scholarly journals A Prospective Randomized Trial of Imipenem-Cilastatin Versus Clindamycin/Tobramycin in the Treatmentof Intra-Abdominal and Pelvic Infections

1993 ◽  
Vol 4 (5) ◽  
pp. 279-287 ◽  
Author(s):  
Lionel A Mandell ◽  
Pierre L Turgeon ◽  
Allan R Ronalds ◽  
The Canadian Clinical Trials Group
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Study Drug ◽  
Efficacy And Safety ◽  
Bacteriological Response ◽  
Intention To Treat ◽  
Days Of Therapy ◽  
Dichotomous Outcomes ◽  
Bacterial Superinfection ◽  
Treat Analysis

Objective: A Canadian multicentre clinical trial in the treatment of intra-abdominal and pelvic infections to compare the efficacy and safety of monotherapy using imipenem-cilastatin (imipenem) (500 mg intravenously every 6 h) versus combination therapy with clindamycin/tobramycin (clindamycin 600 mg intravenously every 6 h and tobramycin 1.7 mg/kg intravenously every 8 h).Methods: Two hundred and fifty patients were entered (88 definite and 162 possible infections) and all were evaluable for analysis of adverse events and intention to treat analysis of efficacy. Dichotomous outcomes used were: cured versus noncured (improved, failed, relapsed).Results: No statistically significant differences were found with the intention to treat analysis (P=0.88) or with definite infections (P=0.81). For overall bacteriological response, no significant differences were noted (P=0.1). Eleven and 15 patients on imipenem and clindamycin/tobramycin, respectively, were colonized with bacteria. Enterococci colonized four of 11 imipenem cases and five of 15 clindamycin/tobramycin cases while fungi colonized six patients on imipenem and four on clindamycin/tobramycin. Five patients on imipenem and seven on clindamycin/tobramycin developed superinfection. In the imipenem group, one case had a bacterial superinfection while four cases were due toCandida albicans.Seven of seven superinfections on clindamycin/tobramycin were bacterial. Three bacteria initially sensitive to the assigned study drug developed resistance. In two patients on imipenem,Enterococcus faecalisandPseudomonas aeruginosabecame resistant after 14 and 10 days of therapy, respectively. On clindamycin/tobramycin, one instance ofBacteroides fragilisresistance after eight days of therapy was seen. Eighty-three adverse events occurred; 47 in the imipenem group and 36 in the clindamycin/tobramycin group. This resulted in discontinuation of antibacterial therapy in 13 patients, seven of whom were on imipenem and six on clindamycin/tobramycin. Comparison of adverse effects showed statistically significant differences for nausea (P=0.02) and hepatotoxicity (P=0.05) occurring with greater frequency in the imipenem and clindamycin/tobramycin groups, respectively.Conclusions: These data support the conclusion that monotherapy with imipenem (500 mg intravenously every 6 h) is as efficacious as clindamycin/tobramycin for treatment of intra-abdominal and pelvic infections. Both regimens are well tolerated.

scholarly journals Normalization of the epidermal barrier as a method of pathogenetic therapy of Atopic Dermatitis in children

2021 ◽  
Vol 97 (5) ◽  
pp. 52-65
Author(s):  
D. V. Zaslavsky ◽  
A. V. Sobolev ◽  
S. V. Skrek ◽  
A. A. Yunovidova ◽  
M. I. Zelyanina ◽  
...  
Keyword(s):  
Atopic Dermatitis ◽  
Adverse Events ◽  
Skin Diseases ◽  
Palliative Therapy ◽  
Study Drug ◽  
Severity Index ◽  
Efficacy And Safety ◽  
Cosmetic Product ◽  
Average Value ◽  
Days Of Therapy

