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Showing 20 of 28810 trials
Autologous Nerve Graft Breast Reconstruction Neurotization
NCT06629012
Active, positions filled
Conditions Breast Reconstruction, Breast Cancer Pat...
Phase Not Applicable
Enrollment 250
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Breast reconstruction with neurotization
  • Breast reconstruction without neurotization

Primary Outcomes

  • Pre-operative Quality of life
  • Post-operative-two-year Quality of life
  • Post-operative-one-year Quality of life
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2021-11-29
Completion: 2026-12-31
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: false
Enrollment: 250 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Chang Gung Memorial Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Breast reconstruction with neurotization
  • Breast reconstruction without neurotization
Study Locations (1 sites)
Chang Gung Memorial Hospital, Taoyuan, 33305 Taiwan
Eligibility Criteria
Inclusion Criteria: * Patient who receive breast reconstruction * Patient who is willing to fill in the questionnaire Exclusion Criteria: * Patient who receive breast reconstruction for the reason other than breast cancer
Evaluating the Role of the Microbiome in Antidepressant Treatment in Adolescents.
NCT06633497
Not yet recruiting
Conditions Depression in Adolescence
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Gut microbiome composition
  • Efficacy of fluoxetine to treat depression symptoms in adolescents
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: 2026-10
Eligibility
Age: 13 Years
Sex: ALL
Volunteers: true
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, San Diego
Collaborators: Rady Children's Hospital, San Diego
Principal Investigators:
  • Rob Knight, PhD (PRINCIPAL_INVESTIGATOR) - University of California, San Diego
Contact Information
Study Contact:
Aaron Besterman, MD
8589668145
abesterman@rchsd.org
Abbey Albertazzi, MA
8589661700
aalbertazzi@rchsd.org
Interventions
N/A
Study Locations (1 sites)
Rady Children's Hospital San Diego, San Diego, California 92123 United States
Eligibility Criteria
Inclusion Criteria: * Subjects from all ethnic backgrounds will be eligible to participate. * Having clinically significant depressive symptoms based on a score \>40 on the Children's Depression Rating Scale-Revised * Prescribed more than 5mg of Fluoxetine (Prozac) * Has an identifiable legal guardian. Exclusion Criteria: * Has been taking a standing psychotropic medication in the past 6 months * Has been taking antibiotics or metformin during the past 6 months (known strong effects on gut microbiome) * Admitted to RCHSD CAPS post-overdose (potential strong effects on gut microbiome) * Currently using nicotine-containing substances (known strong effects on gut microbiome)
Bronchoprovocation Study to Demonstrate the Pharmacodynamic Bioequivalence of Albuterol Sulfate HFA Inhalation Aerosol (E.Q. 90 mcg of Albuterol Base/Inh) of Macleods Pharmaceuticals Ltd
NCT06618105
Not yet recruiting
Conditions Mild Asthma
Phase PHASE3
Enrollment 144
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
  • Test Placebo
  • Reference Placebo
  • Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations

