Randomized, controlled trial of TNF-α antagonist in CTL-mediated severe cutaneous adverse reactions

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points

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Efficacy and Safety of Xiaoyao Pills for Mild to Moderate Depression With Syndrome of Liver Stagnation and Spleen Deficiency: Study Protocol for a Randomized Controlled Trial

10.21203/rs.3.rs-449004/v1 ◽

2021 ◽

Author(s):

Zhe Xue ◽

Zhen Huang ◽

Shu-li Cheng ◽

Xi-hong Wang ◽

Xuan Zhou ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Chinese Medicine ◽

Traditional Chinese Medicine ◽

Adverse Reactions ◽

Controlled Trial ◽

Secondary Outcome ◽

Efficacy And Safety ◽

Spleen Deficiency ◽

Randomized Controlled ◽

Moderate Depression

Abstract Background: Depression is one of the most frequent and severe psychiatric conditions. Many chemical drugs to treat depression are associated with adverse reactions and have shortcomings. Traditional Chinese medicine is of great significance in the prevention and treatment of depression. Xiaoyao pills has achieved good results in clinical application, which has the advantages of quick effect and no obvious adverse reactions. The aim of our study is to evaluate the efficacy and safety of Xiaoyao pills on mild to moderate depression patients with syndrome of liver stagnation and spleen deficiency.Methods: This study is a multi-center, double-blinded, randomized and placebo-controlled clinical trial. A total of 108 participants will be assigned to three groups: Xiaoyao pill group taking Xiaoyao pills twice daily for 4 weeks, placebo group taking placebos twice daily for 4 weeks and normal group without taking any drug. The primary and secondary outcome measures are the Hamilton Depression Scale (HAMD) and Traditional Chinese Medicine (TCM) Syndrome Scale. The assessment is at baseline(before treatment initiation), 1 week, 2 weeks 4 weeks after the first treatment. Exploratory outcome is also assessed to explore the mechanism of Xiaoyao pills at baseline and 4 weeks.Discussion: The results from this study will provide clinical evidence on the efficacy and safety of Xiaoyao pills in patients with mild to moderate depression with syndrome of liver stagnation and spleen deficiency.Trial registration: International Standard Randomized Controlled Trial Number Register: ISRCTN12746343. Registered on September 25, 2020.

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Effectiveness of analgesia with hydromorphone hydrochloride for postoperative pain following surgical repair of structural congenital malformations in children: a randomized controlled trial

BMC Anesthesiology ◽

10.1186/s12871-021-01412-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Yongying Pan ◽

Yimin Wang ◽

Dongxu Lie ◽

Di Liu ◽

Xi Chen ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Postoperative Pain ◽

Congenital Malformation ◽

Postoperative Analgesia ◽

Adverse Reactions ◽

Pediatric Patients ◽

Surgical Repair ◽

Controlled Trial ◽

Randomized Controlled

Abstract Background Effective postoperative analgesia is needed to prevent the negative effects of postoperative pain on patient outcomes. To compare the effectiveness of hydromorphone hydrochloride and sufentanil, combined with flurbiprofen axetil, for postoperative analgesia in pediatric patients. Methods This prospective randomized controlled trial included 222 pediatric patients scheduled for repair of a structural congenital malformation under general anesthesia. Patients were randomized into 3 groups: hydromorphone hydrochloride 0.1 mg/kg (H1), hydromorphone hydrochloride 0.2 mg/kg; (H2) or sufentanil 1.5 µg/kg (S). Analgesics were diluted in 0.9% saline to 100 ml and infused continuously at a basic flow rate of 2 mL per h. The primary outcome measure was the Face, Legs, Activity, Cry, and Consolability (FLACC) pain score. Secondary outcomes included heart rate (HR), respiration rate (RR), SpO2, Ramsay sedation scores, scores on the Paediatric Anaesthesia Emergence Delirium (PAED) scale, adverse reactions, parent satisfaction with analgesia. Results The FLACC score was significantly lower in H1 and H2 groups compared to S. The Ramsay sedation score was significantly higher in H1 and H2 groups compared to S. Recovery time was shorter in H1 group compared to patients H2 group or S group. There were no significant differences in the PAED scale, HR, RR, SpO2, adverse reactions, satisfaction of parents with analgesia, or length and cost of hospital stay. Conclusions Hydromorphone hydrochloride is a more effective analgesic than sufentanil for postoperative pain in pediatric patients following surgical repair of a structural congenital malformation, however, hydromorphone hydrochloride and sufentanil had similar safety profiles in this patient population. Trial registration Chinese Clinical Trial Register ChiCTR-INR-17013935). Clinical trial registry URL: Date of registration: December 14, 2017.

