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Recruiting Phase 3

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Untreated Follicular Lymphoma

This is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.

Начало: 07.08.2024 Край: 26.11.2031 Възраст: 18–130 г. Treatment

Australia, Belgium, Brazil +15 AstraZeneca NCT06549595

Recruiting Phase 4

VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease

Moderately to Severely Active Crohn's Disease Crohn Disease Disease Crohn

Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups. Group 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.

Начало: 07.08.2024 Край: 06.02.2029 Възраст: 18–80 г. Treatment

Australia, Belgium, Canada +8 Alimentiv Inc. NCT06257706

Recruiting Phase 2

Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer

Borderline Resectable Pancreatic Ductal Adenocarcinoma Resectable Pancreatic Adenocarcinoma Stage I Pancreatic Cancer AJCC v8 Stage II Pancreatic Cancer AJCC v8 +1

This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy is more feasible and could improve outcomes compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.

Начало: 06.08.2024 Край: 31.12.2027 Възраст: от 18 г.

United States Emory University NCT06423326

Recruiting Phase 1

A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia

Advanced Chronic Myeloid Leukemia Philadelphia Chromosome-Positive Acute Myeloid Leukemia

To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.

Начало: 06.08.2024 Край: 01.01.2029 Възраст: от 18 г.

United States M.D. Anderson Cancer Center NCT06401603

Recruiting Phase 4

Anesthesia and Non-small Cell Lung Cancer Recurrence

Non-small Cell Lung Cancer Surgery Anesthesia

There has been ongoing debate about the relationship between cancer recurrence and anesthetic management. Therefore, the investigators will test the hypothesis that the recurrence free survival (RFS) after curative resection of NSCLC is higher in patient who received total intravenous anesthesia (TIVA) than volatile anesthetics in this multi-center randomized trials.

Начало: 05.08.2024 Край: 31.12.2028 Възраст: от 19 г.

South Korea Samsung Medical Center NCT06330038

Recruiting Phase 4

Utilising Genotype Informed Bayesian Dosing of Tacrolimus in Children Post Solid Organ Transplantation.

Solid Organ Transplant

This study aims to evaluate the efficacy of genotype-informed Bayesian dosing of tacrolimus in optimising drug exposure among paediatric solid organ transplant recipients. By tailoring tacrolimus dosage based on individual genetic makeup and using Bayesian modeling to predict drug levels, the researchers hope to increase the likelihood of achieving therapeutic drug concentrations while minimising the risk of adverse events associated with subtherapeutic or supratherapeutic exposure.

Начало: 05.08.2024 Край: 02.08.2027 Възраст: 1–18 г. Supportive care

Australia Murdoch Childrens Research Institute NCT06529536

Recruiting

End-Tidal Oxygen for Intubation in the Emergency Department

Critical Illness Hypoxia Respiratory Failure

Rapid Sequence Intubation (RSI) is a high-risk procedure in the emergency department (ED). Patients are routinely preoxygenated (given supplemental oxygen) prior to RSI to prevent hypoxia during intubation. For many years anaesthetists have used end-tidal oxygen (ETO2) levels to guide the effectiveness of preoxygenation prior to intubation. The ETO2 gives an objective measurement of preoxygenation efficacy. This is currently not available in most EDs. This trial evaluates the use of ETO2 on the rate of hypoxia during intubation for patients in the ED.

Начало: 05.08.2024 Край: 31.12.2025 Възраст: от 18 г. Diagnostic

Australia, United States Sydney Local Health District NCT06578468

Recruiting Phase 3

A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia

Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety of venetoclax in combination with obinutuzumab or acalabrutinib in the treatment of CLL. Adverse events and change in disease activity will be assessed. Venetoclax in combination with obinutuzumab or acalabrutinib is being investigated in the treatment of CLL. Study doctors put the participants in 1 of 4 groups, called treatment arms. Participants will receive oral venetoclax in combination with intravenously (IV) infused obinutuzumab or oral acalabrutinib at in different dosing schemes as part of treatment. Approximately 170 adult participants with CLL who are being treated with venetoclax will be enrolled in the study in approximately 80 sites worldwide. Participants in Arm A will receive oral venetoclax in combination with IV infused obinutuzumab, with a 5 week venetoclax ramp up. Participants in Arm B will receive oral venetoclax in combination with oral acalabrutinib, with a 5 week venetoclax ramp up. Participants in Arm C and Arm D will receive oral venetoclax in combination with oral acalabrutinib, with differing venetoclax ramp up periods. The total study duration is approximately 28 months. 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Начало: 05.08.2024 Край: 01.03.2028 Възраст: от 18 г. Treatment

Australia, France, Greece +6 AbbVie NCT06428019

Recruiting Phase 1

Study of STP938 in Advanced Solid Tumours

Solid Tumor

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy. The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.

Начало: 02.08.2024 Край: 01.05.2027 Възраст: от 18 г.

France, United Kingdom, United States Step Pharma, SAS NCT06297525

Recruiting

Targeted Pediatric High-Grade Glioma Therapy

High Grade Glioma Diffuse Intrinsic Pontine Glioma Anaplastic Astrocytoma Glioblastoma +5

The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.

