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NCT ID: NCT05455684 Recruiting - Clinical trials for Depressive Disorder, Major

A Study of Aticaprant as Adjunctive Therapy in Adult Participants With Major Depressive Disorder (MDD) With Moderate-to-severe Anhedonia and Inadequate Response to Current Antidepressant Therapy

VENTURA-1
Start date: June 22, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of aticaprant compared with placebo as adjunctive therapy to an antidepressant in improving depressive symptoms in adult participants with major depressive disorder (MDD) with moderate-to-severe anhedonia (ANH+) who have had an inadequate response to current antidepressant therapy with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI).

NCT ID: NCT05455112 Recruiting - Clinical trials for Tuberculosis, Pulmonary

Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis

CONSTAN-ARG
Start date: October 29, 2022
Phase: Phase 2
Study type: Interventional

This study is proposed to evaluate the safety and efficacy of the RUTI vaccine in patients with pulmonary tuberculosis. Therapeutic vaccination of RUTI would stimulate the immune response not only against growing bacteria, but also against bacteria in a latent state that are less sensitive to antibiotic treatments. Therapeutic vaccination in patients with pulmonary tuberculosis could improve the speed of recovery of patients without inducing the appearance of drug resistance.

NCT ID: NCT05453370 Recruiting - Clinical trials for Self-Injurious Behavior

CALMA App as an Adjunct to Therapy for Reduction of Suicidal and Non-Suicidal Self-Injurious Behaviors in Adolescents

Start date: February 24, 2022
Phase: N/A
Study type: Interventional

Suicide in the second cause of death in subjects between 15 and 24 years of age. Despite the efficacy of interventions for the management of suicidal crises observed in some clinical trials, a crucial aspect for their effectiveness is accessibility. This leaves little time to intervene during the suicidal process. New platforms to provide evidence-based interventions, universally, economically, and quickly are needed. Smartphones appear to be a good alternative considering the high penetration of these devices locally. The research group carried out a pilot randomized controlled cluster trial with four weeks of follow-up that provided initial evidence on the safety and acceptability of the app for reducing self-injurious thoughts and behaviors when used as an adjunct to conventional Dialectical Behavioral Therapy (DBT). This study conducted with a group of patients who were already undergoing DBT treatment program, and have shown good acceptability of CALMA as an adjunct to therapy targeting suicidal and non-suicidal self-injury behaviors. Although effectiveness was not the main outcome, results revealed a high probability to decrease suicidal outcomes including ideation, suicidal behaviors, Non-Suicidal Self-Injury (NSSI) and thoughts about NSSI in the group that received CALMA compared to the comparison group. No specific app for adolescents and young people is available in Spanish. The research group developed CALMA (the Spanish word for "calm"), the first user-interactive mobile app in Spanish. It provides evidence-based tools to manage a suicidal or non-suicidal self-directed violence crisis. CALMA also interacts with the user between crises by promoting activities that reduce their vulnerability to suicide by provide psychoeducation about suicide and its prevention. Based on these encouraging initial findings, in this project the investigators propose to scale the intervention to a larger group of patients, focus it on adolescents and including public hospitals not specialized in DBT. This is a parallel group, two-arm randomized controlled trial design, which will employ an intervention condition (CALMA app) and a control condition (Treatment as usual) with a 3-month follow-up for each participant, to evaluate the effectiveness, safety and acceptability of CALMA, a suicide prevention app for smartphones, to reduce the frequency of self-injurious thoughts and behaviors in adolescents who are assisted in a Mental Health service of three Public Hospitals.

NCT ID: NCT05452603 Recruiting - Clinical trials for Gastroesophageal Reflux

Usefulness of Wireless pH Monitoring in GERD Diagnosis

Start date: June 20, 2021
Phase:
Study type: Observational

Gastroesophageal reflux disease (GERD) is extremely common in our environment. Its diagnosis is complex. The Lyon Consensus defined, based on 24-hour pH monitoring, that an acid exposure time greater than 6% is definitely abnormal, less than 4% is normal, and between 4 and 6% is a gray area. The objective of this study is to describe the change in therapeutic behavior based on the result of prolonged pH recording performed with a 96-hour wireless pH measurement capsule in patients with GERD symptoms and an acid exposure time measured by impedanciometry/pH of 24 hours in the gray area. Also, describe the therapeutic outcomes.

