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NCT ID: NCT04557462 Recruiting - Clinical trials for Primary IgA Nephropathy

A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy

Start date: September 20, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.

NCT ID: NCT04557059 Recruiting - Prostatic Neoplasms Clinical Trials

A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer

PRIMORDIUM
Start date: November 12, 2020
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to determine if the addition of apalutamide to radiotherapy (RT) plus luteinizing hormone-releasing hormone agonist (LHRHa) delays metastatic progression as assessed by prostate specific membrane antigen-positron emission tomography (PSMA-PET) or death compared with RT plus LHRHa alone.

NCT ID: NCT04548687 Recruiting - Carbon Dioxide Clinical Trials

a Randomized Clinical Trial Evaluating the Effectiveness of Carbon Dioxide Use in Cardiac Surgery

CAR-DRIVER
Start date: June 19, 2020
Phase: N/A
Study type: Interventional

study of the efficacy and safety of carbon dioxide in cardiac surgery: repeated or minimally invasive

NCT ID: NCT04547816 Recruiting - Clinical trials for Functional Constipation

Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse

Start date: July 1, 2020
Phase: Phase 3
Study type: Interventional

This study is planned to evaluate the efficacy of complex conservative treatment (including tibial neuromodulation, biofeedback therapy, special pelvic floor training and diet modification) in women with pelvic organ prolapse

NCT ID: NCT04546750 Recruiting - Clinical trials for Venous Insufficiency

Prospective Cohort Study for Varicose Veins Incidence and Natural Course

VINCI
Start date: September 1, 2020
Phase:
Study type: Observational

A prospective study of individuals without varicose veins and who have primary varicose veins to assess the morbidity, risk factors and natural course of chronic lower limb vein disease.

NCT ID: NCT04545268 Recruiting - Heart Failure Clinical Trials

Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance

Start date: September 2020
Phase: N/A
Study type: Interventional

Among patients awaiting cardiac surgery, a significant proportion are patients with severe angina, heart failure (HF) and peripheral atherosclerosis. These factors are predictors of an unfavorable near and long-term prognosis after open cardiac surgery. It is known that the restriction of motor activity in patients with peripheral atherosclerosis and HF leads to loss of muscle mass, as well as to a decrease in its strength and endurance: secondary (disuse) sarcopenia is formed. In patients with peripheral atherosclerosis and HF, the low functional status of skeletal muscles is associated with a poor prognosis, regardless of gender, age, and concomitant coronary artery disease. A number of studies have shown that the deterioration of muscle status before abdominal, orthopedic and vascular surgery interferes with the close results of surgery, increases the number of complications, the length of ICU and in-hospital stay. Thus, sarcopenia serves as an additional factor worsening the prognosis. Therefore, efforts aimed at improving the functional status in patients planning an open cardiosurgical surgery seem to be very justified. Standard preoperative management of patients includes the identification and correction of comorbidities and the optimal medical treatment. The idea of "rehabilitation" means an additional improvement in the functional capabilities of patients awaiting surgery. Prevention includes outpatient outreach and educational work by nurses, as well as preoperative physical exercises. For this, multi-level training is used: respiratory exercises for the patients with the most severe illness, free movements of the limbs without load, or bike or treadmill training with increasing load for tolerable patients. However, adequate physical rehabilitation is difficult particularly on an outpatient basis. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity due to angina, chronic lower limb ischemia and heart failure symptoms. In this study, the investigators propose to use neuromuscular electrical stimulation (NMES) to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.

NCT ID: NCT04522609 Recruiting - Sarcopenia Clinical Trials

Electrostimulation of Skeletal Muscles in Patients Listed for a Heart Transplant

Start date: September 2020
Phase: N/A
Study type: Interventional

Heart transplantation is the best way to treat terminal heart failure, which can improve the quality and life expectancy of patients, as well as contribute to their social and labor rehabilitation. Actually, the procedure of heart transplantation is a complex procedure that requires the coordinated work of cardiologists, cardiac surgeons, anesthetists, perfusionist, nurses, as well as the administration of medical organizations. It is known that the restriction of motor activity in patients with heart failure leads to a loss of muscle mass, as well as a decrease in its strength and endurance. In patients with heart failure, the low functional status of skeletal muscle is associated with poor prognosis, regardless of gender, age, and concomitant coronary heart disease. Optimization of drug therapy and appropriate use of resynchronization therapy can improve functional status, as can patient engagement in exercise. Although exercise is recommended as a component of heart failure management, adherence is consistently low. This is particularly troubling because exercise has great potential as a low-risk, low-cost intervention to improve functional status and quality of life while decreasing heart failure symptoms and hospitalizations in patients with heart failure. Low adherence is due in part to inadequate strength and inability to tolerate or sustain even low levels of activity. In this study, we propose to use neuromuscular electrical stimulation to assist patient initiation of quadriceps strengthening in order to progressively increase low exercise tolerance.

NCT ID: NCT04520204 Recruiting - Clinical trials for Acute Myocardial Infarction

National, Multi-center, Prospective, and Retrospective Cohort Study.

REGION
Start date: October 1, 2020
Phase:
Study type: Observational [Patient Registry]

National, multi-center, observational, prospective, and retrospective cohort study. The study does not provide for intervention in routine clinical practice. Key goals: • Obtaining real-world evidence on the diagnosis and treatment of AIM in Russian hospitals, including both long- and short-term findings and outcomes (i.e. during hospitalization, and 6-12 months after the diagnosis establishment). - Evaluation of the applied approaches to the management of AIM patients for compliance with the clinical recommendations across various hospitals, with a breakdown by equipment status; - Assessment of patients' treatment adherence after 6 and 12 months. The expected project duration is 3 years. The study subjects will be recruited during the first 24 months unless the investigators decide to terminate or extend the study period. The period of observation for each patient is 6 to 12 months. The project involves retrospective and prospective collection of information from medical records. All patient data shall be recorded by the Investigator into an approved electronic case report form (eCRF). Recruitment period: 2020-2022. Expected number of subjects: 10,000.

NCT ID: NCT04519593 Recruiting - Clinical trials for Postoperative Complications

ABSOLUTELY: A Temporary Uterine Blood Supply Occlusion for Laparoscopic Myomectomy in Patients With UTErine LeiomYoma

Start date: September 27, 2020
Phase: N/A
Study type: Interventional

A phase 3 multicenter unblinded randomized controlled trial comparing the temporary uterine blood supply occlusion with conventional approach during laparoscopic myomectomy in patients with uterine leiomyoma.

NCT ID: NCT04519099 Recruiting - Schizophrenia Clinical Trials

Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Patients With Schizophrenia

Start date: July 30, 2018
Phase: Phase 3
Study type: Interventional

1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 mg/d compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d