Search trials – HealthDB

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Recruiting Phase 2

Multicenter Trial of ESK981 in Patients With Select Solid Tumors

Pancreatic Adenocarcinoma Adenosquamous Carcinoma Pancreatic Neuroendocrine Tumor Pancreatic Neuroendocrine Carcinoma +3

This protocol will enroll patients with pancreatic adenocarcinoma and adenosquamous carcinoma (Cohort 1), gastrointestinal/pancreatic neuroendocrine neoplasms with Ki-67 \> 20% (Cohort 2) and neuroendocrine prostate carcinoma (Cohort 3)). Each cohort will have its own interim analysis after enrollment of 10 patients. Subjects will be given a one-month (28 day) supply of study drug (ESK981). Subjects will be instructed to take 4 capsules, with or without food, once per day for 5 consecutive calendar days, then take a drug holiday for 2 consecutive days before repeating the 5 days on-2 days off cycle in sets of 4 weeks or 28 calendar days. Subjects will be asked to keep a pill diary noting the date they take their study drug.

Начало: 19.04.2024 Край: 01.04.2029 Възраст: от 18 г.

United States University of Michigan Rogel Cancer Center NCT05988918

Recruiting

Pre-operative Hypofractionated Proton Therapy

Soft Tissue Sarcoma

This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures. Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.

Начало: 18.04.2024 Край: 01.12.2032 Възраст: от 18 г.

United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopk NCT05917301

Recruiting Phase 3

A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

Non-Muscle Invasive Bladder Neoplasms

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.

Начало: 18.04.2024 Край: 31.12.2032 Възраст: от 18 г. Treatment

Argentina, Austria, Belgium +16 Janssen Research & Development, LLC NCT06319820

Recruiting Phase 3

Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients

Crohn's Disease

The purpose of this study is to evaluate the efficacy of guselkumab in healing of all layers of the digestive tract (transmural healing) with the help of a score called Magnetic Resonance Index of Activity (MaRIA) based on a scan at Week 48.

Начало: 17.04.2024 Край: 06.03.2028 Възраст: от 18 г. Treatment

Australia, Belgium, Brazil +11 Janssen-Cilag Ltd. NCT06408935

Recruiting Phase 2

A Study of BV-AVD in People With Bulky Hodgkin Lymphoma

Hodgkin Lymphoma

The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease. BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.

Начало: 17.04.2024 Край: 01.04.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT06377566

Recruiting

Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma

Gastric Cancer

To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen

Начало: 15.04.2024 Край: 30.12.2026 Възраст: от 18 г.

China Cancer Institute and Hospital, Chinese Academy of Medic NCT06417892

Recruiting Phase 3

A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)

Breast Neoplasms

The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.

Начало: 14.04.2024 Край: 12.04.2031 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +33 Merck Sharp & Dohme LLC NCT06312176

Recruiting Phase 1

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors

Advanced Solid Tumor

This is a first-in-human, dose finding and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C9074 alone and in combination with other anticancer therapies in patients with advanced solid tumors.

Начало: 12.04.2024 Край: 15.05.2028 Възраст: от 18 г. Treatment

Australia, Brazil, China +2 BeOne Medicines NCT06233942

Recruiting Phase 3

Study to Evaluate the Effect of Balcinrenone/Dapagliflozin in Patients With Heart Failure and Impaired Kidney Function

Heart Failure and Impaired Kidney Function

This is a Phase III, international, multi-centre, randomised, double-blind, parallel-group, double-dummy, active-controlled, event-driven study in patients with chronic HF and impaired kidney function who had a recent HF event. The aim is to evaluate the effect of balcinrenone/dapagliflozin vs dapagliflozin, given once daily on top of other classes of SoC, on CV death and HF events.

Начало: 12.04.2024 Край: 11.06.2027 Възраст: 18–130 г. Treatment

Argentina, Australia, Brazil +35 AstraZeneca NCT06307652

Recruiting

Efficacy and Adverse Side Effects of Two Forms of Iron in Pregnancy

Pregnancy Iron Deficiency

This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until \~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline (13-25 weeks gestation) and follow-up (35-37 weeks gestation) to assess how different forms of iron impact body iron stores. Stool samples will be obtained within 1 week of both baseline and follow-up visits to assess changes in gut microbiome composition. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.

Начало: 12.04.2024 Край: 01.01.2027 Възраст: 19–42 г.

Canada University of British Columbia NCT06014983

Recruiting

Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Behavior Hyperactive Behavior Disorders

The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as usual adapted to each situation.

Начало: 11.04.2024 Край: 31.12.2026 Възраст: 18–99 г.