Primary Outcomes

  • Post-dose PC20 (MG/ML)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2024-10-15
Completion: 2025-05-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 144 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Macleods Pharmaceuticals Ltd
Contact Information
Study Contact:
Dr. Ashish Mungantiwar Avinash Ashish
01-22-48890100
drashish@macleodspharma.com
Priyanka Shrivastava
01-22-48890100
priyankas@macleodspharma.com
Interventions
  • Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
  • Test Placebo
  • Reference Placebo
  • Albuterol Sulfate 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations
Study Locations (1 sites)
Multiple Locations, Multiple Locations, India
Eligibility Criteria
Inclusion Criteria: 1. Male and non-pregnant, non-lactating female subjects aged between 18 to 65 years (both ages inclusive) 2. Stable mild asthmatics based on National Asthma Education and Prevention Programme (NAEPP) guidelines 3. Subjects who were diagnosed by physician with mild asthma at least 6 months prior to screening visit date 4. Pre-bronchodilator forced expiratory volume in one second (FEV1) ≥ 80% of predicted 5. Airway responsiveness to methacholine demonstrated by pre-albuterol-dose (baseline) PC20 less than or equal to 1.56 mg/mL using AeroEclipse II BAN and 1-minute tidal breathing method at Screening MCT A 6. The ≥20% reduction in FEV1 at Screening MCT A relative to post-saline FEV1 should be obtained above the lowest methacholine concentration 7. At Screening MCT-B, subjects should have at least four-fold increase in PC20 over Screening MCT-A 8. At Screening MCT -B, the ≥ 20% reduction in FEV1 relative to post saline FEV1 must be obtained up to methacholine concentration 24.96 mg/mL 9. Non-smokers for at least six months prior to screening visit and a maximum smoking history of five-pack years (the equivalent of one pack per day for five years) 10. Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must have negative result for urine pregnancy test 11. Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit must agree to the use of a reliable and medically acceptable method of contraception throughout the duration of the study 12. Women of child-bearing potential or women who are less than or equal to 1 year postmenopausal prior to screening visit using hormonal contraception must be on the same hormonal contraceptive for at least thirty days before the screening period and must be continued same throughout the study. 13. Able to provide signed written informed consent and willing to comply with all aspects of the clinical study protocol Exclusion Criteria: * 1.Subjects with FEV1 \< 1.5L during methacholine challenge test 2.Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study. 3.History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season 4.History of cystic fibrosis, bronchiectasis or other respiratory diseases other than asthma (e.g., COPD, interstitial lung disease) 5.Treatment in an emergency room or hospitalization for acute asthmatic symptoms within past three months prior to screening visit 6.Need for daily oral corticosteroids within past three months prior to screening visit 7.History of life-threatening asthma leading to hospitalization within the past 1 year prior to screening visit 8.Known intolerance or hypersensitivity to any component of the albuterol metered dose inhaler (MDI) 9.Uncontrolled hypertension (systolic BP \>200 mmHg, or diastolic BP \>100 mmHg) 10.History or evidence of myocardial infarction or stroke 11.History of known aortic aneurysm 12.Current use of cholinesterase inhibitor medication (for myasthenia gravis) 13.Clinically significant ECG recording at screening such as flattening of T wave, prolongation of QTc interval (\>450 milliseconds), and ST segment depression, which in the opinion of the Investigator, would compromise subject's safety or interfere with the study results 14.History of recent eye surgery or intracranial pressure elevation risk 15.Uncontrolled diabetes (HbA1c ≥9%) at screening 16.Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled artery disease, cardiac dysrhythmia, or ECG with evidence of ischemic heart disease. In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other disease or that, in the opinion of the Investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbates in the study 17.Presence of any abnormal clinically significant laboratory investigation at screening visit 18.History of paradoxical bronchospasm 19.Has participated in another investigational study or device research study within 30 days before screening visit date 20.Women are pregnant, breast-feeding, or planning pregnancy during study Period continuation criteria If subject does not meet any one Period continuation criteria at any visit of Period; retest visit will be conducted and study treatment dosing should not be administered. Period continuation criteria will be checked for maximum three visits. If subject does not meet all Period continuation criteria at any one visit and within three consecutive visits: At Period 1: subject should not be randomized and will be considered a 'randomization failure' At Period 2 to Period 4: subject should not administer study treatment dosing and must be discontinued from the study 1. Baseline FEV1 should not be less than 70% of predicted normal value and should be within 88 -112% of qualifying day FEV1 value. Baseline FEV1: highest pre-saline FEV1 obtained prior to saline control test at Period MCT and which has met the acceptability criteria and have repeatable quality grade A, B, C mentioned in ATS 2019 standards Qualifying day FEV1 value: highest pre-saline FEV1 obtained prior to saline control test on qualifying day and which has met the acceptability criteria and have repeatable quality grade A, B, C mentioned in ATS 2019 standards and which has not met the retest criteria for Scr-MCT A on qualifying day -Qualifying day: Scr-MCT A PC20 is obtained and the results of the Scr-MCT A on this day confirms that subject has met inclusion criteria 4, 5, and 6 2. Baseline FEV1 should be ≥ 1.5 L 3. Baseline FEV1 should meet FEV1 acceptability criteria as mentioned in ATS 2019 standards 4. Baseline FEV1 should meet repeatability quality grade A, B, or C as mentioned in ATS 2019 standards 5. Fall in FEV1 due to the saline control (i.e. post-saline FEV1) should not be more than 10% from the baseline FEV1 Post-saline FEV1: is the highest post-saline FEV1 value from at least one acceptable FEV1 maneuver obtained after nebulization with normal saline is completed (i.e. after saline control test is completed) 6. At least one FEV1 obtained after saline control test (post-saline FEV1) should meet acceptability criteria mentioned in ATS 2019 standards
To Evaluate the Efficacy and Safety of Ipsilateral Supraclavicular Lymph Node Dissection for Breast Cancer Patients
NCT06605521
Recruiting
Conditions Locally Advanced Breast Cancer
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Subclavian lymph node dissection+radiotherapy
  • Simple clavicular region radiotherapy

Primary Outcomes

  • Intraclavicular recurrence free survival in group A patients
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: 2023-04-04
Completion: 2027-04-04
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: Not specified
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Henan Cancer Hospital
Principal Investigators:
  • xiuchun Chen (STUDY_CHAIR) - Henan Cancer Hospital
Contact Information
Study Contact:
xiuchun Chen
0371-65587405
zlyychenxiuchun3921@zzu.edu.cn
Minhao Lv
0371-65587405
zlyylvminhao2789@zzu.edu.cn
Interventions
  • Subclavian lymph node dissection+radiotherapy
  • Simple clavicular region radiotherapy
Study Locations (1 sites)
Henan Cancer Hospital, Zhengzhou, Henan 450000 China
Eligibility Criteria
Inclusion Criteria: 1. Female patients aged ≤ 80 years old. 2. ECOG score 0-1 points; 3. Breast cancer meets the following criteria: histologically diagnosed as invasive breast cancer, known ER, PR, HER2, KI67 status, pathologically diagnosed as ipsilateral supraclavicular lymph node metastasis (both cytology and histopathology); 4. Estimated patient survival time exceeding three months; 5. No obvious contraindications for surgery or radiotherapy; 6. The researcher judged that they were able to comply with the research protocol. 7. Those who participate in other clinical trials (including intervention or non intervention studies) at the same time and are judged by the researchers not to affect the research protocol can be enrolled normally. 8. Voluntarily participate in this study and sign an informed consent form. Exclusion Criteria: 1. Stage IV (metastatic) breast cancer; 2. Bilateral breast cancer; 3. Received radiotherapy and surgical treatment (excluding local puncture) for ipsilateral supraclavicular metastatic lymph nodes before enrollment; 4. History of breast cancer or other malignant tumors, but excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma; 5. Individuals with severe primary diseases such as cardiovascular, cerebrovascular, liver, and kidney that are difficult to tolerate surgery or radiation therapy; 6. Having a history of immunodeficiency, including HIV testing positive, or having other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation; 7. Suffering from severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other circumstances in which the researcher deems the patient unsuitable to participate in this study.
Ovarian Hormone Withdrawal, Anhedonia, and Reward Sensitivity in Women With Premenstrual Exacerbations of Depression
NCT06610305
Recruiting
Conditions Major Depressive Disorder
Phase PHASE4
Enrollment 75
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

