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Showing 20 of 26396 trials
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
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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?
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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
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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?
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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
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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?
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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
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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
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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?
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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
20 Years Results by HBP and DBP in Patients With Type 2 Diabetes Mellitus After Following-up
NCT02569151
Not yet recruiting
Conditions Diabetes Mellitus
Phase Not Applicable
Enrollment 600
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

Participants were examined using the methods reported previous. All chemical laboratory data were obtained at each clinic visit in the morning in a non-fasting state. A single specimen at each visit was used to assess urinary albumin levels based on the 2009 guidelines of the ADA. CBP was measured once in each clinic visit. HBP was measured every day in the morning within 10 minutes after awakening in the sitting position, but HBP value assessed for this study used the value measured once in the same morning at each clinic visit. Clinic hypertension (CH) and morning hypertension (MH) were defined as systolic BP (SBP) 130 mmHg and/or diastolic BP (DBP) 85 mmHg; clinic normotension (CN) and morning normotension (MN) were defined as SBP \<130 mmHg and DBP \<85 mmHg, respectively. The reason underlying that same threshold was used for both clinic and morning values was based on criteria of the 1999 WHO-International Society of Hypertension guidelines, because this study started in 1999. Based on HBP, subjects were divided into MH and MN patients, and anti-hypertensive drug use was determined in each group. In addition, based on CBP, subjects were divided into CH and CN patients. These patients were followed using the same methods used for MH and MN patients. Outcome considered only the first event in each subject. Primary end-point was death from any cause. Secondary end-points were new, worsened, or improved microvascular and macrovascular events. Risk factors related to each outcome were determined, and therapy which was added to baseline used for each disease in patients with MH was recorded at base- and end-points. All results are presented as means ± SD. Mean values were compared using the paired or unpaired student t test. To compare the prevalence of events or medical treatment in patients with and without HT on basis of HBP or CBP, Fisher's exact test with two-tailed P values was used, and then hazard ratio and 95% confidence intervals were calculated. Differences in outcomes between patients with HT and NT on basis of HBP or CBP at base- and end-points in the home or in the clinic, respectively, were assessed using Kaplan-Meier survival curves and then compared by hazard rate using the log-rank test. Risk factors determined to be statistically related to outcomes were assessed by Cox proportional hazard analysis.

Design

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

Interventions / Regimen

  • Device: HBP & CBP measurement using systo 130 mmHg

Primary Outcomes

  • Death (20 years)
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: 2016-04
Completion: 2027-04
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kyuzi Kamoi
Principal Investigators:
  • Kyuzi Kamoi, MD (PRINCIPAL_INVESTIGATOR) - Jyoetsu General Hospital
Contact Information
Study Contact:
Kyuzi Kamoi, MD
+81-0258-36-3968
kkam-int@echigo.ne.jp
Kyuzi Kamoi, MD
+81-0258-36-3986
kkam-int@echigo.ne.jp
Interventions
  • Device: HBP & CBP measurement using systo 130 mmHg
Eligibility Criteria
Inclusion Criteria: * Patients with type 2 diabetes mellitus Exclusion Criteria: * Patients with type 1 diabetes mellitus and with other diseases except diabetes mellitus
Improvement of Portal Hypertension During Viral Suppression in Patients With Hepatitis Delta (IMPHROVE-D)
NCT04863703
Active, positions filled
Conditions Hepatitis D, Hepatitis B, Portal Hyperte...
Phase Not Applicable
Enrollment 11
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

Portal hypertension (PH) is one of the key drivers of clinical deteoration in patients with liver cirrhosis. It has been demonstrated that antiviral therapy in patients with chronic hepatitis C infection leads to a decrease of PH and is associated with an improved outcome. Recently, Bulevirtide was approved for the treatment of patients coinfected with hepatitis B (HBV) and chronic hepatitis delta (HDV) infection, which helps to achieve viral supression in these patients. This study investigates the potential effects of viral supression on PH in patients with chronic HBV/HDV infection and liver cirrhosis.

Design

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

Interventions / Regimen

  • Drug: Bulevirtide — Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.

Primary Outcomes

  • Change the degree of portal hypertension after inducing viral suppression via antiviral treatment with Bulevirtide (Measurement before antiviral treatment (baseline) and one year after inducing viral suppression with Bulevirtide.)
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: 2021-05-07
Completion: 2026-12-31
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 11 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hannover Medical School
Principal Investigators:
  • Benjamin Maasoumy, MD (PRINCIPAL_INVESTIGATOR) - Hannover Medical School
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Bulevirtide — Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.
Study Locations (1 sites)
Hannover Medical School, Hanover, Lower Saxony 30625 Germany
Eligibility Criteria
Inclusion Criteria: * Chronic HBV/HDV Coinfection * suspected or diagnosed liver cirrhosis, indication for hepatovenous pressure gradient (HVPG) measurement or liver cirrhosis and HVPG measurement conducted in the past 12 months (conducted prior to antiviral treatment) * indication for antiviral treatment with Bulevirtide * age \>18years * Must be willing to participate in the study and provide written informed consent Exclusion Criteria: * patient rejects study participation * no conducted or no indication for HVPG measurement * age \<18years
Anti-hypertensive Therapy and Exercise Treatment to Improve Vascular Health in Patients With Hypertension.
NCT06823570
Recruiting
Conditions Hypertension, Vascular Function, Fitness...
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

This is a prospective, monocentric, randomized controlled trial to investigate the effect of anti-hypertensive treatment and/or individualized exercise training intervention on blood pressure and vascular health. Furthermore the investigators want to decipher mechanisms, which contribute to vascular health by analyzing changes in metabolism and cell function in relation to vascular reaction.

Design

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

Interventions / Regimen

  • Behavioral: Individualized exercise therapy — Patients in the intervention group will receive an individualized exercise training program 3x/week.
  • Behavioral: Lifestyle recommendations — The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.