France Nantes University Hospital NCT06232226

Recruiting Phase 3

Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations

Non-Small Cell Lung Cancer

The purpose of this study is to evaluate efficacy and safety of Dato-DXd in combination with rilvegostomig or rilvegostomig monotherapy compared with pembrolizumab monotherapy as a first line therapy in participants with locally advanced or metastatic non-squamous NSCLC with high PD-L1 expression (TC ≥ 50%) and without actionable genomic alterations.

Начало: 11.04.2024 Край: 28.12.2029 Възраст: от 18 г. Treatment

Australia, Belgium, Brazil +17 AstraZeneca NCT06357533

Recruiting Phase 3

Concomitant Use of Clopidogrel With Atorvastatin or Rosuvastatin in Patients With Small Vessel Stroke

Ischemic Stroke

Along with the current clinical trial, the impact of adding atorvastatin or rosuvastatin in the first 24 hours on the clinical outcomes of first-ever small vessel stroke patients treated with clopidogrel and aspirin assessed through NIHSS, mRS, and possible adverse effects.

Начало: 10.04.2024 Край: 30.05.2026 Възраст: 18–75 г.

Egypt Kafrelsheikh University NCT06358313

Recruiting Phase 2

A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

Recurrent or Metastatic Solid Tumors

This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.

Начало: 10.04.2024 Край: 25.07.2028 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +14 Daiichi Sankyo NCT06330064

Recruiting Phase 2/3

Study to Evaluate Adverse Events, Optimal Dose, and Change in Disease Activity, With Livmoniplimab in Combination With Budigalimab Plus Chemotherapy Versus IV Infused Pembrolizumab Plus Chemotherapy in Adult Participants With Untreated Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer

Non-Squamous Non-Small Cell Lung Cancer (NSCLC) remains a leading cause of cancer mortality worldwide, with poor survival prospects for metastatic disease. The purpose of this study is to evaluate the optimized dose, adverse events, and efficacy of livmoniplimab in combination with budigalimab plus chemotherapy versus pembrolizumab plus chemotherapy in participants with untreated metastatic non-squamous non-small cell lung cancer. Livmoniplimab is an investigational drug being developed for the treatment of NSCLC. There are 2 stages to this study. In Stage 1, there are 4 treatment arms. Participants will either receive livmoniplimab (at different doses) in combination with budigalimab (another investigational drug) + chemotherapy, budigalimab +chemotherapy, or pembrolizumab +chemotherapy. In Stage 2, there are 2 treatments arms. Participants will either receive livmoniplimab (optimized dose) in combination with budigalimab +chemotherapy or placebo in combination with pembrolizumab +chemotherapy. Chemotherapy consists of IV Infused pemetrexed + IV infused cisplatin or IV infused or injected carboplatin. Approximately 840 adult participants will be enrolled in the study across 200 sites worldwide. Stage 1: In cohort 1, participants will receive intravenously (IV) infused livmoniplimab (dose A)+ IV infused budigalimab, + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + IV Infused pemetrexed. In cohort 2, participants will receive livmoniplimab (dose B) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In cohort 3, participants will receive budigalimab + chemotherapy for 4 cycles followed by budigalimab + pemetrexed . In cohort 4, participants will receive IV Infused pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. Stage 2: In arm 1, participants will receive livmoniplimab (dose optimized) + budigalimab + chemotherapy for 4 cycles followed by livmoniplimab + budigalimab + pemetrexed. In arm 2, participants will receive IV Infused placebo + pembrolizumab + chemotherapy for 4 cycles followed by pembrolizumab + pemetrexed. The estimated study duration is 55 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 and may require frequent medical assessments, blood tests, questionnaires, and scans.

Начало: 10.04.2024 Край: 01.10.2031 Възраст: от 18 г. Treatment

Australia, Belgium, Chile +9 AbbVie NCT06236438

Recruiting

Feasibility Study of a Group Intervention for Youth Wellbeing

Psychological Distress Trauma, Psychological Emotional Problem

Psychological distress, anxiety and depression are common in adolescence, and even more so following traumatic events. On Friday 15 March 2019, two mosques in Ōtautahi, Christchurch were targeted in an act of terrorism, resulting in 71 people being injured and 51 people being shot dead. This has had widespread repercussions in the Muslim and wider community in Christchurch and New Zealand. Uptake of a response pathway set up by community and district health board groups has been low despite reports of high levels of distress in the adolescent population. The proposed study offers a transdiagnostic group treatment approach (ie. Targeting a broad range of emotional difficulties) for teenagers from a community impacted by the March 15th shootings, incorporating well-evidenced transdiagnostic treatment principles into an Islamic Psychology framework to address the local population's need. We will determine the feasibility and effectiveness of this approach in increasing wellbeing in teenagers. We will run gender-specific treatment groups (8 participants in each group) recruited from the community, with one individual session (for information and consent) and 6 group sessions. We will measure symptoms of emotional difficulties, trauma symptoms and functioning at baseline, end of treatment and at 3 months follow-up. In addition, we will check in weekly with participants to monitor for any increased distress. We will also measure parental distress to explore whether an intervention for adolescents has an impact on parental wellbeing.

