Efficacy of adipose-derived stromal vascular fraction cells in the management of chronic ulcers: a randomized clinical trial

2021 ◽  
Author(s):  
Emil Tanios ◽  
Tohamy M Ahmed ◽  
Engy A Shafik ◽  
Mahmoud Farouk Sherif ◽  
Douaa Sayed ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Stromal Vascular Fraction ◽  
Treatment Method ◽  
Control Group ◽  
Study Group ◽  
Clinical Trial Registry ◽  
Ethical Committee Approval ◽  
Chronic Ulcers ◽  
And Control

Background: Cell therapy is a promising method for improving healing in chronic ulcers through delivery of isolated adipose-derived stromal vascular fraction. Objectives: This study investigates the autologous stem cell yield of adipose tissue and its efficacy in chronic ulcers compared with conventional methods. Methods: This study was a randomized controlled trial. After the study design and protocol were established and ethical committee approval was obtained, we enrolled 100 patients divided into study and control groups. In the study group, we performed debridement and autologous stem cells injection every 3 weeks. The control group was treated with debridement and conventional dressing. Assessments included clinical and histological parameters. Results: The study group showed improved healing. Conclusion: Using autologous adipose-derived stromal vascular fraction cells is an effective treatment method for chronic ulcers. This study was registered on the Pan-African Clinical Trial Registry and the number of the registry was PACTR201709002519185 .

scholarly journals Cryotherapy Reduced Postoperative Pain in Gynecologic Surgery: A Randomized Controlled Trial

2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
Apisada Chumkam ◽  
Densak Pongrojpaw ◽  
Athita Chanthasenanont ◽  
Junya Pattaraarchachai ◽  
Kornkarn Bhamarapravatana ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Statistical Difference ◽  
Controlled Trial ◽  
Exploratory Laparotomy ◽  
Gynecologic Surgery ◽  
Control Group ◽  
Study Group ◽  
Control Groups ◽  
Vas Score ◽  
And Control

Objective. To examine the effectiveness of cryotherapy for reducing postoperative pain in patients who underwent exploratory laparotomy for gynecologic surgery. Materials and Methods. Patients who had indication for an exploratory laparotomy gynecologic procedure were selected by attending physicians to undergo abdominal surgery via low transverse skin incision. The participants were randomized into study and control groups with simple random sampling methods. Cold packs were applied at two hours after operation for 6 hours. The visual analog scale (VAS) score was recorded at two, 6, and 12 hours after operation. Result. One hundred cases were recruited and then divided into study and control groups equally. The mean age of both groups was 43 years. There was no difference in demographics data of both groups. Half of the participants in both groups underwent hysterectomies. At two hours after surgery, both groups had similar VAS scores. The study group had a lower VAS score at 6 and 12 hours after surgery than the control group with statistical difference. Morphine consumption within 24 hours after surgery in both the study and control groups was 2.8±3.4 and 3.0±4.4 mg, respectively, with no statistical difference. However the registration time of the first morphine requirement in the study group was statistically more prolonged than that of the control group. The lengths of hospital stay in both groups were similar. There was no complication reported in this study. Conclusion. Cryotherapy can reduce postoperative pain. In this presented study the patients who underwent gynecologic surgery had improved pain relief and prolonged time for the first dose of the analgesic drug.

scholarly journals Efficacy and safety of Jie-du-qing-nao granules for first-episode schizophrenics: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Ziyan Li ◽  
Yanzhe Ning ◽  
Pei Chen ◽  
Yi Zhang ◽  
Dongqing Yin ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Complete Blood Count ◽  
Controlled Trial ◽  
First Episode ◽  
Control Group ◽  
Study Group ◽  
Efficacy And Safety ◽  
Clinical Trial Registry ◽  
Symptom Scale ◽  
Double Blind