Primary Outcomes

  • The additional effect of an anti-hypertensive treatment plus an individualizes exercise therapy on the retinal vessel diameters compared to a guideline based anti-hypertensive treatment with general lifestyle recommendations. (From enrollment to the end of treatment after six month.)
  • Effect of an guideline based anti-hypertensive therapy on the retinal vessel diameters. (From enrollment to the end of treatment after six month.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-01
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Heinrich-Heine University, Duesseldorf
Contact Information
Study Contact:
Johannes Stegbauer, Prof. Dr.
+49 211 81 080 74
Studienzentrum-Nephrologie@med.uni-duesseldorf.de
Lukas Streese, PhD
Interventions
  • Behavioral: Individualized exercise therapy — Patients in the intervention group will receive an individualized exercise training program 3x/week.
  • Behavioral: Lifestyle recommendations — The lifestyle recommendation group will receive general recommendations such as salt reduction, higher physical activity levels and stress reduction.
Study Locations (1 sites)
Universitätsklinik Düsseldorf, Düsseldorf, Düsseldorf 40225 Germany
Eligibility Criteria
Inclusion Criteria: \- systolic hypertension grade I-II (BP values \>140 mmHg to \<180 mmHg) without anti-hypertensive medication treatment Exclusion Criteria: * no written informed consent * age \<18 years * isolated diastolic hypertension * medical contraindications for the exercise treatment (for example orthopedic problems or an abnormal ECG during the cardio respiratory exercise test) * chronic eye diseases on both eyes (for example macular degeneration or glaucoma) or high intraocular pressure (\>20 mmHg)
Intranasal Dexmedetomidine on Blood Pressure in Elderly Hypertensive Patients Undergoing Cataract Surgery
NCT07080229
Recruiting
Conditions Cataract, Hypertension
Phase PHASE3
Enrollment 126
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Cataract surgery in elderly patients with controlled hypertension carries a risk of hemodynamic instability, particularly fluctuations in mean arterial blood pressure (MAP). Dexmedetomidine, a selective α2-adrenergic agonist, offers hemodynamic stabilization and sedation when administered intranasally and provides a simple and non-invasive premedication option. This study evaluates the effects of intranasal dexmedetomidine on perioperative mean arterial blood pressure in patients undergoing cataract surgeries. Research Question: Does intranasal dexmedetomidine premedication control blood pressure in elderly hypertensive patients undergoing cataract surgery? Research Hypothesis: Intranasal dexmedetomidine significantly reduces MAP and improves secondary outcomes compared to placebo. Primary Objective: To evaluate the efficacy of intranasal Dexmedetomidine as a premedication to control hypertension in elderly patients scheduled for cataract surgery. Secondary Objectives: 1. To assess surgery cancellation rates. 2. To evaluate satisfaction levels among patients, anesthesiologists, and surgeons using the Modified Observer's assessment of alertness/sedation scale (MOAA/S). 3- To evaluate the effect of intranasal dexmedetomidine on HR multiple readings starting from preoperative hold area till 2 hours postoperatively. This randomized, double-blinded clinical trial will include 126 elderly hypertensive patients (≥65 years) undergoing cataract surgery under local anesthesia. Inclusion Criteria will consist of patients aged ≥65 years, ASA II or III, stage 2 hypertension as per ACC / AHA guidelines (SBP\>140 and DBP\> 90 mmHg), undergoing elective cataract surgery under local anesthesia. Exclusion Criteria will include allergy or contraindication to dexmedetomidine, significant baseline bradycardia (\<50 bpm) or arrhythmia, use of sedative or anxiolytic medications, history of severe hepatic, renal, or cerebrovascular disease. Participants will be randomly assigned to receive either intranasal dexmedetomidine (1 mcg/kg ideal body weight) or a placebo (normal saline) 30 minutes before surgery. MAP, HR, and SpO₂ will be recorded at multiple perioperative intervals, and surgical cancellation rates, satisfaction levels will be noted, surgical duration, and hospital stay will be documented.

Design

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

Interventions / Regimen

  • Drug: Intranasal dexmedetomidine — Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
  • Drug: Intranasal normal saline — Intranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.

Primary Outcomes

  • Mean arterial blood pressure (MAP) (From preoperative baseline until 2 hours postoperatively)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2025-07-16
Completion: 2026-05
Eligibility
Age: 65 Years
Sex: ALL
Volunteers: false
Enrollment: 126 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Suez Canal University
Contact Information
Study Contact:
Mohammad E Salama, MD
+201016865861
MohammadElhossieny88@med.suez.edu.eg
Abdelrhman M Alshawadfy, MD
+201091091620
abdelrhmanalshawadfy@gmail.com
Interventions
  • Drug: Intranasal dexmedetomidine — Intranasal dexmedetomidine (1 mcg/kg ideal body weight) will be diluted to a total volume of 1 ml and will be administered via a mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
  • Drug: Intranasal normal saline — Intranasal normal saline (1 ml) will be administered via mucosal atomization device (MAD) 30 minutes before surgery. The dose will be divided evenly, with 0.5 mL sprayed into each nostril while the patient is in a semi-recumbent position.
Study Locations (1 sites)
Suez Canal University Hospitals, Ismailia, Ismailia Governorate 41522 Egypt
Eligibility Criteria
Inclusion Criteria: 1. Patients aged ≥65 years. 2. Patients who will have stage 2 hypertension as per ACC/AHA guidelines (Systolic BP \> 140 and Diastolic BP\> 90 mmHg) 3. Elective cataract surgery under local anesthesia. 4. American Society of Anesthesiologists (ASA) physical status II or III. Exclusion Criteria: 1. Allergy or contraindication to dexmedetomidine. 2. Significant baseline bradycardia (\<50 bpm) or arrhythmias. 3. Use of sedative or anxiolytic medications. 4. History of severe hepatic, renal, or cerebrovascular diseases.
Assessment of Heart Rate Variability for Predicting Obstructive Sleep Apnea in Patients With Hypertension
NCT07603583
Recruiting
Conditions Obstructive Sleep Apnea, 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