Background. A key link in the pathogenesis of atopic dermatitis is a violation of the barrier function of the skin. Artificial skin moisturizing with emollients is the basis of palliative therapy for the disease. Aims. The purpose of the study was to assess the effectiveness and tolerability of the cosmetic product Admera. Materials and methods. The article presents the results of an open non-comparative prospective observational study of the efficacy and safety of Admera cream in pediatric patients with mild to moderate atopic dermatitis, conducted at the Pierre Wolkenstein Clinic for Skin Diseases in June-August 2020. Results. The study included 35 patients aged 4 to 17 years. The study included 35 patients aged 4 to 17 years inclusive. The clinical study demonstrated a statistically significant decrease in the Severity scoring of atopic dermatitis (SCORAD) index total score. The average value of this indicator decreased by 33% from the value 36.2 12.3 at the screening visit to 24.2 11.4 at the visit 3 (p 0.001). Assessment of the dynamics of the Eczema area and severity index (EASI) index showed a significant decrease in the total score of the indicator after 14 and 28 days of therapy relative to the baseline (p 0.001). The cosmetic product studied was well tolerated by patients. During the present study, 3 adverse events were reported in 2 patients. According to expert opinion, the recorded undesirable phenomena were not associated with the application of the studied cosmetic product. Reported adverse events were gastrointestinal disorders and included cases of diarrhea, abdominal pain and at the end of the study completely Conclusions. Evaluation of the results of the study showed high efficacy and safety of the study drug as a moisturizing agent: four-week therapy leads to a decrease in the severity of Atopic dermatitis manifestations, a decrease in the intensity of pruritus, an increase in the level of skin hydration in the T-zone and on the patient's body.

Selpercatinib efficacy and safety in patients with RET-altered thyroid cancer: A clinical trial update.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6073-6073
Author(s):  
Eric Jeffrey Sherman ◽  
Lori J. Wirth ◽  
Manisha H. Shah ◽  
Maria E. Cabanillas ◽  
Bruce Robinson ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Thyroid Cancer ◽  
Adverse Events ◽  
Kinase Inhibitor ◽  
Objective Response ◽  
Integrated Analysis ◽  
Low Grade ◽  
Efficacy And Safety ◽  
Thyroid Cancers ◽  
Altered Thyroid

6073 Background: Selpercatinib, is a first-in-class, highly selective, CNS active and potent RET inhibitor approved in multiple countries for treatment of RET-fusion positive lung or thyroid cancers. Reported is an update of efficacy and safety results in RET-altered thyroid cancer, with a longer follow up (30 Mar 2020 data cutoff vs 16 Dec 2019) and additional enrolment. Methods: Patients (pts) with RET-mutant medullary thyroid cancer (MTC) and RET-fusion positive thyroid cancer (TC) were enrolled in the global (16 countries, 89 sites) Phase 1/2 LIBRETTO-001 trial (NCT03157128). The primary endpoint was objective response rate (ORR) per RECIST 1.1 by independent review committee (IRC). Secondary endpoints included duration of response (DoR), progression-free survival (PFS), clinical benefit rate (CBR; CR+PR+SD ≥16 weeks), and safety. The integrated analysis set (IAS, n = 143) includes efficacy evaluable MTC pts previously treated with cabozantinib and/or vandetanib (cabo/vande). The primary analysis set (PAS), a subset of IAS, is the first 55 enrolled pts. Cabo/vande naïve MTC pts (N = 112) and TC pts with prior systemic treatment (N = 22) were also analyzed. Safety population includes all pts who received ≥1 dose of selpercatinib (MTC N = 315; TC N = 42) by data cutoff. Results: For MTC patients, the ORR for IAS was 69.2%, in the PAS it was 69.1%, and 71.4% for cabo/vande naïve MTC pts. The ORR for TC pts (n = 22) was 77.3% (see table). Most treatment-emergent adverse events (TEAEs) were low grade; the most common (≥25% of MTC and/or TC pts treated with selpercatinib) were dry mouth, diarrhea, hypertension, fatigue and constipation for both MTC and TC pts, increased ALT/AST, peripheral edema and headache in MTC pts and nausea in TC pts. 4.8% of MTC and TC pts discontinued selpercatinib due to TEAEs but only 1.9% with MTC and none with TC discontinued due to treatment-related adverse events. Conclusions: In this updated analysis, selpercatinib continued to show marked and durable antitumor activity in pts with RET-altered thyroid cancers. Selpercatinib was well tolerated and no new safety concerns were identified. A global, randomized, phase 3 trial (LIBRETTO-531) evaluating selpercatinib compared to cabo/vande in kinase inhibitor naïve MTC pts is ongoing. Clinical trial information: NCT03157128. [Table: see text]

