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Active (not recruiting) Phase 2

Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome

Cushing Syndrome

This is an open-label extension study to evaluate the long-term safety of relacorilant in patients with endogenous Cushing syndrome who successfully completed participation in a Corcept-sponsored study of relacorilant and may benefit from continuing treatment.

Начало: 07.05.2018 Край: 01.12.2026

Austria, Canada, Germany +7 Corcept Therapeutics NCT03604198

Active (not recruiting) Phase 2

Extended Access of Momelotinib in Adults With Myelofibrosis

Neoplasms Post-polycythemia Vera Myelofibrosis (Post-PV MF) Primary Myelofibrosis (PMF) Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) +1

The primary objective of this study is to provide extended access and assess long-term safety of momelotinib (MMB) in participants with primary myelofibrosis (PMF) or post-polycythemia vera or post-essential thrombocythemia myelofibrosis (Post-PV/ET MF) enrolled in studies GS-US-352-0101 (NCT01969838), GS-US-352-1214 (NCT02101268), GS-US-352-1154 (NCT02124746), SRA-MMB-301 who are currently receiving treatment with MMB (available as 50mg,100 mg, 150 mg and 200 mg tablets) and have not experienced progression of disease. The secondary objective is to assess overall survival (OS) and leukemia free survival (LFS) in all subjects.

Начало: 03.05.2018 Край: 11.12.2026 Възраст: от 18 г. Treatment

Australia, Austria, Belgium +17 GlaxoSmithKline NCT03441113

Active (not recruiting) Phase 2

Los Tres Paso: Neoadjuvant Palbociclib Monotherapy, Concurrent Chemoradiation Therapy, Adjuvant Palbociclib Monotherapy in Patients With p16INK4a Negative, HPV-Unrelated Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Cell Carcinoma

The purpose of this study is to evaluate the results of treating patients with HPV-unrelated head and neck squamous cell carcinoma with neoadjuvant single-agent palbociclib, followed by chemoradiation (either cisplatin + IMRT or cetuximab + IMRT depending on patient characteristics), followed by adjuvant single-agent palbociclib.

Начало: 27.04.2018 Край: 06.04.2027 Възраст: от 18 г.

United States Washington University School of Medicine NCT03389477

Active (not recruiting)

Pyruvate Kinase Deficiency Global Longitudinal Registry

Pyruvate Kinase Deficiency

This study is an observational (ie, noninterventional), longitudinal, multicenter, global registry for patients with pyruvate kinase (PK) deficiency, a rare nonspherocytic hemolytic anemia. This Registry will be open for enrollment for 7 years and all enrolled participants will be followed prospectively for a minimum of 2 years, and up to 9 years. Data will be collected from participating Registry Physicians, participants, and, where appropriate, parents/guardians who have provided informed consent or assent (where relevant) and authorization pursuant to applicable laws and regulations. Data should include demographic, clinical, and treatment data; and other data of relevance to the management of patients with PK deficiency. Annual chart review and data entry are expected in order to enhance longitudinal understanding of PK deficiency; however, no specific protocol schedule of assessment is required by this Registry protocol.

Начало: 23.04.2018 Край: 31.05.2027

Canada, Czechia, Denmark +13 Agios Pharmaceuticals, Inc. NCT03481738

Active (not recruiting)

RESOLUTE ONYX China RCT Study

Ischemic Heart Disease Stenotic Coronary Lesion Cardiovascular Diseases Arteriosclerosis +1

It is a randomized controlled trial to evaluate the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in comparison with the Medtronic Resolute Integrity™ Zotarolimus-Eluting coronary stent system in the treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) in China.

Начало: 12.04.2018 Край: 31.07.2026 Възраст: от 18 г.

China Medtronic Vascular NCT03466151

Active (not recruiting)

RESOLUTE ONYX China Single Arm Study

Ischemic Heart Disease Stenotic Coronary Lesion Cardiovascular Diseases Arteriosclerosis +1

It is a single arm clinical evaluation of safety and efficacy of the Medtronic Resolute Onyx™ zotarolimus-eluting coronary stent system in subjects who are eligible for percutaneous transluminal coronary angioplasty (PTCA) in de novo lesions amenable to treatment with Resolute Onyx™ Stent System in China.