This study aims to investigate the relationship between hypertension and obstructive sleep apnea (OSA) using heart rate variability (HRV) as a non-invasive biomarker of autonomic nervous system function. Hypertensive patients at high risk for OSA will undergo 24-hour Holter electrocardiogram monitoring to assess HRV parameters, along with overnight polysomnography (PSG) to determine OSA severity. The study will analyze the association between HRV indices and the apnea-hypopnea index (AHI), and develop predictive models using machine learning techniques. In addition, patients diagnosed with OSA will be followed after treatment, and changes in HRV and blood pressure will be evaluated to assess treatment effects and autonomic function recovery. The results of this study may provide a cost-effective and clinically applicable approach for early detection, risk stratification, and management of OSA in patients with hypertension.

Design

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

Interventions / Regimen

  • Diagnostic Test: Polysomnography — Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.

Primary Outcomes

  • Prediction of OSA Severity Using Heart Rate Variability (Baseline (at time of HRV monitoring and polysomnography))
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: 2026-04-30
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kaohsiung Armed Forces General Hospital
Principal Investigators:
  • Yung Kuo Lee, PhD (PRINCIPAL_INVESTIGATOR) - Kaohsiung Armed Forces General Hospital
Contact Information
Study Contact:
Yung Kuo Lee, PhD
+886910977485
abstyle0204@gmail.com
Chih-Hsuan Chang, MS
+886905163699
abstyle0204@gmail.com
Interventions
  • Diagnostic Test: Polysomnography — Overnight polysomnography (PSG) will be performed to evaluate sleep parameters and determine the severity of obstructive sleep apnea.
Study Locations (1 sites)
Kaohsiung Armed Forces General Hospital, Kaohsiung City, Kaohsiung Taiwan
Eligibility Criteria
Inclusion Criteria: * Age 18 to 65 years * Diagnosed hypertension or resistant hypertension * STOP-Bang score ≥3 indicating high risk of obstructive sleep apnea * Willing and able to provide informed consent Exclusion Criteria: * Refusal to undergo HRV monitoring or polysomnography * Unstable medical condition that may interfere with study participation * Inability to comply with study procedures
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
NCT06616974
Active, positions filled
Conditions Pulmonary Hypertension, Heart Failure Wi...
Phase PHASE2
Enrollment 191
Locations 72 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).

Design

Study type: Interventional Phases: Phase2 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Double

Interventions / Regimen

  • Drug: TX000045- Dose A — The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
  • Drug: TX000045- Dose B — The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
  • Drug: Placebo — The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.

Primary Outcomes

  • Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). (Baseline up to Week 24 post first dose)
  • Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs. (Baseline up to Week 30 post first dose)
  • Number of participants with abnormal laboratory values and/or adverse events that are related to treatment. (Baseline up to Week 30 post first dose)
  • Number of participants with treatment-related adverse events. (Baseline up to Week 30 post first dose)
  • Number of participants with changes in the physical examination findings. (Baseline to Week 30 post first dose)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2024-09-04
Completion: 2027-01-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 191 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tectonic Therapeutic
Principal Investigators:
  • Robert Rogers, MD (STUDY_DIRECTOR) - Tectonic Therapeutic
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: TX000045- Dose A — The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
  • Drug: TX000045- Dose B — The participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
  • Drug: Placebo — The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Study Locations (72 sites)
Phoenix, Phoenix, Arizona 85283 United States
Scottsdale, Scottsdale, Arizona 85258 United States
San Francisco, San Francisco, California 94143 United States
Santa Rosa, Santa Rosa, California 95405 United States
Aurora, Aurora, Colorado 80045 United States
Jacksonville, Jacksonville, Florida 32216 United States
Augusta, Augusta, Georgia 30912 United States
McDonough, McDonough, Georgia 30253 United States
Boise, Boise, Idaho 83706 United States
USA, Louisville, Kentucky 40202 United States
Eligibility Criteria
Inclusion Criteria: 1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years. 2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC). 3. Has NYHA functional class II- III heart failure. 4. Has 6MWT distance from 100 to 450m. 5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening. 6. Is able to understand and provide documented consent for participation. Exclusion Criteria: 1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. 2. Current or recent hospitalization prior to screening. 3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist. 4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study. 5. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square. 6. Was previously administered TX000045, relaxin, or a relaxin fusion protein. 7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy. 8. Has any of the following clinical laboratory values during screening: 1. Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN; 2. eGFR \<30 mL/min/1.73 m2; 3. HbA1c (glycosylated hemoglobin) \>9%; 4. Platelet count \<50,000/millimeter cube; 5. Hemoglobin \<10.0g/dL; 9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045. 10. Is pregnant or breastfeeding. 11. Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin. 12. Has a history of drug or alcohol abuse. 13. Was recently dosed in any clinical research study.
Effectiveness of Treatments for Cirrhosis With Varicose Veins
NCT06961474
Active, positions filled
Conditions Esophageal Varices Bleeding, Portal Hype...
Phase Not Applicable
Enrollment 1900
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

