: In this randomized, double-blind, placebo-controlled trial, pts with fatigue score = 4 on a 0 to 10 scale (10 = worst fatigue) for > 1 week, hemoglobin = 10g/dl for = 4 weeks, and no major contraindication to D were randomized to receive D 5 mg or P orally every morning for 7 days. All pts were offered open-label D during week 2. Assessment included: research nurse daily phone call for fatigue and toxicity evaluation, Edmonton Symptom Assessment System (ESAS), Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F), Sleeping Pattern Assessment, and overall effectiveness of the treatment. The FACIT-F fatigue subscale score on day 8 was considered the primary endpoint. Results: 103 pts were evaluable for final analysis. Mean difference in scores for symptoms intensity between baseline and day 8 are shown in Table 1 . FACIT-F fatigue subscale score at day 8 decreased a mean of 6 (10.6 SD) in the D arm (p < 0.001) and 7.2 (9.5 SD) in the P arm (p < 0.001). There was no significant difference in fatigue improvement between both arms according to the FACIT-F subscale (p = 0.57) and ESAS fatigue (p = 0.18) scores, and no significant difference in sleep quality score between D and P. On day 15 of the open-label phase, mean fatigue intensity remained significantly improved as compared to baseline on FACIT-F fatigue subscale (p < 0.001) and ESAS fatigue (p < 0.001) scores. No significant toxicities were observed. Conclusions: Both donepezil and placebo resulted in significant fatigue improvement. Donepezil was not significantly superior to placebo after one week. Our pilot findings are probably due to placebo effect. No significant financial relationships to disclose. [Table: see text]

scholarly journals Assessment of Deep Partial Thickness Burn Treatment with Keratin Biomaterial Hydrogels in a Swine Model

2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
D. Poranki ◽  
C. Goodwin ◽  
M. Van Dyke
Keyword(s):  
Early Time ◽  
Tissue Perfusion ◽  
Swine Model ◽  
Burn Wound ◽  
Burn Treatment ◽  
Time Points ◽  
Collagen Hydrogel ◽  
Partial Thickness ◽  
Partial Thickness Burn ◽  
Significant Difference

Partial thickness burns can advance to full thickness after initial injury due to inadequate tissue perfusion and increased production of inflammatory cytokines, which has been referred to as burn wound progression. In previous work, we demonstrated that a keratin biomaterial hydrogel appeared to reduce burn wound progression. In the present study, we tested the hypothesis that a modified keratin hydrogel could reduce burn wound progression and speed healing. Standardized burn wounds were created in Yorkshire swine and treated within 30 minutes with keratin hydrogel (modified and unmodified), collagen hydrogel, or silver sulfadiazine (SSD). Digital images of each wound were taken for area measurements immediately prior to cleaning and dressing changes. Wound tissue was collected and assessed histologically at several time points. Wound area showed a significant difference between hydrogels and SSD groups, and rates of reepithelialization at early time points showed an increase when keratin treatment was used compared to both collagen and SSD. A linear regression model predicted a time to wound closure of approximately 25 days for keratin hydrogel while SSD treatment required 35 days. There appeared to be no measurable differences between the modified and unmodified formulations of keratin hydrogels.

scholarly journals Open-label, add-on trial of cetirizine for neuromyelitis optica

2018 ◽  
Vol 5 (2) ◽  
pp. e441 ◽  
Author(s):  
Ilana Katz Sand ◽  
Michelle T. Fabian ◽  
Russell Telford ◽  
Thomas A. Kraus ◽  
Mirna Chehade ◽  
...  
Keyword(s):  
Pilot Study ◽  
Neuromyelitis Optica ◽  
Standard Therapy ◽  
Small Sample Size ◽  
Small Sample ◽  
Open Label ◽  
End Point ◽  
Disease Modifying Therapy ◽  
Significant Difference ◽  
Disease Modifying

ObjectiveThis pilot study preliminarily examined the efficacy and tolerability of cetirizine as an add-on to standard therapy for neuromyelitis optica (NMO).MethodsEligible participants met the Wingerchuk 2006 diagnostic criteria or had a single typical episode along with positive NMO immunoglobulin G. After baseline clinical and laboratory assessments, participants began treatment with cetirizine 10 mg orally daily, in addition to their usual disease-modifying therapy for NMO, and continued for 1 year. The primary end point was the annualized relapse rate (ARR) while on the same disease-modifying therapy before starting cetirizine compared with after taking cetirizine. Additional end points included disability (Expanded Disability Status Scale [EDSS]), relapse severity, tolerability, especially with respect to drowsiness measured by the Epworth Sleepiness Scale (ESS), and laboratory parameters.ResultsThe ARR before cetirizine was 0.4 ± 0.80 and after cetirizine was 0.1 ± 0.24 (p = 0.047). There was no statistically significant difference in the EDSS (mean 3.9 ± 2.18 before the start of the study and 3.2 ± 2.31 at the conclusion of the study, p = 0.500). The ESS remained fairly consistent throughout the study (mean 6.5 ± 5.33 at baseline and 6.9 ± 4.50 at month 12, p = 0.740). Laboratory studies were unrevealing.ConclusionsIn this pilot study, cetirizine was well tolerated, and the prespecified primary efficacy end point was satisfied. However, the open-label design and the small sample size of this pilot study preclude definitive conclusions. Further research is needed.Classification of evidenceThis study provides Class IV evidence that in patients with NMO, the addition of cetirizine to standard therapy is safe, well tolerated, and reduces relapses.