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A Randomized Controlled Trial of Anti-TNF α Bio-similar Adalimumab vs. Prednisolone in the Management of Leprosy Patients with New Type 1 Lepra Reaction

Open Forum Infectious Diseases ◽

10.1093/ofid/ofx163.1805 ◽

2017 ◽

Vol 4 (suppl_1) ◽

pp. S675-S675 ◽

Cited By ~ 1

Author(s):

Debdeep Mitra

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Randomized Controlled ◽

Tnf Α ◽

Leprosy Patients ◽

New Type

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Dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke: a single-blind, two-arm parallel group, randomized controlled feasibility trial

Clinical Rehabilitation ◽

10.1177/0269215519840403 ◽

2019 ◽

Vol 33 (8) ◽

pp. 1331-1343 ◽

Cited By ~ 3

Author(s):

Jacqui H Morris ◽

Alexandra John ◽

Lucy Wedderburn ◽

Petra Rauchhaus ◽

Peter T Donnan

Keyword(s):

Randomized Controlled Trial ◽

Action Research ◽

Confidence Interval ◽

Odds Ratio ◽

Adverse Reactions ◽

Controlled Trial ◽

Randomized Controlled ◽

Arm Rehabilitation ◽

Parallel Group ◽

Single Blind

Objective: The aim of this study was to explore the feasibility of conducting a randomized controlled trial of dynamic Lycra® orthoses as an adjunct to arm rehabilitation after stroke and to explore the magnitude and direction of change on arm outcomes. Design: This is a single-blind, two-arm parallel group, feasibility randomized controlled trial. Setting: In-patient rehabilitation. Subjects: The study participants were stroke survivors with arm hemiparesis two to four weeks after stroke receiving in-patient rehabilitation. Interventions: Participants were randomized 2:1 to wear Lycra® gauntlets for eight hours daily for eight weeks, plus usual rehabilitation ( n = 27), or to usual rehabilitation only ( n = 16). Main measures: Recruitment, retention, fidelity, adverse events and completeness of data collection were examined at 8 and 16 weeks; arm function (activity limitation; Action Research Arm Test, Motor Activity Log) and impairment (Nine-hole Peg Test, Motricity Index, Modified Tardieu Scale). Structured interviews explored acceptability. Results: Of the target of 51, 43 (84%) participants were recruited. Retention at 8 weeks was 32 (79%) and 24 (56%) at 16 weeks. In total, 11 (52%) intervention group participants and 6 (50%) control group participants (odds ratio = 1.3, 95% confidence interval = 0.2 to 7.8) had improved Action Research Arm Test level by 8 weeks; at 16 weeks, this was 8 (61%) intervention and 6 (75.0%) control participants (odds ratio = 1.1, 95% confidence interval = 0.1 to 13.1). Change on other measures favoured control participants. Acceptability was influenced by 26 adverse reactions. Conclusion: Recruitment and retention were low, and adverse reactions were problematic. There were no indications of clinically relevant effects, but the small sample means definitive conclusions cannot be made. A definitive trial is not warranted without orthoses adaptation.

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Effect of Almond Consumption on Metabolic Risk Factors—Glucose Metabolism, Hyperinsulinemia, Selected Markers of Inflammation: A Randomized Controlled Trial in Adolescents and Young Adults

Frontiers in Nutrition ◽

10.3389/fnut.2021.668622 ◽

2021 ◽

Vol 8 ◽

Author(s):

Jagmeet Madan ◽

Sharvari Desai ◽

Panchali Moitra ◽

Sheryl Salis ◽

Shubhada Agashe ◽

...

Keyword(s):