Liver cirrhosis is the fifth leading cause of death among adults, characterized by diffuse fibrous tissue proliferation and the formation of regenerative nodules and false lobules on the basis of widespread hepatocyte necrosis, leading to severe complications such as portal hypertension and liver failure. Cirrhosis is categorized into compensated and decompensated stages based on the presence or absence of clinical events such as ascites, variceal rupture bleeding, and hepatic encephalopathy. Patients with decompensated cirrhosis have a significantly shorter median survival time compared to those in the compensated stage. Esophagogastric variceal hemorrhage is a common life-threatening complication in patients with portal hypertension due to cirrhosis, with high incidence rates and mortality. Current preventive and therapeutic approaches for variceal bleeding include pharmacological therapy, endoscopic treatment, transjugular intrahepatic portosystemic shunt (TIPS), and surgical interventions. However, mortality remains high, and each treatment modality has its own limitations and controversies. This study aims to prospectively investigate the clinical characteristics of portal hypertension caused by various etiologies (e.g., hepatitis B, autoimmune diseases, schistosomiasis) and to compare the efficacy and safety of endoscopic and interventional treatments for varices, providing evidence-based medical support for clinical diagnosis and treatment. The study includes patients admitted for portal hypertension-related esophagogastric varices from February 2022 to December 2024, excluding those under 18 years of age, without varices, or with incomplete medical records. Baseline data, including demographic features, medical history, laboratory tests, imaging examinations, and Child-Pugh classification, will be collected. Follow-up assessments will be conducted at 1, 2, 6, and 12 months post-treatment to monitor adverse events (e.g., rebleeding, hepatic encephalopathy, ascites) and survival status. The primary endpoint is the rebleeding rate within one year, while secondary endpoints include mortality and the incidence of portal hypertension-related complications. The sample size is estimated at 1,900 patients, with 1,500 in the endoscopic treatment group and 400 in the non-endoscopic treatment group. Statistical analysis will be performed using SPSS 24.0 and R software, with continuous data analyzed using t-tests or rank-sum tests and categorical data analyzed using chi-square tests or Fisher's exact test. The study has been approved by the ethics committee, and informed consent will be obtained from all participants.

Design

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

Interventions / Regimen

  • Procedure: Endoscopic treatment — The endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive.

Primary Outcomes

  • Rebleeding within one year (1 year)
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: 2022-02-01
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 1900 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Shanghai Zhongshan Hospital
Principal Investigators:
  • Shiyao Chen, Ph.D. (PRINCIPAL_INVESTIGATOR) - Shanghai Zhongshan Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Procedure: Endoscopic treatment — The endoscopic treatment methods for patients with esophageal variceal rupture bleeding usually include variceal ligation and injection of tissue adhesive.
Study Locations (1 sites)
Zhongshan Hospital, Shanghai, Shanghai Municipality 200000 China
Eligibility Criteria
Inclusion Criteria: ① Age greater than 18 years, with no gender restriction. ② Patients admitted for portal hypertension-related esophageal and gastric varices from February 2022 to December 2024. Exclusion Criteria: * Age \< 18 years ② Absence of esophageal or gastric varices ③ Incomplete medical history records
Different Treatment Frequencies for Hepatic Fibrosis Due to Schistosomiasis
NCT07754617
Not yet recruiting
Conditions Schistosomiasis, Schistosoma Mansoni, Li...
Phase PHASE2, PHASE3
Enrollment 600
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn if treating individuals living in Uganda who have liver fibrosis (scarring) due to schistosomiasis would benefit from more frequent treatment with drug praziquantel. This drug is already approved to treat schistosomiasis and is used globally. The study will include individuals who have schistosomiasis and some degree of liver fibrosis. The main questions it aims to answer are: 1. Does treating participants three times per year as compared to once per year as currently recommended improve the likelihood the hepatic fibrosis will improve over three years. 2. Does treating participants three times per year as compared to once per year as currently recommended decrease the risk they have for bleeding due to portal hypertension over three years. 3. Is there a blood test that can tell us which individuals will experience worsening liver fibrosis before this happens. Participants will: Be screened for schistosomiasis using a urine test If participants have schistosomiasis they will undergo other screening procedures including a liver ultrasound, blood tests, and a physical exam if they have both schistosomiasis and liver (fibrosis) they will be invited to participate in the trial If they are in the trial they will: Take the drug praziquantel once per year or three times per year based on randomization for three years Have a liver ultrasound and blood samples for markers of liver fibrosis once per year Provide a urine sample to test for schistosomiasis each year

Design

Study type: Interventional Phases: Phase2, Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Quadruple

Interventions / Regimen

  • Drug: Praziquantel 40 mg/kg per dose given once annually — Standard recommended by World Health Organization (annual treatment)
  • Drug: Praziquantel 40 mg/kg given three times per year — This intervention provides Praziquantel treatment three times per year (enhanced frequency compared to current WHO guidelines)

Primary Outcomes

  • Improvement in liver fibrosis grade (three years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Status: Not yet recruiting
Start Date: 2026-11
Completion: 2029-11
Eligibility
Age: 15 Years
Sex: ALL
Volunteers: false
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rhode Island Hospital
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), MRC/UVRI and LSHTM Uganda Research Unit
Contact Information
Study Contact:
Jennifer F Friedman, MD, PhD
401 444 7990
jennifer_Friedman@Brown.edu
Haiwei W Wu, MD, PhD
401 444 7339
Haiwei_wu@Brown.edu
Interventions
  • Drug: Praziquantel 40 mg/kg per dose given once annually — Standard recommended by World Health Organization (annual treatment)
  • Drug: Praziquantel 40 mg/kg given three times per year — This intervention provides Praziquantel treatment three times per year (enhanced frequency compared to current WHO guidelines)
Study Locations (1 sites)
Uganda Virus Research Institute, Entebbe, Uganda
Eligibility Criteria
Inclusion Criteria: 1. S. mansoni infection as determined by urine Circulating Cathodic Antigen (CCA) 2. Otherwise healthy as determined by history and physical examination conducted by the study clinician 3. Not Pregnant 4. Age 15-40 years 5. Consent for individuals 18 years of age and older, and parental consent and adolescent assent for participants ages 15-17 years. 6. The presence of hepatic fibrosis due to S. mansoni (Niamey protocol grade C-F) and compensated (without late-stage portal hypertension) after ruling out other causes of hepatic fibrosis as below. Exclusion Criteria: 1. . History of upper gastrointestinal bleeding 2. Hepatic fibrosis that is not deemed to be due to schistosomiasis based on ultrasound and hepatitis serologies. For example, alcoholic cirrhosis or presence of chronic Hepatitis B or C by point of care test 3. Known neurocysticercosis or ocular cysticercosis
Electrical Impedance Tomography for Assessment of Pulmonary Hypertension
NCT07453017
Recruiting
Conditions Pulmonary Hypertension, Pulmonary Thromb...
Phase NA
Enrollment 120
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

