scholarly journals Increasing the Radioiodine Dose Does Not Improve Cure Rates in Severe Graves' Hyperthyroidism: A Clinical Trial with Historical Control

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Jose Miguel Dora ◽  
Walter Escouto Machado ◽  
Vânia A. Andrade ◽  
Rafael Selbach Scheffel ◽  
Ana Luiza Maia

Objective. It is generally accepted that higher doses of radioiodine (131I) improve cure rates in Graves’ disease (GD). In this trial we sought to evaluate whether very high131I doses increase the efficacy of treatment in severe GD.Design. Clinical trial with historical control. Patients with GD and a goiter ≥48 mL were eligible for the study. The patients in the contemporaneous intervention cohort were treated with 250 μCi of131I/mL thyroid tissue, corrected by 24-RAIU values (Group 1;n=15). A subgroup of patients with GD and a goiter ≥48 mL who were treated with 200 μCi of131I/mL/24-RAIU in a previously published randomized controlled trial served as a historical control group (Group 2;n=15). The primary outcome evaluated was the one-year cure rate.Results. There were no significant baseline differences regarding age, gender, body mass index, smoking status, pretreatment with methimazole, thyroid volume, or thyroid hormone levels of the two treatment groups. The cumulative 12-month cure rate for the patients in Group 1 was 66.6%, a figure similar to the 12-month cure rate observed in Group 2 (60.0%;P=0.99).Conclusions. Our results suggest that increasing the131I dose does not improve cure rates in severe GD. This trial is registered with ClinicalTrials.govNCT01039818.

2022 ◽  
Vol 15 (6) ◽  
pp. 695-704
Author(s):  
E. A. Orudzhova

Aim: to study the role of antiphospholipid antibodies (AРA) and genetic thrombophilia as a potential cause of the development or a component in the pathogenesis of early and late fetal growth retardation (FGR).Materials and Methods. There was conducted a prospective randomized controlled trial with 118 women enrolled. The main group consisted of 83 patients, whose pregnancy was complicated by FGR degrees II and III, stratified into two groups: group 1 – 36 pregnant women with early FGR, group 2 – 47 pregnant women with late FGR. Women were subdivided into subgroups according to the FGR severity. The control group consisted of 35 pregnant women with a physiological course of pregnancy. АРА were determined according to the Sydney antiphospholipid syndrome criteria by enzyme immunoassay (ELISA): against cardiolipin, β2 -glycoprotein 1, annexin V, prothrombin, etc. (IgG/IgM isotypes); lupus anticoagulant – by the three-stage method with Russell's viper venom; antithrombin III and protein C levels – by chromogenic method; prothrombin gene polymorphisms G20210A and factor V Leiden – by polymerase chain reaction; homocysteine level – by ELISA.Results. AРA circulation (medium and high titers), genetic thrombophilic defects and/or hyperhomocysteinemia were detected in 40 (48.2 %) patients with FGR, which was significantly higher than that in the control group (p < 0.05): in group 1 (41.7 % of women) AРA (30.6 %) and AРA with genetic thrombophilia or hyperhomocysteinemia (11.1 %) were revealed; in group 2 (51.1 % of women) AРA (21.3 %), AРA with hyperhomocysteinemia (4.3 %), genetic thrombophilia (25.5 %), and due to hyperhomocysteinemia (2.1 %) were found. No differences in prevalence of thrombophilia rate in patients were observed related to FGR severity, but a correlation between the FGR severity and AРA titers was found.Conclusion. Testing for the presence of AРA, genetic thrombophilia and hyperhomocysteinemia should be recommended for patients with FGR (including those with FGR in medical history), especially in the case of its early onset. It is recommended to determine the full AРA spectrum.


