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Набира участници

Tender Loving Care for Recurrent Pregnancy Loss

Recurrent Pregnancy Loss

The goal of this investigational study is to evaluate participation in a weekly, interactive, tender loving care messaging platform impact on pregnancy outcomes in patients with recurrent pregnancy loss. The main questions it aims to answer are: (1) does participation in weekly, interactive tender loving care messages increase live birth rates in patients with recurrent pregnancy loss? (2) Does participation in weekly, interactive tender loving care messages increase patients' quality of life? Does participation in weekly, interactive tender loving care messages decrease patients' depressive symptoms? Participants will be asked to interact with weekly messages providing prenatal counseling and support. Additionally, patients will be asked to complete the fertility quality of life survey several times over the course of the pregnancy.

Начало: 01.01.2024 Край: 01.12.2026 Възраст: 18–44 г.

United States Walter Reed National Military Medical Center NCT06182878

Набира участници Фаза 3

A Study of Bomedemstat (IMG-7289/MK-3543) Compared to Best Available Therapy (BAT) in Participants With Essential Thrombocythemia and an Inadequate Response or Intolerance of Hydroxyurea (MK-3543-006)

Essential Thrombocythemia

This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).

Начало: 31.12.2023 Край: 18.08.2028 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +21 Merck Sharp & Dohme LLC NCT06079879

Набира участници Фаза 1/2

Study of CTO1681 for the Prevention and Treatment of CRS in DLBCL Patients Receiving CAR T-Cell Therapy

Cytokine Release Syndrome

This is an interventional study to evaluate the use of CTO1681 in preventing or reducing CAR T-cell-induced toxicities like cytokine release syndrome (CRS). This study will enroll adult patients with DLBCL who are scheduled to receive CD19-directed CAR T-cell therapy. The first phase of the study will be open label with dose escalation. Participants will start taking CTO1681 just prior to receiving their CAR T-cell therapy and continue to take the study drug three times daily for a total of 15 days.

Начало: 28.12.2023 Край: 01.06.2027 Възраст: от 18 г.

United States CytoAgents, Inc. NCT05905328

Набира участници Фаза 2

A Study to Evaluate the Efficacy and Safety of Sutetinib Maleate Capsule in Locally Advanced or Metastatic NSCLC

Non-small Cell Lung Cancer

The main objective of the study will be to evaluate the efficacy of sutetinib maleate capsules in participants with locally advanced or metastatic non-small cell lung cancer NSCLC (uncommon EGFR mutations only).

Начало: 27.12.2023 Край: 01.12.2028 Възраст: от 18 г.

United States Teligene US NCT06010329

Набира участници Фаза 3

A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung Neoplasm Metastasis

The purpose of this study is to assess if adding LY3537982 (olomorasib) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.

Начало: 21.12.2023 Край: 01.01.2031 Възраст: от 18 г. Лечение

Australia, Austria, Belgium +26 Eli Lilly and Company NCT06119581

Набира участници Фаза 3

PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

Cervical Carcinoma Adenocarcinoma Adenosquamous Carcinoma

This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation. The planned sample size is 510; including 200 patients in France. In this trial, patients will be assigned in one of the two following treatments arms: * Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations. * Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy. Considering the changing standard treatment landscape of locally advanced cervical cancer, both arms (control arm and experimental arm) may also be treated according to the INTERLACE and KEYNOTE-A18 studies, if applicable, at the discretion of the attending physician. Each patient will be followed up for 5 years. A cost-utility study will be performed in patients included in France. Other countries could be involved in this specific study. It will assess the incremental cost-utility ratio (cost per QALY gained) of para-aortic lymphadenectomy followed by tailored chemo-radiation in patients with positive PALN compared to patients staged with PET/CT only followed by chemo-radiation. This study also has ancillary objectives: * Biologic: To study T cell exhaustion, immune changes during chemoradiation, HPV ctDNA dynamic evolution, and the par-aortic lymph node as a premetastatic niche. * Radiomics: To study the contribution of radiomics and FDG-PET/CT metabolic parameters to predict para-aortic lymph node involvement and clinical outcome. * Senti-PAROLA: To evaluate the accuracy (Sensitivity, specificity, positive and negative predictive value) of the para-aortic sentinel lymph node (SPA) for PALN staging, and to evaluate the prognostic value of low volume metastasis of SPA.

