A randomized controlled study comparing omeprazole and cimetidine for the prophylaxis of stress-related upper gastrointestinal bleeding in patients with intracerebral hemorrhage

Object Patients with intracerebral hemorrhage (ICH) are at high risk for severe stress-related upper gastrointestinal (UGI) bleeding, which is predictive of higher mortality. The aim of this study was to evaluate the effectiveness of omeprazole and cimetidine compared with a placebo in the prevention and management of stress-related UGI bleeding in patients with ICH. Methods In a single-center, randomized, placebo-controlled study, 184 surgically treated patients with CT-proven ICH within 72 hours of ictus and negative results for gastric occult blood testing were included. Of these patients, 165 who were qualified upon further evaluation were randomized into 3 groups: 58 patients received 40 mg intravenous omeprazole every 12 hours, 54 patients received 300 mg intravenous cimetidine every 6 hours, and 53 patients received a placebo. Patients whose gastric occult blood tests were positive at admission (n = 70) and during/after the prophylaxis procedure (n = 48) were treated with high-dose omeprazole at 80 mg bolus plus 8 mg/hr infusion for 3 days, followed by 40 mg intravenous omeprazole every 12 hours for 7 days. Results Of the 165 assessable patients, stress-related UGI bleeding occurred in 9 (15.5%) in the omeprazole group compared with 15 patients (27.8%) in the cimetidine group and 24 patients (45.3%) in the placebo group (p = 0.003). The occurrence of UGI bleeding was significantly related to death (p = 0.022). Nosocomial pneumonia occurred in 14 patients (24.1%) receiving omeprazole, 12 (22.2%) receiving cimetidine, and 8 (15.1%) receiving placebo (p > 0.05). In patients with UGI bleeding in which high-dose omeprazole was initiated, UGI bleeding arrested within the first 3 days in 103 patients (87.3%). Conclusions Omeprazole significantly reduced the morbidity of stress-related UGI bleeding in patients with ICH due to its effective prophylactic effect without increasing the risk of nosocomial pneumonia, but it did not reduce the 1-month mortality or ICU stay. Further evaluation of high-dose omeprazole as the drug of choice for patients presenting with UGI bleeding is warranted. Clinical trial registration no.: ChiCTR-TRC-12001871, registered at the Chinese clinical trial registry (http://www.chictr.org/en/proj/show.aspx?proj=2384).

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Comparative study between intrathecal dexmedetomidine and intrathecal magnesium sulfate for the prevention of post-spinal anaesthesia shivering in uroscopic surgery; (RCT)

BMC Anesthesiology ◽

10.1186/s12871-019-0853-0 ◽

2019 ◽

Vol 19 (1) ◽

Cited By ~ 3

Author(s):

Heba Omar ◽

Wessam Adel Aboella ◽

Mohammed Mahmoud Hassan ◽

Amany Hassan ◽

Passaint Hassan ◽

...

Keyword(s):

