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Набира участници

Diagnostic Efficacy of CNN in Predicting Intraoperative Complications and Postoperative Outcomes in SMILE

Deep Convolutional Neural Network Small-incision Lenticule Extraction (SMILE) Surgery Intraoperative Complications Postoperative Outcomes

To evaluate the diagnostic efficiency of the neural network in predicting complications of Small Incision Lenticule Extraction in a multi-center cross-sectional study.

Начало: 15.06.2021 Край: 01.12.2027 Възраст: 18–45 г.

China Second Affiliated Hospital of Nanchang University NCT06204926

Набира участници

Device Global Registry for the IlluminOss Bone Stabilization System

Traumatic Fracture Pathological Fracture

This is a multi-center, observational patient registry. The primary objective of the study is to collect safety and performance data on the IlluminOss Device when used to provide stabilization and alignment for the treatment of traumatic or impending and pathologic fractures.

Начало: 11.06.2021 Край: 01.12.2026 Възраст: от 50 г.

Germany, United States IlluminOss Medical, Inc. NCT05206981

Набира участници

ALND vs ART in Positive Sentinel Node After Neoadjuvant Therapy in Breast Cancer

Breast Cancer Chemotherapy Sentinel Lymph Node Axillary Lymph Nodes Dissection +1

In the case of primary surgery, in patients with sentinel node involvement, it has already been shown that omitting axillary lymph node dissection (ALND), often combining axillary radiotherapy (RT), does not worsen the prognosis and does significantly reduce the appearance of lymphedema. However, patients who have received neoadjuvant systemic treatment cannot benefit from this option, even though in the majority of those who have responded well to treatment, a residual disease in the armpit is low, but there are no studies yet published that supports the possibility of not performing lymphadenectomy. The primary endpoint is to evaluate wether axillary radiotherapy (ART) presents a lower risk of lymphedema with respect to lymphadenectomy (ALND) in patients with breast cancer who, after neoadjuvant systemic treatment (NST), present the sentinel node affected. Likewise, we will evaluate recurrences and overall survival in both groups. Finally, we will analyze the quality of life of these patients.

Начало: 11.06.2021 Край: 31.12.2028 Възраст: от 18 г. Лечение

Australia, Spain Hospital Universitari de Bellvitge NCT04889924

Набира участници Фаза 3

Testing if High Dose Radiation Only to the Sites of Brain Cancer Compared to Whole Brain Radiation That Avoids the Hippocampus is Better at Preventing Loss of Memory and Thinking Ability

Metastatic Lung Small Cell Carcinoma Metastatic Malignant Neoplasm in the Brain Recurrent Lung Small Cell Carcinoma Stage IV Lung Cancer AJCC v8

This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.

Начало: 08.06.2021 Край: 01.07.2030 Възраст: от 18 г.

Canada, United States NRG Oncology NCT04804644

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Influence of Cerebral Oedema in Intracerebral Haemorrhage

Stroke Intra Cerebral Hemorrhage

In 2020, IntraCerebral Haemorraghe (ICH) remains the most devastating type of stroke. Besides stroke unit care, no specific treatment has been proven effective yet. Perihaematomal oedema (PHO) could be a promising therapeutic target. However, the mechanisms, the natural history as well as the clinical impact of this PHO remain unclear. The COPITCH study has been designed to answer these questions

Начало: 04.06.2021 Край: 03.12.2027 Възраст: от 18 г.

France University Hospital, Lille NCT04621357

Набира участници Ранна Фаза 1

Concomitant Renal and Urinary Bladder Allograft Transplantation

Chronic Kidney Diseases Bladder Dysfunction Bladder Absence Posterior Urethral Valve +5

The purpose of this study is to establish if concomitant renal and vascularized urinary bladder allograft transplantation is feasible.

Начало: 01.06.2021 Край: 01.08.2026 Възраст: 1–60 г.

United States Mayo Clinic NCT04626167

Набира участници Фаза 3

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease

The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.

Начало: 26.05.2021 Край: 01.12.2030 Възраст: 2–19 г.

Austria, Belgium, Brazil +13 Eli Lilly and Company NCT04844606

Набира участници Фаза 1

Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma

Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System

This phase I trial tests the safety, side effects, best dose and effectiveness of lenalidomide when added to nivolumab and the usual drugs (rituximab and methotrexate) in patients with primary central nervous system (CNS) lymphoma. Lenalidomide may stop or slow primary CNS lymphoma by blocking the growth of new blood vessels necessary for tumor growth. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Methotrexate is frequently combined with other chemotherapy agents to improve response. This study may help increase the understanding of lenalidomide and nivolumab use in primary CNS lymphoma treatment. In addition, it may help researchers see whether the control of CNS lymphoma can be extended by using these study drugs as maintenance (prolonged therapy) after control is achieved with the initial chemotherapy regimen (induction).

Начало: 24.05.2021 Край: 01.04.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT04609046

Набира участници Фаза 1/2

A Study of BGB-11417 in Participants With Myeloid Malignancies

Acute Myeloid Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasm

The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS/myeloproliferative neoplasm (MPN) .

Начало: 24.05.2021 Край: 08.02.2028 Възраст: от 18 г. Лечение

Australia, China, France +7 BeiGene NCT04771130

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 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

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 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

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