Parent-Administered Oral Stimulation in Preterm Infants: A Randomized, Controlled, Open-Label Pilot Study

2021 ◽  
Author(s):  
Marta Majoli ◽  
Laura Costanza De Angelis ◽  
Monica Panella ◽  
Maria Grazia Calevo ◽  
Simona Serveli ◽  
...  
Keyword(s):  
Pilot Study ◽  
Preterm Infants ◽  
Length Of Hospital Stay ◽  
Oral Feeding ◽  
Transition Time ◽  
Open Label ◽  
Active Involvement ◽  
Randomized Controlled ◽  
Oral Stimulation ◽  
Significant Difference

Objective The study aimed to assess whether there was any difference in the transition time to full oral feedings between parent-administered and professional-administered premature infant oral motor intervention (PIOMI). The study also evaluated parental satisfaction with performing the intervention through an open-ended questionnaire. Study Design A single-center, randomized, controlled, open-label pilot study was carried on between March 2017 and May 2019. A total of 39 infants born ≤32 weeks' gestation were randomly assigned to either parent-performed or professionally performed oral stimulation. The oral stimulation was performed once a day for seven consecutive days between 31 and 32 weeks' postmenstrual age. Results There was no statistically significant difference in transition time, weight gain, or length of hospital stay between the two groups. No adverse events were observed. Parents' satisfaction was high, and their active involvement enhanced their perception of adequacy to care for their infant. Conclusion Following adequate training, a parent-administered PIOMI may be considered in preterm infants to reduce the transition time to full oral feeding and enhance the direct involvement of parents in neonatal care. Key Points

scholarly journals Effects of sevoflurane and propofol on the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery: a randomized controlled clinical studies

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Weilian Geng ◽  
Changxing Chen ◽  
Xingfeng Sun ◽  
Shaoqiang Huang
Keyword(s):  
Optic Nerve ◽  
Optic Nerve Sheath Diameter ◽  
Optic Nerve Sheath ◽  
Controlled Study ◽  
Anesthesia Induction ◽  
Gynecological Surgery ◽  
Time Points ◽  
Randomized Controlled ◽  
Nerve Sheath ◽  
Significant Difference

Abstract Background The results of studies on changes in intracranial pressure in patients undergoing laparoscopic surgery are inconsistent. Meanwhile, previous neurosurgery studies have suggested that propofol and sevoflurane have inconsistent effects on cerebral blood flow and cerebrovascular self-regulation. The purpose of this study is to compare changes in the optic nerve sheath diameter in patients undergoing laparoscopic gynecological surgery under anesthetic maintenance with propofol versus sevoflurane. Methods This study included 110 patients undergoing laparoscopic gynecological surgery with an estimated operative time of more than 2 h under general anesthesia. The study was a randomized controlled study. The optic nerve sheath diameter (ONSD) at various time points was measured by ultrasound, including when the patients entered the operating room (Tawake), after successful anesthesia induction and endotracheal intubation (Tinduction), when the body position was adjusted to the Trendelenburg position and the CO2 pneumoperitoneum pressure reached 14 mmHg, which was recorded as T0. Then, measurements were conducted every 15 min for the first 1 h and then once every hour until the end of the surgery (T15, T30, T45, T1h, T2h …), after the end of surgery and the tracheal tube was removed (Tend), and before the patients were transferred to the ward (Tpacu). Results A significant difference in optic nerve sheath diameter was found between two groups at T15, T30, T45 (4.64 ± 0.48 mm and 4.50 ± 0.29 mm, respectively, p = 0.031;4.77 ± 0.45 mm and 4.62 ± 0.28 mm, respectively, p = 0.036;4.84 ± 0.46 mm and 4.65 ± 0.30 mm, respectively, p = 0.012), while there was no significant difference at Tawake and other time points. Conclusion During laparoscopic gynecological surgery lasting more than 2 h, the optic nerve sheath diameter was slightly larger in the propofol group than that in the sevoflurane group in the first 45 min. No significant difference was observed between the two groups 1 h after surgery. Trial registration clinicaltrials.gov, NCT03498235. Retrospectively registered 1 March 2018. The manuscript adheres to CONSORT guidelines.

THERAPEUTIC EFFECT OF INTRANASAL EVAPORATIVE COOLING IN PATIENTS WITH MIGRAINE. A REPORT OF THE RESULTS OF THE COOL HEAD I, PILOT STUDY

2015 ◽  
Vol 86 (11) ◽  
pp. e4.177-e4
Author(s):  
Jitka Vanderpol ◽  
Barbara Bishop ◽  
Manjit Matharu ◽  
Mark Glencorse
Keyword(s):  
Pilot Study ◽  
Venous Blood ◽  
Evaporative Cooling ◽  
Vascular Anatomy ◽  
Controlled Study ◽  
Open Label ◽  
Anatomical Basis ◽  
Severity Scores ◽  
Considerable Benefit ◽  
Randomised Controlled

BackgroundIntranasal evaporative cooling due to vascular anatomy, allows the transfer of venous blood from nasal and paranasal mucous membranes to the dura mater, providing an excellent anatomical basis for the cooling processes. The aim of this study was to ascertain whether it may be an effective intervention in an acute migraine attack.MethodsWe conducted a prospective, open-label, observational, pilot study. A total of 20 treatments were administered in 15 patients who satisfied the ICHD 2 diagnostic criteria for migraine. All patients provided pain and migraine-associated symptoms severity scores.ResultsImmediately after the treatment, 8 treatments (40%) resulted in pain and symptoms freedom, a further 10 treatments (50%) resulted in partial pain and symptoms relief. At 2 hours, 9 treatments (45%) provided full pain and symptoms relief, with a further 9 treatments (45%) resulting in partial pain and symptoms relief. In summary 13 patients (87%) had benefit from the treatment within 2 hours that was sustained at 24 hours; without significant side effects.ConclusionsIntranasal evaporative cooling was safe and gave considerable benefit to patients with migraine. An adequately powered randomised controlled study will be required to confirm the potential of this application in the treatment of migraine.

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