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Showing 20 of 26908 trials
Treatment of Acute Mood Depressive Episode in Borderline Personality Disorder With rTMS
NCT04870255
Recruiting
Conditions Depressive Disorder, Major, Borderline P...
Phase NA
Enrollment 45
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study evaluates the antidepressant effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), in individuals with borderline personality disorder (BPD) or trait and comorbid mood depressive disorder (MDD) or bipolar II disorder in a current mood depressive episode (MDE).

Design

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

Interventions / Regimen

  • Device: Left Dorsolateral Prefrontal Cortex (L-DLPFC) — Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
  • Device: Dorsomedial Prefrontal Cortex (DMPFC) — Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the DMPFC. Stimulation intensity will be standardized at 100% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
  • Device: Sham Stimulation — Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC. Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.

Primary Outcomes

  • Change in the clinician rated Montgomery-Asberg Depression Rating Scale (MADRS-C) in active L-DLPFC vs. sham aiTBS. (At baseline (pre-intervention), during the intervention and immediately after the intervention.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2021-07-20
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 45 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Stanford University
Principal Investigators:
  • David Spiegel, MD (STUDY_DIRECTOR) - Stanford University
Contact Information
Study Contact:
Bora Kim, MD, MAS
650-800-6929
borakim2@stanford.edu
Nick Bassano, MSW
650-800-6929
nbassano@stanford.edu
Interventions
  • Device: Left Dorsolateral Prefrontal Cortex (L-DLPFC) — Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
  • Device: Dorsomedial Prefrontal Cortex (DMPFC) — Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the DMPFC. Stimulation intensity will be standardized at 100% of resting motor threshold (adjusted for cortical depth). Stimulation will be delivered using the Magventure Magpro X100 TMS system.
  • Device: Sham Stimulation — Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC. Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.
Study Locations (1 sites)
Stanford Hospital, Stanford, California 94305 United States
Eligibility Criteria
Inclusion Criteria: * Male or Female, between the ages of 18 and 80 at the time of screening. * Able to read, understand, and provide written, dated informed consent prior to screening. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and aiTBS interventions. Stated willingness to comply with all study procedures, including availability for the duration of the study, and to communicate with study personnel about adverse events and other clinically important information. * Diagnosed with Major Depressive Disorder (MDD) or Bipolar II, or unspecified depressive disorder AND Borderline Personality Disorder or trait, with a current Mood Depressive Episode (MDE), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5). * MADRS score of ≥20 at screening (Visit 1). * TMS naive. * Access to ongoing psychiatric care before and after completion of the study. * Access to clinical rTMS after study completion. * In good general health, as evidenced by medical history. * For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation. * Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration. Exclusion Criteria: * Pregnancy * The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia * Current severe insomnia (must sleep a minimum of 5 hours each night before stimulation) * Current mania or psychosis * Bipolar I Disorder and primary psychotic disorders. * Autism Spectrum disorder or Intellectual Disability * A diagnosis of obsessive-compulsive disorder (OCD) * Current moderate or severe substance use disorder or demonstrating signs of acute substance withdrawal. * Urine screening test positive for illicit substances. * Any history of ECT (greater than 8 sessions) without meeting responder criteria * Recent (during the current depressive episode) or concurrent use of a rapid acting antidepressant agent (i.e., ketamine or a course of ECT). * History of significant neurologic disease, including dementia, Parkinson's or Huntington's disease, brain tumor, unexpected seizure/epilepsy disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma. * Untreated or insufficiently treated endocrine disorder. * Contraindications to receiving rTMS (e.g., metal in head, history of seizure, known brain lesion) * Contraindications to MRI (ferromagnetic metal in their body). * Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation. * Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO) * Treatment with another investigational drug or other intervention within the study period. * Any other condition deemed by the PI to interfere with the study or increase risk to the participant.
Therapy and Tech Study
NCT07225192
Not yet recruiting
Conditions Generalized Anxiety Disorder (GAD), Majo...
Phase NA
Enrollment 204
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The investigators want to test if gen AI can support therapy by recruiting patients already in therapy.

Design

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

Interventions / Regimen

  • Behavioral: Chatbot Therapy — This group will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy

Primary Outcomes

  • Generalized Anxiety Disorder (GAD-7) (Baseline, 4-week follow-up, 8-week follow-up)
  • Patient Health Questionnaire (PHQ-9) (Baseline, 4-week follow-up, 8-week follow-up)
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: 2025-11
Completion: 2026-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 204 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, Irvine
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Chatbot Therapy — This group will be asked to use an AI chatbot like chatgpt as an adjunct to their regular therapy
Eligibility Criteria
Inclusion Criteria: * 18+ * US Resident * English-speaking * Self-report having been treated for or diagnosed with generalized anxiety disorder or major depressive disorder by a licensed provider (e.g., MD, DO, LPCC, LCSW, LMFT) in the past 12 months * Self-report currently being in individual therapy Exclusion Criteria: * Ever diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or hospitalized for suicidality
Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments
NCT06777758
Recruiting
Conditions Postoperative Complications, Respiratory...
Phase PHASE4
Enrollment 90
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes.

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Remimazolam — Remimazolam
  • Drug: Propofol — Propofol dose reduction ratio

Primary Outcomes

  • Dose change (Perioperatively (during upper gastrointestinal endoscopy))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-02-12
Completion: 2026-12-31
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kaohsiung Veterans General Hospital.
Principal Investigators:
  • CHIA-HAO YANG, M.D (PRINCIPAL_INVESTIGATOR) - employe
  • Tzung-Jim Tsai, M.D (PRINCIPAL_INVESTIGATOR) - employe
Contact Information
Study Contact:
Yuan-Yi Chia, M.D
886-7-342-2121
yychia@vghks.gov.tw
Chen-Hsiu Chen, Ph.D
886-7-342-2121
chschen@vghks.gov.tw
Interventions
  • Drug: Remimazolam — Remimazolam
  • Drug: Propofol — Propofol dose reduction ratio
Study Locations (1 sites)
Kaohsiung Veterans General Hospital, Kaohsiung City, 81362 Taiwan
Eligibility Criteria
Inclusion Criteria: * Subjects are between 20-80 years old. * Anesthesiologists rated ASA as between I and III. * Patients undergoing upper gastrointestinal endoscopic examination or therapy. Exclusion Criteria: * Allergy to Propofol, Remimazolam, or opioid medications. * Emergency surgery. * Pregnancy. * History of malignant hyperthermia. * Impaired liver or kidney function. * Airway difficulties due to pharyngeal tumors. * Refusal to participate.
Ketamine Treatment Plans for Chronic Conditions
NCT06038409
Recruiting
Conditions Chronic Pain, Depressive Disorder, Anxie...
Phase Not Applicable
Enrollment 500
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.

