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NCT ID: NCT05399992 Recruiting - Clinical trials for Primary Hypercholesterolemia

Study Evaluating Effectiveness and Adherence of Inclisiran Plus Standard of Care (SoC) Lipid-lowering Therapy Compared to SoC in ASCVD

VICTORION REAL
Start date: September 12, 2022
Phase:
Study type: Observational

This observational matched prospective study aims to assess the effectiveness and adherence for inclisiran in combination with Lipid lowering therapies or Lipid lowering treatments (LLT) compared to other LLTs under conditions of routine clinical practice.

NCT ID: NCT05381987 Recruiting - Clinical trials for Myofascial Pain Syndrome of Neck

The Effectiveness of Radial Shockwave Therapy on Myofascial Pain Syndrome in Neck and Upper Back.

Start date: April 21, 2022
Phase: N/A
Study type: Interventional

Introduction: Myofascial pain syndrome (MPS) is a common, costly and often persistent musculoskeletal problem. Radial shockwave (RSW) is one of the most common treatment for MFS. However, a recent systematic review found very low-level evidence to support its short-term benefit, due to poor methodological qualities. The authors therefore recommended further large scale, good quality placebo-controlled trials (RCT) in this area. Further still, previous studies have not considered the experiences of patient regarding this intervention. Study Objectives: To determine the effectiveness of RSW compared to placebo for the treatment of patients with MPS in neck and upper back, and to establish the experiences of patients receiving the treatment. Research Questions: Is RSW therapy more effective at improving MPS compared to a placebo? What are the experiences of patients with MPS receiving this treatment? Methods: A pragmatic double blind RCT to investigate the effectiveness of RSW on patients with MPS and a semi-structured-interview to investigate the patients' experience of receiving the treatment. Sample: 120 potential participants with MPS for the RCT and 20 participants for the semi-structured qualitative interview. Interventions: The Intervention group will receive a total of 6 sessions of RSW following manufacturer's parameters: 1.5 bar, pulses 2000, frequency 15 Hz (Time 3 minutes). The Control group will receive an identical treatment except that the they will receive a no energy shock of 0.3 bar, frequency 15 and no pulses. Outcome measures: Improvements in the patient's numeric pain scale (NPS), neck disability index (NDI), pressure pain threshold (PPT) and SF-12 questionnaires at 4, 8 and 12 weeks' follow-up between the two groups. Significance of the Study's Outcome: The expectation is that this study will add to the body of knowledge required to help patients, healthcare practitioners, policy makers and researchers make effective treatment choices on RSW in the management MFS.

NCT ID: NCT05361434 Recruiting - Clinical trials for Advanced Renal Cell Carcinoma

A Study of the Effectiveness of Cabozantinib in Combination With Nivolumab as First-line Treatment of Advanced Renal Cell Carcinoma (aRCC) in Adults

CaboCombo
Start date: September 26, 2022
Phase:
Study type: Observational

The purpose of this study is to collect data to describe the safety and effectiveness of cabozantinib and nivolumab in combination as a first-line treatment in adults with aRCC with clear cell-component, according to real-world clinical practice. The decision to prescribe cabozantinib and nivolumab in combination will be made prior to, and independently from, the decision to enrol the participant in study.

NCT ID: NCT05348733 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

Start date: June 13, 2022
Phase:
Study type: Observational

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: - Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants - Reasons for starting finerenone - Reasons for stopping finerenone early - How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) - Dosing of finerenone - Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: - Stopping finerenone treatment too early - Dialysis (a medical procedure to filter the blood of extra water and waste) - Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.

NCT ID: NCT05347095 Recruiting - Clinical trials for Perianal Crohns Disease

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

FUZION CD
Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

NCT ID: NCT05342350 Recruiting - Clinical trials for Hepatocellular Carcinoma

International Study of High-Risk Patients for Hepatocellular Carcinoma Using Liquid Biopsy

STOP-HCC
Start date: April 15, 2022
Phase:
Study type: Observational [Patient Registry]

This study has two purposes. One is to conduct a phase IV biomarker validation study in which the investigators will prospectively survey a cohort of patients at risk for liver cancer using semi-annual abdominal ultrasound and GALAD Score for 5 years. The GALAD score is a serum biomarker-based panel that can aid in early detection among patients with a high risk for liver cancer. One is to establish a bio-repository of longitudinally collected bio-specimens from patients with fibrosis/cirrhosis as a reference set for future research.

NCT ID: NCT05330325 Recruiting - Clinical trials for SGA, Turner Syndrome, Noonan Syndrome, ISS

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

REAL 8
Start date: August 10, 2022
Phase: Phase 3
Study type: Interventional

The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for about 3 years. The participants will either get somapacitan once a week for 3 years or Norditropin® once a day for 1 year followed by somapacitan once a week for 2 years. Which treatment the participants get is decided by chance.

NCT ID: NCT05327894 Recruiting - Clinical trials for Acute Lymphoblastic Leukemia

Interfant-21 Treatment Protocol for Infants Under 1 Year With KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

Interfant-21
Start date: December 15, 2022
Phase: Phase 3
Study type: Interventional

This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.

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: NCT05296798 Recruiting - Clinical trials for Locally Advanced or Metastatic Breast Cancer

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

Start date: July 4, 2022
Phase: Phase 3
Study type: Interventional

This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.