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Активно (без набиране) Фаза 1

Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax

Recurrent Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia

This phase Ib trial is to find the side effect and best dose of navitoclax when given together with venetoclax and decitabine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory) after previous treatment with venetoclax. Chemotherapy drugs, such as navitoclax, venetoclax, and decitabine, 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.

Начало: 29.07.2022 Край: 02.03.2027 Възраст: от 16 г.

United States City of Hope Medical Center NCT05222984

Активно (без набиране)

Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock

Cardiogenic Shock Acute Myocardial Infarction STEMI - ST Elevation Myocardial Infarction NSTEMI - Non-ST Segment Elevation MI +5

The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.

Начало: 22.07.2022 Край: 31.12.2026 Възраст: от 18 г.

United States Henry Ford Health System NCT05800951

Активно (без набиране) Фаза 2

Testing the Addition of Nivolumab to Standard Treatment for Patients With Metastatic or Unresectable Colorectal Cancer That Have a BRAF Mutation

Metastatic Colon Adenocarcinoma Metastatic Rectal Adenocarcinoma Stage III Colon Cancer AJCC v8 Stage III Rectal Cancer AJCC v8 +4

This phase II trial tests whether adding nivolumab to the usual treatment (encorafenib and cetuximab) works better than the usual treatment alone to shrink tumors in patients with colorectal cancer that has spread to other places in the body (metastatic) or that cannot be removed by surgery (unresectable) and whose tumor has a mutation in a gene called BRAF. Encorafenib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the BRAF gene. It works by blocking the action of mutated BRAF that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with encorafenib and cetuximab may be more effective than encorafenib and cetuximab alone at stopping tumor growth and spreading in patients with metastatic or unresectable BRAF-mutant colorectal cancer.

Начало: 19.07.2022 Край: 30.09.2026 Възраст: от 18 г.

Puerto Rico, United States National Cancer Institute (NCI) NCT05308446

Активно (без набиране) Фаза 3

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Melanoma

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life

Начало: 14.07.2022 Край: 16.09.2031 Възраст: от 12 г. Лечение

Argentina, Australia, Austria +21 Regeneron Pharmaceuticals NCT05352672

Активно (без набиране) Фаза 1/2

Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder

Amphetamine-Related Disorders

This is a proof-of-concept randomized clinical trial of psilocybin-enhanced psychotherapy versus treatment-as-usual among individuals being treated for methamphetamine use disorder.

Начало: 07.07.2022 Край: 31.12.2026 Възраст: 25–65 г.

United States Portland VA Research Foundation, Inc NCT04982796

Активно (без набиране) Фаза 2

Quantitative Assessment of Radiation-induced Neuroinflammation - A Proof of Principle Study

Brain Tumor Medulloblastoma

QARIN 1 is a study of \[18F\]DPA-714 Translocation Protein (TSPO) Positron Emission Tomography (PET) for longitudinal, quantitative assessment of brain neuroinflammation following whole brain radiation therapy. This TSPO PET, uses a radioactive tracer. An optional MRI (magnetic resonance imaging) will also be performed to monitor brain microstructure damages induced by neuroinflammation. Primary Objectives * Assessment of temporal and regional variability of uptake of translocator protein (TSPO) positron emission tomography (PET) tracer. * Regional variability will be assessed in medial temporal lobe, frontal lobe, and in white matter * Temporal variability will be assessed by scanning each subject four-times: at baseline (before or within 2 weeks of start of radiation therapy), before start of chemotherapy, at 1 year from the initiation of the radiation therapy, and at 1.5-2 years from the initiation of the radiation therapy * Correlation of radiation dose in specific brain regions with radiation induced neuroinflammation as measured by uptake of TSPO PET tracer. Exploratory Objectives * Assessment of radiation-induced brain microstructure injuries (RIBMI) in specific brain regions (medial temporal lobe, frontal lobe, and in white matter) using advanced magnetic resonance imaging (MRI) techniques. * Association of radiation dose with MRI measures of RIBMI in these specific brain regions. * Association of PET measures of RIN with MRI measures of RIBMI. * Association of PET measure of RIN and MRI measures of RIBMI in specific regions of interest (ROI) with specific domain of neuro-cognition. For example, to investigate whether PET measure of RIN and MRI measures of RIBMI in hippocampal ROI have strongest association with episodic memory; whether frontal lobe cortical ROI are associated with attention and executive function. * Association of a novel MRI based technique for assessment of RIN with TSPO PET. * Association of the PET and MRI measure of neuroinflammation within 2- years of completion of radiation with delayed cognitive outcome that will be measured at 3, 4 and 5 years from the completion of radiation

