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Showing 20 of 25890 trials
Evolution of Insomnia During the First Year in Patients Newly Diagnosed With Cancer
NCT07280416
Recruiting
Conditions Cancer, Insomnia, Pain, Depression Anxie...
Phase Not Applicable
Enrollment 260
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The diagnosis of cancer can be a major trigger for new sleep problems, especially insomnia, in people who did not have sleep issues before. Insomnia may appear early in the care pathway and can continue over time, often interacting with other physical or emotional symptoms. The main goal of this preliminary study is to describe how insomnia develops during the first months after a cancer diagnosis in patients who had no sleep problems at the time of diagnosis. This will be done through regular follow-up over time. A secondary aim is to identify the factors that may contribute to the onset or persistence of insomnia, such as the cancer treatments patients receive, as well as any medical or non-medical therapies used to manage sleep difficulties. The study will also look at whether patients who develop sleep problems are referred to psychologists trained in specific therapies for insomnia, and how well they follow and adhere to these treatments.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • The primary objective is to characterize the evolution, severity, and incidence of insomnia in patients newly diagnosed with cancer (over a 12-month period)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-12-16
Completion: 2028-11-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 260 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier Emile Roux
Contact Information
Study Contact:
Emilie GADEA, PhD
+33 471 043 538
science.writer@ch-lepuy.fr
Interventions
N/A
Study Locations (1 sites)
12 boulevard du Dr Chantemesse, Le Puy-en-Velay, 43000 France
Eligibility Criteria
Inclusion Criteria: * Confirmed diagnosis of metastatic or non-metastatic cancer, * Cancer treated with intravenous chemotherapy and/or immunotherapy administered intravenously or subcutaneously, * Age ≥ 18 years, * Ability to read and understand French, * Patient covered by a social security system, * Signed informed consent. Exclusion Criteria: * SCI questionnaire score \<16 * Diagnosed or controlled sleep disorders * Presence of severe cognitive disorders (e.g., Alzheimer's disease) or major psychiatric disorders (e.g., psychosis), as noted in the medical record, observed at recruitment, or reported by the patient * Patient in an emergency situation, or subject to a legal protection measure (guardianship, curatorship, or judicial protection) and unable to provide consent
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throughput Theory in Patients With Treatment-Resistant Major Depression
NCT03973268
Recruiting
Conditions Depression, Major Depressive Disorder, M...
Phase PHASE1
Enrollment 70
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Background: Most drugs that treat mood disorders take a long time to work. Ketamine works within hours. A dose can last for a week or more. Certain receptors in the brain might help ketamine work. A drug that blocks these receptors might affect how it works. Objective: To see if the antidepressant response of ketamine is linked to AMPA receptors. Eligibility: Adults ages 18-70 with major depression disorder without psychotic features Design: Participants will be screened under protocol 01-M-0254. They will have blood tests and a physical exam. Participants will stay at the NIH Clinical Center for 5 weeks. Phase 1 lasts 4 weeks. For 2 weeks, participants will taper off their psychiatric medicine. Then they will have the following tests: * Blood draws * Psychological tests * MRI: Participants will lie in a machine that takes pictures of their brain. * MEG: Participants will lie down and do tasks. A cone lowered on their head will record brain activity. * Optional sleep tests: Electrodes on the scalp and body and belts around the body will monitor participants while they sleep. * Optional TMS: Participants will do tasks while a wire coil is held on their scalp. An electrical current will pass through the coil that affects brain activity. For phase 2, on day 0 participants will take the study drug or a placebo orally. While having a MEG, they will get ketamine infused into a vein in one arm while blood is drawn from a vein in the other arm. On day 1, participants will again take the study drug or a placebo orally. On days 3-7, they will repeat many of the phase 1 tests. Days 8 and 9 are optional and include an open label ketamine treatment and many of the phase 1 tests.

Design

Study type: Interventional Phases: Phase1 Allocation: Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: Triple

Interventions / Regimen

  • Device: Arm 1, 2, 3 device interventions — MagPro 100 TMS Therapy System
  • Other: Arm 2 Interventions — Placebo
  • Drug: Arm 1, 2, 3 drug Interventions — Ketamine
  • Drug: Arm 1 and 2 Interventions — Perampanel