Abstract BackgroundAt present, the focus and difficulty of schizophrenia (SCZ) treatment is to improve cognitive function and negative symptoms. Jie-du-qing-nao granules(JQG) , a traditional Chinese medicine(TCM) prescription , has a good clinical effectiveness in enhancing the cognition and negative symptoms of patients with SCZ. However, its clear effectiveness and safety have not been adequately supported by clinical studies. The main objective of this study is to explore the efficacy and safety of JQG for first-episode schizophrenics.Methods/designThis trial is a prospective, randomized, single-centered, parallel-controlled clinical study with double-blind design. A total of 96 eligible participants will be randomly assigned to either the study group or the control group in a ratio of 1:1. Participants allocated to the study group will receive JQG and aripiprazole, control group will receive placebo and aripiprazole. The treatment course will last 12 weeks, with follow-up every 4 weeks. Outcome measurements include Positive and Negative Syndrome Scale (PANSS), self face test , MATRICS Consensus Cognitive Battery (MCCB), TNFα, IL-6, IL-1β, BDNF, vital signs, complete blood count, liver and kidney function tests, urinalysis, and electrocardiograph. Adverse reactions will be evaluated using the Treatment Emergent Symptom Scale (TESS).DiscussionThis study will provide evidence for the efficacy and safety of JQG as a complementary approach, which can be initiated following with antipsychotics therapy. Trial registration Chinese Clinical Trial Registry, ID: ChiCTR1900028250 . Registered on December 16, 2019, http://www.chictr.org.cn/edit.aspx?pid=41880&htm=4 .

scholarly journals Breast Microecology Improvement Using Probiotics Following Needle Aspiration in Patients With Lactational Breast Abscess: a Multi-center Randomized Double-blind Controlled Trial

2021 ◽  
Author(s):  
Yi Zhang ◽  
Yajun Gao ◽  
Jing Qin ◽  
Xiaoting Li ◽  
Fei Jiang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Reaction Rates ◽  
Needle Aspiration ◽  
Healing Time ◽  
Control Group ◽  
Cure Rate ◽  
Control Groups ◽  
Clinical Trial Registry ◽  
Double Blind ◽  
And Control

Abstract Background: Studies show that oral probiotics can improve the breast microecology and thus alleviate the inflammatory response; however, there is a lack of experimental data corresponding to cases with existing abscesses. We aimed to investigate the effect of Lactobacillus fermentum CECT5716 during needle aspiration in patients with lactational breast abscesses.Methods: Patients (aged 20–41 years) with lactational single-cavity breast abscesses (diameter 3–6 cm) from 12 hospitals were randomly assigned to the experimental (n=51) and control groups (n=50). Outcome measures included the abscess cure rate on day-5 of treatment, delactation rate, relieving pain rate, and the number of needle aspirations until day-28.Results: The experimental group’s 5-day cure rate (43.1%, 22/51) was significantly higher (p<0.05). The breastfeeding continuation on day-5 did not differ significantly (experimental group: 88.2%, 45/51; control group: 96.0%, 48/50; p=0.269). In the experimental and control groups, 19.6% and 14.0% of patients experienced moderate to severe pain on day-5, respectively, with no statistically significant differences (p=0.451). The median number of needle aspirations up to day-28 was two in the experimental (1–3 times) and control (1–4 times) groups, with no statistically significant differences (Mann–Whitney U test, p=0.322). Four patients in each group developed diarrhea, with adverse reaction rates of 7.84% (4/51) and 8.0% (4/50), respectively. No adverse reactions were reported in the infants.Conclusion: L. fermentum can shorten the healing time in patients with lactational breast abscesses.Trial registration: This study was registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn), registration number: ChiCTR2000032682, registration date: May 6, 2020.

scholarly journals Stuck-moving Needle acupuncture the Myofascial Triggers Point to treat Idiopathic Frozen Shoulders: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
YANG BAI ◽  
Ying Wang ◽  
Bo Chen ◽  
Qianqian Lei ◽  
Hailong Zhao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Frozen Shoulder ◽  
Baseline Period ◽  
Control Group ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Randomized Controlled ◽  
Needle Acupuncture