2020 ◽  
Author(s):  
Huan Liu ◽  
Jun Jin ◽  
Qiao Chen ◽  
Zhongmin Li

Abstract BackgroundThe incidence of thyroid nodules increased significantly, but the mortality rate of thyroid cancer remained stable or even decreased. However, surgical treatment of thyroid nodules is more aggressive, including the number and scope of surgery. the purpose of our study was to evaluate whether unilateral thyroid nodules affect the malignancy risk of contralateral thyroid nodules. Methods We conducted a retrospective study on all patients with thyroid nodules in a tertiary hospital within one year. Unilateral and bilateral thyroid nodules were the control group and the experimental group, respectively. Based on the TI-RADS grades, the experimental group and the control group were divided into two subgroups. We used chi-square test or Fisher's exact test to evaluate whether there were statistical differences in the incidence and pathological types of thyroid cancer between the experimental group and the control group. Results Our study showed that there was no significant difference in malignant risk between the experimental group 1 and the control group 1, and the experimental group 2 and the control group 2 (20%vs35%, p=0.724, 63.16%vs76.32%, p=0.297, respectively). Both the a-side thyroid of the experimental group and the control group were papillary thyroid carcinoma, including micropapillary thyroid carcinoma, and there was no difference in the proportion of micropapillary thyroid carcinoma (p = 0.200, 0.620, respectively). Conclusions There is no evidence that bilateral thyroid nodules affect each other in terms of malignant risk, that is, in bilateral thyroid nodules, unilateral thyroid cancer does not change the malignant risk of contralateral thyroid nodules.This study has been registered with the Chinese Clinical Trial Registry, clinical trial registration number: ChiCTR2000038611, registration time: 2020-09-26.


Author(s):  
Hira Abbasi ◽  
Abhishek Lal ◽  
Ammara Shamim Jaffrani

Aims: This study aims to compare the efficacy in alleviating pain between intracanal medicaments, namely Nitrofurantoin and Calcium Hydroxide Paste. Study Design:  Randomized Controlled Trial. Place and Duration of Study: Sample: Department of Operative Dentistry, Sir Syed College of Medical Sciences, Pakistan, between January 2021 and May 2021. Methodology: 60 patients were randomly divided into 3 groups, each group having 20 patients as following: Group 1: Nitrofurantoin, Group 2: Calcium Hydroxide and Group 3: Control. Preoperative pain was recorded using a numerical pain scale. After access preparation, chemomechanical preparation was performed with subsequent placement of intracanal medicaments. Pre-operative pain score was initially recorded, followed by post-operative pain at 12, 24, 48, and 72 hours, respectively. Root canal treatment was performed in single rooted teeth with patients suffering from symptomatic irreversible pulpitis Results: Majority of the patients in all 3 groups were initially presented with moderate to severe pre-operative pain. After 72 hours post-operatively, 50% patients in Group 1 reported no pain, while 5% patients in both Group 2 and 3 had no pain. Pain significantly subsided in Group 1 as compared to Group 2 and 3. Regarding age and gender, both had no significant relationship with the pain scores in all of the 3 groups Conclusion: Nitrofurantoin has been proven to be an effective intracanal medicament in alleviating immediate post-operative pain in patients with symptomatic irreversible pulpitis as compared to calcium hydroxide. While the control group with no intracanal medicament showed little reduction in pain scores. So, nitrofurantoin can be used as a substitute to currently available standard intracanal medicaments.


BMC Surgery ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Isaac Kim ◽  
Hee Jun Choi ◽  
Jai Min Ryu ◽  
Se Kyung Lee ◽  
Jong Han Yu ◽  
...  

Abstract Background Increasing rates of breast cancer screening have been associated with an increasing frequency of non-palpable breast lesions detection. Preoperative breast lesion localization is essential for optimizing excision accuracy. This study aimed to evaluate the efficacy and safety of indocyanine green (ICG) hyaluronic acid injection as a novel mixture for localization. Methods We performed a prospective clinical trial with female patients who underwent surgery for non-palpable breast lesions. All patients were sequentially assigned to the control group (localization with activated charcoal), Test Group 1 (ICG-hyaluronic acid mixture 0.1 mL), or Test Group 2 (ICG-hyaluronic acid mixture 0.2 mL) by 1:1:1 ratio. Results A total of 44 patients were eligible for this study (Control Group = 14, Test Group 1 = 15, Test Group 2 = 15 patients). Fibroadenoma (n = 17, 38.6%) accounted for the largest proportion of diagnoses, and five patients (11.4%) were diagnosed with malignancies. There were no statistically significant differences in baseline characteristics among the three groups. The marking rate was over 86% in all groups, with no significant intergroup differences. Skin pigmentation was only observed in the control group. The mean accuracy of resection (the greatest diameter of the excised specimen divided by the greatest diameter of the preoperative lesion as observed using ultrasonography, with values closer to 1 reflecting a higher accuracy) was 3.7 in the control group, 2.2 in Test Group 1, and 2.1 in Test Group 2 (p = 0.037 between Controls and Test Group 1, p = 0.744 between Test Group 1 and Test Group 2, and p = 0.026 between Controls and Test Group 2). Conclusion ICG-hyaluronic acid injection is a novel method that was shown to accurately localize non-palpable breast lesions and was associated with no skin pigmentation. Further research is required to apply this method to malignant breast lesions. Trial registration “A Multicenter Open-label, Parallel, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of LuminoMark™ Inj. (Conc. for Fluorescence) Localization in Patients with Non-palpable Breast Lesions” was prospectively registered as a trial (ClinicalTrials. gov Identifier: NCT03743259, date of registration: May 29, 2018, https://clinicaltrials.gov/ct2/show/NCT03743259)


