scholarly journals A Phase I Randomized Placebo Controlled Trial of the Safety of 3% SPL7013 Gel (VivaGel®) in Healthy Young Women Administered Twice Daily for 14 Days

PLoS ONE ◽  
2011 ◽  
Vol 6 (1) ◽  
pp. e16258 ◽  
Author(s):  
Craig R. Cohen ◽  
Joelle Brown ◽  
Anna-Barbara Moscicki ◽  
Elizabeth A. Bukusi ◽  
Jeremy R. A. Paull ◽  
...  
Keyword(s):  
Phase I ◽  
Young Women ◽  
Controlled Trial

Effects of omega-3 supplementation on muscle damage after resistance exercise in young women: a randomized placebo-controlled trial

2021 ◽  
pp. 026010602110222
Author(s):  
Letícia Chisini Loss ◽  
Diane Benini ◽  
Felipe Xavier de Lima-e-Silva ◽  
Gabriella Berwig Möller ◽  
Luiza Rissi Friedrich ◽  
...  
Keyword(s):  
Fish Oil ◽  
Resistance Exercise ◽  
Muscle Damage ◽  
Young Women ◽  
Muscle Soreness ◽  
Controlled Trial ◽  
Omega 3 ◽  
Significant Group ◽  
Balanced Diet ◽  
Strength Capacity

Background: Omega-3 is a nutritional strategie that have been used to recover muscles from exercise-induced muscle damage in a preventive perspective. Aim: To verify whether omega-3 (ω-3) supplementation after a session of resistance exercise facilitates muscle recovery in women undergoing a balanced diet. Methods: This clinical trial was registered under the number NCT02839525. Thirty healthy women (22.2 ± 3.3 years) participated in this double-blinded, placebo-controlled trial. They were randomly distributed into ω-3 ( n=15) and placebo ( n=15) groups. They ingested ω-3 fish oil (3200 mg/day) or placebo (olive oil) at the dinner after the exercise bout (10 sets of 10 unilateral eccentric contractions in a knee extension chair), as well as at lunch for the three subsequent days. In addition, both groups followed a balanced diet along the four days. Muscle soreness and maximal isometric and isokinetic voluntary contractions were assessed immediately before, and 24, 48, and 72 hours after the resistance exercise. Main findings: There was no significant group-time interaction for any outcome. Participants presented increased levels of muscle soreness and reduced muscle strength capacity along the three days after exercise. There was no difference between placebo and ω-3 groups. Conclusion: Supplementation of ω-3 fish oil for three days after resistance exercise provided no additional benefits compared to placebo supplementation on recovery of healthy young women following a balanced diet.

A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems

Vaccine ◽  
2011 ◽  
Vol 29 (48) ◽  
pp. 8974-8981 ◽  
Author(s):  
Alexander R. Precioso ◽  
João L. Miraglia ◽  
Lúcia Maria A. Campos ◽  
Alessandra C. Goulart ◽  
Maria do Carmo S.T. Timenetsky ◽  
...  
Keyword(s):  
Phase I ◽  
Influenza A ◽  
Controlled Trial ◽  
Double Blind ◽  
Influenza A H1n1

scholarly journals Food allergy symptom self-management with technology (FASST): An mHealth intervention to address psychosocial outcomes in caregivers of children with newly diagnosed food allergy: Protocol for a pilot randomized controlled trial. (Preprint)

2020 ◽  
Author(s):  
Brantlee Broome ◽  
Mohan Madisetti ◽  
Margaret Prentice ◽  
Kelli Wong Williams ◽  
Teresa Kelechi
Keyword(s):  
Randomized Controlled Trial ◽  
Food Allergy ◽  
Phase I ◽  
Phase Ii ◽  
Controlled Trial ◽  
Self Management ◽  
Newly Diagnosed ◽  
Randomized Controlled ◽  
Allergy Symptom

BACKGROUND Approximately 2.4 million children in the United States suffer from food-induced anaphylaxis; a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including: fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns. OBJECTIVE In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management mHealth smartphone app intervention Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy. METHODS This pilot study uses pre-formative qualitative work (Phase I) to inform a 4 -week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (<18 years old) with established food allergy (diagnosed  1 year) will participate in semi-structured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children with a newly diagnosed food allergy (diagnosed  90 days) will be randomized 2:1 to receive FASST intervention (n = 20) or the control condition (basic app with educational resources) (n = 10). Process measures include feasibility, caregiver acceptability, adherence and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life mesasured at baseline,week 4, and at 3-months post study completion. RESULTS Pre-formative Phase I study activities have been completed and Phase II participant enrollment into the randomized controlled trial is expected to commence 2021. CONCLUSIONS With limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time-period in the caregiving/condition trajectory. CLINICALTRIAL ClinicalTrials.gov Identifier NCT04512924 (posted 08/14/2020).