  • Transdermal estradiol
  • Progesterone
  • Transdermal placebo patch
  • placebo capsule

Primary Outcomes

  • Dimensional Anhedonia Rating Scale (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase)
  • Reward Positivity (Luteal Phase Stabilized vs Luteal Phase Unstabilized Hormones vs Follicular Phase)
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2024-09-02
Completion: 2028-06-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 75 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of North Carolina, Chapel Hill
Collaborators: National Institute of Mental Health (NIMH)
Principal Investigators:
  • Chris Sikes-Keilp, MD (PRINCIPAL_INVESTIGATOR) - University of North Carolina, Chapel Hill
Contact Information
Study Contact:
Study Coordinator
(919) 445-6814
pearstudy@unc.edu
Interventions
  • Transdermal estradiol
  • Progesterone
  • Transdermal placebo patch
  • placebo capsule
Study Locations (1 sites)
University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 27707 United States
Eligibility Criteria
Inclusion Criteria: * Biologically female and between the ages of 18-45 years (45 set as upper limit to avoid endocrine changes associated with perimenopause). * Self-reported regular menstrual cycles between 25 and 35 days. * A previous diagnosis of major depressive disorder, with self-reported premenstrual worsening of symptoms. * If the woman has children, she must be at least 1 year postpartum. * English-speaking Exclusion Criteria: * Pregnant, breastfeeding, or trying to become pregnant. Pregnancy status will be confirmed using a urine pregnancy test at the enrollment visit and again at the first visit of the second condition. Women will be instructed to use a barrier method of birth control during the study. * Taking any form of exogenous hormones or IUD, and must have ended previous use of hormonal preparations at least one month prior to the study. Women who were previously taking oral contraceptives or other hormonal medications must have one normal menstrual cycle (menstrual period) prior to enrollment in the study. * BMI less than 18 or greater than 29. * A personal history of any chronic medical condition that could confound the experimental protocol, including but not limited to metabolic or autoimmune disease, epilepsy, endometriosis, cancer, diabetes, cardiovascular, gastrointestinal, hepatic, renal, pulmonary disease, migraine with aura, hypertension, Parkinson's disease, chronic pain, and thromboembolic events. * A family history indicative of increased risk of breast cancer or thromboembolic disorders. * Current cigarette smoking. * A history of mania, psychosis, or substance use disorder. * Any recent history (last 12 months) of active suicidal ideation, or suicide attempt within the last 5 years.
Anxiety is One of the Most Frequent Disorders During the Perinatal Stage Which is Associated with Adverse Health Effects for Women and Their Babies. This Study Will Be to Evaluate the Effectiveness of a Telematic Cognitive-behavioral Preventive Intervention to Manage Anxiety During Pregnancy.
NCT06609291
Not yet recruiting
Conditions Anxiety Disorder (Panic Disorder or GAD)...
Phase NA
Enrollment 130
Locations 1 sites
Compensation incentive available
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology

Primary Outcomes

  • Reduced anxiety
  • Reduced anxiety
  • Reduced anxiety
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: 2024-12
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Santiago de Compostela
Contact Information
Study Contact:
Mª del Carmen V Míguez
+34 881813740
mcarmen.miguez@usc.es
Alba N Val
alba.val@rai.usc.es
Interventions
  • Telematic Prenatal Psychological Intervention for Preventing Anxious Symptomatology
Study Locations (1 sites)
Facultade de Psicoloxía, Universidade de Santiago de Compostela, Santiago de Compostela, A Coruña 15782 Spain
Eligibility Criteria
Inclusion Criteria: * Women over 18 years of age living in the Region of Galicia (Spain) * Pregnant with a gestational age ≤ 16 * Understand and speak Spanish fluently * Informed consent to participate in the study * Accessibility to the internet and a digital device ( computer, tablet or smartphone) Exclusion Criteria: * High-risk pregnancy or twins * Being pharmacological treatment for anxiety and/or depression * Not giving their consent
CGM for Management of Type 2 Diabetes in Pregnancy
NCT06628453
Recruiting
Conditions Type 2 Diabetes Mellitus (T2DM), Pregnan...
Phase NA
Enrollment 564
Locations 7 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • CGM

Primary Outcomes

  • Time in Range (TIR) at 34 weeks gestation
  • Composite Neonatal Morbidity
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-08
Completion: 2029-07
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 564 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Alabama at Birmingham
Collaborators: National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigators:
  • Ashley Battarbee, MD, MSCR (PRINCIPAL_INVESTIGATOR) - University of Alabama at Birmingham
Contact Information
Study Contact:
Ashley Battarbee, MD, MSCR
205-975-2361
anbattarbee@uabmc.edu
Interventions
  • CGM
Study Locations (7 sites)
University of Alabama at Birmingham, Birmingham, Alabama 35233 United States
University of California at San Diego, San Diego, California 92121 United States
University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599 United States
Oregon Health and Science University, Portland, Oregon 97213 United States
University of Pennsylvania, Philadelphia, Pennsylvania 19104 United States
Prisma Health Greenville Memorial Hospital, Greenville, South Carolina 29605 United States
University of Texas Health Science Center at Houston, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Type 2 diabetes mellitus treated with daily insulin injections or oral hypoglycemic agents diagnosed before pregnancy or at less than 14 weeks gestation with hemoglobin A1c 6.5% or greater * Pregnant with viable fetus at 6 to less than 23 weeks gestation * Maternal age 18-50 years old Exclusion Criteria: * Unable or unwilling to wear CGM due to intolerance to medical-grade adhesives or skin conditions * Multiple gestation * Major fetal anomaly or two or more minor fetal anomalies * Planned delivery outside study consortium * Participating in another conflicting interventional study * Participation in this trial in a previous pregnancy * Patient unable to consent * Physician refusal for other reasons
Behavioral Study to Predict the Efficacy of a Self-Help Tool
NCT06631183
Active, positions filled
Conditions Self-reported Symptoms of Depression
Phase NA
Enrollment 1500
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Self-help information based on principles of behavioral activation
  • Self-help information based on principles of cognitive restructuring

