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NCT ID: NCT05307705 Recruiting - Breast Cancer Clinical Trials

A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

PIKASSO-01
Start date: May 11, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-783. LOXO-783 may be used to treat breast cancer and other solid tumors that have a change in a particular gene (known as the PIK3CA gene). Participation could last up to 36 months (3 years) and possibly longer if the disease does not get worse.

NCT ID: NCT05306574 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Start date: June 20, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

NCT ID: NCT05306340 Recruiting - Clinical trials for Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With The Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

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

This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.

NCT ID: NCT05306041 Recruiting - Clinical trials for HER2-positive Breast Cancer

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

GeparPiPPa
Start date: January 2, 2023
Phase: Phase 2
Study type: Interventional

Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.

NCT ID: NCT05304377 Recruiting - Clinical trials for Chronic Myeloid Leukemia

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

CML
Start date: May 22, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

NCT ID: NCT05303857 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Analyse the Effect of Semaglutide on Vascular Structure and Function in Patients With Early Type 2 Diabetes

SEMA
Start date: March 3, 2022
Phase: Phase 4
Study type: Interventional

This is a phase IV, randomized (1:1), prospective, double-blind, placebo controlled, parallel-group, single center study at the Clinical Research Unit (CRC) of the Department of Nephrology and Hypertension, with its two separate locations: - Nürnberg, Kreuzburger Str. 2, 90471 Nürnberg, and - Erlangen, Ulmenweg 18, 91054 Erlangen The main goal of the study is to demonstrate the effect of semaglutide on different vascular parameters of the macro- and microcirculation. The primary objective is to analyze the effect of semaglutide, compared to placebo on central (aortic) pulse pressure. At least 90 patients will be randomized (1:1) and included (informed consent, intention to treat population) in order to obtain 80 fully evaluable subjects (per protocol population). Patients will be simultaneously recruited from investigator's outpatient clinics, referring physicians, and advertisement in local newspapers, and social media. Those patients that appear to potentially fulfill the inclusion criteria will be invited to a screening visit (visit 1). After providing informed consent, patients will be tested for inclusion/exclusion criteria. Patients will provide a blood sample for laboratory testing. If the patient then fulfills inclusion criteria and in the absence of exclusion criteria, the patient will be enrolled into the trial, and the study visits will be scheduled. Randomization will take place at the latest one day prior to the study visit 2 (e.g. at the latest at visit 2a). At visit 2 (2a and 2b), baseline vascular function parameters will be obtained and the patient will be given a SC injection of the study drug (either SC 0.25 mg semaglutide or SC placebo). After giving detailed instructions to the patient how to apply the injections, the patient will be advised to apply the injection once weekly. A safety visit will be conducted 1 week after first administration of study drug (visit 3). At visit 4 and 5, semaglutide will be up-titrated to 0.5 mg and 1.0 mg respectively. At visit 6, a safety visit will be conducted and the dose of semaglutide will be kept at 1.0 mg. After 16 weeks of treatment (visits 7a and 7b), testing of vascular function will be repeated. At visit 7b, a final close out visit will be performed to gather additional safety information.

NCT ID: NCT05303012 Recruiting - Clinical trials for Overweight and Obesity

Multicentre Study to Record the Mental and Physical Effects of the COVID-19 Pandemic (COBESITY-Study)

Start date: December 1, 2021
Phase:
Study type: Observational

Prospective, international multicenter study to investigate the physical and psychological effects of the COVID-19 pandemic in two obese patient cohorts (BMI ≥ 25 kg/m²) pre- and post-bariatric surgery. In addition, the investigation of country-specific differences will be performed.

NCT ID: NCT05302934 Recruiting - Clinical trials for Rheumatoid Arthritis

Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty

Pheno4U Pilot
Start date: September 28, 2022
Phase:
Study type: Observational

Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients

NCT ID: NCT05301842 Recruiting - Clinical trials for Hepatocellular Carcinoma

Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

EMERALD-3
Start date: March 28, 2022
Phase: Phase 3
Study type: Interventional

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

NCT ID: NCT05300724 Recruiting - Clinical trials for Age-Related Macular Degeneration

An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration

HONU
Start date: May 27, 2022
Phase:
Study type: Observational

This is a multicenter prospective study in participants with intermediate age-related macular degeneration (iAMD). One primary objective of this study is to assess iAMD disease progression, by the timeline and rates of conversion for high-risk iAMD at baseline to more advanced atrophic AMD stages. The other primary objective of this observational study is to assess the feasibility of measuring the rate of photoreceptor loss as a potential clinical endpoint. The study will consist of an observation period of approximately 3 years (~144 weeks) for participants.