Phase I/II trial of pembrolizumab and cabozantinib in the treatment of metastatic renal cell carcinoma (mRCC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 4544-4544
Author(s):  
Elizabeth R Kessler ◽  
Junxiao Hu ◽  
Geetika Srivastava ◽  
Douglas Jerome Kemme ◽  
Praveena Iruku ◽  
...  
Keyword(s):  
Phase I ◽  
Primary Endpoint ◽  
Clinical Benefit ◽  
Clear Cell ◽  
Checkpoint Inhibitors ◽  
Controlled Trial ◽  
Objective Response ◽  
Risk Category ◽  
Serious Adverse Events ◽  
Line Therapy

4544 Background: Checkpoint inhibitors (CPI) and vascular endothelial growth factor receptor inhibitors (VEGFi) are standard treatments for patients (pts) with mRCC. This phase I/II study evaluated the safety and efficacy of the novel combination of pembrolizumab (pembro) and cabozantinib (cabo). The phase I dose escalation data was presented at ASCO GU 2019. We now report the objective response rate (ORR), progression free survival (PFS), overall survival (OS), and toxicity of patients in the phase II dose expansion. Methods: Eligible pts had metastatic clear cell (ccRCC) or non-clear cell (nccRCC) histology, normal organ function, ECOG 0-1, and no prior exposure to pembro or cabo. Pts could be treatment-naïve or have received prior CPI and/or VEGFi. Pts were dosed at the recommended phase 2 dose of pembro 200 mg IV Q3W in combination with cabo 60 mg PO QD. Scans were obtained every 9 weeks. Treatment beyond progression, in the setting of continued clinical benefit, was allowed. The primary endpoint was ORR. Simon’s two-stage design was implemented to test the null hypothesis that ORR ≤ 0.20 versus the alternative that ORR ≥ 0.50. Results: Forty pts were enrolled, of which 34 pts (85%) had ccRCC and 6 pts (15%) had nccRCC. This was first-line treatment for 15 pts (38%) and second- and subsequent-line therapy for 25 pts (62%). IDMC risk category was favorable in 15%, intermediate in 72.5%, and poor in 12.5% of pts. Prior therapies included VEGFi in 17 pts (43%), CPI in 17 pts (43%), and 9 pts (23%) had both prior VEGFi and CPI in combination or sequentially. At a median follow up of 17.8 months (mo), the ORR was 60% (95% CI 0.458-1.00), clinical benefit rate (CBR) was 92.5% (95% CI 0.817-1.00), median time to response was 4.2 mo; median duration of response was 8.4 mo. Three of six nccRCC pts achieved partial response. Median PFS was 10.4 mo (95% CI 6.3 mo-NR). Median OS was not reached. Twelve patients remain on treatment. The most common grade 1 and 2 (G1/2) treatment-related AEs were diarrhea (53%), fatigue (49%), weight loss (47%), nausea (43%), and dysgeusia (43%). Twenty-five patients (47%) experienced a treatment-related G3 AE and there were no G4 related AEs. Thirteen pts experienced serious adverse events, 8 of which were related to treatment: G3 transaminitis and hypoglycemia were attributed to the combination; G3 pancreatitis, nephritis, and pneumonitis attributed to pembro; G3 pulmonary embolus, confusion due to reversible posterior leukoencephalopathy (RPLS), and stroke attributed to cabo. There was one treatment-related death in the pt with RPLS, possibly related to cabo. Conclusions: This study of the combination of pembrolizumab 200mg and cabozantinib 60mg met the primary endpoint of ORR. Benefit was seen in first- and subsequent-line therapy. The safety profile was manageable. This combination warrants further confirmation in a randomized controlled trial. Clinical trial information: NCT03149822.

scholarly journals Impact of group-based dietary education on the dietary habits of female adolescents: a cluster randomized trial

2010 ◽  
Vol 14 (4) ◽  
pp. 702-708 ◽  
Author(s):  
Kazue Yamaoka ◽  
Mariko Watanabe ◽  
Eisuke Hida ◽  
Toshiro Tango
Keyword(s):  
Dietary Intake ◽  
Energy Intake ◽  
Young Women ◽  
Dietary Habits ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Female Adolescents ◽  
Control Group ◽  
Dietary Education ◽  
Cluster Randomized

AbstractObjectiveThe number of extremely thin young women has increased and education at school on maintaining an optimal weight has become important. The aim of the present study was to assess the effectiveness of a group-based home-collaborative dietary education (HCDE) programme to maintain appropriate dietary intake compared to conventional school classroom education.DesignTwo-arm cluster randomized controlled trial. Twelve classes were randomly assigned as clusters to either the HCDE group or the control group. Each participant in the HCDE group received twelve sessions of group counselling aimed at increasing energy intake at breakfast by modifying dietary intake and adopting appropriate habits. The hypothesis underlying the study was that after 6 months of HCDE the total energy intake would be increased by 627 kJ from baseline (primary endpoint). Secondary outcomes were differences in intake of various nutrients from baseline. Outcome measures after log transformation were examined by t tests and linear mixed models (crude and baseline-adjusted).SettingYoung women among Japanese female adolescents in Tokyo.SubjectsFour hundred and seventy-four participants aged 13–15 years.ResultsStudents in twelve classes were used for analysis (n 459). Energy intake was decreased in many of the classes during the 6-month period, especially for those in the control group. After adjustment for the baseline value, significant increases in energy intake and protein, calcium, magnesium and iron intakes at breakfast were observed (P < 0·05)ConclusionsAlthough energy intake was increased in the HCDE group compared to the control group, further study of the HCDE is warranted.

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