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Medication for management of pregnancy-induced hypertension
Yi Lin, Ying Zhang, Yi-Nong Jiang, Wei Song
April-June 2018, 3(2):83-87
Hypertension refers to increased arterial blood pressure and can be divided into two categories: primary and secondary. Primary hypertension caused by angiogenic degenerative changes is a degenerative disease. With liberalization of China’s reproduction policy and increases in maternal age, the prevalence of pregnancy-induced hypertension (PIH) in China has increased gradually. PIH is not a type of primary hypertension, but there are differences in the treatment of these two types of hypertension. Here, we review the choice and use of drugs for PIH management using drugs for the management of primary hypertension as a reference. First-line drugs such as labetalol, nifedipine, or methyldopa should be taken via the oral route if blood pressure is ≥ 150/90 mmHg. For chronic hypertension, other drugs should be added after the first drug at the highest concentration has been revealed to be ineffective. If the blood pressure of patients with acute hypertension is ≥ 160/110 mmHg, maternal stroke or eclampsia can result. If PIH patients are about to deliver, they can be given labetalol (i.v.), hydralazine (i.v.) or nifedipine (p.o.). Moreover, all anti-hypertensive treatments should be based on considerations of maternal and fetal safety.
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Efficacy and safety of Mamajjaka Ghanavati in the treatment of type 2 diabetes mellitus: A prospective open label multi-center clinical study
Malalur Nagesh Shubhashree, Bikartan Das, Gopal Chandra Nanda, Gaddam Kumara Swamy, Sarada Ota, Shashidhar Doddamani, Meda Mruthyumjaya Rao, Vimal Tewari, Baghwan Sahai Sharma, Shruti Khanduri, Rakesh Rana, Richa Singhal, Adarsh Kumar, Narayanam Srikanth
January-March 2019, 4(1):7-13
Background and objectives: The purpose of this study is to investigate the efficacy and safety of Mamajjaka Ghanavati on blood glucose level, symptoms, and quality of life in patients with type 2 diabetes mellitus. Subjects and methods: This prospective, multi-center, open-label, single-arm clinical study was performed at three peripheral institutes of the Central Council for Research in Ayurvedic Sciences, New Delhi during April 2016 to May 2017. A total of 177 eligible patients with type 2 diabetes mellitus were included and administered Mamajjaka Ghanavati two tablets (500 mg each) twice daily after food for 84 days. At the end of the treatment period (84th day), the changes in Diabetes Symptom Questionnaire (i.e., glycosylated hemoglobin and fasting and postprandial blood sugar levels) were analyzed. Quality of life was evaluated using 36-Item Short Form Health Survey (SF-36). Clinical safety of Mamajjaka Ghanavati was assessed by liver and renal function tests. This study was approved by the Medical Ethics Committee of Central Council for Research in Ayurvedic Sciences, New Delhi (approval number: CTRI Reg No Ref/2016/06/011468) on March 14, 2016. Results: Compared to baseline data, after 84 days of treatment with Mamajjaka Ghanavati, Diabetes Symptom Questionnaire score was significantly decreased, and SF-36 score was significantly increased (both P < 0.01). However, compared to baseline data, no significant differences in glycated hemoglobin, fasting and postprandial blood sugar levels as well as hepatic and renal parameters were observed after 84 days of treatment with Mamajjaka Ghanavati. Conclusion: Mamajjaka Ghanavati can greatly improve the quality of life and is safe in the treatment of type 2 diabetes mellitus. Actually, Mamajjaka Ghanavati does not change blood sugar level greatly. Trial registration: This study was registered in the Clinical Trial Registry of India (CTRI/2017/09/009887) on September 22, 2017.
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Efficacy and safety of freeze-dried form of Tragia involucrata L. decoction in treating diabetes: a randomized controlled clinical trial
Mumtaz Pallie, Pathirage Kamal Perera, Charitha Lakshini Goonasekara, Nishantha Kumarasinghe, Menuka Arawwawala
July-September 2020, 5(3):31-36
Background and objectives: Tragia involucrata L. (Family: Euphorbiaceae, S. Wel Kahambiliya) is a highly used medicinal plant in both systems of Sri Lankan traditional medicine and Ayurveda medicine. This plant is used for the treatment of diseases such as diabetes, wounds, dysuria, and epilepsy. The aim of this study was to evaluate the efficacy and safety of the freeze-dried form of Tragia involucrata L. decoction in the treatment of diabetes. Subjects and methods: This randomized, two-arm, open-label, controlled clinical trial was conducted in type 2 diabetes patients at National Ayurveda Teaching Hospital in Colombo, Sri Lanka during the year 2016–2017. Thirty-six type 2 diabetes patients aged 18–70 years were included in each group. Patients received treatment with 120 mL of Tragia involucrata L. decoction and 500 mg of metformin, twice a day, for 14 days used as the test drug and positive control drug groups. Fasting blood glucose level was measured on days 0, 8, and 15. Lipid profile and liver and kidney functions were measured on days 0 and 15. This study was approved by the Ethics Review Committee, Institute of Indigenous Medicine (ERCIIM), University of Colombo, Rajagiriya, Sri Lanka (approval No. ERC 16/61) on October 27, 2016. Results: Fasting blood glucose levels in the test group were significantly decreased on days 8 and 15 compared to day 0 (P < 0.05). There was no significant change in the lipid profile values before and after treatment (P > 0.05). Also the decoction did not cause changes in the function of the liver and kidneys. Further no other adverse reactions were recorded in the patients. Conclusion: Tragia involucrata L. can reduce fasting blood glucose level and has antidiabetic effects in diabetes.
