scholarly journals Longitudinal trajectory analysis of antipsychotic response in patients with schizophrenia: 6-week, randomised, open-label, multicentre clinical trial

BJPsych Open ◽  
2020 ◽  
Vol 6 (6) ◽  
Author(s):  
Minhan Dai ◽  
Yulu Wu ◽  
Yiguo Tang ◽  
Weihua Yue ◽  
Hao Yan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Treatment Response ◽  
Trajectory Analysis ◽  
Open Label ◽  
Longitudinal Dynamic ◽  
Early Treatment Response ◽  
Significant Difference ◽  
Trajectory Group ◽  
Treatment Responses ◽  
New Perspective

Background Understanding the patterns of treatment response is critical for the treatment of patients with schizophrenia; one way to achieve this is through using a longitudinal dynamic process study design. Aims This study aims to explore the response trajectory of antipsychotics and compare the treatment responses of seven different antipsychotics over 6 weeks in patients with schizoprenia (trial registration: Chinese Clinical Trials Registry Identifier: ChiCTR-TRC-10000934). Method Data were collected from a multicentre, randomised open-label clinical trial. Patients were evaluated with the Positive and Negative Syndrome Scale (PANSS) at baseline and follow-up at weeks 2, 4 and 6. Trajectory groups were classified by the method of k-means cluster modelling for longitudinal data. Trajectory analyses were also employed for the seven antipsychotic groups. Results The early treatment response trajectories were classified into a high-trajectory group of better responders and a low-trajectory group of worse responders. The results of trajectory analysis showed differences compared with the classification method characterised by a 50% reduction in PANSS scores at week 6. A total of 349 patients were inconsistently grouped by the two methods, with a significant difference in the composition ratio of treatment response groups using these two methods (χ2 = 43.37, P < 0.001). There was no differential contribution of high- and low trajectories to different drugs (χ2 = 12.52, P = 0.051); olanzapine and risperidone, which had a larger proportion in the >50% reduction at week 6, performed better than aripiprazole, quetiapine, ziprasidone and perphenazine. Conclusions The trajectory analysis of treatment response to schizophrenia revealed two distinct trajectories. Comparing the treatment responses to different antipsychotics through longitudinal analysis may offer a new perspective for evaluating antipsychotics.

scholarly journals Response to combination of sofosbuvir and daclatasvir in chronic hepatitis C infection.

2020 ◽  
Vol 27 (12) ◽  
pp. 2596-2600
Author(s):  
Irfan Ahmad ◽  
Muhammad Israr ul Haq ◽  
Ghulam Abbas
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Treatment Response ◽  
Chronic Hepatitis C ◽  
Hepatitis C Infection ◽  
Open Label ◽  
College Hospital ◽  
End Of Treatment ◽  
Significant Difference ◽  
Chronic Hepatitis C Patients

Objectives: To determine efficacy of sofosbuvir and daclatasvir in the treatment of chronic hepatitis C infection. Study Design: Open label uncontrolled interventional study. Setting: Hepatitis Clinic, Sheikh Zayed Medical College/Hospital, Rahim Yar Khan. Period: June to December 2018. Material & Methods: Five hundred treatment naïve chronic hepatitis C patients including those with compensated cirrhosis were included in the study. They were given sofosbuvir 400 mg daily and daclatasvir 60 mg daily. Weight based ribavirin was added if patient has evidence of cirrhosis. Treatment duration was 12 weeks for non-cirrhotic and 24 weeks for cirrhotics. End of treatment response (ETR) was recorded. Results: Mean age of the included patients was 41±11.69 with range from 8 to 82 years, while 217 (43.4 %) patients were male and 283 (56.6 %) were female. Cirrhosis was present in 59 (11.8 %) patients; among these 35.6 % were in Child A and 64.4 % in early Child B. End of treatment response occurred in 491 (98.2 %) patients and there was no significant difference in ETR between male and female patients, and between cirrhotic and non-cirrhotic. Similarly, there was no significant difference in age between those having ETR and those having no ETR. Fatigue was experienced by 13.2 % and headache by 4.2 % patients. Conclusion: The combination of sofosbuvir and daclatasvir has high response rate in chronic hepatitis C patients of our population.

