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Testing FIRST in Youth Outpatient Psychotherapy

Anxiety Depression Trauma Behavior Problem

The study will compare the impact FIRST (a transdiagnostic treatment built upon five empirically supported principles of change) versus usual care outpatient psychotherapy on youths' mental health outcomes and a candidate mechanism of change: regulation of negative emotions.

Начало: 27.09.2021 Край: 01.02.2027 Възраст: 7–15 г.

United States Harvard University NCT04725721

Активно (без набиране)

Improving the Part C Early Intervention Service Delivery System for Children With ASD

Autism Spectrum Disorder

Despite strong consensus that early, specialized intervention for children with autism spectrum disorder (ASD) can have a dramatic impact on outcomes, the public health system's capacity to provide such services is severely challenged by the rapid rise in ASD prevalence. The goal of this research project is to increase timely and equitable access to ASD-specialized early intervention during the critical first three years of life by capitalizing on the existing infrastructure of the Part C Early Intervention (EI) system, which is publicly funded and available in all states in the United States. This project will train EI providers to use an evidence-based, parent-mediated intervention that can improve child and family outcomes as well as mitigate the long-term substantial economic costs associated with ASD.

Начало: 27.09.2021 Край: 31.05.2026 Възраст: 16–33 г.

United States University of Washington NCT05114538

Активно (без набиране) Фаза 2

Relevance of [68Ga]Ga -PentixaFor-PET for Initial Staging and Therapeutic Evaluation of Multiple Myeloma

Multiple Myeloma

The aim of our study is to confirm the relevance of PET using \[68Ga\]Ga -PentixaFor ligand, in comparison with FDG, for initial staging and therapeutic evaluation of symptomatic multiple myeloma patients in first line treatment or in relapse. The prognostic value of positive CXCR4 expression will also be assessed and \[68Ga\]Ga -PentixaFor/FDG discordances explored.

Начало: 21.09.2021 Край: 21.05.2030 Възраст: от 18 г.

France Nantes University Hospital NCT04561492

Активно (без набиране) Фаза 1/2

A Phase I/II Study of Sacituzumab Govitecan Plus Berzosertib in Small Cell Lung Cancer, Extra-Pulmonary Small Cell Neuroendocrine Cancer and Homologous Recombination-Deficient Cancers Resistant to PARP Inhibitors

HRD Cancer SCLC Advanced Solid Tumors

Background: Small cell lung cancer and PARP inhibitor resistant tumors are aggressive cancers. Current treatments for people with these tumors yield little benefit. Researchers want to see if a combination of drugs can help. Objective: To find a safe combination of sacituzumab govitecan and berzosertib and to see if this will cause small cell lung cancer and PARP inhibitor resistant tumors to shrink. Eligibility: People ages 18 and older with a solid tumor, small cell lung cancer, or a homologous recombination-deficient cancer that is resistant to PARP inhibitors Design: Participants will be screened with: Standard clinical exams and tests EKG to test the heart Medical documentation to confirm cancer diagnosis Participants will get sacituzumab govitecan by vein on days 1 and 8 of each 21-day cycle. They will get berzosertib by vein on days 2 and 9. Treatment will continue as long as they can tolerate the drugs and their tumors are either stable or getting better. Before treatment and at least once per cycle, participants will have a physical exam and blood tests. Before treatment and every 2 or 3 cycles, they will have a CT scan. They will have a contrast agent injected into a vein for the scan. Participants will give blood and hair samples and tumor biopsies for research. Biopsies will be taken with a small needle under imaging guidance. After they stop treatment, participants will have a visit 1 month later. They will then be contacted by phone or email every 3 months for the rest of their lives....

Начало: 20.09.2021 Край: 01.03.2029 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT04826341

Активно (без набиране)

Laparoscopic Approach for Emergency Colon Resection

Laparoscopic Surgery Colorectal Cancer Colorectal Disorders Emergencies +2

This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.

Начало: 17.09.2021 Край: 30.07.2031 Възраст: 18–100 г.

Finland Joint Authority for Päijät-Häme Social and Health Care NCT05005117

Активно (без набиране)

Ovarian Tumor Organotypic Slices Cultures for functionAl Drug Testing and Therapy Response Prediction

Ovarian Cancer

Ex vivo organotypic tumor slice cultures (OTSC) have unique characteristics in terms of tissue processing time and the maintenance of original microenvironment. Moreover, drug screening has been successfully performed on OTSC in a clinically meaningful time window. For these reasons, we designed a study to assess the feasibility of establishing OTSC in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, OTSC could be introduced into clinical practice as empirical predictor of patients' response to platinum.