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Efficacy and safety of Vidangadi Yoga (ayurvedic polyherbal medicine) in type 2 diabetes mellitus: A randomized controlled clinical study
Shailesh Vinayak Deshpande, Krutika Subhash Jadhav
October-December 2018, 3(4):123-129
Background and objectives: Incidence of diabetes mellitus is increasing due to genetic predisposition, high body fat, and insulin resistance. Though multiple oral hypoglycaemic agents and insulin are available, these are associated with side effects, primary and secondary failure. Hence, evaluation of antidiabetic potential of medicines described in traditional health sciences such as Ayurveda (Indian system of medicine) is also important. This study aimed to assess the efficacy and safety of Vidangadi Yoga (ayurvedic polyherbal medicine) and metformin in the management of type 2 diabetes mellitus (T2DM) based on biochemical parameters and adverse events. Methods: In this prospective, randomized, open-label, active-controlled, two-arm study, 61 patients with T2DM were included and randomly divided two groups. Patients in the Vidangadi Yoga group received Vidangadi Yoga tablet 500 mg thrice daily before food with water, while patients in the metformin group received metformin 500 mg after food twice daily for 90 days. Subjects were asked to undergo follow-up at the interval of 15 days until the completion of 90 days. Assessment was done on changes observed in fasting and postprandial blood glucose, glycosylated haemoglobin, lipid profile, haemogram, hepatic, renal profile, and clinical symptoms. Results: After 90 days of medication, fasting and postprandial blood glucose levels in both groups were significantly decreased when compared with baseline (P < 0.001). There were no significant differences in fasting and postprandial blood glucose levels between both groups. After 90 days of medication, haemogram, and hepatic and renal profiles (safety parameters) in the two groups were not significantly different from baseline. No adverse events were related with the use of the studied medicine. Conclusion: Vidangadi Yoga exhibits equivalent efficacy to metformin and is safe in lowering fasting and postprandial blood glucose levels. Ethics and trial registration: This study was approved by the institutional ethics committee of PDEA’s College of Ayurved and Research Centre, Pune, Maharashtra, India (approval number 6833) on March 22, 2014 and was registered with Clinical Trials Registry- India (CTRI) (No. CTRI/2015/04/005719) on April 25, 2015.
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Efficacy and safety of Qufushengji powder in patients with diabetic foot ulcers: study protocol for a parallel randomized controlled trial
Guo-Dong Qi, Wei Qi, Hua Wen, Kai-Qin Shen
July-September 2020, 5(3):37-41
Background and objective: Qufushengji powder is a classical external medicine in Chongqing Orthopaedic Hospital of Traditional Chinese Medicine for surgical ulcer. This trial is designed to demonstrate the safety and efficacy of Qufushengji powder for treatment of diabetic foot ulcers. Participants and methods: This is a parallel randomized controlled trial, which will be conducted at Chongqing Orthopaedic Hospital of Traditional Chinese Medicine, China. The included patients with moderate to severe diabetic foot ulcers will be randomly divided into control group and intervention group. Patients in the control and intervention groups will be sterilely bandaged with Kangfuxin solution and applied gauze strips of Qufushengji powder based on conventional therapy. In the study execution time of each stage, patient recruitment began in June 2020. The analysis of primary outcome measure will be completed in July 2021, and the study will be finished in May 2022. The protocol was approved by the Ethics Committee for Research Involving Human Subjects from Chongqing Orthopedics Hospital of Traditional Chinese Medicine on May 24, 2019 (approval No. 2019-17). Outcome measures: Ulcer healing rate after 12 weeks of treatment is primary outcome measure. Secondary outcome measures include relief of local foot symptoms, functional recovery and adverse events. Discussion: Results of this trial will provide preliminary evidence for the use of Qufushengji powder in the clinical treatment of diabetic foot ulcers. Trial registration: This trial was registered in the Chinese Clinical Trial Registry on April 25, 2020 (registration number: ChiCTR2000032315).
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Role of trace mineral in periodontal health: a review
Adiya Apon, Praneeta Kamble
April-June 2019, 4(2):30-36
Periodontal diseases are microbial induced chronic inflammatory conditions characterized by infiltration of leukocytes, loss of connective tissue, alveolar bone resorption, and formation of periodontal pockets. In response to periodontal pathogens, leukocytes elaborate destructive oxidants, proteinases and other factors. Periodontal disease is a chronic inflammatory disease, which leads to alteration of the micronutrient levels such as zinc, selenium, iron and copper. The imbalance of the micronutrient levels leads to increased susceptibility to oxidative damage of tissues. These micronutrients play a role in both health and disease. The vitality of the periodontal tissues in both health and disease depends on the adequate source of essential nutrients being available to the host. Micronutrients are imperative for optimum host response. Populations worldwide are prone to their insufficiency due to lifestyle changes or poor nutritional intake. Balanced levels of these trace minerals such as iron, zinc, selenium and copper are essential to prevent progression of chronic conditions like periodontitis. Their excess as well as deficiency is detrimental to periodontal health. Selenium, zinc and copper are integral components of antioxidant enzymes and prevent reactive oxygen species induced destruction of tissues. Their deficiency can worsen periodontitis associated with systemic conditions like diabetes mellitus. This review focused on the role of micronutrients, namely, iron, zinc, selenium and copper in periodontal health and their association with chronic periodontitis.