Начало: 20.12.2023 Край: 20.12.2033 Възраст: от 18 г.

Czechia, France, Italy +1 Institut Claudius Regaud NCT05581121

Набира участници

RCT on Intralesional Rituximab Injection Versus ISRT in Ocular Adnexal MALT Lymphoma

Primary Ocular Adnexal MALT Lymphoma

This project proposes to establish a prospective, multicenter, randomized, controlled clinical study to compare the safety and efficacy of Intralesional Rituximab Injection versus Involved Site Radiation Therapy for the treatment of primary ocular adnexal MALT lymphoma. The aim is to provide high-level clinical evidence for the treatment of ocular adnexal MALT lymphoma and to offer patients treatment options that have fewer complications and comparable therapeutic effects.

Начало: 20.12.2023 Край: 31.12.2029 Възраст: 18–75 г.

China Zhongshan Ophthalmic Center, Sun Yat-sen University NCT06190301

Набира участници Фаза 2/3

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Idiopathic Inflammatory Myopathy Dermatomyositis Anti-Synthetase Syndrome Immune-Mediated Necrotizing Myopathy +4

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Начало: 20.12.2023 Край: 01.07.2028 Възраст: 6–75 г.

United Kingdom, United States Cabaletta Bio NCT06154252

Набира участници Фаза 1

Lopinavir/Ritonavir in PLWH With High-Grade AIN

High-Grade Anal Intraepithelial Neoplasia

This study is being done to assess the safety of lopinavir/ritonavir in patients with PLWH with AIN. 30 participants will be recruited and can expect to be on active study for approximately 3 months and long term follow up for 40 weeks.

Начало: 19.12.2023 Край: 01.06.2026 Възраст: от 18 г.

United States University of Wisconsin, Madison NCT05334004

Набира участници Фаза 1

Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficiency

Inherited Bone Marrow Failure Syndrome Familial Platelet Disorder With Predisposition to Myeloid Malignancies

Background: Runt-related transcription factor 1 (RUNX1) gene regulates the formation of blood cells. People with mutations of this gene may bleed or bruise easily; they are also at higher risk of getting cancers of the blood, bone marrow, and lymph nodes. Objective: The purpose of the study includes determining which dose of imatinib is best for people with pathogenic or likely pathogenic RUNX1 mutations without blood cancers, and to determine whether there are any changes in platelet function and inflammatory markers. Eligibility: Adults aged 18 and older with RUNX1 mutations. Healthy people without this mutation, including family members of affected participants, are also needed. Design: Participants with the RUNX1 mutation will be screened. They will have a physical exam with blood tests. They will have a test of their heart function. They may need a new bone marrow biopsy if they haven't had one in the past year. Imatinib is a tablet taken by mouth once a day, every day, at home. Affected participants in different parts of the study will take imatinib for either 28 days or up to 84 days. They will fill out questionnaires about how they are feeling. For the first part of the study, participants will have blood tests every 2 weeks, either at home or at the NIH, while they are taking the imatinib. They will have a follow up visit, at home or at the NIH, when they are done taking imatinib on Day 28. Participants on the second part of the study will come to NIH on days 1 and days 84. They will have blood tests every 2 weeks (at home or the NIH) while they are taking imatinib. They may opt to have a bone marrow biopsy repeated after they finish their course of imatinib. Participants will have a follow-up visit (at home or the NIH) 30 days after they stop taking imatinib. Participants who do not have the RUNX1 mutation will have 1 clinic visit. They will have blood tests. They will fill out questionnaires. They may opt to have a bone marrow biopsy.

