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Recruiting Phase 4

Improving Therapeutic Drug Monitoring and Dosing for Vancomycin in Young Infants With Infections (VANCAPP) (Part 2)

Sepsis Infections Bacteremia

A challenge to intermittent vancomycin dosing in young infants is the avoidable delay caused by the need to wait until steady state (i.e. when the drug concentrations are in equilibrium) to measure a vancomycin concentration, as this generally occurs 24 to 48 hours after starting treatment. If the target concentration is not achieved, the dose needs to be adjusted, resulting in further delays in an infant achieving the concentration required to treat their infection. The purpose of this study is to assess the use of early therapeutic drug monitoring (first-dose trough) and, if needed, early dose adjustment, in achieving target vancomycin concentrations at steady state. A dose adjustment calculator (available through a web application) will be used to determine the need for dose adjustment (based on predicted steady state concentration) and recommend an adjusted dose if required.

Начало: 10.11.2024 Край: 01.04.2027 Възраст: до 90 г. Treatment

Australia Murdoch Childrens Research Institute NCT05770622

Recruiting

Finishing HIV Project

Hiv

This study aims to learn how to help enable healthy behaviors and lower the risk of HIV among Latinx Men.

Начало: 08.11.2024 Край: 31.05.2030 Възраст: 18–54 г.

United States University of Miami NCT06406049

Recruiting Phase 1

A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation

Advanced Solid Tumors Harboring KRAS G12C Mutation

Researchers are looking for a better way to treat people who have advanced solid cancers with a KRASG12C mutation. Sotorasib is a drug that targets cancer cells which contain mutated KRASG12C protein; it can stop the cancer cells from growing and can lead to their death. Sotorasib is already approved to be used by doctors. However, when sotorasib works, it normally only works for a period of time, after which the cancer starts to grow again, and the patient may need a different treatment. BAY3498264 is a drug that is currently under development. It is expected to prevent the activity of a protein called son of sevenless 1 (SOS1). The SOS1 protein works together with KRAS; by blocking the activity of SOS1 with BAY3498264, it is hoped that the benefit offered by treatment with sotorasib may be increased - for example, resulting in a longer or deeper response. The main purpose of this first-in-human study is to learn how safe BAY3498264 is when given together with sotorasib and what is the maximum dose of BAY3498264 that can be safely given to participants together with sotorasib. During the study, participants will receive the following treatments: * BAY3498264: participants will first receive BAY3498264 alone for seven days and then BAY3498264 in combination with sotorasib. These combination treatments will be given in cycles, each lasting 21 days. * Sotorasib: participants will receive a standard, approved dose of Sotorasib once every day with BAY3498264. The treatment will continue for as long as participants benefit from it without any severe medical problems or until they or their doctor decide to stop the treatment, or until their cancer starts to grow again despite the treatment (also called 'progression'). This study has 3 parts, the dose escalation part, the backfill part and the expansion part. During the study, researchers will collect blood, urine, and take imaging scans like CT, PET, MRI, and X-rays, and examine the participants' heart health using an electrocardiogram (ECG). Participants' health is monitored throughout the study.

Начало: 08.11.2024 Край: 07.03.2028 Възраст: от 18 г. Treatment

Australia, Denmark, Italy +2 Bayer NCT06659341

Recruiting Phase 1

Phase I/IIa study of concomitant radiotherapy with olaparib and temozolomide in unresectable high grade gliomas patients

Glioblastoma

Trial status: Authorised

Начало: 08.11.2024 Възраст: от 18 г.