Clinical Trial ◽

Magnesium Sulfate ◽

Spinal Anaesthesia ◽

Sedation Score ◽

Trial Registration ◽

Controlled Study ◽

Clinical Trial Registry ◽

Hyperbaric Bupivacaine ◽

Clinical Trial Registration ◽

Group D

Abstract Background Hypothermia and shivering are common complications after spinal anaesthesia, especially after uroscopic procedures in which large amounts of cold intraluminal irrigation fluids are used. Magnesium sulfate and dexmedetomidine are the most effective adjuvants with the least side effects. The aim of this study was to compare the effects of intrathecal dexmedetomidine versus intrathecal magnesium sulfate on the prevention of post-spinal anaesthesia shivering. Methods This prospective randomized, double-blinded controlled study included 105 patients who were scheduled for uroscopic surgery at the Kasr El-Aini Hospital. The patients were randomly allocated into three groups. Group C (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 0.5 ml of normal saline, Group M (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 25 mg of magnesium sulfate in 0.5 ml saline, and Group D (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 5 μg of dexmedetomidine in 0.5 ml saline. The primary outcomes were the incidence and intensity of shivering. The secondary outcomes were the incidence of hypothermia, sedation, the use of meperidine to control shivering and complications. Results Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other. The time between block administration and meperidine administration was similar among the three groups. Hypothermia did not occur in any of the patients. The three groups were comparable regarding the occurrence of nausea, vomiting, bradycardia and hypotension. All the patients in group C, 32 patients in group M and 33 patients in group D had a sedation score of 2. Three patients in group M and 2 patients in group D had a sedation score of 3. Conclusions Intrathecal injections of both dexmedetomidine and magnesium sulfate were effective in reducing the incidence of post-spinal anaesthesia shivering. Therefore, we encourage the use of magnesium sulfate, as it is more physiologically available, more readily available in most operating theatres and much less expensive than dexmedetomidine. Trial registration Clinical trial registration ID: Pan African Clinical Trial Registry (PACTR) Trial Number PACTR201801003001727; January 2018, “retrospectively registered”.

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Expression of inflammatory mediators in biofilm samples and clinical association in inflammatory bowel disease patients—a preliminary study

Clinical Oral Investigations ◽

10.1007/s00784-021-04093-2 ◽

2021 ◽

Author(s):

Mayte Buchbender ◽

Jakob Fehlhofer ◽

Peter Proff ◽

Tobias Möst ◽

Jutta Ries ◽

...

Keyword(s):

Clinical Trial ◽

Inflammatory Bowel Disease ◽

Oral Cavity ◽

Bowel Disease ◽

Trial Registry ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Expression Levels ◽

Inflammatory Bowel ◽

Group 2

Abstract Objectives Inflammatory bowel disease (IBD) has multiple impacts on soft and hard tissues in the oral cavity. The aim of this study was to analyze the expression of cytokines in biofilm samples from patients suffering from IBD and compare them to healthy patients. It was hypothesized that different cytokine expression levels and clinical associations might be drawn. Material and methods A total of 56 biofilm samples from three different patient cohorts (group 0 = healthy, HC n = 30; group 1 = Crohn’s disease, CD, n = 19; group 2 = ulcerative colitis, UC, n = 7) were examined for the expression levels of the cytokine interleukins IL-2, -6, and -10; matrix metalloproteinases 7 and 9; and surface antigens CD90/CD11a by quantitative real-time PCR and according to clinical parameters (plaque index, BOP, PD, DMFT, CAL). Relative gene expression was determined using the ∆∆CT method. Results The mean BOP values (p = 0.001) and PD (p = 0.000) were significantly higher in the CD group compared to controls. Expression of IL-10 was significantly higher in the CD (p = 0.004) and UC groups (p = 0.022). Expression of MMP-7 was significantly higher in the CD group (p = 0.032). IBD patients treated with TNF inhibitors (p = 0.007) or other immunosuppressants (p = 0.014) showed significant overexpression of IL-10 compared to controls. Conclusion Different expression levels of IL-10 and MMP-7 were detected in plaque samples from IBD patients. As only BOP was significantly increased, we conclude that no clinical impairment of periodontal tissue occurred in IBD patients. Clinical relevance With the worldwide increasing incidence of IBD, it is important to obtain insights into the effects of the disease on the oral cavity. The study was registered (01.09.2020) at the German clinical trial registry (DRKS00022956). Clinical trial registration The study is registered at the German clinical trial registry (DRKS00022956).