Primary Outcomes

  • Acute Antidepressant Efficacy: Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) score post ketamine infusion (Baseline, Day 1)
  • Continued Antidepressant Efficacy: Change from baseline MADRS score post treatment with ketamine with perampanel versus placebo. (Baseline, Day 1, Day 2 Day 7)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2020-01-21
Completion: 2027-02-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Institute of Mental Health (NIMH)
Principal Investigators:
  • Carlos A Zarate, M.D. (PRINCIPAL_INVESTIGATOR) - National Institute of Mental Health (NIMH)
Contact Information
Study Contact:
Yamila I Carmona
(301) 256-8971
yamila.carmona@nih.gov
Interventions
  • Device: Arm 1, 2, 3 device interventions — MagPro 100 TMS Therapy System
  • Other: Arm 2 Interventions — Placebo
  • Drug: Arm 1, 2, 3 drug Interventions — Ketamine
  • Drug: Arm 1 and 2 Interventions — Perampanel
Study Locations (1 sites)
National Institutes of Health Clinical Center, Bethesda, Maryland 20892 United States
Eligibility Criteria
* INCLUSION CRITERIA: Phases I-II 1. 18 to 70 years of age. 2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. 3. All subjects must have undergone a screening assessment under protocol 01-M-0254, "The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers". 4. Subjects must fulfill DSM-IV or -5criteria for Major Depression (Major Depressive Disorder) without psychotic features, based on clinical assessment and informed by a structured diagnostic interview (SCID-P). 5. Subjects must have an initial score on the MADRS greater than or equal to 22 and a YMRS score of \<12 within one week of study entry and upon entry into Phase II. 6. Lack of response to two adequate antidepressant trials, with \[at least\] one in the current major depressive episode, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT \[or TMS\] would count as an adequate antidepressant trial. 7. Current major depressive episode lasting at least four weeks 8. Agree to be hospitalized Open-Label Ketamine Treatment 1. Participants must have met all inclusion criteria for and completed Study Phase II 2. Individuals who are able to get pregnant must be willing to remain sexually abstinent or use at least one form of effective birth control during participation in Phase III. EXCLUSION CRITERIA: Phases I-II 1. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5. 2. Subjects with a history of substance abuse or dependence diagnosis (DSM-IV) or substance use disorder (DSM-5 equivalent) (except for caffeine or nicotine dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screening and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines or stimulants) at screening. 3. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease, coronary artery disease, atherosclerotic ischemic stroke, and atrial fibrillation), endocrinologic, neurologic, immunologic, or hematologic disease. 4. Pregnant or nursing individuals or those who are physically able to become pregnant. Participants who are physically able to become pregnant or cause a pregnancy must use at least one form of effective birth control or remain completely abstinent from sexual intercourse during the entire period of study participation (or until the last clinical labs and ratings). Participants able to become pregnant must have negative urine pregnancy tests no more than 24 hours prior to receiving the study drugs and undergoing imaging procedures. 5. Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold. History of seizure (regardless of age or etiology), history of epilepsy in self or first-degree relatives, stroke, brain surgery, head injury, or known structural brain lesion will be excluded from the TMS procedures. 6. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 7. Clinically significant abnormal laboratory tests. 8. (For imaging procedures) Subjects with hearing loss that has been clinically evaluated and diagnosed and may be worsened through participation in imaging procedures 9. Positive HIV test 10. Weight \> 119 kg 11. Treatment with any concomitant psychiatric medication prior to entering Phase II. \[Medications must be tapered during Phase I.\] 12. Treatment with any non-psychiatric medication/s. 13. Any use of opioid medication in the past 3 months 14. Treatment with a reversible monoamine oxidase inhibitor (MAOI) prior to entering Phase II. \[Medications must be tapered during Phase I.\] 15. Treatment with fluoxetine or aripiprazole at the time of screening. 16. Unwilling to stop undergoing structured, individualized psychotherapy. (Such therapy, including CBT, will not be permitted during Phases I and II of the study.) 17. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clip). 18. Participants who are uncomfortable in small closed spaces (have claustrophobia). 19. Are unable to lie comfortably supine for up to 90 minutes and would feel uncomfortable in the MRI and MEG machines. 20. Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk. 21. Subjects who have a history of aggressive behavior towards others 22. A current NIMH employee/staff or their immediate family member Open-Label Ketamine Treatment 1. Intolerable or serious adverse reaction to ketamine during Phase II 2. Participants with a positive urine for an illicit substance no more than 24 hours prior to ketamine treatment. 3. Pregnant or nursing individuals or those who plan to become pregnant.
Morning Activation to Improve Mood After Stroke
NCT07719517
Recruiting
Conditions Stroke, Depressive Symptoms
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a six-week behavioral intervention designed to improve mood and daily functioning in adults who have experienced a stroke and report depressive symptoms and difficulty becoming engaged in activities after waking. Participants will be randomly assigned to either the behavioral intervention or a health education program. Assessments will be completed before and immediately after the six-week program and will include questionnaires and seven-day monitoring of sleep, activity, and mood. The study will also examine feasibility indices such as participant retention, intervention attendance, acceptability, and preliminary changes in mood.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Behavioral: Morning Activation Program — A six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes. The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke. Sessions will be tailored to participants' needs and abilities.
  • Behavioral: Health Education Program — A six-week health education program delivered in weekly sessions of approximately 60 minutes. The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration. It will not include the individualized behavioral strategies provided in the experimental arm.

Primary Outcomes

  • Recruitment Rate (From the start of recruitment until enrollment of the final participant.)
  • Retention Rate (Immediately after completion of the 6-week intervention)
  • Intervention Attendance (Throughout the 6-week intervention period)
  • Intervention Acceptability (Immediately after completion of the 6-week intervention)
  • Participants Experiencing Adverse Events (From enrollment through completion of the immediate post-intervention assessment.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-05-15
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Hong Kong Polytechnic University
Contact Information
Study Contact:
Stephen Lau
+852 2766 4283
chun-lun-stephen.lau@polyu.edu.hk
Interventions
  • Behavioral: Morning Activation Program — A six-week individualized behavioral program delivered in weekly sessions of approximately 60 minutes. The program is designed to support engagement in daily activities after waking, establish consistent daily routines, and improve mood and functioning after stroke. Sessions will be tailored to participants' needs and abilities.
  • Behavioral: Health Education Program — A six-week health education program delivered in weekly sessions of approximately 60 minutes. The program will provide general information relevant to health and recovery after stroke and will be matched to the experimental program in session frequency and duration. It will not include the individualized behavioral strategies provided in the experimental arm.
Study Locations (1 sites)
The Hong Kong Polytechnic University, Hong Kong, Hong Kong
Eligibility Criteria
Inclusion Criteria: * Age 18 years or older. * History of stroke at least 6 months before enrollment. * Patient Health Questionnaire-9 score of 10 or higher. * Difficulty getting started or engaging in activities in the morning. * Able to provide informed consent. Exclusion Criteria: * Conditions that would interfere with study participation. * Neurological condition other than stroke. * Currently receiving psychological therapy for depression. * Significant cognitive impairment or dementia. * Current or past diagnosis of psychosis, bipolar disorder, or mania. * Hospitalization that would interfere with study participation. * Acute or significant suicidal ideation * Alcohol or substance use problems within the past month. * Use of antidepressant or anti-anxiety medication unless the dosage has been stable for at least 4 weeks and no changes are planned during the study.
LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2
NCT07288398
Recruiting
Conditions Pulmonary Hypertension Associated With H...
Phase PHASE3
Enrollment 540
Locations 141 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to assess the efficacy and safety of the study drug, levosimendan (given orally), compared to placebo in participants with pulmonary hypertension with heart failure with preserved left ventricular ejection fraction (PH-HFpEF) as measured by the change in 6-Minute Walk Distance.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: TNX-103 — Oral levosimendan
  • Drug: Placebo — Matching placebo (oral)

Primary Outcomes

  • 6-Minute Walk Distance (6MWD) (26 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2026-03-03
Completion: 2029-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 540 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tenax Therapeutics, Inc.
Contact Information
Study Contact:
Akshata Ashokkumar
(919) 855-2118
a.ashokkumar@tenaxthera.com
Katelyn Jansson
(919) 855-2119
k.jansson@tenaxthera.com
Interventions
  • Drug: TNX-103 — Oral levosimendan
  • Drug: Placebo — Matching placebo (oral)
Study Locations (141 sites)
Tenax Investigational Site, Alexander City, Alabama 35010 United States
Tenax Investigational Site, Tucson, Arizona 85724 United States
Tenax Investigational Site, Sacramento, California 95816 United States
Tenax Investigational Site, San Francisco, California 94143 United States
Tenax Investigational Site, Stanford, California 94305-5208 United States
Tenax Investigational Site, Torrance, California 90502 United States
Tenax Investigational Site, Athens, Georgia 30606 United States
Tenax Investigational Site, Atlanta, Georgia 30322 United States
Tenax Investigational Site, Chicago, Illinois 60611-4494 United States
Tenax Investigational Site, Chicago, Illinois 60637 United States
Eligibility Criteria
Inclusion Criteria: 1. Men or women, ≥18 to 85 years of age 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms 3. A diagnosis of World Health Organization (WHO) Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization (RHC) 4. A qualifying baseline RHC 5. A qualifying echocardiogram 6. A qualifying 6-MWD 7. A 48-hour ambulatory cardiac rhythm monitor during the Screening Period 8. Requirements related to child bearing potential, contraception, and egg/sperm donation) Exclusion Criteria: 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5 2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy 3. Structural heart repair or replacement of the aortic valve or mitral valve (surgical or percutaneous) OR, planned valve intervention OR, the presence of significant valve disease 4. A diagnosis of pre-existing lung disease 5. History of severe allergic or anaphylactic reaction or hypersensitivity to the excipients in the investigational product 6. Major surgery within 60 days 7. Prior heart, lung, or heart-lung transplants or life expectancy of \<12 months 8. History of clinically significant other diseases that may limit or complicate participation in the study
Postcapillary Blood Gas Analysis in Wedge Position (Wedge-BGA)
NCT04993612
Recruiting
Conditions Pulmonary Hypertension
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