Design

Study type: Observational Observational model: Cohort Time perspective: Cross Sectional

Interventions / Regimen

  • Drug: Ketamine — The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the treatment plan of those with chronic conditions

Primary Outcomes

  • Ketamine route of use acceptability. (through study completion, an average of 1 year)
  • Mental Health PHQ9 (through study completion, an average of 1 year)
  • Mental Health GAD7 (through study completion, an average of 1 year)
  • Mental Health PCL5 (through study completion, an average of 1 year)
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: 2023-01-01
Completion: 2029-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: RIVER Foundation
Principal Investigators:
  • Edward Lesofski, MS (STUDY_DIRECTOR) - RIVER Foundation
Contact Information
Study Contact:
Ed Lesofski
406-465-9504
ed@riverofchange.org
James Taggart, MD
415-713-6654
jrtaggartmd@aol.com
Interventions
  • Drug: Ketamine — The efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the treatment plan of those with chronic conditions
Study Locations (1 sites)
RIVER Telehealth, Helena, Montana 59601 United States
Eligibility Criteria
Inclusion Criteria: Must have an identifiable chronic condition. Exclusion Criteria: Healthy population
Meditation Accelerated Brain Stimulation for Depression
NCT04586699
Active, positions filled
Conditions Depression
Phase NA
Enrollment 50
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Repetitive Transcranial magnetic stimulation (rTMS) is an FDA-approved treatment for depression that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex (DLPFC) brain region. The ultimate goal of this treatment is to increase excitability and long-term plasticity in DLPFC, a brain region shown to be hypo-active in depression. Unfortunately, rTMS only has low to moderate efficacy; remission rates for patients range from \~15-30% in large randomized controlled trials. The focus of this research is to develop a next-generation rTMS protocol that is guided by the basic principles underlying brain plasticity, in order to improve the efficacy of rTMS for the treatment of depression. Specifically, in this study the investigators will test rTMS paired with a depression-relevant cognitive state of internal attention.

Design

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

Interventions / Regimen

  • Device: Medi1TMS — rTMS theta-burst protocol paired with a consistent attention-to-breath task
  • Device: Medi2TMS — rTMS theta-burst protocol paired with an intermittent deep breathing task

Primary Outcomes

  • Change from baseline Clinical Depression (Remission) (up to 6 weeks)
  • Change from baseline brain activity in attention-to-breath task (up to 6 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2021-07-15
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, San Diego
Principal Investigators:
  • Jyoti Mishra, PhD (PRINCIPAL_INVESTIGATOR) - University of California, San Diego
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Medi1TMS — rTMS theta-burst protocol paired with a consistent attention-to-breath task
  • Device: Medi2TMS — rTMS theta-burst protocol paired with an intermittent deep breathing task
Study Locations (2 sites)
Neuromodulation Clinic Veterans Affairs San Diego, San Diego, California 92037 United States
UC San Diego Health Psychiatry, San Diego, California 92127 United States
Eligibility Criteria
Inclusion Criteria: * moderate to severe depression (PHQ-9 scale score \>9 with confirmation using the Structured Clinical Interview for DSM-5 Disorders) * treatment refractory to antidepressants (i.e. failed 1-3 antidepressants in current episode) or intolerant to antidepressants (i.e. tried 2 antidepressant of inadequate dose/duration in current episode) Exclusion Criteria: * active substance abuse/dependence * psychotic disorders * any factor that increases risk of TMS (metal implants/history of stroke/seizure disorder). * displaying acutely suicidal behaviors on the Columbia Suicide Severity Rating Scale.
The Impact of Low Sodium Salt Substitute Use on Serum Potassium Levels Among Patients With Hypertension
NCT07460882
Recruiting
Conditions Hypertension
Phase NA
Enrollment 607
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this pre-post study is to assess the risk of hyperkalemia in adults with hypertension on medication in Bangladesh. The main questions it aims to answer are: Is the risk of hyperkalemia after the initiation of Low Sodium Salt Substitute (LSSS) in people on antihypertensive medication (especially RASi) large enough to be concerned about its broad use in this population? Does initiation of LSSS correct hypokalemia in people on antihypertensive medication (especially RASi) with low serum potassium levels? Participants will be asked to reduce overall salt intake and to use LSSS on every occasion where regular salt would normally be used, including as cooking salt.

Design

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

Interventions / Regimen

  • Dietary Supplement: Low-sodium salt substitute — The low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)

Primary Outcomes

  • Incident hyperkalemia (K ≥5.5 mmol/L) (4 and 8 weeks)
  • Proportion of the correction of hypokalemia (from K <3.5 mmol/L to 3.5-5.0 mmol/L) (4 and 8 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-08-08
Completion: 2027-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 607 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Johns Hopkins University
Collaborators: National Heart Foundation of Bangladesh, Vital Strategies
Principal Investigators:
  • Junichi Ishigami, MD, PhD (PRINCIPAL_INVESTIGATOR) - Johns Hopkins University
Contact Information
Study Contact:
Junichi Ishigami, MD, PhD
14432877262
jishiga1@jhu.edu
Sohel Reza Choudhury, MD, PhD
Interventions
  • Dietary Supplement: Low-sodium salt substitute — The low sodium salt substitute contains 25% potassium chloride (KCl range; 20%-35%)
Study Locations (1 sites)
The National Heart Foundation of Bangladesh, Dhaka, Bangladesh
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 years with clinically diagnosed hypertension treated with medication \[on a stable dose at least for 2 months\] * Have a phone for contact Exclusion Criteria: * Those with baseline K ≥5.0 or K \<3.0 mmol/L * Advanced kidney disease (eGFR \<45 ml/min/1.73m2). * Those on potassium sparing diuretics (e.g., spironolactone) * Other medical conditions determined by physicians (e.g., heart failure treated with medication; life expectancy less than 12 months) * Dine out for dinner more than 3 times a week
Mobile Health Program for Post-Preeclampsia Hypertension
NCT07599579
Recruiting
Conditions Hypertension (HTN), Preeclampsia, Hypert...
Phase NA
Enrollment 50
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.

