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Treatment for Migraine and Mood

Migraine Depressive Symptoms

The researchers propose a three-arm pilot study of Mindfulness-Based Cognitive Therapy (MBCT) delivered via telephone (MBCT-T), video (MBCT-V) or Enhanced Usual Care (EUC).

Начало: 17.03.2024 Край: 20.10.2026 Възраст: от 18 г.

United States Amanda Shallcross NCT05576467

Активно (без набиране)

Mobile Mental Health Stigma Reduction Intervention Among Black Adults

Anxiety Depression Health Knowledge, Attitudes, Practice Stigmatization +1

Major depressive and anxiety disorders are highly prevalent in the general population and are a leading cause of disability. Black adults have a high burden of depression and anxiety. This study aims to assess a self- administered video-based intervention to reduce mental illness stigma and medical mistrust among Black adults with moderate to severe depression or anxiety.

Начало: 15.03.2024 Край: 31.07.2027 Възраст: 18–45 г.

United States Massachusetts General Hospital NCT06316804

Активно (без набиране) Фаза 1

Neoadjuvant ADI-PEG 20 + Ifosfamide + Radiotherapy in Soft Tissue Sarcoma

Soft Tissue Sarcoma Sts Sarcoma,Soft Tissue

In this study, patients with soft tissue sarcoma (STS) will receive ADI-PEG 20 and ifosfamide in combination with radiation as neoadjuvant therapy. In phase I of the study, up to 5 dose levels will be tested to find the recommended phase II dose (RP2D), after which patients enrolling to phase II will be treated at that dose level to assess efficacy.

Начало: 14.03.2024 Край: 22.07.2026 Възраст: от 18 г.

United States Washington University School of Medicine NCT05813327

Активно (без набиране) Фаза 3

Psilocybin for Major Depressive Disorder (MDD)

Depressive Disorder, Major

Approximately 240 eligible adult participants (≥18 years old) who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5-TR) criteria for Major Depressive Disorder (MDD) will be enrolled. Participants will be randomly assigned to receive a single oral dose of Psilocybin 25 mg, Psilocybin 5 mg, or inactive placebo. The purpose of this study is to evaluate the efficacy, safety, and tolerability of Psilocybin 25 mg versus placebo in adults with MDD, as assessed by the difference between groups in change in depressive symptoms from Baseline to Day 43 post-dose, and to characterize the durability of initial treatment effect and subsequent response to optional Psilocybin 25 mg re-administration(s) during the 1-year Follow-up Period.

Начало: 13.03.2024 Край: 30.01.2027 Възраст: от 18 г.

United States Usona Institute NCT06308653

Активно (без набиране)

Accessing Care, Clinical Trials and Screening for Underserved Children and Adults With Type 1 Diabetes (ACCESS-T1D)

Type 1 Diabetes Celiac Disease

The purpose of this study is to identify people with T1D or celiac disease (CD) early in the course of their disease and to improve the methods of screening for these diseases.

Начало: 11.03.2024 Край: 01.06.2026 Възраст: от 2 г.

United States AdventHealth Translational Research Institute NCT06908057

Активно (без набиране)

Development and Evaluation of 'My Voice': A Randomized Controlled Trial

Advance Care Planning Heart Failure

The study aims to develop and evaluate a web-based interactive platform (called 'My Voice') that helps to educate patients with heart failure and their caregivers about heart failure, identify their goals for end-of-life care, and share these with their caregivers and doctors.

Начало: 07.03.2024 Край: 01.03.2027 Възраст: от 21 г.

Singapore Duke-NUS Graduate Medical School NCT06090734

Активно (без набиране) Фаза 3

A Study to Investigate the Effect of Lepodisiran on the Reduction of Major Adverse Cardiovascular Events in Adults With Elevated Lipoprotein(a) - ACCLAIM-Lp(a)

Atherosclerotic Cardiovascular Disease (ASCVD) Elevated Lp(a)

The purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. The study drug will be administered subcutaneously (SC) (under the skin). Approximately 1700 additional participants will be enrolled in an addendum to explore Lp(a) lowering with an alternative dosing schema.