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Practical and conceptual issues of clinical trial registration for Brazilian researchers

Sao Paulo Medical Journal ◽

10.1590/1516-3180.2014.00441803 ◽

2015 ◽

Vol 134 (1) ◽

pp. 28-33 ◽

Cited By ~ 3

Author(s):

Carolina Gomes Freitas ◽

Thomas Fernando Coelho Pesavento ◽

Maurício Reis Pedrosa ◽

Rachel Riera ◽

Maria Regina Torloni

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

International Committee ◽

New Drugs ◽

Trial Registration ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Registration Process ◽

Trial History ◽

Definition Of

CONTEXT AND OBJECTIVE: Clinical trial registration is a prerequisite for publication in respected scientific journals. Recent Brazilian regulations also require registration of some clinical trials in the Brazilian Clinical Trials Registry (ReBEC) but there is little information available about practical issues involved in the registration process. This article discusses the importance of clinical trial registration and the practical issues involved in this process. DESIGN AND SETTING: Descriptive study conducted by researchers within a postgraduate program at a public university in São Paulo, Brazil. METHODS: Information was obtained from clinical trial registry platforms, article reference lists and websites (last search: September 2014) on the following topics: definition of a clinical trial, history, purpose and importance of registry platforms, the information that should be registered and the registration process. RESULTS: Clinical trial registration aims to avoid publication bias and is required by Brazilian journals indexed in LILACS and SciELO and by journals affiliated to the International Committee of Medical Journal Editors (ICMJE). Recent Brazilian regulations require that all clinical trials (phases I to IV) involving new drugs to be marketed in this country must be registered in ReBEC. The pros and cons of using different clinical trial registration platforms are discussed. CONCLUSIONS: Clinical trial registration is important and various mechanisms to enforce its implementation now exist. Researchers should take into account national regulations and publication requirements when choosing the platform on which they will register their trial.

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Relationship between corneal stiffness parameters and lamina cribrosa curvature in normal tension glaucoma

European Journal of Ophthalmology ◽

10.1177/1120672120982521 ◽

2020 ◽

pp. 112067212098252

Author(s):

Yunxiao Sun ◽

Yiqin Guo ◽

Kai Cao ◽

Yue Zhang ◽

Yuan Xie ◽

...

Keyword(s):

Clinical Trial ◽

Amplitude Ratio ◽

Statistical Significance ◽

Normal Tension Glaucoma ◽

Lamina Cribrosa ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Curvature Index ◽

Biomechanical Parameters ◽

The Relationship

Purpose: To evaluate the relationship between corneal biomechanical parameters and lamina cribrosa (LC) curvature in normal tension glaucoma (NTG). Methods: 95 eyes of 56 NTG patients were enrolled in this prospective, observational study. Corneal biomechanical parameters, including stiffness parameters at applanation 1 (SP-A1), deformation amplitude ratio (DA ratio), inverse concave radius and biomechanically corrected intraocular pressure estimate (bIOP), were captured using the Corneal Visualization Scheimpflug Technology instrument (Corvis-ST). LC curvature was evaluated by mean adjusted LC curvature index (maLCCI) averaged by the measurements on 12 radial B-scan images obtained using swept-source optical coherence tomography (SS-OCT). Linear mixed models were constructed to assess the relationship between corneal biomechanical parameters and LC curvature. Results: The mean age of participants was 51.04 ± 13.74 years (range, 24–82 years). The SP-A1 and maLCCI were 93.50 ± 13.82 mm Hg/mm and 7.57 ± 1.58, respectively. In univariate and multivariate analysis, SP-A1 ( p < 0.001 and p = 0.001) and age ( p = 0.010 and p = 0.024) were both significantly associated with maLCCI. The LC curvature increased with softer cornea demonstrated by lower SP-A1 and younger eyes. There was no statistical significance interaction between SP-A1 and age ( p = 0.194). Conclusions: The greater posterior LC curvature was associated with lower corneal stiffness parameters and younger eyes in NTG patients. Clinical Trial Registration: Chinese Clinical Trial Registry, ChiCTR1900021465.

