Open-label Uncontrolled Clinical Trial Research Articles

Effects of a Protocol Combining a Non-Irritating Shampoo and an Adelmidrol-Based Adsorbent Mousse on Seborrhoea and Other Signs and Symptoms Secondary to Canine Atopic Dermatitis: A Multicenter, Open-Label Uncontrolled Clinical Trial.

The present study aimed at evaluating the effect of a gentle shampoo and a mousse containing Adelmidrol, tapioca starch and a non-prescription antimicrobial complex on seborrhoea and other clinical signs secondary to canine atopic dermatitis (cAD). Forty-six dogs with cAD-associated seborrhoea and/or pruritus > 4 cm on the pruritus visual analogue scale (P-VAS) and/or bacterial/Malassezia overgrowth were enrolled. The mousse was applied twice daily, and dogs were evaluated at days (D)0, 7, 14 and optionally 28, by means of a skin seborrheic index (SSI), P-VAS, cAD lesion index (CADLI), and a semiquantitative cytological score. The mean SSI value improved during the first two weeks (4.1 ± 0.37 to 1.9 ± 0.30; p < 0.0001). The mean P-VAS score (cm) decreased from 6.6 ± 0.19 at D0 to 3.8 ± 0.31 at D14 (p < 0.0001). The mean CADLI score dropped from 13.7 ± 1.24 to 8.5 ± 1.14 at D14 (p < 0.001). The cytological score for bacteria and Malassezia decreased from 3.2 ± 0.10 and 3.2 ± 0.11, respectively, to 1.2 ± 0.19 and 1.2 ± 0.24 (p < 0.0001). All the investigated signs further improved at D28. Altogether, these observations suggest that the tested protocol might be useful in managing cAD-associated signs.

Nasal disinfection for the prevention and control of COVID-19: A scoping review on potential chemo-preventive agents.

BackgroundNeither pre-exposure nor post-exposure chemo-prophylaxis agents are currently available to prevent COVID-19. On the other hand, high loads of SARS-CoV-2 are shed from the nasal cavity before and after symptoms onset.ObjectiveTo conduct a scoping review on the available evidence on tolerable nasal disinfectants with encouraging health outcomes against SARS-CoV-2, i.e., agents effective against at least two different viruses beyond SARS-CoV-2.MethodsOnline databases were searched to identify papers published during 2010–2020. Publications were selected if they were relevant to the scoping review. The review was narrative, describing for each treatment the mechanism(s) of action, tolerability, in vitro and in vivo evidence of the effects against SARS-CoV-2 and whether the product had been marketed.ResultsEight treatments were scrutinized: hypothiocyanite, lactoferrin, N-chlorotaurine, interferon-alpha, povidone-iodine, quaternary ammonium compounds, alcohol-based nasal antiseptics and hydroxychloroquine. In vitro viricidal effect against SARS-CoV-2 was reported for ethanol, alcohol-based hand sanitizers and povidone-iodine. Inhibition of other coronaviruses was described for lactoferrin, ethanol, hydroxychloroquine and quaternary ammonium compound. No treatment has been tested against SARS-CoV-2 in randomized controlled clinical trials thus far. However, interferon-alpha, lactoferrin and hydroxychloroquine were tested in one-arm open label uncontrolled clinical trial. Oxidant activity (hypothiocyanite, N-chlorotaurine and povidone-iodine), enhancement of endocytic and lysosomal pH (quaternary ammonium compounds and hydroxychloroquine) and destruction of the viral capsid (quaternary ammonium compounds, alcohol-based nasal antiseptics) were the main mechanisms of action. Lactoferrin and interferon-alpha have subtle biological mechanisms. With the exception of N-chlorotaurine, all other products available on the market.ConclusionsEffective and safe chemo-prophylactic drugs against SARS-CoV-2 do not exist yet but most eligible candidates are already in the market. Whilst the human nasal cavity is the port of entry for SARS-CoV-2, the mouth is involved as exit site through emission of respiratory droplets. The well-known hand-to-nose-to-hand cycle of contamination requires appropriate additional strategies for infection control. To narrow down the subsequent laboratory and clinical investigations, a case-control approach could be employed to compare the use of candidate drugs among individuals testing positive and negative to COVID-19 swabs.

Effect of Combined Heat killed Probiotic and Wheat Bran on Gastrointestinal Symptoms in Hemodialysis Children.