Начало: 05.07.2022 Край: 31.12.2035 Възраст: 8–39 г.

United States St. Jude Children's Research Hospital NCT05128903

Активно (без набиране)

Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes

Diabetes Type 2

Type 2 diabetes is a chronic disease that can lead to a number of complications if uncontrolled and there is a projected increase of 33% patients living with diabetes over the next 10 years. There can be improvements to modifiable risk factors such as diet and exercise, in addition to medications. Treatment often involves a multidisciplinary approach with a physician, endocrinologist, dietitian, pharmacist and other support health professionals as required. This study will evaluate the effects of the pharmacists (or pharmD interns) intervention, looking at changes to the patients HbA1C, which is a measure of the patients blood glucose control over the previous 3 months as well as the patients understanding and comfort with managing their own diabetes via participant survey.

Начало: 04.07.2022 Край: 01.12.2026 Възраст: от 18 г.

Canada University of Manitoba NCT05442840

Активно (без набиране) Фаза 3

Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

Erosive Esophagitis

The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

Начало: 01.07.2022 Край: 19.08.2026 Възраст: 1–11 г. Лечение

Argentina, Australia, Belgium +7 AstraZeneca NCT05267613

Активно (без набиране)

Realistic Computational Electrophysiology Simulations for the Targetted Treatment of Atrial Fibrillation

Atrial Fibrillation

The aim of this research is to classify patients by the dominant mechanism of continuous atrial electrical activation during atrial fibrillation. This approach seeks to improve on existing classifications which are based solely on the duration of the arrhythmia (\7 days and \>1 year). This is a cohort study. Patients undergoing clinically indicated electrophysiology study or AF ablation will have invasive assessment of cardiac electrophysiological profile at the time of their planned procedure, undergo 2-week ambulatory monitoring before and after the procedure, complete symptom questionnaires before and after their procedure and undergo atrial cardiac magnetic resonance imaging before their procedure.

Начало: 01.07.2022 Край: 31.07.2026 Възраст: 18–80 г.

United Kingdom University of Edinburgh NCT05057507

Активно (без набиране)

Laparoscopic Inguinal and Femoral heRniA rePaIr Using Pre-shapeD 4DMESH® (4DLap)

Inguinal Hernia Femoral Hernia

The purpose of this study is to evaluate the safety and performance of the 4DMESH® used in (robot-assisted) laparoscopic inguinal and femoral hernia repair. The goal of the study will be achieved by assessing the prevalence of recurrences, pain, quality-of-life (QoL), return to daily activities and work and groin symptoms, and by reporting of peri- and postoperative complications in a prospectively maintained database.

Начало: 30.06.2022 Край: 30.09.2029 Възраст: от 18 г.

Belgium, France, Spain Cousin Biotech NCT05306496

Активно (без набиране) Фаза 1/2

Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Recurrent Mantle Cell Lymphoma Refractory Mantle Cell Lymphoma

This phase I/II trial studies the side effects, best dose, and effectiveness of copanlisib and venetoclax in treating patients with mantle cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Copanlisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving copanlisib and venetoclax may help treat patients with mantle cell lymphoma.

Начало: 29.06.2022 Край: 12.02.2027 Възраст: от 18 г.