scholarly journals The Impact of Colchicine on The COVID-19 Patients; A Clinical Trial Study

2020 ◽  
Author(s):  
Farhad Salehzadeh ◽  
Farhad Pourfarzi ◽  
Sobhan Ataei
Keyword(s):  
Clinical Trial ◽  
Medical Treatment ◽  
Open Label ◽  
Post Discharge ◽  
Double Blind ◽  
End Points ◽  
Mortality And Morbidity ◽  
Significant Difference ◽  
Standard Medical Treatment ◽  
The Impact

Abstract Background: Severe acute respiratory syndrome COVID-19 infection has evolved into a global pandemic. This study has been designed to evaluate colchicine anti-inflammatory effect on the symptoms course, duration of hospitalization, morbidity and mortality rate, of COVID-19 patients.Methods: In this prospective, open-label, randomized and double blind clinical trial, 100 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from May 21 to June 20, 2020, to either standard medical treatment (Hydroxychloroquine) or colchicine with standard medical treatment. The study took place in Imam Reza hospital of Ardabil city in Iran, with trial registration ID: 47707 (irct.ir). Colchicine group were received 1 mg tablet of colchicine daily alongside the Hydroxychloroquine for 6 days. Primary end points were (1) Length of hospitalization; (2) symptoms and (3) Co-existed disease. Secondary end points were examined 2 weeks after discharge and included (1) mortality and morbidity; (2) re-admission and (3) symptoms. Results: Overall, 100 patients (59 [59%] female; median age, 56 years) fulfilled the admission criteria and were included and randomized at 2 clinical groups. There was no significant difference between the two groups in terms of age and sex. Two groups were not significantly different in terms of underlying diseases and various clinical and para clinical findings although there were not any different during Post-discharge follow-up except for duration of fever (P<0.05). Comparing two groups showed significantly different only in the duration of hospitalized (P<0.05). Although in colchicine group dyspnea was improved more rapid than the placebo group, but it was not meaningful. Conclusion: Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers.Current Controlled prospective Trials registration ID that has been approved by ICMJE and WHO ICTRP registry is IRCT20200418047126N1, and the date of registration is 2020-05-14.

scholarly journals Convalescent plasma for COVID-19 in hospitalised patients: an open-label, randomised clinical trial

2021 ◽  
pp. 2101471
Author(s):  
Leo Sekine ◽  
Beatriz Arns ◽  
Bruna R. Fabro ◽  
Murillo M. Cipolatt ◽  
Rafael R. G. Machado ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Improvement ◽  
Critically Ill ◽  
Primary Outcome ◽  
Ventilatory Support ◽  
Standard Of Care ◽  
Randomised Clinical Trial ◽  
Open Label ◽  
Hospitalised Patients ◽  
Significant Difference

BackgroundThe effects of convalescent plasma (CP) therapy hospitalised patients with coronavirus disease 2019 (COVID-19) remain uncertain. This study investigates the effect CP on clinical improvement in these patients.MethodsThis is an investigator-initiated, randomised, parallel arm, open-label, superiority clinical trial. Patients were randomly (1:1) assigned to two infusions of CP plus standard of care (SOC) or SOC alone. The primary outcome was the proportion of patients with clinical improvement 28 days after enrolment.ResultsA total of 160 (80 in each arm) patients (66.3% were critically ill and 33.7%, severe) completed the trial. The median age was 60.5 years (interquartile range [IQR], 48–68), 58.1% were men and the median time from symptom onset to randomisation was 10 days (IQR, 8–12). Neutralising antibodies titres >1:80 were present in 133 (83.1%) patients at baseline. The proportion of patients with clinical improvement on day 28 was 61.3% in the CP+SOC and 65.0% in the SOC group (difference, −3.7%; 95% Confidence Interval [CI], −18.8%-11.3%). The results were similar in the subgroups of severe and critically ill. There was no significant difference between CP+SOC and SOC groups in prespecified secondary outcomes, including 28-day mortality, days alive and free of respiratory support and duration of invasive ventilatory support. Inflammatory and other laboratorial markers values on days 3, 7 and 14 were similar between groups.ConclusionsCP+SOC did not result in a higher proportion of clinical improvement on at day 28 in hospitalised patients with COVID-19 compared to SOC alone.