Design

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

Interventions / Regimen

  • Behavioral: Coaching application — A digital application for providing education and support for home-based blood pressure monitoring.
  • Behavioral: Home-based blood pressure monitoring — Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
  • Other: WebMD — Smartphone-based application for health education and/or monitoring.

Primary Outcomes

  • Change in systolic blood pressure from baseline to 3 months (Baseline, 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: 2026-07-22
Completion: 2027-10
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Pittsburgh
Collaborators: McKamish Family Foundation
Principal Investigators:
  • Malamo Countouris, MD, MS (PRINCIPAL_INVESTIGATOR) - University of Pittsburgh
Contact Information
Study Contact:
Amy Travis
4126413295
travisam@upmc.edu
Samantha Bryan
412-641-1363
myslinskisg@mwri.magee.edu
Interventions
  • Behavioral: Coaching application — A digital application for providing education and support for home-based blood pressure monitoring.
  • Behavioral: Home-based blood pressure monitoring — Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
  • Other: WebMD — Smartphone-based application for health education and/or monitoring.
Study Locations (1 sites)
UPMC Magee Womens Hospital, Pittsburgh, Pennsylvania 15213 United States
Eligibility Criteria
Inclusion Criteria: * Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP. * Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication). Exclusion Criteria: * Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease). * Males will also be excluded from this study as it focuses on pregnancy related conditions. * Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.
A Study of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension
NCT07373613
Not yet recruiting
Conditions Essential Hypertension
Phase PHASE2
Enrollment 330
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The objective of this clinical trial is to evaluate the antihypertensive efficacy and safety of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 with essential hypertension.

Design

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

Interventions / Regimen

  • Drug: BR1400-1 — One tablet administered alone
  • Drug: BR1400-2 — One tablet administered alone
  • Drug: BR1400-3 — One tablet administered alone
  • Drug: BR1400-4 — One tablet administered alone
  • Drug: BR1400-5 — One tablet administered alone
  • Drug: BR1400-A — One tablet administered alone
  • Drug: BR1400-B — One tablet administered alone
  • Drug: BR1400-C — One tablet administered alone

Primary Outcomes

  • Change from baseline to treatment of 8 weeks in MSSBP (8 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2026-03-01
Completion: 2027-02-01
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 330 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Boryung Pharmaceutical Co., Ltd
Contact Information
Study Contact:
Soo Hee Kim
+82-2-708-8000
shkim0127@boryung.co.kr
Interventions
  • Drug: BR1400-1 — One tablet administered alone
  • Drug: BR1400-2 — One tablet administered alone
  • Drug: BR1400-3 — One tablet administered alone
  • Drug: BR1400-4 — One tablet administered alone
  • Drug: BR1400-5 — One tablet administered alone
Study Locations (1 sites)
Hanyang University Hospital, Soeul, South Korea
Eligibility Criteria
Inclusion Criteria: \<Screening Visit (V1)\> Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the screening (Visit 1) meets the following criteria: * For patients not currently receiving antihypertensive therapy: 140 mmHg ≤ MSSBP \< 180 mmHg * For patients receiving antihypertensive therapy : 130 mmHg ≤ MSSBP \< 180 mmHg For patients receiving antihypertensive therapy at the screening (Visit 1), those for whom the investigator determines that it is medically appropriate to temporarily discontinue their current antihypertensive treatment during the study. \<Baseline Visit (V2)\> Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the baseline (Visit 2) prior to randomization meets the following criteria: * For patients without cardiovascular disease: 140 mmHg ≤ MSSBP \< 180 mmHg * For patients with cardiovascular disease, diabetes with cardiovascular disease, albuminuria, or diabetes with chronic kidney disease (CKD): 130 mmHg ≤ MSSBP \< 180 mmHg Exclusion Criteria: * Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1) and baseline(V2) * Patients with a history of secondary hypertension or suspected secondary hypertension; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.) * Patients with shock * Patients with orthostatic hypotension accompanied by symptoms
Dapagliflozin in Mangement of Pulmonary Hypertension Patients
NCT06612086
Not yet recruiting
Conditions Pulmonary Hypertension
Phase PHASE1
Enrollment 70
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Effect of SGLT2 (Dapagliflozin)on prognosis of patient with pulmonary Hypertension and Effect on RV function By speckle tract echocardiography at Assiut University Hospital.

Design

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

Interventions / Regimen

  • Drug: Dapagliflozin (Forxiga) — we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient

Primary Outcomes

  • Effect of Dapagliflozin on Right ventricle systolic function in patient with pulmonary Hypertension by speckle tract Echocardiography(RV Strain ) (6 month)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2024-10-25
Completion: 2026-10-10
Eligibility
Age: 18 Months
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assiut University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Dapagliflozin (Forxiga) — we study effect of dapagliflozin on patient with pulmonary hypertension by follow up RV function and prognosis of life of patient
Study Locations (1 sites)
Assiut university, Asyut, Egypt
Eligibility Criteria
Inclusion Criteria: that the patients were diagnosed with pulmonary hypertension By Right heart cath OR suspected By Echocardiograghy according to the ESC guidelines for pulmonary hypertension that they were aged 18 years or older Exclusion Criteria: 1. symptomatic hypotension (systolic blood pressure \&amp;lt; 95 mmHg) 2. impaired renal function (eGFR \&amp;lt; 30 mL/min/1.73 m2 calculated according to the CKD-EPI formula) and serum potassium level \&amp;gt; 5.2 mmol/L 3. hepatic dysfunction (defined as liver parameters such as ALT, AST, and/or ALP, which are three times above the upper 99-th percentile of the reference range 4. biliary cirrhosis and cholestasis, active malignancies (regardless of the stage and type of malignancy)), 5. the current use of hormone replacement therapy, chemotherapy, or immunotherapy 6. Type 1 diabetes mellitus 7. Acute pulmonary embolism (15) 8. Signficant Primary valvular Heart disease 9. Ischemic heart disease
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
NCT06246396
Recruiting
Conditions Hypertension, Resistant to Conventional ...
Phase PHASE4
Enrollment 120
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn about the mechanisms by which minocycline effect blood pressure in individuals with treatment-resistant hypertension. The main questions it aims to answer are: * To what extent does minocycline lower blood pressure? * Are such blood pressure effects mediated through changes in gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or some combination of these? Participants will be randomly assigned to treatment with minocycline or placebo, treated daily for 3 months, to evaluate these questions.