Pulmonary hypertension is a serious and progressive disease that is difficult to treat and diagnose, mainly because its symptoms are nonspecific and often delay recognition. Early diagnosis is a major challenge. Although several tests may suggest the disease, the definitive diagnosis still requires right heart catheterization, an invasive procedure that directly measures pulmonary hemodynamics such as pulmonary artery pressure, cardiac output, and vascular resistance. Electrical impedance tomography (EIT) is a non-invasive, radiation-free bedside monitoring method that can evaluate ventilation and pulmonary perfusion. The number of studies investigating perfusion with EIT has been increasing, since the possibility of having a safe, radiation-free, and repeatable method available at the bedside is of great clinical interest in different fields of medicine. Our hypothesis is that EIT provides information that correlates with the findings of right heart catheterization in patients with suspected pulmonary arterial hypertension (PAH). EIT may serve as a useful screening tool prior to catheterization and may also help in risk stratification of patients with pulmonary hypertension

Design

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

Interventions / Regimen

  • Diagnostic Test: Electrical Impedance Tomography (EIT) — Non-invasive, radiation-free bedside monitoring of ventilation and pulmonary perfusion. Patients will be monitored for a short period using EIT, with data analyzed offline to assess pulsatility and perfusion indices.
  • Procedure: Right Heart Catheterization — Standard invasive hemodynamic assessment performed for clinical indication, including measurement of pulmonary artery pressure, cardiac output, pulmonary vascular resistance, and stroke volume. Used as the gold standard comparator for EIT-derived measures.

Primary Outcomes

  • Sensitivity (%) of Electrical Impedance Tomography (EIT)-Derived Pulsatility Amplitude for Detection of Pulmonary Hypertension Defined by Mean Pulmonary Artery Pressure (At the time of right heart catheterization (baseline, single 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: 2024-04-26
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Sao Paulo General Hospital
Contact Information
Study Contact:
Marcelo BP Amato, MD PhD
+55113061-7361
marcelo.amato@hc.fm.usp.br
Jade Lara de Melo, PT
+5534992911757
jade.l.melo.l@gmail.com
Interventions
  • Diagnostic Test: Electrical Impedance Tomography (EIT) — Non-invasive, radiation-free bedside monitoring of ventilation and pulmonary perfusion. Patients will be monitored for a short period using EIT, with data analyzed offline to assess pulsatility and perfusion indices.
  • Procedure: Right Heart Catheterization — Standard invasive hemodynamic assessment performed for clinical indication, including measurement of pulmonary artery pressure, cardiac output, pulmonary vascular resistance, and stroke volume. Used as the gold standard comparator for EIT-derived measures.
Study Locations (1 sites)
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo, São Paulo 05403-900 Brazil
Eligibility Criteria
Inclusion Criteria: * Patients with a diagnosis or clinical suspicion of pulmonary arterial hypertension (PAH) and with a medical indication for right heart catheterization. * Patients evaluated at the Pulmonology Service of InCor-HCFMUSP. Exclusion Criteria: * Pregnancy. * Structural heart disease, such as atrial septal defect, ventricular septal defect, or valvular disease. * Cardiac arrhythmias. * Presence of a cardiac pacemaker or other implantable electronic device. * Skin lesions at the thoracic region that would prevent placement of the EIT electrode belt. * WHO functional class IV of new york heart association (NYAH).. * Inability to perform a voluntary respiratory pause (apnea) of at least 30 seconds or inability to understand and follow instructions required. * Decline to participate in the study by not signing the informed consent form or refusal by the attending medical team.
Comparison of Visual Outcomes and Patient Satisfaction in Mild to Moderate Glaucoma Patients Undergoing Cataract Surgery With EDOF Versus Monofocal IOLs
NCT07436871
Not yet recruiting
Conditions GLAUCOMA 1, OPEN ANGLE, D (Disorder), Ca...
Phase NA
Enrollment 74
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

Cataract is the leading cause of reversible vision loss, while glaucoma remains the primary cause of irreversible blindness, often impairing contrast sensitivity (CS), glare tolerance, and dark adaptation. These visual challenges are particularly relevant when selecting intraocular lenses (IOLs) for glaucoma patients undergoing cataract surgery. Monofocal IOLs are the safest and most commonly used option for glaucoma patients due to their optical simplicity and low incidence of photic phenomena, though they do not provide spectacle independence for near or intermediate vision. Multifocal IOLs (MFIOLs), while offering greater spectacle independence, are relatively contraindicated in glaucoma due to increased visual disturbances like glare and halos. Extended Depth of Focus (EDOF) IOLs offer an intermediate solution, using advanced optics to provide a continuous range of vision and fewer photic disturbances than MFIOLs. EDOF lenses have demonstrated good uncorrected distance and intermediate visual acuity in patients with mild to moderate glaucoma, with promising CS outcomes and high patient satisfaction. However, findings on CS performance remain inconsistent across studies. Given these considerations, this study seeks to determine whether EDOF IOLs can be a viable alternative to monofocal lenses in glaucoma patients, potentially expanding their options for spectacle independence without compromising visual quality. The trial, conducted at OMIQ (Barcelona), will directly compare an EDOF IOL and a monofocal IOL made from the same material to assess their effects on visual acuity, contrast sensitivity, and photic phenomena in this specific patient population.