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Sacubitril/valsartan improves ejection fraction in heart failure with reduced ejection fraction: A retrospective study
Walid Ibrahim, Ahmed S Yassin, Ahmed Subahi, Hassan Mohamed, Ayman Khaddam, Muhammad Bajwa, Ashraf Abugroun, Amir Kaki, Mahir Elder, Tamam Mohamad
October-December 2018, 3(4):119-122
Background and objectives: The discovery and introduction of Neprilysin inhibitor in treating chronic heart failure (New York Heart Association class II–IV) with reduced ejection fraction (HFrEF) is a remarkable landmark in therapy. The clinical outcome of reducing the incidence of death from cardiovascular causes or first hospitalization for worsening heart failure was demonstrated at the large randomized, double blind, “Angiotensin-Neprilysin inhibition versus enalapril in heart failure (PARADIGM-HF trial).” We studied a total of 228 patients with HFrEF who was recently started on sacubitril/valsartan (EntrestoTM; previously known as LCZ696) testing the hypothesis of improving ejection fraction with sacubitril/valsartan, defined as an increase of ejection fraction from the baseline before treatment by 10–15%. Methods: This is a single-center, retrospective, descriptive study. The data was collected from the charts of patients followed up for a mean of 4.7 weeks after initiation of treatment with sacubitril/valsartan. A total of 228 patients with heart failure were prescribed 200 mg of sacubitril/valsartan twice daily, an improvement in ejection fraction by 10–15% was considered a successful response. Results: Out of the 228 patients, 51.3% showed a successful response. Most of the patients 97.9% and 58.0% were taking beta-blockers and aspirin respectively. The absolute number of black patients who improved was higher than others ethnic groups. However, the higher percentage of ejection fraction improvement 71% was reported among other ethnicities (not blacks or Caucasians). Patients without episodes of hospitalization showed better improvement than those with one or more episodes. Conclusion: In a predominantly black population with HFrEF, sacubitril/valsartan has shown improvement in ejection fraction effect. This finding was independent of other risk factors and concomitant heart failure treatment; however, further studies are recommended to validate this result. Ethics: Ethical approval of this study was obtained from the Research Committee, DMC/Wayne State University (IRB# 015618MP4X) on February 14, 2018.
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Pain treatment with cooled radiofrequency in osteoarthritis and total knee arthroplasty: case series in Hospital Universitario de Son Espases
Andres Camprodon Alberca, José Andrés López-Riquelme, María del Pilar Sanchis Cortés
October-December 2017, 2(4):77-83
Background and objectives: Cooled radiofrequency (RF) for neurotomy of genicular nerves has been proved to be efficient in short-term (12 weeks) to relieve the knee pain in severe osteoarthritis (OA) and total knee arthroplasty (TKA). This study is aimed to analyze the results of cooled radiofrequency in patients with chronic knee pain after one year of follow-up. Design: A retrospective case-series study. Methods: Forty patients underwent cooled RF of genicular nerves. We evaluated results of 36-Item Short Form Survey (SF-36), Knee Society Score (KSS) and Visual Analogue Scale (VAS) preoperatively and after one-year follow-up. Results: Regarding SF-36, a significant improvement in pain, general health and overall outcome was obtained. Preoperative average VAS score was 8.5; 1 year after surgery this score was 5.3. Significant differences were found at the knee score (KS) in KSS but not in the function score (FS) in KSS. Conclusion: Cooled RF for neurotomy of genicular nerves is still effective after 1 year of the procedure in the treatment of chronic knee pain due to osteoarthritis. The rate of conversion to arthroplasty is low. This technique could be a good alternative for chronic pain management in patients in whom TKA is not the first option of treatment.
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Systematic review on effectiveness of theory-based intervention on self-care behaviors among patients with type 2 diabetes
Abeer Yahya Ahmed Al-Washali, Hayati Kadri, Suriani Ismail, Hejar Abdul Rahman, Yahya A Elezzy
July-September 2018, 3(3):88-94
Objective: To investigate the effectiveness of theory-based intervention on self-care behaviors among patients with type 2 diabetes. Data sources: Medline, PubMed, ScienceDirect, and CINAHL database were searched to identify relevant English studies published during 2005–2017. Data selection: The key words that have been used to search for relevant studies were type 2 diabetes, diabetes self-care behaviors, theory-based intervention, and the name of the behavior theories such as social cognitive theory, health belief model, and other theories. Because self-care and self-management are being used interchangeably in some literature, self-management was entered to obtain all relevant studies. Included studies were randomized controlled trials and quasi-experimental studies. Outcome measures: The outcome was diabetes self-care behaviors. Results: Thirteen studies met all the inclusion criteria and had been reviewed and included in this systematic review. The interventions in eleven studies were based on one theory. Conclusion: Theory-based interventions are effective in enhancing diabetes self-care behaviors among patients with type 2 diabetes.
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An update on clinical trials targeting human tauopathies
Monica Javidnia, Bahjat T Kurd-Misto, Charbel E-H Moussa
July-September 2017, 2(3):66-76
The microtubule-associated protein 'tau' is primarily expressed within axons in the central nervous system where it stabilizes microtubules and aids in cargo transport. While basal phosphorylation of tau is normal, tau modifications, predominantly hyperphosphorylation, are critical in the pathogenesis of numerous neurodegenerative disorders known as the tauopathies. Over the years, tau has been shown to be a valuable and elusive target for the treatment of neurodegenerative diseases. Targeting tau via genetic, biological, and pharmacological approaches in vitro and in vivo may prevent degenerative pathologies. However, to date none of these approaches have been successful in human studies, albeit some promising studies are currently underway. This review aims to briefly discuss the biology and pathology of tau and summarize current treatment strategies in clinical trials.
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What the future holds for the challenging hereditary spastic paraplegia?