If pulmonary hypertension is suspected, a right heart catheterization is usually performed to confirm or rule out the diagnosis. As part of this examination, blood samples are taken from various locations as standard and blood gas analyses are performed. One of the most important measurements during the right heart catheterization is the measurement of the pulmonary arterial occlusion pressure by the so-called wedge maneuver. To measure this value, the catheter with inflated balloon must be advanced into the pulmonary vessels until the "wedge" position is reached, i.e. the balloon completely occludes a branch of the pulmonary artery. In this study, the investigators want to characterize patients with pulmonary hypertension of different causes in more detail. To do that, two blood samples (totaling approximately 4 mL of blood, one sample directly after occlusion and the other one two minutes later) will be drawn during the right heart catheterization from the above-mentioned "wedge" position", behind the inflated balloon, and blood gas analyses will be performed on these samples. In addition, various clinical parameters (comorbidities, etc.) will be recorded by means of clinical questionnaires. Follow-up data will be analyzed and correlations with the aforementioned blood gas analyses will be examined. The results of the study will be used to more precisely characterize the still vague concept of secondary pulmonary hypertension. This could help to develop new therapeutic strategies in some subgroups in the future.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Diagnostic Test: Blood gas analysis — Two blood samples will be drawn from the "wedge" position", behind the inflated balloon, during the right heart catheterization, and blood gas analyses will be performed. First sample will be drawn directly after inflating the ballon, and the second one 2 minutes later.

Primary Outcomes

  • Between group differences (At the time of recruitment)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2021-06-25
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ayham Daher
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Diagnostic Test: Blood gas analysis — Two blood samples will be drawn from the "wedge" position", behind the inflated balloon, during the right heart catheterization, and blood gas analyses will be performed. First sample will be drawn directly after inflating the ballon, and the second one 2 minutes later.
Study Locations (1 sites)
University Hospital RWTH Aachen, Aachen, 52062 Germany
Eligibility Criteria
Inclusion Criteria: * Patients who have a clearly defined indication for Right heart catheterization. * Age \> 18 years * Informed consent for participation in the study will sign Exclusion Criteria: * Individuals who are not fully capable of giving consent and understanding the nature, significance, and scope of the study * Pregnancy and lactation * Wedge-BGA not possible
Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After LSD
NCT07461532
Recruiting
Conditions Cirrhosis, Splenectomy, Portal Vein Thro...
Phase NA
Enrollment 20
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy and azygoportal disconnection.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Apixaban 2.5 MG — If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time.

Primary Outcomes

  • Proportion of complete recanalization of portal vein thrombosis (Follow-up of 6 months or greater)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-04-01
Completion: 2027-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Northern Jiangsu People's Hospital
Principal Investigators:
  • Dou-Sheng Bai (STUDY_CHAIR) - Clinical Medical College, Yangzhou University
Contact Information
Study Contact:
Guo-Qing Jiang, MD
+8651487373272
jgqing2003@hotmail.com
Dou-Sheng Bai, MD
+8651487373275
bdsno1@hotmail.com
Interventions
  • Drug: Apixaban 2.5 MG — If portal vein thrombosis occurs more than one year after laparoscopic splenectomy and azygoportal disconnection, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time.
Study Locations (1 sites)
Clinical Medical College, Yangzhou, Jiangsu 225001 China
Eligibility Criteria
Inclusion Criteria: 1. A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology. 2. Portal hypertension bleeding . 3. Splenomegaly with secondary hypersplenism. 4. No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery. 5. Underwent laparoscopic splenectomy at our center. 6. Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3. 7. subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3 8. Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3. 9. Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12. 10. Developed portal vein thrombosis after 12 months post-surgery. 11. Provided informed consent to participate in the study. Exclusion Criteria: 1. Hepatocellular carcinoma or any other malignancy. 2. Hypercoagulable state other than the liver disease related. 3. DRUGS- oral contraceptives, anticoagulation or anti-platelet drugs. 4. Child - Pugh C 5. Recent peptic ulcer disease 6. History of Hemorrhagic stroke 7. Pregnancy. 8. Uncontrolled Hypertension 9. Human immunodeficiency virus (HIV) infection
A Study to Investigate the Safety, Pharmacodynamic and Pharmacokinetic Characteristics of CBP-4888 in Hospitalized Participants With Preterm Preeclampsia and Their Children up to 24 Months
NCT07282171
Recruiting
Conditions sFlt1 Mediated Preterm Preeclampsia, Pre...
Phase PHASE1
Enrollment 60
Locations 3 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CBP-4888 in hospitalized participants with Preterm Preeclampsia receiving Standard of Care, Expectant Management. Eligible participants are between 26 +0/7 and 35 +6/7 weeks gestational age and clinically appropriate for inpatient expectant management. Eligible participants will receive standard of care expectant management for their pregnancy with the only study interventions being one subcutaneous dose of CBP-4888. Participants will: * receive a single subcutaneous injection dose of CBP-4888 and will be followed through delivery and for 42 days (+14 days) after delivery. Participants will be followed through 6 weeks post delivery. * Infants will be evaluated immediately postpartum and then followed through 24 months of age with standard infant and pediatric assessments with phone calls made to parents.

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: CBP-4888 — Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.