The efficacy and safety of anlotinib in neoadjuvant treatment in locally advanced thyroid cancer: A single-arm phase II clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6069-6069
Author(s):  
Naisi Huang ◽  
Guohua Sun ◽  
Yulong Wang ◽  
Jiaying Chen ◽  
Qing Guan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Thyroid Cancer ◽  
Adverse Events ◽  
Objective Response ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Primary Treatment ◽  
Tumor Diameter ◽  
Efficacy And Safety ◽  
Advanced Thyroid Cancer

6069 Background: Surgery is the primary treatment for locally advanced thyroid cancer (TC). For some locally advanced TC, R0/R1 resection could not be achieved at initial diagnosis and neoadjuvant treatment would be an option. However, there is still little evidence regarding neoadjuvant treatment in locally advanced TC. Methods: This single-arm, phase 2 study investigated the efficacy and safety of Anlotinib (12mg orally daily, for two weeks on/on week off) for 2-6 cycles in patients with locally advanced TC in the neoadjuvant setting. Operable patients received surgery after neoadjuvant treatment. The primary endpoint was objective response rate (ORR). Results: A total of 13 patients were included and received an average of 3.5 cycles (range: 3-6 cycles) of Anlotinib treatment. 12 cases were papillary thyroid cancer, and 1 was follicular thyroid cancer. The ORR of Anlotinib was 76.9% with 10 partial response (PR), 2 stable disease (SD), and 1 progressive disease (PD). 8 PR and 1 SD patients received surgery after neoadjuvant treatment, of whom 8 had R0/1 resections and 1 had R2 resection. 2 PR patients refused to have surgery and the rest 2 patients were not operable. The R0/1 resection rate for intent to treat population was 61.5% and for per-protocol population was 72.7%. The maximum reduction in sum of tumor diameter was an average of 34.8% (range: 30.9%-45.5%) for PR patients. Most adverse events were grade 1 or 2. Common adverse events of all grade were hypertension (76.9%), hypertriglyceridemia (69.2%), proteinuria (53.8%), TSH increase (53.8%), cholesterol elevation (53.8%) and hand-foot syndrome (38.5%). The majority of adverse events discontinued after the neoadjuvant treatment stopped. Conclusions: Anlotinib demonstrated antitumor activity in the neoadjuvant treatment in locally advanced TC and the majority of patients achieved R0/1 resection. Adverse events were consistent with the known Anlotinib adverse event profile. These results suggest that Anlotinib neoadjuvant treatment represents a new option for locally advanced TC. Clinical trial information: NCT04309136.

scholarly journals COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions

2020 ◽  
Vol 41 (27) ◽  
pp. 2541-2552 ◽  
Author(s):  
Sabine Steiner ◽  
Andrej Schmidt ◽  
Thomas Zeller ◽  
Gunnar Tepe ◽  
Marcus Thieme ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Lower Bound ◽  
Adverse Events ◽  
Low Dose ◽  
Primary Patency ◽  
High Dose ◽  
Primary Efficacy ◽  
Efficacy And Safety ◽  
Wide Range ◽  
Major Adverse Events

Abstract Aims Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 μg/mm2. Methods and results Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2–4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of −10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) −5.2%]; Pnon-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference −1.6% (lower bound of the 90% two-sided CI −6.5%); Pnon-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. Conclusion Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. Clinical trial registration The trial is registered with ClinicalTrials.gov (NCT02701543).