NCT ID: NCT05447338 Recruiting - Neck Pain Clinical Trials

Manual Therapy in Patients With Neck Pain

Start date: August 1, 2022
Phase: N/A
Study type: Interventional

Neck pain is a common clinical condition of some diseases that affect the soft tissues, musculotendinous structures and joints of the cervical spine. It is characterized by pain in the posterior and lateral muscles of the neck, muscle contractures and partial functional impotence. An important finding is that approximately 60% of total cervical rotation takes place at C1-C2, regardless of age. The test used to diagnose dysfunction of the upper cervical spine is the Cervical Rotation Flexion Test (CRFT) and is measured in degrees through various instruments, the most current validated by scientific literature are mobile applications (Clinometer and Compass ). Having in clear the importance of the location (C1-C2) of the origin of many of the symptoms and signs that cervicalgia generates and mainly the restriction of the range of movement that they produce in the cervical spine. It is that the manual therapy technique: Joint mobilization post muscular inhibition (MAEPI) that is included in this study for its analysis, is directed to this segment of the cervical spine. This differs from other similar techniques, in terms of location and movement of the joint surfaces, which have been previously studied and have shown their effectiveness (techniques that will be used in the control group), in that the micro movements of the joint surfaces ( joint arthrokinematics) based on the principles of Kaltenborn-Evjenth will be combined with the principles of the hold relax technique belonging to the Proprioceptive Neuromuscular Facilitation method. The main therapeutic objective of the MAEPI technique is to improve mobility and reduce pain in the cervical spine. Hypothesis: The MAEPI technique will improve mobility and reduce neck pain as well as other symptoms associated with neck pain, such as headache, dizziness and nausea, and will be more effective than those of the control group (Maitland central posterior-anterior passive joint mobilization in C2 and natural apophyseal slippage sustained (SNAG) in rotation about Mulligan's C1). The MAEPI technique will be more effective when applied later to myofascial induction techniques.

NCT ID: NCT05437263 Recruiting - Dermatomyositis Clinical Trials

A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis

VALOR
Start date: October 31, 2022
Phase: Phase 3
Study type: Interventional

This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of treatment with brepocitinib (TYK2/JAK1 inhibitor) in adults with dermatomyositis (DM). The primary objective of this study is to assess the efficacy of two dose levels of brepocitinib in comparison to placebo, as measured by differences in the Total Improvement Score (TIS). After 52 weeks of double-blind treatment, participants have the option to continue therapy in a 52 week open-label extension phase where all participants will receive brepocitinib.

NCT ID: NCT05429632 Recruiting - Clinical trials for Adult Acute Myeloid Leukemia

Mocravimod as Adjunctive and Maintenance Treatment in AML Patients Undergoing Allo-HCT

MO-TRANS
Start date: June 16, 2022
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blinded, placebo controlled trial.

NCT ID: NCT05421533 Recruiting - Atrial Fibrillation Clinical Trials

Study in Atrial Fibrillation (AF) Patients at High Risk of Stroke

GARDENIA
Start date: September 14, 2022
Phase:
Study type: Observational [Patient Registry]

The GARDENIA registry will collect real-world clinical data on the anticoagulant strategies in patients with AF at elevated risk of stroke but also elevated risk of bleeding.

NCT ID: NCT05409066 Recruiting - Clinical trials for Follicular Lymphoma (FL)

Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma

EPCORE FL-1
Start date: September 20, 2022
Phase: Phase 3
Study type: Interventional

Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05402397 Recruiting - Clinical trials for Uric Acid Nephropathy

Losartan and Uric Acid Metabolism in Children With Proteinuric Nephropathies

Start date: July 1, 2022
Phase: Phase 4
Study type: Interventional

The aim of this study is to assess the serum uric-acid lowering effect of losartan in children with proteinuric nephropathies. Patients already treated with enalapril will be randomized to receive losartan and/or enalapril in a cross-over designed study. Those who recruit the inclusion criteria will receive enalapril and/or losartan during a one month period, followed by a 15 days of wash out (under enalapril treatment). On day 46, the second period of 30 days of treatment start (enalapril or losartan, whichever was not received initially). Before randomization, a baseline 24 hours urine and a fasting blood sample will be obtained to assess uric acid excretion and serum uric acid values along with renal function and electrolyte levels. Then, similar determinations will be performed at days 30, 46 and 76.