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Triple

Interventions / Regimen

  • Drug: Minocycline Hydrochloride — Minocycline Hydrochloride 100 mg twice daily
  • Drug: Placebo — Placebo

Primary Outcomes

  • 24-h systolic blood pressure (3 months)
  • Gut microbiome (3 months)
  • Gut inflammation and leakiness (3 months)
  • Neuroinflammation (3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-01-08
Completion: 2028-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Florida
Collaborators: Emory University, National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Steven M Smith, PharmD, MPH (PRINCIPAL_INVESTIGATOR) - University of Florida
Contact Information
Study Contact:
Joshua N Terrell
352-294-8297
jterrell5102@ufl.edu
David B Smith
352-294-8297
dbsmith@cop.ufl.edu
Interventions
  • Drug: Minocycline Hydrochloride — Minocycline Hydrochloride 100 mg twice daily
  • Drug: Placebo — Placebo
Study Locations (1 sites)
UF Clinical Research Center (UF CRC) - CTSI, Gainesville, Florida 32610 United States
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Uncontrolled TRH, defined as uncontrolled blood pressure (mean 24-hour ambulatory systolic BP ≥125 mm Hg or diastolic BP ≥80 mm Hg) while being adherent to a stable (no changes in ≥14 days prior) antihypertensive regimen of 3 or more drugs, including an adequately dosed diuretic or unable to tolerate a diuretic. * The participant agrees to have all study procedures performed Exclusion Criteria: * Known hypersensitivity or contraindication to minocycline or other tetracyclines * Recent (≤3 months prior), ongoing, or expected use of oral antibiotics * Estimated glomerular filtration rate (eGFR) of \<45mL/min/1.73m2, using the MDRD equation * Known secondary hypertension * History of hypertensive crisis, defined as any in-patient hospitalizations for hypertensive crisis/emergency within the past year * History of orthostatic hypotension, defined as two or more episode(s) of orthostatic hypotension (reduction of SBP of \>20 mm Hg or DBP of \>10 mm Hg within 3 minutes of standing) in the past year * History of myocardial infarction, unstable angina, syncope, or cerebrovascular accident in prior 6 months * Evidence of alcoholism or drug abuse * Severe comorbid conditions (i.e., neoplasms or HIV positive or AIDS) * Current pregnancy or anticipated pregnancy during the study.
Evaluating Whether Treating Elevated Blood Pressure in the Inpatient Setting Impacts Patient Outcomes
NCT07208669
Recruiting
Conditions Blood Pressure Control
Phase NA
Enrollment 4
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The vast majority of the 36.2 million individuals admitted to U.S. hospitals are diagnosed with hypertension and experience an elevated blood pressure (BP) reading during hospitalization. There are no guidelines for managing asymptomatically elevated BPs in the inpatient setting, and growing observational evidence suggests that antihypertensive medication intensification increases harm. The proposed study tests whether a unit-based intervention (ACT-BP) can reduce antihypertensive medication intensification and provides information that is scientifically necessary for designing a cluster-randomized clinical trial that identifies the impact of intensification after experiencing an asymptomatically elevated BP on patient outcomes.

Design

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

Interventions / Regimen

  • Other: ACT-BP Intervention — In our intervention units, the study team will change the unit-based protocols to follow the ACT-BP intervention. First, it prompts the nurse to identify if a patient is experiencing hypertensive emergencies or cardiac symptoms. If so, it suggests calling the physician. If not, it prompts assessment for pain, anxiety, nausea, or hunger and provides evidence-based suggestions. It also prompts monitoring to enhance patients' safety in the case of rapidly rising BP. This algorithm will provide a path for ensuring patients receive appropriate treatment.

Primary Outcomes

  • Primary Outcome (From date of first elevated BP reading until the end of hospitalization, assessed up to 13 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: 2025-11-11
Completion: 2027-07-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 4 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Elizabeth Pfoh
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Elizabeth Pfoh, PhD, MPH (PRINCIPAL_INVESTIGATOR) - The Cleveland Clinic
Contact Information
Study Contact:
Elizabeth Pfoh, PhD, MPH
12162963034
pfohe@ccf.org
Interventions
  • Other: ACT-BP Intervention — In our intervention units, the study team will change the unit-based protocols to follow the ACT-BP intervention. First, it prompts the nurse to identify if a patient is experiencing hypertensive emergencies or cardiac symptoms. If so, it suggests calling the physician. If not, it prompts assessment for pain, anxiety, nausea, or hunger and provides evidence-based suggestions. It also prompts monitoring to enhance patients' safety in the case of rapidly rising BP. This algorithm will provide a path for ensuring patients receive appropriate treatment.
Study Locations (2 sites)
Cleveland Clinic Main Campus, Cleveland, Ohio 44195 United States
Cleveland Clinic Hillcrest, Mayfield Heights, Ohio 44124 United States
Eligibility Criteria
Inclusion Criteria: * At the unit level: Medical units that do not typically care for patients requiring step-down care. Exclusion Criteria: 1. Patients less than 18 2. Patients experiencing hypertensive emergencies or cardiac symptoms 3. Patients with active cardiovascular events, such as * Stroke * Non-ST-elevation * Myocardial infarction * End-stage renal disease * Patients on dialysis * Those with acute decompensated heart failure 3\. Patients on the unit for more than 10 days 4\. Patients transferred in after being in the intensive care unit (ICU) 5\. Pregnant and post-partum women 6\. Patients discharged within 24 hours of admission 7\. Patients whose systolic BP remains below 160 mmHg during hospitalization.
Myopic Optic Neuropathy in Chinese High Myopia Population
NCT04302220
Active, positions filled
Conditions Eye Diseases
Phase Not Applicable
Enrollment 813
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study intends to establish a registry cohort to enroll patients with high myopia to study the natural course of myopic optic neuropathy in Chinese adult population.