A multinational phase II clinical trial of neoadjuvant imatinib for large gastrointestinal stromal tumor of the stomach.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 130-130
Author(s):  
Han-Kwang Yang ◽  
Yukinori Kurokawa ◽  
Min-Hee Ryu ◽  
Haruhiko Cho ◽  
Sook Ryun Park ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Gastrointestinal Stromal Tumor ◽  
Neoadjuvant Treatment ◽  
Stromal Tumor ◽  
Maximal Response ◽  
R0 Resection ◽  
Gastric Gist ◽  
Efficacy And Safety ◽  
Resection Rate

130 Background: Neoadjuvant therapy is expected to reduce the risk of primary surgery, such as rupture of the tumor, hemorrhage, and multi-visceral resection, and to improve survivals for patients with a large gastric gastrointestinal stromal tumor (GIST). This study aims to evaluate the efficacy and safety of neoadjuvant imatinib therapy for a large gastric GIST. Methods: Patients with gastric GIST, which is 10cm or larger and without metastasis, received neoadjuvant imatinib (400mg/day) for 6 months, and up to 9 months if maximal response is expected. Postoperative adjuvant imatinib was prescribed for at least 1 year and up to 3 years according to adjuvant treatment guideline. The primary endpoint was complete (R0) resection rate. A primary analysis were performed by the time all the operations were finished, to examine the efficacy and safety of the neoadjuvant treatment. Results: Between Feb 2010 and Sep 2014, 55 patients were enrolled in Japan and Korea. One patient with a jejunal GIST and one patient with PDGFRA-18 D842V mutation were excluded from analysis. Mean tumor diameter was 12cm (10-23). 86.8% of patients (46/53) completed neoadjuvant treatment. Dose reduction of imatinib was performed in 26.4% (14/53). The most frequent Grade 3 or 4 adverse events were G3 rash (5/53, 9.4%) and G3/4 neutropenia (4/53, 7.5%). Disease control rate (PR+SD) and response rate (PR) of neoadjuvant imatinib was 100% and 62.3% by RECIST, and 100% and 98.1% by Choi criteria, respectively. There was no case of CR or PD. 50 patients underwent operation, and R0 resection rate was 90.6% (n = 48, 95% CI 79.3% - 96.9%), which was significantly higher than the threshold value of 70% (p < 0.001). Combined resection of other organs (except gall bladder) was performed in 24.5% (n = 13), and 83.0% of patients (n = 44) could preserve ≥ 50% of the stomach. Postoperative complication occurred in 18.0% (9/50). Conclusions: Neoadjuvant imatinib treatment is effective and safe treatment option for a large primary GIST allowing high R0 resection rate with acceptable incidence of adverse events and postoperative complications. Clinical trial information: UMIN000003114.

Hepatic arterial infusion of oxaliplatin plus raltitrexed in patients with unresectable hepatocellular carcinoma (HAIROX): A phase II, single-arm, prospective study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4574-4574
Author(s):  
Shiguang Chen
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Adverse Events ◽  
Phase Ii ◽  
Objective Response ◽  
Hepatic Arterial Infusion ◽  
Arterial Infusion ◽  
Intention To Treat ◽  
Unresectable Hepatocellular Carcinoma ◽  
Treat Population