Design

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

Interventions / Regimen

  • Procedure: Cataract surgery (Monofocal intraocular lens implantation) — This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.
  • Procedure: cataract surgery (Extended depht of focus intraocular lens implantation) — This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.

Primary Outcomes

  • Binocular distance-corrected intermediate visual acuity (DCIVA) (3 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: 2026-01-31
Completion: 2027-02
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 74 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: OMIQ Research
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Procedure: Cataract surgery (Monofocal intraocular lens implantation) — This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.
  • Procedure: cataract surgery (Extended depht of focus intraocular lens implantation) — This intervention consists of bilateral cataract surgery, a microsurgical procedure in which the eye's natural, clouded lens is removed and replaced with an artificial intraocular lens (IOL) to restore clear vision. In this study, patients with early to moderate primary open-angle glaucoma (POAG) will receive either a monofocal or extended depth-of-focus (EDOF) IOL. The surgical technique involves standard phacoemulsification through a small corneal incision, followed by IOL implantation into the capsular bag. What distinguishes this intervention from others is the glaucoma-specific population, with perioperative protocols designed to minimize intraocular pressure fluctuations and preserve optic nerve function. Additionally, both IOLs share the same material and platform, allowing for an isolated comparison of optical design effects.
Eligibility Criteria
Inclusion criteria: * Patients of any sex aged 18 years or older willing to participate and sign the informed consent form. * Clinically significant cataracts in both eyes. * Patients clinically diagnosed of primary open angle glaucoma (POAG) in both eyes. * Early to moderate POAG, as defined by a mean deviation in the Humphrey Visual Field Analyzer (HFA) no worse than ≤ -12 dB and worse ≥ -2 dB at least in one eye, using a 24-2 SITA standard strategy * Two visual field tests without progression and stability of RNFL in Optical Coherence Tomography (OCT) thickness remaining same or less than 10 um in the previous 6 months, with pharmacologically controlled IOP in both eyes \<21mmHg. * Potential for post-surgery monocular distance corrected visual acuity of ≤ 0.10 LogMAR. * Normal corneal topography. * Able to attend all study visits. Exclusion criteria: * Patients with uncontrolled glaucoma, defined as those with an IOP ≥21 mm Hg despite maximal medical therapy, requiring glaucoma surgery and/or laser in either eye in the next year. * Pre-surgery refractive error requiring IOL implantation beyond the commercially available range. * Patients with a not reliable visual field, a VFI ≤ 60% or defects of ≤ 10 dB in the 4 central points of the visual field. Any other form of glaucoma (pseudoexfoliative, severe forms of pigmentary, primary angle closure glaucoma, etc.), ocular hypertension, zonular instability or possible intuitive lens decentration after surgery. * Patients with any previous glaucoma surgery or any other ocular surgery that can affect the results, or any ocular surgery in the previous six months. * Any other ocular pathology that can affect the results. * Use of topic or systemic medication that may affect vision * Unable to cooperate to obtain consistent testing results. * Participation in any other trial during or within 30 days of the screening visit.
A Study to Assess Brillouin Hydration Mapping for the Evaluation of Ocular Tissues and Diseases
NCT07780890
Recruiting
Conditions Fuchs Endothelial Corneal Dysfunction, O...
Phase Not Applicable
Enrollment 90
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-14
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Study Details Design, interventions, and primary outcomes

About This Study

The overall goal of this study is to develop Brillouin microscope as a novel tool for measuring biomechanical and hydration properties of human tissues in vivo.

Design

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

Primary Outcomes

  • Number of subjects to successfully complete Brillouin measurement without serious unanticipated adverse events related to application of the device. (Through completion of the single study visit, approximately 1-2 hours)
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: 2026-08-18
Completion: 2027-09-01
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: true
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Massachusetts General Hospital
Collaborators: Massachusetts Eye and Ear Infirmary, National Eye Institute (NEI)
Principal Investigators:
  • Seok-Hyun Yun, PhD (PRINCIPAL_INVESTIGATOR) - Massachusetts General Brigham
Contact Information
Study Contact:
Soyeon (Selina) Ahn, PhD
3396009736
sahn14@mgh.harvard.edu
Seok-Hyun Yun, PhD
6177688704
syun@mgh.harvard.edu
Interventions
N/A
Study Locations (1 sites)
Massachusetts General Brigham, Boston, Massachusetts 02114 United States
Eligibility Criteria
Inclusion Criteria: * Healthy volunteers with normal eyes * Visual acuity between +2 to -6 diopters Exclusion Criteria: * History of refractive or cataract surgery * History of ocular disease * Active non-ophthalmic systemic disease
Evaluation of Maternal and Neonatal Outcomes in Women Are Conceived Through Assisted Reproductive Technology Compared to Other Fertility Treatments and Naturally Conceived Women: It is a Retrospective Cohort Study Conducted Over a 5-year Period at a Fertility Center in a Lebanese Hospital
NCT06836843
Active, positions filled
Conditions Preterm Birth, Gestational Diabetes Mell...
Phase Not Applicable
Enrollment 1000
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

