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Showing 20 of 28810 trials
Echo and Electrocardiographic Findings in Children With Bronchial Asthma At Sohag University Hospital
NCT06637748
Not yet recruiting
Conditions Bronchial Asthma
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Echocardiography
  • Electrocardiography

Primary Outcomes

  • Changes in ECG parameters from baseline to follow-up
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2024-10
Completion: 2025-10
Eligibility
Age: 5 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sohag University
Contact Information
Study Contact:
Safaa A Abodaif, resident
01027315284
safaa.atef@med.sohag.edu.eg
Eman M Fahmy, assistant professor
Interventions
  • Echocardiography
  • Electrocardiography
Study Locations (1 sites)
Sohag university Hospital, Sohag, Sohag Egypt
Eligibility Criteria
Inclusion Criteria: * 1\. Age range: 5-18 years 2. Confirmed diagnosis of bronchial asthma, made in accordance with current international and national consensus documents Exclusion Criteria: * . Known congenital heart disease 2. Presence of acute infectious diseases and fever 3. Diabetes 4. Autoimmune disorders 5. Primary immunodeficiency 6. Cancer 7. Current use of oral glucocorticoids 8. Other chronic respiratory conditions 9. Systemic diseases affecting the cardiovascular system
The Impact of Coach-guided Risk Communication on the Risk of Major Depression
NCT06619366
Recruiting
Conditions Major Depressive Episode, Risk Reduction...
Phase NA
Enrollment 1000
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • coach-guided personalized depression risk communication
  • depression risk information

Primary Outcomes

  • The proportion of major depressive episode cases
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-02-10
Completion: 2029-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dalhousie University
Principal Investigators:
  • JianLi Wang, PhD (PRINCIPAL_INVESTIGATOR) - Dalhousie University
Contact Information
Study Contact:
Jianli Wang, PhD
902-473-6684
jianli.wang@dal.ca
Interventions
  • coach-guided personalized depression risk communication
  • depression risk information
Study Locations (1 sites)
Faculty of Medicine, Halifax, Nova Scotia B3H 1V7 Canada
Eligibility Criteria
Inclusion Criteria: * no MDE at baseline, or full remission for 2 months for those who had a past MDE (see below the question). * Aged 18 and 65 years. * At high risk of MDE based on the depression risk calculators (predicted risk of 6.5%+ for males and 11.2%+ for females), which represent the top two deciles of male and female populations in Canada. * Agreement to be contacted for follow-up assessments, and * no language barriers to English or French Exclusion Criteria: individuals who * cannot provide informed consent, * do not agree to be followed, * cannot communicate in English and French, or * report suicide behaviors (score \>0 on item 9 of the Patient Health Questionnaire (PHQ-9)).
Study SOLACE SEPSIS
NCT06634069
Recruiting
Conditions Septic Shock, Intracranial Hypertension
Phase PHASE2
Enrollment 40
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Sodium Lactate
  • 3% NaCl

Primary Outcomes

  • haemodynamic effects
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-11-24
Completion: 2027-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital Pilsen
Contact Information
Study Contact:
Miroslav Kříž, MD
+420732850912
krizm@fnplzen.cz
Marek Nalos, MD
marek.nalos@gmail.com
Interventions
  • Sodium Lactate
  • 3% NaCl
Study Locations (1 sites)
University Hospital Pilsen, Pilsen, Czech Republic 30100 Czechia
Eligibility Criteria
Inclusion Criteria: * Subjects will be eligible for the trial if they meet all of the following criteria: 1. Age criteria: 18 - 90 years 2. Septic shock - Sepsis 3 criteria : 1. acute change in total SOFA score ≥ 2 due to infection 2. use of vasopressor drug to maintain target mean arterial pressure ≥ 65 mmHg 3. blood lactate level ≥ 2 mmol/L within last 24 hours 3. Likely need for fluid resuscitation 1. poor peripheral perfusion as evidenced by 2 out of 4: i. peripheral cyanosis with delayed capillary refill ≥ 3 seconds ii. low urinary output (\< 0.5 ml/kg/hour for at least 6 hours) iii. central venous O2 saturation \< 70% iv. clouded sensorium/poor mentation 2. dynamic assessment of preload responsiveness as evidenced by 1 out of 3: i. positive passive leg raising test ii. pulse pressure variation and / or stroke volume variation2, both \> 12% iii. distensibility index of inferior vena caval diameter \> 12% 4. Signed the relevant informed consent form Exclusion Criteria: * Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Poor transthoracic echo windows 2. Actual body weight \> 160 kg 3. Hypernatremia: \[Na\] \> 150 mEq/L 4. Cardiac tamponade 5. Uncorrected severe valvular heart disease or life-threatening arrhythmia 6. Moribund patients likely to die before the study protocol is completed 7. Patients with absolute indication for immediate acute hemodialysis/hemofiltration (within 2 hrs) based on pH \< 7.0, K \> 7.0mmol/L 8. Severe liver dysfunction defined by total serum bilirubin \> 120 umol/l 9. Pregnancy and lactation
Losartan and Emotional Learning
NCT06628154
Recruiting
Conditions Emotional Processing
Phase EARLY_PHASE1
Enrollment 60
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Losartan potassium 50mg
  • Placebo