4574 Background: Chemoembolisation and oral sorafenib are the recommended treatment for unresectable hepatocellular carcinoma (HCC); however, some patients respond poorly to these. Hepatic arterial infusion (HAI) chemotherapy may have potential benefit in these patients. We aimed to investigate the efficacy and safety of HAI of oxaliplatin plus raltitrexed in patients with unresectable HCC. Methods: In this phase II, single-arm clinical trial, we enrolled patients aged 18–70 years with unresectable HCC at the Fujian Cancer Hospital (China). We performed HAI with oxaliplatin (100 mg/m2 for 4 hours) and raltitrexed (3 mg/m2 for 1 hour). Treatment was repeated every 3 weeks and was discontinued either because of disease progression, unacceptable toxicity levels, or refusal of further treatment. We used Simon’s two-stage design. The primary endpoint was the objective response rate according to the Response Evaluation Criteria in Solid Tumors version 1.1. Results: Fifty-one patients were screened between January 5, 2018 and August 7, 2019. Of these, 39 patients (34 men and 5 women; median age, 53 years) were enrolled and included in the intention-to-treat population. Objective response was achieved in 18 (51.4%) of 35 patients in the per-protocol population and in 18 (46.2%) of 39 patients in the intention-to-treat population. Treatment-related grade 4 adverse events or deaths were not reported, and the observed grade 3 adverse events were elevated aspartate aminotransferase levels (5[12.8%]), elevated alanine aminotransferase levels (1 [2.6%]), leukopenia (1 [2.6%]), thrombocytopenia (1 [2.6%]), and abdominal infection (1 [2.6%]). Conclusions: HAI of oxaliplatin plus raltitrexed showed promising efficacy and acceptable toxicity levels in patients unresectable HCC, and further evaluation is warranted. Clinical trial information: ChiCTR-OOC-17014182 . [Table: see text]

Impact of the combination of durvalumab (MEDI4736) plus olaparib (AZD2281) administered prior to surgery in the molecular profile of resectable urothelial bladder cancer: NEODURVARIB Trial.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 542-542 ◽  
Author(s):  
Juan Francisco Rodriguez-Moreno ◽  
Guillermo de Velasco ◽  
Inmaculada Bravo Fernandez ◽  
Carlos Alvarez-Fernandez ◽  
Ricardo Fernandez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Molecular Characterization ◽  
Biomarker Discovery ◽  
Checkpoint Inhibitors ◽  
Parp Inhibitor ◽  
Neoadjuvant Treatment ◽  
Molecular Profile ◽  
Efficacy And Safety ◽  
The Impact

542 Background: Cisplatin-based chemotherapy remains the perioperative treatment in muscle-invasive bladder carcinoma (MIBC). Recent evidence suggests that immune checkpoint inhibitors could be incorporated in this setting. Olaparib is a PARP inhibitor with well-established activity in HRD tumor. Results from trials assessing the combination of durvalumab and olaparib suggest a synergistic effect. However, a molecular characterization is crucial to warrant a rational development. Methods: A phase II clinical trial was designed to assess the impact of neoadjuvant treatment with the combination of durvalumab plus olaparib in the molecular profile of MIBC (NCT03534492; SOGUG-2017-A-IEC(VEJ)-2). Efficacy and safety were secondary objectives. Subjects with cT2-T4a MIBC aimed for cystectomy were treated during 6 to 8 weeks pre-cystectomy. Diagnostic and surgical samples, pre and postreatment blood samples have been collected for the molecular analysis. We present results regarding efficacy and safety. Results: From November 2018 to October 2019 28 patients have been enrolled. 52%/48% of patients had PS 0/1. Median age was 70. TNM stage was: pT2 in 73,6% patients, pT3 in 10.6%, pT4 in 15.8% and 10.6% presented nodal spread. 13 patients have completed neoadjuvant treatment so far and 12 have undergone cystectomy. A wound dehiscence and one death related to surgical procedures were postoperative complications. Pathological complete response rate is 44,5%. Radiological evaluation is ongoing. 10 serious adverse events non-treatment related have been communicated. Any grade of toxicity has been reported in 91% of patients but adverse events grade 3-4 was detected in only 8.3% of cases. Grade 1 pruritus was the unique IR adverse event described in one patient. PARP inhibitors-related adverse events were grade 1 nausea and vomiting (25%), and grade 1 anemia (25%). Conclusions: Preliminary clinical data suggest that Durvalumab in combination with Olaparib could be active and well-tolerated neoadjuvant treatment of MIBC. Molecular characterization and biomarker discovery will be presented separately. Clinical trial information: NCT03534492.

