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1.
Vaccimonitor (La Habana, Print) ; 30(2)mayo.-ago. 2021. tab, graf
Article in Spanish | LILACS, CUMED | ID: biblio-1252326

ABSTRACT

Este reporte corresponde al análisis de la calidad de vida de los pacientes que se incluyeron en el ensayo clínico fase III de evaluación de la vacuna CIMAvaxEGF® en cáncer de pulmón de células no pequeñas. La calidad de vida se evaluó empleando los cuestionarios EORTC QLQ-C30 y QLQ-C13, al inicio y cada 3 meses hasta el fallecimiento del paciente a criterio del investigador. Para comparar las medianas entre los dos grupos se utilizó la prueba no paramétrica de Mann-Whitney. Las comparaciones entre el nivel basal y los diferentes tiempos de seguimiento se realizaron a través de la prueba no paramétrica de Wilcoxon. El cuestionario QLQ-C30 evidenció un beneficio en cuanto a calidad de vida para el grupo vacunado con la vacuna CIMAvaxEGF® en las escalas funcionales (global, rol y social), en las escalas de síntomas de la enfermedad y del tratamiento (dolor) se observó que mejora la calidad de los mismos a favor de los pacientes tratados con la vacuna CIMAvaxEGF®. El cuestionario QLQ-C13, también evidenció ventajas para el grupo vacunado desde el punto de vista de beneficio clínico en los síntomas (disnea, disfagia, alopecia y dolor en el pecho). Se señala como significativo que disminuye la hemoptisis y la tos en el grupo vacunado, observándose un empeoramiento en el grupo control(AU)


This report corresponds to quality of life analysis of patient with non-small cell lung cancer included in the phase III clinical trials Evaluation of CIMAvaxEGF® vaccine in lung cancer. The quality of life was evaluate using the EORTC questionnaires QLQ-C30 y QLQ-C13, at the beginning and every 3 months. To compare the median between two groups the Mann-Whitney non-parametric test was used. To compare the baseline and different follows times the Wilcoxon non-parametric test was used. The QLQ-C30 questionnaire showed a benefit in terms of the quality of life for the CIMAvaxEGF® vaccine group on the functional scores (global, role and social) and symptoms of the disease (pain). The QLQ-LC13 questionnaire showed a benefit in terms of the quality of life for the CIMAvaxEGF® vaccine group on the symptoms scores (dyspnea, dysphagia, alopecia and chest pain). It is noted as significant that the hemoptysis decreases in the group vaccinated as well as the dysphagia, the cough and the dyspnea observing a worsening in the control group(AU)


Subject(s)
Humans , Male , Female , Quality of Life , Surveys and Questionnaires , Clinical Trials, Phase III as Topic , Carcinoma, Non-Small-Cell Lung/epidemiology , Cancer Vaccines
10.
Rev. Assoc. Med. Bras. (1992) ; 64(7): 568-574, July 2018. tab
Article in English | LILACS | ID: biblio-976836

ABSTRACT

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.


Subject(s)
Humans , Colorectal Neoplasms/drug therapy , Panitumumab/therapeutic use , Antineoplastic Agents/therapeutic use , Colorectal Neoplasms/pathology , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Practice Guidelines as Topic , Clinical Trials, Phase III as Topic , Evidence-Based Medicine
11.
Rev. Assoc. Med. Bras. (1992) ; 64(6): 484-491, June 2018. tab
Article in English | LILACS | ID: biblio-956480

ABSTRACT

The Guidelines Project, an initiative of the Brazilian Medical Association, aims to combine information from the medical field in order to standardize producers to assist the reasoning and decision-making of doctors. The information provided through this project must be assessed and criticized by the physician responsible for the conduct that will be adopted, depending on the conditions and the clinical status of each patient.