Jumana Bisharat-Kernizan, Carlton Watson, Konstantinos Margetis
July-September 2018, 3(3):95-100
Since it was initially described by and named after Strumpell and Lorrain in the late 1800s, hereditary spastic paraplegia (HSP) or familial spastic paraplegia, has remained a source of interest and study for the medical community. This rare disease, or rather spectrum of neurological diseases, is undergoing a fresh wave of unveiling as molecular and genetic techniques have bolstered our understanding of HSP. HSP is a neurodegenerative disease with a wide range of effects on patients. The mainstays of lower extremity spasticity, urinary urgency and impairment of lower extremity vibratory sensation can present alone or accompanied by a list of additional symptoms such as: epilepsy, dementia and peripheral neuropathy. In this review, some of the more recent studies are discussed, in which pathophysiology, imaging, and genetics are investigated. The review of these studies may not only help to advance our knowledge and management of HSP, but may serve as a future paradigm for similar groups of diseases that experience a wide spectrum of clinical symptoms.
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Neurologic Stem Cell Treatment Study (NEST) using bone marrow derived stem cells for the treatment of neurological disorders and injuries: study protocol for a nonrandomized efficacy trial
Jeffrey N Weiss, Steven Levy
October-December 2016, 1(4):176-180
Background: A large number of approximately 600 known neurological diseases have no or limited medical interventions; many treatments are temporizing or only marginally effective and have changed little over decades. The Neurologic Stem Cell Treatment Study (NEST) utilizes bone marrow derived stem cells (BMSCs) for neurological diseases and injuries to nervous tissue. Methods/Design: Administration of BMSCs is an established approach for the treatment of neurological diseases and injury with its effectiveness verified in the pre-clinical and clinical studies. BMSCs and the associated bone marrow fraction are posited to have a number of different mechanisms by which they may potentially improve neurological function. The circumventricular organs which lie in the wall of the third ventricle are noteworthy for a minimized or absent blood-brain barrier (BBB) facilitating entry of intravenously provided BMSCs. There is documentation in the literature that intranasal delivery of BMSCs may follow the pathways of the trigeminal nerves, facilitating their entry into the pons, brain parenchyma and cerebral spinal fluid (CSF) for effects on the CNS. The NEST is an open label, non-randomized, efficacy study with two arms. Arm 1 consists of intravenous autologous BMSCs alone; Arm 2 combines intravenous with intranasal application of BMSCs to the lower 1/3 of the nasal mucosa. There will be a total of 300 patients in the study. Endpoints include at least a 10% improvement in neurological function. Discussion: There have been a number of preclinical studies establishing the utility of intravenous and intranasal methods in providing access to the CNS for certain drugs, proteins and cellular elements. Preclinical and clinical studies utilizing BMSCs have shown positive effects in various neurological diseases. It is anticipated that combining these two administration methods for BMSCs delivery to the brain may provide a greater therapeutic response. Trial registration: ClinicalTrials.gov identifier NCT02795052; registered on June 6, 2016. Ethics: This study protocol has been Institutional Review Board (IRB) approved and will be performed in accordance with principles of research ethics set forth in the Belmont Report. Informed consent: Signed informed consent will be obtained from the patients or their guardians.
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Skill-building through Task-Oriented Motor Practice (STOMP) intervention for activities of daily living in dementia: study protocol for a randomized controlled clinical trial
Carrie A Ciro, Julie A Stoner, Calin Prodan, Linda Hershey
April-June 2016, 1(2):45-50
Background: Progressive disability in activities of daily living (ADL) is inevitable for people with Alzheimer's disease and related dementias (ADRD). Attempts to slow or prevent ADL disability have been unsuccessful despite making progress in behavioral training methods. Missing from this research is an emphasis on how we maximize a patient's engagement during training and the rigorous examination of implementation protocols (dosing and training methods) which may advantage learning in people with ADRD. Our team addressed this gap with the development of the Skill-building through Task-Oriented Motor Practice (STOMP) intervention which creates methods for obtaining ADL goals that support "personhood" and tests high-intensity protocols that appear to advantage learning and sustained learning over time. Through this study, we aim to evaluate differential outcomes in activities of daily living by two different dose levels of the STOMP intervention. Secondarily, we will assess the moderating effects of participant attention to task during training. Methods/Design: A randomized, single blinded, controlled trial with 32 eligible patients with dementia assigned to either the original, intensive STOMP protocol (3 hours per day, 5 days per week for 2 weeks) or a less-intensive STOMP protocol (1 hour per day, 2 days per week for 2 weeks) delivered by an occupational therapy assistant in the home. ADL training is delivered using motor learning theory techniques of blocked practice, continuous verbal praise, errorless learning and intense dosing schedules. Blinded occupational therapists will complete baseline, post-intervention and 3-month follow-up assessments in the home. Primary outcomes will be examiner and caregiver rated ADL performance. Secondary outcomes will be the amount of time the participant is engaged in the task (e.g., attention to training). Discussion: Through this protocol, we will examine differential ADL outcomes by dose for the STOMP ADL intervention. Our results will inform dosing parameters for future intervention studies for people with ADRD. Trial registration: ClinicalTrials.gov identifier: NCT02356055 Ethics: This study protocol was approved by the University of Oklahoma Health Sciences Center Institutional Review Board (#4648) and will be performed in accordance with the Declaration of Helsinki. Informed consent: Written consent will be obtained by the participant's legally-authorized representative as older adults with dementia are considered a vulnerable population. However, in all cases, assent of the participant will also be obtained at the time of consent.