A comparative study of candesartan versus propranolol for migraine prophylaxis: A randomised, triple-blind, placebo-controlled, double cross-over study

Cephalalgia ◽  
2013 ◽  
Vol 34 (7) ◽  
pp. 523-532 ◽  
Author(s):  
Lars J Stovner ◽  
Mattias Linde ◽  
Gøril B Gravdahl ◽  
Erling Tronvik ◽  
Anne H Aamodt ◽  
...  
Keyword(s):  
Adverse Events ◽  
Primary Outcome ◽  
Rank Test ◽  
Migraine Prevention ◽  
Intention To Treat ◽  
Signed Rank ◽  
Signed Rank Test ◽  
Active Substances ◽  
Treat Analysis ◽  
Double Cross

Objective The objective of this article is to see whether the effect of candesartan for migraine prevention, shown in one previous study, could be confirmed in a new study, and if so, whether the effect was comparable to that of propranolol (non-inferiority analysis), and whether adverse events were different. Methods In a randomised, triple-blind, double cross-over study, 72 adult patients with episodic or chronic migraine went through three 12-week treatment periods on either candesartan 16 mg, propranolol slow-release 160 mg, or placebo. The main outcome measures were days with migraine headache per four weeks (primary outcome), days with headache, hours with headache, proportion of responders (>50% reduction of migraine days from baseline), and adverse events. Results In the modified intention-to treat-analysis, candesartan and propranolol were both superior to placebo: 2.95 (95% confidence interval: 2.35–3.55%) and 2.91 (2.36–3.45%), versus 3.53 (2.98–4.08%) for migraine days per month ( p = 0.02 for both comparisons, Wilcoxon's paired signed rank test, blinded statistical analysis). Candesartan was non-inferior to propranolol (and vice versa). The proportion of responders was significantly higher on candesartan (43%) and propranolol (40%) than on placebo (23%) ( p = 0.025 and <0.050, respectively). There were more adverse events on candesartan ( n = 133%) and propranolol ( n = 143%) than on placebo ( n = 90%), and the adverse event profiles of the active substances differed somewhat. Conclusion It is confirmed that candesartan 16 mg is effective for migraine prevention, with an effect size similar to propranolol 160 mg, and with somewhat different adverse events. Trial registration: EUDRACT (2008-002312-7), ClinicalTrials.gov (NCT00884663).

Efficacy and safety of trimethoprim-sulfamethoxazole in HIV-infected patients with cerebral toxoplasmosis in Brazil: a single-arm open-label clinical trial

2019 ◽  
Vol 30 (12) ◽  
pp. 1156-1162 ◽  
Author(s):  
Daniela Pellegrino ◽  
Ronaldo Gryschek ◽  
Augusto César Penalva de Oliveira ◽  
Rosa Marcusso ◽  
Ademir Correia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Clinical Manifestations ◽  
Altered Mental Status ◽  
Tertiary Hospital ◽  
High Morbidity ◽  
Cerebral Toxoplasmosis ◽  
Efficacy And Safety ◽  
Open Label ◽  
Radiological Response