Начало: 10.04.2024 Край: 01.12.2025 Възраст: 12–19 г. Health services research

New Zealand University of Otago NCT05030909

Recruiting

Mindfulness-Based fMRI Neurofeedback for Depression

Depression in Adolescence Rumination

In the United States, adolescents experience alarmingly high rates of major depression, and gold-standard treatments are only effective for approximately half of patients. Rumination may be a promising treatment target, as it is well-characterized at the neural level and contributes to depression onset, maintenance, and recurrence as well as predicts treatment non-response. Accordingly, the proposed research will investigate whether an innovative mindfulness-based real-time functional magnetic resonance imaging (fMRI) neurofeedback intervention successfully elicits change in the brain circuit underlying rumination to improve clinical outcomes among depressed adolescents.

Начало: 10.04.2024 Край: 30.06.2027 Възраст: 13–18 г.

United States Columbia University NCT05617495

Recruiting Phase 1

A Study to Investigate the Safety and Efficacy of NST-628 Oral Tablets in Subjects With Solid Tumors

Oncology MEK Mutation RAF Gene Mutation Ras (KRAS or NRAS) Gene Mutation +5

This is a two-part Phase 1, open label, multi-center, single arm, non-randomized, multiple dose, safety, pharmacokinetic (PK) and preliminary efficacy study of single agent NST-628 in adult patients with MAPK pathway mutated/dependent advanced solid tumors who have exhausted standard treatment options.

Начало: 09.04.2024 Край: 01.11.2029 Възраст: от 18 г. Treatment

Australia, United States Nested Therapeutics, Inc NCT06326411

Recruiting

Development and Validation of the Observatory Battery of Common Eye Disorders for Adults With Intellectual Disability

Intellectual Disability

Background: Around 15% of the global population has some form of disability. Rights to obtain proper health care is an emphasis in the United Nationals Convention on the Right of People with Disability. Due to the importance of improving vision health for people with disabilities, studies on how to identify vision problems becomes extremely important in policy formulation for all countries. Among all types of disabilities, people with intellectual disability (ID) are among the ones where vision problems are the hardest to detect. Currently, no caregiver assessable scales are available, as a result, adults with ID are at high risk of delayed diagnose for common ocular conditions. Objectives: This is a one-year project. The objective of this study is two folds: 1. To develop an item bank of ocular conditions of adults with ID; 2. To develop a scale for caregivers to detect ocular conditions for adults with ID, and to validate the reliability, construct validity and responsiveness of the scale.

Начало: 09.04.2024 Край: 31.12.2027 Възраст: от 20 г.

Taiwan National Taiwan University Hospital NCT06737627

Recruiting

Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.

Alcohol Drinking Pregnancy

The effects of alcohol consumption during pregnancy have been known for decades. However, alcohol consumption in pregnant women remains today a public health problem and its identification is primordial. During pregnancy, standardized self-reports such as T-ACE would help identify early women with high-risk alcohol consumption. T-ACE appears to be one of the most used during pregnancy but its diagnostic value is not objectively known. To evaluate the diagnostic value of T-ACE self-report in the detection of high-risk alcohol consumption during pregnancy, by comparison with the dosage of a biomarker in blood. Material and methods Multicentric diagnostic prospective study of 2425 pregnant women followed in 3 hospitals of North of France. The self-report will be offered to all women during their prenatal consultation in these 3 maternity clinics. When they returned their self-report to the medical practitioner, a unique blood test of phosphatidylethanol will be proposed to them for a period of one year. Made after informed consent, this dosage will be used as a gold standard of an alcohol consumption during the previous three weeks to establish the diagnostic value of T-ACE. An alcohol consumption will be considered " at high risk " if blood phosphatidylethanol is ≥ 20 µg/L. With a predictable 25% rejection rate and a positive 4% T-ACE frequency, the inclusion of 2425 patients should permit to estimate sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of T-ACE with a satisfactory 95% confidence interval in this population. The evidence of a link between positive T-ACE and real high-risk alcohol consumption in pregnant women would objectively validate the use of this self-report during pregnancy. The T-ACE within the self-report (self-administered questionnaire) set up in these 3 maternity hospitals in the North of France is already a reference thanks to its several advantages to better identify psychosocial risk situations and especially high-risk alcohol consumption during pregnancy than medical history. If T-ACE appeared to be a sensitive and specific method for identifying high-risk alcohol use during pregnancy, it could be generalized in the follow-up of pregnant women in our country.

Начало: 08.04.2024 Край: 01.04.2027 Възраст: от 18 г.

France University Hospital, Lille NCT04786587

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