Primary Outcomes

  • Incidence of treatment emergent events and adverse events of special interest when CBP-4888 is administered to pregnant participants (6 weeks postpartum)
  • Determine recommended phase 2 dose (From pre-dose on Day 1 through the last measurable concentration at approximately 72 hours postpartum in serum)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-02-26
Completion: 2029-03-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Comanche Biopharma
Contact Information
Study Contact:
Aparna Shah, MD
248-520-7361
ashah@comanchebiopharma.com
Interventions
  • Drug: CBP-4888 — Participants will receive a subcutaneous dose of CBP-4888. Dosing is weight based using the participant's first trimester weight.
Study Locations (3 sites)
The Royal Women's Hospital, Parkville, Victoria 3052 Australia
Monash University, Melbourne, Australia
Royal Melbourne, Melbourne, Australia
Eligibility Criteria
Inclusion Criteria: * Hospitalized with a hypertensive disorder of pregnancy (preeclampsia) defined by elevated blood pressure after 20 weeks gestation with proteinuria or, in the absence of proteinuria, with evidence of organ dysfunction (e.g., thrombocytopenia, renal insufficiency, or impaired liver function), and expected to remain hospitalized through delivery * The subject has given written consent to participate in the study. * Pregnant participants aged 18 to 45 years of age * Gestational age at Day 1 between 26 weeks 0/7 days and 35 weeks 6/7 days * Deemed clinically stable and suitable for expectant management for at least 72 hours post CBP-4888 administration * The woman carries a singleton pregnancy * Anticipate that hospitalization will continue through delivery Exclusion Criteria: * Placenta previa, abruption, accreta, or persistent unexplained vaginal bleeding. * Fetal growth restriction (\<3rd percentile, or \<10th percentile with abnormal Doppler) or known major chromosomal/genetic abnormalities. * Maternal conditions requiring immediate delivery (e.g., severe hypertension, eclampsia, non-reassuring fetal status, pulmonary edema). * Known active maternal infections considered to potentially affect placental function. * Significant maternal medical conditions (e.g., HELLP syndrome, advanced kidney disease, severe cardiac disease, uncontrolled neurological disorder, lupus with nephritis/cerebritis). * Use of another investigational drug within 30 days prior to study entry. * Any other condition that, in the investigator's judgment, poses risk to mother or fetus.
Electrical Stimulation for Vision Neuroenhancement in Glaucoma
NCT06685211
Recruiting
Conditions Glaucoma, Glaucoma Open-Angle
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of the study is to evaluate the efficacy, transorbital alternating current stimulation (rtACS) using the EYETRONIC for the treatment in patients with glaucoma.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Device: Eyetronic rtACS — The repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain.
  • Device: Sham rtACS — Participants will wear the Eyetronic system but there will be no active stimulations applied.

Primary Outcomes

  • Visual Field Index (VFI) (3 Months)
  • Mean Deviation (MD) (3 Months)
  • Pointwise Linear Regression (PLR) (3 Months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-07-14
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Stanford University
Collaborators: EYETRONIC, Inc
Principal Investigators:
  • Jeffrey L Goldberg, MD PhD (PRINCIPAL_INVESTIGATOR) - Stanford University
Contact Information
Study Contact:
Study Team
650-497-5942
glaucomatrials@stanford.edu
Interventions
  • Device: Eyetronic rtACS — The repetitive, transorbital alternating current stimulation (rtACS) is a device for non-invasive Interventional Neurophysiology. The electrical charge and current density applied during rtACS safe and able to modulate existing neuronal elements in the eye and brain.
  • Device: Sham rtACS — Participants will wear the Eyetronic system but there will be no active stimulations applied.
Study Locations (1 sites)
Byers Eye Institute at Stanford University, Palo Alto, California 94303 United States
Eligibility Criteria
Inclusion Criteria: * Participant must be at least 18. * Participant must has the ability to comply with the requirements of the study and complete the schedule of events (SOE). * Participant's clinical diagnosis must be consistent with primary open angle glaucoma (including but not limited to normal tension, low tension or general open angle) characterized by the following features: Mean deviation (MD) worse than -6 but better than -20 on reliable Humphrey Visual Field 24-2 testing * Participant's eye pressure must be clinically stable, with IOP \< 18. * If a participant has two eyes meeting study criteria, the worse eye as determined by visual field index (VFI) or patient preference, will be deemed includable. If both eyes qualify and have the same VFI, the patient may choose which eye they are willing to enter, or else a randomization procedure will assign one eye to the study. * Participant must understand and sign the informed consent. If the participant's vision is impaired to the point where he/she cannot read the informed consent document, the document will be read to the participant in its entirety. Exclusion Criteria: * Participant is unable to comply with study procedures or follow-up visits. * Participant has a history of ocular herpes zoster. * Participant has a requirement of acyclovir and/or related products during study duration. To be eligible for this study, the participant must discontinue use of these products prior to enrollment and must not continue with the products until after they have completed the study. * Participant has evidence of corneal opacification or lack of optical clarity. * Participant has uveitis or other ocular inflammatory disease. * Participant is receiving systemic steroids or other immunosuppressive medications. * Participant is currently participating in or has within the last 3 months participated in any other clinical trial of a drug by ocular (if in the study eye) or systemic administration. * Participant is pregnant or lactating. * Participant has, in the opinion of the investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments. * Patients with opened skull, after trepanation or with heart and brain pacemaker. * Patients with implanted intracranial metals such as clippings, coilings, ventriculo-peritoneal shunts, endoprosthesis etc. * Patients with any skin damage in the area of electrode placement. * Children and comatose patients. * Patients with recent history of epileptic seizure. * Patients with uncontrolled high levels of blood pressure (\<160 mmHg) or uncontrolled high levels of intraocular pressure (\<27 mmHg). * Patients abusing drugs or alcohol.
Determinants of Malignant Hypertension Onset and Related Target Organ Damages: the HAMA Biobank
NCT06629363
Not yet recruiting
Conditions Malignant Hypertension
Phase Not Applicable
Enrollment 1000
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The HAMA bank is an initiative aimed at collecting, preparing, and storing biological samples from patients treated for malignant hypertension and included in the HAMA cohort. Conducted under CRB (ISO20387) conditions, this biobank serves as an essential resource for understanding the disease's pathophysiology, as well as for identifying novel biomarkers and therapeutic targets

Design

Study type: Observational Observational model: Other Time perspective: Prospective

Interventions / Regimen

  • Other: biobank — The following samples will be collected : * Serum samples and plasma sample: inclusion visit and follow up visit * Urines samples : inclusion visit and follow up visit * blood DNA: inclusion visit * Blood RNA: inclusion visit and follow up visit

Primary Outcomes

  • Decipher the mechanisms responsible for the transition from severe to malignant hypertension (At inclusion and 6 month)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2025-08-01
Completion: 2036-04-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier de PAU
Principal Investigators:
  • Romain BOULESTREAU (PRINCIPAL_INVESTIGATOR) - University Hospital, Bordeaux
Contact Information
Study Contact:
Alice SERIS
0559726997
alice.seris@ch-pau.fr
Interventions
  • Other: biobank — The following samples will be collected : * Serum samples and plasma sample: inclusion visit and follow up visit * Urines samples : inclusion visit and follow up visit * blood DNA: inclusion visit * Blood RNA: inclusion visit and follow up visit
Eligibility Criteria
Inclusion Criteria: * patients included in the HAMA cohort with the following critera : * Malignant hypertension according to the classic definition (Severe hypertension associated with severe hypertensive retinopathy) * Severe hypertension associated with acute target organ damage due to high blood pressure Exclusion Criteria: * Refusal to participate to the substudy " HAMA bank " * patient on chronic dialysis
DSLT Performance in Treatment-naïve Patients With Newly Diagnosed Open Angle Glaucoma
NCT06933836
Recruiting
Conditions Open Angle Glaucoma (OAG)
Phase Not Applicable
Enrollment 55
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