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Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study

Alimentary Pharmacology & Therapeutics ◽

10.1111/j.1365-2036.2010.04511.x ◽

2010 ◽

Vol 33 (2) ◽

pp. 225-234 ◽

Cited By ~ 86

Author(s):

N. J. Shaheen ◽

S. D. Crockett ◽

S. D. Bright ◽

R. D. Madanick ◽

R. Buckmire ◽

...

Keyword(s):

Clinical Trial ◽

Chronic Cough ◽

Randomised Clinical Trial ◽

Acid Suppression ◽

Controlled Study ◽

High Dose ◽

Double Blind ◽

Double Blind Placebo

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Modulation of Cardiac Injury by ACE inhibitor/ARB in Patients with Severe COVID-19

10.21203/rs.3.rs-29994/v1 ◽

2020 ◽

Author(s):

Beibei Du ◽

Daoyuan Si ◽

Bo Yang ◽

Guohui Liu ◽

Qian Zhang ◽

...

Keyword(s):

Clinical Trial ◽

Treatment Group ◽

Small Sample Size ◽

Cardiac Injury ◽

Ventilatory Support ◽

Small Sample ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Significant Difference ◽

Ctni Level

Abstract Introduction: Cardiac injury occurs in 7-22% of patient hospitalized with COVID-19 and an elevation in troponin is associated with a 4.2-fold increase in the risk of mortality. Preliminary data showed ACEi/ARB usage might not increase mortaily in COVID-19 patients. However, it is unknown if cardiac injury in patients with severe COVID-19 can be modulated by ACEi/ARB usage during evolution of the cardiac injury.Methods: In 154 COVID-19 patients with cardiac injury, the effect of ACEi/ARB treatment (17 patients) was compared with 137 patients without ACEi/ARB treatment. Cardiac injury was indicated by cTnI level.Results: In ACEi/ARB treatment group and no ACEi/ARB treatment group, peak cTnI level did not show significant difference (150.5 pg/ml [31.75-1179], vs 207 pg/ml [54.65-989.4], respectively, P = 0.21). Evolution of Cardiac injury (temporal change of cTnI at day 6, 9, 12, 15, 18, 21, 24, 27, 30, and 33) showed no statistical difference. Mortality (ACEi/ARB group vs no ACEi/ARB group; 52.9% vs 69.9%, P = 0.17), atrial arrhythmias (11.7% vs 24.4%, P = 0.36), requirement for invasive ventilatory support (29.4% vs 48.2%, P = 0.14) also showed no significant difference in two groups.Conclusions: ACEi/ARB usage during the COVID-19 was not associated with exacerbation of cardiac injury. These data should be interpreted as essentially hypothesis-generating due to small sample size.Clinical Trial Registration: This retrospective study was registered in Chinese clinical trial registry (ChiCTR 2000031301).

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Design and Methodology of a Multicenter Randomized Clinical Trial to Evaluate the Efficacy of Tongmai Jiangtang Capsules in Type 2 Diabetic Coronary Heart Disease Patients

Frontiers in Pharmacology ◽

10.3389/fphar.2021.625785 ◽

2021 ◽

Vol 12 ◽

Author(s):

Yu Wang ◽

Yilei Guo ◽

Ye Lei ◽

Shuwei Huang ◽

Liping Dou ◽

...

Keyword(s):

Clinical Trial ◽

Coronary Heart Disease ◽

Heart Disease ◽

Vascular Complications ◽

Complementary Therapy ◽

Controlled Clinical Trial ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Type 2 Diabetic