Abstract Background There are evidences for the efficacy of acupuncture treatment for chronic shoulder pain, however it remains unclear the best acupuncture modes for effective treatment. We compared the effect of myofascial trigger point (MTrp) Stuck-moving Needle acupuncture with that of common acupuncture treatments. Further, we evaluated the efficacy and safety of stuck-moving needle acupuncture for the MTrp in improving pain and range of motions in patients with idiopathic frozen shoulder. The ultimate aim of the study is to select an effective therapy for patients with idiopathic frozen shoulder. Methods Randomized controlled trial will be conducted in the 3 clinical centers of Qingyang Traditional Chinese Medicine Hospital, Qingyang Xifeng district People's Hospital and Qingyang Second People's Hospital in China from February 2020 to January 2021. One-hundred and eight frozen shoulder patient will be recruited and randomized into one of three groups in a 1:1:1 ratio of the Stuck-moving Needle acupuncture group, Common acupuncture control group and physical exercise control group. This trial will include a 1-week baseline period, a 3-weeks of treatment period, and a 12-weeks of follow-up period. During the 3-weeks of treatment period, patients will receive 9 sessions of acupuncture. The primary outcome will be related to change in the Visual Analogue Scale (VAS) and Measurement of range of joint motion (ROM) from baseline period to the 12-week follow-up period. Secondary outcome measures will include, measurement of Pressure Pain Threshold (PPT), Pressure Pain Tolerance (PTT) Oxford Shoulder Score (OSS), 36-item Short Form survey and Patient satisfaction evaluation. Adverse events also will be recorded for safety assessment. Discussion The results of this trial will allow us to compare the difference in efficacy between Stuck-moving Needle acupuncture MTrP with that of common acupuncture treatments. The findings from this trial will be published in the peer-reviewed journals. Trial registration: Acupuncture-Moxibustion Clinical Trial Registry (ChiMCTR1900002862) and Chinese Clinical Trial Registry (ChiCTR1900028452). registered on 22, Dec. 2019

scholarly journals Tianwang Buxin Granules Influence the Intestinal Flora in Perimenopausal Insomnia

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).

scholarly journals TELENURSING FOR THE CONTROL OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING: A RANDOMIZED CLINICAL TRIAL

2019 ◽  
Vol 28 ◽  
Author(s):  
Andressa Carneiro França ◽  
Andrea Bezerra Rodrigues ◽  
Maria Isis Freire de Aguiar ◽  
Renan Alves Silva ◽  
Fernanda Macedo Cartaxo Freitas ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Nursing Intervention ◽  
Nausea And Vomiting ◽  
Rank Test ◽  
Control Group ◽  
Telephone Intervention ◽  
Clinical Trial Registry ◽  
Experimental Group ◽  
Antineoplastic Chemotherapy

ABSTRACT Objective: to verify the effectiveness of telenursing in the control of nausea and vomiting induced by antineoplastic chemotherapy. Method: a randomized controlled trial of 61 cancer patients undergoing outpatient chemotherapy treatment, randomized into experimental group and control group. Nausea and vomiting were evaluated by the instrument Multinational Association on Supportive Care in Cancer. The telephone intervention was performed four times after chemotherapy. To verify the effects of this on the variables, the Mann-Whitney test and Student's t-test were used. Wilcoxon signed-rank test was applied to confirm the hypothesis of differences in the pre- and post-test intragroup scores. Results: the groups were homogeneous regarding sociodemographic and clinical characteristics. The experimental group showed a statistically significant reduction in the occurrence of nausea (p=0.0089), in the degree of nausea, in two moments, between 24 hours and three days, and three days and five days (p=0.007 and p=0.009, respectively), in the occurrence of vomiting (p=0.008) and in the number of vomiting episodes (p=0.020). Conclusion: telephone intervention is a potential nursing intervention to reduce nausea and vomiting associated with antineoplastic chemotherapy. Brazilian Clinical Trial Registry: RBR-6s8qm5.