France Centre Francois Baclesse 2024-514144-85-02

Recruiting Phase 3

A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer

Metastatic Colorectal Cancer

Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide and in China. The purpose of this study is to assess adverse events disease activity when comparing intravenously (IV) infused telisotuzumab adizutecan to trifluridine and tipiracil (LONSURF) oral tablets plus IV infused bevacizumab in adult participants with c-Met protein above cutoff level refractory metastatic colorectal cancer (mCRC). Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants are put into treatment arms as part of 2 stages. Each treatment arm in stage 1 receives a different dose of telisotuzumab adizutecan. Each treatment arm in stage 2 receives the optimal dose of telisotuzumab adizutecan or LONSURF plus bevacizumab. Up to approximately 460 adult participants with c-Met protein above cutoff level refractory mCRC, will be enrolled in the study in approximately 160 sites in 15-20 countries. In stage 1, participants will receive intravenously (IV) infused telisotuzumab adizutecan dose A or B. In stage 2, participants will receive the optimal dose of IV infused telisotuzumab adizutecan or the standard of care (SOC), LONSURF oral tablets plus IV infused bevacizumab. The total study duration will be approximately 4 years. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Начало: 08.11.2024 Край: 01.10.2028 Възраст: от 18 г. Treatment

Australia, Israel, Japan +4 AbbVie NCT06614192

Recruiting

Early Recognition of Progressive Lung Fibrosis in Systemic Rheumatic Diseases

Connective Tissue Diseases Interstitial Lung Disease

Connective tissue diseases (CTDs) cover a broad range of systemic rheumatic disorders characterized by abnormal immune activation, chronic inflammatory response, and fibrosis of internal organs. The most prevalent is interstitial lung disease (ILD), a severe pulmonary complication seen in 10 to 50% of CTDs and a major determinant of disability and death. Prevalence and clinical course of CTD-ILDs vary widely and seem to be independent of treatment. Current screening and prognosis prediction strategies based on clinical variables and auto-antibodies are inadequate, and disease biomarkers are lacking. The research project aims to identify biomarkers of ILD involvement in CTD patients by characterizing the proteome and transcriptome of extracellular vesicles (EVs) isolated from serum. This will be integrated with high-resolution computed tomography (HRCT) using artificial intelligence (AI)-based imaging assessment. These novel biomarkers are expected to address some current limitations of standard laboratory biomarkers and conventional HRCT imaging. The investigator will involve a total of 200 CTD patients divided into two equal groups: those with ILD and those without. Serum EVs will be extracted from patient sera and characterized based on proteome and transcriptome content using mass spectrometry analysis and next-generation RNA-sequencing. The investigator will compare CTD patients with and without ILD, and progressive and non-progressive ILD patients according to OMERACT (Outcome Measures in Rheumatology) initiative criteria during a 12-month follow-up. HRCT features analyzed by a commercially available deep learning AI software will also be compared among CTD-ILD patients based on the occurrence of progression during follow-up. An advanced approach combining EVs analysis in serum and AI algorithms of HRCT images, and functional fibrosis assessment in vivo, could enhance our understanding of CTD-ILDs pathogenesis. The proposal aims to investigate for the first time the EVs proteomic and transcriptomic profile in serum of patients with CTDs to identify possible biomarkers of lung involvement. The integration of circulating EVs biomarkers with clinical phenotype and with advanced imaging technologies will provide novel diagnostic algorithms that early identify patients with lung involvement in CTD and patients at risk of pulmonary progression.

Начало: 07.11.2024 Край: 31.12.2026 Възраст: 18–75 г.

Italy Fondazione Policlinico Universitario Agostino Gemelli I NCT07541638

Recruiting

Behavioral Parenting Skills as a Novel Target for Improving Pediatric Medication Adherence: Study 3

Acute Lymphoblastic Leukemia, Pediatric

The current study will assess the acceptability and feasibility of the CareMeds intervention with a larger sample (N = 100) across multiple sites in Buffalo, NY, and Atlanta, GA.

Начало: 07.11.2024 Край: 01.10.2027 Възраст: 3–9 г.

United States Roswell Park Cancer Institute NCT06074666

Recruiting Phase 1

Study of IMC-P115C in Advanced PRAME-Positive Cancers

PRAME Positive Cancer HLA-A*02:01-positive

Phase 1 First-in-human study of the safety and efficacy of IMC-P115C as a single agent and in combination with standard of care (SOC) agents in participants with advanced PRAME positive cancers. IMC-P115C is a half-life extended (HLE) ImmTAC targeting PRAME.

