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NCT ID: NCT06066528 Recruiting - Obesity Clinical Trials

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight

SYNCHRONIZE™-2
Start date: November 15, 2023
Phase: Phase 3
Study type: Interventional

This study is open to adults who are at least 18 years old and have a body mass index of 27 kg/m² or more. People can take part if they have type 2 diabetes and if they are currently being treated only with diet and exercise or with specific diabetes medications. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity who also have diabetes to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The study staff also regularly measure participants' body weight. The results are compared between the groups to see whether the treatment works.

NCT ID: NCT06065748 Recruiting - Clinical trials for Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

Start date: December 11, 2023
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

NCT ID: NCT06065540 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

REIMAGINE 2
Start date: September 27, 2023
Phase: Phase 3
Study type: Interventional

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

NCT ID: NCT06062420 Recruiting - Clinical trials for Neoplasms, Head and Neck

Phase 2 Platform Study of Novel Immunotherapy Combinations as First-Line Treatment in Participants With PD-L1 Positive Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Start date: November 14, 2023
Phase: Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the antitumor activity and safety of novel immunotherapy combinations compared with dostarlimab in participants with Programmed death ligand 1 (PD-L1) positive Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC).

NCT ID: NCT06059846 Recruiting - Clinical trials for Urinary Tract Infection

A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

PIVOT-PO
Start date: December 21, 2023
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (≥18 years of age) with cUTI or AP.

NCT ID: NCT06059638 Recruiting - Hypertension Clinical Trials

BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT

BACKBEAT
Start date: December 27, 2023
Phase: N/A
Study type: Interventional

A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a previously implanted dual-chamber Medtronic Astra/Azure DR MRI IPG.

NCT ID: NCT06057168 Recruiting - Clinical trials for Brain Tumor, Recurrent

Performance of Elucirem® in DSC-MRI Perfusion of Brain Gliomas

GDX-44-016
Start date: September 7, 2023
Phase: Phase 3
Study type: Interventional

This trial aims to study the performance of Elucirem® (gadopiclenol) in Dynamic Susceptibility Contrast Magnetic Resonance Imaging (DSC-MRI) perfusion of brain gliomas.

NCT ID: NCT06052267 Recruiting - Asthma Clinical Trials

A Study to Test if a Fixed-Dose Combination of Fluticasone Propionate/Albuterol Sulfate is Effective in Preventing Asthma Exacerbations

Start date: August 30, 2023
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to demonstrate the efficacy of high dose and low dose fluticasone propionate (Fp)/albuterol sulfate (ABS) integrated electronic module multidose dry powder inhaler (eMDPI) compared to ABS eMDPI in decreasing severe clinical asthma exacerbation (CAEs). Secondary Objectives: To evaluate the efficacy of Fp/ABS compared to ABS and the effect on systemic corticosteroid (SCS) exposure To evaluate the safety and tolerability of Fp/A BS The duration for each participant will be a minimum of 28 weeks including 2 weeks of screening, 2-4 weeks of run-in period and a double blind treatment period of minimum 24 weeks, however due to the event-driven nature of this study, the duration may range up to approximately 35 months depending on the timing when the participant was enrolled to the study, and when the study reaches its completion criteria.

NCT ID: NCT06049017 Recruiting - Colitis, Ulcerative Clinical Trials

A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis

ANTHEM-UC
Start date: October 9, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of JNJ-77242113 compared with placebo in participants with moderately to severely active ulcerative colitis.

NCT ID: NCT06048731 Recruiting - Tachycardia Clinical Trials

Enlighten Study: The EV-ICD Post Approval Registry

Start date: September 1, 2023
Phase:
Study type: Observational

Medtronic is sponsoring Enlighten: The EV-ICD Post Approval Registry, to further confirm safety and effectiveness of EV-ICD in routine clinical practice, following commercial release of EV-ICD devices.