Primary Outcomes

  • Predictive accuracy of sum of self-reported depression symptoms (assessed with Patient Health Questionnaire) after engagement with self-help tool using behavioral tasks
  • Predictive accuracy of sum of self-reported anhedonia symptoms (assessed with Snaith-Hamilton Pleasure scale) after engagement with self-help tool using behavioral tasks
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: 2024-01-23
Completion: 2025-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 1500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Trustees of Princeton University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Self-help information based on principles of behavioral activation
  • Self-help information based on principles of cognitive restructuring
Study Locations (1 sites)
Princeton Neuroscience Institute, but recruitment and study are conducted completely online and can occur anywhere in the US., Princeton, New Jersey 08540 United States
Eligibility Criteria
Inclusion Criteria: * Fluent in English * The primary mental health concern participants want to work on must be that they would like to improve their mood, to reduce negative thoughts, to enjoy more activities again and/or to reduce symptoms of depression * Having a picture ID and be willing to meet with us on a video zoom call for identity verification if invited to do so Exclusion Criteria: * Lack of attention when completing parts of the study, lack of honesty or not completing parts of the study in a timely way * Identity check failure
Measuring Psychomotor Response to L-DOPA Challenge As a Biomarker for Outcomes in Late-Life Depression: a Pilot Feasibility Trial
NCT06626152
Recruiting
Conditions Major Depressive Disorder
Phase PHASE2
Enrollment 50
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Apo-levocarb

Primary Outcomes

  • L-DOPA challenge completion rate
  • Depressive symptoms
  • Gait speed
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-08-15
Completion: 2026-05-30
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of British Columbia
Collaborators: Providence Health & Services
Contact Information
Study Contact:
Nicholas J Ainsworth, MD
6048069090
nainsworth@providencehealth.bc.ca
Interventions
  • Apo-levocarb
Study Locations (1 sites)
St. Paul's Hospital, Vancouver, British Columbia V6Z 1Y6 Canada
Eligibility Criteria
Inclusion Criteria: * Outpatient persons capable of providing informed consent * Minimum age of 60 years old * MINI International Neuropsychiatric Interview diagnosis of major depressive disorder, based on DSM-5 criteria * MADRS score of ≥15 (moderate/severe depression) * On stable doses of psychotropic medication, including antidepressant medication, for at least 4 weeks * Able to adhere to the intervention schedule Exclusion Criteria: * Current diagnosis of major neurocognitive disorder * Current active psychosis * Unstable medical illness, including clinical or laboratory evidence of uncompensated cardiovascular, endocrine, hematologic, hepatic, pulmonary (including bronchial asthma), or renal disease * Diagnosis of narrow angle glaucoma * Suspicious, undiagnosed skin lesions or a history of melanoma * History of myocardial infarction * Atrial, nodal, or ventricular arrhythmias * History of seizures or seizure disorder * History of peptic ulcer disease * History of allergy or other hypersensitivity to levodopa, carbidopa, or to any other ingredient in the formulation of Levocarb * Active suicidal ideation * Psychotropic medication initiation or dose change \<4 weeks prior to enrolment * Regular use of dopamine antagonist or benzodiazepines ≥2mg lorazepam equivalent per day * Unable to complete neuropsychological testing in the English language * Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests) * History of falls, with ≥1 fall per week during the past 4 weeks
Swebcg 91:A RT. Breast Conserving Surgery With or Without Radiotherapy for Breast Cancer Patients
NCT06637202
Active, positions filled
Conditions Breast Cancer Early Stage Breast Cancer ...
Phase NA
Enrollment 1187
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • postoperative radiotherapy

Primary Outcomes

  • Loco-regional recurrence
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: 1991-01-01
Completion: 2025-12-31
Eligibility
Age: No restriction
Sex: FEMALE
Volunteers: false
Enrollment: 1187 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Region Skane
Principal Investigators:
  • Karlsson Per, MD, prof (PRINCIPAL_INVESTIGATOR) - Göteborg University, Västra Götaland Region
  • Erik Holmberg, PhD (PRINCIPAL_INVESTIGATOR) - Göteborg University
  • Emma Nimeus Malmström, MD, ass prof (PRINCIPAL_INVESTIGATOR) - Lund University, Region Skane
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • postoperative radiotherapy
Study Locations (1 sites)
Region Skane, Lund, Sweden
Eligibility Criteria
Inclusion Criteria: * female * not over the age of 75 years * operated because of stage 1-2 invasive adenocarcinoma of the breast * radical excision of the tumour Exclusion Criteria: * earlier cancer except cancer in situ of the cervix or skin * distant metastases
Effect of Yoga Program on Quality of Life in Women With Breast Cancer Receiving Endocrine Therapy
NCT06605261
Active, positions filled
Conditions Breast Cancer, Yoga, Quality of Life, Nu...
Phase NA
Enrollment 64
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Yoga (intervention) group