Начало: 19.12.2023 Край: 30.10.2027 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT06090669

Набира участници Фаза 3

A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)

Metastatic Castration-resistant Prostate Cancer (mCRPC) Prostatic Neoplasms

The purpose of this study is to assess the efficacy and safety of opevesostat plus hormone replacement therapy (HRT) compared to alternative abiraterone acetate or enzalutamide in participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) previously treated with one next-generation hormonal agent (NHA). The primary study hypothesis is that opevesostat is superior to alternative abiraterone acetate or enzalutamide with respect to radiographic progression free survival (rPFS) per Prostate Cancer Working Group (PCWG) Modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Blinded Independent Central Review (BICR), in androgen receptor ligand binding domain (AR LBD) mutation positive and negative participants.

Начало: 18.12.2023 Край: 02.12.2030 Възраст: от 18 г. Лечение

Australia, Brazil, Canada +36 Merck Sharp & Dohme LLC NCT06136650

Набира участници Фаза 3

Efficiency of a Composite Personalised Care on Functional Outcome in Early Psychosis

Psychosis

Chronic psychosis, including schizophrenia is now viewed as a progressive disorder where cognitive deficits predate the clinical onset. Early intervention programs improve the general outcome with staged care strategies, supporting the view that the period before and around the first episode of psychosis is a window of opportunity for improving its functional recovery. Pioneering epigenetic analyses indicate that psychosis onset involves oxidative stress and inflammation suggesting that neuroprotective strategies could limit or even prevent the onset of or the transition into a chronic disorder. Several biological factors associated with the emergence of psychosis can all be rectified by using safe and easily accepted supplements including alterations folate deficiency/hyperhomocysteinemia; redox imbalance and deficit in polyunsaturated fatty acids (PUFA). The prevalence of these anomalies (20-30%) justifies a systematic detection and could guide personalised add-on strategy. Cognitive remediation improves quality of life (QoL) and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in patients at ultra-high risk (UHR) for psychosis and patient with a first episode of psychosis (FEP) and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatising tools, such as applications with cognitive strategies, motivational tools and functioning guidance personalised according to the need of each individual. Patients can have access to it, wherever they live. Early psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training. The study hypothesis is that promoting neuroplasticity by cognitive training and personalised virtual psychoeducation guidance could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients UHR or FEP and that this effect is modulated by individual brain plasticity abilities. The overall objective of PsyCARE\_trial is to improve early intervention in psychosis by providing a composite personalised care (CPC) that will enable personalised cognitive training and psychoeducation guidance, adapted to individuals' needs, cognitive abilities and biological background.

Начало: 15.12.2023 Край: 15.02.2029 Възраст: 15–30 г.

France Centre Hospitalier St Anne NCT05796401

Набира участници Фаза 2

Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer

Castrate Resistant Prostate Cancer Metastatic Castration-resistant Prostate Cancer Prostate Cancer Prostate Carcinoma

This is a single-center, open-label, study of Prostate-Specific Membrane Antigen (PSMA)-targeted radionuclide therapy with 177Lu-PSMA-617 in combination with pembrolizumab in participants with metastatic castrate-resistant prostate cancer (mCRPC) who have previously progressed on at least one prior androgen pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide).

Начало: 15.12.2023 Край: 31.05.2031 Възраст: от 18 г.

United States University of California, San Francisco NCT05766371

Набира участници

Chest Pain Nurse Track

Chest Pain

Chest pain is a commonly encountered presentation in the emergency department (ED), with an incidence ranging from 5 to 12%. Chest pain has a wide range of aetiologies from the mildest to the most severe. In benign forms these pains can be musculoskeletal, psychogenic or even indeterminate (\>60% depending on the place of recruitment). Coronary aetiology represents 12 to 25% of severe forms. The management of chest pain in the emergency department is part of the daily life of nurses. According to the french 2020 Nurse Reception Organizer (IOA) guidelines, a nurse who has been trained for this role is required to "triage" (severity grade and orientation) patients presenting for this reason. The presence of specialized nurses in the management of chest pain allows faster initial management. To date, no study has been conducted to assess the diagnostic and treatment performance of a nursing pathway for the management of patients presenting with acute chest pain regardless of the suspected diagnosis and not only acute coronary syndrome.