Primary Outcomes

  • Reinforcement Learning
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Recruiting
Start Date: 2024-08-14
Completion: 2025-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Oxford
Collaborators: National Institute for Health Research, United Kingdom
Principal Investigators:
  • Andrea Reinecke, PhD (PRINCIPAL_INVESTIGATOR) - University of Oxford
Contact Information
Study Contact:
Andrea Reinecke, PhD
+44 01865 618320
andrea.reinecke@psych.ox.ac.uk
Sanika Kulkarni, MSc
sanika.kulkarni@psych.ox.ac.uk
Interventions
  • Losartan potassium 50mg
  • Placebo
Study Locations (1 sites)
Warneford Hospital, University of Oxford, Oxford, Oxfordshire OX37JX United Kingdom
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide informed consent * Aged 18-50 years * Score of or below 45 on the Dimensional Anhedonia Rating Scale (DARS; Rizvi et al., 2015) * Sufficient written and spoken English skills to understand what the study involves, and to complete the questionnaires * Non- or light-smoker (5 cigarettes a day) Exclusion Criteria: * Past or present DSM-5 axis-I diagnosis (based on SCID results at screening) other than anxiety disorder, dysthymia or unipolar depression * First-degree family member with severe psychiatric illness * CNS-medication last 6 weeks (including as part of another study) * Current blood pressure or other heart medication (especially aliskiren or beta blockers) * Diagnosis of intravascular fluid depletion or dehydration * History of angioedema * Impaired kidney function (based on self-report) * Very low blood pressure (defined as repeated (at least three consecutive measurements) measures of blood pressure under standardised conditions where either the systolic or the diastolic blood pressure or both are below 90/50 mmHg (in accordance with established standard definitions: DOI 10.1186/s12887-016-0633-7)) * Lifetime history of epilepsy or other neurological disease (e.g. autism, ADHD) * Lifetime history of systemic infection, or clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, metabolic, endocrine or pulmonary disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study * Significant loss of hearing that is not corrected with a hearing device * Women: pregnancy, breast-feeding
"Smart Family Doctor" Assisted Comprehensive Management of Secondary Prevention Among Post Coronary Artery Bypass Graft Patients or Post Percutaneous Coronary Intervention Patients
NCT06615609
Recruiting
Conditions Post Coronary Artery Bypass Grafting, Hy...
Phase NA
Enrollment 536
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Smart family doctor
  • Health manager

Primary Outcomes

  • The control rates of hypertension, diabetes and hyperlipidemia
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-24
Completion: 2026-11-15
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 536 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: China National Center for Cardiovascular Diseases
Collaborators: Chinese Academy of Medical Sciences, Fuwai Hospital
Principal Investigators:
  • Xin Yuan, PhD (PRINCIPAL_INVESTIGATOR) - Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Information
Study Contact:
Lihua Zhang Zhang, PhD
8601060866780
zhanglihua@fuwai.com
Interventions
  • Smart family doctor
  • Health manager
Study Locations (1 sites)
Xinjiang's First Affiliated Hospital of medical university, Ürümqi, Xinjiang 102300 China
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years. * History of CABG surgery or PCI with history of hypertension, diabetes, and dyslipidemia. * At least one of the following criteria is meet: * Systolic blood pressure no less than 130 mmHg or diastolic blood pressure no less than 80 mmHg * HbA1c no less than 7% * LDL-C no less than 1.4 mmol/L * Use of a smartphone. * Signed informed consent. Exclusion Criteria: * History of heart failure or severe arrhythmias. * Presence of other severe underlying conditions such as cancer or liver and kidney insufficiency. * Pregnancy, lactation, or plans for pregnancy within the next year. * Cognitive, communication impairments, or limitations in daily activities.
ACT_for Alcohol Use Disorder and Depression
NCT06620276
Recruiting
Conditions Depression - Major Depressive Disorder, ...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Acceptance and Commitment Therapy
  • Ketamine