Начало: 05.03.2024 Край: 01.03.2029 Възраст: от 18 г. Лечение

Argentina, Australia, Austria +25 Eli Lilly and Company NCT06292013

Активно (без набиране)

Specified Drug-use Survey of Leqvio for s.c. Injection.

Familial Hypercholesterolaemia Hypercholesterolaemia

The objective of this study is to evaluate the long-term safety of Leqvio in patients with familial hypercholesterolaemia or hypercholesterolaemia in post-marketing clinical practice

Начало: 04.03.2024 Край: 17.12.2026 Възраст: 15–100 г.

Japan Novartis Pharmaceuticals NCT06275724

Активно (без набиране) Фаза 2

Combination of Cadonilimab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-006)

Esophagus Cancer

Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable locally advanced esophageal cancer. However, as high as more than 40% of patients with esophageal cancer experienced locoregional recurrence after definitive CRT. Immune checkpoint inhibitors targeting PD-1/PD-L1 and/or CTLA-4 have shown substantial clinical benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with CRT has emerged as a promising strategy to improve clinical outcomes in esophageal cancer. The aim of this study was to evaluate the efficacy and safety of cadonilimab (a bispecific PD-1/CTLA-4 antibody) combined with induction chemotherapy followed by definitive radiotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Начало: 02.03.2024 Край: 31.12.2027 Възраст: 18–75 г.

China Sun Yat-sen University NCT06143748

Активно (без набиране) Фаза 2

Comparative Evaluation of Three Different Pulpotomy Agents in Primary Molars

Pulpotomies Primary Teeth Dental Pulp Disease Primary Teeth

Comparative Evaluation of Mineral Trioxide Aggregate (MTA), Ferric Sulfate, and Chitosan Hydrogel for Primary Molar Pulpotomy: An 18-Month Randomized Controlled Trial Why is this study being done? When a child's tooth has a deep cavity, the decay can reach the soft inner part of the tooth called the pulp. A common treatment is called a pulpotomy - the dentist removes the infected part of the pulp and places a special material to protect the healthy root and save the tooth. Several materials are used for this treatment, but dentists do not yet agree on which one works best. This study compares three materials: (1) Mineral Trioxide Aggregate (MTA) - a well-known dental cement; (2) Ferric Sulfate (FS) - a liquid that stops bleeding; and (3) Chitosan Hydrogel - a new, natural gel made from shellfish shells. The goal is to find out which material keeps the treated tooth healthy for the longest time. Who can take part? Healthy children aged 5 to 8 years who have at least one baby back tooth (primary molar) that needs a pulpotomy treatment may be eligible. Children with tooth pain, swelling, infection, or teeth that are too damaged will not be included. A parent or guardian must give written permission for their child to join the study. What will happen during the study? 165 children will join the study and be randomly placed (like a coin toss) into one of three groups - each group receives a different pulpotomy material. The treatment is a routine pulpotomy done under local anesthesia (numbing injection) by an experienced pediatric dentist. After the pulpotomy material is placed, the tooth is sealed with a protective metal crown. Children will have check-up visits at 3, 6, 12, and 18 months. At each visit, the dentist checks the tooth by examination and by taking a small X-ray. What are the possible risks? The risks are similar to those of any routine pulpotomy. Some children may feel mild soreness for 1 to 2 days after treatment. All three materials used in this study have been used in previous dental research. Children with shellfish allergies will be screened before enrollment. What are the possible benefits? Participating children receive free professional dental treatment and regular check-ups at no cost for 18 months. The treatment aims to save the child's baby tooth, helping with chewing, speech, and guiding permanent teeth into the right position. The results of this study will help dentists choose the best treatment for children's teeth. Is participation voluntary? Yes. Joining this study is completely voluntary. Parents and children may choose not to participate or may withdraw at any time without any effect on their future dental care. If a family does not join or decides to leave, their child will still receive standard dental treatment. How is my child's information kept private? All information collected during this study is kept strictly confidential. Children's names are replaced with codes. Only the research team can access identifiable information. Results will be published in a way that does not identify any individual child.