scholarly journals Topical estrogen, testosterone, and vaginal dilator in the prevention of vaginal stenosis after radiotherapy in women with cervical cancer: a randomized clinical trial

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jumara Martins ◽  
Ana Francisca Vaz ◽  
Regina Celia Grion ◽  
Lúcia Costa-Paiva ◽  
Luiz Francisco Baccaro
Keyword(s):  
Clinical Trial ◽  
Cervical Cancer ◽  
Randomized Clinical Trial ◽  
Open Label ◽  
Treatment Groups ◽  
Vaginal Stenosis ◽  
Significant Difference ◽  
Vaginal Dilators ◽  
The Mean ◽  
Topical Estrogen

Abstract Background We aimed to evaluate the effects of different therapeutic options to prevent the evolution of vaginal stenosis after pelvic radiotherapy in women with cervical cancer. Methods open-label randomized clinical trial of 195 women, stage I-IIIB, aged 18–75 years, using topical estrogen (66), topical testosterone (34), water-based intimate lubricant gel (66), and vaginal dilators (29) to assess the incidence and severity of vaginal stenosis after radiotherapy at UNICAMP-Brazil, from January/2013 to May/2018. The main outcome measure was vaginal stenosis assessed using the Common Terminology Criteria for Adverse Events (CTCAE) scale and percental changes in vaginal volume. The women were evaluated at four different times: shortly after the end of radiotherapy, and four, eight, and 12 months after the beginning of the intervention. Statistical analysis was carried out using Symmetry test, Kruskal-Wallis test and multiple regression. Results the mean age of women was 46.78 (±13.01) years, 61,03% were premenopausal and 73,84% had stage IIB-IIIB tumors. The mean reduction in vaginal volume in the total group was 25.47%, with similar worsening in the four treatment groups with no statistical difference throughout the intervention period. There was worsening of vaginal stenosis evaluated by CTCAE scale after 1 year in all groups (p < 0.01), except for the users of vaginal dilator (p = 0.37). Conclusions there was a reduction in vaginal volume in all treatment groups analyzed, with no significant difference between them. However, women who used vaginal dilators had a lower frequency and severity of vaginal stenosis assessed by the CTCAE scale after one year of treatment. Trial registration Brazilian Registry of Clinical Trials, RBR-23w5fv. Registered 10 January 2017 - Retrospectively registered.

scholarly journals Comparison of Generic (Rolexan) and Brand (Clexan) Forms of Enoxaparin in Critically Ill Patients: A Cross Over, Open Label, Randomized Prospective Clinical Trial

2020 ◽  
Author(s):  
Shadi Ziaie ◽  
Hanieh Malekmohammadi ◽  
Mohammad Sistanizad
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Critically Ill ◽  
Enoxaparin Sodium ◽  
Critically Ill Patients ◽  
Comparable Efficacy ◽  
Thromboembolic Events ◽  
Open Label ◽  
Significant Difference