Subject(s)
Oligonucleotides/therapeutic use , Spinal Muscular Atrophies of Childhood/drug therapy , Oligonucleotides, Antisense/therapeutic use , Oligonucleotides/administration & dosage , Brazil , Spinal Muscular Atrophies of Childhood/physiopathology , Ventilators, Mechanical , Randomized Controlled Trials as Topic , Oligonucleotides, Antisense/administration & dosage , Treatment Outcome , Clinical Trials, Phase III as Topic , Motor Skills/classification
12.
Article in English | WPRIM | ID: wpr-691357

ABSTRACT

<p><b>OBJECTIVE</b>To assess the efficacy of Chinese medicine (CM) on patients with pancreatic cancer (PC) in a retrospective population-based study.</p><p><b>METHODS</b>Between January 1, 2013, and August 30, 2016, according to whether received Western medicine treatment, the patients were included into either integrative medicine (IM) group or CM group. All enrolled patients were orally administrated with Gexia Zhuyu Decoction () or Liujun Ermu Decoction () by syndrome differentiation, twice a day, last for at least 2 months. The primary end point was overall survival (OS).</p><p><b>RESULTS</b>A total of 174 patients with PC were enrolled in this study. In stage I/II, the median OS was 20.5 months in the IM group [95% confidence interval (CI), 12.499 to 28.501] and 11.17 months in the CM group (95% CI, 5.160 to 17.180, P=0.015). The 1- and 2-year survival rates for the two groups were 47.0%, 40.0% and 21.0%, 21.0%, respectively. In stage III/IV, median OS was 13.53 months (95% CI, 8.665 to 18.395) in the IM group versus 6.4 months (95% CI, 0.00 to 15.682) in the CM group, respectively (P=0.32). The 1- and 2-year survival rate for the IM and CM groups were 27.0%, 7.0% and 20.0%, 2.0%, respectively.</p><p><b>CONCLUSIONS</b>Intervention of CM contributes to the different survival benefits for PC in different stages. Multimodality treatment might be a promising strategy for PC patients in early stage. While, in advanced stage, CM might be an alternative candidate for PC patients.</p>


Subject(s)
Adult , Aged , Aged, 80 and over , Clinical Trials, Phase III as Topic , Female , Humans , Integrative Medicine , Male , Medicine, Chinese Traditional , Middle Aged , Multivariate Analysis , Neoplasm Staging , Pancreatic Neoplasms , Drug Therapy , Pathology , Survival Analysis
13.
Acta Pharmaceutica Sinica ; (12): 1461-1463, 2015.
Article in Chinese | WPRIM | ID: wpr-320058

ABSTRACT

Electronic case report forms (eCRFs) instead of the traditional paper case report forms (pCRFs) are increasingly used by investigators and sponsors of clinical research. We include a total of 14 phase III studies (8 pCRF, 6 eCRF) to compare paper and electronic data documentation both quantitatively and qualitatively in clinical studies. The result suggests that adaptions of electronic data capture (EDC) in clinical trials have the advantages in optimization of data capture process, improvement of data quality and earlier clinical decision compared to paper-based methods. Furthermore, the successful implementation of EDC requires accouplements with corresponding data management processes and reallocation of resources.


Subject(s)
Clinical Trials, Phase III as Topic , Data Collection , Methods , Information Storage and Retrieval , Methods , Medical Informatics
14.
Gut and Liver ; : 208-213, 2015.
Article in English | WPRIM | ID: wpr-136383

ABSTRACT

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.


Subject(s)
Abdominal Pain/chemically induced , Adult , Aged , Aged, 80 and over , Asian Continental Ancestry Group/statistics & numerical data , Benzofurans/adverse effects , Clinical Trials, Phase III as Topic , Constipation/drug therapy , Diarrhea/chemically induced , Double-Blind Method , Female , Headache/chemically induced , Humans , Male , Middle Aged , Multicenter Studies as Topic , Nausea/chemically induced , Randomized Controlled Trials as Topic , Regression Analysis
15.
Gut and Liver ; : 208-213, 2015.
Article in English | WPRIM | ID: wpr-136382

ABSTRACT

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.