Primary Outcomes

  • Study completion AND Adherence to ketamine infusions and ACT psychotherapy sessions
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-05-01
Completion: 2028-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Principal Investigators:
  • Nicolas Garel, MD MSc (PRINCIPAL_INVESTIGATOR) - Centre Hospitalier d'Université de Montréal
Contact Information
Study Contact:
Nicolas Garel, MD MSc
514-890-8000
nicolas.garel.med@ssss.gouv.qc.ca
Samuel Cyr, PhD
514-890-8000
samuel.cyr.chum@ssss.gouv.qc.ca
Interventions
  • Acceptance and Commitment Therapy
  • Ketamine
Study Locations (1 sites)
Centre Hospitalier de l&#39;Université de Montréal, Montreal, Quebec H2X3E4 Canada
Eligibility Criteria
Inclusion Criteria: * Provision of written informed consent after reading and understanding the patient information handout * Alcohol Use Disorder (AUD) diagnosed by a trained psychiatrist * Diagnosis of treatment resistant unipolar or bipolar depression, defined as failure to respond to ≥2 adequate trials per Canadian national depression guidelines * Willingness to engage in 8 weekly psychotherapy sessions * No changes to psychotropic medications during treatment * Average daily ethanol consumption of at least moderate risk as per WHO risk levels (Men: \>40 to 60 g per day or \>2.9 to 4.3 drinks / Women: \>20 to 40 g per day or \>1.4 to 2.9 drinks) * Bipolar or unipolar depressive episode (DSM5), current episode, with MADRS ≥ 20 * Age 18 to 70 years * Agreement to abstain from consuming grapefruit juice on ketamine infusion days * Agreement to abstain from driving or operating heavy machinery after infusions until the next day Exclusion Criteria: * Current participation in other evidence based psychotherapeutic interventions for mood disorders or substance abuse * Inability to commit to the study protocol due to professional or personal obligations * Non English or non French speaking * Psychiatric comorbidity likely to take precedence over AUD or TRD * Acute psychotic disorder or acute psychotic symptoms * Current or prior substance abuse or dependence other than AUD (except caffeine or nicotine) * Non response to esketamine or ketamine during the current depressive episode * Known intellectual disability or autism spectrum disorder * Inability to attend regular visits to the CHUM Neuromodulation clinic * Depression secondary to stroke, cancer, or severe medical conditions * Risk factors for intracranial hemorrhage (trauma, aneurysm, neurosurgery) * Uncontrolled hypertension or significant coronary or cerebrovascular disease * Renal or hepatic impairment * Pregnant, lactating, or of childbearing potential without approved contraception use during ketamine treatment, with a negative urine pregnancy test required at baseline * Abnormal liver function tests (AST or ALT ≥ 3 times upper normal limit) * Clinically significant abnormal ECG results * Unstable thyroid hormone levels or uncorrected hypo or hyper thyroidism * Any unstable or clinically significant condition judged by the study physician to interfere with treatment * Positive toxicology screen for drugs not prescribed * Unwillingness to abstain from benzodiazepines, narcotics, or NMDA antagonists (including memantine and lamotrigine) 12 hours before infusions * Known intolerance or hypersensitivity to ketamine * Significant hearing impairment not improved by aids * Any recent significant decline in exercise tolerance
Supplemental Screening for Women With Extremely Dense Breast Tissue: the DENSE-2 Trial
NCT06636370
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 36000
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Contrast-enhanced mammography (CEM)
  • Abbreviated MRI (AB-MRI)

Primary Outcomes

  • Interval Cancer Rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-11-11
Completion: 2031-09-01
Eligibility
Age: 49 Years
Sex: FEMALE
Volunteers: true
Enrollment: 36000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: C.H. van Gils
Collaborators: University Medical Center Groningen, Ziekenhuisgroep Twente, Radboud University Medical Center, Rijnstate Hospital, Zuyderland Medical Centre, Maastricht University Medical Center, Elisabeth-TweeSteden Ziekenhuis, Catharina Ziekenhuis Eindhoven, Jeroen Bosch Hospital, Erasmus Medical Center, Albert Schweitzer Hospital, St. Antonius Hospital, Antoni van Leeuwenhoek Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Bevolkingsonderzoek Nederland, Borstkankervereniging Nederland
Principal Investigators:
  • Carla van Gils, Prof. (PRINCIPAL_INVESTIGATOR) - UMC Utrecht
Contact Information
Study Contact:
Carla van Gils, Prof
0031-88-7568181
dense-2@umcutrecht.nl
Evelyn Monninkhof, Dr.
e.monninkhof@umcutrecht.nl
Interventions
  • Contrast-enhanced mammography (CEM)
  • Abbreviated MRI (AB-MRI)
Study Locations (1 sites)
UMC Utrecht, Utrecht, Netherlands
Eligibility Criteria
Inclusion Criteria: * Participant in the Dutch population-based breast cancer screening program with a negative mammography result (BI-RADS classification 1 or 2). * Extremely dense breast tissue (assessed with Quantra software, category D). * Age between 49-72 years (women are invited to the Dutch screening program in the year they turn 50, so the minimum age is 49 years. The maximum age for inclusion is 72 years to ensure that women can still participate in a second round of supplemental screening). * Living in the service area (travel distance of up to 60 km) of the 15 participating hospitals. * Absence of breast implants (Quantra cannot provide an accurate density determination for breasts with implants). * No objection to data sharing. * Not a participant in the DENSE trial or STREAM trial (participants in the DENSE and STREAM trials are known to the Dutch screening organization). Exclusion Criteria: The additional exclusion criteria for the intervention arms are checked after randomization and recruitment (this order is due to the pre-randomization design): * Presence of in-body metals (only for AB-MRI, this involves specific metals and is asked by telephone). * Previous allergic reaction to the provided contrast agent. * Renal insufficiency (glomerular filtration rate \<30 ml/min) (only for CEM, is checked for with questionnaire I and possibly renal function measurement). * Severe claustrophobia (only for AB-MRI). * Severe obesity (weight \>150 kg) (only for AB-MRI).
The Exhale Study: Treating Maternal Depression in an Urban Pediatric Asthma Clinic
NCT06623981
Recruiting
Conditions Asthma in Children, Depression
Phase NA
Enrollment 60
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Enhanced Brief Interpersonal Psychotherapy
  • Supplemented Usual Care