Backgrounds: Several generic forms of enoxaparin were introduced to the market after expiring the patent of Clexane. But the main problem with generic forms is its bio-equivalency with brand form as a little difference in active ingredients characteristics, could led to significant clinical differences. For evaluating the efficacy of enoxaparin, it is recommended to measure its activity against Anti Xa. The aim of this study was comparison of Anti Xa Activity of Enoxan® versus Clexane ® in critically ill patients with prophylactic doses. Methods: This was a cross over, open label, randomized prospective study which was performed between September 2016 and December 2017 in intensive care unit of Labbafinezhad hospital, Tehran, Iran. Thirty adult patients, who received enoxaparin for prophylaxis of thromboembolic events, were recruited. Subjects were subsequently randomized to one of the treatment sequences (Generic–brand or brand–generic). The generic drug was enoxaparin sodium 40 mg (4,000 IU anti-FXa/0.4 mL), manufactured by Ronakpharm, Iran; the brand drug was enoxaparin sodium 40 mg (Clexane® 4,000 IU anti-FXa/0.4 mL), manufactured by Sanofi, France. Results: Anti-Xa activity was assessed with Stago kit. The anti-Xa activity between 0.2 and 0.5 U/mL was defined as prophylaxis. The average Anti-Xa activities of Clexan and Rolexan were 0.3±0.12 and 0.22±0.10, respectively which reveals statistically no significant difference (P: 0.35). Also Anti-Xa activity in 6 and 11 patients in Clexan and Rolexan groups were under 0.2 (P: 0.16). Conclusion: Our study showed comparable efficacy of prophylactic doses between Clexan and Rolexan in critically ill patients. Further studies in different patient population are recommended. J Pharm Care 2020; 8(1): 23-25.

scholarly journals Long-term effectiveness of carglumic acid in patients with propionic acidemia (PA) and methylmalonic acidemia (MMA): a randomized clinical trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Majid Alfadhel ◽  
Marwan Nashabat ◽  
Mohammed Saleh ◽  
Mohammed Elamin ◽  
Ahmed Alfares ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Treatment ◽  
Propionic Acidemia ◽  
Methylmalonic Acidemia ◽  
First Episode ◽  
Controlled Clinical Trial ◽  
Open Label ◽  
Significant Difference ◽  
Secondary Outcomes

Abstract Background Propionic acidemia (PA) and methylmalonic acidemia (MMA) are rare, autosomal recessive inborn errors of metabolism that require life-long medical treatment. The trial aimed to evaluate the effectiveness of the administration of carglumic acid with the standard treatment compared to the standard treatment alone in the management of these organic acidemias. Methods The study was a prospective, multicenter, randomized, parallel-group, open-label, controlled clinical trial. Patients aged ≤ 15 years with confirmed PA and MMA were included in the study. Patients were followed up for two years. The primary outcome was the number of emergency room (ER) admissions because of hyperammonemia. Secondary outcomes included plasma ammonia levels over time, time to the first episode of hyperammonemia, biomarkers, and differences in the duration of hospital stay. Results Thirty-eight patients were included in the study. On the primary efficacy endpoint, a mean of 6.31 ER admissions was observed for the carglumic acid arm, compared with 12.76 for standard treatment, with a significant difference between the groups (p = 0.0095). Of the secondary outcomes, the only significant differences were in glycine and free carnitine levels. Conclusion Using carglumic acid in addition to standard treatment over the long term significantly reduces the number of ER admissions because of hyperammonemia in patients with PA and MMA.

scholarly journals Low Dose Theophylline and Tiotropium Rotacap as Add on Therapy in COPD Patients-Clinical Trial

2021 ◽  
Vol 10 (02) ◽  
pp. 137-141
Author(s):  
Muzna Hameed Dar ◽  
Syed Mehboob Alam ◽  
Qurrat ul Ain Bukhari ◽  
Kauser Ismail ◽  
Syed Azhar Hussain Zaidi
Keyword(s):  
Clinical Trial ◽  
Low Dose ◽  
Therapy Group ◽  
Treated Group ◽  
Open Label ◽  
Treatment Groups ◽  
Copd Patients ◽  
Percentage Improvement ◽  
Significant Difference ◽  
Group B

