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Набира участници Фаза 1/2

A Phase 1/2 Study of Bleximenib in Participants With Acute Leukemia (cAMeLot-1)

Acute Leukemia

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2D\[s\]) of bleximenib in phase 1 Part 1 (Dose Escalation) and to determine the safety and tolerability at RP2D in Phase 1 Part 2 (Dose expansion). The purpose of the Phase 2 part of the study is to evaluate the efficacy of bleximenib at the RP2D.

Начало: 19.05.2021 Край: 22.09.2030 Възраст: от 2 г. Лечение

Australia, Belgium, Brazil +10 Janssen Research & Development, LLC NCT04811560

Набира участници Фаза 1

Novel Approaches for Improving Vascular Function in Veterans With HFpEF

Heart Failure With Preserved Ejection Fraction Inflammation

This project will evaluate the impact of L-Citrulline, tetrahydrobiopterin (BH4), and atorvastatin administration on physical capacity and vascular function in Veterans with heart failure with preserved ejection fraction (HFpEF).

Начало: 19.05.2021 Край: 30.09.2030 Възраст: от 18 г.

United States VA Office of Research and Development NCT06312748

Набира участници

Longitudinal Assessment of Autonomic and Sensory Nervous System in ALS

Amyotrophic Lateral Sclerosis

The goal of this interventional non-pharmacological study is to evaluate, using a multimodal approach, the progression of autonomic and sensory involvement in in amyotrophic lateral sclerosis (ALS) patients enrolled within 18 months from motor onset and its relationship with the progression of overall clinical disability. The main questions it aims to answer are: * Is autonomic dysfunction at diagnosis associated with disease progression and survival in patients with Amyotrophic Lateral Sclerosis ? * Can we identify in the skin biomarkers to be used as reliable measures of disease progression and to apply in future clinical trials for patient stratification and to assess response to drug treatment ? Participants at time 0 will receive a full clinical and instrumental examination and a blood sample testing to check inclusion and exclusion criteria, genetic screening for the most common genes associated with ALS (SOD1, FUS, TARDBP and c9orf72), questionnaires about clinical characteristics, quality of life, pain and a multidomain battery of neuropsychological tests, multimodal assessment of the autonomic nervous system including skin biopsy for morphological study. At follow-up we'll perform clinical scales and skin biopsy. Researchers will compare results from ALS patients with data obtained from a population of age and sex matched healthy subjects.

Начало: 15.05.2021 Край: 30.12.2026 Възраст: от 18 г.

Italy Istituti Clinici Scientifici Maugeri SpA NCT05747937

Набира участници Фаза 1/2

Neural Response to Inflammatory Challenge in Major Depressive Disorder

Major Depressive Disorder

This is a parallel group, double-blinded, placebo-controlled study. Participants with MDD (n=90) and HC (n=90) will be randomly assigned (2:1) to receive either lipopolysaccharide (LPS) (0.8ng/kg of body weight) or placebo (same volume of 0.9% saline) administered as an intravenous bolus. This will yield the following groups: MDD-LPS (n=60), MDD-Placebo (n=30), HC-LPS (n=60), HC-placebo (n=30). There are three main aims: to identify immune pathways and neural circuits that respond differently to LPS in MDD vs. HC subjects; (2) to test whether the strength of inflammatory changes induced by LPS is associated with degree of change in anhedonic symptoms and neural circuits in the MDD group, and (3) to identify a biotype of MDD that shows a differential immunological and neurophysiological response to LPS. The main outcome variables are symptoms of anhedonia measured with the Snaith-Hamilton Pleasure Scale (SHAPS), cytokines (Il-6, IL-8, IL-10, and TNF), and BOLD signal change in the neural circuitry mediating interoceptive processing, i.e. the insula and cingulate cortex. The exploratory aim is to determine whether the acute inflammatory response to LPS can predict the clinical course of depression over a period of six months. The main outcome of this component of the study is self-reported depressive symptoms assessed with the QIDS-SR.

Начало: 15.05.2021 Край: 01.12.2026 Възраст: 18–65 г.

United States Laureate Institute for Brain Research, Inc. NCT04751331

Набира участници

Predicting Appendicular Lean and Fat Mass With Bioelectrical Impedance Analysis Among Adult Patients With Obesity.

Obesity

This study aims to develop and cross-validate novel bioelectrical impedance analysis (BIA) equations for predicting appendicular soft tissue masses, specifically fat mass (FM) and appendicular lean mass (ALM), in a sample of Caucasian adult subjects affected by obesity. The research will compare these new BIA equations with three established BIA-derived prediction models and validate them using dual-energy X-ray absorptiometry (DXA) and magnetic resonance imaging (MRI) data. This study utilizes existing datasets to enhance the accuracy and applicability of BIA in assessing body composition and supports the development of standardized algorithms for converting raw BIA data across different devices and populations.