Начало: 30.03.2018 Край: 30.08.2026 Възраст: от 18 г.

China Medtronic Vascular NCT03471845

Active (not recruiting) Phase 2

Testing Afatinib as Potentially Targeted Treatment in Cancers With EGFR Genetic Changes (MATCH - Subprotocol A)

Advanced Lymphoma Advanced Malignant Solid Neoplasm Refractory Lymphoma Refractory Malignant Solid Neoplasm +1

This phase II MATCH treatment trial tests how well afatinib works in treating patients with cancer that has certain genetic changes. Afatinib is in a class of medications called kinase inhibitors. It is used in patients whose cancer has a certain mutation (change) in the EGFR gene. It works by blocking the action of mutated EGFR that signals cancer cells to multiply. This helps to stop or slow the spread of cancer cells.

Начало: 28.02.2018 Край: 15.01.2027 Възраст: от 18 г.

United States National Cancer Institute (NCI) NCT06385483

Active (not recruiting) Phase 1

Haploidentical Transplantation With Pre-Transplant Immunosuppressive Therapy for Patients With Sickle Cell Disease

Sickle Cell Disease

This is a study to evaluate the safety and toxicity of a treatment regimen consisting of 2 cycles of pre-transplant immunosuppressive therapy followed by myeloablative preparative regimen and allogeneic hematopoietic stem cell transplantation from a haploidentical donor in patients with sickle cell disease. The overall goal of this study is to expand the donor pool for hematopoietic stem cell transplantation in sickle cell disease using haploidentical donors, and to develop a non-toxic, myeloablative regimen, with the goal of achieving a consistent donor chimerism utilizing pre-transplant immunosuppressive therapy.

Начало: 02.02.2018 Край: 25.01.2027 Възраст: 1–30 г.

United States City of Hope Medical Center NCT03279094

Active (not recruiting) Phase 1

A Study of AZD6738 and Acalabrutinib in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Chronic Lymphocytic Leukemia

This study evaluates the safety, pharmacokinetics, pharmacodynamics and efficacy of acalabrutinib and ceralasertib (known as AZD6738) when taken in combination.

Начало: 31.01.2018 Край: 26.08.2026 Възраст: 18–130 г.

Poland, United Kingdom Acerta Pharma BV NCT03328273

Active (not recruiting)

Obstructive Sleep Apnea in Survivors of Hodgkin Lymphoma Treated With Thoracic Radiation

Obstructive Sleep Apnea Hodgkin Lymphoma

While thoracic radiation therapy (TRT) has been a primary component in successful treatment of Hodgkin lymphoma, exposure to this treatment has been associated with significant cardiovascular, cerebrovascular, and pulmonary morbidity in long-term survivors. Survivors of Hodgkin lymphoma (HL) are also at risk for fatigue and excessive daytime sleepiness. Insufficient sleep is recognized as an important public health concern, and is associated with cardiovascular disease, diabetes, obesity, neurocognitive problems, and reduced quality of life and productivity. Survivors of HL, who are already at risk for cardiac and neurologic morbidity due to their treatment exposures, could face catastrophic cardiovascular and cerebrovascular events with the added risk associated with obstructive sleep apnea (OSA). The investigators propose to examine indices of sleep quality using polysomnography, and associated neurocognitive performance, brain MRI, and structure and strength of neck muscles in 220 long-term adult survivors of Hodgkin lymphoma treated with thoracic radiation. OBJECTIVES: 1. To estimate the prevalence of OSA in adult survivors of HL treated with thoracic radiation, and compare the frequency to community controls matched on age, gender, race and body mass index. 2. To identify specific therapeutic factors associated with OSA in adult survivors of HL treated with thoracic radiation. 3. To identify biomarkers of OSA in adult survivors of HL treated with thoracic radiation. 4. To examine associations between OSA and cardiac morbidity and brain integrity in the adult survivors of HL treated with thoracic radiation.

Начало: 23.01.2018 Край: 10.07.2028 Възраст: от 18 г.