DSLT demonstrates a ≥ 20% reduction of IOP from pre-treatment baseline in POAG patients naïve of previous glaucoma treatment at 12 months.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Device: DSLT enables newly diagnosed patients to remain well controlled and off medications — DSLT enables newly diagnosed patients to remain well controlled and off medications

Primary Outcomes

  • Success of IOP Reduction Through DSLT Utilization (12 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-03-31
Completion: 2027-12-31
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 55 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Barnet Dulaney Perkins Eye Centers
Collaborators: Alcon, a Novartis Company
Principal Investigators:
  • Christine Funke, Medical Doctor (PRINCIPAL_INVESTIGATOR) - Barnet Dulaney Perkins Eye Centers
Contact Information
Study Contact:
Derek J Arnson, Master of Education
4804201005
derek.arnson@researchavp.com
Christine Funke, Medical Doctor
4804201005
christine.funke@BDPEC.com
Interventions
  • Device: DSLT enables newly diagnosed patients to remain well controlled and off medications — DSLT enables newly diagnosed patients to remain well controlled and off medications
Study Locations (1 sites)
Barnet Dulaney Perkins Eye Centers, Mesa, Arizona 85206 United States
Eligibility Criteria
Inclusion Criteria: * Primary open angle glaucoma * Patients age 30 or greater with an IOP of 18-26 mmHg * Mild to moderate POAG patients (mild or moderate according to the AAO PPP Guidelines) * DSLT procedure Exclusion Criteria: * History of prior glaucoma treatment - this includes past medication use (in either eye), previous lasers or incisional surgery * Angle closure patients * Ocular Hypertension * Baseline VF MD of worse than -12dB * Uncontrolled systemic microvascular disease (eg. HTN, DM) * Subjects with peri-limbal findings (e.g. melanosis, tumors, extensive pterygium, significant senile arcus and pterygium)
Impact of Advanced Practical Nursing Intervention Versus Usual Care on Hypertension Control
NCT05917600
Not yet recruiting
Conditions Hypertension
Phase NA
Enrollment 330
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Hypertension is the most frequent chronic pathology in France and in the world. It is one of the main modifiable cardiovascular risk factors. In France, 50% of treated hypertensives are uncontrolled and only 30% of treated patients are fully adherent to their antihypertensive treatment. Poor adherence to drug treatments is considered as one of the main causes of non-control of hypertension. Since 2018, a new profession has entered the French healthcare system: Advanced Practice Nurses (APN). They have many broad skills, at the interface of nursing and medical exercises. The purpose of this interventional study is to assess the impact of APN on blood pressure (BP) control in the context of usual care of hypertension thanks to a better adhesion of patients and a better therapeutic alliance. The hypothesis formulated is that an individual APN intervention, included in a usual hypertension management, improves BP control.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: None

Interventions / Regimen

  • Other: APN intervention — Advanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the MD consultation APN intervention is divided into five main steps: * clinical and paraclinical examinations, * appraisal of patient's knowledge, * health education on hypertension and treatments, * setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary * decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to.

Primary Outcomes

  • Blood pressure control (Medical consultation, from 2 months to 12 months after inclusion)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2023-06
Completion: 2027-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 330 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Principal Investigators:
  • Jacques BLACHER, MD, PhD (PRINCIPAL_INVESTIGATOR) - Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
  • Juliette VAY-DEMOUY, MSc, PhD (STUDY_DIRECTOR) - Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Assistance Publique-Hôpitaux de Paris
Contact Information
Study Contact:
Juliette VAY-DEMOUY, MSc, PhD student
0033142348551
juliette.vaydemouy@aphp.fr
Marie BENHAMMANI-GODARD
0033158411190
marie.godard@aphp.fr
Interventions
  • Other: APN intervention — Advanced Practice Nurses (APN) intervention between the ambulatory hospitalization (AH) and the MD consultation APN intervention is divided into five main steps: * clinical and paraclinical examinations, * appraisal of patient's knowledge, * health education on hypertension and treatments, * setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary * decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to.
Study Locations (1 sites)
Diagnosis and Therapeutic Center, Hôtel-Dieu Hospital, Paris, IDF 75004 France
Eligibility Criteria
Inclusion Criteria: * At least 18 years of age, * Essential Hypertension * Hypertension management in Hôtel-Dieu Hospital * Ability to provide a written informed consent. Exclusion Criteria: * Have already benefited from an APN follow-up before the day of inclusion * Being under guardianship or curatorship * Pregnant patient * Beneficiary of the AME (state medical aid)
Dilapan-S®: A Multicenter US E-registry
NCT04451109
Active, positions filled
Conditions Post Term Pregnancy, Premature Rupture o...
Phase Not Applicable
Enrollment 1200
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Objective of this registry is to collect a representative set of real world data on the use of Dilapan-S® for pre-induction cervical ripening in daily clinical practice. Upon completion of the registry, relevant collected data will be analyzed and published.

Design

Study type: Observational Observational model: Case Only Time perspective: Retrospective

Interventions / Regimen

  • Device: Dilapan-S — Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.

Primary Outcomes

  • Rate of overall vaginal delivery (right after child delivery)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2020-12-01
Completion: 2025-06-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 1200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medicem Technology s.r.o.
Collaborators: The University of Texas Medical Branch, Galveston
Principal Investigators:
  • Antonio Saad, MD (PRINCIPAL_INVESTIGATOR) - The University of Texas Medical Branch, Galveston
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Dilapan-S — Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.
Study Locations (1 sites)
The University of Texas Medical Branch, Galveston, Texas 77555 United States
Eligibility Criteria
Inclusion Criteria: * Pregnant woman whose plan of care is induction of labor * Maternal age ≥ 18 years * Gestational age ≥ 37 +0/7 weeks * Dilapan-S® used for cervical ripening Exclusion Criteria: * Data not available for extraction
Patient-Reported Outcomes and Adherence After Transition From Inhaled Iloprost to Oral Selexipag in Pulmonary Arterial Hypertension
NCT07356375
Not yet recruiting
Conditions Pulmonary Arterial Hypertension (PAH)
Phase Not Applicable
Enrollment 32
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Pulmonary arterial hypertension (PAH) is a rare and serious condition that affects the blood vessels of the lungs and can significantly limit daily activities and quality of life. Some patients with PAH use inhaled iloprost, a medication that requires several inhalations per day, which can be difficult to maintain over time. Oral selexipag is an alternative treatment that may reduce treatment burden and improve adherence. The PROMISE study aims to evaluate how switching from inhaled iloprost to oral selexipag affects patients' quality of life, satisfaction with treatment, and adherence in real-world clinical practice. Patient-reported outcome questionnaires will be used to understand patients' perceptions of symptoms, daily functioning, and overall improvement after the transition. Adult patients with PAH who are receiving inhaled iloprost and whose physicians decide to switch treatment to oral selexipag will be followed over time. A comparison group of patients who continue using inhaled iloprost will also be observed. The study does not involve any experimental treatment or changes to routine clinical care. All medications are prescribed as part of standard medical practice. The results of this study may help improve understanding of the patient experience during treatment transitions in PAH and support more patient-centered treatment decisions.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Drug: Selexipag — Exposure to oral selexipag following transition from inhaled iloprost as part of routine clinical care in adults with pulmonary arterial hypertension. The decision to initiate, titrate, or discontinue selexipag is made exclusively by the treating physician, independent of study participation. No study-mandated intervention or treatment assignment is performed. The study observes patient-reported outcomes, treatment satisfaction, and adherence associated with this treatment transition.