Primary Outcomes

  • Maternal depressive symptoms
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-10-15
Completion: 2027-03-15
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Children's National Research Institute
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Principal Investigators:
  • Rachel Margolis, PhD, MSW (PRINCIPAL_INVESTIGATOR) - Children's National Research Institute
Contact Information
Study Contact:
Geraldine Mendez-Gonzalez
(202) 476-6956
GMENDEZGON@childrensnational.org
Interventions
  • Enhanced Brief Interpersonal Psychotherapy
  • Supplemented Usual Care
Study Locations (1 sites)
Children's National Hospital, Washington D.C., District of Columbia 20010 United States
Eligibility Criteria
Inclusion Criteria: Maternal: * Primary caregiver of the child with asthma seen at the community-based asthma clinic * Female (self-identified) * Black (self-identified) * ≥ 18 years of age * English-speaking * PHQ-9 ≥ 8 during standardized screening at the child with asthma's clinic visit Child: * \<18 years old for the duration of the 6-month study period * Publicly insured * Physician-diagnosed persistent asthma Exclusion Criteria: Maternal: * Acutely suicidal (high risk on the C-SSRS at child's asthma clinic visit) * Bipolar disorder or mania * Schizophrenia * Current substance abuse/dependence * Current serious physical intimate partner violence (IPV) * Lack of capacity to meaningfully participate in study procedures, as assessed by study staff during screening Child: * Significant medical co-morbidity (e.g., disorders of the cardiorespiratory system, significant developmental delay, diabetes, seizure disorder, and sickle cell disease) * Enrolled in another intervention with a behavioral component and/or novel asthma therapeutics
Additive Effects of Alternative Nostril Breathing with Pharmacological Management on Dyspnea and Control Pause in Patients with Bronchial Asthma
NCT06609941
Recruiting
Conditions Bronchial Asthma
Phase NA
Enrollment 32
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Alternative nostril breathing
  • Pharmacological therapy

Primary Outcomes

  • Dyspnea
  • Control pause
  • Asthma control
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-06-18
Completion: 2025-02-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Foundation University Islamabad
Contact Information
Study Contact:
Bazkha Tariq Aslam Khawaja, DPT
0333-1281293
bazkhatariq@gmail.com
Interventions
  • Alternative nostril breathing
  • Pharmacological therapy
Study Locations (1 sites)
Foundation University College of Physical Therapy, Rawalpindi, Punjab Province 46000 Pakistan
Eligibility Criteria
Inclusion Criteria: * Adults: aged (18-45 years) * Gender: Both males and females * Grade1- Grade 4 on Modified MRC dyspnea scale * Asthma severity classes (intermediate, mild persistent and moderate persistent asthma) acc. to NAEPP national asthma education and prevention program guidlin Exclusion Criteria: * Patients having acute exacerbation of COPD or status asthmaticus * Patients diagnosed with acute infections * Patients unable to follow command/ instructions * Asthma patients with \>40 sec control pause duration * Patients who fall in red zone of asthma action plan (PEFR \< 50%)
Test of Reproducibility of [15O]H20-PET Assessment of Brain Perfusion
NCT06624267
Not yet recruiting
Conditions Microvascular Disease, Microvascular Com...
Phase Not Applicable
Enrollment 8
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • PET

Primary Outcomes

  • [15O]H2O PET assessment of the blood perfusion of the brain
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: 2024-11
Completion: 2027-12
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: true
Enrollment: 8 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Hospital Bispebjerg and Frederiksberg
Collaborators: Danish Cardiovascular Academy, Bispebjerg Hospital, The Dagmar Marshall Foundation, Steno Diabetes Center Copenhagen
Principal Investigators:
  • Thomas EHJ Primary Investigator, Medical Doctor (PRINCIPAL_INVESTIGATOR) - University Hospital Bispebjerg and Frederiksberg
Contact Information
Study Contact:
Primary Investigator, Medical Doctor
4551903442
thomasehlighjermindjustesen@regionh.dk
Lisbeth Marner, Ph.d.
4591171938
lisbeth.marner@regionh.dk
Interventions
  • PET
Study Locations (1 sites)
Bispebjerg and Frederiksberg Hospital, Copenhagen, 2400 Denmark
Eligibility Criteria
Inclusion Criteria: * Age \&gt; 60 years * No diagnosis of T2D according to WHO\&#39;s criteria. * Speaks and understands Danish (required for reliable cognitive testing) * Able to provide informed and written consent Exclusion Criteria: * Moderate to high intensity training \&gt;2 times/week. * Previous AMI, atrial fibrillation, significant cardiac valve disease, HFrEF (LVEF \&lt;45%), asthma. * Previous stroke or significant neurological disease including cognitive dysfunction. * Ongoing depression. * Hypothyroidism * Unable or unwilling to participate in training, e.g., due to injury, arthrosis or lung disease.
Nitrous Oxide in the Treatment of Acute Suicidal Ideation
NCT06636357
Recruiting
Conditions Suicidality, EEG, Suicidal Ideation, Nit...
Phase PHASE2
Enrollment 85
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • 50% N2O plus 50% O2
  • Oxygen (O2)