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Chinese medicine packet plus wax therapy for periarthritis of the shoulder: study protocol for a multi-center, randomized controlled trial
Ye Wang
January-March 2016, 1(1):25-31
Background: Periarthritis of the shoulder clinically manifests as pain and functional disorder of the shoulder joint. Although there is a tendency to self-heal, results are unsatisfactory. Nonsurgical treatments often used for clinical treatment of periarthritis, including simple closure, massage and acupuncture, do not improve symptoms. Chinese medicine packets and wax treatment effectively improves the local micro-circulation and regulates body functions. Therefore, this study aims to develop a new Chinese medicine wax treatment for periarthritis of the shoulder using these two techniques, and to observe its safety and efficacy. Methods/Design: A prospective, multi-center randomized, double-blind, placebo-controlled clinical trial will enroll patients with periarthritis of the shoulder who will be randomized into treatment and control groups. In the treatment group, packets will be immersed in a decoction of Chinese medicine. Prepared packets will be placed onto the shoulder joint followed by warm paraffin cake, once a day for 20 minutes, for 4 weeks. In the control group, Chinese medicine packets will be replaced by placebo; all other procedures will be identical. Outcome measures will be assessed at baseline and 1, 2, and 4 weeks after treatment. Primary outcome is the McGill Pain Questionnaire score. Secondary outcomes include shoulder disability questionnaire score, Oxford shoulder score, American Shoulder and Elbow Surgeons score, University of California, Los Angeles shoulder score, the efficacy in treating Traditional Chinese Medicine syndromes, visual analog scale score, and Constant-Murley shoulder score. Discussion: This trial will provide a quantitative basis to establish therapeutic guidelines and technical standards for Chinese medicine packet plus wax therapy for the treatment of periarthritis of the shoulder. Trial registration: Chictr.org.cn identifier: ChiCTR-IOR-15006149; registered on 11 March 2015. Written approval for this protocol was obtained from the Ethics Committee of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine in China (approval No. 2014ZX (KT)-010-02).
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Wharton’s jelly derived allogeneic mesenchymal stromal cells for treatment of type 1 diabetes: Study protocol for a double-blinded, randomized, parallel, placebo-controlled trial
Per-Ola Carlsson, Mathias G Svahn
April-June 2018, 3(2):32-37
Background and objectives: The Wharton’s jelly of the umbilical cord tissue contains a high density of mesenchymal stromal cells (MSCs). Wharton’s jelly derived mesenchymal stromal cells have immunosuppressive potential that can be utilized for treatment of autoimmune diseases such as type 1 diabetes (T1D). The objectives of this study are to assess the safety and efficacy of allogeneic Wharton’s Jelly derived MSCs (WJMSCs) in the treatment of T1D from the viewpoints of changes in beta-cell function, metabolic control, and diabetes treatment satisfaction during one year study period. Design: A two stage design. An open, non-randomized, dose-escalation scheme will be used in the first stage of the study, and a randomized, double-blinded, parallel, placebo-controlled scheme in the second stage of the study. Methods: The study population will consist of adult patients with T1D for < 2 years, 18–40 years of age (inclusive at both ends), only male in the first stage and both sexes in the second stage. In the first stage, a dose-escalation scheme with three doses will be evaluated for safety. The second stage will not be started until all patients in the first stage will have completed the 1-month follow-up visit. The second stage will recruit 15 patients who will be randomized to active treatment or placebo (2:1 ratio). Both patients and investigators will be blinded to the study protocol used in the second stage. Outcome measures: The primary outcome measure of this study will be safety. The secondary outcome measure will be efficacy of treatment, i.e., preservation of endogenous insulin production. This will be evaluated as delta change in C-peptide concentration in response to a mixed meal tolerance test, compared with before treatment. Discussion: By combining the first part (dose-escalation scheme) with the second part (double-blinded, parallel, placebo-controlled scheme), this study will provide both safety and efficacy data for the use of WJMSCs in the treatment of T1D. Obtained findings will guide on how to pursue this concept and indicate what dose of cells will be optimal for future trials. Ethics and dissemination: This study protocol was approved by the Ethics Committee Stockholm (approval number: 2017/1533-31/2) and the Swedish Medicinal Product Agency (EudraCT number: 2017-002766-50), and will be performed in accordance with the Declaration of Helsinki. Dissemination plans include presentations at scientific conferences and scientific publications. Patient recruitment was initiated in January 2018, and the first stage of the trial, the dose escalation, is expected to be completed for 1-month follow-up safety data, in the fourth quarter of 2018. Primary outcome measure will be estimated in 2020. Trial registration: ClinicalTrials.gov identifier: NCT03406585.
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Can early counselling and support for Alzheimer's disease caregivers reduce burden? Study protocol for a multicenter randomized controlled trial
Serena Amici, Pamela Iannizzi, Alessandra Di Pucchio, Iosief Abraha, Alessandro Montedori, Rabih Chattat, Nicola Vanacore
July-September 2016, 1(3):99-106
Background: The activity of "caregiving" for people affected with Alzheimer's disease (AD) is associated with an augmentation in health problems (anxiety, depression, stress, increased mortality), as well as in social and financial problems. Different methods of counselling, to reduce caregiver anxiety and depression, have been shown to be effective. Methods/Design: This study will be a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) controlled superiority trial with two parallel groups. Two hundred and sixty-four caregivers of AD patients will be randomly allocated to the modified Mittelmann psychosocial intervention or an educational intervention. The treatment will consist of 6 hours of counselling and psychosocial support to caregivers, administered by psychologists, along with a specific telephone support service, whereas the active control treatment will be 6 hours of general information about AD. The primary endpoint is change in caregiver burden measured with the Zarit Burden Interview. Secondary endpoints comprise caregiver depression, anxiety and quality of life. All endpoints will be measured at baseline, 6, 12 and 24 months post treatment. Discussion: The results of this trial will be helpful to supply the efficacy of early counselling and psychosocial support for AD caregivers and offer in-depth useful information for stakholders and policy makers to implement strategies for caregivers. Trial registration: Clinical Trials.gov identifier: NCT02685787; registered on 6 February 2016. Ethics: This trial has been approved by Umbria Ethical Review Committee, Italy and will be performed in accordance with the norms on Good Clinical Practice and the Helsinki Declaration. Informed consent: Written informed consent will be obtained from the caregivers.