Subject(s)
Abdominal Pain/chemically induced , Adult , Aged , Aged, 80 and over , Asian Continental Ancestry Group/statistics & numerical data , Benzofurans/adverse effects , Clinical Trials, Phase III as Topic , Constipation/drug therapy , Diarrhea/chemically induced , Double-Blind Method , Female , Headache/chemically induced , Humans , Male , Middle Aged , Multicenter Studies as Topic , Nausea/chemically induced , Randomized Controlled Trials as Topic , Regression Analysis
16.
Chinese Journal of Cancer ; (12): 105-114, 2014.
Article in English | WPRIM | ID: wpr-320573

ABSTRACT

Both platinum-based doublet chemotherapy (PBC) and epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) prolong the survival of patients with advanced non-small cell lung cancer (NSCLC). In early studies, most patients underwent PBC as first-line treatment, but not all patients could afford EGFR-TKIs as second-line treatment. To understand the impact of PBC and EGFR-TKIs on NSCLC prognosis, we evaluated the association between the receipt of both regimens and overall survival (OS). Using MEDLINE and EMBASE, we identified prospective, randomized, controlled phase III clinical trials in advanced NSCLC that met the inclusion criteria: in general population with advanced NSCLC, the percentage of patients treated with both PBC and EGFR-TKIs was available in the trial and OS was reported. After collecting data from the selected trials, we correlated the percentage of patients treated with both PBC and EGFR-TKIs with the reported OS, using a weighted analysis. Fifteen phase III clinical trials--involving 11,456 adult patients in 32 arms--were included in the analysis, including 6 trials in Asian populations and 9 in non-Asian (predominantly Caucasian) populations. The OS was positively correlated with the percentage of patients treated with both PBC and EGFR-TKIs (r = 0.797, P < 0.001). The correlation was obvious in the trials in Asian populations (r = 0.936, P < 0.001) but was not statistically significant in the trials in predominantly Caucasian populations (r = 0.116, P = 0.588). These results suggest that treatment with PBC and EGFR-TKIs may provide a survival benefit to patients with advanced NSCLC, highlighting the importance of having both modalities available for therapy.


Subject(s)
Aged , Antineoplastic Combined Chemotherapy Protocols , Therapeutic Uses , Carcinoma, Non-Small-Cell Lung , Drug Therapy , Genetics , Pathology , Clinical Trials, Phase III as Topic , Disease-Free Survival , Female , Humans , Lung Neoplasms , Drug Therapy , Genetics , Pathology , Male , Middle Aged , Neoplasm Staging , Platinum , Protein Kinase Inhibitors , Therapeutic Uses , Randomized Controlled Trials as Topic , ErbB Receptors , Genetics , Survival Rate
17.
Article in English | WPRIM | ID: wpr-108335

ABSTRACT

BACKGROUND/AIMS: The aim of this study was to assess the efficacy and safety of tofacitinib (5 and 10 mg twice daily) in patients with active rheumatoid arthritis (RA). METHODS: A systematic review of randomized controlled trials (RCTs) that examined the efficacy and safety of tofacitinib in patients with active RA was performed using the Medline, Embase, and Cochrane Controlled Trials Register databases as well as manual searches. RESULTS: Five RCTs, including three phase-II and two phase-III trials involving 1,590 patients, met the inclusion criteria. The three phase-II RCTs included 452 patients with RA (144 patients randomized to 5 mg of tofacitinib twice daily, 156 patients randomized to 10 mg of tofacitinib twice daily, and 152 patients randomized to placebo) who were included in this meta-analysis. The American College of Rheumatology 20% response rate was significantly higher in the tofacitinib 5- and 10-mg groups than in the control group (relative risk [RR], 2.445; 95% confidence interval [CI], 1.229 to 4.861; p = 0.011; and RR, 2.597; 95% CI, 1.514 to 4.455; p = 0.001, respectively). The safety outcomes did not differ between the tofacitinib 5- and 10-mg groups and placebo groups with the exception of infection in the tofacitinib 10-mg group (RR, 2.133; 95% CI, 1.268 to 3.590; p = 0.004). The results of two phase-III trials (1,123 patients) confirmed the findings in the phase-II studies. CONCLUSIONS: Tofacitinib at dosages of 5 and 10 mg twice daily was found to be effective in patients with active RA that inadequately responded to methotrexate or disease-modifying antirheumatic drugs, and showed a manageable safety profile.