Начало: 14.12.2023 Край: 14.12.2027 Възраст: от 18 г.

France University Hospital, Grenoble NCT06149819

Набира участници

Transgenerational Metabolic-Immune Biomarkers of Neurological and Neurodevelopmental Disorders

Autism Spectrum Disorder Mitochondrial Pathology Epilepsy Brain Tumor +2

The study involves up to 5 visits for a fasting blood draw, behavioral assessments, and/or questionnaires. Other samples may be collected when appropriate. This study is currently recruiting. There is no cost for visits or study-related exams.

Начало: 13.12.2023 Край: 31.12.2028 Възраст: до 18 г.

United States Southwest Autism Research & Resource Center NCT04322734

Набира участници

Barriers and Facilitators of Parent-Child Communication in Children With Cancer Predisposition

Genetic Predisposition

Testing children, adolescents, and young adults (CAYA) for a genetic risk for cancer can help with early prevention and detection of cancers through regular follow-ups and medical care. After receiving genetic test results, CAYA may not accurately understand what their results mean, and parents are often unsure about talking with their CAYA about their genetic risk for cancer. By understanding how parents communicate with their CAYA, the investigators can improve future genetic education to reduce cancer risk. Primary Objectives: * Identify qualities of parent-CAYA (child, adolescent, and young adults) communication about CAYAs' genomic cancer risk, and their association with CAYAs' psychosocial and prevention outcomes. * Examine the association between sociodemographic, cancer-related, and psychosocial factors and parent-CAYA communication regarding CAYAs' genomic risk for cancer. * Identify barriers and facilitators of parent-CAYA communication regarding CAYAs' genomic risk for cancer.

Начало: 12.12.2023 Край: 01.10.2028 Възраст: 10–24 г.

United States St. Jude Children's Research Hospital NCT05849155

Набира участници Фаза 1

A Study of LY3971297 in Healthy Participants

Healthy Obesity Hypertension

The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.

Начало: 07.12.2023 Край: 01.09.2026 Възраст: 18–75 г.

Japan, Singapore, United States Eli Lilly and Company NCT06148272

Набира участници Фаза 3

A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Non-small Cell Lung Cancer

The goal of this study is to evaluate intismeran autogene plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of margin negative, completely resected Stage II, IIIA, IIIB (with nodal involvement \[N2\]) non-small cell lung cancer (NSCLC). The primary hypothesis is that intismeran autogene plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

Начало: 06.12.2023 Край: 21.12.2035 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +30 Merck Sharp & Dohme LLC NCT06077760

Набира участници

Performance of the Treatment of Periodontitis According to the Bioperio® Protocol

Periodontitis

This multicenter, prospective, single-arm observational study evaluated the clinical performance of the Bioperio® protocol, a standardized, patient-centered framework for managing periodontitis. The protocol combined professional supra-gingival scaling, oral hygiene instruction and motivation, full-mouth subgingival instrumentation, and-in Stage III/IV cases-adjunctive enamel matrix derivative application in deep pockets.

Начало: 05.12.2023 Край: 05.12.2030 Възраст: от 18 г.

Italy University of Pisa NCT07507474

Набира участници

Intermittent Fasting in Prostate Cancer Patients Receiving Androgen Deprivation Therapy

Prostate Cancer

This is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. Study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.

Начало: 05.12.2023 Край: 31.12.2028 Възраст: от 18 г.

United States State University of New York at Buffalo NCT06172283

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