Background Gastrointestinal (GIT) disturbances are recorded in patients with end stage renal diseases (ESRD) frequently, killed probiotic was reported in to decrease GIT problems many other diseases ; So The aim of our study is to evaluate whether a combination of heat killed probiotic and wheat bran affect the presence and severity of gastrointestinal symptoms (GIS) in hemodialysis children Patients and methods Our study was Open label uncontrolled clinical trial conducted on 35 pediatric patients on regular hemodialysis for end stage renal disease. Every patient received one sachet of killed probiotic and wheat bran twice daily for two months. Assessment of GIT symptoms were done one month before administration of the drug, then follow them for two months during intervention then reassess the symptoms. Result We found that combined heat killed probiotic +wheat bran administration to hemodialysis children produced significant differences in urea, Hb and Po4 levels compared to baseline levels, in addition children produced highly significant decrease in all gastrointestinal symptoms (P<0.001) after 1 month, after 2 months in comparison to baseline. Conclusion We concluded that combination of heat killed probiotic and wheat bran decreases presence and severity of gastrointestinal symptoms (GIS) in hemodialysis children; thus we hypothysed that, our results could represent an important preliminary work that need further justification.

Treatment of Unruptured Cerebral Aneurysms with the Mineralocorticoid Receptor Blocker Eplerenone—Pilot Study

Currently there are no pharmacological therapies for patients with unruptured cerebral aneurysms. Elsewhere we showed that the mineralocorticoid receptor antagonist eplerenone prevented the formation of cerebral aneurysms in our ovariectomized hypertensive aneurysm rat model. The current pilot study evaluated whether it can be used to prevent the growth and rupture of cerebral aneurysms in hypertensive patients. Between August 2011 and May 2014, we enrolled 82 patients with 90 aneurysms in an open-label uncontrolled clinical trial. All provided prior informed consent for inclusion in this study, and all were treated with eplerenone (25-100 mg/d). The primary end points of our study were the rupture and enlargement of the cerebral aneurysms. Of the 82 patients, 80 (88 unruptured aneurysms) were followed for a mean of 21.3 months (153.4 aneurysm-years); 12 patients (15.0%) permanently discontinued taking the drug. One month after the start of eplerenone administration and throughout the follow-up period, eplerenone kept the blood pressure within the normal range. Most notably, no aneurysms smaller than 9 mm ruptured or enlarged. However, of 2 large thrombosed aneurysms, 1 enlarged and the other ruptured. The overall annual rupture rate was .65%; it was 13.16% for aneurysms larger than 10 mm; the overall annual rate for reaching the primary end points was 1.30%. Our observations suggest that eplerenone may help to prevent the growth and rupture of unruptured cerebral aneurysms smaller than 9 mm. To assess its potential long-term clinical benefits, large clinical trials are needed.

Outcomes of autologous bone marrow mononuclear cells for cerebral palsy: an open label uncontrolled clinical trial

BackgroundStem cell therapy has emerged as a promising method for improving motor function of patients with cerebral palsy. The aim of this study is to assess the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation in patients with cerebral palsy related to oxygen deprivation.MethodsAn open label uncontrolled clinical trial was carried out at Vinmec International Hospital. The intervention consisted of two administrations of stem cells, the first at baseline and the second 3 months later. Improvement was monitored at 3 months and 6 months after the first administration of stem cells, using the Gross Motor Function Measure (GMFM) and Modified Ashworth Score which measures muscle tone.ResultsNo severe complications were recorded during the study. After transplantation, 12 patients encountered fever without infections and 9 patients experienced vomiting which was easily managed with medications. Gross motor function was markedly improved 3 months or 6 months after stem cell transplantation than at baseline. The post-transplantation GMFM-88 total score, each of its domains and the GMFM-66 percentile were all significantly higher (p-value < 0.001). Muscle spasticity also reduced significantly after transplantation (p-value < 0.001). The therapy was equally effective regardless of sex, age and GMFCS level (p-value > 0.05).ConclusionAutologous bone marrow mononuclear cell transplantation appears to be a safe and effective therapy for patients with cerebral palsy.Trial registrationClinicalTrials.gov Identifier: NCT02569775. Retrospectively registered on October 15, 2015.