Subject(s)
Antirheumatic Agents/administration & dosage , Arthritis, Rheumatoid/drug therapy , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Humans , Janus Kinases/antagonists & inhibitors , Methotrexate/therapeutic use , Piperidines/administration & dosage , Protein Kinase Inhibitors/administration & dosage , Pyrimidines/administration & dosage , Pyrroles/administration & dosage , Randomized Controlled Trials as Topic , Treatment Outcome
18.
Rev. medica electron ; 35(3): 218-225, mayo-jun. 2013.
Article in Spanish | LILACS | ID: lil-679069

ABSTRACT

La Medicina Natural y Tradicional ha entrado en una nueva etapa de desarrollo con el incremento en la demanda de sus alternativas terapéuticas. Se realizó una investigación descriptiva transversal, mediante la cual se identificaron las necesidades de aprendizaje de 20 médicos, entre especialistas y residentes de Medicina Natural y Tradicional, acerca de los aspectos básicos de ensayos clínicos. Existe desconocimiento acerca de las fases y pilares fundamentales de un ensayo clínico y los aspectos éticos importantes al ser una investigación en seres humanos, por lo que demuestra la falta de capacitación que existe sobre el tema. Es imprescindible fomentar una cultura de ensayos clínicos en los médicos que se desempeñan en el área de la Medicina Natural y Tradicional. Esto permitiría elevar la calidad y rapidez con que se desarrollan estos estudios en Cuba.


The Natural and Traditional Medicine has entered a new developmental stage with the increase in the requests of its therapeutic alternatives. We carried out a crossed descriptive research, through which we identified the learning necessities of 20 doctors, between specialist and residents of Traditional and Natural Medicine, about the main aspects of clinical researches. There is a lack of knowledge on the main phases and bases of a clinical research and on the important ethical aspects for being a research in human beings, showing the lack of knowledge on the theme. It is unavoidable to promote a culture of clinical researches among the doctors working in the area of Traditional and Natural Medicine. This will allow increasing the quality and speed of these researches development in Cuba.


Subject(s)
Humans , Clinical Trials, Phase I as Topic , Clinical Trials, Phase II as Topic , Clinical Trials, Phase III as Topic , Clinical Trials, Phase IV as Topic , Education, Medical, Continuing , Health Knowledge, Attitudes, Practice , Medicine, Traditional , Cross-Sectional Studies , Epidemiology, Descriptive
19.
Actual. SIDA. infectol ; 21(79): 3-21, apr.2013. tab, graf
Article in Spanish | LILACS | ID: lil-776936

ABSTRACT

Aproximadamente 175 millones de personas están infectadas por el virus de la hepatitis C (VHC), lo que representa un 3% de la población mundial. En ausencia de tratamiento eficaz, un 25% de los pacientes desarrollan complicaciones hepáticas tras 25 años de hepatitis crónica C. Hasta hace poco, la única opción terapéutica en estos pacientes era la combinación de interferón pegilado (peg-IFN) y ribavirina (RBV). Alcanzaban la erradicación del VHC un 30-40% de los pacientes infectados con el genotipo 1 del VHC. Recientes avances han permitido desarrollar replicones y sistemas de cultivo tisulares para el VHC. Esto ha facilitado el diseño de fármacos antivirales directos (DAA) que inhiben específicamente la replicación del VHC. Los dos primeros inhibidores de la proteasa del VHC fueron aprobados en mayo de 2011. Permiten obtener tasas de curación en el 70% de los pacientes infectados con el genotipo 1 sin experiencia previa a interferón. La respuesta es menor en pacientes con fracasos previos, excepto en los recidivantes, en los que tasa de curación es del 90%...


Approximately 175 million people worldwide are chronically infected with the hepatitis C virus (HCV), representing 3% of the total world population. In the absence of successful therapy nearly 25% of these patients will develop hepatic complications within 25 years. Until recently, the only available therapeutic option for these patients was the combination of peginterferon-a plus ribavirin. Overall it allowed achievement of eradication in only 30-40% of patients infected by HCV genotype 1. The development of HCV replicons and the chance of producing infectious viral particles in culture systems have both enabled the rational design of direct-acting antivirals (DAA) that specifically inhibit HCV replication. The first two HCV protease inhibitors were marketed in May 2011. Triple therapy has increased the response rate to 70% in HCV genotype 1 carrier naïve to interferon. Although response rates are lower in prior failures, 90% sustained virological response rates are achieved in prior relapsers...


