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NCT ID: NCT05608187 Recruiting - Diabetic Foot Ulcer Clinical Trials

Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers

Start date: September 26, 2022
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled, parallel, exploratory phase 2a study to evaluate safety and biologic efficacy on wound healing of ILP100-Topical in subjects with diabetic foot ulcers during 26 weeks with a 5-year long-term follow-up period. A total of 30 subjects will be randomized to low dose of ILP100-Topical (ILP100Lo), high dose of ILP100-Topical (ILP100Hi) or Placebo according to a 1:1:1 randomization schedule. The study will consist of a 3-weeks Screening and Run-in Phase, followed by a 5-week Treatment Phase starting from Baseline and an Assessment Phase from Week 5 to Week 26. Thereafter, the subjects will be followed yearly during 5 years in a Long-Term Safety Follow-up Phase.

NCT ID: NCT05607992 Active, not recruiting - Clinical trials for Acute Coronary Syndrome

Brief Internet-delivered CBT After ACS

Start date: May 18, 2023
Phase: N/A
Study type: Interventional

The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early after acute coronary syndrome (ACS).

NCT ID: NCT05604846 Recruiting - Death Clinical Trials

Probiotic Supplementation in Extremely Preterm Infants in Scandinavia

PEPS
Start date: December 16, 2022
Phase: N/A
Study type: Interventional

The primary aim of this research is to determine whether supplementation with probiotics during the first weeks of life reduces the risk of necrotizing enterocolitis (NEC) and neonatal mortality and is safe to use among extremely preterm (EPT) infants born before gestational week 28. P: The study population include EPT infants (n= 1620) born at six tertiary neonatal units in Sweden and four units in Denmark. I: This is a double-blinded multicenter randomized controlled trial where infants in the intervention group will as soon as they tolerate 3 mL breastmilk per feed receive a probiotic combination of Bifidobacterium infantis, Bifidobacterium lactis, and Streptococcus thermophilus diluted in 3 mL breastmilk and given once daily until gestational week 34. C: The control group will receive 3 mL breastmilk without probiotic supplementation (blinded) daily. O: Primary outcome variables is a composite endpoint of incidence of NEC and mortality. Secondary outcomes include incidence of sepsis, duration of hospital stay, use of antibiotics, feeding tolerance, growth, and body composition after hospital discharge. Patient benefit: To provide evidence on the usage of probiotics among EPT infants that are not currently covered by clinical recommendations. As EPT infants have the highest risk for NEC and mortality our results have the potential to change current recommendations and improve patient outcomes, decrease mortality, shorten hospitalization, and decrease overall health-care costs.

NCT ID: NCT05604729 Recruiting - Bruxism Clinical Trials

The Effect on Envelope of Motion in Asymptomatic Bruxers

Start date: September 1, 2023
Phase: N/A
Study type: Interventional

Investigating the effect of botulinum neurotoxin on the jaw-neck envelope of motion.

NCT ID: NCT05604183 Not yet recruiting - Clinical trials for Cognitive Impairment

Hyperspectral Retinal Observations for the Cross-sectional Detection of Alzheimer's Disease

Start date: November 2022
Phase: N/A
Study type: Interventional

Two devices will be tested in this research: 1. Mantis Photonics' hyperspectral camera for non-invasive retinal examination (i.e., a hardware medical device under investigation). 2. Blekinge CoGNIT cognitive ability test (i.e., an assessment).

NCT ID: NCT05602662 Recruiting - Music Therapy Clinical Trials

Music as a Complement to Pharmacological Sedation in Ventilator Treated ICU Patients.

Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Can music theraphy during mechanical ventilation in the ICU, decrease the need of pharmacological sedation? Included patients will listen to music selected by a music therapist via headphones two times one hour during two days. Effects on heart rate, blood pressure, respiratory rate and dosing of pharmacological sedation will be observed. 100 patients will be included and radomized equally to earphones with and without music.

NCT ID: NCT05601882 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Evaluate Adverse Events and Change in Disease Activity Comparing Oral Upadacitinib to Subcutaneous Dupilumab in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis

Level Up
Start date: November 28, 2022
Phase: Phase 3
Study type: Interventional

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe AD who have inadequate response to systemic therapies. Adverse events and change in the disease activity will be assessed. Upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (AD). The study is comprised of a 35-day Screening Period, a 16-week treatment period 1 and a 16-week treatment period 2. During period 1, participants are randomly assigned in 1 of 2 groups, called treatment arms to receive upadacitinib Dose A or dupilumab. In Period 2, participants will receive upadacitinib Dose A or Dose B. Approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe AD who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. Participants will receive upadacitinib oral tablets once daily or dupilumab as per its label for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care . Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05600517 Recruiting - Caries,Dental Clinical Trials

Evaluation of Caries Prevention Based on Genetic Etiology and Risk.

PRECARIES
Start date: August 25, 2021
Phase: N/A
Study type: Interventional

Dental caries affects billions of people worldwide and involves saliva immunodeficiency, commensal pathogen and exposure (lifestyle) causal subtypes of the disease. Up to 85% of adolescents in Swedish and other low prevalence populations are caries-free while the remaining 15% show high, recurrent caries activity. Accordingly, there is a lack of cost-effective risk assessment and prevention tools for personalized oral care. This randomized adaptive clinical trial (RCT) evaluates both caries prevention based on genetic etiology and risk, as a consequence of saliva immunodeficiency genes specifying individuals as susceptible or resistant to caries, and the effect of intensified versus selfcare traditional prevention on the two groups.

NCT ID: NCT05597254 Completed - Healthy Clinical Trials

Facial Skin Clinical and Microbial Profiling From Oral Probiotic Supplementation

Start date: September 26, 2022
Phase: N/A
Study type: Interventional

The goal of this double-blind randomized clinical trial is to investigate the effects on the skin from oral intake of probiotic supplements in healthy adult men and women. The main questions it aims to answer are: • Will probiotic supplementation result in beneficial changes to different skin parameters? • Will probiotic supplementation result in alterations in the skin microbiome? Participants will consume the study product daily for 8 weeks and come in for skin measurements at baseline and after 8 weeks.

NCT ID: NCT05597072 Recruiting - Infection Control Clinical Trials

Bacterial Air Contamination

Start date: May 17, 2022
Phase: N/A
Study type: Interventional

Aim is to compare the effect of number of persons and time-dependant bacterial air contamination on sterile goods, using different preparation conditions and protective sterile covers. Research questions Is there a difference in bacterial air contamination during preparation of the sterile surgical goods with 2 persons (intervention) compared with 4-5 persons (control) in the OR? Is there a time-dependent difference in bacterial air contamination pending surgery for 1 hour (control) compared to approximately 12 hours (intervention) when the sterile goods are protected with sterile covers? Is there a time-dependent difference in bacterial air contamination pending surgery if sterile goods are protected or not, by sterile covers? Is there any differences in surgical site infections between the groups? What type of bacteria contain the air contamination? Is there antibiotic resistant bacterial air contamination?