Primary Outcomes

  • Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
  • Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
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: 2024-10-29
Completion: 2026-08-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 64 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Gözde Gür
Principal Investigators:
  • Gözde Gür, MSc (PRINCIPAL_INVESTIGATOR) - İstanbul University Cerrahpaşa
  • Aysun Ardıç, Assoc Prof (PRINCIPAL_INVESTIGATOR) - İstanbul University Cerrahpaşa
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Yoga (intervention) group
Study Locations (1 sites)
Istanbul University, Istanbul, Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Being over 18 years of age, * Having the ability to read, write, and speak Turkish, * Having a diagnosis of breast cancer, * Having completed surgical treatment, * Having completed chemotherapy or radiation therapy, * Recently starting endocrine therapy, * Having a Body Mass Index (BMI) below 35. Exclusion Criteria: * Being over 70 years of age, * Having a diagnosis of metastatic disease, * Previous participation in yoga or similar exercises, * Having a physical disability that prevents practicing yoga, * Having a condition that causes shortness of breath (e.g., COPD), * Having another chronic heart or lung disease that prevents yoga practice, * Having a serious psychiatric illness or cognitive impairment.
Continuous Glucose Monitoring in Dialysis Patients With Diabetes
NCT06641765
Active, positions filled
Conditions Diabetes Mellitus, Type 2, Diabetes Mell...
Phase NA
Enrollment 96
Locations 5 sites
Compensation compensation available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Continous Glucose Monitoring

Primary Outcomes

  • Change in time-in-target-range (3.9-10 mmol/L) from baseline through to study end between the three groups.
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: 2024-11-01
Completion: 2026-10-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 96 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Bo Feldt-Rasmussen
Collaborators: Steno Diabetes Center Copenhagen
Principal Investigators:
  • Tobias Bomholt, MD, PhD (PRINCIPAL_INVESTIGATOR) - Department of Nephrology, Rigshospitalet, University of Copenhagen
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Continous Glucose Monitoring
Study Locations (5 sites)
Rigshospitalet, Copenhagen, 2100 Denmark
Herlev Hospital, Herlev, 2730 Denmark
North Zealand Hospital, Hillerød, Hillerød, 3400 Denmark
Holbæk Sygehus, Holbæk, 4300 Denmark
Zealand University Hospital, Roskilde, 4000 Denmark
Eligibility Criteria
Inclusion Criteria: * Written informed consent obtained before any trial-related procedures are performed * Diabetes, one of the following groups: Type 1 diabetes OR Type 2 diabetes receiving glucose-lowering therapy OR Type 2 diabetes managed with lifestyle changes with an HbA1c ≥ 50 mmol/mol * Maintenance haemodialysis or peritoneal dialysis (minimum of two weeks) * Subject must be willing and able to comply with trial protocol and be fluent in Danish or English Exclusion Criteria: * Major allergy to tape/adhesives * Women who are pregnant or planning pregnancy * Ongoing use of CGM * Ongoing use of insulin pump
TIPS for Platinum-Related Porto-Sinusoidal Vascular Disease With Variceal Bleeding
NCT06635122
Active, positions filled
Conditions Porto-Sinusoidal Vascular Disease, Cirrh...
Phase Not Applicable
Enrollment 150
Locations 1 sites
Compensation compensation available
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Transjugular intrahepatic portosystemic shunt
  • Endoscopic treatment

Primary Outcomes

  • Cumulative incidence of clinically significant variceal rebleeding
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: 2024-07-01
Completion: 2025-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Air Force Military Medical University, China
Collaborators: Shanghai Zhongshan Hospital
Principal Investigators:
  • Jun Tie, M.D.,Ph.D. (PRINCIPAL_INVESTIGATOR) - Air Force Military Medical University, China
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Transjugular intrahepatic portosystemic shunt
  • Endoscopic treatment
Study Locations (1 sites)
Air Force Military Medical University, Xi'an, Shaanxi 710032 China
Eligibility Criteria
Inclusion Criteria: * Patients aged 18 to 75 years and confirmed diagnosis of Platinum-Related Porto-Sinusoidal Vascular Disease or Cirrhosis Due to Hepatitis B * Acute esophagogastric variceal bleeding or history of gastroesophageal variceal bleeding episodes * The patients was received endoscopic variceal ligation/histoacryl injection therapy or TIPS treatment * At least one postoperative follow-up data Exclusion Criteria: * Primary tumor recurrence and metastasis * Hepatocellular carcinoma or other malignant tumors * Common contraindications of TIPS * HIV, AIDS, Serious acute and chronic disease * Pregnant or breast-feeding woman * Without postoperative follow-up data
Stress Management with Real-time Bio-signal Biofeedback
NCT06616116
Recruiting
Conditions Bipolar Disorder (BD), Major Depressive ...
Phase NA
Enrollment 100
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Biosignal feedback
  • Sham Comparator