Начало: 13.05.2021 Край: 31.12.2025 Възраст: от 18 г.

Australia, Brazil, Canada +3 University of Roma La Sapienza NCT06545435

Набира участници Фаза 3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

Pulmonary Arterial Hypertension

Researchers are looking for more ways to treat PAH. In PAH, the blood vessels in the lungs become thick and narrow, which makes it harder for blood to flow. This causes high blood pressure in the lungs and overworks the heart. PAH can make it hard to breathe and be active. Some standard (usual) treatments for PAH can treat symptoms of PAH but do not stop PAH from getting worse. Sotatercept is a study medicine designed to treat PAH. It is a targeted therapy, which is a treatment that works on certain proteins that play a role in causing PAH. This is a long-term follow-up (LTFU) study. People who took part in certain other studies testing sotatercept for PAH may be able to join this study. The goal of this study is to learn about the long-term safety of sotatercept and if people tolerate it when taken with standard PAH treatment over a longer period of time.

Начало: 12.05.2021 Край: 07.12.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +20 Merck Sharp & Dohme LLC NCT07218029

Набира участници Фаза 3

Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Locally Advanced (Inoperable) or Metastatic Breast Cancer

A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Начало: 10.05.2021 Край: 14.08.2029 Възраст: 18–99 г. Лечение

Argentina, Australia, Belgium +20 AstraZeneca NCT04862663

Набира участници Фаза 2

Gemcitabine and Oxaliplatin Chemotherapy With or Without a Floxuridine and Dexamethasone Pump in People With Cholangiocarcinoma That Cannot Be Removed With Surgery

Intrahepatic Cholangiocarcinoma

This study will compare the safety and effects of HAI floxuridine and dexamethasone combined with the standard chemotherapy drugs gemcitabine and oxaliplatin (GemOx) with those of GemOx alone in people with untreated cholangiocarcinoma that cannot be removed with surgery. The researchers want to find out whether the study treatment works better than the standard chemotherapy to delay progression of disease. For the study treatment to be considered better than the standard treatment, the study treatment should increase the time until progression of disease by an average of 3 months, compared with the usual approach.

Начало: 07.05.2021 Край: 01.05.2027 Възраст: от 18 г.

Netherlands, United States Memorial Sloan Kettering Cancer Center NCT04891289

Набира участници Фаза 2

Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer

Metastatic Non Small Cell Lung Cancer

This is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer

Начало: 07.05.2021 Край: 01.12.2031 Възраст: 18–70 г. Лечение

Australia, Canada, France +9 Iovance Biotherapeutics, Inc. NCT04614103

Набира участници Фаза 3

Low Dose ColchicinE in pAtients With Peripheral Artery DiseasE to Address Residual Vascular Risk

Peripheral Arterial Disease Atherosclerosis of Extremities Inflammation

The Low dose ColchicinE in pAtients with peripheral Artery DiseasE to address residual vascular Risk (LEADER-PAD) trial will evaluate if anti-inflammatory therapy with colchicine will reduce vascular events in patients with symptomatic peripheral artery disease.

Начало: 06.05.2021 Край: 01.12.2029 Възраст: от 18 г. Лечение

Australia, Belgium, Brazil +6 Population Health Research Institute NCT04774159

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Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children

Urinary Incontinence Daytime Wetting Urination Disorders Urination Involuntary +6

The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.

Начало: 05.05.2021 Край: 01.12.2027 Възраст: 6–14 г.

Denmark Aalborg University Hospital NCT05989646

Набира участници

ProsTIC Registry of Men Treated With PSMA Theranostics

Prostate Cancer Metastatic Castration-resistant Prostate Cancer

This is a descriptive, observational, prospective, open-ended, registry utilising electronic data capture to collect information on the outcomes of men treated with prostate specific-membrane antigen (PSMA) theranostics.

Начало: 01.05.2021 Край: 31.12.2028 Възраст: от 18 г.

Australia Peter MacCallum Cancer Centre, Australia NCT04769817

Набира участници Фаза 1

Study of Lunresertib Alone or in Combination With RP-3500 or Debio 0123 in Patients With Advanced Solid Tumors

Advanced Solid Tumor

The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with Debio 0123 in patients with eligible advanced solid tumors, determine the maximum tolerated dose (MTD) and assess preliminary anti-tumor activity.

Начало: 30.04.2021 Край: 01.06.2028 Възраст: от 12 г.

Canada, Denmark, United Kingdom +1 Debiopharm International SA NCT04855656

Набира участници Фаза 3

A Histamine Pharmacodynamic Biomarker to Guide Treatment in Pediatric Asthma (HAS3)

Allergic Asthma

This is a randomized, double-blind, placebo-controlled, crossover study comparing asthma control post treatment in African American/Black and Caucasian/White children in both hyper and hypo responsive HILD (Histamine Lontophoresis with Laser Doppler monitoring) phenotypes with uncontrolled persistent allergic asthma using Levocetirizine (LTZ) vs placebo.