Primary Outcomes

  • Change in Health-Related Quality of Life (EMPHASIS-10) (From baseline (prior to transition) to 16-24 weeks of follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-03-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Sao Paulo General Hospital
Principal Investigators:
  • Caio Fernandes, MD (PRINCIPAL_INVESTIGATOR) - UNIVERSIDADE SAO PAULO
Contact Information
Study Contact:
Caio Fernandes Principal Investigator, MD
+551126615034
cjcfernandes@yahoo.com.br
Interventions
  • Drug: Selexipag — Exposure to oral selexipag following transition from inhaled iloprost as part of routine clinical care in adults with pulmonary arterial hypertension. The decision to initiate, titrate, or discontinue selexipag is made exclusively by the treating physician, independent of study participation. No study-mandated intervention or treatment assignment is performed. The study observes patient-reported outcomes, treatment satisfaction, and adherence associated with this treatment transition.
Eligibility Criteria
Inclusion Criteria * Adults aged 18 years or older. * Confirmed diagnosis of pulmonary arterial hypertension (PAH, Group 1) by right heart catheterization. * Current treatment with inhaled iloprost as part of routine clinical care. * Clinical decision by the treating physician to transition from inhaled iloprost to oral selexipag. * Ability to understand and complete patient-reported outcome questionnaires. * Provision of written informed consent. Exclusion Criteria * Significant cognitive impairment or sensory deficits that prevent completion of study questionnaires. * Unstable or decompensated comorbid conditions that may interfere with treatment adherence or study participation. * Refusal or inability to provide informed consent.
Polypills Approach for Multiple Cardiovascular Risk Factors
NCT07679828
Not yet recruiting
Conditions Hypertension, Dyslipidemia, Diabetes
Phase NA
Enrollment 8252
Locations 12 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for integrated management of hypertension, dyslipidemia, and diabetes among adults aged 50 to 75 years in China. The trial will evaluate whether a simplified regimen combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapy improves the 10-year cardiovascular disease risk score at phase 1. Participants will be followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and cognitive function compared with usual care at phase 2.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Drug: Fixed-Dose Combination Strategy — Participants assigned to the intervention group will receive a fixed-dose combination strategy for integrated control of blood pressure, lipid, and glucose. Six predefined medication regimens will be used, differing in antihypertensive intensity and rosuvastatin dose. The antihypertensive component will consist of olmesartan medoxomil/amlodipine at 10/2.5 mg or 20/5 mg, with indapamide 2.5 mg added if needed, and will be titrated toward a blood pressure target of \<130/80 mm Hg according to prespecified protocol rules. The lipid-lowering component will be initiated with rosuvastatin 10 mg plus ezetimibe 10 mg. If suspected statin-associated adverse effects or statin intolerance occur, the rosuvastatin dose may be reduced from 10 mg to 5 mg according to prespecified protocol rules. The glucose-lowering component will consist of dapagliflozin at a fixed dose of 10 mg. Treatment will be selected and adjusted according to treatment targets, tolerability, and safety.

Primary Outcomes

  • 10-year CVD risk (12 months)
  • Composite cardiovascular disease outcome (36 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-07-01
Completion: 2030-03-01
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 8252 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: China Medical University, China
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Fixed-Dose Combination Strategy — Participants assigned to the intervention group will receive a fixed-dose combination strategy for integrated control of blood pressure, lipid, and glucose. Six predefined medication regimens will be used, differing in antihypertensive intensity and rosuvastatin dose. The antihypertensive component will consist of olmesartan medoxomil/amlodipine at 10/2.5 mg or 20/5 mg, with indapamide 2.5 mg added if needed, and will be titrated toward a blood pressure target of \<130/80 mm Hg according to prespecified protocol rules. The lipid-lowering component will be initiated with rosuvastatin 10 mg plus ezetimibe 10 mg. If suspected statin-associated adverse effects or statin intolerance occur, the rosuvastatin dose may be reduced from 10 mg to 5 mg according to prespecified protocol rules. The glucose-lowering component will consist of dapagliflozin at a fixed dose of 10 mg. Treatment will be selected and adjusted according to treatment targets, tolerability, and safety.
Study Locations (12 sites)
Affiliated Hospital of Chifeng University, Chifeng, Inner Mongolia China
Kunshan Hospital of Chinese Medicine, Kunshan, Jiangsu China
Suzhou Wujiang District Hospital of Traditional Chinese Medicine, Suzhou, Jiangsu China
The Fifth People's Hospital of Wujiang District, Suzhou, Jiangsu China
The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu China
Taixing Second People's Hospital, Taizhou, Jiangsu China
Central Hospital of Jinzhou, Jinzhou, Liaoning China
Panjin Central Hospital, Panjin, Liaoning China
First Hospital of China Medical University, Shenyang, Liaoning China
Shengjing Hospital of China Medical University, Shenyang, Liaoning China
Eligibility Criteria
Inclusion Criteria: * Men or women * Age ≥50 years and \<75 years * Hypertension, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg among participants not currently taking antihypertensive medication, or systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥80 mmHg among participants currently taking any antihypertensive medication * Dyslipidemia, defined as LDL-C ≥1.8 mmol/L (70 mg/dL) * Type 2 diabetes with HbA1c ≥6.5% and \<12% * Willing to participate and able to sign informed consent Exclusion Criteria: * Known secondary cause of hypertension * Type 1 diabetes * Pancreatic insufficiency or diabetes secondary to pancreatitis * Triglycerides ≥5.65 mmol/L (500 mg/dL) * History of coronary, carotid, or cerebrovascular revascularization within the previous 12 months * History of myocardial infarction or stroke within the previous 6 months * NYHA class III-IV heart failure at entry or hospitalization for exacerbation of chronic heart failure within the previous 6 months * Abnormal kidney function, defined as estimated glomerular filtration rate \<30 mL/min/1.73 m² or dialysis * Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \>3 times the upper limit of normal * Abnormal serum potassium, defined as serum potassium \>5.5 mmol/L or \<3.5 mmol/L * Contraindication to any of the components of the polypill * Currently living with another PACIF participant * Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control * Clinical diagnosis of dementia or treatment with medications for dementia * History of malignancy * Life expectancy \<3 years * Currently participating in another intervention study * Any factors judged by the clinic team to be likely to limit adherence to interventions
Long-Term Outcomes of Selexipag in Schistosomiasis-Associated Pulmonary Arterial Hypertension
NCT07453030
Not yet recruiting
Conditions Pulmonary Arterial Hypertension (PAH)
Phase Not Applicable
Enrollment 30
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Schistosomiasis-associated pulmonary arterial hypertension is a serious condition that can lead to shortness of breath, heart failure, frequent hospitalizations, and early death. Although treatments for pulmonary arterial hypertension have improved over time, patients with this specific cause of the disease are often not included in long-term studies. Selexipag is an oral medication used to treat pulmonary arterial hypertension and is part of routine clinical care in Brazil. Its long-term effects in patients with schistosomiasis-associated pulmonary arterial hypertension are not well understood. The PROPULSE-Sch study aims to evaluate long-term clinical outcomes in patients with schistosomiasis-associated pulmonary arterial hypertension who received selexipag, compared with similar patients who did not receive this medication before it became available at the study center. This is an observational study using data from routine medical care. All treatments are prescribed by the treating physicians, and participation in the study does not change patient care. The results may help improve understanding of long-term outcomes and support treatment decisions in this population.