United States St. Jude Children's Research Hospital NCT03361020

Active (not recruiting) Phase 2

A Study of Epacadostat, an IDO1 Inhibitor, in Combination With Pembrolizumab in Patients With Metastatic and/or Locally Advanced Sarcoma

Sarcoma

The purpose of this study is to test any good and bad effects of the combination therapy of epacadostat and pembrolizumab and to determine how well the combination therapy works in the treatment of patients with sarcoma.

Начало: 23.01.2018 Край: 01.01.2027 Възраст: от 18 г.

United States Memorial Sloan Kettering Cancer Center NCT03414229

Active (not recruiting)

Evaluation of the 2-year AVF Utilization Rate

Dialysis Access Dysfunction Fistulae

Arteriovenous fistulas (AVFs) are the standard for dialysis sessions. However, this usually requires surgery before dialysis can begin. Given this pre-operative approach, the investigators evaluate the two-year utilization rate of AVFs and seek to understand why they are still not used in some cases.

Начало: 01.01.2018 Край: 01.12.2026 Възраст: от 18 г.

France University Paul Sabatier of Toulouse NCT07548814

Active (not recruiting)

Bidirectional Cohort Study of a Prognosis Model for Acute-on-chronic Liver Failure

Liver Failure

This study constitutes a bidirectional cohort investigation. By collating laboratory parameters and clinical data-including plasma and peripheral blood mononuclear cell (PBMC) analyses-from patients with acute-on-chronic liver failure, it aims to provide a reference framework for predicting prognosis and the occurrence of complications.

Начало: 01.01.2018 Край: 31.12.2026 Възраст: 18–85 г.

China The Second Affiliated Hospital of Chongqing Medical Uni NCT07548190

Active (not recruiting)

Assessment of IOP After Corneal Refractive Surgery Based on AI

Myopia Myopia; Astigmatism Refractive Surgery Intraocular Pressure Changes

Significance, Background, and Current Status Studies show the global average prevalence of myopia is 22%, with hyperopia incidence being similar. In China, the myopia prevalence is 31%, making it one of the countries with the highest rates of myopia. Currently, the safety and efficacy of corneal refractive surgery (CRS), such as LASIK and SMILE, for correcting myopia, hyperopia, and other refractive errors are well-established. An increasing number of patients undergo CRS to alleviate the inconveniences caused by refractive errors. While LASIK has long been regarded as a classic procedure, since the first report of Small Incision Lenticule Extraction (SMILE) for myopia correction in 2008, it has evolved into one of the mainstream surgical techniques. With the rapid advancement of refractive surgery, minimizing postoperative complications while maintaining excellent visual outcomes has become a major focus for clinicians. Postoperative intraocular pressure (IOP) monitoring is a crucial observation index. Theoretically, IOP should not change significantly after CRS, as the surgery does not affect aqueous humor dynamics or intraocular volume. However, numerous studies indicate that alterations in corneal shape and biomechanical properties, particularly corneal thinning, lead to artificially low IOP readings with various tonometers, especially those dependent on corneal thickness. Furthermore, postoperative management often requires prolonged use of corticosteroid eye drops to suppress inflammation and promote wound healing. Extended steroid use can increase aqueous outflow resistance, elevating IOP, particularly in steroid responders, and potentially leading to steroid-induced glaucoma. Additionally, high myopia is a known risk factor for primary open-angle glaucoma. Therefore, based on preoperative and postoperative corneal parameter changes, rapidly and effectively determining the actual IOP range after CRS is of great significance for guiding clinical medication and screening for steroid-induced glaucoma. Big Data and Artificial Intelligence (AI) are increasingly applied in medicine. AI primarily includes two technical branches: machine learning (ML) and deep learning. ML, a novel AI technology, has garnered significant interest in medical applications in recent years. It typically involves computer simulations that integrate human-like learning, refine knowledge structures, and continuously improve performance to aid diagnosis and intelligent decision-making, becoming a pivotal method in AI. Resembling neural network processes, ML systems are trained on selected input data using appropriate algorithms to produce corresponding outputs. It is now widely used to solve complex problems in engineering and science. In ophthalmology, AI/ML has gained attention for assisting in disease detection and monitoring, demonstrating advantages in fundus image diagnosis, keratoconus screening, and glaucoma classification. In corneal refractive surgery, ML has been applied to preoperative parameter design and outcome optimization, showing good safety, efficacy, and predictability. Preliminary attempts have been made to use AI decision trees to evaluate the safety and efficacy of CRS. Building on this advanced technology and our previous research findings-which suggest that IOPcc and Pentacam-derived correction formulas (with the Shah correction method being preferable) provide relatively reliable IOP estimates after SMILE-this study aims to establish a data-driven model. Using Shah-corrected IOP as a reference to define postoperative IOP status, we will train and iteratively optimize a model by incorporating all relevant preoperative and postoperative parameters potentially affecting IOP. The goal is to predict the true IOP after CRS, thereby guiding postoperative follow-up, facilitating early detection of IOP elevation, and identifying potential glaucomatous tendencies.