  7,216 580 3
Coronary artery disease as a cause of morbidity and mortality in patients suffering from schizophrenia: protocol for a prospective cohort study with long-term follow-up
Jørgen Aagaard, Pirathiv Kugathasan, Svend Eggert Jensen
October-December 2016, 1(4):141-148
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Safety and efficacy of human umbilical cord-derived mesenchymal stem cells in patients with Alzheimer's disease: study protocol for an open-label self-control trial
Jing-wen Niu, Bin Zhang, Hu Chen
January-March 2016, 1(1):1-8
Background: Animal model experiments have demonstrated the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of Alzheimer's disease. However, the clinical efficacy of hUC-MSCs in the treatment of Alzheimer's disease in humans remains unclear. This study protocol for a phase I/II clinical trial was designed to investigate the clinical safety (primary outcome) and efficacy (secondary outcome) of hUC-MSCs in the clinical treatment of Alzheimer's disease. Methods/Design: This open-label, self-control, single-center prospective phase I/II clinical trial will be performed at the Department of Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy Center, the 307 th Hospital of Chinese People's Liberation Army, China. Thirty patients with moderate to severe Alzheimer's disease will be included. The primary outcome is the number of patients who have adverse events at 10 weeks and 1 year after hUM-MSCs therapy. Secondary outcomes include cognitive function, overall clinical status, daily living activities, neuropsychiatric symptoms, blood biochemical Alzheimer's disease markers. Discussion: The findings from this trial will provide valuable evidence for the use of hUM-MSCs in the clinical treatment of Alzheimer's disease. Trial registration: ClinicalTrial.gov identifier: NCT01547689; registered on 5 March 2012. This study protocol was approved by the Ethics Committee of the 307 th Hospital of Chinese People's Liberation Army.
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Effect of a long-term modified Tai Chi-based intervention in attenuating bone mineral density in postmenopausal women in southeast China: study protocol for a randomized controlled trial
Li-ye Zou, Chao-yi Wang, Hui-ru Wang
July-September 2017, 2(3):46-52
Background and objectives: According to Chinese White Paper on Osteoporosis Prevention (2009), an estimated number of 69 million Chinese people are experiencing osteoporosis caused by loss and deterioration of bone mineral density (BMD). Middle-aged women have a greater possibility in developing osteoporosis in comparison with men because of a decreased estrogen level and degeneration in physical fitness level. A Tai Chi-based intervention in the present study will be created based on four components consisting of fall-prevention/balance training, stretching/flexibility training, resistance training (Tai Chi push hand), and strength training. Design: A prospective three-arm parallel randomized controlled trial. Methods: This study will take place in ten community centers in southeast China, and postmenopausal women aged 50–65 years and without menses for 6–12 months will be recruited and randomly assigned into three groups with the allocation ratio of 1:1:1 (n = 50 for each group), including two experimental groups (a traditional Tai Chi group and a modified Tai Chi-based intervention group) and a control group. Participants in the control group will be asked to maintain their original lifestyle during the 12-month intervention period. Participants in the traditional Tai Chi and modified Tai Chi-based intervention groups will experience the traditional Yang-style Tai Chi and receive the modified Tai Chi-based intervention, respectively. The modified Tai Chi-based intervention contains four components: 1) eight Tai Chi based fall-prevention movements; 2) ten Qigong-based stretching/flexibility movements; 3) eight resistance training-based Tai Chi push hand movements; 4) eight Chen style-based Tai Chi movements. For both the experimental groups, study participants will experience four 60-minute Tai Chi training sessions weekly for 12 months. Outcome measures: BMD at multiple musculoskeletal regions is primary outcome measure. Secondary outcome measures include low limb muscle strength, physical function, and reaction time at both upper and low limbs, which will be measured at baseline and 12 months (at the end of the intervention). Discussion: Results of this study will provide preliminary evidence regarding the value of Tai Chi movement as an intervention for attenuating BMD loss in postmenopausal women. Ethics and dissemination: This study protocol was approved by the Institution Review Board of Shanghai Sports University (approval No. 11290502800) and will be performed in accordance with the principles of the Declaration of Helsinki. Patient recruitment started in August 2017. The analysis of primary outcome measures will be completed in October 2018. The estimated study completion date is June 2019. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration: This trial was registered with the Chinese Clinical Trial Registry (registration No. ChiCTR-IOR-15005887) on 27 January 2015.