2011 ◽  
Vol 8 (s2) ◽  
pp. S267-S274 ◽  
Author(s):  
Scott J. Strath ◽  
Ann M. Swartz ◽  
Sarah J. Parker ◽  
Nora E. Miller ◽  
Elizabeth K. Grimm ◽  
...  

Background:Increasing physical activity (PA) levels in older adults represents an important public health challenge. The purpose of this study was to evaluate the feasibility of combining individualized motivational messaging with pedometer walking step targets to increase PA in previously inactive and insufficiently active older adults.Methods:In this 12-week intervention study older adults were randomized to 1 of 4 study arms: Group 1—control; Group 2—pedometer 10,000 step goal; Group 3—pedometer step goal plus individualized motivational feedback; or Group 4—everything in Group 3 augmented with biweekly telephone feedback.Results:81 participants were randomized into the study, 61 participants completed the study with an average age of 63.8 ± 6.0 years. Group 1 did not differ in accumulated steps/day following the 12-week intervention compared with participants in Group 2. Participants in Groups 3 and 4 took on average 2159 (P < .001) and 2488 (P < .001) more steps/day, respectively, than those in Group 1 after the 12-week intervention.Conclusion:In this 12-week pilot randomized control trial, a pedometer feedback intervention partnered with individually matched motivational messaging was an effective intervention strategy to significantly increase PA behavior in previously inactive and insufficiently active older adults.


2019 ◽  
Author(s):  
Cheng-Ming Ni ◽  
Wen-Long Huang ◽  
Yan-min Jiang ◽  
Juan Xu ◽  
Ru Duan ◽  
...  

Abstract Background Polycystic ovary syndrome (PCOS) is defined as a complex endocrine syndrome, and the mechanisms underlying its various clinical signs and symptoms are still poorly understood. It is critical to precisely diagnose the phenotypes of PCOS in order to provide patients with individualized therapy[1, 2] . However, the criteria by which to diagnose different phenotypes, which are mostly based on symptoms, physical examination, and laboratory evaluation, remain unclear. The aim of this study is to compare the accuracy and precision of metabolomic markers with common clinical characteristics to determine a more effective way to diagnose and treat two subgroups, one based on clinical indexes and another based on metabolomic indexes[3], of PCOS patients. The effects of different the interventions based on the two subgroups will also be observed. Methods This is a prospective, multicenter, analyst-blinded, randomized controlled trial. There will be one healthy control group and two parallel experimental arms in this study: (1) people without PCOS (health control group); (2) PCOS patients diagnosed based on clinical indexes (group 1); (3) PCOS patients diagnosed based on metabolomic indexes (group 2). A total of 276 eligible people will be recruited, including 60 healthy people and 216 PCOS patients, who will be randomly assigned to different diagnosis groups in a 1:1 ratio. Patients in the two different diagnosis groups will be divided into two different subgroups based on their clinical characteristics (group 1 based on clinical indexes, group 2 based on metabolomic indexes); thereafter, they will receive a 6-month different treatment. The primary outcome for experimental groups will be the treatment effect of PCOS. Discussion The purpose of this trial is to determine whether integrated metabolomic indexes are more accurate and effective than clinical characteristics in the diagnosis of the phenotypes of reproductive females with PCOS. This trial will therefore contribute to the provision of a solid foundation for the precise clinical diagnosis of two PCOS subgroups, as well as for future research on individualized PCOS therapy.