Background: The number of couples experiencing difficulties conceiving and seeking treatment for infertility has increased dramatically over time. Treatment options for infertility have evolved significantly over the past four decades, expanding to include assisted reproductive technologies (ART). However, the impact of ART on pregnancy outcomes remains unclear. Studies have shown that ART pregnancies are associated with a higher risk of maternal and neonatal adverse outcomes compared to those resulting from spontaneous conception. To this date, no comprehensive studies have been conducted in Lebanon to assess this association. Therefore, it is crucial to evaluate whether Lebanese women who conceive via ART are at higher risk for maternal and birth-related complications. Objective: The aim of this study is to evaluate maternal and neonatal outcomes among women who conceived through assisted reproductive technology (ART), compared to those who conceived via other fertility treatments or naturally, at Dr. Ghazeeri's clinic at the American University of Beirut Medical Center. Methods: Investigators propose to conduct an observational retrospective cohort study involving all pregnant women treated by Dr. Ghazeeri who delivered at the American University of Beirut Medical Center between 2018 and 2023. Pregnancies exposed to assisted reproductive technology (ART) or other fertility treatments will be matched to a group of spontaneous pregnancies based on propensity scores. The study has been initiated following approval from the Institutional Review Board (IRB) at the American University of Beirut Medical Center. Data analysis will be performed using SPSS version 26. Expected Results: If no associations are found between ART or other fertility treatments and an increased risk of maternal and neonatal outcomes, the results will provide reassurance for mothers seeking these treatments. However, if associations are identified, policymakers will need to establish comprehensive regulations outlining the appropriate use of these technologies. Additionally, these findings would lay the groundwork for obstetricians to implement closer monitoring and more careful management during pregnancy.

Design

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

Interventions / Regimen

  • Other: Since this is an observational study rather than an interventional study, the exposure type refers to all potential factors influencing pregnancy both before and during pregnancy — Since this is an observational study rather than an interventional study or clinical trial, the exposure type refers to all potential factors influencing pregnancy both before conception and during pregnancy. These exposures include: Lifestyle habits: Such as obesity, smoking and alcohol use before and during pregnancy. Sociodemographic factors: Such as age, residence, medical insurance. Medications: Any prescription, over-the-counter, or herbal medications used before or during pregnancy. Past medical history: Pre-existing medical conditions or illnesses, such as hypertension, diabetes, or autoimmune diseases, that could affect pregnancy. Past surgical history: Previous surgeries, especially those related to the reproductive system or any that may impact pregnancy outcomes. Previous pregnancies: Information about past pregnancies, including the number of full-term and preterm births, complications, and outcomes. Abortions: Any history of miscarriages

Primary Outcomes

  • Percentage of Pregnant Women with Gestational Diabetes Mellitus (GDM) in the Exposed Group versus Non-Exposed Group (24-28 weeks of gestation)
  • Percentage of Pregnant Women with Gestational Hypertension in the Exposed Group versus the Non-Exposed Group (from 20 weeks + 1 day to 40 weeks of gestation)
  • Percentage of Babies Born Preterm to Women in the Exposed Group versus Non-Exposed Group (Before 37 weeks of gestation)
  • Percentage of Babies Born Small for Gestational Age to Women in the Exposed Group versus Non-Exposed Group (day one of birth)
  • Percentage of Babies Born Large for Gestational Age to Women in the Exposed Group versus Non-Exposed Group (day one of birth)
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: 2023-09-01
Completion: 2025-08
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: true
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Lebanese University
Collaborators: American University of Beirut Medical Center
Principal Investigators:
  • Ghina Ghazeeri, Professor of OBGYN and REI (PRINCIPAL_INVESTIGATOR) - American University of Beirut Medical Center
  • Amal Al Hajje, PhD in Clinical Pharmacy (STUDY_DIRECTOR) - Professor at the Lebanese University
  • Roula Ajrouche, PhD in Epidemiology (STUDY_DIRECTOR) - Associate Professor at the Lebanese University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: Since this is an observational study rather than an interventional study, the exposure type refers to all potential factors influencing pregnancy both before and during pregnancy — Since this is an observational study rather than an interventional study or clinical trial, the exposure type refers to all potential factors influencing pregnancy both before conception and during pregnancy. These exposures include: Lifestyle habits: Such as obesity, smoking and alcohol use before and during pregnancy. Sociodemographic factors: Such as age, residence, medical insurance. Medications: Any prescription, over-the-counter, or herbal medications used before or during pregnancy. Past medical history: Pre-existing medical conditions or illnesses, such as hypertension, diabetes, or autoimmune diseases, that could affect pregnancy. Past surgical history: Previous surgeries, especially those related to the reproductive system or any that may impact pregnancy outcomes. Previous pregnancies: Information about past pregnancies, including the number of full-term and preterm births, complications, and outcomes. Abortions: Any history of miscarriages
Study Locations (1 sites)
Lebanese University, Beirut, Hadath Lebanon
Eligibility Criteria
Inclusion Criteria: * All pregnant ladies of Lebanese Nationality only who delivered at the American University of Beirut Medical Center (AUB-MC) between Nov 2018- Nov 2023 * Pregnancies that were delivered at least 20 weeks of gestation (≥ 20 weeks) * All pregnant women who are in procreation age (20-50 years old) * For pregnant women by ART: only if ART is done at the AUB-MC * Subject's file being accessible for all the three trimesters * Subjects being followed up until delivery only at the AUB-MC * Subjects whom their baby or babies' records are available (it could be multiples) Exclusion Criteria: * Subjects who started their follow-up after the 1st trimester (missing data before 12 weeks). * All subjects with history of severe chronic conditions before gestation such as, pre-existing cancer, heart diseases (coronary artery disease, arrhythmia, cardiac defects, ischemic stroke, venous thromboembolism, liver disease and/or kidney disease, history of nervous system disorders (seizures, depression). * Subjects who undergone ART elsewhere * Subjects who lost to follow up during their pregnancies (missing data) * Moms who delivered outside the AUBMC hospital
Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt
NCT07359547
Recruiting
Conditions GLAUCOMA 1, OPEN ANGLE, D (Disorder)
Phase NA
Enrollment 166
Locations 3 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 goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery.  The main questions it aims to answer are: * Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to the XEN®-63 Gel Stent? * How do the two devices compare over 24 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures? Participants will: * Be randomly assigned (1:1) to receive either the XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery. * Attend scheduled follow-up visits over 24 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments. * Receive standard postoperative care and report any complications or additional treatments during the study period.