Background: Population-based studies have consistently showed an increased incidence of coronary heart disease and cardiac mortality in patients with type 2 diabetes mellitus (T2DM). Tongmai Jiangtang capsules (TJC) are Chinese patent medicines that have been approved in China for the treatment of diabetic vascular complications. However, the evidence supporting the efficacy of Tongmai Jiangtang capsules in type 2 diabetic coronary heart disease (T2DM-CHD) remains unclear. Herein, we designed a randomized, parallel-controlled clinical trial to investigate a new complementary therapy for T2DM-CHD patients.Methods: A total of 360 T2DM-CHD subjects (aged 18–75 years) will be randomly assigned to the TJC group or the placebo group at a 2:1 ratio. On the basis of western medicine therapy, all the participants will receive TJC or placebo, orally, three capsules/treatment, three per day for 12 weeks. The primary outcomes will be assessed according to the Canadian Cardiovascular Society (CCS) classification. All statistical analyses will be performed setting a two-sided 0.05 significance level, using SAS 9.4 statistical software.Discussion: The efficacy of TJC for the treatment of T2DM-CHD patients will be evaluated. The study will provide reliable clinical research evidence for application of TJC in treating T2DM-CHD patients.Clinical Trial Registration:https://www.chictr.org.cn/enIndex.aspx, Chinese Clinical Trial Registry ChiCTR2000037491.

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Efficacy of an Internet-Based Intervention for Subclinical Depression (MoodBox) in China: Study Protocol for a Randomized Controlled Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2020.585920 ◽

2021 ◽

Vol 11 ◽

Author(s):

Xu Chen ◽

Xiaolong Zhang ◽

Xuequan Zhu ◽

Gang Wang

Keyword(s):

Clinical Trial ◽

Intervention Program ◽

Psychological Intervention ◽

Controlled Trial ◽

Well Being ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Randomized Controlled ◽

Alternative Treatment Option ◽

Subclinical Depression

Background: Subclinical depression is a prevalent mental health problem and increases the incidence of the onset of major mood disorders, such as major depressive disorder (MDD). Psychological interventions have been proved to be effective for reducing depressive symptoms for people with subclinical depression and can prevent the onset of MDD. However, people have limited access to face-to-face psychotherapy. Internet-based psychological intervention is an alternative treatment option. The aim of the study is to evaluate the efficacy of MoodBox, an online psychological intervention program, for subclinical depression.Methods: This study is a multicenter, randomized, controlled, non-blinded superiority study with three parallel groups. A total of 435 first-year university students with subclinical depression will be recruited. Eligible participants will be randomly assigned to the MoodBox group, the online psychoeducation group, and the naturalistic observation group at a ratio of 1:1:1. The intervention period is 8 weeks, and participants will be continuously followed up for 1 year. The primary outcome of the study is the efficacy of the intervention, defined as measured by the Patient Health Questionnaire (PHQ-9).Discussion: This is the first study to innovatively develop and test an intervention to improve psychological well-being and decrease the incidence of MDD in a subclinical depression population in China. Once proven effective and acceptable, MoodBox could be potentially integrated into the routine clinical service to facilitate the management for people with subclinical depression.Clinical Trial Registration: The trial is registered with the Chinese Clinical Trial Registry on 21 July 2020 (No. ChiCTR2000034826).

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Tianwang Buxin Granules Influence the Intestinal Flora in Perimenopausal Insomnia

BioMed Research International ◽

10.1155/2021/9979511 ◽

2021 ◽

Vol 2021 ◽

pp. 1-9

Author(s):

