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NCT ID: NCT05769777 Recruiting - Dermatitis Atopic Clinical Trials

Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis

ATLANTIS
Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD). The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD. The study duration per participant will be up to 180 weeks, including: - A screening period of up to 2 to 4 weeks - An open label treatment period of up to 160 weeks (approximately 3 years) - A post-treatment safety follow-up period of at least 20 weeks after the last dose administration The planned number of visits will be 26 visits.

NCT ID: NCT05768854 Active, not recruiting - Clinical trials for Osteogenesis Imperfecta

Setrusumab vs Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta

Cosmic
Start date: June 14, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the effect of setrusumab vs intravenous bisphosphonates (IV-BP) on reduction in fracture rate, including morphometric vertebral fractures in pediatric participants.

NCT ID: NCT05767723 Recruiting - Clinical trials for Acute Coronary Syndrome

Platelet Sub-study of the Neomindset Trial

Start date: February 6, 2023
Phase: Phase 4
Study type: Interventional

The general purpose of the Neomindset trial is to evaluate the non-inferiority hypothesis for ischemic events and the superiority hypothesis for bleeding events resulting from platelet P2Y12 receptor inhibitors given as monotherapy in comparison with conventional dual antiplatelet therapy in acute coronary syndrome patients treated with percutaneous coronary intervention. The platelet sub-study will be conducted at the Hospital Israelita Albert Einstein. This sub-study will recruit randomized patients from the Neomindset trial to evaluate platelet function after at least 30 days of study treatment with either P2Y12 inhibitor monotherapy or dual antiplatelet therapy.

NCT ID: NCT05767112 Completed - Healthy Clinical Trials

Pharmacokinetic Profile of the Calcium-salt and Free Acid Forms of β-hydroxy-β-methylbutyrate in Humans

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

HMB supplementation has been shown to have potential to optimize resistance training responses, which may have important implications for sport, exercise, and health. However, HMB literature shows uncertainties as to which is the superior pharmaceutical form of supplemental HMB (i.e., the calcium salt or the free acid form) in terms of pharmacokinetic profile and bioavailability when consumed by humans. This research project investigated the bioavailability and pharmacokinetics of two different forms of supplemental HMB, namely HMB calcium-salt (HMB-Ca) and HMB Free Acid (HMB-FA). Further, HMB-Ca was provided both diluted in water and encapsulated in gelatine capsules. This pharmacokinetics study adopted a crossover design, open-label design in which male and female participants visited the laboratory on 3 different occasions to receive one the 3 treatments: 1g of HMB; the equivalent of 1g of HMB-Ca in water; the equivalent of 1g of HMB-Ca in gelatine capsules. Venous blood samples were collected before and multiple time points after treatment ingestion, for a period of 12 hours in total. A pre-ingestion midstream urine sample was collected as well as a 24-h post-ingestion total urine sample. All plasma and urine samples were analysed for their HMB concentrations via LC/MS. Time to peak, maximum concentration, area under the curve, half-life time and slope of the incremental phase were calculated to examine the pharmacokinetic profile of HMB and compare the 3 different pharmaceutical forms.

NCT ID: NCT05767034 Recruiting - Clinical trials for Polymyalgia Rheumatica

Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)

REPLENISH
Start date: March 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 300 milligram (mg) and 150 mg administered subcutaneously (s.c.) for 52 weeks in combination with prednisone tapered over 24 weeks in adult participants with PMR who have recently relapsed.

NCT ID: NCT05764044 Not yet recruiting - Cervical Cancer Clinical Trials

Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer

AddChemo
Start date: April 1, 2023
Phase: Phase 3
Study type: Interventional

This study hypothesizes that patients who persist with cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) plasma expression at the end of standard treatment, can derive the benefit of using adjuvant chemotherapy in locally advanced cervical cancer (CC). After standard treatment based on concomitant chemoradiotherapy regime, a qualitative and quantitative research of cfHPV-DNA in plasma of patients will be conducted. Those with a negative qualitative research result will leave the study. Patients who have positive research for plasma 16/18 cfHPV-DNA at the end of chemoradiotherapy treatment will be randomized to receive two additional cycles of adjuvant chemotherapy or observation. Patients will be followed with conduction of computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.