United States City of Hope Medical Center NCT04939272

Активно (без набиране)

Investigation of Prostate Artery Embolization Compared to Holmium Laser Enucleation of Prostate

Benign Prostatic Hyperplasia

The purpose of this research study is to evaluate prostate artery embolization (PAE) compared to Holmium laser enucleation of prostate (HoLEP) in improving a patient's overall prostate related symptoms.

Начало: 17.06.2022 Край: 01.12.2027 Възраст: от 50 г.

United States University of Miami NCT05155891

Активно (без набиране) Фаза 1

An Immunotherapy Vaccine (PIpepTolDC) for the Treatment of Patients With Type 1 Diabetes

Type 1 Diabetes Mellitus

This phase I trial investigates the side effects of PIpepTolDC vaccine in treating patients with type 1 diabetes who use insulin and don't have any other diabetes-related health complications. Type 1 diabetes is an autoimmune disease. This means that the immune system, which usually protects against foreign invaders like bacteria and viruses, attacks the body's insulin-producing betacells in the pancreas (autoimmune response). Overtime, the beta cells are destroyed by the immune system. To stay alive, people with type 1 diabetes must use insulin. PIpepTolDC vaccine is a type of immunotherapy (a treatment that uses a person's own immune system) that works like an allergy shot. The vaccine is made using one's own immune cells (dendritic cells) and a beta cell protein. The vaccine may teach the immune system to stop attacking the beta cells, which may help the beta cells recover and make enough insulin to control blood sugar levels. The vaccine may also help reduce future type 1 diabetes related complications.

Начало: 16.06.2022 Край: 15.12.2026 Възраст: 18–45 г.

United States City of Hope Medical Center NCT04590872

Активно (без набиране) Фаза 3

Study of JDQ443 in Comparison With Docetaxel in Participants With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

Non-Small Cell Lung Cancer

This is a phase III randomized open label study designed to compare JDQ443 as monotherapy to docetaxel in participants with advanced non-small cell lung cancer (NSCLC) harboring a KRAS G12C mutation who have been previously treated with a platinum-based chemotherapy and immune checkpoint inhibitor therapy either in sequence or in combination.

Начало: 15.06.2022 Край: 23.09.2026 Възраст: 18–100 г. Лечение

Argentina, Australia, Canada +22 Novartis Pharmaceuticals NCT05132075

Активно (без набиране)

ProVee Urethral Expander System IDE Study (ProVIDE)

BPH With Symptomatic Lower Urinary Tract Symptoms

A study to evaluate the safety, performance, and effectiveness of the ProVee Urethral Expander System (Investigational Device) when used in subjects with symptomatic urinary obstruction related to benign prostatic hyperplasia (BPH).

Начало: 09.06.2022 Край: 01.12.2028 Възраст: от 45 г.

Canada, Ireland, United States ProVerum Medical NCT05186740

Активно (без набиране)

Bevacizumab Plus Nab-paclitaxel and Platinum for Immunotherapy-treated Non-squamous Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Metastatic

Immune checkpoint inhibitor (ICI)-based regimen has been widely used in first-line treatment of driver-gene-negative non-squamous non-small cell lung cancer. This study investigate the efficacy and safety of the combination of bevacizumab plus nab-paclitaxel and platinum as second-line treatment for driver-gene-negative non-squamous non-small cell lung cancer patients progressed after ICI-based treatments.

Начало: 09.06.2022 Край: 30.08.2026 Възраст: 18–75 г.

China Fudan University NCT05407155

Активно (без набиране) Фаза 3

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Regularly Transfused, Followed by a 5-Year Extension Period

Pediatric Pyruvate Kinase Deficiency Pediatric Hemolytic Anemia

ACTIVATE-KidsT (AG348-C-022) is a multicenter study designed to evaluate the efficacy and safety of treatment with mitapivat compared with placebo in pediatric participants with pyruvate kinase deficiency (PK deficiency) who are regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to \< 6 years, 6 to \< 12 years, 12 to \< 18 years) and splenectomy status. Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 24-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat in the open-label extension (OLE) period.