Primary Outcomes

  • Changes from baseline Korean Perceived Stress Scale (K-PSS) score at 8wks, and 16 wks
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-06-13
Completion: 2025-12-31
Eligibility
Age: 15 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Seoul National University Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Biosignal feedback
  • Sham Comparator
Study Locations (1 sites)
Seoul National University Hospital, Seoul, Jongno-gu 03080 South Korea
Eligibility Criteria
Inclusion Criteria: * Individuals aged 15 to 59 years. * Patients diagnosed with mood disorders (e.g., bipolar disorder, major depressive disorder) through screening and clinician interviews, according to DSM-5. * Patients with accompanying anxiety symptoms. * Patients with stress symptoms (Perceived Stress Scale score ≥ 10) * Individuals able to independently complete questionnaires and communicate in Korean. * Individuals who voluntarily agree to participate in weekly treatment sessions. Exclusion Criteria: * Patients diagnosed with major psychiatric disorders other than mood disorders (e.g., schizophrenia, substance use disorders including alcohol, obsessive-compulsive disorder). * Patients diagnosed with bipolar disorder who are currently experiencing acute psychotic symptoms or are in a manic state. * Individuals with acute suicidal ideation. * Individuals with co-occurring personality disorders (e.g., borderline personality disorder, antisocial personality disorder, narcissistic personality disorder). * Individuals who have participated in mindfulness-based cognitive therapy within the last 3 months. * Individuals currently receiving other non-pharmacological treatments (e.g., cognitive-behavioral therapy, psychoanalysis). * Individuals with neurological damage or conditions that may cause brain injury (e.g., seizure disorder, cerebrovascular or neoplastic lesion, neurodegenerative disorder, significant head trauma with loss of consciousness lasting more than 5 minutes). * Individuals diagnosed with cardiovascular diseases (e.g., hypertension, coronary artery disease, arrhythmia). * Individuals with hearing impairment or tinnitus. * Individuals with impaired ability to understand the study's purpose or make decisions about participation (e.g., IQ \&lt; 70, dementia). * Individuals with medical, psychological, social, or legal issues that would interfere with continued participation in the program.
Comparison of Differencens in VO2-max, Perfusion of the Heart and Brain and Cognitive Performance Between Patients with Type 2 Diabetes and Healthy Age Matched Controls.
NCT06628297
Not yet recruiting
Conditions Microvascular Disease, Microvascular Com...
Phase Not Applicable
Enrollment 72
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 to the brain
  • [15O]H2O PET assessment of the blood perfusion of the heart
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: 72 (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 for the patients with type 2 diabetes: Diabetes type II diagnose with one of the following: * Duration over 5 years * Moderate microalbuminuria * Non-proliferative diabetic retinopathy * Speaks and understands Danish (required for reliable cognitive testing) * Able to provide informed and written consent Exclusion Criteria or the patients with type 2 diabetes: Moderate to high intensity training \&gt;1 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. Inclusion Criteria for the healthy age-matched controls: * 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 for the healthy age-matched controls: * 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.
MBSR and NLP, Postpartum Breastfeeding and Depression
NCT06628986
Recruiting
Conditions Breastfeeding, Exclusive, Fatigue, Sleep...
Phase NA
Enrollment 90
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • MBSR
  • NLP
  • control

Primary Outcomes

  • Visual Analogue Scale for Fatigue (VAS-F)
  • Visual Analogue Scale for Fatigue (VAS-F)
  • Visual Analogue Scale for Fatigue (VAS-F)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-10-08
Completion: 2025-10-30
Eligibility
Age: 19 Years
Sex: FEMALE
Volunteers: true
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Aysegul Kilicli
Principal Investigators:
  • AYŞEGÜL KILIÇLI, Dr. (STUDY_DIRECTOR) - Muş Alparslan University
Contact Information
Study Contact:
AYŞEGÜL KILIÇLI, Dr.
04143181717
aysegul_ay_9@hotmail.com
AYŞEGÜL KILIÇLI, PhD.
04143180000
aysegul_ay_9@hotmail.com
Interventions
  • MBSR
  • NLP
  • control
Study Locations (1 sites)
Şanlıurfa training and research hospital, Sanliurfa, Eyalet/Yerleşke 63000 Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * 19-35 years old * caesarean section * primiparous * breastfeeding women Exclusion Criteria: * women who refused to participate in the research.
Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer
NCT06607757
Recruiting
Conditions CCCA Assessed by Ki67 Drop Below <2.7% F...
Phase PHASE2
Enrollment 120
Locations 25 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Capivasertib
  • Fulvestrant injection