Начало: 02.08.2024 Край: 28.08.2034 Възраст: 12–39 г.

Australia, Canada, Germany +4 Nationwide Children's Hospital NCT05839379

Recruiting

Effect of Changes in Carbohydrate Intake Patterns on Glucose Control in Patients With Type 1 Diabetes

Type 1 Diabetes Diet Intervention Glucose Control

The blood glucose fluctuates greatly in T1DM patients, especially in the middle and late stages of the disease, and carbohydrate (CHO) is the main determinant of postprandial glucose response (PGR). Based on the previous investigation to understand how nutritional habits affect blood glucose control, we will conduct dietary intervention studies in T1DM patients to explore whether the adjustment of dietary pattern is beneficial to blood glucose control, and further explore the relevant mechanism through the detection of related metabolic indicators.

Начало: 01.08.2024 Край: 31.12.2027 Възраст: 18–70 г.

China Yang Tao NCT06273631

Recruiting

Monitoring of Antimicrobial Resistance Based on Metagenomics Analyses in Pneumonia Patients

Pneumonia Next-generation Sequencing Microbiome Antimicrobial Resistance

Monitoring of antimicrobial resistance (AMR) based on metagenomics analyses in pneumonia patients is critical for optimizing clinical diagnosis and treatment and improving clinical prognosis. This study is designed to ask the following key questions: 1. What is the microbiome maps of patients with severe pneumonia and mild pneumonia ? 2. How many pathogen resistance genes are carrying in severe pneumonia and mild pneumonia ? 3. What is the genetic diversity of key pathogens detected in severe pneumonia and mild pneumonia during 2019-2025?

Начало: 01.08.2024 Край: 30.09.2026

China Shanghai General Hospital, China NCT06566898

Recruiting

RCT of an Intersectional Stigma Intervention to Sustain Viral Suppression Among Women Living With Serious Mental Illness and HIV in Botswana

Hiv Serious Mental Illness

The study goal is to promote viral load suppression among women with serious mental illness (SMI) and HIV in Botswana, given that these women are especially vulnerable to psychiatric medication nonadherence and symptom exacerbation, which are made worse by stigma and threaten antiretroviral therapy (ART) adherence. The investigators propose to test an intervention to reduce stigma due to the statuses of SMI and HIV, against an attention control condition, in the high-risk transition period after discharge from an initial psychiatric hospitalization. Specifically, the investigators are conducting a two-arm randomized controlled trial (RCT) with a 4-month follow-up to compare the effectiveness of 1) What Matters Most (WMM)-based intersectional stigma intervention delivered as clients transition from psychiatric hospitalization to outpatient care; and 2) an attention placebo control condition that follows a similar format to isolate the effects of the intervention. The investigators will also assess policymaker workshops where peer women with SMI and HIV co-lead the reporting of RCT findings via lived experience to policymakers to initiate structural change. Enabling women with SMI and HIV to resist stigma has the potential to improve their HIV outcomes and empower these women to elicit broader, structural-level change.

Начало: 01.08.2024 Край: 01.12.2027 Възраст: 18–65 г.

Botswana New York University NCT05807867

Recruiting

Predictive Algorithms for Critical Rehabilitation Outcomes

Intensive Care Mechanical Ventilation Rehabilitation Algorithms

An increasing amount of evidence from evidence-based medicine indicates that early rehabilitation intervention for patients receiving mechanical ventilation is safe and feasible, and can promote functional recovery and reduce hospital stay. However, the conscious state, respiratory function, and daily living activities of these patients after being discharged from the ICU vary greatly, and some patients do not show obvious benefits. How to identify which patients may have benefit from early rehabilitation is a key issue that needs to be addressed in critical care rehabilitation. This study aims to investigate the clinical data related to the disease of the ICU survivors who received mechanical ventilation as the research object, by collecting their clinical data when receiving early rehabilitation intervention, and constructing a clinical prediction model for the efficacy of early rehabilitation intervention in the ICU through the selection of optimal regression equation or machine learning algorithm. The application of this model can effectively determine whether ICU inpatients need early rehabilitation intervention, thereby reducing complication rates and improving their quality of life.

Начало: 01.08.2024 Край: 30.12.2026 Възраст: 18–90 г.

China Wuhan University NCT06532994

Recruiting Phase 2

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

Extensive-stage Small-cell Lung Cancer

This study is a single arm, open, multicenter phase II study. The main purpose of this study was to evaluate preliminary efficacy and safety of Tislelizumab combined with thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.

Начало: 01.08.2024 Край: 31.12.2026 Възраст: 18–80 г.