Abstract TP90: A Pilot Study of the Mineralocorticoid Receptor Blocker Eplerenone in Hypertensive Patients with Unruptured Cerebral Aneurysms

Background: There are no pharmacological therapies for patients with unruptured cerebral aneurysms. Elsewhere we showed that the mineralocorticoid receptor antagonist eplerenone prevented the formation of cerebral aneurysms in ovariectomized rats. This pilot study was designed to evaluate whether it can be used to prevent the growth and rupture of cerebral aneurysms in humans with hypertension. Methods: Between August 2011 and May 2014, 82 patients with 89 aneurysms were enrolled in an open-label uncontrolled clinical trial. Of these, 81 patients (88 unruptured aneurysms) were followed for a mean of 21.2 months (153.7 aneurysm-years). All patients had a history of hypertension and were treated with eplerenone (20 - 100 mg per day). The primary endpoints were rupture and enlargement of the intracranial aneurysms. Results: The mean aneurysmal size was 4.6 ± 2.6 mm. During follow-up period that included 153.7 aneurysm-years, 3 aneurysms enlarged and one large thrombosed aneurysm rupture. The annual rupture was 0.65% overall and 13.16% for aneurysms larger than 10 mm. No aneurysms smaller than 9 mm ruptured. The annual rate for reaching the primary endpoint was 2.60% overall. It was 1.37% for aneurysms smaller than 9 mm and thus seems to be lower than in other studies. Eplerenone had no protective effects in aneurysms larger than 10 mm. In the course of our study, 12 patients (14.8%) permanently discontinued taking the eplerenone. Conclusions: Our observations suggest that it is clinically feasible to prevent growth and rupture of cerebral aneurysms smaller than 9 mm by treatment with eplerenone. Protocols for large clinical trial are needed to assess the possible long-term clinical benefits the drug may confer on patients with unruptured cerebral aneurysms.

The efficacy and safety of combination therapy with mizoribine and methotrexate for rheumatoid arthritis resistant with methotrexate

Background. MZB is a purine analog, and is used as a disease modifying anti-rheumatic drug (DMARD). We conducted an open label uncontrolled clinical trial to evaluate the efficacy and safety of combination therapy with methotrexate (MTX) and mizoribine (MZB). Methods. Thirty one RA patients (9 males, 22 females, 68±12 year-old) who fulfilled ACR criteria of RA and did not show sufficient clinical response to MTX were included. MZB (150 mg/day, once a day) were added to MTX. DAS28-CRP was measured at day 0 and 1, 3, 6, and 12 months after the treatment. Adverse events were recorded. Results. Overall DAS28-CRP was significantly decreased from 4.4±1.0 to 3.1±1.3 at 3 months (p<0.01), 2.7±0.68 at 6 months (p<0.01), 2.4±1.4 at 12 months (p<0.01). Seventeen patients (55%) achieved significant improvement of DAS28-CRP. Number of swollen joints of responders before the treatment was significantly fewer than that of non-responders. Improvement of DAS28-CRP was significantly different between the responders (0.91±0.74) and non-responders (0.18±0.66) at 1 month (p<0.01). Nine patients (29%) could achieve remission Four patients experienced adverse events. Conclusions. MTX and MZB combination therapy was effective and relatively safety.

An uncontrolled, open label study of sulfasalazine in severe alopecia areata

Alopecia areata (AA) is an autoimmune disease mediated by T lymphocytes. Many treatments have been used but their results remain disappointing. There is a need to propose new therapeutic alternatives. During a period of 3 years, 26 patients with recalcitrant or severe AA (>40% hair loss) were enrolled in an open-label uncontrolled clinical trial. According to the response to sulfasalazine, patients were grouped into 3 categories: no hair regrowth (< 10% terminal hair), partial hair regrowth (10%-90% terminal hair), and complete hair regrowth (90%-100% terminal hair). Efficacy evaluation was performed with clinical examination. Twenty-two patients completed the treatment. Overall, 68.2% (15 of 22 patients) responded to therapy: 27.3% (6 of 22 patients) achieved complete hair regrowth, and 40.9% had partial hair regrowth. Seven (31.8%) patients had no hair regrowth. Of the 22 patients with complete and partial remission, 10 (45.5%) suffered a partial or complete relapse. Side effects following treatment were seen in 7 (31.8%) patients. Sulfasalazine could be considered as a therapeutic alternative in the treatment of AA, because of its safety profile, cosmetically acceptable efficacy, and good tolerability.

