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NCT ID: NCT05027802 Active, not recruiting - Clinical trials for Fibrodysplasia Ossificans Progressiva (FOP)

A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies.

PIVOINE
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

The main objective of this study is to further evaluate the safety and efficacy of palovarotene in adult and paediatric participants with FOP. The aim of the study is also to ensure treatment continuity to participants who have completed one of the parent studies (Study PVO-1A-301, Study PVO-1A-202 and Study PVO-1A-204) and who, in the investigator's judgement, may benefit from palovarotene therapy.

NCT ID: NCT05027399 Not yet recruiting - Heart Failure Clinical Trials

Nursing Teleconsultation for Patients With Heart Failure

NurTHF
Start date: October 20, 2022
Phase: N/A
Study type: Interventional

The incidence and prevalence of heart failure are increasing and represent a large portion of hospitalizations in Brazil, are also associated with high rates of morbidity, mortality and costs for the service of health. Such data, added to the current scenario of the pandemic caused by COVID-19, reveal the need for changes in clinical practice, so that health care is more effective and cost-effective and reaches patients without exposing them to risks. Thus, the application of nursing interventions through of telephone technology, which has strong evidence of effectiveness found in the literature, has become an alternative for the implementation of clinical interventions. Objective: Evaluate the effectiveness of nursing consultations performed remotely in improving quality of life and adherence to therapy of patients with HF due to cardiomyopathy of different etiologies. Method: The study will have as methodological framework the randomized clinical trial, with the recruitment of 60 volunteers with a diagnosis of chagasic HF, Hypertensive or Idiopathic, who are monitored at the outpatient clinic of Clinical Unit of Cardiomyopathies and Aortic Diseases or Clinical Unit of Hypertension, InCor-HCFMUSP, included by drawing lots into two groups. group A (n=30) will be monitored in biweekly nursing consultations by a period of three months added to the outpatient follow-up, and group B (n = 30) will follow the usual outpatient follow-up. Hypothesis: Patients HF carriers who periodically make telephone consultations of nursing have better quality of life and better therapeutic adherence when compared to patients who only have regular follow-up.

NCT ID: NCT05027152 Not yet recruiting - Dermatomyositis Clinical Trials

Muscle Function and Effects of Repetitive Task Training in Patients With Inflammatory Myopaties

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Idiopathic inflammatory myopathies lead to important functional limitations resulting from the loss of muscle strength and endurance, especially in the hip and shoulder, which leads to a significant loss of quality of life for patients. The aim of this study is to correlate the "Myositis Functional Index-3 (FI-3)" with muscle function assessed by computerized isokinetic dynamometry, electromyography and magnetic resonance through an observational study; and to compare the effects of a repetitive task training program with a resistance exercise program through an interventional study in patients with inflammatory myopathies. It is expected that FI-3 will present a good correlation with muscle function assessed by computerized isokinetic dynamometry and electromyography, given its reduced cost and less time spent on evaluation. It is also expected to demonstrate that repetitive task training is as efficient and safe as resistance exercises.

NCT ID: NCT05027074 Active, not recruiting - Clinical trials for Kidney Failure, Chronic

Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)

Start date: September 17, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection of MK-2060 in future studies. The primary hypothesis is that at least one of the MK-2060 doses is superior to placebo in increasing the time to first occurrence of AVG event.

NCT ID: NCT05024500 Completed - Clinical trials for Acute Respiratory Distress Syndrome (ARDS)

Clinical and Functional Outcomes of Critically Ill Patients With COVID-19

COVIDPTcare
Start date: October 21, 2020
Phase: N/A
Study type: Interventional

People affected by Severe Acute Respiratory Syndrome (SARS) by COVID-19 virus my require a long lasting invasive mechanical ventilation life support. To prevent damages to the lungs a number of protective lung ventilation measures are taken, one of them encounters the positive end expiratory pressure (PEEP) titration. Up to date, it is unclear the best method to titrate PEEP considering this unconventional syndrome compared to other etiologies. In addition to the long lasting advanced life support and bedridden condition, other factors may affect respiratory and peripheral muscle function of these patients. Therefore, the investigators intend to follow up these patients randomized to one of the three-arm experimental PEEP titration and after ICU discharge their status on clinical, laboratory and physical functions assessments.

NCT ID: NCT05023980 Active, not recruiting - Clinical trials for Chronic Lymphocytic Leukemia

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

BRUIN CLL-313
Start date: September 23, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

NCT ID: NCT05023642 Completed - Resistance Training Clinical Trials

Training-induced Muscle Strength and Its Role in Interface Pressure in Inelastic Compression

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

The present study will answer the following question: what are the effects of strength gain and muscle hypertrophy on interface pressure, static stiffness index, and working pressure amplitude in the elderly using inelastic compression?

NCT ID: NCT05022108 Completed - Wounds and Injuries Clinical Trials

Alpha-Bisabolol Gel With Antihistamine Action

Start date: April 1, 2020
Phase: Phase 1
Study type: Interventional

It will be developed and evaluated the antihistamine potential of a gel containing alpha-bisabolol. Method: Interventional and cross-sectional study, with convenience sampling, conducted with 20 volunteers. The forearm will be sensitized at four points (A, B, C and D). Point A: positive control will be sensitized with a drop of histamine at a concentration of 10 mg / Ml. Point B: histamine will apply and immediately after, the alpha bisabolol gel with a concentration of 0.5%. Point C: histamine and gel with 2.5% alpha-bisabolol will apply. Point D will be sensitized with a drop of histamine and 5.0% alpha-bisabolol gel. The test reading at each point will occur 15 minutes after the procedure. For the analysis of the results, the T Test will be applied.

NCT ID: NCT05021835 Recruiting - Inflammation Clinical Trials

ZEUS - A Research Study to Look at How Ziltivekimab Works Compared to Placebo in People With Cardiovascular Disease, Chronic Kidney Disease and Inflammation

ZEUS
Start date: August 30, 2021
Phase: Phase 3
Study type: Interventional

This study is conducted to see if ziltivekimab reduces the risk of having cardiovascular events (for example heart attack and stroke) in people with cardiovascular disease, chronic kidney disease and inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body). This is known as the study medicine. Which treatment participants get is decided by chance. Participants chance of getting ziltivekimab or placebo is the same. Ziltivekimab is not yet approved in any country or region in the world. It is a new medicine doctors cannot prescribe. Participants will get the study medicine in a pre filled syringe. Participants will need to use the pre filled syringe to inject the study medicine into a skinfold once-monthly. The study is expected to last for up to 4 years. Participants will have up to 20 clinic visits. Participants will have blood and urine samples taken at most of the clinic visits. Participants will have their heart examined using sound waves (echocardiography) and electrodes (electrocardiogram). Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.

NCT ID: NCT05020743 Recruiting - ALSP Clinical Trials

Natural History Study in Adult-Onset Leukoencephalopathy With Axonal Spheroids and Pigmented Glia

ALSP
Start date: September 13, 2021
Phase:
Study type: Observational

Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) is a rare, rapidly progressing, genetic, neurodegenerative disease for which no definitive treatment options and limited information on the natural history of the disease are available. The structural, genetic, and neuropathophysiological abnormalities of ALSP lead to the onset of neurologic symptoms, such as moderate to severe motor and neuropsychiatric impairments. This natural history study will collect data to contribute to the development of future novel therapies that focus on the neuropathophysiological features that underlie ALSP and that are essential to reverse, delay, or stop progression of this debilitating disorder.