Risk Factors ◽

Randomized Controlled Trial ◽

Young Adults ◽

Fasting Glucose ◽

Controlled Trial ◽

Adolescents And Young Adults ◽

Control Group ◽

Post Intervention ◽

Randomized Controlled ◽

Tnf Α

A large percentage of the Indian population has diabetes or is at risk of pre-diabetes. Almond consumption has shown benefits on cardiometabolic risk factors in adults. This study explored the effect of almond consumption on determinants of metabolic dysfunction—blood glucose, lipids, insulin and selected inflammatory markers in adolescents and young adults aged 16–25 years from Mumbai city. This randomized controlled trial was conducted for a period of 90 days on individuals with impaired levels of fasting glucose levels between 100–125 mg/dL (5.6–6.9 mmol/L) and 2-h post-glucose value 140–199 mg/dL (7.8–11.0 mmol/L) and/or fasting insulin (≥15 mIU/ml)/stimulated insulin (≥80 mIU/ml). Of 1,313 individuals screened, 421 met the inclusion criteria, of which 275 consented to participate and 219 completed the trial. The trial was registered with Clinical Trials Registry India (CTRI) CTRI/2018/02/011927. The almonds group (n = 107) consumed 56 g almonds daily, the control group (n = 112) was provided an iso-caloric cereal-pulse based snack. At baseline and endline, blood glucose, insulin, HbA1c, LDL-c, HDL-c, total and ox-cholesterol, triglycerides, hs-CRP, IL-6, TNF-α, adiponectin, leptin were measured and HOMA-IR and FG:FI ratios were calculated. Dietary intakes were assessed. The anthropometric measurements, biochemical markers as well as macronutrient intakes did not differ significantly between the two groups at baseline. Almond consumption significantly decreased HbA1c, total cholesterol and LDL-c. Stimulated insulin decreased post-intervention in both groups, but the decrease was greater in the almonds group. Fasting glucose was reduced post intervention in the controls with no change in the almonds group. FG:FI ratio decreased in the almonds group. TNF-α and IL-6 decreased in the almonds group, while it increased in the control group. Our results showed that almonds reduced HbA1c, LDL-c and total cholesterol levels in just 12 weeks of consumption in these adolescents and young adults who were at risk for developing diabetes. Almonds can be considered as part of food-based strategies for preventing pre-diabetes.Clinical Trial Registration:ClinicalTrials.gov, identifier: CTRI/2018/02/011927.

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Potential mechanisms underpinning aerobic exercise-induced analgesia in primary dysmenorrhea: a controlled non-randomized pilot trial

10.21203/rs.2.15666/v1 ◽

2019 ◽

Author(s):

Priya Kannan ◽

Kwok-Kuen Cheung ◽

Chan Sheung Chi ◽

Lam King Yan ◽

Law Yee Xi ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Aerobic Exercise ◽

Controlled Trial ◽

Exercise Group ◽

Control Group ◽

Primary Dysmenorrhea ◽

Beneficial Effects ◽

Randomized Controlled ◽

Tnf Α ◽

Exercise Induced

Abstract BackgroundAerobic exercise has been shown to alleviate the pain of primary dysmenorrhea in several studies however, no study has yet identified the physiological mechanisms underlying the beneficial effects of aerobic exercise-induced pain relief in primary dysmenorrhea. The objectives of the study are: (1) To evaluate the feasibility of the protocol for a randomized controlled trial to investigate the physiological mechanisms underlying the beneficial effects of aerobic exercise on the pain associated with primary dysmenorrhea and (2) to obtain preliminary results (effect size) to estimate the sample size for the future randomized controlled trial.MethodsTwenty women aged 18–29 years were divided into two groups (high-intensity aerobic-exercise group and no-exercise control group) in a 1:1 ratio. Women assigned to the exercise group performed high-intensity treadmill-based aerobic exercise for three days a week, at 70–85% of maximum heart rate for 30 minutes for 4 weeks. The control group did not receive trial intervention but provided blood for estimation of plasma variables. Blood plasma levels of progesterone, metabolites of prostaglandin (PG) F2-alpha (13,14-dihydro-15-keto-prostaglandin F2 alpha [KDPGF2α]) and PGE2 (13,14-dihydro-15-keto-prostaglandin E2 [KDPGE2]), and tumor necrosis factor-alpha (TNF-α) were measured at 4-weeks post-intervention.ResultsWith respect to feasibility outcomes, 90% of the required number of participants were recruited in 3-4 weeks. Adherence to the intervention was 97% and the retention rate was 90%. There was an increase in progesterone levels (d = 0.36) and decreases in KDPGF2α (d = 0.35), KDPGE2 (d = 0.47), and TNF-α (d = 0.33) from baseline to week 4 in the exercise group compared with the control group.ConclusionThe study methodology appears to be feasible for conducting a full-scale randomized controlled trial. The findings indicated a trend towards an increase in progesterone levels and decreases in inflammatory pain mediators, including KDPGF2α, KDPGE2, and TNF-α, in the exercise group compared with the control group, suggesting the possibility that aerobic exercise may be effective for primary dysmenorrhea via its influence on progesterone and inflammatory pain mediators. Trial Registration Our trial is registered in the Australian New Zealand Clinical Trials Registry (ACTRN12618000784213). The date of registration is 09 May 2018. Trial registration was completed prior to enrollment of the first participant.

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