Design

Study type: Observational Observational model: Cohort Time perspective: Other

Primary Outcomes

  • Time to Clinical Worsening (From index date (T0) up to 36 months of follow-up)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-03-01
Completion: 2027-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Caio Júlio César dos Santos Fernandes
Principal Investigators:
  • Caio Fernandes, MD (PRINCIPAL_INVESTIGATOR) - UNIVERSIDADE SAO PAULO
Contact Information
Study Contact:
Caio Fernandes, Principal Investigator, MD
+551126615034
cjcfernandes@yahoo.com.br
Interventions
N/A
Study Locations (1 sites)
Instituto do Coração (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, São Paulo 05403-900 Brazil
Eligibility Criteria
Inclusion Criteria Adults aged 18 years or older. * Confirmed diagnosis of pulmonary arterial hypertension associated with schistosomiasis (PAH-Sch). * Diagnosis of pre-capillary pulmonary arterial hypertension confirmed by right heart catheterization, performed at any time prior to the index date (T0), as documented in the medical record. * Evidence of schistosomiasis infection, including epidemiological history and ultrasonographic findings compatible with hepatosplenic schistosomiasis. * Previous antiparasitic treatment for schistosomiasis. * Clinical stability at the index date, defined as absence of progressive right heart failure or clinical worsening within the previous 12 weeks. * World Health Organization (WHO) functional class I-III at the index date. * Stable background pulmonary arterial hypertension-specific therapy with a phosphodiesterase-5 inhibitor and/or endothelin receptor antagonist for at least 12 weeks prior to the index date. * For the treated cohort: initiation of oral selexipag as part of routine clinical care. * For the mirror cohort: eligibility for therapeutic escalation at the index date without exposure to selexipag. Exclusion Criteria * World Health Organization (WHO) functional class IV at the index date. * Progressive right heart failure or clinical deterioration within the 12 weeks prior to the index date. * Documented formal contraindication to selexipag in the medical record. * Insufficient baseline data at the index date to allow clinical characterization or inclusion in propensity score analyses.
Personalized Mobile Reminders for Medication Adherence and Intraocular Pressure Control in Primary Open-Angle Glaucoma
NCT07480577
Not yet recruiting
Conditions Primary Open-Angle Glaucoma (POAG)
Phase NA
Enrollment 84
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study evaluates whether a personalized mobile reminder program improves treatment adherence and clinical outcomes in adults with primary open-angle glaucoma (POAG) using topical antiglaucoma eye drops. Poor adherence to long-term eye-drop therapy is common in glaucoma care and may contribute to inadequate intraocular pressure (IOP) control and disease progression. Participants are randomized to either (1) a digital adherence intervention or (2) standard outpatient follow-up. The intervention consists of daily interactive SMS/WhatsApp medication reminders plus weekly brief educational messages for 3 months. The primary outcome is change in medication adherence measured by the Morisky Medication Adherence Scale-8 (MMAS-8) at month 3. Secondary outcomes include change in IOP, eye-drop instillation technique, and treatment satisfaction. Exploratory analyses assess the relationship between adherence level and OCT-based retinal nerve fiber layer (RNFL) progression metrics. The goal is to determine whether a low-cost, scalable mobile strategy can improve short-term glaucoma management in routine practice.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Behavioral: Digital Reminder Intervention — A behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.

Primary Outcomes

  • Change in Medication Adherence (Baseline and Month 3)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-04-01
Completion: 2026-08-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sakarya Yenikent State Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Digital Reminder Intervention — A behavioral adherence support intervention consisting of daily interactive SMS/WhatsApp reminders for eye-drop use and weekly educational reinforcement messages over 3 months.
Eligibility Criteria
Inclusion Criteria: Adults aged 18 to 75 years. Diagnosis of primary open-angle glaucoma (POAG) in at least one eye. Currently treated with at least one topical antiglaucoma medication. Able to read and understand study procedures and provide written informed consent. Has regular access to a mobile phone capable of receiving SMS or WhatsApp messages. Willing to comply with follow-up visits and study procedures for 3 month Exclusion Criteria: Secondary glaucoma (e.g., neovascular, uveitic, steroid-induced) or angle-closure glaucoma. Ocular surgery or laser procedure within the previous 3 months, or planned ocular surgery during study follow-up. Advanced ocular comorbidity likely to affect IOP assessment or adherence evaluation (e.g., severe corneal disease, active ocular infection/inflammation). Cognitive impairment, severe psychiatric disease, or communication barriers that prevent reliable participation. Inability to use or access mobile messaging tools required for the intervention. Participation in another interventional clinical study that may interfere with outcomes
Study of Maternal and Fetal Cardiovascular Function in Hypertensive States of Pregnancy
NCT06858345
Recruiting
Conditions Preeclampsia
Phase Not Applicable
Enrollment 50
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The pharmacological treatment strategy is then tailored to the underlying hemodynamic phenotype of each patient. That is, rather than applying a one-size-fits-all treatment for all patients, therapy is tailored to the specific characteristics of how the cardiovascular system functions in each patient (e.g., whether the problem is more related to blood volume, vascular resistance, cardiac output, etc.). The goal is to personalize therapy to more effectively treat hypertensive states of pregnancy.