Начало: 08.06.2022 Край: 01.06.2029 Възраст: 1–17 г.

Canada, Czechia, Denmark +7 Agios Pharmaceuticals, Inc. NCT05144256

Активно (без набиране) Фаза 3

A Study to Evaluate the Efficacy and Safety of Mitapivat in Pediatric Participants With Pyruvate Kinase Deficiency (PKD) Who Are Not Regularly Transfused, Followed by a 5-Year Extension Period

Pediatric Pyruvate Kinase Deficiency Pediatric Hemolytic Anemia

Study ACTIVATE-Kids (AG348-C-023) will evaluate the efficacy and safety of orally administered mitapivat as compared with placebo in pediatric participants with pyruvate kinase deficiency (PKD) who are not regularly receiving blood transfusions. Participants will be randomized 2:1 to receive either mitapivat or matching placebo. Randomization will be stratified by age (1 to \< 6 years, 6 to \< 12 years, 12 to \< 18 years). Participants will be dosed by age and weight during a double-blind period consisting of an 8-week dose titration period followed by a 12-week fixed-dose period. Participants who complete the double-blind period will be eligible to receive mitapivat for up to 5 years in the open-label extension (OLE) period.

Начало: 06.06.2022 Край: 01.01.2030 Възраст: 1–17 г.

Canada, France, Germany +4 Agios Pharmaceuticals, Inc. NCT05175105

Активно (без набиране) Фаза 2

An Open-Label Intervention Trial to Reduce Senescence and Improve Frailty in Adult Survivors of Childhood Cancer

Frailty Childhood Cancer

This is a first-in survivor pilot study with the goal of establishing preliminary evidence of efficacy, safety, and tolerability of two senolytic regimens to reduce markers of cellular senescence (primary outcome: p16\^INK4a) and improve frailty (primary outcome: walking speed) in adult survivors of childhood cancer. If successful, this pilot would provide the preliminary evidence needed for a phase 2, randomized, placebo-controlled trial to establish efficacy. Primary Objective * The primary aim of this proposal is to test the efficacy of two, short duration senolytic regimens: 1) combination of Dasatinib plus Quercetin and 2) Fisetin alone, to improve walking speed and decrease senescent cell abundance in blood (p16\^INKA): * Primary endpoints of this trial will be change in walking speed and senescent cell abundance in blood (p16\^INK4A) determined at baseline and again at 60 days, within an individual arm. Extended follow up at 150 days will assess the permanence of change after completion of the trial. Secondary endpoints of this trial will be effect of intervention on additional measures of frailty (beyond walking speed; Fried criteria) and on other cell senescence markers, markers of inflammation, insulin resistance, bone resorption, and cognitive function. Secondary Objectives The secondary aim is to test the safety and tolerability of two different senolytic therapies. Exploratory Objectives * To compare the efficacy of the two senolytic regimens in improving walking speed and decreasing senescent cell abundance * To evaluate the longitudinal pattern in measures of frailty.

Начало: 06.06.2022 Край: 01.12.2027 Възраст: от 18 г.

United States St. Jude Children's Research Hospital NCT04733534

Активно (без набиране) Фаза 3

Testing the Addition of the Anti-cancer Drug, Cabozantinib, to the Usual Immunotherapy Treatment, Avelumab, in Patients With Metastatic Urothelial Cancer, MAIN-CAV Study

Advanced Bladder Urothelial Carcinoma Advanced Renal Pelvis Urothelial Carcinoma Advanced Ureter Urothelial Carcinoma Advanced Urethral Urothelial Carcinoma +14

This phase III trial compares the effect of adding cabozantinib to avelumab versus avelumab alone in treating patients with urothelial cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib and avelumab together may further shrink the cancer or prevent it from returning/progressing.

Начало: 03.06.2022 Край: 15.06.2026 Възраст: от 18 г.

Canada, United States National Cancer Institute (NCI) NCT05092958

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