Design

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

Primary Outcomes

  • Progression of glaucoma within 36 months (3 years)
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: 2019-06-06
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 813 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sun Yat-sen University
Principal Investigators:
  • Xiulan Zhang, MD, PhD (PRINCIPAL_INVESTIGATOR) - Zhongshan Ophthalmic Center, Sun Yat-sen University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Zhongshan Ophthalmic Center, Guangzhou, Guangdong 510000 China
Eligibility Criteria
Inclusion Criteria * Age ≥18 years * Equivalent spherical ≤-6D or axial length ≥26.5mm * Best corrected visual acuity ≥ 6/12 Exclusion Criteria * Unwilling or unable to give consent, or unable to return for scheduled protocol visits. * Glaucoma secondary to penetrating keratoplasty, trauma, steroids, retinal disease/surgery, or neovascular disease. * Obvious corneal and iris lesions, or severe cataracts interfering with fundus examinations, VF test or monophthalmia. * Need for ocular surgery/laser or anticipated need for cataract surgery during the study period. * Other serious systemic diseasesf (i.e. hypertension, heart disease, diabetes, or rheumatic immune system diseases); * Pregnant or nursing women
Medication Self-Management Technology for Older Adults
NCT07754994
Not yet recruiting
Conditions Mild Cognitive Impairment (MCI)
Phase NA
Enrollment 40
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this feasibility study is to evaluate the preliminary impact of a mobile health application (app) called bpMedManage-R, designed to support hypertension medication self-management in persons with mild cognitive impairment (PwMCI) who live alone. The main questions this study aims to answer are whether the bpMedManage-R app shows preliminary impact on medication-related self-regulation (the ability to consistently take medications as prescribed) and self-efficacy (confidence in independently managing medication use). Participants will be randomized after a baseline assessment to the bpMedManage-R Immediate Group or the bpMedManage-R Delayed Group. Participants assigned to the Immediate Group will complete a 4-week baseline adherence period, at the end of which they will enter the intervention phase. A remote training session will be conducted to initiate the intervention phase, during which participants will download the app, learn to use it, and set up their medication schedule and reminders within the app with support from the study team. They will then use the app for 8 weeks to self-manage their medications, take part in brief weekly check-ins to review progress, and complete Outcome Assessment 1 at the end of the 8-week intervention phase. Participants assigned to the Delayed Group will complete a 12-week baseline adherence period, at the end of which they will complete Outcome Assessment 1. Subsequently, they will enter the intervention phase and will follow a process similar to that of the Immediate Group. At the end of the 8-week intervention phase, they will complete Outcome Assessment 2. Researchers will compare participants who receive the bpMedManage-R app intervention immediately to those assigned to the delayed control group.

Design

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

Interventions / Regimen

  • Other: Immediate Intervention Arm — Participants will first complete a 4 week baseline medication adherence monitoring period. After this period, they will attend a video conferencing session with the research team to receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks to monitor their medication adherence along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, participants will complete a final assessment.
  • Other: Delayed Intervention Arm — Participants will first complete a 12 week baseline medication adherence monitoring period. At the end of this period, they will attend a video conferencing session with the research team during which they will complete a brief assessment and receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks, along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, they will complete a final assessment.

Primary Outcomes

  • Change in Self-regulation Measured by Adapted Short Self-Regulation Questionnaire (SSRQ) (Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention)
  • Change in Medication Usage Self-efficacy Measured by Medication Usage Self-Efficacy (MUSE) questionnaire (Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention)
  • Change in Medication Usage Self-efficacy Measured by Medication Adherence Self-Efficacy Scale-revised (MASES-R) (Immediate Group: Baseline; 8 weeks post-intervention Delayed Group: Baseline; 8 weeks post wait-list period; 8 weeks post-intervention)
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: 2026-10
Completion: 2028-06
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Illinois at Urbana-Champaign
Collaborators: Arizona State University
Contact Information
Study Contact:
Raksha Mudar
217-333-4718
raksha@illinois.edu
Interventions
  • Other: Immediate Intervention Arm — Participants will first complete a 4 week baseline medication adherence monitoring period. After this period, they will attend a video conferencing session with the research team to receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks to monitor their medication adherence along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, participants will complete a final assessment.
  • Other: Delayed Intervention Arm — Participants will first complete a 12 week baseline medication adherence monitoring period. At the end of this period, they will attend a video conferencing session with the research team during which they will complete a brief assessment and receive guidance on downloading and using the bpMedManage R app. They will also set personalized goals for self-monitoring their medication daily and weekly using the app. Participants will then use the app for 8 weeks, along with brief weekly check ins to address questions or technical issues. At the end of the 8 week intervention, they will complete a final assessment.
Eligibility Criteria
Inclusion Criteria: * Age 60+ * Fluent in English * Adequate visual and auditory acuity * Community dwelling * Lives alone * Self-reported memory problems * Manage at least one hypertension medication * Passing score on Telephone Interview for Cognitive Status - Modified (TICS- M) between 27-37 * Passing score on Montreal Cognitive Assessment (MoCA) between 20 and 26 * Geriatric Depression Scale (GDS) score of 6 or lower * Stated willingness to comply with all study procedures and availability for the duration of the study Exclusion Criteria: * Diagnosis of dementia * Major communication difficulties
A Study of the Helix Surgical System in Primary Open-Angle Glaucoma (POAG) and Cataract (HELIX)
NCT06948773
Active, positions filled
Conditions Primary Open Angle Glaucoma, Cataract
Phase NA
Enrollment 25
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A study to assess the safety of the Helix Surgical System in cataract surgery and to gain early evidence of its effectiveness in lowering intraocular pressure (IOP) in subjects with mild to moderate primary open-angle glaucoma (POAG) and cataracts.

Design

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

Interventions / Regimen

  • Device: Helix Surgical System — A handheld device to viscodilate up to 360 degrees of Schlemm's canal and collector channels that also enables intracanalicular scaffolding procedure to restore the aqueous outflow system of a glaucomatous eye.