Начало: 13.09.2021 Край: 03.08.2026 Възраст: 18–80 г.

Italy Fondazione Policlinico Universitario Agostino Gemelli I NCT06065358

Активно (без набиране) Фаза 3

A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer

The study will evaluate the efficacy and safety of treatment with chemotherapy in combination with osimertinib compared to chemotherapy in combination with placebo in patients whose disease has progressed extracranially following first-line osimertinib treatment.

Начало: 12.09.2021 Край: 02.06.2027 Възраст: 18–130 г.

China, Germany, Israel +3 AstraZeneca NCT04765059

Активно (без набиране)

Solutions for Hunger And Regulating Eating

Overweight and Obesity

The objective of this proposed study is to collect efficacy data on ROC+ compared to an active comparator (AC) and to Behavioral Weight Loss (BWL) for participants who are high in Food Responsiveness.

Начало: 01.09.2021 Край: 15.08.2026 Възраст: 18–65 г.

United States University of California, San Diego NCT05004883

Активно (без набиране)

Sleep Disturbance and Emotion Regulation Brain Dysfunction as Mechanisms of Neuropsychiatric Symptoms in Alzheimer's Dementia

Alzheimer Disease Mild Cognitive Impairment Neuropsychiatric Symptoms Sleep Disturbance

Recent findings suggest that sleep disruption may contribute to the generation and maintenance of neuropsychiatric symptoms including anxiety, depression, agitation, irritation, and apathy while treating sleep disruption reduces these symptoms. Impairments in the neural systems that support emotion regulation may represent one causal mechanism mediating the relationship between sleep and emotional distress. However, this model has not yet been formally tested within a sample of individuals with or at risk for developing Alzheimer's Disease (AD) This proposal aims to test a mechanistic model in which sleep disturbance contributes to neuropsychiatric symptoms through impairments in fronto-limbic emotion regulation function in a sample of individuals at risk for developing, or at an early stage of AD. This study seeks to delineate the causal association between sleep disruption, fronto-limbic emotion regulation brain function, and neuropsychiatric symptoms. These aims will be achieved through a mechanistic, randomized 2-arm controlled trial design. 150 adults experiencing sleep disturbances and who also have cognitive impairment with the presence of at least mild neuropsychiatric symptoms will be randomized to receive either a sleep manipulation (Cognitive Behavioral Therapy for Insomnia CBT-I; n=75) or an active control (n=75). CBT-I improves sleep patterns through a combination of sleep restriction, stimulus control, mindfulness training, cognitive therapy targeting dysfunctional beliefs about sleep, and sleep hygiene education. Neuropsychiatric symptoms, fronto-limbic functioning, and sleep disruption will be assessed at baseline and at the end of the sleep manipulation through functional Magnetic Resonance Imaging (fMRI), clinical interviews, PSG recordings, and self-report questionnaires. Neuropsychiatric symptoms (anxiety and depression) and sleep disturbance (actigraphy, Insomnia Severity Index, and sleep diaries) will be assayed at baseline and each week throughout the sleep manipulation to assess week-to-week changes following an increasing number of CBT-I sessions. Wristwatch actigraphy will be acquired from baseline to the end of the sleep manipulation at week 11. Neuropsychiatric symptoms and sleep will be assessed again at six months post-manipulation.

Начало: 31.08.2021 Край: 30.11.2026 Възраст: 50–90 г.