Long-term treatment with sildenafil in chronic thromboembolic pulmonary hypertension

For chronic thromboembolic pulmonary hypertension not amenable to pulmonary endarterectomy, effective medical therapy is desired. In an open-label uncontrolled clinical trial, 104 patients (mean +/- sem age 62 +/- 11 yrs) with inoperable chronic thromboembolic pulmonary hypertension were treated with 50 mg sildenafil t.i.d. At baseline, patients had severe pulmonary hypertension (pulmonary vascular resistance 863 +/- 38 dyn.s.cm(-5)) and a 6-min walking distance of 310 +/- 11 m. Eight patients were in World Health Organization functional class II, 76 in class III and 20 in class IV. After 3 months' treatment, there was significant haemodynamic improvement, with reduction of pulmonary vascular resistance to 759 +/- 62 dyn.s.cm(-5). The 6-min walking distance increased significantly to 361 +/- 15 m after 3 months' treatment, and to 366 +/- 18 m after 12 months' treatment. A subset of 67 patients received a single dose of 50 mg sildenafil during initial right heart catheterisation. The acute haemodynamic effect of this was not predictive of long-term outcome. In this large series of patients with inoperable chronic thromboembolic pulmonary hypertension, open-label treatment with sildenafil led to significant long-term functional improvement. The acute effect of sildenafil may not predict the long-term outcome of therapy.

Using Urgotul dressing for the management of epidermolysis bullosa skin lesions

To evaluate the acceptability, tolerance and efficacy of Urgotul wound dressing in the management of epidermolysis bullosa (EB) skin lesions. This was an open-label uncontrolled clinical trial involving 20 patients (I I adults and nine children) with EB simplex or dystrophic EB. Patients were selected from the register of EB patients at the investigating centre and included if they presented with at least one skin lesion requiring management with a non-adherent wound dressing. Lesions were treated with the study dressing for a maximum of four weeks. All dressing changes, wound parameters, pain and effect on quality of life were recorded. All patients completed the trial. Nineteen out of 20 wounds healed within 8.7 +/- 8.5 days. Overall, 11 patients (55%) considered that their quality of life had improved following use of the dressing, which was also reported to be pain free and 'very easy' or 'easy' to remove at most dressing changes. Nineteen out of 20 patients stated that they would use the study dressing to manage their lesions in future. This study confirmed the very good acceptability and efficacy of Urgotul in the treatment of skin lesions in patients with EB.

THE EFFECT OF BOTULINUM-A TOXIN ON PATIENTS WITH SEVERE URGE URINARY INCONTINENCE

We determined the effect of 150 units of botulinum-A toxin (Botox, Allergan, Irvine, California) on subjects with severe urge urinary incontinence (UUI). This was an open label uncontrolled clinical trial. Subjects were recruited from the female urology and urogynecology clinics at Duke University. Inclusion criteria included evidence of UUI on 3-day bladder diary, a 24-hour pad weight of 100 gm or greater, absent or minimal stress leakage, absent detrusor dysfunction, and a history of failed anticholinergic and physical therapies. Exclusion criteria included evidence of a urinary tract infection, or other correctable or neurological etiology for UUI. The detrusor of each subject was injected with 150 units of botulinum-A toxin. Evaluations were performed at 2 weeks, 6 weeks, 3 months and 6 months after injection. Outcome measures included daily incontinence episodes, Urogenital Distress Inventory and the Incontinence Impact Questionnaire, 24-hour pad weights, daily pad usage and urinalysis at all visits. Urodynamic studies were performed at the 6-week and 3-month visits. Three subjects had uncomplicated urinary tract infections during followup. No other adverse effects occurred. Statistically and clinically significant decreases greater than 50% were seen in virtually all outcome measures at all visits up to 3 months. Most subjects showed signs of recurrent UUI by 6 months. All subjects reported remarkable subjective improvement in incontinence. No significant changes in maximal cystometric capacity, maximal detrusor pressure, peak flow or post-void residual volumes were seen. Botulinum-A toxin can significantly decrease urge urinary incontinence and improve quality of life for 3 months after injection. Additional studies are needed to determine ideal doses, dosing intervals, safety and cost-effectiveness of this therapy.