Objectives: To compare the role of low dose Theophylline and Tiotropium rotacap in improving the lung functions and day to day life of patients suffering from COPD. Study Design and Setting: A Clinical trial study was conducted at Department of Pharmacology and Therapeutics, BMSI in association with Department of Chest Medicine, JPMC. Methodology: This study was planned as an open label and parallel clinical trial study. A total of 168 patients of COPD were selected for this study and only 161 patients completed the 3 months duration of the study. The enrolled patients were grouped into 2, namely A and B. Tab. Theophylline 350 mg was given to Group A in two divided doses while Tiotropium rotacap18µg through rotahaler was given to group B once a day. Results: Mean FEV1 ± SD was improved by 0.04 ± 0.02 in Theophylline therapy group while by 0.07 ± 0.01 in the Tiotropium therapy treated group and a significant difference between the changes in the two treatment groups was evident. There was a percentage improvement in PEFR of 8.9 ± 5.8 in the Theophylline therapy treated group and of 13.2 ± 4.7 in Tiotropium therapy treated group. When Tiotropium group was compared with Theophylline group for improvement in percentage change in PEFR from day 0, a significant difference was evident between the two groups. There was a significant improvement from day 0 in CAT score in Tiotropium treated groups versus Theophylline group after 3 months of therapy. Conclusion: Tiotropium rotacap was more effective as compared to low dose Theophylline in improving pulmonary functions and CAT score in patients with COPD

Randomized use of anti-GD2 antibody dinutuximab beta (DB) long-term infusion with and without subcutaneous interleukin-2 (scIL-2) in high-risk neuroblastoma patients with relapsed and refractory disease: Results from the SIOPEN LTI-trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 10014-10014
Author(s):  
Holger N. Lode ◽  
Dominique Valteau-Couanet ◽  
Juliet Gray ◽  
Roberto Luksch ◽  
Aleksandra Wieczorek ◽  
...  
Keyword(s):  
Clinical Trial ◽  
High Risk ◽  
Interleukin 2 ◽  
Hematological Toxicity ◽  
Antibody Concentration ◽  
Mycn Amplification ◽  
Open Label ◽  
Significant Difference ◽  
Enzyme Elevation

10014 Background: We determined the role of scIL-2 combined with long term infusion (LTI) of DB in patients (pts) with high-risk relapsed/refractory neuroblastoma. Methods: 160 pts were enrolled into an open label SIOPEN Phase II clinical trial (EudraCT 2009-018077-31). Pts were randomly assigned to receive up to 5 cycles of 100 mg/m2 DB-LTI (d8-17) and 160 mg/m2 oral isotretinoin (d19-32) (81 pts) with and without 6x106IU/m2 scIL-2 (d1-5; 8-12) (79 pts). Endpoints were toxicity, response rates and 2yrs-event free and -overall survival. Results: Between 07/2014 and 07/2017, 160 pts from 11 countries were randomised. Median follow-up is 2.6 years. Pts were well balanced between arms according to stage, age, MYCN amplification, patients with relapse and remission status. The 2yrs-EFS and -OS for DB (81 pts) vs. DB combined with scIL-2 (79 pts) was 59%±6% vs 65%±6% (p = 0.721) and 79%±5% vs 84%±4% (p = 0.904). In 97 pts with evaluable disease, a response rate of 49% (9% CR, 40% PR) vs 52% (26% CR, 26% PR) after treatment with DB vs DB and scIL-2 was observed. Grade 3&4 fever (16% vs 46%, P = 0.000), allergic reaction (1% vs 14%, P = 0.004), hematological toxicity (46% vs 66%, P = 0.013) and neurotoxicity (0% vs 8%, p = 0.003) were significantly worse in the combination arm, but no difference was seen for capillary leak, gastrointestinal, liver enzyme elevation and pain. Paraplegia possibly related to the treatment was observed in 2 pts in the combination arm, none in the arm without scIL-2, and one resolved to baseline. A subgroup of 34 pts who had a relapse and measurable disease at treatment start, showed a 2yrs-EFS and -OS in DB (17 pts) vs DB combined with scIL-2 (17 pts) of 35%±12% vs 69%±12% (p = 0.116) and 59%±12% vs 81%±10% (p = 0.167). However, this trend was statistically not significant. Pharmacokinetic and HACA response between both arms was not different with overlapping antibody concentration-time curves and a HACA response of 15/81 (19%) (DB) vs 16/79 (20%) (DB and scIL-2). Conclusions: No significant difference in efficacy of DB combined with scIL-2 and increased toxicity in this arm suggests that this schedule of scIL-2 is of no additional benefit. Clinical trial information: 2009-018077-31.