Начало: 28.04.2021 Край: 31.05.2027 Възраст: 6–17 г.

United States Bridgette Jones NCT04699604

Набира участници Фаза 2

Testing What Happens When an Immunotherapy Drug (Pembrolizumab) is Given by Itself Compared to the Usual Treatment of Chemotherapy With Radiation After Surgery for Recurrent Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma +1

This phase II trial studies the effect of pembrolizumab alone compared to the usual approach (chemotherapy \[cisplatin and carboplatin\] plus radiation therapy) after surgery in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or patients with a second head and neck cancer that is not from metastasis (primary). Radiation therapy uses high energy radiation or protons to kill tumor cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Carboplatin is also in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab alone after surgery may work better than the usual approach in shrinking recurrent or primary head and neck squamous cell carcinoma.

Начало: 27.04.2021 Край: 30.06.2029 Възраст: 18–79 г.

United States National Cancer Institute (NCI) NCT04671667

Набира участници

Effects of an Evening PROtein PrEload on Metabolic Health in Night ShIfT Workers (PROPENSITy)

Type 2 Diabetes Shift-work Disorder

This study will compare the effects of a whey protein supplement or a placebo consumed before the evening meal on health outcomes in night shift workers.

Начало: 27.04.2021 Край: 31.07.2026 Възраст: 35–65 г. Превенция

Australia University of Adelaide NCT04869098

Набира участници

DiamondTemp Global Registry

Arrhythmia

The DiamondTemp™ Global Registry is a prospective, global, multi-center, observational post-market registry.

Начало: 22.04.2021 Край: 01.03.2031 Възраст: от 18 г.

Australia, Belgium, France +8 Medtronic Cardiac Ablation Solutions NCT04735016

Набира участници Фаза 2

A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

Low-grade Glioma Advanced Solid Tumor

This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors. Qualifying genomic alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories prior to enrollment into any of the arms. The study will consist of a screening period, a treatment period, a long-term extension phase, end of treatment (EOT) visit(s), a safety follow-up visit, and long-term follow-up assessments.

Начало: 22.04.2021 Край: 31.05.2027 Възраст: 6–25 г. Лечение

Australia, Canada, Denmark +7 Day One Biopharmaceuticals, Inc. NCT04775485

Набира участници Фаза 1/2

LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

Superficial Bladder Cancer Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

This study will evaluate the safety and efficacy of intravesical administration of EG-70 in the bladder and its effect on bladder tumors in patients with NMIBC. This study study consists of two phases; a Phase 1 dose-escalation to establish safety and recommended the phase 2 dose, followed by a Phase 2 study to establish how effective the treatment is. The Study will include patients with NMIBC with Cis for whom BCG therapy is unresponsive and patients with NMIBC with Cis who are BCG-naïve or inadequately treated.

Начало: 22.04.2021 Край: 30.11.2028 Възраст: от 18 г. Лечение

Australia, Canada, France +7 enGene, Inc. NCT04752722

Набира участници

Data Collection Study of Pediatric and Adolescent Gynecology Conditions

Disorders of Sex Development (DSD) Pediatric and Adolescent Cancers of the Genital Tract Reproductive Endocrine Conditions in Puberty Structural Gynecologic Conditions Including Vulvar and Vaginal Conditions

Background: Gynecologic conditions are those that are related to the reproductive system. They can be reproductive gland disorders or reproductive system tumors. They can also be inborn anomalies of the reproductive tract. Researchers want to gather data over time from a large group of young people with these conditions. Objective: To create a database about child and teenage gynecologic conditions. Eligibility: Participants of any age with known or suspected pediatric and adolescent gynecologic conditions, and their adult family members Design: Participants will be screened with a review of their medical records. Participants may have a medical history and physical exam. Participants will have blood drawn using a needle. The blood will be used for genetic tests. Participants will have saliva collected. They will spit into a small plastic container. Or their spit will be absorbed from their mouth using a small sponge. The saliva will be used for genetic tests. Participants may have samples collected from their vagina. A small cotton swab will be used to gather the samples. This procedure is optional. If participants have a surgery related to their condition, a small tissue sample will be taken. It will be stored for future research. Participants may complete optional surveys. These surveys ask about their physical and emotional health. They can choose not to answer any of the questions. Researchers will collect medical data from participants standard tests. Such tests may include blood and urine tests, X-rays, nuclear medicine scans, and other tests. Data will also be collected from standard treatments they may receive.

Начало: 21.04.2021 Край: 02.12.2039 Възраст: 1–100 г.

United States Eunice Kennedy Shriver National Institute of Child Heal NCT04717349

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