Primary Outcomes

  • Beck Scale for Suicidal Ideation (BSS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-01-13
Completion: 2026-09-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 85 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Zurich
Contact Information
Study Contact:
Angelina Frasch
0041583843666
angelina.frasch@pukzh.ch
Interventions
  • 50% N2O plus 50% O2
  • Oxygen (O2)
Study Locations (1 sites)
Psychiatric University Hospital Zurich, Zurich, 8032 Switzerland
Eligibility Criteria
Inclusion criteria: * Ability to give written informed consent * Moderate to severe suicidal ideation defined as a score ≥3 on the Montgomery-Asberg Depression Rating Scale (MADRS; Schmidtke et al., 1985) suicide item (item #10) as well as a self-report Beck Scale for Suicide Ideation (BSS; Kliem et al., 2017) items #4 plus #5 score ≥ 2 * Plasma homocysteine level ≤ 14 µmol/l Exclusion criteria: * Organic, including symptomatic, mental disorders (F00-F09; lifetime diagnosis) * Schizophrenia, schizotypal and delusional disorders (F20-F29; lifetime diagnosis) * Mental and behavioral disorders due to psychoactive substance use. Nicotine and cannabis will be ignored (F10-F19) * Non-medical (i.e., recreational) use of inhalational N2O during the last 12 months * Past intolerance or hypersensitivity to N2O * Critical illness * Severe cardiac disease * Pregnancy or breastfeeding * Pulmonary hypertension * Chronic cobalamin or folate deficiency unless treated with folic acid and/or vitamin B12 * History or evidence of any other medical or neurological condition that would expose the subject to an undue risk of a significant adverse event as determined by the clinical judgment of the investigator * Treatment with ketamine/esketamine during the last 4 weeks * Treatment with opioid medications during the last 3 months * Treatment with vagus nerve stimulation (VNS) or electroconvulsive therapy (ECT) within the last 3 months * Recent (within the last 4 weeks) or current use of benzodiazepines in excess of 5 mg lorazepam or equivalent per day * Finally, any other factors that, in the investigator's judgment, would unduly impact patient safety or compliance during the study.
Online Therapy Youth, Equivalent to Treatment As Usual?
NCT06617663
Recruiting
Conditions Depression, Trauma, Compulsive Disorder,...
Phase NA
Enrollment 172
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • EMDR
  • ACT

Primary Outcomes

  • Change in the level of psychological flexibility (for the ACT arms), as measured by the AFQ-Y.
  • Change in the degree of overall symptomatic distress, as measured by the Youth Outcome questionnaire (YOQ)
  • Change in post-traumatic symptoms (for the EMDR arms), as measured by the KJTS EMDR questionnaire
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-07-01
Completion: 2026-09-01
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: true
Enrollment: 172 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: GGZ Noord-Holland-Noord
Collaborators: UMC Utrecht
Contact Information
Study Contact:
Elles te Brake, Msc
0031623942414
e.tebrake@ggz-nhn.nl
Eva Velthorst, PhD
0031618644345
e.velthorst@ggz-nhn.nl
Interventions
  • EMDR
  • ACT
Study Locations (1 sites)
GGZ NHN, Alkmaar, North Holland 1817 EX Netherlands
Eligibility Criteria
Inclusion Criteria: * Adolescents aged 12-18 years who would benefit from ACT or EMDR within the SGGZ, as determined by the screeners at registration or current primary practitioner. * Client is stable, i.e. there is no serious crisis (to be determined by screener cq primary practitioner) * Sufficient command of the Dutch language to complete the questionnaires. * Client does not participate in other (intervention) studies Exclusion Criteria: * Clients who are crisis-prone or enter in crisis * Clients who are in forced care (wvggz)
A Real-World Evidence Study of Goniotomy With the C-REX™ Instrument in Patients With Primary Open Angle Glaucoma
NCT06615661
Active, positions filled
Conditions Primary Open Angle Glaucoma (POAG)
Phase Not Applicable
Enrollment 100
Locations 6 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • C-Rex Instrument

Primary Outcomes

  • Percent of eyes with intraocular pressure (IOP)reduction ≥20%in comparison with baseline.
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2024-08-14
Completion: 2026-12
Eligibility
Age: 22 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Iantrek, Inc.
Principal Investigators:
  • Tsontcho Ianchulev, MD, MPH (STUDY_DIRECTOR) - CMO
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • C-Rex Instrument
Study Locations (6 sites)
CIRCLE Site 32, Cape Coral, Florida 33904 United States
CIRCLE Site 10, DeLand, Florida 32720 United States
CIRCLE Site 07, Atlanta, Georgia 30342 United States
CIRCLE Site 30, Brentwood, New York 11717 United States
CIRCLE Site 31, Rockville Centre, New York 11570 United States
CIRCLE Site 04, Crossville, Tennessee 38555 United States
Eligibility Criteria
Inclusion Criteria: * Primary open angle glaucoma * Goniotomy surgery performed using the C-Rex Instrument Exclusion Criteria: * History of intraocular surgery within 8 weeks prior to C-Rex surgery * Preoperative IOP higher than 33 mmHg * Presence of a glaucoma type other than POAG * Presence of clinically significant intraocular pathology other than cataract or glaucoma
Effect of Early Combination Antihyperglycemic Treatment on Metabolic Control in Individuals With Type 2 Diabetes
NCT06613854
Recruiting
Conditions Type 2 Diabetes Mellitus (T2DM)
Phase PHASE4
Enrollment 90
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Oral semaglutide
  • Empagliflozin 10 mg