Primary Outcomes

  • ≥ 20% change from baseline in mean IOP at the 3-month post-operative endpoint (3 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2025-05-21
Completion: 2026-09-30
Eligibility
Age: 45 Years
Sex: ALL
Volunteers: false
Enrollment: 25 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sight Sciences, Inc.
Principal Investigators:
  • Jaime Dickerson, PhD (STUDY_DIRECTOR) - Sight Sciences, Inc.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Device: Helix Surgical System — A handheld device to viscodilate up to 360 degrees of Schlemm's canal and collector channels that also enables intracanalicular scaffolding procedure to restore the aqueous outflow system of a glaucomatous eye.
Study Locations (1 sites)
Panama Eye Center, Panama City, Panama
Eligibility Criteria
Inclusion Criteria: * Male or female subjects, 45 years or older * Visually significant age-related cataract. * Intraocular pressure (IOP) at the Screening visit not exceeding 33 mmHg and at least 21 mmHg for unmedicated eyes or 16 mmHg if medicated (1 to 4 ocular hypotensive medications - fixed combinations count as the number of components), with a stable medication regimen for ≥2 months. * Diagnosed with mild to moderate primary open angle glaucoma (POAG). Exclusion Criteria: * Any of the following prior ocular procedures: * Laser trabeculoplasty ≤180 days prior to baseline * Durysta ≤12 months prior to baseline * Any implanted glaucoma device * Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy * Ciliary ablation including endoscopic cyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe), high intensity focused ultrasound (HIFU), * 180 days prior to baseline * Retinal laser procedure ≤3 months prior to baseline * Any form of glaucoma other than POAG * Use of topical ocular steroids. * Clinically significant concurrent ocular pathology or systemic medical condition which, in the Investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period or interfere with compliance to elements of the study protocol * History of penetrating keratoplasty or another corneal transplant * Endothelial cell density \< 2200 cells/mm2 (age 45), \< 2000 cells/mm2 (age 46 to 55), \< 1800 cells/mm2 (age 56 to 65), \< 1600 cells/mm2 (age \> 65). * Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure. * BCVA of logMAR 0.4 (20/50) or worse in the study eye not due to cataract * BCVA of logMAR 0.6 (20/80) or worse in the non-study eye not due to cataract.
Randomized Clinical Trial; Medical vs Bariatric Surgery for Adolescents (13-16 y) With Severe Obesity
NCT02378259
Active, positions filled
Conditions Obesity, Diabetes, Hypertension, Steatoh...
Phase NA
Enrollment 50
Locations 3 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Severe childhood obesity is associated with both immediate and chronic health problems and a severe impact on psychosocial development. Medical and behavioural interventions rarely result in the significant, durable weight loss necessary to improve health outcomes. This is a randomised clinical trial where 50 adolescents, 13-16 years of age, will be randomised to either early bariatric surgery (Roux-en-Y gastric bypass) or intense conservative treatment and possibly surgery after two years of non-surgical treatment or as they have become 18 years.

Design

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

Interventions / Regimen

  • Procedure: Laparoscopic Roux-en-Y gastric bypass — Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
  • Procedure: Intense conservative treatment — Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years

Primary Outcomes

  • Body Mass Index (kg/m2) (2 years after treatment initiation)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2014-08-15
Completion: 2034-06
Eligibility
Age: 13 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Göteborg University
Collaborators: Sahlgrenska University Hospital, Karolinska University Hospital, Lund University
Principal Investigators:
  • Torsten Olbers, MD, PhD (PRINCIPAL_INVESTIGATOR) - University of Gothenburg, Dept of Surgical Sciences
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Procedure: Laparoscopic Roux-en-Y gastric bypass — Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
  • Procedure: Intense conservative treatment — Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years
Study Locations (3 sites)
Sahlgrenska University hospital, Gothenburg, 41345 Sweden
Skåne University Hospital, Malmö, Sweden
Karolinska University hospital, Stockholm, Sweden
Eligibility Criteria
Inclusion Criteria: * Age 13-16 years * BMI \>35 * Failed comprehensive treatment for obesity \> 1 year * Passing assessment of psychologist * Tanner 3 or more Exclusion Criteria: * Monogenic obesity (for example Prader Willis, Laurence Moon-Bardet-Biedl) * Obesity secondary to brain injury * Severely mentally disabled * Not eligible for general anesthesia * Psychotic or other major psychiatric illness * Previous major gastrointestinal surgery
Predictors of Aspirin Failure in Preeclampsia Prevention
NCT05709483
Recruiting
Conditions Preeclampsia
Phase EARLY_PHASE1
Enrollment 130
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Hypertensive disorders of pregnancy (including preeclampsia) are among the leading causes of pregnancy complications and maternal deaths worldwide. They also increase the risks to the babies. Numerous interventions have been suggested in order to reduce the rate of preeclampsia. Low-dose aspirin is the most beneficial prophylactic approach in this regard. Nevertheless, aspirin failure is not uncommon. The genetic, laboratory, and clinical factors associated with low-dose aspirin failure in the prevention of preeclampsia are largely unknown. The presence of a genetic variant in PAR4 receptor expressed on platelets, is associated with increased platelet function and possibly with aspirin failure.

Design

Study type: Interventional Phases: Early Phase1 Allocation: Non Randomized Intervention model: Parallel Primary purpose: Basic Science Masking/blinding: None

Interventions / Regimen

  • Drug: Aspirin — Platelet assays including VerifyNow Aspirin assay, VerifyNow Base assay, platelet aggregometry, Thromboxana A2 levels- will be measured at baseline and 1 hour after administration of single-dose enteric-coated 81 mg aspirin

