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NCT ID: NCT04434092 Active, not recruiting - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

A Phase III Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors.

COMMODORE 2
Start date: October 8, 2020
Phase: Phase 3
Study type: Interventional

A study designed to evaluate the non-inferiority of crovalimab compared with eculizumab in participants with PNH who have not been previously treated with complement inhibitor therapy.

NCT ID: NCT04433585 Completed - Clinical trials for Systemic Lupus Erythematosus

A Study of LY3471851 in Adults With Systemic Lupus Erythematosus (SLE)

ISLAND-SLE
Start date: August 19, 2020
Phase: Phase 2
Study type: Interventional

The reason for this study is to see if the study drug LY3471851 (NKTR-358) is safe and effective in adults with systemic lupus erythematosus (SLE).

NCT ID: NCT04432831 Completed - Clinical trials for Diabetic Macular Edema

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Rhone-X
Start date: August 5, 2020
Phase: Phase 3
Study type: Interventional

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

NCT ID: NCT04432415 Suspended - Root Caries Clinical Trials

Comparison of Silver Diamine Fluoride and Sodium Fluoride Varnish to Prevent and Arrest Root Caries in Older Adults

Start date: September 1, 2017
Phase: N/A
Study type: Interventional

Dental caries (coronal and root) is highly prevalent in older adults. It is important to identify and implement the most effective methods that prevent the formation of root caries lesions and inhibit existing lesions at the community level. A clinical trial will be conducted in three groups of adults 60 years old and older, comparing the application of silver diamine fluoride solution and sodium fluoride varnish in dental root surfaces with caries and sound root surfaces. The objectives are to determine over a 30-month period which of the two agents is most effective in reducing the incidence of root caries, and which is most effective in arresting active root caries lesions. Hypothesis: the incidence of root caries will be lower in the group of subjects treated with silver diamine fluoride compared to sodium fluoride varnish. The arrest of active root lesions will be higher when using silver diamine fluoride compared to sodium fluoride varnish. Signed informed consent will be requested from persons 60 years and over, residents of four long-term care centers and attendees of a day care center in four central states of Mexico: Mexico City, Cuernavaca City, Oaxaca City and Toluca City. All facilities are administered by the National System for Integral Family Development (IFD), a public welfare institution that works at the federal and state levels. Three groups will be formed (60 participants in each), two groups will be administered each of the agents, the third group will be the control group. All groups will receive dental health education (oral hygiene, instructions for care and hygiene of removable dental prosthesis, information on prevention of coronal and root caries and periodontal diseases). The preventive agents will be administered according to the manufacturer's instructions. Clinical evaluations will be carried out at baseline 6, 12, 18, 24 and 30 months. The incidence of root caries among the groups will be compared with the percentage of active root lesions that were arrested and that remained inactive. If the greater efficacy of silver diamine fluoride is proven, it can be proposed for use in caries preventive programs for older persons, reducing the risk of tooth loss and improving quality of life. It will also serve as a guide for dental surgeon in-office decision-making regarding the method to use to prevent and limit root caries lesions in older adults at risk.

NCT ID: NCT04432194 Recruiting - Heart Failure Clinical Trials

Effect of Nutritional Supplementation and Pulmonary Rehabilitation on the Clinical Status of HF and COPD

Start date: August 30, 2019
Phase: N/A
Study type: Interventional

Cardiovascular diseases (CVD) are the leading cause of death in the world and our country. The prevalence of Heart Failure (HF) is 1-2% in the adult population in developed countries, up to 10% among people 70 years of age. Concerning COPD, it is estimated that by 2030 will be the third leading cause of death in the world; the prevalence in Mexico is 18.4%. Also, according to INEGI data, it is the 5th cause of death in people over 65. 50% of patients with COPD die of cardiovascular causes, and they are at higher risk of developing HF, hospital readmissions, and death. Subjects with HF and COPD concomitant have alterations such as; systemic inflammation, loss of muscle mass and strength of both skeletal and respiratory muscles, reduced tolerance to exercise, and lung function, which has an important impact on clinical status, quality of life and prognosis. The objective of nutritional treatment in HF is to reduce heart overload and reduce cardiovascular risk. On the other hand, in COPD, it is to improve lung function. However, this is not enough to maintain the protein reserves of patients due to previously affected factors. Therefore, it is vitally essential to contemplate the supplementation with amino acids that prevent and delay the loss of protein reserves, as well as the delay in clinical status. The β-hydroxy-β-methyl butyrate (HMB) is a metabolite of leucine, with an anticatabolic and anabolic effect. HMB improves the synthesis of proteins, muscle mass, strength, and muscle functionality. Citrulline has been associated with increased muscle mass, VO2, and exercise tolerance. On the other hand, pulmonary rehabilitation (RP) has improved exercise tolerance, mass, and strength of skeletal and respiratory muscles, quality of life, reduction of hospitalizations, and mortality. However, in concomitant HF and COPD, there are no guidelines that specify the type of RP or if there is a synergistic effect with nutritional supplementation and its impact on clinical status.