Primary Outcomes

  • To assess complete cell cycle arrest (CCCA).
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-12-04
Completion: 2026-08-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: GBG Forschungs GmbH
Collaborators: AstraZeneca
Principal Investigators:
  • Sibylle Loibl, Prof. Dr. med. (PRINCIPAL_INVESTIGATOR) - ESMO, ASCO, AGO Kommission Mamma (member); Goethe University Frankfurt; GBG Forschungs GmbH
Contact Information
Study Contact:
Christina Müller-Weisbrod
+49610274800
LOBSTER@gbg.de
Interventions
  • Capivasertib
  • Fulvestrant injection
Study Locations (25 sites)
Haematologie-Onkologie im Zentrum MVZ GmbH, Augsburg, 86150 Germany
Charité, Berlin, 10117 Germany
Onkologische Schwerpunktpraxis - Studiengesellschaft Onkologie Bielefeld GbR, Bielefeld, 33604 Germany
Hämato-Onkologie im Medicum - Onkologie und Hämatologie, Bremen, 28209 Germany
Kliniken der Stadt Köln GmbH - Brustzentrum Köln-Holweide, Cologne, 51067 Germany
Carl-Thiem-Klinikum gGmbH - Frauenklinik, Cottbus, 03048 Germany
Kath. St. Paulus GmbH - Klinische Forschung, Dortmund, 44137 Germany
Universitätsklinikum Essen - Klinik für Frauenheilkunde und Geburtshilfe, Essen, 45147 Germany
Klinikum Frankfurt Höchst GmbH - Klinik für Gynäkologie und Geburtshilfe, Frankfurt am Main, 65929 Germany
Praxis für Interdisziplinäre Onkologie & Hämatologie, Freiburg im Breisgau, 79110 Germany
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and followup, and documented according to the local regulatory requirements. 2. Postmenopausal women with age at diagnosis ≥ 18 years. Postmenopausal status is defined as: * Age ≥60 years * Age \<60 years and amenorrhea for at least 12 continuous months with no identified cause other than menopause * Bilateral oophorectomy Negative pregnancy test (urine or serum) within 14 days prior to randomization for all postmenopausal women 50 years of age or younger without bilateral oophorectomy 3. Unilateral or bilateral primary untreated lobular invasive carcinoma of the breast. In case of bilateral breast cancer, both sides must be lobular; the lead tumor has to be defined by the investigator based on the inclusion criteria for the respective subtype and the risk status. Lobular histology has to be centrally confirmed. 4. Willingness and ability to provide archived formalin fixed paraffin embedded (FFPE) tissue block from core biopsy before the start of neoadjuvant therapy. 5. Centrally confirmed HER2-negative (IHC score 0-1+ or ISH negative according to ASCO/CAP guideline) and HR-positive (≥10% positive stained cells) disease, assessed on the core of diagnostic biopsy. Ki67% \>10% is required. In case of bilateral breast cancer, HER2-negative, HR-positive and lobular histology status has to be confirmed for both sides. 6. Patients with invasive lobular breast cancer at high risk for recurrence defined as cT1c and clinical nodal involvement (cN+) or ≥ cT2 disease (irrespective of nodal involvement). 7. No clinical evidence of distant metastases. 8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. 9. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer. 10. The patient must be accessible for scheduled visits, treatment, and followup. 11. Normal cardiac function must be confirmed according to local guidelines. 12. Laboratory requirements: Hematology * Absolute neutrophil count (ANC) ≥1.5 x 109 / L * Platelets ≥100 x 109 / L * Hemoglobin ≥10 g/dL (≥6.2 mmol/L) Hepatic function * Total bilirubin \<1.25x ULN * AST and ALT \<=1.5x ULN * Alkaline phosphatase \<=2.5x ULN Glucose Metabolism * HbA1c \<8.0% (63.9 mmol/mol) Renal Function * Creatinine \<1.25x ULN or creatinine clearance ≥50 ml/min (if creatinine is above ULN according to Cockroft-Gault) 13. Complete staging work-up prior to the initiation of neoadjuvant therapy as per standard recommendations. Exclusion Criteria: 1. Female patients of childbearing potential. 2. Excisional biopsy or lumpectomy performed prior to study entry. 3. Surgical axillary staging procedure including sentinel lymph node biopsy prior to randomization. Exceptions: FNA or core biopsy of an axillary lymph node. 4. Any previous treatment including endocrine therapy, chemotherapy, radiotherapy or targeted therapy (including AKT inhibitor or PIK3 inhibitor) for the currently diagnosed breast cancer. 5. Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer. 6. Known hypersensitivity reaction to one of the compounds or substances used in this protocol. 7. Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort). 8. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib. 9. Any contraindication for fulvestrant. 10. Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible. 11. Patients with a history of any malignancy are ineligible with the following exceptions: * Patient has been disease-free for at least 5 years and is at low risk for recurrence of that malignancy except for breast cancer. * CIS of the cervix, basal cell and squamous cell carcinomas of the skin. 12. History of type I or type II diabetes mellitus requiring insulin. 13. Severe and relevant co-morbidity that would interact with the application of study drugs or the participation in the study, including cerebrovascular incident including transient ischemic attack, or symptomatic pulmonary embolism, active infection requiring intravenous anti-microbial treatment (antibiotics, anti-fungal, and anti-viral drugs) within 1 week of enrolment. Patients with confirmed Gilbert's syndrome may be included in the study. 14. Known medically history of HIV infection, tuberculosis, or hepatitis B. 15. History of and/or active cardiac disease that would preclude the use of study treatments. This includes but is not confined to any of the following cardiac criteria: * Clinically significant cardiac dysfunction including heart failure (NYHA II-IV), active ventricular arrhythmias requiring medication or arrhythmias requiring a pacemaker, and history of a myocardial infarction within 6 months prior to randomization, angina pectoris, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, angioplasty, or vascular stent. * Mean resting QT interval corrected by Fridericia's formula (QTcF) \>470 msec obtained from 3 consecutive ECGs. * Increased risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled electrolyte disorders (e.g., hypocalcemia, hypokalemia, or hypomagnesemia), potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval. 16. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving therapy. 17. History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent. 18. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension or hypotension (BP \<50mmHg), significant aneurysm, renal transplant and active bleeding diseases). 19. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study. 20. Participation in another clinical study with a study intervention or investigational medicinal device administered in the 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial
NCT06640881
Recruiting
Conditions Recurrent Breast Carcinoma, Ipsilateral ...
Phase PHASE2
Enrollment 25
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

