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NCT ID: NCT04895709 Recruiting - Melanoma Clinical Trials

A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors

Start date: May 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.

NCT ID: NCT04895696 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

Start date: October 11, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness, safety and tolerability of Afimetoran in participants with active Systemic Lupus Erythematosus (SLE). The extension period will provide additional long-term safety and efficacy data and enable those participants initially randomized to placebo to receive treatment with Afimetoran.

NCT ID: NCT04895527 Recruiting - Clinical trials for Postoperative Complications

Air-test as a Predictor of Pulmonary and Systemic Complications After Laparoscopic Surgery

Start date: June 1, 2021
Phase:
Study type: Observational

One of the main risk factors for the development of postoperative pulmonary complications (PPC) in postsurgical patients is the persistence of atelectasis during this period. Therefore, it would be of great clinical interest to establish a causal relationship between postoperative atelectasis and the development of PPC, as well as having a relatively precise, simple and non-invasive method to rapidly diagnose these atelectasis. A prospective observational study will be carried out including all patients undergoing scheduled laparoscopic surgery, excluding pregnant women or women in the period of lactation, patients with moderate - severe acute respiratory distress syndrome, heart failure, need for mechanical ventilation during the 15 days prior to surgery or with a history of cardiothoracic surgery. Demographic variables (age, sex, weight, BMI), preoperative data (presence of allergies, cardiovascular risk factors, personal cardiopulmonary history, presence of toxic habits, baseline peripheral oxygen saturation, ASA classification, ARISCAT and frailty markers will be collected - Fried phenotype, scale clinical frailty and FRAIL scale -) and intraoperative (duration of the procedure, recruitment maneuvers). At 30 postoperative days the history will be reviewed clinic of the patients and the postoperative complications will be collected. Main objective: to demonstrate the veracity of the air-test in the prevention of pulmonary or other systemic complications in patients undergoing laparoscopic surgery. Secondary objectives: - Measure the incidence of positive results in the air-test. - Demonstrate the correlation between the performance of recruitment maneuvers and a negative score in the air-test - Demonstrate the correlation between the degree of frailty of the patients and a positive score in the air-test.

NCT ID: NCT04895488 Recruiting - Clinical trials for Negative Symptoms With Primary Psychotic Disorder

Cognitive Effects of Adjuvant Vortioxetine in Early Schizophrenia

CAVES
Start date: January 20, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Clinical trial to assess the efficacy of Vortioxetine compared with treatment as usual in early schizophrenia.

NCT ID: NCT04895436 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia (CLL)

Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)

ReVenG
Start date: March 28, 2022
Phase: Phase 2
Study type: Interventional

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed. Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide. Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort. 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: NCT04895241 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

TOPAZ-1
Start date: May 25, 2021
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

NCT ID: NCT04893291 Recruiting - Clinical trials for Coronary Artery Disease

Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels

TRANSFORM II
Start date: November 16, 2021
Phase: N/A
Study type: Interventional

International, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the efficacy, of Magic Touch Sirolimus Coated Balloon (SCB) compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).

NCT ID: NCT04892589 Recruiting - Clinical trials for Thumb Osteoarthritis

The Role of the Proprioceptive Training in Functional Recovery of Patient With Thumb Base Osteoarthritis

Start date: May 30, 2021
Phase:
Study type: Observational [Patient Registry]

Diseases that have implications for the thumb impact its function, and consequently, people occupational performance. Carpometacarpal joint (CMC) thumb degeneration translates into osteoarthritis (OA). Joint congruence, ligament integrity and compression of the joint surfaces caused by muscle contraction have historically been considered the three basic pillars for carpus stability. In recent years, a new factor has been proposed to explain carpal stabilization mechanisms: proprioception. The dorsal ligament complex is the structure with the highest concentration of mechanoreceptors, especially Ruffini's corpuscles. This study aims to detect the effect of proprioceptive training on the functional recovery of people with CMC osteoarthritis in conservative treatments.

NCT ID: NCT04892511 Recruiting - Clinical trials for Acute Ischemic Stroke

Hemodynamic Optimization of Cerebral Perfusion After Endovascular Therapy in Patients With Acute Ischemic Stroke

HOPE
Start date: June 1, 2021
Phase: Phase 4
Study type: Interventional

Mechanical thrombectomy is a very effective treatment in patients who have suffered an acute ischemic stroke associated with intracranial large vessel occlusion. However, less than half of the patients achieve functional independence despite treatment. The optimization of blood pressure after mechanical thrombectomy based on the degree of recanalization achieved at the end of the procedure could improve the perfusion of the ischemic brain tissue thanks to the improvement of blood circulation provided by collateral circulation. For this, authorized hypotensive or hypertensive drugs will be used. Moreover, this individualized treatment would allow to decrease reperfusion injury and therefore decrease the risk of intracerebral bleeding complications and cerebral edema. Therefore, we designed a clinical trial in which the standard management of blood pressure after mechanical thrombectomy will be compared with a specific protocol in which blood pressure targets are applied according to the degree of recanalization obtained during the thrombectomy procedure. The beneficial effect and risk reduction of this treatment will translate into a better short and long-term outcome

NCT ID: NCT04892407 Recruiting - Clinical trials for Age-Related Volume Deficit in the Mid-Face

Algeness DF 3.5% Compared to Voluma in Volume Deficit in Mid-face

Start date: September 6, 2021
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled study of Algeness® DF 3.5% Deep Volumizing Filler comparing to Juvéderm Voluma to correct midface volume loss.