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NCT ID: NCT04035486 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)

FLAURA2
Start date: July 2, 2019
Phase: Phase 3
Study type: Interventional

The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR). Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the study centre.

NCT ID: NCT04029194 Active, not recruiting - Aging Clinical Trials

The Causal Effects of Old Age Pensions

Start date: February 4, 2019
Phase: N/A
Study type: Interventional

Old age pensions are a common feature of welfare policy worldwide. However, little is known about the effect of these pensions on the recipients and their families. In this study, the investigators will partner with the government of Tamil Nadu, India to study the effects of old age pensions. Households with a member who is likely to be eligible for the pension but not currently receiving it will be assigned to either a treatment or control condition. Those assigned to treatment will receive assistance in applying for the pension. Investigators will track outcomes of the elderly and their family members for several years following the intervention. In addition to the impact of pensions on economic and health outcomes, the study will also explore how pension receipt affects the elderly's ability to cope with the impact of the COVID crisis.

NCT ID: NCT04023552 Active, not recruiting - Clinical trials for Cardiovascular Disease and Lipoprotein(a)

Assessing the Impact of Lipoprotein (a) Lowering With Pelacarsen (TQJ230) on Major Cardiovascular Events in Patients With CVD

Lp(a)HORIZON
Start date: December 12, 2019
Phase: Phase 3
Study type: Interventional

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a)

NCT ID: NCT04022408 Active, not recruiting - Clinical trials for Pancreatobiliary-Type Carcinoma

To Study the Role of Liquid Based Cytology (LBC) for Diagnosis and Characterization of Biliopancreatic Tumor s Compared With Standard Cytology and On-site Evaluation.

Start date: July 8, 2019
Phase: N/A
Study type: Interventional

Liquid Based Cytology is a method of preparing samples for examination in cytopathology.Liquid-based cytology (LBC), enables cells to be suspended in a monolayer. LBC makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. Conventional cytology is gold standard for biliopancreatic malignancy examination. This method is operator depended and have high inter observer variation . On site evaluation increases the sensitivity of conventional cytology but requires the presence of pathologist at the time of sampling . Our study will compare LBC with conventional cytology ,If found to be non inferior will be great help in centre were on site evaluation cannot be carried out . It will further reduce the interobserver variation

NCT ID: NCT03997786 Active, not recruiting - Clinical trials for Moderate-to-severe Chronic Plaque Psoriasis

A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis

Start date: January 15, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE). The initial PK analysis is first done in adolescent subjects (12 to <18 years) before initiating the PK study in younger cohort (6 to <12 years)

NCT ID: NCT03997123 Active, not recruiting - Clinical trials for Triple Negative Breast Neoplasms

Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC

CAPItello-290
Start date: June 25, 2019
Phase: Phase 3
Study type: Interventional

Phase III Study of Capivasertib + Paclitaxel versus Placebo + Paclitaxel as First line Treatment for Patients with Locally Advanced or Metastatic Triple-negative Breast Cancer (TNBC)

NCT ID: NCT03992430 Active, not recruiting - Clinical trials for Muscular Dystrophy, Duchenne

A Study to Compare Safety and Efficacy of a High Dose of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)

Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

This study will be comprised of 2 parts: Part 1 (dose escalation) will be conducted to evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram [mg/kg] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will be conducted for the selection of a high dose (100 mg/kg versus 200 mg/kg) and its comparison with the 30 mg/kg dose of eteplirsen, in approximately 144 participants with genetically confirmed deletion mutations amenable to treatment by skipping exon 51.

NCT ID: NCT03974113 Active, not recruiting - Hemophilia Clinical Trials

Fitusiran Prophylaxis in Male Pediatric Subjects Aged 1 to Less Than 12 Years With Hemophilia A or B

ATLAS-PEDS
Start date: January 28, 2020
Phase: Phase 3
Study type: Interventional

Primary Objective: - To confirm appropriate dose levels of fitusiran when administered to male pediatric participants (ages 1 to <12 years of age) with severe hemophilia A or B Secondary Objectives: - To characterize the safety and tolerability - To determine fitusiran plasma concentrations at selected time points

NCT ID: NCT03966586 Active, not recruiting - HIV Infections Clinical Trials

Syndemics and Loss From the HIV Care Continuum in India - Intervention

Start date: June 20, 2019
Phase: N/A
Study type: Interventional

The investigators will assess the feasibility and acceptability of a pilot intervention to keep people living with HIV (PLHIV) in southern India in care and virologically suppressed. The lack of understanding of the causes of loss from the HIV care continuum in India stifles the armamentarium of effective interventions to keep Indian PLHIV in care. The results of this research will demonstrate the feasibility and acceptability of a pilot intervention targeting the multiple mechanisms by which PLHIV become lost to care. By targeting these mechanisms, this intervention will be designed to be scalable in a setting where access to mental health specialists is limited.

NCT ID: NCT03955263 Active, not recruiting - Pregnant Women Clinical Trials

Malaria In Pregnancy in Central India

MIP
Start date: September 28, 2018
Phase:
Study type: Observational

The present study is planned to be conducted at a district level women and children`s hospital at Nagpur with the following objectives: Objectives: i) To assess the prevalence of asymptomatic malaria infection with all four species of malarial parasites namely P. falciparum, P. malariae, P. ovale and P. vivax during the first/second trimester of pregnancy among women attending the antenatal clinic at a secondary level urban health facility using PCR (polymerase chain reaction) for malaria parasites. ii) To determine the effect of malaria on duration of pregnancy, adverse outcomes and birth outcomes at delivery