Author(s):  
Vikram Kannan ◽  
Sumathy Sundar ◽  
Sajeesh Manikanda Prabhu ◽  
G. Ezhumalai

Background: An upper gastrointestinal (GI) endoscopy procedure is an invasive medical procedure that is used in diagnosis and treatment of various intestinal disorders. Patients posted for upper GI endoscopy procedures often experience significant levels of pre-procedural fear, anxiety and discomfort during the procedure which can negatively affect cooperation levels during the procedure with the attending doctor. A very few studies have explored the beneficial effects of music therapy in this regard and so our study was planned.Methods: A prospective randomised controlled trial was conducted with a sample of 54 patients who were enrolled for this study. They were randomly divided into two groups - group 1 consisting of 27 patients, receiving a music therapy intervention and group 2 consisting of 27 patients who served as a control group. Group 1 received a receptive music therapy intervention in the form vocal, relaxing, improvisational music with patient preferred chants for fifteen minutes before and during the endoscopy procedure. Group 2 did not receive a music therapy intervention.Results: The results indicated that the post intervention, state-anxiety levels was significantly lower in the music therapy group compared to the control group with (p=0.001). Patients’ cooperation levels during the procedure with the attending doctor was significantly higher in the music therapy group than in the control group (p=0.001).Conclusions: Repeated music therapy intervention is highly beneficial in reducing state anxiety levels and improving cooperation levels during the GI endoscopy procedure.


2021 ◽  
Author(s):  
Luca Cegolon ◽  
Behzad Einollahi ◽  
Sina Imanizadeh ◽  
Mohammad Rezapour ◽  
Mohammad Javanbakht ◽  
...  

Abstract Background. There is a risk of novel mutations of SARS-CoV-2 that may render COVID-19 resistant to most of the therapies, including antiviral drugs. The evidence around the application of therapeutic plasma exchange (TPE) for the management of critically ill COVID-19 patients is still provisional and further investigations are needed to confirm its eventual beneficial effects. Methods. We therefore carried out a single-centered retrospective observational non-placebo-controlled trial enrolling 73 inpatients from Baqiyatallah Hospital in Tehran (Iran) with diagnosis of COVID-19 pneumonia confirmed by real-time polymerase chain reaction (RT-PCR) on nasopharyngeal swabs and high-resolution computerized tomography chest scan. These patients were broken down into two groups: Group 1 (30 patients) receiving standard of care (corticosteroids, ceftriaxone, azithromycin, pantoprazole, hydroxychloroquine, lopinavir/ritonavir); and Group 2 (43 patients) receiving the above regimen plus TPE (replacing 2 liter of patients’ plasma by a solution, 50% of normal plasma and 50% of albumin at 5%) administered according to various time schedules. The follow-up time was 30 days and all-cause mortality was the endpoint. Results. Deaths were 6 (14%) in Group 2 and 14 (47%) in Group 1. However, different harmful risk factors prevailed among patients not receiving TPE rather than being equally split between the intervention and control group. We used an algorithm of Structural Equation Modeling (of STATA) to summarize a large pool of potential confounders into a single score (called with the descriptive name “severity”). Disease severity was significantly (Wilkinson rank sum test p-value=0.0000) lower among COVID-19 patients undergoing TPE (median: -2.82; range: -5.18; 7.96) as compared to those non receiving TPE (median: -1.35; range: -3.89; 8.84), confirming that treatment assignment involved a selection bias of patients according to the severity of COVID-19 at hospital admission. The adjustment for confounding was carried out using severity as covariate in Cox regression models. The univariate Hazard Ratio (HR) of 0.68 (95%CI: 0.26; 1.80; p=0.441) for TPE turned to 1.19 (95%CI: 0.43; 3.29; p=0.741) after adjusting for severity. Conclusions. The lower mortality observed among patients receiving TPE was due to a lower severity of COVID-19 rather than TPE effects. TRIAL REGISTRATIONIRCT registration number: IRCT20080901001165N58 (Iranian Registry of Clinical Trials)Registration date: 2020-05-27, 1399/03/07 (retrospectively registered)


2021 ◽  
Author(s):  
Luca Cegolon ◽  
Behzad Einollahi ◽  
Sina Imanizadeh ◽  
Mohammad Rezapour ◽  
Mohammad Javanbakht ◽  
...  