United States Stanford University NCT04100057

Активно (без набиране) Фаза 2

PRL3-Zumab in Patients With Advanced Solid Tumors

Advanced Malignant Solid Tumor

This is a multicenter, Phase II, open-label, single-dose-level (6 mg/kg) study of PRL3-zumab monotherapy in patients with unresectable or metastatic solid tumors. PRL3-zumab will be administered via intravenous (IV) infusion until discontinuation criteria are met (e.g., disease progression per RECIST v1.1/iRECIST, intolerable toxicity, or withdrawal of consent). Study Periods and Duration The study is divided into the following phases: * Screening Period: Day -21 to Day -1; all assessments must be completed prior to the first dose. * Treatment Period: One cycle is defined as 4 weeks, consisting of two infusions administered 2 weeks apart. * End-of-Treatment (EOT) Visit: To be conducted within 14 days of the last dose or treatment discontinuation. * Safety Follow-Up: A visit scheduled 30 days after the last dose. * Survival Follow-Up: Conducted every 3 months post-discontinuation via telephone or other appropriate methods until the data cutoff date. Assessments * Safety \& QoL: Safety assessments (including laboratory tests) will be performed prior to each infusion. Quality of Life (QoL) will be assessed at screening and every 8 weeks during treatment. * Tumor Imaging: Assessments will be performed at baseline and every 8 weeks following the initiation of study treatment, according to RECIST v1.1 and iRECIST. * Immunogenicity: Assessments will be performed pre-dose on Cycle 1 Day 1, and prior to infusions in Cycles 2, 4, and 6. For patients remaining on treatment, assessments will continue every 3 cycles thereafter. Pharmacokinetic (PK) profiles will be evaluated in two distinct subgroups of 10 patients each. For the intensive PK sampling subgroup, assessments are concentrated in the first three cycles: Cycle 1 monitoring includes Day 1 (pre-dose, end of infusion, 2, and 6 hours post-infusion), Day 2 (24 hours), Day 6 (120 hours), Day 10 (216 hours), and Day 15 (pre-dose). Following pre-dose samples on Cycle 2 (Days 1 and 15) and Cycle 3 (Day 1), a second intensive window occurs on Cycle 3 Day 15 (pre-dose, end of infusion, 2, and 6 hours post-infusion) and continues through Days 16, 20, and 24. Subsequent samples are taken pre-dose on Day 1 of Cycles 4, 5, and 6, concluding at the EOT visit. In contrast, the sparse PK sampling subgroup will undergo limited assessments at Cycle 1 Day 1 (pre-dose and end of infusion), Cycle 1 Day 15 (pre-dose), and the first day of Cycles 2 and 3 (pre-dose and end of infusion), with a final sample collected at the EOT visit.

Начало: 30.08.2021 Край: 01.12.2026 Възраст: от 18 г.

China Intra-IMMUSG Pte Ltd NCT07541001

Активно (без набиране)

MElanoma Research Lymph Node Prediction Implementation National_001

Melanoma

MERLIN\_001 is a prospective registry study of a primary melanoma gene-signature to predict sentinel node (SN) status and to determine its prognostic value for more accurate staging of SN-negative melanoma patients.

Начало: 25.08.2021 Край: 01.06.2029 Възраст: от 18 г.

United States SkylineDx NCT04759781

Активно (без набиране) Фаза 1

NKX019, Intravenous Allogeneic Chimeric Antigen Receptor Natural Killer Cells (CAR NK), in Adults With B-cell Cancers

Lymphoma, Non-Hodgkin B-cell Acute Lymphoblastic Leukemia Large B-cell Lymphoma Mantle Cell Lymphoma +6

This is a single arm, open-label, multi-center, Phase 1 study to determine the safety and tolerability of an experimental therapy called NKX019 (allogeneic CAR NK cells targeting CD19) in patients with relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B cell acute lymphoblastic leukemia (B-ALL)

Начало: 20.08.2021 Край: 01.12.2038 Възраст: от 18 г. Лечение

Australia, United States Nkarta, Inc. NCT05020678

Активно (без набиране)

Supportive Oncology Care at Home Post-Discharge

Cancer

This study is evaluating if a program that involves remote monitoring and home-based care may improve the post-discharge care of recently hospitalized patients with advanced cancer. The Supportive Oncology Care at Home intervention consists of three key components: 1. Remote patient monitoring (e.g. patient-reported symptoms, home-monitored vital signs and body weight); 2. A Medically Home care model for symptom assessment, evaluation, and management (e.g. triggers for phone calls and visits to patients' homes to address and manage any concerning issues identified); 3. Structured communication with the oncology team to ensure continuity of care.

Начало: 19.08.2021 Край: 31.12.2026 Възраст: от 18 г.

United States Massachusetts General Hospital NCT04637035

Активно (без набиране)

A Study to Learn More About the Long-term Safety and Effectiveness of Molidustat as a Treatment for Japanese Men and Women With Renal Anemia

Renal Anemia

In this study, the researchers want to learn more about the safety and effectiveness of Molidustat in Japanese men and women who have renal anemia, a condition in which the kidneys do not make enough of a hormone that helps the body make new red blood cells. In previous clinical trials with a small number of participants, several important adverse events were observed. The researchers in this study want to know how many patients also have these adverse events under the real world, and if the number of the red blood cells will be increased after the treatment of Molidustat. The researchers will collect the participants' health information from their medical records and their regular check-ups for up to 2 years. The data from this study will be submitted to the health authority in Japan in accordance with the local regulation.

Начало: 06.08.2021 Край: 30.09.2027 Възраст: от 20 г.

Japan Bayer NCT04899661

Активно (без набиране)

Myocardial Injury and Outcomes Following COVID-19 Vaccination (MYOVAX Study)

Myocardial Injury Myocarditis COVID-19 Vaccination SARS-CoV-2 +1

The study will focus on cardiac blood and imaging biomarkers to facilitate early recognition of patients at risk for myocardial injury after COVID-19 vaccination. Ultimately, the intention is to identify patients at risk, reduce adverse events, and determine the need for longer-term follow-up in patients with myocardial injury after vaccination.