Primary Outcomes

  • Time in Range (TIR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-10-01
Completion: 2027-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Medical Centre Ljubljana
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Oral semaglutide
  • Empagliflozin 10 mg
Study Locations (1 sites)
University Medical Centre Ljubljana, Diabetes Outpatient Clinic, Ljubljana, 1000 Slovenia
Eligibility Criteria
Inclusion Criteria: * Diagnosed with type 2 diabetes for up to 2 years (prior to randomization); * Aged between 18 and 70 years, both sexes, of any race or ethnicity; * HbA1c ≤8.0% at randomization; * Baseline treatment with metformin at a steady daily dose of ≥1500 mg; * Signed informed consent to participate in the study. Exclusion Criteria: * Treatment at any time in the past with SGLT2i, GLP-1RA, or DPP-4 inhibitors; * Insulin treatment for longer than 2 weeks in the past; * Body Mass Index below 22 kg/m2 or BMI above 40 kg/m2; * Chronic kidney disease stages 3-5 (eGFR below 60 ml/min or the presence of albuminuria (urine albumin-to-creatinine ratio above 34 g/mmol); * Known cardiovascular disease (angina pectoris, history of myocardial infarction, ischemic heart disease, heart failure, known carotid atherosclerosis, objectively proven peripheral arterial disease, or other known atherosclerotic disease at other locations); * Moderate or severe liver disease (Child-Pugh stage B or C); * Personal history of pancreatitis; * Advanced heart failure (NYHA III-IV); * Retinopathy or maculopathy or their active treatment; * Pregnancy, expected pregnancy, or breastfeeding; * Presence of active malignancy or personal history of malignancy within 5 years of study enrollment; * Personal history of thyroid cancer; personal or family history of multiple endocrine neoplasia type 2 or family history of medullary thyroid carcinoma; * Chronic inflammatory bowel disease; * History of bariatric surgery or other gastrointestinal surgery that could affect drug or nutrient absorption; * Frequent or severe urinary tract infections; * Presence of a urinary catheter; * Troublesome and recurrent genital fungal infections; * Personal history of ketoacidosis; * Symptomatic hypotension or predisposition to hypovolemia; * History of organ transplantation; * Allergy to any component in the semaglutide or empagliflozin oral tablet; * Any medical or social circumstance that may limit participation in the study (e.g., inability to attend regular study visits); * Any other condition that, in the opinion of the principal and responsible investigators, may affect the safety or efficacy of the treatment.
Dietary Restriction to Prevent Cardiotoxicity in Breast Cancer Patients
NCT06622954
Recruiting
Conditions Cardiotoxicity, Breast Cancer
Phase NA
Enrollment 32
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Protein- and Calorie restriction

Primary Outcomes

  • High-sensitivity troponin T (hsTnT)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-05-10
Completion: 2026-05
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 32 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Erasmus Medical Center
Principal Investigators:
  • Franny Jongbloed, MD/PhD (PRINCIPAL_INVESTIGATOR) - Erasmus Medical Center
Contact Information
Study Contact:
Sheraz Ditta, PharmD
+31639462883
s.ditta@erasmusmc.nl
Franny Jongbloed, MD/PhD
f.jongbloed@erasmusmc.nl
Interventions
  • Protein- and Calorie restriction
Study Locations (1 sites)
Erasmus MC, Rotterdam, South Holland 3015 GD Netherlands
Eligibility Criteria
Inclusion Criteria: * women with newly diagnosed triple negative breast cancer with an indication for (neo-)adjuvant ATC-based chemotherapy and of intent to start anticancer treatment; * age between 18 and 75 years; * written informed consent; * body mass index ≥ 19. Exclusion Criteria: * Allergic to any of the ingredients of the diet; * Known history of cardiac dysfunction; * Severe morbidity with the inability to receive anticancer treatment. * Participation in another clinical trial with an intervention arm (database and/or biobank studies excluded); * Pregnant women * Previous treatment with anthracycline * Estrogen receptor positive status
PAS 1ml Magtrace® for Sentinel Lymph Node Biopsy in Breast Cancer Patients
NCT06610539
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 184
Locations 2 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Frequency of Magtrace-related skin discoloration as a proportion of patients receiving Magtrace, overall and by sub-sample
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-04-22
Completion: 2028-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 184 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Endomagnetics Ltd.
Collaborators: Endomagnetics Inc
Contact Information
Study Contact:
Vicky Crawford
+441223652617
vcrawford@endomag.com
Interventions
N/A
Study Locations (2 sites)
UNC, Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina 27599 United States
VCU Massey Comprehensive Cancer Center, Richmond, Virginia 23298 United States
Eligibility Criteria
Inclusion Criteria: * Patient is willing and able to give informed consent for participation in the study * Patient is aged 18 years or older at the time of consent * Patients undergoing planned breast conserving surgery (for example, lumpectomy or partial mastectomy) and SLNB with Magtrace Exclusion Criteria: * The patient is pregnant or lactating * The patient has had prior breast radiation to the ipsilateral breast * The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes * The patient has recevied a Feraheme (ferumoxytol) injection within the past 6 months * The patient has intolerance or hypersensitivity to iron or dextran compounds or to Magtrace * The patient has iron overload disease * The patient has discoloration on the breast (such as tattoo, birthmark, tanning, rash etc.), that in the Investigator's opinion, could impact the clinical trial results, specifically the assessment of any skin discoloration, or plans to have a tattoo on the breast post-operatively.
International Severe CRSwNP Registry 2024-2028
NCT06617754
Active, positions filled
Conditions Chronic Rhinosinusitis With Nasal Polyps...
Phase Not Applicable
Enrollment 3000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biologic drugs

Primary Outcomes

  • Change in The Sino-Nasal Outcome Test 22 (SNOTT22) score
  • Change in Nasal Polyp Score (NPS)
  • Change in visual analogue scale (VAS)
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: 2025-03-31
Completion: 2032-01
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 3000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Vibeke Backer
Collaborators: The European Forum for Research and Education in Allergy and Airway Diseases
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Biologic drugs
Study Locations (1 sites)
Department of Rhinolaryngology Head & Neck surgery and Audiology, Copenhagen, Denmark DK-2100 Denmark
Eligibility Criteria
Inclusion Criteria: * Symptoms of CRSwNP * Indication for biologic treatment as suggested by EPOS/EUFOREA * Have been followed for 6 months Exclusion Criteria: * Unilateral polyps * Non-Type-2 inflammation * Treatment less than 6 months
A Pilot Study to Assess the Impact of Breath Awareness Using Pyramid on Symptoms of Anxiety and Depression in People with T2DM
NCT06632782
Recruiting
Conditions Depression, Anxiety
Phase NA
Enrollment 152
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Breath Awareness using pyramid