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Outcomes in obese patients undergoing direct anterior hip replacement: a nonrandomized study
Sophia Stasi, Dimitrios Tzefronis, George Papathanasiou, Michail Sarantis, George A Macheras
April-June 2020, 5(2):25-30
Background and objective: In recent years, there has been growing interest in the minimally invasive surgical techniques used for the performance of total hip arthroplasty (THA). Among these, direct anterior approach–minimally invasive surgery (DAA-MIS) has generated scientific interest because of its soft-tissue–preserving nature. Data from studies involving obese patients in relation to minimally invasive techniques such as DAA-MIS are controversial, while further comparative studies are needed between nonobese and obese patients. The aim of this study was to compare pain levels, functionality and quality of life between obese and nonobese hip osteoarthritic patients who underwent THA via DAA-MIS. Subjects and methods: This nonrandomized study included 60 patients aged > 50 years. Patients were divided into two equal groups according to their body mass index (< 30 kg/m2 vs. ≥ 30 kg/m2). Measurements were recorded prior to surgery and postoperatively (6th and 12th weeks). Pain was measured using the Face Pain Scale–Revised. Functionality was measured with the Timed Up & Go test and the modified Harris Hip Score-Greek version. Quality of life was evaluated using the 12-item International Hip Outcome Tool–Greek version. The protocol of this study was approved by both the Ethics Committee and Scientific Research Council of the “KAT” General Hospital of Attica, Athens, Greece (ref: ΔΣ234/12-03-2019) on March 12, 2019. Results: Six weeks after DAA-MIS, both obese and nonobese patients had significantly less pain (Face Pain Scale-Revised), higher functionality (Timed Up & Go test and modified Harris Hip Score-Greek version) and better quality of life (12-item International Hip Outcome Tool–Greek version), compared to preoperative measurements (P < 0.001). The improvement in all overall outcomes continued, with a further statistically significant difference in the 12th week’s measurements (P < 0.001). There were no statistically significant differences between groups at the 6th and 12th postoperative weeks (P > 0.05). Conclusion: Both obese and nonobese patients benefited from the DAA-MIS procedure. The obesity should not be considered as a contraindication to DAA-MIS in patients undergoing THA. Trial registration: This study analyzes part of data collected for an ongoing larger trial [World Health Organization’s International Clinical Trials Registry Platform (ISRCTN15066737)].
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Safety of intrathecal transplantation of human umbilical cord mesenchymal stem cells for treating hereditary cerebellar ataxia: study protocol for a randomized controlled trial
Yi-hua An
January-March 2016, 1(1):9-16
Background: Intrathecal transplantation of human umbilical cord mesenchymal stem cells (hUCMSCs) has been shown to be effective for treating spinocerebellar ataxia and can improve patient's neurological function to a certain degree without safety concerns. However, further validation by randomized controlled trials is needed. The present study aims to fill this gap. Methods/Design: A single-center, parallel group, open-label, randomized controlled trial will be performed at General Hospital of Chinese Armed Police Forces, China. A total of 100 patients with hereditary cerebellar ataxia will undergo hUCMSC transplantation in the subarachnoid space through lumbar puncture (hUCMSCs transplantation group) or not (control group). The outcome observation time will be designated within 1 week before transplantation, as well as 1, 3, 6, and 12 months after transplantation. Primary outcomes include neurological function evaluation (International Cooperative Ataxia Rating Scale, Modified Falls Efficacy Scale, Berg Balance Assessment, Tremor Rating Scale, and the Timed Up and Go test) and blood tests. Secondary outcomes include electrophysiology examination, mental state evaluation, and urine testing. Discussion: This trial protocol is designed to provide reference data for the safety and rational use of hUCMSC transplantation in the treatment of hereditary cerebellar ataxia. Trial registration: ClinicalTrials.gov identifier: NCT01489267; registered on 30 October 2011. The study protocol has been approved by the ethics committee of the General Hospital of Chinese Armed Police Forces, China (approval No. 201117).
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Potentially Prescriptions Inappropriate (PPIs) in elderly patients in polytherapy: structured discussion on the effect of medication therapy review using evaluation criteria listed in literature on the administrative health care database
Lorella Magnani
January-March 2018, 3(1):22-26
In the last few years numerous evidences have shown an increased prevalence of “Potential Inappropriate Prescriptions (PPIs)” in the elderly (>/=65 years) and have estimated that more than 10% of all hospitalizations in this population are hospitalized for problems consequent to drugs given. The predictive factors more strongly related to the inappropriate use of drugs are polytherapy (>/= 5 drugs contemporary), uncritical application of guidelines in many cases inadequate and built with data from young subjects-adults affected by a single pathology, recommend drug regimens that do not consider the changes in the pharmacokinetics and pharmacodynamics parameters, exposing to significant risks. Considering that polytherapy is any case necessary (due to the effect of comorbidity and longer life expectancy), is unavoidable not acknowledge the impossibility, as much for clinicians as for any guideline all interactions: in this perspective the application of evaluation scientifically based criteria and information technology tools could represent a resource for to tend to prescriptive appropriateness, still a challenge for researchers, clinicians, manager, third-payers. The application of explicit criteria (ex. Beers and STOPP & START) to the administrative data base of pharmaceutical prescriptions could represent a screening too, not only to qualitatively and quantitatively asses PPIs, given immediate availability of information, but above all to create practical support for the clinician’s work by crating “adaptive database” for interactive research for specific conditions. However, regardless of more or less functional software applications, more multidimensional and multidisciplinary efforts (ex. geriatric counseling) are needed to take on problems related to polypharmacy in elderly patients: the most appropriate therapeutic regimen should combine guidelines, geriatric assessment, social and economic considerations, the patient’s will and should be periodically reviewed, especially as the presence of multiple comorbidities increases the risk of adverse reactions.