Начало: 05.08.2021 Край: 05.08.2026 Възраст: от 17 г.

Canada University Health Network, Toronto NCT04967807

Активно (без набиране)

Physical Activity, Cardiac and Skeletal Muscle Energetics in Healthy Subjects and HFpEF Patients

Heart Failure With Preserved Ejection Fraction

This research is being done to better understand the relationship between information collected by wearable devices and clinical measurements in people with heart failure with preserved ejection fraction (HFpEF) and others without HFpEF. This is an observational study with no study intervention or randomization. Participants will undergo baseline history and physical, 12-lead EKG, laboratory studies of blood/serum/urine, echocardiography, activity questionnaire, 6 minute walk test, and placement of wearable devices to be worn for up to 14 days (activity monitors, EKG monitor and continuous glucose monitor). Participants will return after \~14 days of wearing the devices and repeat of physical examination, 12-lead EKG, 6 minute walk test, activity questionnaire. Additionally, participants will undergo magnetic resonance imaging (MRI) of their leg with exercise, cardiopulmonary exercise testing (CPET) and, for those who qualify, magnetic resonance imaging (MRI) of their heart with exercise.

Начало: 04.08.2021 Край: 01.07.2026 Възраст: 40–85 г.

United States Johns Hopkins University NCT04998877

Активно (без набиране) Фаза 1

Durvalumab and Tremelimumab After Radioembolization for the Treatment of Unresectable, Locally Advanced Liver Cancer

BCLC Stage B Hepatocellular Carcinoma BCLC Stage C Hepatocellular Carcinoma Locally Advanced Hepatocellular Carcinoma Stage III Hepatocellular Carcinoma AJCC v8 +6

This phase Ib trial investigates the side effects of durvalumab and tremelimumab after radioembolization (radiation particles against liver tumors) and to see how well they work in treating patients with liver cancer that cannot be removed by surgery (unresectable) and has spread to nearby tissues and lymph nodes (locally advanced). Durvalumab and tremelimumab are antibodies (proteins produced by the defense system of the body \[immune system\]) that have been made in the laboratory and may improve the ability of the immune system to detect and fight cancer.

Начало: 03.08.2021 Край: 23.02.2027 Възраст: от 18 г.

United States City of Hope Medical Center NCT04605731

Активно (без набиране) Фаза 3

Japan Expansion Cohort: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Japanese participants with relapsed refractory multiple myeloma.

Начало: 28.07.2021 Край: 30.06.2028 Възраст: от 18 г.

Japan GlaxoSmithKline NCT06868667

Активно (без набиране)

National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer

Hepatocellular Carcinoma Liver Cancer Cholangiocarcinoma

Background: Primary Liver Cancer is the second most common cause of cancer-related death worldwide. It is the cancer with the fastest rising incidence and mortality in the United States. Researchers want to learn more about liver cancer to help them design better treatments. Objective: To better understand liver cancer. Eligibility: People ages 18 and older who have liver cancer and had or are planning to have immune therapy Design: Participants will be screened with a review of their medical records. They will be asked about their medical history and test results. Participants will come to the NIH Clinical Center. During this visit, their medical records, test results, imaging studies, and tissue samples (if available) will be gathered. Participants will learn the results of a test to see if they have any mutations known to be connected to cancer. They will learn if there are treatment options for them. Participants will give blood, urine, and stool samples or rectal swabs. Participants will not have follow-up visits just for this study. If they join another NIH research study and have visits for this other study, their medical records; test results; and blood, urine, and stool samples may be collected. This will occur about every 3 months. If they have a biopsy or surgery on another study or as part of treatment and there is leftover tissue, researchers would like to collect some of that tissue. Participants will be contacted every 6 months by phone or e-mail. They will be asked about their health. They will provide any medical records, test results, and imaging studies. Participants will be followed on this study for life.

Начало: 28.07.2021 Край: 31.12.2027 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT04145141

Активно (без набиране) Фаза 3

China Subpopulation: Evaluation of Efficacy and Safety of Belantamab Mafodotin, Bortezomib and Dexamethasone Versus Daratumumab, Bortezomib and Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma

This study is designed to evaluate safety and efficacy of belantamab mafodotin in combination with bortezomib/dexamethasone versus daratumumab in combination with bortezomib/dexamethasone in the Chinese participants with relapsed/refractory multiple myeloma.

Начало: 28.07.2021 Край: 30.06.2028 Възраст: от 18 г.

China GlaxoSmithKline NCT06868654

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