Subject(s)
Humans , Antiviral Agents/immunology , Clinical Trials, Phase III as Topic , Hepacivirus , HIV , Hepatitis C, Chronic/immunology , Hepatitis C, Chronic/therapy , Hepatitis C, Chronic/transmission , Protease Inhibitors/pharmacokinetics , Protease Inhibitors , Ribavirin/pharmacokinetics
20.
Rio de Janeiro; s.n; 2013. 78 p. ilus, tab, graf.
Thesis in Portuguese | LILACS | ID: lil-751590

ABSTRACT

Fundamento: Na atualidade, há um corpo crescente de pesquisas que apontam para novas drogas e esquemas alternativos de antimônio para o tratamento da leishmaniose tegumentar americana (LTA). [...] Embora o tratamento alternativo com dose baixa de antimônio venha sendo utilizado nos últimos 30 anos, a evidência disponível provém de dois estudos retrospectivos, dois estudos prospectivos e relatos de caso. Em nosso conhecimento, este é o terceiro estudo randomizado que compara dose baixa com a dose alta de antimônio pentavalente (Sb5+) para o tratamento da LTA. Métodos: Em um estudo de não inferioridade, randomizado, controlado, cego realizado no estado do Rio de Janeiro, uma área endêmica de transmissão de Leishmania (Viannia) braziliensis, o tratamento em dose baixa de antimoniato de meglumina (5 mg Sb5+/kg/dia durante 30 dias) foi comparado com o tratamento em dose alta (20 mg Sb5+/kg/dia durante 20 dias) para leishmaniose cutânea americana (LCA). Participantes com idade maior ou igual a 13 anos com diagnóstico parasitológico de LCA foram randomizados para tratamento com dose baixa ou dose alta de antimoniato de meglumina. Os investigadores foram mascarados para o tratamento alocado. O desfecho primário foi a cura clínica no dia 360 nas populações de intenção de tratar modificada (mITT) e por protocolo (PP). Os desfechos secundários foram tempo de epitelização, tempo de cura clínica, grau de redução da lesão e da úlcera no dia 30. A margem de não inferioridade predeterminada foi de 15 por cento. Este estudo foi registrado no endereço eletrônico ClinicalTrials.gov, registro número NCT01301924. Resultados: Entre outubro de 2008 e dezembro de 2011, um total de 60 pacientes com LCA foi alocado para receber tratamento com antimoniato de meglumina em dose baixa ou em dose alta (30 por grupo)...


Background: There is an expanding field of research focusing on alternative schemesof antimony and new drugs to treat American tegumentary leishmaniasis (ATL). [...] Although thealternative low dose antimony treatment has been used for the past 30 years, theavailable evidence comes from two retrospective, two prospective cohort studies andcase reports. To our knowledge, this is the third randomized trial comparing low doseand high dose pentavalent antimony (Sb5+) to treat ATL. Methods: In a randomized,controlled, single blind, non-inferiority trial undertaken in Rio de Janeiro State, Brazil,an endemic area of Leishmania (Viannia) braziliensis transmission, low dose regimen ofmeglumine antimoniate (5 mg Sb5+/kg/day for 30 days) was compared with high doseregimen (20 mg Sb 5+/kg/day for 20 days) to treat American cutaneous leishmaniasis(ACL). Participants aged more than or equal to 13 years with parasitologically confirmed ACL wererandomly assigned to low dose or high dose treatment with meglumine antimoniate.Investigators were masked to treatment allocation. The primary endpoint was clinicalcure at day 360 on modified intention to treat (mITT) and per protocol (PP) populations. Secondary endpoints were time to epithelization, time to clinical cure, adverse events,degree of total lesion and ulcer diameter reduction at day 30. The predetermined noninferioritymargin was 15 percent. This trial is registered with ClinicalTrials.gov, numberNCT01301924. Results: Between October, 2008, and December, 2011, a total of 60patients with ACL were randomly assigned to low dose or high dose treatment ofmeglumine antimoniate (30 per group)...


Subject(s)
Humans , Antimony , Clinical Trials, Phase III as Topic , Leishmania braziliensis , Leishmaniasis, Cutaneous/epidemiology , Meglumine
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