scholarly journals Pain in full term newborns submitted to music and swaddling during venipunctures

Rev Rene ◽  
2020 ◽  
Vol 21 ◽  
pp. e43904
Author(s):  
Tamires Rebeca Forte Viana Viana ◽  
Gleicia Martins de Melo ◽  
Maria Vera Lucia Moreira Leitão Cardoso ◽  
Paulo César de Almeida ◽  
Lusiana Moreira de Oliveira ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Heart Rate ◽  
Control Group ◽  
Coding System ◽  
Clinical Trial Registry ◽  
Pain Scores ◽  
Term Newborns ◽  
Initial Recovery ◽  
And Control ◽  
Experimental Group

Objective: to compare pain scores in term newborns submitted to music and swaddling interventions during venipuncture. Methods: pilot study of a clinical trial, carried out with 11 newborns in rooming-in care who received venipunctures. The newborns were randomly allocated into two groups: Experimental (20 minutes of music + swaddling) and Control (swaddling). Newborns were filmed and pain was assessed by the Neonatal Facial Coding System at baseline, procedure, and initial recovery phases. Results: the Experimental Group at baseline, procedure (antisepsis, puncture, and milking), and recovery showed less pain reactions and lower heart rate mean and variation (p<0.05) than the Control Group. Conclusion: newborns who received the intervention of music combined with swaddling had less pain reactions and less variations in heart rate during venipuncture. Brazilian Clinical Trial Registry: RBR-8x8v2r.

A prospective, multicenter, randomized clinical trial of UGT1A1 promoter polymorphism for irinotecan dose escalation in metastatic colorectal cancer patients treated with bevacizumab plus FOLFIRI as the first-line setting (PURE FIST).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 625-625
Author(s):  
Jaw-Yuan Wang
Keyword(s):  
Colorectal Cancer ◽  
Clinical Trial ◽  
Metastatic Colorectal Cancer ◽  
Dose Escalation ◽  
Control Group ◽  
Study Group ◽  
First Line ◽  
Line Setting ◽  
And Control ◽  
Irinotecan Dose

625 Background: The polymorphisms of genes encoding drug-metabolizing enzymes can play a crucial role in the increased susceptibility of patients to chemotherapy. This study is a prospective, multicenter, randomized clinical trial to compare the clinical outcomes and adverse events in metastatic colorectal cancer (mCRC) patients treated with bevacizumab plus 5-fluorouracil/leucovorin/irinotecan (FOLFIRI) with or without UGT1A1genotyping and irinotecan dose escalation as the first-line setting (NCT02256800). Methods: The enrolled patients were randomly assigned to one of two groups on the basis of receiving UGT1A1 genotyping or not. The study group receives a biweekly FOLFIRI plus bevacizumab, with irinotecan dose escalation based on UGT1A1 genotyping; whereas the control group receives the conventional biweekly FOLFIRI plus bevacizumab without UGT1A1 genotyping. The primary endpoint was the overall response rate (ORR), and the second endpoint was progression-free survival (PFS), overall survival (OS) and toxicities between the two groups. Results: BetweenAugust 2013 and May 2016, eighty-eight mCRC patients were enrolled, including 45 patients in the study group and 43 patients in the control group. With a median follow up time of 12.5 months (range, 5-30), the ORR was 71.4% vs. 44.2% ( P = 0.011). The PFS was 14.04 ± 1.44 vs. 9.08 ± 0.58 months in study group and control group ( P = 0.195), OS was 19.12 ± 1.24 vs. 14.16 ± 1.04 months ( P = 0.098), and ≥ Gr. III anemia was 2.2% vs. 23.3% ( P= 0.002) in study group and control group, respectively. However, there were no significant differences in ≥ Gr. III leukopenia or diarrhea even though the 1.36 fold relative dose intensity (RDI) in the study group. Conclusions: In the current study, patients with mCRC undergoing UGT1A1 genotyping may receive escalated doses of irinotecan for a potentially more favorable clinical response and outcome, in addition to acceptable toxicities. Such a personalized medicine based on genotyping may be feasible for potentially clinical practice. Clinical trial information: NCT02256800.