Cerebral toxoplasmosis continues to cause high morbidity and mortality in developing countries. The association of sulfadiazine and pyrimethamine is considered the standard therapy; however, it has potential disadvantages. This single-arm open-label clinical trial was carried out in a tertiary hospital in São Paulo, Brazil. We included patients of at least 18 years of age, whose HIV infection was confirmed, and clinical and brain computed tomography (CT) findings were compatible with cerebral toxoplasmosis upon admission. Patients received trimethoprim (TMP) 10 mg/kg/day sulfamethoxazole (SMX) 50 mg/kg/day, in two divided doses. Brain CT was performed at study entry and after two weeks. The endpoints of the study were: (i) the proportion of patients with clinical and radiological response after two weeks of TMP-SMX and (ii) the proportion of patients who discontinued TMP-SMX due to adverse events. Forty-six patients were included (23 males, median age 35 years). The main clinical manifestations were headache, hemiparesis and altered mental status. The proportion of patients who obtained clinical and radiological response after two weeks of anti-toxoplasma treatment was 85% (n = 39). Overall, TMP-SMX was safe, with only 2 (4%) discontinuations due to adverse events. In this study, TMP-SMX was effective and safe in the treatment of HIV-related cerebral toxoplasmosis.

Effectiveness of a conversational chatbot in the smartphone to cease smoking in the adult population: pragmatic, controlled, randomized clinical trial in primary care (Dejal@). (Preprint)

2021 ◽  
Author(s):  
EDUARDO OLANO-ESPINOSA ◽  
Jose Francisco Avila-Tomas ◽  
Cesar Minue-Lorenzo ◽  
Blanca Matilla Pardo ◽  
Encarnación Serrano-Serrano ◽  
...  
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Clinical Practice ◽  
Randomized Clinical Trial ◽  
Control Group ◽  
Evidence Based ◽  
Intention To Treat ◽  
Usual Clinical Practice ◽  
Treat Analysis

BACKGROUND The magnitude and severity of smoking, the benefits of quitting, and the existence of effective and efficient interventions make it a priority problem. Health professionals intervene less than they should, and the most effective interventions are more expensive, require specific training and more time, which is a disadvantage for the service provider and for the accessibility of the services. Information and communication technologies avoid these problems thanks to their accessibility, privacy, customization possibilities, access to social support, and scalability. OBJECTIVE To assess the effectiveness of an evidence-based intervention to cease smoking via a chatbot in the smartphone compared to usual clinical practice in primary care. METHODS Pragmatic randomized clinical trial in 34 primary healthcare centers within the Madrid Health Service (Spain). Smokers over 18 years of age who attended on-site consultation and accepted help to quit tobacco were recruited by their doctor or nurse and randomly allocated to receive usual care (control group, CG) or an evidence-based chatbot intervention (intervention group, IG). The interventions in both arms were based on the 5A´s by the US clinical practice guideline, which combines behavioral and pharmacological treatments and is structured in several follow-up appointments. The primary outcome was continuous abstinence from smoking that was biochemically validated after 6 months by the collaborators. The outcome analysis was blinded to allocation of subjects although participants were unblinded to group assignment. An intention-to-treat analysis, entering the basal observation carried forward in cases of missing data, and logistic regression models with robust estimators were employed for assessing the primary outcomes. RESULTS The trial was conducted between October 1st of 2018 and March 31st of 2019. The sample comprised 513 patients (242 in the IG and 271 in the CG), with an average age of 49.8 years (SD 10.82) and gender ratio of 59.3% women and 40.7% men. Of them, 232 patients (45.2%) completed the follow-up, 104 (42.9%) in the IG and 128 (47.2%) in the CG. Main outcome: In the intention-to-treat analysis, the biochemically-validated abstinence rate at 6 months was higher in the IG with 26.03% (63/242) versus 18.82% (51/271) in the CG (odds ratio (OR)=1.52, 95% CI: 1.00–2.31, P=.05). After adjusting for basal CO-oxymetry and bupropion intake, no substantial changes were observed (OR=1.52, 95% CI 0.99–2.33 P= .053; pseudo R2=0.045). In the IG, 61.16% (148/242) of users accessed the chatbot, average bot-patient interaction time was 121 minutes (CI 95% 121.1–140.0), and average number of contacts was 45.56 (SD 36.32). CONCLUSIONS A treatment including a chatbot for helping in tobacco cessation was more effective than usual clinical practice in primary care. CLINICALTRIAL ClinicalTrials.gov, reference number NCT 03445507.

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