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Transcutaneous electrical acupoint stimulation with different acupoint combinations on opioid consumption in patients undergoing off-pump coronary artery bypass grafting: study protocol for a randomized double-blind controlled trial
Hui Zhang, Chong Lei, Tao-yuan Zhang, Li-hong Hou, Qiang Wang, Hai-long Dong, Jian-ge Han, Li-ze Xiong
January-March 2016, 1(1):17-24
Background: The demand for improved anesthesia during off-pump coronary artery bypass grafting (OP-CABG) is continually increasing. Ensuring stable hemodynamics and balanced myocardial oxygen supply during OP-CABG are key issues that remain to be resolved. There is evidence that acupuncture anesthesia can decrease mortality after OP-CABG, while reducing the dose of anesthesia required, minimizing surgical complications, and decreasing medical costs. Acupuncture at distal-proximal acupoints in combination is the most commonly used method requiring acupoint compatibility. We hypothesize that electroacupuncture at distal-proximal and regional acupoints prior to OP-CABG will reduce the dosage of anesthesia required during OP-CABG, and minimize postoperative complications. Methods/Design: This prospective, randomized, double-blind, controlled trial will be performed at the Departments of Anesthesiology at Xijing Hospital, Fourth Military Medical University, and Tianjin Chest Hospital, China. A total of 186 patients scheduled for OP-CABG in these two hospitals will be included in the study. The patients will be divided into three groups: distal-proximal acupoints group (acupuncture at the Danzhong (CV17) and Hegu (LI4) acupoints); regional acupoints group (acupuncture at the Danzhong (CV17) and Juque (CV14) acupoints); and non-acupoint group (acupuncture at a site 2 cm lateral from the Danzhong (CV17) and Juque (CV14) acupoints). All interventions will start 30 minutes prior to anesthesia and continue until the beginning of anesthesia. The primary outcome is the dose of sufentanil used for anesthesia. Secondary outcomes are cardiac troponin I content, inotropic score, dose of propofol used for anesthesia, duration of mechanical ventilation, duration of stay in the intensive care unit, length of postoperative hospital stay, incidence of overall complications within 30 days of surgery, and incidence of overall mortality within 30 days of surgery. Adverse events will be also evaluated. Discussion: This trial protocol will determine whether acupuncture at distal-proximal or regional acupoints can reduce anesthetic dose and postoperative complications in OP-CABG surgery, with the purpose of ensuring patient safety in the perioperative phase. Trial registration: ClinicalTrals.gov identifier: NCT02443220; registered on 18 August 2014. Ethical approval: The protocol was approved by the Ethics Committee on Clinical Trials of Drugs, Xijing Hospital, and the Ethics Committee on Clinical Trials, Tianjin Chest Hospital, China. Written informed consent regarding trial procedure and treatment protocol will be obtained from each subject.
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Local administration of enriched mononuclear cells, platelets and zoledronic acid for preventing collapse of the femoral head in the early stage of osteonecrosis: study protocol for a prospective randomized parallel-controlled clinical trial
Ning Ma, Jiang Peng, Quan-yi Guo
January-March 2016, 1(1):32-37
Background: Although there are many treatments for osteonecrosis of the femoral head, conservative treatment is often ineffective. Once collapse of the femoral head occurs, the damage is irreversible. Our previous animal studies have shown that local administration of zoledronic acid prevents collapse of the osteonecrotic femoral head. Additionally, bone marrow mononuclear cell therapy has a good short-term clinical effect on osteonecrosis of the femoral head. Currently, it is unclear whether a combination of bone marrow mononuclear cells and platelet-rich plasma may have efficacy in preventing early-stage collapse of the osteonecrotic femoral head. Methods/Design: A prospective, randomized, parallel-controlled, single-center clinical trial will be completed at the Chinese PLA General Hospital, China. One hundred patients with Ficat I-II osteonecrosis of the femoral head will be recruited and equally randomized into treatment and control groups. The treatment group will be given injection of enriched autologous mononuclear cells and zoledronic acid into the necrotic area following core decompression by drilling. In the control group, core decompression by drilling will be done, but no treatment will be given. Patients will be followed up at 3, 6, 12 and 18 months. Dynamic perfusion MR imaging, three-dimensional CT reconstruction, and anteroposterior and lateral X-ray observations of the hip joint will be performed to observe blood supply, bone formation and femoral appearance in the necrotic area. Harris score of the hip joint and a numeric rating scale score will be used to evaluate hip function and pain. These indicators will be used as primary outcome measures. Scores from the 36-Item Short-Form Health Survey and activity of daily living scale will be used as secondary outcome measures. Discussion: The outcomes of this trial will provide quantitative data and related information for evaluating the efficacy of local administration of enriched bone marrow mononuclear cells, platelets and zoledronic acid for the clinical prevention of collapse of the early-stage osteonecrotic femoral head. Trial registration: ClinicalTrial.gov identifier: NCT02721940. Written approval for this protocol was obtained from the ethics committee of the Chinese PLA General Hospital in China (approval No. S2015-082-01).
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Oxidative stress response in patients with severe aortic stenosis undergoing transcatheter or surgical aortic valve replacement: protocol for a prospective observational study
Gabriel Maluenda, Nick Curzen, Michael Mahmoudi
October-December 2016, 1(4):149-153
Background: Myocardial ischemia and reperfusion injury mediated by reactive oxygen species (ROS) related to cardiopulmonary bypass has been linked to adverse clinical outcomes following cardiac surgery. The generation of ROS and its clinical impact in patients undergoing transcatheter aortic valve replacement (TAVR) have not been studied. Methods/Design: This is a prospective observational study that will compare the generation of ROS between 12 consecutive patients undergoing TAVR and 12 patients undergoing isolated surgical aortic valve replacement (SAVR) and will determine whether any potential differences are related to the 3-month composite endpoints of cardiovascular mortality, myocardial infarction, stroke, major bleeding or life threatening bleeding. Peripheral blood will be taken immediately before aortic intervention, at the completion of the procedure, 6-8 hours after the procedure, and 24 hours after the procedure for measurements of ROS. Clinical follow-up at 3 months post discharge will be undertaken either in the outpatient clinic or by telephone. Discussion: This study will determine changes in the levels of ROS in patients undergoing TAVR and identify whether any potential changes are correlated with clinical outcomes. Trial registration: ClinicalTrials.gov identifier: NCT02841917; registered on December 29, 2015. Ethics: The study protocol has been approved by the RES Committee North West Liverpool East (IRAS Project ID: 206946). Informed consent: Signed informed consent will be obtained from each patient who wishes to participate in this study.
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