Xiqian Yang ◽

Hesong Xiao ◽

Yi Zeng ◽

Liangliang Huang ◽

Ke Ji ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Trial ◽

Intestinal Flora ◽

World Health ◽

Control Group ◽

Metagenomic Sequencing ◽

Clinical Trial Registry ◽

Clinical Trial Registration ◽

Faecalibacterium Prausnitzii ◽

Health Organization

Study Objectives. To study the relationship between perimenopausal insomnia (PI) and intestinal flora and the potential mechanism of Tianwang Buxin granules (TWBXG) in exerting its clinical efficacy. Methods. The subjects included 13 PI patients from the Hubei Provincial Hospital of TCM, Hubei University of TCM, and Wuhan Traditional Chinese Medicine Hospital, and the corresponding noninsomniac spouses of the patients were selected as controls. TWBXG was continuously administered for 4 weeks. The feces of PI patients and their noninsomniac spouses before and after treatment with TWBXG were collected. The intestinal flora composition of each group was detected by metagenomic sequencing, and the efficacy of TWBXG was evaluated by the PSQI scale. Results. Compared with the control group, the model group showed an increase in the abundance of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum, while those of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii were decreased. Compared with pretreatment, the PSQI score was significantly reduced ( P < 0.05 ), the abundance of Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii increased, and that of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, and Blautia obeum decreased after treatment. However, there was still a certain gap in the abundance of related flora in the treatment group compared with the control. Conclusion. PI is associated with disturbances in the intestinal flora and is mainly related to the disorders of Roseburia faecis, Ruminococcus, Prevotella copri, Fusicatenibacter saccharivorans, Blautia obeum, Bacteroides, fecal Bacteroidetes, and Faecalibacterium prausnitzii. TWBXG can effectively treat PI, and its effect may be achieved by regulating the disordered intestinal flora. Clinical Trials. The study was registered in the Chinese clinical trial registry and approved by the World Health Organization clinical trial registration platform (Effects of the modified Tianwang Buxin granule and modified Tianwang Buxin decoction pieces on insomnia: a randomized, controlled trial, ChiCTR-IPR-17011549).

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Clinical and immunological benefits of convalescent plasma therapy in severe COVID-19: insights from a single center open label randomised control trial

10.1101/2020.11.25.20237883 ◽

2020 ◽

Cited By ~ 1

Author(s):

Yogiraj Ray ◽

Shekhar Ranjan Paul ◽

Purbita Bandopadhyay ◽

Ranit D’Rozario ◽

Jafar Sarif ◽

...

Keyword(s):

Clinical Trial ◽

Passive Immunization ◽

Neutralizing Antibody ◽

Randomised Control Trial ◽

Single Center ◽

Clinical Trial Registry ◽

Open Label ◽

Plasma Therapy ◽

Clinical Trial Registration ◽

Clinical Benefits

AbstractIntroductionA single center open label phase II randomised control trial was done to assess the pathogen and host-intrinsic factors influencing clinical and immunological benefits of passive immunization using convalescent plasma therapy (CPT), in addition to standard of care (SOC) therapy in severe COVID-19 patients, as compared to patients only on SOC therapy.MethodsConvalescent plasma was collected from patients recovered from COVID-19 following a screening protocol which also included measuring plasma anti SARS-CoV2 spike IgG content. Retrospectively, neutralizing antibody content was measured and proteome was characterized by LC-MS/MS for all convalescent plasma units that were transfused to patients. Severe COVID-19 patients with evidence for acute respiratory distress syndrome (ARDS) with PaO2/FiO2 ratio 100-300 (moderate ARDS) were recruited and randomised into two parallel arms of SOC and CPT, N=40 in each arm. Peripheral blood samples were collected on the day of enrolment (T1) followed by day3/4 (T2) and day 7 (T3). RT-PCR and sequencing was done for SARS-CoV2 RNA isolated from nasopharyngeal swabs collected at T1. A panel of cytokines and neutralizing antibody content were measured in plasma at all three timepoints. Patients were followed up for 30 days post-admission to assess the primary outcomes of all cause mortality and immunological correlates for clinical benefits.ResultsWhile across all age-groups no statistically significant clinical benefit was registered for patients in the CPT arm, significant immediate mitigation of hypoxia, reduction in hospital stay as well as survival benefit was recorded in severe COVID-19 patients with ARDS aged less than 67 years receiving convalescent plasma therapy. In addition to its neutralizing antibody content a prominent effect of convalescent plasma on attenuation of systemic cytokine levels possibly contributed to its benefits.ConclusionPrecise targeting of severe COVID-19 patients is necessary for reaping the clinical benefits of convalescent plasma therapy.Clinical trial registrationClinical Trial Registry of India No. CTRI/2020/05/025209

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