Influence of Short-Term Conservative Treatment Using Kinesiotape On Hallux Valgus Angle

2021 ◽  
Author(s):  
Mohamed Ahmed ◽  
Magdy Gharib ◽  
Mahmoud Moustafa ◽  
Mohammed Qasheesh
Keyword(s):  
Conservative Treatment ◽  
Hallux Valgus ◽  
Controlled Trial ◽  
Exercise Program ◽  
Metatarsophalangeal Joint ◽  
Lymphatic Drainage ◽  
Control Group ◽  
Study Group ◽  
Clinical Trial Registration ◽  
And Control

Abstract Background: Hallux Valgus HV was first proposed as a common pathologic condition affecting the great toe. The mechanism behind it is yet unknown. It has an impact on one's quality of life and ability to perform since it alters the mechanics of the foot and causes pain. conservative treatment is crucial. Kinesiotape (KT) has been demonstrated to be challengeable, cost-effective, and effective tool for restoring muscle function and strength, improving range of motion, reducing discomfort, and increasing lymphatic drainage, as well as having a mechanical correction effect. Objective: The purpose of this study was to investigate the influence of 8 weeks KT for HV-on-HV angle (HVA) and subsequently on pain.Design: pretest posttest control group randomized controlled trial.Subjects: Thirty HV patients their mean age 29.07 ±6.3 years.Methods: Patients were assigned randomly to study(A) and control(B) groups, study group received KT for HV which is replaced every 5 days for 8 weeks, and home regular exercise program for HV, control group received placebo KT replaced every 5 days and the same exercise program for HV, HVA was measured using x-ray pre and post taping also pain intensity was measured using visual analogue scale (VAS) Results: HVA showed a significant reduction in study group (p = 0.001) for right and left feet while non-significant reduction occurred in control group (p = 0.11 for right foot, p = 0.09 for left foot, while pain showed significant improvement in both study and control groups in both feet (p = 0.001). Conclusion: The results of this study revealed that KT in mobile hallux valgus for 8 weeks is effective on improving the metatarsophalangeal joint angle, decreasing pain, and hence may has positive functional impact in patients with hallux valgus.Clinical trial registration: retrospectively registered 5th of DEC. (NCT05165134)

scholarly journals "Heterozygous Treatment" Method to Improve the Biased Status of the Damp-heat Constitution and Symptom Integral: Randomized Controlled Trial

2018 ◽  
Vol 1 (1) ◽  
pp. 33
Author(s):  
Xianbing Hou ◽  
Haizhang Wang ◽  
Yanzhen Huo ◽  
Hui Zhao
Keyword(s):  
Clinical Symptoms ◽  
Controlled Trial ◽  
Treatment Method ◽  
Control Group ◽  
Observation Group ◽  
Randomized Controlled ◽  
Dark Urine ◽  
Significant Difference ◽  
Before And After ◽  
And Control

Objective: To observe the clinical effect of "heterozygous treatment" intervening the damp-heat constitution. Method: 106 cases with damp-heat constitution were randomly divided into the observation group and control group, 53 cases for each group. Lianpu drink was given to the two groups, and the observation group was treated with scraping, acupuncture, cupping, constitution care and popularization of constitution science for "heterozygous treatment" based on the control group. 70 days later, "constitution classification and determination table of traditional Chinese medicine" was used to determine, and statistics was applied to analyze the change of the symptoms of the two groups before and after the intervention. Results: in the observation group, compared to before the intervention, symptoms like dirty and oily complexion, yellow greasy tongue, bitter taste, dullness and scanty dark urine were significantly improved (P < 0.05), and improvement of the above symptoms was greater than the control group (P < 0.05) .Conclusion: There is no significant difference between the two groups (P > 0.05). Conclusion: the "heterozygous treatment" method can significantly improve the clinical symptoms of people with damp-heat constitution, with a better role in regulating.

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