Primary Outcomes

  • Allelic frequency of the PAR4 variant (rs773902) in relation to aspirin success in preeclampsia prevention (At study enrollment)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Recruiting
Start Date: 2023-04-13
Completion: 2026-11-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rockefeller University
Principal Investigators:
  • Amihai Rottenstreich, MD (PRINCIPAL_INVESTIGATOR) - Rockefeller University
Contact Information
Study Contact:
Recruitment Office
1-800-782-2737
RUcares@Rockefeller.edu
Amihai Rottenstreich, MD
+1-2123277245
arottenstr@rockefeller.edu
Interventions
  • Drug: Aspirin — Platelet assays including VerifyNow Aspirin assay, VerifyNow Base assay, platelet aggregometry, Thromboxana A2 levels- will be measured at baseline and 1 hour after administration of single-dose enteric-coated 81 mg aspirin
Study Locations (1 sites)
Rockefeller University, New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: 1. Women aged 18-45 years with prior history of preeclampsia who received low dose aspirin in their subsequent gestation and either did or did not have a recurrence of preeclampsia. 2. Aspirin was given in their subsequent pregnancy in a 81 mg dose prior to 16 weeks of gestation, and was taken with a self-reported compliance rate of at least 80% 3. Subsequent pregnancy lasted beyond 20 weeks of gestation 4. Willingness to abstain from non-prescription non-steroidal anti-inflammatory drugs (NSAIDs), which are known to interfere with platelet function assays, for one week prior to platelet function analyses. 5. Healthy controls recruited for SNP assay optimization: Women aged 18 years or older, with no other specific inclusion criteria that need to be met in order to be enrolled for the study. Exclusion Criteria: 1. Age \<18 years or \>45 years 2. Any clinically significant adverse reaction to aspirin on prior exposure 3. Known bleeding disorder based on personal or family history 4. History of kidney or liver impairment 5. Current pregnancy 6. Current use of antithrombotic agents (e.g., aspirin, clopidogrel, warfarin, direct acting oral anticoagulants). 7. Chronic hypertension (systolic blood pressure \>140 mmHG or diastolic pressure \>90 mmHG, or use of antihypertensive drugs or diagnosis made by clinician) 8. Diabetes mellitus 9. Current known malignancy 10. History of hemorrhagic stroke 11. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons 12. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation. 13. Healthy controls: A. \<18 years of age. B. Participants may be excluded at the discretion of the investigator for medical, psychological or other reasons C. Rockefeller students, and Rockefeller employees in the Coller lab, are excluded from participation.
Arm and Finger Measurement for Blood Pressure Surveillance
NCT04012151
Active, positions filled
Conditions Hypertension, Pregnancy-Induced
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Accurate blood pressure (BP) measurement is critical in peripartum care. The cuff and bladder sizes affects the accuracy of BP measurement. Current international BP measurement recommendations are based on mid-arm circumference (MAC). However, evidence have shown the discrepancies between these sizes, leading to inaccuracy of BP measurement. This study will measure arm and finger size of 300 parturients in third trimester to determine whether the MAC, finger measurement or body mass index (BMI) is the best clinical predictor for non-standard cuff sizes for BP measurement.

Design

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

Interventions / Regimen

  • Other: Physical measurement — Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.
  • Other: Cuff size fitting — Fit on arm cuff and finger cuff as selected by investigators based on the measurement.

Primary Outcomes

  • Arm length (Left, Right) (During antenatal visit (1-2 hours). One visit only)
  • Mid Arm circumference (MAC)(Left, Right) (During antenatal visit (1-2 hours). One visit only)
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: 2019-07-10
Completion: 2027-12-31
Eligibility
Age: 21 Years
Sex: FEMALE
Volunteers: false
Enrollment: 300 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: KK Women's and Children's Hospital
Principal Investigators:
  • Farida Ithnin, MMED (Anaes) (PRINCIPAL_INVESTIGATOR) - KK Women's and Children's Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Other: Physical measurement — Parturients of gestational week \>= 32 weeks will have their arms and fingers measured to generate the conicity index.
  • Other: Cuff size fitting — Fit on arm cuff and finger cuff as selected by investigators based on the measurement.
Study Locations (1 sites)
KK Women's and Children's Hospital, Singapore, 229899 Singapore
Eligibility Criteria
Inclusion Criteria: * American Society of Anaesthesiologists physical status 1 or 2 (ASA 1 or 2) parturients at 32 or more weeks of gestation * Multiparous or nulliparous; * Age 21-50 years old; * Undergoing Caesarean section in our institution. Exclusion Criteria: * Emergent Caesarean section such that consent and measurements cannot be taken.
Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure
NCT07070583
Recruiting
Conditions Aorto Iliac Occlusive Disease, Blood Pre...
Phase NA
Enrollment 20
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Hypertension is a major risk factor for a variety of cardiovascular diseases. When hypertension results from increased vascular resistance due to a narrowing of the descending aorta, it can be effectively treated with stenting. More recently, evidence suggest that stenting in more distal parts of the arterial vascular bed is also associated with a reduction in blood pressure. The investigators hypothesize that stenting of occlusions more distal of the descending aorta decreases the central blood pressure and afterload as reflected by NT-proBNP (N-terminal pro-Brain Natriuretic Peptide), a biomarker of intracardiac pressures and predictor of heart failure events. The goal of this pilot study is to prospectively investigate changes in blood pressure after stent placement in the aorto-iliac region.

Design

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

Interventions / Regimen

  • Procedure: Stent placement — Patients with an aorto-iliac occlusion will receive a stent, according to standard care

Primary Outcomes

  • The primary objective is to describe the changes in arterial blood pressures between baseline and 12 months follow-up after endovascular treatment of an occlusion of the infrarenal aorta and/or common iliac arteries. (12 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: 2026-03-30
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rijnstate Hospital
Contact Information
Study Contact:
Michel Reijnen, prof.dr.
0031 88 005 7282
vascularsurgery@rijnstate.nl
Interventions
  • Procedure: Stent placement — Patients with an aorto-iliac occlusion will receive a stent, according to standard care
Study Locations (1 sites)
Rijnstate, Arnhem, 6815AD Netherlands
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Singed informed consent * Chronic occlusion in the infrarenal aorta and/or one or both common iliac arteries * Total lesion length of ≥30mm * Clinical indication for treatment of the pathology (Chronic limb threatening ischemia or disabling intermittent claudication not responding to supervised exercise training) Exclusion Criteria: * Patient is unable to understand the study requirements and/ or is unwilling to adhere to the follow-up * Juxtarenal pathology (\<2cm below the lowest renal artery) * Acute occlusion of the target area (Acute Leriche Syndrome) * Embolic disease
Safety and Efficacy of Balloon Pulmonary Angioplasty in China
NCT04206852
Recruiting
Conditions Chronic Thromboembolic Pulmonary Hyperte...
Phase Not Applicable
Enrollment 200
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-09-11
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Balloon pulmonary angioplasty (BPA) is a potential treatment for non-operable patients with chronic thromboembolic pulmonary hypertension (CTEPH). The aim of this study was to evaluate the safety and efficacy of BPA in CTEPH patients not amenable to pulmonary endarterectomy(PEA) or suffered from persistent CTEPH after PEA.

Design

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

Interventions / Regimen

  • Procedure: Balloon pulmonary angioplasty — Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.

