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NCT ID: NCT04997122 Completed - Healthy Clinical Trials

Health Effects of Consuming Olive Pomace Oil

ORUJOSALUD-1
Start date: April 2, 2018
Phase: N/A
Study type: Interventional

Healthy and at risk (hypercholesterolemic) subjects consumed during 4 weeks 45 g/d of either olive pomace oil (OPO) or high oleic acid sunflower oil (HOSO) as the only dietary fat in a randomized, crossover trial. The effects on blood lipids, glucose homeostasis, endothelial function, inflammatory cytokines, oxidative stress biomarkers and anthropometry were measured.

NCT ID: NCT04993209 Completed - Healthy Clinical Trials

Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil

ADAPTCOV
Start date: July 9, 2021
Phase: Phase 1
Study type: Interventional

NDV-HXP-S is an inactivated COVID-19 vectored-vaccine virus using the Newcastle Disease Virus as basis and expressing S protein from SARS-CoV-2 stabilized in pre-fusion form with Hexapro technology. This vaccine was successfully tested in non-clinical study with a good safety profile and eliciting neutralizing antibodies against SARS-CoV-2. Clinical testing is conducted by an international consortium including three different manufacturers. Butantan, in Brazil, is one of them.

NCT ID: NCT04991766 Completed - Healthy Clinical Trials

A Study of [¹⁴C]-LY3484356 in Healthy Female Participants

Start date: August 13, 2021
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study has two parts. It will involve a single dose of 14C radiolabeled LY3484356. This means that a radioactive substance C14 will be incorporated into the study drug, to investigate the study drug and its breakdown products, to find out how much of these pass from blood into urine, feces and expired air. The study will last about 4 weeks. Screening is required within 28 days prior to the start of the study and follow up is required approximately 7 days after discharge.

NCT ID: NCT04990648 Completed - Healthy Clinical Trials

Buzzy® Application in Pain

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

The research was conducted as a randomized controlled experiment to investigate the effect of Buzzy® on pain level during the measles-rubella-mumps (MMR) vaccine injection in 12-month-old infants. This study was done with infants meeting the sampling criteria (buzzy group: 30, control group: 30) on November 2018-May 2019 in Istanbul Bakirkoy 9 Family Health Center.

NCT ID: NCT04990622 Completed - Healthy Clinical Trials

The Effect of Diet on Parents' Mental Health in the Postnatal Period

Start date: June 28, 2021
Phase: N/A
Study type: Interventional

Postnatal depression (PND) is a type of depression that can occur in some parents after the birth of their baby. PND has been estimated to affect 1 in 10 new parents; mothers in particular are at an increased risk of developing PND in the first year after childbirth. Symptoms of PND include a persistent feeling of sadness or low mood, a lack of enjoyment and loss of interest in the wider world, lack of energy and feeling tired all the time, difficulty bonding with your baby, withdrawing from contact with other people and problems concentrating and making decisions. Research has shown that mothers with PND have more cognitive, behavioural and interpersonal issues, and lower mood, energy and concentration than mothers without PND. Current treatments for PND include self-help resources, support from local and national organisations, psychological therapy or antidepressants with varying success rates. Further research is required to investigate accessible, cost-effective preventions or treatments for new mothers who are at risk or have been diagnosed with PND. There is also a pressing need to investigate natural alternatives to medication, especially for breastfeeding mothers who do not want to expose their infants to pharmaceuticals through breast milk. Flavonoids are naturally occurring compounds found in high levels in foods such as berry and citrus fruits, leafy green vegetables, tea, dark chocolate and red wine. Evidence suggests that consumption of high flavonoid foods can improve health and cognitive outcomes. Prior research investigating daily dietary flavonoid intervention in a postnatal population for 2 weeks indicated significantly higher physical quality of life and significantly lower state anxiety in mothers of infants under 1 year old, at the end of the intervention. These benefits were not observed in the control group. This data shows promise for the management of mood in a key period for mothers and their babies, where risk of PND is high. The research aim of the current study will be to further these investigations to see whether implementation of a high flavonoid diet across a 2 week period positively affects maternal mental health, specifically mood, anxiety, depressive symptoms and perceived quality of life. The study will involve recruiting mothers of infants under 6 months old to take part in an online study investigating diet and mental health. Mothers will be assigned to either a high flavonoid diet or a control condition for 2 weeks. They will complete online questionnaires (Positive and Negative Affect Scale (PANAS), Edinburgh Postnatal Depression Scale (EPDS), Postpartum-Specific Anxiety Scale (PSAS), World Health Organization Quality of Life (WHOQOL), State-Trait Anxiety Inventory (STAI) and Food Frequency Questionnaire (FFQ) at the start (day 0) and end (day 14) of the dietary intervention. In this study, a sub-sample of fathers will also be recruited to take part in the same study to assess if dietary or mood outcomes are similar or different in this population. This pilot data will inform future research of dietary interventions in new fathers. The study does not pose ethical issues. Participants will be asked to complete non-invasive questionnaires about their mood and quality of life. For those in the high flavonoid group the change to diet will not be extreme; this group will be encouraged to include 2 items from a list of high flavonoid foods in their daily food consumption. All participants will be provided with helplines and web links upon debrief should they wish to seek further support. The helplines provided will be Samaritans UK and PANDAs Foundation. Web links to NHS, MIND and the Association for Postnatal Illness will also be listed.

NCT ID: NCT04990310 Completed - Healthy Clinical Trials

Single Dose Absorption, Distribution, Metabolism, and Excretion Study of [14C]-CORT113176 in Healthy Male Participants

Start date: August 18, 2021
Phase: Phase 1
Study type: Interventional

This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of [14C]-CORT113176 in healthy male participants.

NCT ID: NCT04985955 Completed - Healthy Clinical Trials

A Study Validating the Use of Candin as a Challenge Agent in Healthy Participants - Intervention Specific Appendix 3

Start date: July 30, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to characterize the delayed-type hypersensitivity (DTH) response at the site of Candin intradermal injection in the presence of a targeted immune pathway inhibitor.

NCT ID: NCT04984525 Completed - Healthy Clinical Trials

Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers

Start date: July 2, 2021
Phase: Phase 1
Study type: Interventional

This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV). Eligible subjects receive investigational product (IP) and undergo safety monitoring, evaluations, and subsequent follow-up after IP administration.

NCT ID: NCT04981704 Completed - Healthy Clinical Trials

A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants

Start date: April 8, 2021
Phase: Phase 1
Study type: Interventional

The purpose of the study is to evaluate the effect of multiple-doses of itraconazole, phenytoin and paroxetine on the single-dose pharmacokinetics (PK) of poziotinib in healthy adult participants.

NCT ID: NCT04979702 Completed - Healthy Clinical Trials

mHealth Biometrics for Sedentary People (MotivateLJMU)

Start date: August 1, 2020
Phase: N/A
Study type: Interventional

The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in previously sedentary individuals. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.