Primary Outcomes

  • Change in Hospital Anxiety and depression score(HADS)
  • Change in Patient Health Questionnaire PHQ-9 score
  • Change in Pitssburgh Sleep Quality Index PSQI score
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-11-01
Completion: 2026-12-31
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 152 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dasman Diabetes Institute
Principal Investigators:
  • Rashmi Shiju (PRINCIPAL_INVESTIGATOR) - Dasman Diabetes Institute
Contact Information
Study Contact:
Rashmi Shiju, MPharmacy
22242999
rashmi.shiju@dasmaninstitute.org
Abdullah Bennakhi, MD
22242999
abdullah.bennakhi@dasmaninstitute.org
Interventions
  • Breath Awareness using pyramid
Study Locations (1 sites)
Dasman Diabetes Institute, Kuwait City, Kuwait 15462 Kuwait
Eligibility Criteria
Inclusion Criteria: • More than 1 year of T2DM diagnosis * T2DM with HbA1c greater than 5.7 and less than 9.5% * T2DM patients, age greater than 30 years and on oral hypoglycaemic agents or on insulin * No cardiac problems * Score 8.0 and above as per the anxiety and depression questionnaires. * Able to be aware of breath and provide written informed consent. Exclusion Criteria: * T1DM patients * On antidepressant drugs * Bipolar disorders * Any acute coronary events in the past 6 months * Any acute renal diseases including transplant or dialysis. * Artificial pacemaker * Any breath awareness or yoga course within 6 months. * Pregnancy
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
NCT06637306
Recruiting
Conditions Locally Advanced Triple Negative Breast ...
Phase EARLY_PHASE1
Enrollment 15
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Dupilumab
  • Pembrolizumab
  • Paclitaxel
  • Carboplatin

Primary Outcomes

  • Incidence of severe immune-related adverse events (irSAE)
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: 2025-03-05
Completion: 2027-03-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rima Patel
Principal Investigators:
  • Rima Patel, MD (PRINCIPAL_INVESTIGATOR) - Icahn School of Medicine at Mount Sinai
  • Joseph Sparano, MD (PRINCIPAL_INVESTIGATOR) - Icahn School of Medicine at Mount Sinai
Contact Information
Study Contact:
Rima Patel, MD
(212) 604-6010
Rima.Patel2@mssm.edu
Katherine Vandris
Katherine.Vandris@mssm.edu
Interventions
  • Dupilumab
  • Pembrolizumab
  • Paclitaxel
  • Carboplatin
Study Locations (1 sites)
Mount Sinai Health System, New York, New York 10029 United States
Eligibility Criteria
Inclusion Criteria: * Patients with pathologically confirmed diagnosis of triple negative breast cancer, as defined by the most recent ASCO/CAP guidelines. * Patients must have previously untreated, localized TNBC with either tumor size ≥ 2 centimeters (T2-4N0) or lymph node involvement with at least a 1cm tumor (T1c-T4N1-3). * Patients must have previously untreated disease with no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer. * Patients must be eligible to receive chemotherapy agents in the study including paclitaxel and carboplatin. * Patients must be willing and able to provide blood samples at the time points indicated in the study calendar. * Patients must be willing and able to have core needle biopsies of tumor prior to initiation of treatment. Should patients undergo pre-treatment or on-treatment biopsy procedure and inadequate number of biopsies are obtained, they may proceed with initiation/continuation of treatment at the discretion of the investigator and treating physician. * Age ≥ 18 years. * ECOG performance status 0-1. * Adequate organ and marrow function as defined below: * absolute neutrophil count ≥ 1,500/mcL * platelets ≥ 100,000/mcl * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal * creatinine within normal institutional limits * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or any treatment with therapeutic intent for the breast cancer. * Patients may not be receiving any other investigational agents. * Patients who have any distant metastases and considered to have Stage IV disease. * Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded. * Patients with active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, dupilumab or pembrolizumab used in study. Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps). * HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \<350 CD4+ T cells/microliter in the peripheral blood. * Known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug. * Known, untreated helminth infections. Patients with prior history of a helminth infection who were fully treated are permitted. * History of allogeneic hematopoietic cell transplantation or solid organ transplantation. * Receipt of a live vaccine within 30 days of planned start of study medication. * History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy. * History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. History of radiation pneumonitis treated with glucocorticoids. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Drug-Drug Interaction Study Between HUC2-565-A and HUC2-565-B
NCT06618079
Active, positions filled
Conditions Hypertension
Phase PHASE1
Enrollment 46
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • HUC2-565-A, HUC2-565-A and HUC2-565-B
  • HUC2-565-B, HUC2-565-A and HUC2-565-B