NCT ID: NCT04432103 Terminated - Covid-19 Clinical Trials

Treatment of Severe and Critical COVID-19 Pneumonia With Convalescent Plasma

Start date: August 8, 2020
Phase: Phase 3
Study type: Interventional

Open label two arms, non randomized Convalescent Plasma treatment to severe and critical pneumonia COVID-19 hospitlaized patients compared to a historical cohort with matched controls.

NCT ID: NCT04431414 Completed - COVID-19 Clinical Trials

A Study of Immune Responses to the Virus That Causes COVID-19

CoVPN 5001
Start date: July 20, 2020
Phase:
Study type: Observational

The purpose of this study is to learn more about the acute response to infection with and recovery from the virus called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Some people know this virus by the name "coronavirus." It can cause the disease called COVID-19. The information gained from the study can be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines, other prevention strategies, and treatments.

NCT ID: NCT04430777 Completed - Clinical trials for Blood Loss, Surgical

Use of Tranexamic Acid in Liposculpture

Start date: January 17, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Blood loss during a surgical procedure is inevitable, its reduction is a key factor for surgical success. Also, to avoid progress to severe complications like hemodynamic decompensation, cardiac arrest or the need to blood transfusions. According to the Center for Disease Control (CDC), there is a usage of more than 17 million transfused blood products units per year. Blood transfusion is a convenient technique for reposition of blood during major bleed, but it involves several probable complications like anaphylaxis, bloodborne infections and others. Consequently, meticulous hemostasis during surgery is crucial to diminish blood loss. Hemostatic agents play a pivotal role during surgical time. Amongst them topical, energy-based and systemic agents are the vast majority. Tranexamic acid (TXA) is a lysine synthetic derivate that inhibits fibrinolysis by blocking the 5 lysine-binding sites to plasminogen. It has been used in clinical practice since 1962 and become very popular after 2010 when the CRASH-2 study showed a decreased risk of death in trauma patients. Tranexamic acid use is widely extended among diverse surgical fields: orthopedics, cardiac surgery and obstetrics. In plastic surgery it uses is limited mainly to craniofacial surgery as a local agent. The aim of this trial is to show the efficacy of tranexamic acid as hemostatic agent in liposuction and to compare its efficacy among different administration routes.

NCT ID: NCT04430556 Active, not recruiting - Clinical trials for Major Depressive Disorder

Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

The objective of this transversal study is to determine if there is a difference in the volume of the hippocampus with the degree of anxiety.

NCT ID: NCT04429672 Active, not recruiting - Sexual Health Clinical Trials

Effect of a Socio-educational Intervention on Sexual Health in Young University Students

Start date: September 9, 2019
Phase: N/A
Study type: Interventional

The sexual health is considered as a state of physical, mental and social well-being in relation to sexuality that requires a positive and respectful approach to sexuality, as well as the possibility of having pleasant and safe sexual experiences, free from all coercion, discrimination and violence. However, lack of family planning, having unprotected sex, unwanted pregnancies, abortions, Sexually Transmitted Infections, lack of acceptance of sexual identity, sexism, having multiple sexual partners and having sex under the influence of alcohol and drugs are some of the main elements that alter the well-being of people's sexual health, especially in the young population. In this sense, different organizations have pointed out the importance of promoting in young people strategies related to providing an adequate level of knowledge in sexual health from a perspective of the exercise of sexual rights to reduce alterations in risky sexual practices and it has been identified that the school environment can be the ideal space for a health services approach to this age group to strengthen their well-being and ensure their development during adulthood. However, the sexual health interventions traditionally implemented by the health services are usually aimed mainly at transmitting knowledge about the benefits of condom use, sexually transmitted diseases and unwanted pregnancies and violence, excluding other elements that make up the sexual health and making use of conventional educational strategies through print media or short educational sessions, which causes little interaction between health personnel and users that consolidates the purpose of the interventions. That said, the implementation of a socio-educational intervention in sexual health that promotes sexual rights, positive attitudes towards sexuality and the prevention of risky sexual behaviors articulated in a model of a life project that motivates them to achieve the ideal stage of life for starting a family in a healthy way through family planning, can promote the strengthening not only of their sexual health but also their well-being for their future development as adults.