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NCT ID: NCT06256367 Recruiting - Bipolar I Disorder Clinical Trials

Observational Study of Oral Cariprazine Capsules to Assess Change in Disease Activity in Adult Participants With Bipolar I Disorder

CReW BP-I
Start date: April 18, 2024
Phase:
Study type: Observational

Bipolar I disorder (BP-I) is a common, chronic, and disabling mental illness with significant morbidity and mortality defined by episodes of mania and depression (or symptoms of both at once, known as mixed features). This prospective, observational study will examine effectiveness, functioning and quality of life outcomes in adult patients with BP-I experiencing a major depressive episode (with or without mixed features) requiring treatment and initiating treatment with cariprazine. It will examine outcomes of cariprazine treatment in a real-world setting in patients with BP-I commonly seen in clinical practices. Cariprazine (Vraylar) is a medication indicated in the United States and Canada to treat adult patients experiencing manic, mixed or depressive episodes associated with BP-I. This study plans to enroll approximately 170 adult patients with BP-I from the United States and Canada. Cariprazine should be prescribed by the physician under the usual and customary practice of physician prescription. The decision to initiate treatment with cariprazine should be made prior to, and independently from, the patient's decision to participate in the study. Participants will receive cariprazine as prescribed by their physician. Observational data will be collected during visits which should align to routine standard of care for a duration of up to 24 weeks.

NCT ID: NCT06261528 Recruiting - Clinical trials for Progressive Multiple Sclerosis

Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis

NO-FATIGUE
Start date: April 18, 2024
Phase: Phase 1
Study type: Interventional

The study is being done to determine if treatment with a novel form of light therapy is tolerated in patients with progressive multiple sclerosis. The goal of this trial to establish the safety profile of this light therapy while generating data on its impact on fatigue, as well as its mechanism of action. Fatigue is often a complex symptom in multiple sclerosis, without any FDA-approved direct therapy. Fatigue is traditionally treated with symptom management through a multidisciplinary team.

NCT ID: NCT06262594 Recruiting - Epilepsy Clinical Trials

Lemborexant Treatment of Insomnia Linked to Epilepsy

L'ÉTOILE
Start date: April 18, 2024
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to assess whether Lemborexant can improve sleep in patients with epilepsy.

NCT ID: NCT06286501 Recruiting - Periodontitis Clinical Trials

Targeting of Preventive Treatment for Adolescents at Risk of Oral Diseases

LumoPrevent
Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The aim of the study is to identify adolescent patients that are at risk of developing oral diseases, and to assess if targeted preventive oral treatment with antibacterial dual-light therapy as an adjunctive treatment method can have a positive impact in preventing oral diseases from emerging.

NCT ID: NCT06291961 Recruiting - Clinical trials for Beta-Thalassemia Major

A Safety and Efficacy Study Evaluating CS-101 in Subjects With β-Thalassemia Major

Start date: April 18, 2024
Phase: Phase 1
Study type: Interventional

The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 in treating patients with β-thalassemia major anemia.

NCT ID: NCT06294912 Recruiting - Malaria Clinical Trials

A Study to Evaluate Antimalarial Activity and Safety of MK-7602 in Healthy Adults (MK-7602-003)

Start date: April 18, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the antimalarial activity, pharmacokinetics, and safety of MK-7602 in healthy adults following Plasmodium falciparum (P. falciparum) infection.

NCT ID: NCT06295809 Recruiting - Clinical trials for Carcinoma, Squamous Cell

A Study of (Neo)Adjuvant V940 and Pembrolizumab in Cutaneous Squamous Cell Carcinoma (V940-007)

Start date: April 18, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

This is a two-part (Phase 2/Phase 3) study of V940, an individualized neoantigen therapy (INT), plus pembrolizumab in participants with locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC). Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator's discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC. This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC as compared to standard of care SOC only. The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only with respect to event free survival (EFS) as assessed by the investigator. Phase 3 expansion will be determined by prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.

NCT ID: NCT06296251 Recruiting - Dyslipidemias Clinical Trials

Dietary Supplementation on Body Fat Composition

Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The purpose of the current study is to examine the effects of a dietary supplement containing plant derived phenolics at two different dose levels in otherwise generally healthy adults with risk factors (high BMI at dyslipidemia and/or pre-diabetes) for body fat composition. The primary hypothesis is that supplementation with plant derived phenolics will decrease body fat composition compared to placebo.

NCT ID: NCT06318637 Recruiting - Newborn Clinical Trials

Evaluation of the Acceptability and Feasibility of a Bedtime Routine for Neonates

Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to assess, via caregiver questionnaire, the acceptability and feasibility of implementing a bedtime routine for newborns.

NCT ID: NCT06319820 Recruiting - Clinical trials for Non-Muscle Invasive Bladder Cancer

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

MoonRISe-1
Start date: April 18, 2024
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.