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NCT ID: NCT05537090 Completed - Healthy Volunteers Clinical Trials

A Study to Assess Effect of BV100 on the Pharmacokinetics of Midazolam in Healthy Participants

Start date: September 1, 2022
Phase: Phase 1
Study type: Interventional

To evaluate the effect of repeated doses of intravenous BV100 on the pharma-cokinetics of midazolam and 1-hydroxymidazolam.

NCT ID: NCT05507437 Completed - Clinical trials for Acute Kidney Injury Due to Sepsis

Pharmacokinetics and Safety of TIN816 in Patients With Sepsis-associated Acute Kidney Injury

Start date: November 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile and to evaluate the safety and tolerability of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).

NCT ID: NCT05486065 Completed - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

Start date: August 8, 2022
Phase: Phase 2
Study type: Interventional

This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide [2 milligrams (mg), 8 mg, or 16 mg] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.

NCT ID: NCT05483205 Completed - Acne, Adult Clinical Trials

Normaderm Phytosolution Global Observational Study

Start date: July 1, 2019
Phase:
Study type: Observational

The objective of this 3-month observational study was to assess, in 2827 adults, the benefit of NP alone or as adjunctive or maintenance care in mild acne, or as adjunctive care in subjects with moderate acne.

NCT ID: NCT05459831 Completed - Atrial Fibrillation Clinical Trials

Efficacy Comparison of High and Very High Power Short Duration Pulmonary Vein Isolation

HPSD-Remap
Start date: February 15, 2022
Phase: N/A
Study type: Interventional

Objective: To evaluate the long-term durability of PVI performed with 90W and 50W (QDot catheter). Primary hypothesis: Pulmonary vein isolation performed with 90W (QMODE+) and inter-tag distance <5 mm is non-inferior to pulmonary vein isolation performed with 50W guided by ablation index (QMODE) and inter-tag distance <5 mm. Study Design: 40 patients will be randomized in a 1:1 ratio to 50W and 90W PVI. Study procedures: Initial PVI will be performed via femoral access and double transseptal puncture guided by fluoroscopy and pressure monitoring. If necessary intracardiac echocardiography (ICE) will be used for the transseptal puncture. A fast anatomical left atrial map will be created with a multipolar mapping catheter; then, point-by-point PVI will be performed with QDot catheter with 50W or 90W according to randomization. Three months after the initial procedure, patients will undergo a repeated high density left atrial mapping with PentaRay or OctaRay catheter to evaluate the durability of the PVI. Exact gap numbers and locations will be registered. If necessary, reablation of the pulmonary veins (rePVI) will be performed. Inclusion criteria: Symptomatic paroxysmal/persistent AF, >18 years, willingness to sign informed consent form. Exclusion criteria: Long-standing persistent AF, active malignancy, contraindication for anticoagulant therapy, life expectancy <1 year, valvular AF, hyperthyroidism. Endpoints: At repeat procedure, a high density left atrial map will be created with PentaRay or if available OctaRay catheter to evaluate the durability of the PVI. Primary endpoint will be pulmonary vein reconnection.

NCT ID: NCT05438602 Completed - COVID-19 Clinical Trials

A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System

Start date: August 3, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Nirmatrelvir/Ritonavir) for the possible treatment of COVID-19. Patients with COVID-19 who have more difficulty in fighting against infections have a higher chance of severe illness. Such patients may benefit from longer treatment durations compared to the standard treatment regimen. The study is seeking participants who: - Have a confirmed COVID-19 infection - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 5 days prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. In addition, this study will also evaluate the efficacy and safety of a second treatment course of nirmatrelvir/ritonavir in people who experience that their COVID-19 is flaring up within 14 days of having taken a 5-day treatment course of nirmatrelvir/ritonavir. For this group, the study is seeking participants who: - Have a confirmed COVID-19 infection - Experience a worsening of signs/symptoms after completing an initial 5-day course of nirmatrelvir/ritonavir - The worsening of COVID-19 symptoms must occur within 14 days after completion of the initial 5-day course of nirmatrelvir/ritonavir - Are Immunocompromised - Experience onset of signs/symptoms attributable to the current COVID-19 infection within 48 hours prior to screening and ≥1 signs/symptoms attributable to COVID-19 present on the day of randomization. All participants will be taking the study medicine for either 5, 10, or 15 days. The study medication will be taken by mouth 2 times a day. Participants will take part in this study for about 24 weeks. The first dose of study medication is taken at the study site and the rest at home. Selected participants will need to visit the study site at least 10 times during the study.

NCT ID: NCT05409196 Completed - Clinical trials for Gastrointestinal Disease

Phase 1 Trial for Safety, Tolerability, and Immunogenicity of a Live, Attenuated, Oral Shigella/ETEC Combination Vaccine to Healthy Adults

Start date: September 16, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1 dose escalating study to assess the safety, tolerability, and immunogenicity of ShigETEC, a live, attenuated Shigella/ETEC combination vaccine given orally to healthy European adults 18 to 45 years of age. The major aim is the development of an efficacious and safe vaccine that prevents diarrhea caused by Shigella and ETEC in travelers, military personal visiting endemic countries and children of the developing world. This Phase 1 safety and immunogenicity study used a double-blind, placebo-control design and was conducted in two stages, a single ascending and a multiple ascending stage.

NCT ID: NCT05408429 Completed - Clinical trials for Pneumococcal Disease

Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13

Start date: June 24, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in toddlers who had 2 prior doses of Prevnar 13. This study is being conducted in children who: - are between 12 to 23 months of age; - are healthy as determined by the study doctors; - have received 2 doses of Prevnar 13 during the first year in life. Participants in this study will receive either 1 dose or 2 doses of the study vaccine or 1 dose of Prevnar 13 as a shot in the muscle. During the study, participants will have to come to the study clinic to receive the vaccines and have blood sample collected. The study team will work with participants' parents or legal guardians to monitor any unwanted reactions to the vaccines. Participants are expected to take part in this study for about 1 or 3 months, for 1 dose or 2 dose schedules, respectively.

NCT ID: NCT05387811 Completed - Acute Kidney Injury Clinical Trials

International Registry of Acute Kidney Injury in Cirrhosis: The GLOBAL AKI Project

GLOBAL-AKI
Start date: July 1, 2022
Phase:
Study type: Observational [Patient Registry]

The aims of this study will be to identify the clinical characteristics, the management and the outcomes of acute kidney injury in patients with cirrhosis worldwide. Specific aims: 1. To establish the severity of AKI across different regions 2. To identify precipitants of AKI across different centers 3. To identify the phenotypes of AKI across different centers 4. To evaluate differences in the management of AKI across different centers and their impact on clinical outcomes 5. To assess outcomes of acute kidney injury (resolution of AKI, in-hospital mortality, 28-day mortality, 90-day mortality)

NCT ID: NCT05378529 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: - Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD - Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions