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NCT ID: NCT05132075 Active, not recruiting - Clinical trials for Non-Small Cell Lung Cancer

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

KontRASt-02
Start date: June 15, 2022
Phase: Phase 3
Study type: Interventional

This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.

NCT ID: NCT05030428 Active, not recruiting - Clinical trials for Atherosclerotic Cardiovascular Disease

Study of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease

VICTORION-2P
Start date: November 23, 2021
Phase: Phase 3
Study type: Interventional

Study CKJX839B12302 is a pivotal Phase III trial to evaluate the benefits of inclisiran on major adverse cardiovascular (MACE) events in participants with established cardiovascular disease (CVD).

NCT ID: NCT04859361 Active, not recruiting - Clinical trials for Intraepithelial Neoplasia, Cervical

Comparison of Treatment of Cervical Intraepithelial Lesions With Imiquimod or LLETZ

Start date: November 20, 2018
Phase: N/A
Study type: Interventional

Purpose: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. LLETZ as standard treatment is possibly associated with premature labour, higher subfertility rate and a higher rate of spontaneous abortion. Since premature delivery is one of the most important causes of perinatal morbidity and mortality, alternative conservative methods for SIL treatment are constantly being evaluated. The immunomodulator imiquimod is one of the main target compounds for treating HSIL. Primary objective: to establish the efficacy of treatment with imiquimod (experimental arm) and compare it to the standard treatment with LLETZ (control arm). Secondary objective: - incidence and severity of the side effects in both groups; - need for treatment with LLETZ two years after primary treatment with imiquimod in the experimental arm or re-treatment with LLETZ two years after primary treatment with LLETZ in the control arm; - modulatory effect of imiquimod on immunoregulatory molecules. Study design: Single-centre randomized controlled intervention trial. Study population: 104 women with HSIL (52 in each arm). Intervention: - randomization in two arms: 1. Experimental arm (imiquimod): treatment for 16 weeks with 5% imiquimod. 2. Control arm (LLETZ). Successful treatment in the experimental arm is defined as absence of histological HSIL in diagnostic biopsies at 20-week follow-up (4 weeks after treatment completion) and in the control arm successful treatment is defined as absence of cytological HSIL in cytology 6 months after LLETZ (same as in our national guidelines).

NCT ID: NCT04786873 Active, not recruiting - Clinical trials for Growth Hormone Deficiency

A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is

DETECT
Start date: November 16, 2021
Phase: Phase 3
Study type: Interventional

This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can get this new stimulation test. The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test. The macimorelin test will be compared to a clonidine and an arginine test. Both are known standard stimulation tests. Altogether two macimorelin tests are planned to be performed in the study, to show how repeatable macimorelin tests results are (under a set of similar conditions).

NCT ID: NCT04777409 Active, not recruiting - Clinical trials for Early Alzheimer´s Disease

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)

Start date: May 18, 2021
Phase: Phase 3
Study type: Interventional

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

NCT ID: NCT04777396 Active, not recruiting - Clinical trials for Early Alzheimer's Disease

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)

Start date: May 18, 2021
Phase: Phase 3
Study type: Interventional

This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.

NCT ID: NCT04770896 Active, not recruiting - Clinical trials for Unresectable Hepatocellular Carcinoma

A Study of Atezolizumab With Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib Alone in Hepatocellular Carcinoma Previously Treated With Atezolizumab and Bevacizumab

IMbrave251
Start date: April 26, 2021
Phase: Phase 3
Study type: Interventional

This is a Phase III, open-label, multicenter, randomized, two-arm study designed to evaluate the efficacy and safety of atezolizumab plus either lenvatinib or sorafenib versus lenvatinib or sorafenib alone in participants with locally advanced or metastatic Hepatocellular Carcinoma (HCC) who have progressed on prior systemic treatment with atezolizumab plus bevacizumab combination.

NCT ID: NCT04740918 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)

KATE3
Start date: June 7, 2021
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or MBC.Participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for LABC/MBC; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.

NCT ID: NCT04652726 Active, not recruiting - Clinical trials for Familial Hypercholesterolemia - Heterozygous

Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Heterozygous Familial Hypercholesterolemia

ORION-16
Start date: January 27, 2021
Phase: Phase 3
Study type: Interventional

This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C).

NCT ID: NCT04628481 Active, not recruiting - Clinical trials for New-onset type1 Diabetes

A Study of Oral Ladarixin in Recent Onset Type 1 Diabetes and a Low Residual β-cell Function

Start date: December 21, 2020
Phase: Phase 3
Study type: Interventional

The objective of this clinical trial is to assess whether ladarixin treatment is effective in preserving beta-cell function and delaying the progression of type 1 diabetes (T1D) in adolescent and adult patients. The safety of ladarixin in the specific clinical setting will be also evaluated.