Primary Outcomes

  • Incidence of Treatment-Emergent Adverse Events of BPA procedure. (From initiation of BPA to 3-12 months after last session)
  • Change of Pulmonary artery pressure in mmHg caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of Pulmonary vascular resistance (PVR) in Wood U caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of cardiac index (CI) in L/m^2 caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of World Health Organization (WHO) functional capacity classification caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of six minutes walk distance in meter caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of N-terminal B-type natriuretic peptide in pg/ml caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
  • Change of Peak VO2/kg in ml/min/kg caused by series of BPA. (From initiation of BPA to 3-12 months after last session)
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: 2018-05-11
Completion: 2028-05-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chinese Pulmonary Vascular Disease Research Group
Contact Information
Study Contact:
Zhihong Liu, doctor
86-010-88396589
zhihongliufuwai@163.com
Interventions
  • Procedure: Balloon pulmonary angioplasty — Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
Study Locations (2 sites)
center of pulmonary vascular disease, Fuwai hospital, Beijing, 100037 China
Chinese Academy of Medical Sciences Fuwai hospital, Beijing, 100037 China
Eligibility Criteria
Inclusion Criteria: 1. diagnosed with CTEPH according to ESC Guidelines (1) Mean PAP ≥ 25mmHg at rest; or if mean PAP \< 25mmHg at rest, have exercise limitations from chronic thromboembolic disease (2)Abnormal ventilation perfusion lung scanning (VQ) scan, pulmonary angiogram, computer tomographic pulmonary angiogram, or magnetic resonance pulmonary angiogram confirming chronic thromboembolic disease as recommended by standard guidelines 2. Treatment with anticoagulation for ≥ 3 months before diagnosis of CTEPH 3. Not amenable to pulmonary endarterectomy 4. Willing to provide informed consent Exclusion Criteria: 1. Patients unwilling or unable to provide written consent for participation in the study. 2. Impossible to follow up.
Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD
NCT05169021
Not yet recruiting
Conditions Cerebral Small Vessel Diseases, Stroke
Phase PHASE4
Enrollment 15000
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-09-11
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Study Details Design, interventions, and primary outcomes

About This Study

The primary objectives of this trial are: 1. Efficacy evaluation of amlodipine folic acid tablets: To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level. 2. Intensive Antihypertensive Therapy: To assess the effect of intensive antihypertensive therapy (SBP\<130 mmHg) versus standard antihypertensive therapy (SBP 130-\<140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.

Design

Study type: Interventional Phases: Phase4 Allocation: Randomized Intervention model: Parallel Primary purpose: Prevention Masking/blinding: None

Interventions / Regimen

  • Drug: Amlodipine folic acid 5.8mg+intensive antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure(SBP\<130mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine folic acid 5.8mg+standard antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP:130-140mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+intensive antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+standard antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.

Primary Outcomes

  • All-cause stroke (including fatal and non-fatal stroke) (4 year after randomization)
  • Combined cardio-cerebrovascular events (4 year after randomization)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Not yet recruiting
Start Date: 2021-12-31
Completion: 2028-12-31
Eligibility
Age: 35 Years
Sex: ALL
Volunteers: false
Enrollment: 15000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beijing Tiantan Hospital
Principal Investigators:
  • Yongjun Wang (PRINCIPAL_INVESTIGATOR) - Beijing Tiantan Hospital
Contact Information
Study Contact:
Jinglin Mo
+86 18801125231
mojinglin_dmu@163.com
Anxin Wang
0086-010-59978350
anxin0907@163.com
Interventions
  • Drug: Amlodipine folic acid 5.8mg+intensive antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure(SBP\<130mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine folic acid 5.8mg+standard antihypertensive therapy — Amlodipine folic acid tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP:130-140mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+intensive antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
  • Drug: Amlodipine+standard antihypertensive therapy — Amlodipine tablet 5.8mg, taken daily, in the morning after waking. To achieve target blood pressure (SBP: 130-140 mmHg), this study will provide, if needed, concurrent antihypertensive medications. Patients will be asked to discontinue all prior concurrent medications. Recommended treatment options are described below: 1. Add candesartan 4mg; 2. Add indapamide 2.5mg; 3. Increase dose of candesartan to 8mg; 4. Increase dose of amlodipine to 7.5mg-10mg.
Study Locations (1 sites)
Beijing Tiantan Hospital, Beijing, Beijing Municipality 100070 China
Eligibility Criteria
Inclusion Criteria: 1. Age 35-75 years; 2. Meets any of the following criteria: 1\) Lacunar infarction occurring within the period of seven days up to one year post-infarction, diagnosed by head MRI/CT (meeting modified Fisher criteria\*); 2)Head MRI indicating white matter hyperintensity, 4≥Fazekas score\*≥2; 3)Head MRI indicating white matter hyperintensity, Fazekas=1, combined with old subcortical vascular lacunar infarction; * For modified Fisher criteria and Fazekas score, see FAITH main study appendix 1 and appendix 6). 3\. Medical recorded history of hypertension. Systolic blood pressure SBP: 130-180 mm Hg on 0 or 1 medication SBP: 130-170 mm Hg on up to 2 medications SBP: 130-160 mm Hg on up to 3 medications. 4. mRS score ≤2; 5. Serum Hcy ≥10 µmol/L or MTHFR 677 TT genotype; 6. Signed informed consent form. Exclusion Criteria: 1. Patients with secondary hypertension; 2. Symptomatic intracranial and extracranial artery stenosis (stenosis ≥50%), or asymptomatic intracranial and extracranial artery stenosis (stenosis≥70%); 3. Patients who have undergone revascularization of the heart, brain, or kidney, or other aortic stenting procedures; 4. Any symptoms of orthostatic hypotension when measuring standing blood pressure, or if standing SBP \<110mmHg; 5. Bilateral renal artery stenosis; 6. Patients who have previously taken candesartan or other angiotensin receptor antagonist (ARB) type medication, indapamide or other similar diuretic type medication, or any medication or health product containing folic acid, and reported adverse reactions; 7. Patients who have indicators for specific antihypertensive medications (e.g. β-blockers after acute myocardial infarction, RAS blockers for prevention of cardiovascular disease, α-blockers for treatment of benign prostate hyperplasia); 8. Within the last three months, regular usage of vitamin supplements containing folic acid, B6, or B12, or usage of folic acid antagonists (e.g. methotrexate); 9. Patients undergoing dialysis or with stage 4-5 chronic kidney disease, or estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m²; 10. History of epilepsy or currently using anti-epileptic medication; 11. Pregnant and lactating women, or women planning to become pregnant; 12. Life expectancy less than four years; 13. Within the last month, participation in another clinical trial; 14. Any patient determined by the researchers to be unsuitable for the present study.