Начало: 07.11.2024 Край: 30.08.2029 Възраст: от 18 г. Treatment

Australia, France, Italy +1 Immunocore Ltd NCT07156136

Recruiting Phase 2/3

A Study Evaluating the Safety and Efficacy of PRV111, PRV211, and PRV131 in Subjects With Oral and Lung Cancers

Oral Squamous Cell Carcinoma

Arm 1 ( Phase 2/3 Run in ): PRV111: Topical Locoregional Delivery Placed Over the Tumor Region Primary Endpoint: Overall Response Rate (ORR) Primary Objective: Demonstrate the safety and efficacy of PRV111 in patients with Carcinoma in Situ (CIS) (WHO 2017) Arm 2 (Phase 1) PRV211: Intraoperative Locoregional Delivery Placed into the Resected Tumor Bed Primary Endpoint: Safety Primary Objective: Determine Safety of PRV211 in intraoperative setting Arm 3 (Phase 1/2) PRV131: Intratumoral Injectable delivery into the Tumor Primary Endpoint: Safety and Objective Response Rate (ORR) Primary objective: Determine a safe and effective dose for PRV131 intratumoral injectable Subject Assignment: Subjects will be assigned to Arm 1, Arm 2, or Arm 3 of this study based on disease staging Arm 1: Pathologically proven and clinically confirmed Tis/CIS of the lip or oral cavity Arm 2: Pathologically proven and clinically confirmed T1-T3, Nx, M0 of the lip or oral cavity Arm 3a: Histologically confirmed squamous cell carcinoma (SCC) of the oral cavity, classified as clinical stage T1-T3, N0-1, M0 Arm 3b: Histologically confirmed malignant tumor in the lungs (primary or secondary), classified as clinical stage T1-2, N0, M0

Начало: 07.11.2024 Край: 31.05.2027 Възраст: 18–100 г.

United States Privo Technologies NCT05893888

Recruiting Phase 3

LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis

Metabolic Dysfunction Associated Steatohepatitis

This study is open to adults who are at least 18 years old and have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Начало: 07.11.2024 Край: 05.06.2029 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +31 Boehringer Ingelheim NCT06632457

Recruiting Phase 2

Individualizing Corticosteroid Use in Pneumonia

Pneumonia

In this study, researchers propose a unique (individualized) approach to steroid treatment seeking to give the right dose of steroid to the right patient and at the right time. This study seeks to compare usual care to an individualized steroid dosing strategy by testing a marker of inflammation in the blood called C- reactive protein (CRP). The overall goal is to reduce an individual's exposure to steroids and the risk of potential side effects thereby increasing the potential benefit of using steroids to control inflammation in pneumonia.

Начало: 06.11.2024 Край: 01.12.2026 Възраст: от 18 г.

United States Mayo Clinic NCT05334316

Recruiting Phase 2

A Study of Melphalan With or Without Siltuximab in People With Multiple Myeloma Having an Autologous Stem Cell Transplant

Multiple Myeloma

The purpose of this study is to see if siltuximab plus population pharmacokinetic (PK)-dosed melphalan works as well as the usual approach (body surface area \[BSA\]-dosed melphalan) in people with multiple myeloma (MM) who are receiving an autologous stem cell transplant (ASCT) as part of their standard treatment. The researchers will also see if siltuximab in combination with population PK-dosed melphalan works to decrease symptoms after an ASCT, and will study the safety of siltuximab. For the run-in, 15 patients will receive siltuximab, 11 mg/kg, seven days before and 14 days after autologous hematopoietic stem cell infusion (+/-2 day).

Начало: 06.11.2024 Край: 01.11.2027 Възраст: от 60 г.

United States Memorial Sloan Kettering Cancer Center NCT06679829

Recruiting

A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

SCI - Spinal Cord Injury

The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).