Начало: 01.03.2024 Край: 01.04.2026 Възраст: 5–8 г.

Iraq Al-Mustansiriyah University NCT07541976

Активно (без набиране) Фаза 3

STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma

Severe Eosinophilic Asthma

This is a prospective, multi-center, single-arm Phase 3b study designed to evaluate the potential benefit to patients if benralizumab treatment could enable reduction in asthma maintenance controllers while allowing patients to maintain asthma control in Chinese patients.

Начало: 28.02.2024 Край: 29.05.2026 Възраст: 12–75 г.

China AstraZeneca NCT06465485

Активно (без набиране) Фаза 2

A Study to Investigate Efficacy and Safety of TOUR006 in Participants 18 to 80 Years of Age With Thyroid Eye Disease

Thyroid Eye Disease

Phase 2b trial of TOUR006 in Thyroid Eye Disease (TED) to evaluate 20mg and 50mg doses against placebo given by a subcutaneous injection every eight weeks to TED patients who are in the active inflammatory phase of disease.

Начало: 19.02.2024 Край: 01.09.2027 Възраст: 18–80 г. Лечение

Brazil, France, Italy +8 Tourmaline Bio, Inc. NCT06088979

Активно (без набиране)

Psilocybin in Functional Neurological Disorder

Functional Neurological Disorder

The goal of this study is to learn about the brain network response in people who have functional neurological disorder who are administered with a single dose of the psychedelic psilocybin with therapeutic support. The main question it aims to answer is: Can the default mode network, a brain network thought to be relevent in FND, be modified by the administration of psilocybin based on functional magnetic resonance imaging before and after the dose?

Начало: 14.02.2024 Край: 01.05.2026 Възраст: 25–60 г.

United Kingdom King's College London NCT05723276

Активно (без набиране) Фаза 4

EMPagliflozin After Aortic Valve Replacement

Aortic Valve Stenosis

The study is a randomized, placebo-controlled, and double-blinded trial in patients with aortic stenosis (AS) undergoing aortic valve replacement (AVR). After AVR, patients will be randomized 1:1 to empagliflozin (SGLT2i) or placebo to investigate whether empagliflozin is superior to placebo in reducing left ventricular mass and improve symptoms to 6 months.

Начало: 14.02.2024 Край: 01.06.2026 Възраст: от 18 г.

Denmark Rigshospitalet, Denmark NCT06171802

Активно (без набиране) Фаза 1

Study of CMP-CPS-001 in Healthy Volunteers and Participants With Abnormal Heterozygous OTC Genotype

Healthy Volunteers OTC Deficiency

The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CMP-CPS-001 administered as a subcutaneous injection in adult healthy volunteers and participants with abnormal heterozygous OTC genotype.

Начало: 05.02.2024 Край: 01.12.2027 Възраст: 16–65 г. Лечение

Australia, Netherlands CAMP4 Therapeutics Corporation NCT06247670

Активно (без набиране)

Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa

Peri-Implantational Loss Surgical Wound Healing Surgical Wounds Thin-gingiva

The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with \

Начало: 29.01.2024 Край: 09.04.2027 Възраст: 18–80 г.

Spain Universidad Complutense de Madrid NCT06261268

Активно (без набиране) Фаза 2

A Study of Continued Treatment With Regorafenib in Participants With Solid Tumors Who Have Participated in Other Bayer Studies

