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NCT ID: NCT06061354 Recruiting - Bone Regeneration Clinical Trials

Teriparatide on Maxillary Sinus Floor Osseointegration

Start date: August 23, 2023
Phase: Phase 4
Study type: Interventional

The aim of this triple blind randomized controlled trial will be to analyze the effect of a dose of teriparatide combined with a xenograft on bone augmentation of the maxillary sinus, to observe the microarchitecture of the newly formed bone and the primary and late stability of implants placed on these grafts. The sample is composed of 42 participants who have a clinical indication for maxillary sinus floor augmentation with bone grafting due to residual bone height less than or equal to 5mm for the installation of dental implants. Each side will be grafted with Bio-Oss® or Bio-Oss® combined with 1 dose (20 µg) of teriparatide (Forteo®). Three months after grafting, at the time of placement of dental implants, bone biopsies will be obtained using a short 2mm trephine bur. These bone cores will be submitted to histological and histomorphometric analysis. The stability of the implants will be measured, at the time of their installation, through the insertion torque, and through the use of resonance frequency equipment (Ostell®) in three moments: immediately and at 3 and 6 months after the installation of the dental implants.

NCT ID: NCT06056245 Recruiting - Clinical trials for Chronic Kidney Diseases

Methadone Pharmacokinetics in End-stage Renal Disease

MCKD
Start date: April 5, 2024
Phase:
Study type: Observational

The goal of this observational study is to describe the influence of renal function on the pharmacokinetics of methadone used through an intravenous patient-controlled analgesia (IV-PCA) pump for the management of acute postoperative pain. After surgery the participants will use an IV-PCA of methadone and blood samples will be withdrawn to measure the plasmatic levels of it. The main question the study aims to answer is: • Is the pharmacokinetic of methadone used in an IV-PCA pump impaired in patients with chronic kidney disease?

NCT ID: NCT06054555 Recruiting - Melanoma Clinical Trials

A Study to Evaluate ABP 206 Compared With OPDIVO® (Nivolumab) in Subjects With Unresectable or Metastatic Melanoma

Start date: November 2, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy, safety, and immunogenicity of ABP 206 compared with Nivolumab in Subjects with Treatment-Naïve Unresectable or Metastatic Melanoma.

NCT ID: NCT06052059 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.

NCT ID: NCT06042036 Recruiting - Clinical trials for Respiratory Insufficiency

Adherence to Low Tidal Volume in the Transition to Spontaneous Ventilation in Patients With Acute Respiratory Failure

SPIRAL
Start date: June 12, 2023
Phase:
Study type: Observational

The goal of this observational study is to estimate the prevalence of the use of protective ventilation with low tidal volume ventilation in the transition of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure in ICUs in Latin America and its association with patient outcomes. The main questions it aims to answer are: - what is the prevalence of the use of low tidal volume ventilation (VT <8 mL/kg of predicted body weight) in the first 24 hours of spontaneous ventilation modes in patients with hypoxemic acute respiratory failure? - Is there an association between the rate of adherence to low tidal volume ventilation in spontaneous ventilation modes and the ability to stay off ventilatory support and mortality? Participants are patients with acute respiratory failure under mechanical ventilation. Investigators will collect data on the ventilatory parameters of participants - 24 hours before they begin to be ventilated with spontaneous modes of ventilation - during the first 24 hours of spontaneous ventilation Investigators will collect several patient-centered clinical outcomes at 28 days after study inclusion, including ventilator-free days and mortality

NCT ID: NCT06040086 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations

MIRANDA
Start date: September 22, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab administered subcutaneously (SC) in adult participants with symptomatic COPD with a history of ≥ 2 moderate or ≥ 1 severe exacerbations of COPD in the 12 months prior to enrolment. Participants should be receiving optimised treatment with inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) throughout at least the last 3 months prior to enrolment.

NCT ID: NCT06033833 Recruiting - Asthma Clinical Trials

Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study

RIVER-ASTHMA
Start date: September 5, 2023
Phase: Phase 2
Study type: Interventional

This is a study of amlitelimab for the treatment of participants with moderate-to-severe asthma. The study will have a double-blind treatment period until Week 24 for each participant and an open-label treatment period where each participant will receive open-label amlitelimab from Week 24 onwards. The purpose of this study is to evaluate long-term safety, tolerability, and efficacy of amlitelimab for the treatment of adult participants with moderate-to-severe asthma who have previously been enrolled and completed the treatment period of the parent study. The study duration will be up to 156 weeks. The treatment duration will be up to 144 weeks. The number of visits will be 18.

NCT ID: NCT06025578 Recruiting - Clinical trials for Progressive Pulmonary Fibrosis

A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive Pulmonary Fibrosis

Start date: October 25, 2023
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis.

NCT ID: NCT06012240 Recruiting - Alopecia Areata Clinical Trials

A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata

Up-AA
Start date: October 11, 2023
Phase: Phase 3
Study type: Interventional

Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA. Upadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1 or Study 2, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 240 sites worldwide. Participants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose. 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: NCT06008756 Recruiting - Arteriosclerosis Clinical Trials

MK-0616 (Oral PCSK9 Inhibitor) Cardiovascular Outcomes Study (MK-0616-015) CORALreef Outcomes

Start date: October 9, 2023
Phase: Phase 3
Study type: Interventional

This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.