There is a risk of novel mutations of SARS-CoV-2 that may render COVID-19 resistant to most of the therapies, including antiviral drugs. The evidence around the application of therapeutic plasma exchange (TPE) for the management of critically ill COVID-19 patients is still provisional and further investigations are needed to confirm its eventual beneficial effects. We therefore carried out a single-centered retrospective observational non-placebo-controlled trial enrolling 73 inpatients from Baqiyatallah Hospital in Tehran (Iran) with diagnosis of COVID-19 pneumonia confirmed by real-time polymerase chain reaction on nasopharyngeal swabs and high-resolution computerized tomography chest scan. These patients were broken down into two groups: Group 1 (30 patients) receiving standard of care (corticosteroids, ceftriaxone, azithromycin, pantoprazole, hydroxychloroquine, lopinavir/ritonavir); and Group 2 (43 patients) receiving the above regimen plus TPE (replacing 2 liter of patients plasma by a solution, 50% of normal plasma and 50% of albumin at 5%) administered according to various time schedules. The follow-up time was 30 days and all cause mortality was the endpoint. Deaths were 6 (14%) in Group 2 and 14 (47%) in Group 1. However, different harmful risk factors prevailed among patients not receiving TPE rather than being equally split between the intervention and control group. We used an algorithm of Structural Equation Modeling (of STATA) to summarize a large pool of potential confounders into a single score (called with the descriptive name Sseverity). Disease severity was significantly (Wilkinson rank sum test p-value=0.0000) lower among COVID-19 patients undergoing TPE (median: -2.82; range: -5.18; 7.96) as compared to those non receiving TPE (median: -1.35; range: -3.89; 8.84), confirming that treatment assignment involved a selection bias of patients according to the severity of COVID-19 at hospital admission. The adjustment for confounding was carried out using severity as covariate in Cox regression models. The univariate Hazard Ratio (HR) of 0.68 (95%CI: 0.26; 1.80; p=0.441) for TPE turned to 1.19 (95%CI: 0.43; 3.29; p=0.741) after adjusting for severity. Thus, the lower mortality observed among patients receiving TPE was due to a lower severity of COVID-19 rather than TPE effects. Keywords: Therapeutic plasma exchange (TPE), COVID-19, Clinical and laboratory indexes, Cytokine storm.


2010 ◽  
Vol 11 (4) ◽  
pp. 9-16 ◽  
Author(s):  
Ahmed Abd El-Meguid Mostafa Hamdy ◽  
Mohamed Abd El-Moneam Ibrahem

Abstract Aim Recurrent aphthous ulceration is the most commonly known oral mucosal disease. Quercetin is a useful therapeutic agent for the treatment of colitis and gastric ulcer. The objective of this study was to determine the effect of topical application of quercetin in the treatment of minor aphthous ulcers. Methods and Materials Forty male patients with no known pathology of the oral mucosa other than minor aphthous ulcers were enrolled in this study. Patients were randomly divided into two groups, each consisting of 20 patients. Group 1 (control group) patients used a benzydamine hydrochloride mouthwash three times daily. Group 2 patients placed two to three dabs of quercetin three times daily directly on their ulcers. Clinical evaluation of patients included assessment of ulcer size, pain measure, and interviews regarding the topical application of quercetin in terms of consistency, taste, local tolerability, and ease of application. Results The topical application of quercetin cream to minor mouth ulcers relieved pain and produced complete healing in seven of the Group 2 patients (35 percent) in 2–4 days, 18 patients (90 percent) in 4–7 days, and 20 patients (100 percent) in 7–10 days. When comparing the mean ulcer size after 10 days, lesions in the Group 2 patients were smaller than those in Group 1, and the size difference between the two groups was significantly different (p<0.004). Also, 90 percent of patients responded that they appreciated the ease of application when using the topical quercetin, and they did not object to its consistency or taste. Conclusion Quercetin is a safe, well-tolerated, and highly effective promising new, adjunctive treatment for healing common aphthous ulcers. Clinical Significance Although aphthous ulcers typically resolve on their own in one to two weeks, the daily topical application of quercetin may be useful in accelerating the healing process of minor aphthous ulcers. Citation Hamdy AAEM, Ibrahem MAE. Management of Aphthous Ulceration with Topical Quercetin: A Randomized Clinical Trial. J Contemp Dent Pract [Internet]. 2010 July; 11(4):009-016. Available from: http://www.thejcdp. com/journal/view/volume11-issue4-hamdy


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