Solid Malignant Tumors

Regorafenib is an anti-cancer drug that blocks several proteins which are involved in the growth of cancer. It has been approved for different types of cancers of the digestive system and is being tested for use in some other solid tumors. Cancers that start in an organ, a muscle, or a bone form a solid tumor. This study is for participants with solid tumors who have been taking regorafenib in other Bayer studies. They can continue taking regorafenib if it is working when treatment with regorafenib in their previous study ends. The main purpose of this study is to find: * How safe is the continued treatment with regorafenib in participants with solid tumors? * How well is the continued treatment with regorafenib tolerated by participants with solid tumors? Participants will continue with the same dose of regorafenib that they were taking in their previous study as long as the treatment works for them/they want to continue the treatment/other medical conditions do not prevent them from participating in the study. For participants that are under 18 years of age, regorafenib tablets will be taken by mouth once daily for 2 weeks and repeat again after a 1-week gap. For participants that are over 18 years of age, regorafenib tablets will be taken by mouth once daily for 3 weeks and repeat again after a 1-week gap. At the start of the study, researchers will review participants' records from the previous study. During the study, researchers will use blood samples and X-rays taken from participants under the age of 18 years to check how safe regorafenib is for children. They will also monitor any medical problems that participants may have during the study. After the last dose, follow-up will be done either within 14 days when participants visit their study doctor or within 30-35 days by phone call. Both the researchers and the participants will know the dose of regorafenib the participants receive during the study.

Начало: 24.01.2024 Край: 27.04.2028 Възраст: от 10 г.

France, Japan, South Korea +2 Bayer NCT06246643

Активно (без набиране) Фаза 2/3

Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)

Metastatic Urothelial Cancer

This is a global, multicenter, randomized, open-label study, with an adaptive design. The main objective of the study is to measure the efficacy and safety of BT8009 (zelenectide pevedotin) as monotherapy and in combination with pembrolizumab in participants with locally advanced or metastatic urothelial cancer (UC). The study includes a dose selection phase followed by an adaptive design continuation. The study is comprised of 2 cohorts. Cohort 1 will include participants who have not received any prior systemic therapy for locally advanced or metastatic UC and are eligible to receive platinum-based chemotherapy, whereas Cohort 2 will include participants who have received ≥ 1 prior systemic therapy for locally advanced or metastatic UC.

Начало: 24.01.2024 Край: 01.12.2030 Възраст: от 18 г. Лечение

Argentina, Australia, Belgium +18 BicycleTx Limited NCT06225596

Активно (без набиране) Фаза 2

Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

Metastatic Triple-Negative Breast Cancer

The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative breast cancer. The main questions it aims to answer are: * to evaluate the anti-cancer efficacy (assess how well it works) * to evaluate the safety and tolerability (how well the body can handle the treatment) of this combination of anti-cancer therapy

Начало: 10.01.2024 Край: 01.03.2027 Възраст: от 18 г.

United States Wake Forest University Health Sciences NCT06027268

Активно (без набиране) Фаза 2

A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

Recurrent Acute Leukemia of Ambiguous Lineage Recurrent Acute Lymphoblastic Leukemia Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged +8

This phase II trial tests the safety and best dose of revumenib in combination with chemotherapy, and evaluates whether this treatment improves the outcome in infants and young children who have leukemia that has come back (relapsed) or does not respond to treatment (refractory) and is associated with a KMT2A (MLL) gene rearrangement (KMT2A-R). Leukemia is a cancer of the white blood cells, where too many underdeveloped (abnormal) white blood cells, called "blasts", are found in the bone marrow, which is the soft, spongy center of the bones that produces the three major blood cells: white blood cells to fight infection; red blood cells that carry oxygen; and platelets that help blood clot and stop bleeding. The blasts crowd out the normal blood cells in the bone marrow and spread to the blood. They can also spread to the brain, spinal cord, and/or other organs of the body. The leukemia cells of some children have a genetic change in which a gene (KMT2A) is broken and combined with other genes that typically do not interact with one another; this is called "rearranged". This genetic rearrangement alters how other genes are turned on or off in the cell, turning on genes that drive the development of leukemia. Patients with KMT2A rearrangement have higher risk for cancer coming back after treatment. Revumenib is an oral medicine that directly targets the changes that occur in a cell with a KMT2A rearrangement and has been shown to specifically kill these leukemia cells in preclinical laboratory settings and in animals. Drugs used in chemotherapy, such as vincristine, prednisone, asparaginase, fludarabine and cytarabine work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial is being done to find out if the combination of revumenib and chemotherapy would be safe and/or effective in treating infants and young children with relapsed or refractory KMT2A-R leukemia.

Начало: 08.01.2024 Край: 31.12.2027 Възраст: 1–6 г.

Canada, United States Children's Oncology Group NCT05761171

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