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NCT ID: NCT05636761 Active, not recruiting - Clinical trials for Reliability and Validity

Heart Rate Variability Recording With Elite HRV Application and Polar V800

Start date: April 13, 2020
Phase:
Study type: Observational

The Elite HRV is a reliable HRV analysis tool and could be a valid option to replace the Polar V800. The objective of study is Comparing the HRV index recorded with the mobile app Elite HRV and with the multisport watch Polar V800. Individuals will submit to two RR interval recordings with a Polar H7 strap that sent the data either to the Polar V800 heart rate monitor or to the Elite HRV app. The volunteers will supine position and breathing spontaneously, and the RR intervals will collect during 25 minutes. Subsequently, without warning the subject, the strap will connect to a nother device, and the second 25minute evaluation was made. The order in which the devices will use is randomized and the HRV indexes will generated via Kubios HRV.

NCT ID: NCT05633355 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

ROCKET-Orbit
Start date: January 30, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to describe the safety and tolerability of rocatinlimab in adolescents with moderate-to-severe AD.

NCT ID: NCT05630859 Active, not recruiting - Clinical trials for Sexually Transmitted Diseases

Safety and Efficacy of GSK Neisseria Gonorrhoeae GMMA (NgG) Investigational Vaccine When Administered to Healthy Adults 18 to 50 Years of Age.

Start date: November 28, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this first time in human proof of concept (FTiH-PoC) study is to evaluate safety and reactogenicity, to demonstrate efficacy and to explore immunogenicity of GlaxoSmithKline's (GSK) Neisseria gonorrhoeae generalized modules for membrane antigens (GMMA) (NgG) investigational vaccine compared to placebo (saline).

NCT ID: NCT05630820 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)

B-Well 2
Start date: December 6, 2022
Phase: Phase 3
Study type: Interventional

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.

NCT ID: NCT05630807 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)

B-Well 1
Start date: December 7, 2022
Phase: Phase 3
Study type: Interventional

This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.

NCT ID: NCT05629962 Active, not recruiting - COVID-19 Clinical Trials

SUNRISE-3: Efficacy and Safety of Bemnifosbuvir in High-Risk Outpatients With COVID-19

Start date: November 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate whether bemnifosbuvir (BEM) is effective and safe in adults with COVID-19 who do not need to be in the hospital but who are at high risk for progression to severe disease. Eligible subjects will be randomly assigned (by chance) to receive BEM or matching placebo orally for 5 days. Co-administration of locally available standard of care (SOC) is allowed. The total duration of the study is 60 days.

NCT ID: NCT05621928 Active, not recruiting - COVID-19 Vaccines Clinical Trials

Effectiveness of Vaccination Against COVID-19 in Brazil: Case-Control Study

Start date: February 7, 2022
Phase:
Study type: Observational [Patient Registry]

The main objective of the study is to evaluate the effectiveness of the vaccine against covid-19, recommended by the national immunization program. This is a multicentric, observational, case-control study. Participants Cases with the disease will be compared to Control Participants, that is, without the disease, regarding the vaccination history for Covid-19.Complementarily, an evaluation of cellular and humoral immunity will be carried out in a sample of both case and control participants, taking into account the vaccination history.

NCT ID: NCT05608044 Active, not recruiting - Clinical trials for Metastatic Colorectal Cancer

A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer

Start date: November 30, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, Phase 2, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetic profiles of botensilimab as monotherapy and in combination with balstilimab or standard-of-care treatments in participants with refractory metastatic colorectal cancer.

NCT ID: NCT05605210 Active, not recruiting - Fatigue Clinical Trials

Stimulation Sites and Fatigue Induced by Neuromuscular Electrical Stimulation in Healthy Individuals

Start date: January 25, 2023
Phase: N/A
Study type: Interventional
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NCT ID: NCT05603845 Active, not recruiting - Severe Asthma Clinical Trials

Patient-Reported OUTcomes of Benralizumab in Real-World Use in Severe EosiNophilic Asthma Patients

iOUTRUN
Start date: February 20, 2023
Phase:
Study type: Observational

This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment.