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NCT ID: NCT04933721 Active, not recruiting - Clinical trials for Hereditary Angioedema

Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

APeX-A
Start date: July 23, 2021
Phase: Phase 3
Study type: Interventional

This is a phase 3b open-label study providing access to berotralstat for HAE patients who were previously enrolled in berotralstat studies.

NCT ID: NCT04925752 Active, not recruiting - Clinical trials for Pre-Exposure Prophylaxis of HIV Infection

Study of Lenacapavir for HIV Pre-Exposure Prophylaxis in People Who Are at Risk for HIV Infection

PURPOSE 2
Start date: June 28, 2021
Phase: Phase 3
Study type: Interventional

The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in preventing the risk of HIV.

NCT ID: NCT04915755 Active, not recruiting - Neoplasms, Breast Clinical Trials

Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease

ZEST
Start date: June 28, 2021
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and TNBC) or tumor BRCA wild type (tBRCAwt) TNBC with molecular disease based on the presence of circulating tumor Deoxyribonucleic acid (ctDNA) following surgery or completion of adjuvant therapy.

NCT ID: NCT04886596 Active, not recruiting - Clinical trials for Respiratory Syncytial Virus Infections

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy of the RSVPreF3 OA investigational vaccine in preventing Lower Respiratory Tract Disease (LRTD) caused by RSV in adults ≥60 years of age following a single dose of the RSVPreF3 OA vaccine and following annual revaccination doses in Northern Hemisphere (NH) and in Southern Hemisphere (SH). This study will also assess if the vaccine is safe and induces an immune response.

NCT ID: NCT04882878 Active, not recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus

Start date: August 20, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).

NCT ID: NCT04875195 Active, not recruiting - Hodgkin's Lymphoma Clinical Trials

A Study of Pembrolizumab (MK-3475) in Relapsed or Refractory Classical Hodgkin's Lymphoma (rrcHL) or Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma (rrPMBCL) (MK-3475-B68)

Start date: June 7, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the objective response rate (ORR), by cohort, rrcHL and rrPMBCL, as assessed by the investigator according to Lugano classification criteria 2014 in participants treated with pembrolizumab Q6W.

NCT ID: NCT04865770 Active, not recruiting - Clinical trials for Diabetes Mellitus, Type 2

A Research Study to Find Out How Semaglutide Works in the Kidneys Compared to Placebo, in People With Type 2 Diabetes and Chronic Kidney Disease (the REMODEL Trial)

REMODEL
Start date: April 28, 2021
Phase: Phase 3
Study type: Interventional

We are doing this study to learn more about how semaglutide may help fight chronic kidney disease in people with type 2 diabetes. We are doing this by looking into how semaglutide works in the kidneys. Participants will either get semaglutide or placebo (a 'dummy' medicine) - which treatment participants get is decided by chance. Semaglutide is a medicine doctors can prescribe in some countries for the treatment of type 2 diabetes. Participants will get the study medicine in a pen. Participants will use the pen to inject the medicine into the skin once a week. The study will last for about 1 year. Participants will have 11 visits to the clinic, and 2 phone visits. Some of the visits could be in different locations. Study staff will take blood samples at most of these visits. At 9 visits, participants will be asked to bring a sample of their first morning urine. At 4 of the visits participants will have to bring urine that they have collected over the last 24 hours. The study includes magnetic resonance imaging (MRI) scans of participants' kidneys which is a test that shows a detailed picture of organs and other parts inside the body. The scan will last for 30 minutes, and is free of radiation.

NCT ID: NCT04833127 Active, not recruiting - HIV Infections Clinical Trials

A Gender-Enhanced Pre-Exposure Prophylaxis (PrEP) Information-Motivational Workshop for Young South African Women

Masibambane
Start date: March 30, 2021
Phase: Phase 1
Study type: Interventional

This is a phase 1 pilot study to assess feasibility and acceptability and potential for impact of a gender-enhanced virtual group workshop focused on oral Pre-Exposure Prophylaxis (PrEP) as an HIV prevention method for young South African women. It was developed in collaboration with South African adolescent girls and young women (AGYW) aged 18-25. The investigators will compare AGYW (N=100) assigned to the virtual group-based (GE) workshop to those assigned to an Individually Accessed (IA) condition in which women are given access to a PrEP video and to websites that provide information on PrEP and on contraception options. Investigators also are evaluating the acceptability and feasibility of peer-driven recruitment (PDR). AGYW assigned to either intervention condition will be invited to become Peer Health Advocates (PHAs), who are incentivized to talk to social network members and refer up to three to the intervention type the PHA attended. The aim is to assess if PDR is self-sustaining and is effective at reaching women who might not be reached in clinics.

NCT ID: NCT04829318 Active, not recruiting - Clinical trials for Depressive Disorder, Major

A Long-Term Extension Study for Participants With Treatment-resistant Major Depressive Disorder Who Are Continuing Esketamine Nasal Spray Treatment

ESCAPE-LTE
Start date: April 26, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to assess the long-term safety and tolerability of esketamine nasal spray in combination with a selective serotonin reuptake inhibitor/serotonin-norepinephrine reuptake inhibitor (SSRI/SNRI) in participants who have completed 32 weeks of esketamine nasal spray treatment in Study 54135419TRD3013 (NCT04338321).

NCT ID: NCT04825327 Active, not recruiting - Tuberculosis Clinical Trials

Predicting the Future: Incipient Tuberculosis

PreFIT
Start date: April 21, 2021
Phase:
Study type: Observational [Patient Registry]

The investigators will study, prospectively, if contacts (household or close contacts) of tuberculosis (TB) patients with high C-reactive protein (CRP), low hemoglobin (Hb) levels, and a positive Xpert Host Response (HR) cartridge result develop active TB within 12 months. They will also investigate if there is a correlation between progressing to active TB within 12 months and having high levels of the iron homeostasis markers (Hepcidin, Ferritin and Transferrin). Identified index cases who agree to participate will refer their household or close contacts to also join the study. These contacts will be tested for TB and only contacts who are negative will be enrolled and followed-up at 6 months and 12 months. Blood samples will be collected at baseline and 6 months for testing. During the study period, TB testing will be done on contacts who meet symptoms criteria. At 12 months, all contacts will undergo a chest x-ray to assist in the diagnosis of TB. PreFIT will target people aged 12 to 60 years of age and both HIV negative and positive. 1515 trial participants will be recruited at Stellenbosch University in South Africa, 1515 at Fundaçao Manhiça in Mozambique and 1010 at Makerere University in Uganda, respectively.