Primary Outcomes

  • AUCtau,ss
  • Cmax,ss
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2024-04-20
Completion: 2024-10-01
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: true
Enrollment: 46 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Huons Co., Ltd.
Principal Investigators:
  • Min Gyu Park (PRINCIPAL_INVESTIGATOR) - Chungbuk National University Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • HUC2-565-A, HUC2-565-A and HUC2-565-B
  • HUC2-565-B, HUC2-565-A and HUC2-565-B
Study Locations (1 sites)
Chungbuk national university hospital, Taebuk, 28644 South Korea
Eligibility Criteria
\[ Inclusion Criteria \] 1. Healthy adult volunteer aged 19 years or older at the pre-study(screening) 2. Volunteer with a body mass index(BMI) of 18.0 kg/m2 or more and 30.0 kg/m2 or less, with a 50kg or more weight at the pre-study(screening) 3. A person who has no chronic disease requiring birth or treatment and has no pathological symptoms or findings as a result of medical examination 4. Volunteer who is judged to be suitable as a clinical trial subject as a result of screening test within 28 days of the first administration of the investigational product. 5. A person who, after hearing and fully understanding the details of this clinical trial, voluntarily decides to participate and agrees to comply with the compliance of the test subjects during the clinical trial period \[ Exclusion Criteria \] 1. Current or past medical history of the liver, kidney, nervous system, respiratory system, endocrine system, blood disease, tumor, Urogenital system, cardiovascular system, digestive system, musculoskeletal system, etc., which are clinically significant, in addition to current symptoms or past medical history. 2. Person with a history of gastrointestinal diseases(Crohn's disease, ulcers, acute or chronic pancreatitis) or gastrointestinal surgery(except for simple appendectomy or hernia surgery) that may affect Investigational product absorption 3. Pregnant women(Urine-HCG positive person) or breastfeeding mother 4. Person with a history of hypersensitivity(anaphylaxis or angioedema, etc) or clinically significant hypersensitivity reactions to drugs, formulation additives, and other drugs(aspirin, penicillin antibiotics, macrolide antibiotics, etc), including components Azilsartan and S-amlodipine 5. Those who have clinically significant findings, including the following findings on 12-lead electrocardiogram test(screening) * in case of men QTc \> 450ms, in case of women QTc \> 470ms * PR interval \> 200ms * QRS duration \> 120ms 6. Those who show clinically significant results on the clinical laboratory examination, including the following results(screening) * Those whose AST, ALT, ALP, r-GT and Bilirubin total exceed twice the upper limit of the normal range in the clinical laboratory test for liver function evaluation. * If the level of creatine in the blood is outside the reference range or the eGFR calculated by the CKD-EPI formula is less than 60mL/min/1.73m2 * Those whose blood total cholesterol and LDL-cholesterol levels exceed 1.5 times the upper limit of the normal range * Clinical laboratory examination in which CPK exceeds 2.5 times the upper limit of the normal range 7. A person with a history of substance abuse or who has tested positive for substance abuse in a urine drug test. 8. A person whose blood pressure and pulse rate fall within the following range in the vital signs measured from the upper left after resting for at least 3 minutes during screening * systolic blood pressure ≥ 150 mmHg or ≤ 90mmHg * diastolic blood pressure ≥ 100 mmHg or ≤ 60mmHg * pulse ≤ 40 bpm ≥ 100 bpm 9. Food eaters who eat abnormal diets that may affect absorption, distribution, metabolism and excretion of investigational products or may affect drug metabolism 10. A person who has administered a prescription drug or herbal medicine that may affect the characteristics of the clinical trial drug within two weeks of the first administration of the clinical trial drug, or has administered a over the counter drug(OTC drug) or health functional food within two weeks. (However, if the drug does not affect the pharmacokinetic properties of the investigational products, it may participate in the clinical trial at the discretion of the investigator.) 11. A person who has taken drug metabolism enzyme induction and inhibitory drugs such as barbiturates drugs within one month prior to the first administration date of the investigational products. 12. A person who participated in other clinical trials and received the administration within 6 months prior to the first administration of the investigational products for clinical trials 13. A person who has donated whole blood within two months prior to the first administration of the investigational products, or has donated ingredients within one month, received a blood transfusion within one month, or is prohibited from donating blood from the time of written consent until the time of PSV 14. A person who has been drinking continuously(over 21 units/week, 1unit=10g=12.5mL of pure alcohol) within 6 months prior to the first administration date of the investigational products or who is unable to abstain from drinking from the time of written consent until the time of PSV 15. Smokers whose average daily amount of smoking exceeds 10 cigarettes within three months prior to the first administration date of clinical trials and those who are unable to quit smoking from 24 hours before the first administration to the last time of blood collection. 16. A person who has consumed or cannot prohibit the consumption of grapefruit-containing food from 48 hours before the first administration of the clinical trial drug to the time of PSV 17. A person who has consumed or cannot prohibit the consumption of caffeine-containing food(coffee, green tea, black tea, soda, coffee milk, nutritional tonic drink, etc) during the period from 24 hours before the first administration of the investigational products to the time of last blood collection 18. A person who has exercised intense exercise exceeding the standard of daily life or is forced to exercise intensely during the period from 48 hours before the first administration of clinical trials drugs to the time of PSV 19. A person who is not using a recognized contraceptive method(For example: Contraceptive administration and transplantation or intrauterine devices, fertility procedures (such as tubectomy, sphincter ligation), blocking methods (used in combination with condoms, contraceptive vaginal membranes, vaginal sponges or cervical caps)) even if he/she, his/her spouse, or his/her partner is planning to become pregnant or not until two weeks after the date of last clinical trial drug administration from the time of written consent 20. A person who is not suitable for participation in clinical trials due to other reasons other than the above inclusion/exclusion criteria at the discretion of the examiner