Начало: 01.01.2018 Край: 01.12.2026 Възраст: 18–45 г.

China Tianjin Eye Hospital NCT07544615

Active (not recruiting) Phase 1/2

Breast Cancer Study of Preoperative Pembrolizumab + Radiation

Breast Cancer

This study is being done to assess the feasibility of pembrolizumab (study drug) combined with standard radiation to the tumor (tumor boost) before patients undergo standard treatment that can consist of one or more of the following: breast-conserving surgery, radiation to the entire breast/chest wall after surgery, and chemotherapy. Study participants will receive two doses of the study drug intravenously (through the vein) before their planned breast surgery or chemotherapy. The study drug will be administered three weeks apart. At the time of the second dose, radiation to the tumor in the affected breast will be given. This type of radiation treatment is called a "tumor boost", which is a standard part of radiation therapy for breast cancer that may occur either before or after planned breast-conserving surgery. Patients will receive breast surgery or begin chemotherapy approximately six weeks after your first dose of the study drug.

Начало: 22.12.2017 Край: 07.12.2030 Възраст: от 18 г.

United States Stephen Shiao NCT03366844

Active (not recruiting) Phase 3

Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC

mCRPC

This study compares rPFS in men with mCRPC treated with talazoparib plus enzalutamide vs. enzalutamide after confirmation of the starting dose of talazoparib in combination with enzalutamide.

Начало: 18.12.2017 Край: 30.06.2027 Възраст: от 18 г. Treatment

Argentina, Australia, Belgium +23 Pfizer NCT03395197

Active (not recruiting)

Assessment of Safety and Performances of HYPE Stems Associated to a SERF Acetabular Cup in Hip Arthroplasty (2017-01-NH)

Hip Arthropathy

The use of cementless femoral stems is known to provide satisfactory long-term clinical results. Extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. This study will validate the performance and safety of the HYPE (SERF) stems in the context of the 93/42/EEC directive and in relation to the recommendations of the MEDDEV 2.7.1 (Guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.

Начало: 05.12.2017 Край: 20.01.2031 Възраст: от 18 г.

France Societe dEtude, de Recherche et de Fabrication NCT05524350

Active (not recruiting) Phase 2

Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma

Metastatic Melanoma

This research study is studying a combination of drugs as a possible treatment for unresectable or metastatic melanoma. The drugs involved in this study are: * Pembrolizumab (Keytruda) * Trametinib (Mekinist) * Dabrafenib (Tafinlar)

Начало: 27.11.2017 Край: 31.12.2026 Възраст: от 18 г.

United States Massachusetts General Hospital NCT03149029

Active (not recruiting)

Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer

Gynecologic Cancer

The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.

Начало: 13.11.2017 Край: 15.09.2027 Възраст: от 18 г.

United States Brigham and Women's Hospital NCT03277469

Active (not recruiting)

Circulating Tumor Cells (CTC) in Lung Cancer

Lung Neoplasms

The primary objective of this study is to establish circulating tumor cell (CTC) derived xenografts and assess the activity of novel DNA repair inhibitors as a function of DNA repair mutations detected in CTC samples (personalize DNA repair therapy).

Начало: 19.10.2017 Край: 01.10.2026 Възраст: от 18 г.

United States Shadia Jalal NCT02630615

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