Начало: 04.11.2024 Край: 30.12.2026 Възраст: 18–70 г.

United States University of Miami NCT06494059

Recruiting Phase 2

Rivastigmine to Prevent Recurrence of Antimuscarinic Delirium

Anticholinergic Toxicity

Antimuscarinic delirium (AMD) is a common and dangerous toxicology condition caused by poisoning by medications and other chemicals that block muscarinic receptors. Physostigmine is effective in reversing AMD but has a short duration of action, and patient commonly experience recurrence of AMD after initial control with physostigmine. Recent case reports and small observational studies suggest that rivastigmine, which has a longer duration of action than physostigmine, might be useful in the treatment of AMD. In order to investigate the effectiveness of rivastigmine in preventing recurrence of AMD after initial control with physostigmine, the investigators propose a randomized, placebo-controlled clinical trial of rivastigmine for AMD. The investigators hypothesize that patients treated with rivastigmine after initial control of AMD with physostigmine will experience less recurrence of antimuscarinic delirium than those treated with placebo.

Начало: 04.11.2024 Край: 01.11.2026 Възраст: от 10 г.

United States Washington University School of Medicine NCT06399679

Recruiting

Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program

Glycogen Storage Disease Type Ia

The main objective of this observational study is to evaluate the long-term safety and effectiveness of DTX401 for at least 10 years after DTX401 administration.

Начало: 04.11.2024 Край: 01.12.2036 Възраст: от 2 г.

Brazil, Canada, Denmark +6 Ultragenyx Pharmaceutical Inc NCT06636383

Recruiting Phase 1/2

An Open Label Dose Finding Study of PTT-4256 in Patients With Solid Tumours (RAISIC-1).

Advanced Solid Tumor

This open label, dose escalation module will evaluate the safety, tolerability, PK, PD, and preliminary efficacy of PTT-4256 in participants with solid tumours using a combination of accelerated dose titration (ADT) and Bayesian Optimal Interval (BOIN) design.

Начало: 04.11.2024 Край: 30.10.2027 Възраст: от 18 г. Treatment

Australia Pathios Therapeutics Pty Ltd NCT06634849

Recruiting

Accelerated Flap Coverage in Severe Lower Extremity Trauma

Open Tibia Fracture Open Dislocation of Ankle Extremity Fracture Lower Extremity Injuries Lower

The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and/or dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and/or flap complication (flap compromise, partial and/or complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).

Начало: 04.11.2024 Край: 01.02.2030 Възраст: от 18 г. Treatment

Australia, Spain, United States Johns Hopkins University NCT06293469

Recruiting Phase 1/2

Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

Gastrointestinal Cancer

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

Начало: 03.11.2024 Край: 07.12.2028 Възраст: от 18 г. Treatment

Australia, Canada, Chile +12 Merck Sharp & Dohme LLC NCT06596694

Recruiting Phase 2

Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations.

Lung Cancer Stage III Mutation

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

Начало: 01.11.2024 Край: 01.11.2029 Възраст: 18–75 г.

China Sun Yat-sen University NCT06563999

Recruiting

Epidemiological Data on Mast Cell Pathologies in France

Mast Cell Disorder

Mast cell disorders constitute a heterogeneous group of diseases, including : * mastocytosis, i.e. cutaneous, indolent and severe forms of the disease, such as aggressive mastocytosis and mast cell leukemia) ; * mast cell-associated diseases such as mast cell activation syndrome (idiopathic, secondary or clonal), affecting both children and adults. No epidemiological data are currently available in France. In France, medical care of mast cell disorders is mainly provided by a rare disease network (CEREMAST), whose CRMR is located at the Necker Enfants Malades hospital in Paris. A total of 20 centers are located throughout France. Our aim is to use this network to study patients suffering from these diseases. The overall aim of the study is to improve the understanding, diagnosis, prognosis, recognition and management of patients with mastocytosis.

Начало: 01.11.2024 Край: 31.12.2038

France Imagine Institute NCT06186856

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