Design

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

Interventions / Regimen

  • Device: XEN®-63 Gel Stent — The XEN®-63 Gel Stent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.
  • Device: PRESERFLO™ MicroShunt — The PRESERFLO™ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.

Primary Outcomes

  • Intraocular pressure (1 year)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-01-01
Completion: 2028-01
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 166 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Universitaire Ziekenhuizen KU Leuven
Collaborators: University Hospital, Bonn, Hospital de Santa Maria, Lisbon
Contact Information
Study Contact:
Ingeborg Stalmans, MD, PhD
+3216340391
oogziekten.glaucoomstudies@uzleuven.be
Thomas Jacobs, MD
+16346108
thomas.jacobs@uzleuven.be
Interventions
  • Device: XEN®-63 Gel Stent — The XEN®-63 Gel Stent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.
  • Device: PRESERFLO™ MicroShunt — The PRESERFLO™ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark.
Study Locations (3 sites)
University Hospitals UZ Leuven, Leuven, Vlaams-brabant 3000 Belgium
Universitätsklinikum Bonn, Bonn, North Rhine-Westphalia D-53127 Germany
ULS Santa Maria, Lisbon, Lisbon District 1649-028 Portugal
Eligibility Criteria
Inclusion Criteria: * \>40 years of age * An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX) * Inadequately controlled on maximum tolerated medical therapy. * Mean Deviation (MD) \</= -3 * Intraocular pressure of 14-28 mmHg * Endothelial Cell Count ≥1000 cells/mm2 Exclusion Criteria: * An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX) * Lens status: Aphakic patients or Anterior chamber intraocular lens * Previous procedures: Glaucoma shunt/valve/ surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months. * Presence of intraocular silicone oil * No light perception vision * Current corticosteroid use (ocular or oral) * Conjunctival pathologies (e.g., pterygium) * Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) * Vitreous present in the anterior chamber * Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date * Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits
Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant
NCT07495852
Recruiting
Conditions Glaucoma
Phase PHASE3
Enrollment 510
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant

Design

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

Interventions / Regimen

  • Drug: Gen 2 Travoprost Intracameral Implant — Travoprost
  • Drug: Timolol eye drops 0.5% — Timolol 0.5%
  • Procedure: Sham Procedure — Sham implant administration
  • Other: placebo eye drops — Artificial Tears

Primary Outcomes

  • Intraocular pressure (IOP) (3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2026-02-17
Completion: 2032-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 510 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Glaukos Corporation
Contact Information
Study Contact:
Study Director
949-739-8749
ClinicalResearch@glaukos.com
Interventions
  • Drug: Gen 2 Travoprost Intracameral Implant — Travoprost
  • Drug: Timolol eye drops 0.5% — Timolol 0.5%
  • Procedure: Sham Procedure — Sham implant administration
  • Other: placebo eye drops — Artificial Tears
Study Locations (1 sites)
Glaukos Investigative Site, Dothan, Alabama 36301 United States
Eligibility Criteria
Inclusion Criteria: * Diagnosis of Ocular Hypertension or Open-Angle Glaucoma in the study eye Exclusion Criteria: * Prior incisional glaucoma surgery in the study eye * Prior argon laser trabeculoplasty (ALT) in the study eye * Prior minimally invasive glaucoma (MIGS) surgery in the study eye
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
NCT05840211
Active, positions filled
Conditions Locally Advanced or Unresectable Metasta...
Phase PHASE3
Enrollment 654
Locations 288 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-14
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Sacituzumab Govitecan-hziy — Administered intravenously
  • Drug: Paclitaxel — Administered intravenously
  • Drug: Nab-paclitaxel — Administered intravenously
  • Drug: Capecitabine — Administered orally

Primary Outcomes

  • Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (Up to approximately 29 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2023-05-08
Completion: 2028-04
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 654 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Gilead Sciences
Principal Investigators:
  • Gilead Study Director (STUDY_DIRECTOR) - Gilead Sciences
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Sacituzumab Govitecan-hziy — Administered intravenously
  • Drug: Paclitaxel — Administered intravenously
  • Drug: Nab-paclitaxel — Administered intravenously
  • Drug: Capecitabine — Administered orally
Study Locations (288 sites)
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers, Chandler, Arizona 85224 United States
Los Angeles Hematology Oncology Medical Group, Los Angeles, California 90017 United States
Stanford Cancer Institute, Palo Alto, California 94305 United States
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, San Francisco, California 94143 United States
Rocky Mountain Cancer Centers, LLP, Littleton, Colorado 80120 United States
Yale-New Haven Hospital-Yale Cancer Center, New Haven, Connecticut 06510 United States
Investigational Drug Services, AdventHealth Orlando, Altamonte Springs, Florida 32701 United States
Florida Cancer Specialists, Brooksville, Florida 34613 United States
Florida Cancer Specialist, Leesburg, Florida 34748 United States
Florida Cancer Specialist, St. Petersburg, Florida 33705 United States
Eligibility Criteria
Key Inclusion Criteria: * Able to understand and give written informed consent. * Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site. * Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably from a locally recurrent or metastatic site. * Documented evidence of HER2- status. * Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria. * Candidate for the first chemotherapy in the locally advanced or metastatic setting. * Eligible for capecitabine, nab-paclitaxel, or paclitaxel. * Individuals must have at least one of the following: * Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting. * Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting. * Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor (if ineligible or if unable to access a CDK 4/6 inhibitor) in the metastatic setting. * Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting. * Individuals may have received prior targeted therapies, including but not limited to PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations), or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies. * Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease. * Demonstrates adequate organ function. * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: * Progressive disease within 6 months of completing (neo)adjuvant chemotherapy. * Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment. * Current enrollment in another clinical study and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer. * Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization. * Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I. * Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC. * Have an active second malignancy. * Have an active serious infection requiring antibiotics. * Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). * Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. * Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth. Note: Other protocol defined Inclusion/Exclusion criteria may apply.