Design

Study type: Observational Observational model: Other Time perspective: Prospective

Primary Outcomes

  • Prolongation of at least one week of gestation in pregnancy complicated by hypertensive state of pregnancy with antihypertensive therapy guided by hemodynamic phenotypes (Up to 40 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-01-01
Completion: 2026-01-15
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Contact Information
Study Contact:
Catalina de Paco Matallana, MD
968369500
katy.depaco@gmail.com
Interventions
N/A
Study Locations (1 sites)
HCUVA, El Palmar, Murcia 30120 Spain
Eligibility Criteria
Inclusion Criteria: * Age greater than or equal to 18 years * Women with singleton and twin pregnancies complicated by hypertensive states of pregnancy. Exclusion Criteria: * Minors under 18 years of age. * Women with mental disabilities. * Major congenital fetal anomaly.
Artificial Intelligence-assisted Evaluation of Pulmonary HYpertension
NCT05566002
Recruiting
Conditions Pulmonary Hypertension, Pulmonary Arteri...
Phase Not Applicable
Enrollment 2000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Pulmonary hypertension represents a challenging and heterogeneous condition that is associated with high mortality and morbidity if left untreated. Artificial intelligence is used to study and develop theories and methods that simulate and extend human intelligence, which is being applied in fields related to cardiovascular diseases. The study intends to combine multimodal clinical data of patients who undergo right heart catheterization at Fuwai Hospital with artificial intelligence techniques to create programs that can screen and diagnose pulmonary hypertension.

Design

Study type: Observational Observational model: Case Only Time perspective: Retrospective

Interventions / Regimen

  • Diagnostic Test: Right heart catheterization — RHC is commonly used essential test to make gold-standard diagnosis of PH with mPAP \>20 mmHg. All multimodal data from patients eligible for inclusion would be randomly assigned to development datasets (70% of the study population) to train the artificial intelligence models for the detection of PH, which would be validated and tested by other datasets (30% of the study population).

Primary Outcomes

  • Accuracy of diagnosis by artificial intelligence-assisted algorithm (Baseline)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2022-06-01
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 2000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese Pulmonary Vascular Disease Research Group
Principal Investigators:
  • Zhihong Liu, MD, PhD (PRINCIPAL_INVESTIGATOR) - Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Contact Information
Study Contact:
Zhihong Liu, MD, PhD
13269276067
zhihongliufuwai@163.com
Interventions
  • Diagnostic Test: Right heart catheterization — RHC is commonly used essential test to make gold-standard diagnosis of PH with mPAP \>20 mmHg. All multimodal data from patients eligible for inclusion would be randomly assigned to development datasets (70% of the study population) to train the artificial intelligence models for the detection of PH, which would be validated and tested by other datasets (30% of the study population).
Study Locations (1 sites)
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality 100037 China
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years old * Patients previously received chest X-ray, electrocardiography, echocardiography, other routine examinations, and RHC at the Fuwai Hospital, CAMS \& PUMC, Beijing, China Exclusion Criteria: * Patients without RHC * The quality of routine examinations and RHC cannot meet the requirement for further analysis * Severe loss of results of routine examinations (chest X-ray, electrocardiography, echocardiography, etc.)
REmote Physical ACtivity Intervention for High Blood Pressure Postpartum
NCT07127731
Not yet recruiting
Conditions Hypertension (HTN), Hypertension ,Pregna...
Phase NA
Enrollment 60
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this intervention is to help new mothers who had elevated blood pressure during pregnancy become more physically active after birth. The investigators will connect data from FitBits to the electronic health record. Women will then get weekly messages with feedback and goals to help them stay active. The investigators will test if the intervention improves step counts and blood pressure after pregnancy. The investigators will also test if the intervention is feasible and enjoyed by postpartum women.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Behavioral: Patient Portal Messaging — Participants will receive weekly messages via their patient portal including feedback on their step counts and step count goals based on data from their FitBits
  • Behavioral: FitBit EHR Linkage — Participants will receive FitBits and link this step count data with the Electronic Health Record (EHR)

Primary Outcomes

  • Feasibility of Recruitment (From enrollment to the end of the 24 week intervention)
  • Feasibility of Participant Retention (At study weeks 12 and 24)
  • Feasibility of FitBit+EHR linkage (From enrollment to the end of the 24 week intervention)
  • Feasibility of Intervention Messaging (From enrollment to the end of the 24 week intervention)
  • Acceptability of the Intervention (Study week 24)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2027-04
Completion: 2028-04
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Northwestern University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Contact Information
Study Contact:
Natalie A Cameron, MD, MPH
312-503-2137
natalie.cameron@northwestern.edu
Interventions
  • Behavioral: Patient Portal Messaging — Participants will receive weekly messages via their patient portal including feedback on their step counts and step count goals based on data from their FitBits
  • Behavioral: FitBit EHR Linkage — Participants will receive FitBits and link this step count data with the Electronic Health Record (EHR)
Eligibility Criteria
Inclusion Criteria: * Delivery of a live birth at Northwestern Medicine 6-12 weeks prior * Systolic blood pressure 120-139 or diastolic blood pressure 80-89 during the first 20 weeks of gestation * Low self-reported physical activity levels * Able to access the internet at least weekly * Have patient portal account or willing to set one up * Willing to wear a FitBit * Spoken and written English or Spanish language fluency Exclusion Criteria: * Medical contraindications to participating in a structured physical activity program * Currently participating in a structured physical activity or weight loss program * Hypertensive disorder of pregnancy (e.g., preeclampsia, gestational hypertension, eclampsia)
A Registry Study on the "Action of Controlling Ambulatory Blood Pressure to Target in Ten Thousand Patients"
NCT03547856
Recruiting
Conditions Hypertension, Blood Pressure, Cardiovasc...
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

24 hour ambulatory blood pressure (ABP) monitoring should be the first choice for diagnosis and treatment of hypertension according to European Societyof Hypertension (ESH) and the European Society of Cardiology (ESC) guideline on ambulatory blood pressure monitoring. Finally, we should promote the clinical application of 24 hour ambulatory blood pressure monitoring to greatly improve the management level of hypertension in China and effectively reduce the risk caused by hypertension in the population. Information of hypertensive patients with ambulatory blood pressure monitoring was prospectively registered nationwide,and then to investigate whether there was difference in cardiovascular prognosis according to the control of ABP.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Primary Outcomes

  • Composite end point of major cardiovascular and cerebrovascular events (From date of enrollment until date of first documented event or date of death from cardiovascular and cerebrovascular events, whichever came first, assessed up to 3 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2018-07-18
Completion: 2026-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yan Li
Principal Investigators:
  • Yan Li (PRINCIPAL_INVESTIGATOR) - Shanghai Institute of Hypertension
Contact Information
Study Contact:
Yan Li, Professor
021-64370045
liyanshcn@yahoo.com
Interventions
N/A
Study Locations (1 sites)
Ruijin Hospital, Shanghai, Shanghai Municipality 200025 China
Eligibility Criteria
Inclusion Criteria: * Age 18-80 years old * Clinical diagnosed hypertension with the use of antihypertensive drugs * A 24-hour ambulatory blood pressure monitoring was performed with validated equipment. * Willing to provide information about disease history and blood biochemical test data within 6 months. * Sign the informed consent Exclusion Criteria: * Without antihypertensive drug use * Hospitalized hypertension patients * Non-compliant patient