  • ablative single-dose PBI

Primary Outcomes

  • Acute toxicity
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-01-01
Completion: 2026-12
Eligibility
Age: 50 Years
Sex: FEMALE
Volunteers: false
Enrollment: 25 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Amsterdam UMC, location VUmc
Principal Investigators:
  • Desiree HJG van den Bongard, MD PhD (PRINCIPAL_INVESTIGATOR) - Amsterdam UMC
Contact Information
Study Contact:
Janneke F van Roij, MD
+31 611094077
j.s.vanroij@amsterdamumc.nl
Interventions
  • ablative single-dose PBI
Study Locations (1 sites)
Amsterdam UMC / VU Medical Centre, Amsterdam, Netherlands
Eligibility Criteria
Inclusion criteria: * WHO performance scale ≤ 2 * Females at least 50 years of age with an ipsilateral invasive breast cancer event or DCIS (i.e. recurrence, second primary) after previous breast conserving surgery and radiotherapy (for invasive breast cancer/carcinoma in situ) * Tumor characteristics: - - Tumor size ≤ 2 cm, unifocal on MRI On tumor biopsy: * Bloom-Richardson grade 1 or 2, * non-lobular invasive histological type carcinoma, * accompanying (non-extensive) DCIS is accepted within the tumor size of 2 cm on mammography and/or tumor biopsy, including no non-mass enhancement on MRI, * ER-positive and HER2-negative tumor, * No lymphovascular invasion. * Clinical node negative on PET-CT, ultrasound and MRI * No distant metastases * Repeat breast-conserving surgery is feasible, if no or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapy * Adequate communication and understanding skills of the Dutch language * Written informed consent Exclusion criteria: * Ipsilateral invasive breast cancer recurrence less than 2 years after first breast conserving therapy for breast cancer or ductal carcinoma in situ * Legal incapacity * Known breast cancer mutation gene carrier * Previous ipsilateral mastectomy * Collagen synthesis disease (e.g. Osteogeneis imperfecta, Ehlers-Danlos syndrome, systemic lupus erythematosus) * Invasive lobular carcinoma * MRI absolute contraindications as defined by the Department of Radiology * Indication for treatment with neoadjuvant chemotherapy * Non-feasible dosimetric RT plan * Breast implants
Asthma Symptom Perception Study
NCT06612294
Recruiting
Conditions Asthma
Phase NA
Enrollment 300
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • PEF Interventional Session
  • Control Sessions
  • Control Booster
  • Active booster

Primary Outcomes

  • Peak expiratory flow (PEF) Values
  • Mean daily ICS dose used
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-09-18
Completion: 2028-12-22
Eligibility
Age: 60 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: Albert Einstein College of Medicine, Yeshiva University, National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigators:
  • Juan Wisnivesky, MD, DrPH (PRINCIPAL_INVESTIGATOR) - Division Chief, General Internal Medicine
Contact Information
Study Contact:
Juan Wisnivesky, MD, DrPH
212-824-7845
juan.wisnivesky@mountsinai.org
Dhanya Chanumolu, MPH
332-777-5754
dhanya.chanumolu@mountsinai.org
Interventions
  • PEF Interventional Session
  • Control Sessions
  • Control Booster
  • Active booster
Study Locations (2 sites)
Ichan School of Medicine at Mount Sinai, New York, New York 10029 United States
Albert Einstein College of Medicine, The Bronx, New York 10461 United States
Eligibility Criteria
Inclusion Criteria: * Age \> 60 years * English or Spanish speaking * Self-report or physician diagnosis of asthma \>1 year ago * Uncontrolled asthma Exclusion Criteria: * Dementia * Chronic obstructive pulmonary disease (COPD), or other chronic respiratory illnesses, * Congestive Heart Failure (CHF, New York Heart Association \[NYHA\] stages 4-5) * Cigarette smoking \>15 packs-years
Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension
NCT06608472
Not yet recruiting
Conditions Essential Arterial Hypertension
Phase PHASE3
Enrollment 292
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • N0877
  • Benicar HCT ® Tablets 40 mg/25 mg

Primary Outcomes

  • Mean change in SBP in the sitting position at medical office at week 8 after randomization from baseline
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Not yet recruiting
Start Date: 2026-11-30
Completion: 2029-10-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 292 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Eurofarma Laboratorios S.A.
Contact Information
Study Contact:
Gleyce Lima
+55 11 50908411
gleyce.lima@eurofarma.com
Interventions
  • N0877
  • Benicar HCT ® Tablets 40 mg/25 mg
Study Locations (1 sites)
Eurofarma Laboratórios S.A, Itapevi, São Paulo 06696-000 Brazil
Eligibility Criteria
Inclusion Criteria: 1. Ability to confirm voluntary participation and agree to all purposes of the study, signing and dating the Informed Consent Form in two copies. 2. Age ≥ 18 years. 3. Medical office blood pressure with SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg without pharmacological treatment or which is not adequately controlled with monotherapy or with a combination of two drugs in which at least one of the drugs is not at the maximum dose. 4. Uncontrolled arterial hypertension (medical office BP with SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg) after at least two (02) weeks of run-in treatment. 5. Compliance with run-in treatment ≥ 80% and ≤ 120%. Exclusion Criteria: 1. Pregnant or lactating women. 2. Women in the reproductive age or of childbearing potential who do not agree to use a proven effective contraceptive method, unless they are surgically sterile or expressly declare themselves to be free from the risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner. 3. Medical office blood pressure with SBP ≥ 180 mm Hg or DBP ≥ 110 mm mmHg. 4. Resistant hypertension or secondary hypertension of any etiology (including renovascular disease, pheochromocytoma and Cushing\&#39;s syndrome). 5. Concomitant presence of Coronary Artery Disease, Congestive Heart Failure, Liver Failure and/or Chronic Kidney Disease stage IV or V. 6. History of hypertensive emergencies in the last 6 months. 7. Moderate to severe cardiovascular (acute myocardial infarction or unstable angina, unstable or life-threatening arrhythmia) and/or cerebrovascular events within the last 6 months or any other disorder that in the opinion of the investigator excludes the participant from the study. 8. Participant who is unwilling to switch from hypertension treatment to study medications. 9. 12-lead electrocardiogram (ECG) with any clinically significant abnormality. 10. Drug or alcohol abuse in the last 2 years. 11. Allergic or hypersensitivity reactions to angiotensin II receptor blockers, thiazide diuretics or medication excipients.