China Second Hospital of Shanxi Medical University NCT06536868

Recruiting Phase 3

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

Advanced Breast Cancer

The primary objective of the study is to measure efficacy of saruparib (AZD5305) plus camizestrant compared with physician's choice CDK4/6i plus ET in patients with BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative (defined as IHC 0, 1+, 2+/ ISH non-amplified) advanced breast cancer

Начало: 01.08.2024 Край: 18.10.2030 Възраст: от 18 г. Treatment

Argentina, Australia, Brazil +24 AstraZeneca NCT06380751

Recruiting Phase 2

SATELLITE Study (feaSibility sAfeTy Efficacy dostarLimab earLy-stage defIcient endomeTrial cancEr)

Endometrial Cancer Stage I Mmr Deficiency Endometrioid Endometrial Adenocarcinoma Immune-related Adverse Event

The main goal of this clinical trial is to evaluate dostarlimab, an immunotherapy drug, as a potential alternative to surgery for early-stage endometrial cancer with Mismatch Repair deficiency, a genetic cause for 20-30% of cases. The study aims to establish dostarlimab's efficacy and safety in early-stage endometrial cancer, exploring its potential as a non surgical option for those unsuitable or unwilling to undergo major surgery, allowing for fertility preservation or addressing specific health conditions. Participants will have seven dostarlimab sessions over 12 months. The treatment plan involves four cycles every three weeks, followed by a three-week break, and then three cycles every six weeks. This research is a promising step toward a new, less invasive treatment choice for patients with specific genetic traits. It expands the range of care options for endometrial cancer.

Начало: 01.08.2024 Край: 30.06.2028 Възраст: от 18 г. Treatment

Australia Queensland Centre for Gynaecological Cancer NCT06278857

Recruiting

Characteristics of Intestinal Microbiome Following Pancreatic Surgery

Pancreatic Cancer Microbiota Pancreatoduodenectomy

The goal of this observational study is to learn about intestinal microbiome structure and function in individuals who have undergone a pancreatoduodenectomy and compare to healthy matched controls. The primary objectives of the study are: 1. To explore and describe any differences in the gut microbiota especially Shannon diversity index 2. To conduct functional profiling by exploring and describing any differences in functional metabolites produced in the gut in people having had pancreatoduodenectomy greater than 6 months ago compared to healthy matched controls. Participants will be asked to complete the following: * Three-day food, bowel and medication diary (see Protocol appendix 5) * Gastrointestinal Symptom Rating Scale (see Protocol appendix 6) * Quality of life questionnaire (see Protocol appendix 7) * Stool sample test using Microba Insight TradeMark (a small swab is taken from soiled toilet paper, sealed in a room-temperature storage capsule and mailed to the testing laboratory)

Начало: 01.08.2024 Край: 01.08.2025 Възраст: от 18 г.

Australia Royal Prince Alfred Hospital, Sydney, Australia NCT06319755

Recruiting Phase 2

Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as High Grade Neuroendocrine Carcinomas, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile C...

Small Cell Carcinoma of the Bladder Small Cell Carcinoma of the Urinary Tract Squamous Cell Carcinoma of the Bladder Squamous Cell Carcinoma of the Urinary Tract +4

Background: Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU. Objective: To test SG, either alone or combined with atezolizumab, in people with rare GU tumors. Eligibility: Adults aged 18 years and older with rare GU tumors. These may include high grade neuroendocrine carcinomas; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of heart function. They will have imaging scans. They may need a biopsy: A small needle will be used to remove a sample of tissue from the tumor. Both SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm. All participants will receive SG on days 1 and 8 of each 21-day treatment cycle. Some participants will also receive atezolizumab on day 1 of each cycle. Blood and urine tests, imaging scans, and other exams will be repeated during study visits. Treatment may continue for up to 5 years. Follow-up visits will continue for 5 more years.

Начало: 01.08.2024 Край: 01.11.2028 Възраст: 18–120 г.

United States National Cancer Institute (NCI) NCT06161532

Recruiting

RCT of a Weighted Blanket to Reduce Pain in Veterans With Chronic Pain

Chronic Pain Sleep Disturbance

Chronic pain is a major health concern for returning Veterans and is associated with decreases in quality of life. In addition, chronic pain is often accompanied by significant disturbance in sleep. Sensory interventions may offer effective, low-cost complementary tools for chronic pain and sleep disturbance in Veterans. Weighted Blankets (WB)- blankets sewn with weighted material inside to provide widespread pressure to the body- are a low-cost wellness product used for anxiety and sleep. WBs have demonstrated large reductions in insomnia, and the investigators have also shown that they can reduce the severity of chronic pain. However, effects and mechanisms of longer WB use have not been examined in individuals with pain and sleep disturbance. The investigators therefore propose a randomized controlled trial examining the effects of WBs on pain and sleep quality in Veterans. the investigators will recruit Veterans with chronic pain and sleep disturbance from the VA San Diego Healthcare System (VASDHS) and VA San Francisco Healthcare System (VASFHS) and randomize 160 Veterans to receive either a light (3-lb; N = 80) or heavy (15-lb; N = 80) blanket. The investigators will remotely collect measures of pain (primary), pain catastrophizing, and pain medication use, as well as sleep disturbance (primary) and sleep efficiency and total sleep time over 6 weeks of overnight home use of the assigned blanket. The investigators will also explore physiological effects of WBs on sleep quality using actigraphy (exploratory) in VASDHS participants. Ecological momentary assessment (EMA) methods will be deployed via smartphone to capture study adherence.

Начало: 01.08.2024 Край: 30.09.2029 Възраст: от 18 г.

United States VA Office of Research and Development NCT05963607

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