NCT ID: NCT05763121 Recruiting - Asthma Clinical Trials

A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.

EXHALE-2
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

NCT ID: NCT05762926 Not yet recruiting - Alzheimer Disease Clinical Trials

Non-invasive Brain Stimulation by Transcranial Pulse Stimulation as a Coadjunctive Treatment in Alzheimer's Disease

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

This is a randomized, double-blind, placebo-controlled clinical trial; that will evaluate the effectiveness of the use of transcranial pulse stimulation in people living with Alzheimer's disease, coming from the Institute of Psychiatry (IPQ) of the Hospital das Clinicas, Faculty of Medicine, University of São Paulo, and the Institute of Physical Medicine and Rehabilitation (IMREA) at the Hospital das Clínicas, Faculty of Medicine, University of São Paulo. Participants will be classified according to the stage of Alzheimer's disease, determined by a psychiatrist and neuropsychologists. A total of 50 volunteers will be randomized blindly. In addition to evaluating the clinical course and imaging examination, the use of scales that assess functional and cognitive disability will be used for the recruitment of volunteers. Volunteers will be randomized into two study groups, and will receive the intervention that will consist of ten sessions, held twice a week. The Storz Neurolith™ equipment (Storz Medical, Tagerwillen, Switzerland) will be used to administer transcranial pulse stimulation.

NCT ID: NCT05762887 Recruiting - Bipolar Disorder Clinical Trials

Clinical Evaluation of the Antidepressant Effect of the Use of Probiotics in Bipolar Disorder

Start date: January 9, 2023
Phase: N/A
Study type: Interventional

Bipolar Disorder (BD) is highly incapacitating and associated with premature mortality. Depressive symptoms and episodes are the most frequent cause of disability in subjects with BD and over half of patients do not respond adequately to approved treatments for this condition, showing the need for new classes of treatments to complement current pharmacotherapy. Previous studies demonstrated that the intestinal flora have potential positive or negative effects on the Central Nervous System and suggest that adding specific strains of bacteria to people's diet may have antidepressant properties.The study proposes to evaluate the clinical benefit of adding probiotics to pharmacological treatments for bipolar depression. This will be a study with 84 subjects (42 receiving probiotics and 42 placebo). The research team in this department has focused especially on non-pharmacological treatments for bipolar disorder (psychotherapy, nutrition and exercise) and is multidisciplinary in scope with psychiatrists, psychologists, nurses, physiotherapists and nutritionists participating in research projects.

NCT ID: NCT05761106 Recruiting - Clinical trials for Temporomandibular Disorder

Effect of Exercises on Convergence Insufficiency in Individuals With Temporomandibular Disorders

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

Temporomandibular Disorder is a disorder that involves the muscles of mastication, the temporomandibular joint (TMJ), and associated structures. Convergence insufficiency (CI) is characterized by the inability of the eyes to perform the eye adduction movement together, to focus on a nearby object. Studies show that there is a relationship between the presence of TMD and its signs and symptoms in patients with convergence insufficiency. Given this, the research question of this clinical trial is whether the effect of oculomotor therapy would be effective in improving the signs and symptoms of Temporomandibular Disorder. The design of this research is a Clinical Trial, Randomized and Blind. It will be divided into two moments: evaluation and intervention. The evaluations will be carried out using the Diagnostic Criteria for Temporomandibular Disorders: Fonseca Anamnestic Index (IAF), Clinical Protocol and Assessment Instruments (DC/TMD), Mandibular function Impairment Questionnaire (MFIQ), Numerical Pain Scale (END), Convergence Test, Meersseman Test and Convergence insufficiency symptom Survey (CISS). Individuals will be randomized into 2 groups: Group A (Treatment for Temporomandibular Disorder) and Group B (Treatment Oculomotor plus Treatment for Temporomandibular Disorder). Both groups will receive physiotherapeutic treatment for 12 weeks. Patients will be reassessed shortly after treatment, 3 and 6 months later. For data analysis, the statistical significance considered will be p<0.05.