scholarly journals POS1070 ANXIETY IN PSORIATIC ARTHRITIS PATIENTS: RESULTS FROM THE HUR-BIO BIOLOGIC REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 814-814
Author(s):  
G. Ayan ◽  
B. Farisoğullari ◽  
E. Bilgin ◽  
E. C. Bolek ◽  
G. K. Yardimci ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Treatment Response ◽  
Meta Analysis ◽  
Biologic Agents ◽  
Response To Therapy ◽  
Anxiety Score ◽  
Biological Database ◽  
Significant Difference ◽  
Patient Reported ◽  
Treatment Responses

Background:Anxiety is commonly observed, underestimated problem in patients with psoriatic arthritis (PsA). Overall rate has been reported around 20% [1]. However the data on anxiety in PsA patients requiring advanced treatment and change in response to therapy is scarce.Objectives:Our aim was to understand the frequency of anxiety before starting biologic agents and change in the anxiety scores with the treatment.Methods:PsA patients from the Hacettepe University biological database (HUR-BIO) were assessed for anxiety (score ≥ 4) using the patient self-reported measure of anxiety on a 0-10 numerical scale, included in the Psoriatic Arthritis Impact of Disease questionnaire (PSAID-12) [2]. The anxiety rate and scores were determined before starting biologic agents and at first visit in 6 months. Change in the scores were compared between patients according to the favourable treatment responses (Table 1). The correlation between the score-changes in anxiety and treatment response parameters was assessed by spearman correlation analysis.Results:From 520 patients registered, 147 [mean (SD) age 43.3 (12.4) years, 70.7% female] had anxiety score registered both at baseline and first visit in 6 months. Both the frequency and mean (SD) score of anxiety decreased at first visit [63.9% vs 41.4 %, 4.8(3.4) vs 3.2 (3.1) respectively, p<0.001 for both] after a mean (SD) follow-up of 105.7 (22.2) days. There was a statistically significant difference between changes in the anxiety scores in patients with/without treatment responses in pain, PGA, BASDAI, HAQ-DI and DAS-28. A positive correlation between the change in anxiety and all treatment response parameters was observed (Table 1, Figure 1).Table 1.Patient characteristics at baseline and changes in the anxiety score according to treatment responseConclusion:Anxiety is a more frequent problem at the time of biologic initiation compared to rates observed in general PsA population which could be related to the high disease activity. The rates are still high in 6 months under treatment, however both the frequency and score of anxiety showed a decreasing trend parallel to the treatment response.References:[1]Zusman EZ, Howren AM, Park JYE,et. al (2020) Epidemiology of depression and anxiety in patients with psoriatic arthritis: A systematic review and meta-analysis. Semin Arthritis Rheum 50 (6):1481-1488.[2]Gossec L, de Wit M, Kiltz U, Braun J, et al (2014) A patient-derived and patient-reported outcome measure for assessing psoriatic arthritis: elaboration and preliminary validation of the Psoriatic Arthritis Impact of Disease (PsAID) questionnaire, a 13-country EULAR initiative. Ann Rheum Dis 73 (6):1012-1019.Figure 1.Correlation between the score changesDisclosure of Interests:None declared.

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