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Showing 20 of 27881 trials
Psychological Support Interventions for Women With Endometriosis (ENDOPSY)
NCT07280052
Not yet recruiting
Conditions Endometriosis
Phase NA
Enrollment 40
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

  • Individual Psychotherapy
  • Socio-Aesthetic Group Therapy
  • Mixed Psychotherapy

Primary Outcomes

  • Change in Endometriosis-Related Quality of Life (EHP-30 score)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-02
Completion: 2027-06
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hospices Civils de Lyon
Collaborators: Université Lyon 2
Contact Information
Study Contact:
Lecointe Mariane
04 78 86 66 53
mariane.lecointe@chu-lyon.fr
Interventions
  • Individual Psychotherapy
  • Socio-Aesthetic Group Therapy
  • Mixed Psychotherapy
Study Locations (1 sites)
Hôpital Lyon Sud - Hospices Civils de Lyon, Pierre-Bénite, 69310 France
Eligibility Criteria
Inclusion Criteria: * Adult women ≥18 years * Clinical diagnosis of endometriosis * Ability to understand and complete psychological evaluations * Signed written informed consent Exclusion Criteria: * Ongoing psychotherapy * Cognitive, sensory or language impairments preventing participation * Participation in another interventional clinical study * Persons under legal protection * Non-French speakers * Pregnancy or breastfeeding
Pharmacokinetic Study to Evaluate Safety and Tolerability of EG-101 in Healthy Female Volunteers as a Safety Lead-In for Dosing in Pregnant Women With Severe Pre-eclampsia
NCT07327255
Not yet recruiting
Conditions Pre-eclampsia
Phase PHASE1
Enrollment 24
Locations 0 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

  • EG-101

Primary Outcomes

  • Tmax
  • Cmax
  • AUC
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2026-06
Completion: 2027-03
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 24 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Evergreen Therapeutics, Inc.
Contact Information
Study Contact:
Xin Du, Ph.D.
240-406-4016
david.du@egpharm.com
Charles Lee, M.D., Ph.D.
240-406-4016
charles.lee@egpharm.com
Interventions
  • EG-101
Eligibility Criteria
Key Inclusion Criteria: 1. Healthy adult female volunteers, 18 to 55 years of age, inclusive, at first Check-In Visit 2. Body mass index (BMI) ≥18.5 to ≤32 kg/m2 at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared.) 3. All female subjects must be nonpregnant, nonlactating and either postmenopausal, surgically sterile, or using contraceptive regimens more than 3 months. All females must have a negative serum pregnancy test at Screening and Check-in Visit. Effective methods of contraception include a dual method of contraception: condom with spermicide in conjunction with use of an intrauterine device (IUD), condom with spermicide in conjunction with use of a diaphragm, condom with birth control patch or vaginal ring, or condom with oral, injectable, or implanted contraceptive. Surgical sterility is documented through documented: hysterectomy, partial hysterectomy, bilateral oophorectomy, or bilateral tubal ligation at least 6 months prior to Screening. Postmenopausal sterility is documented by absence of menses for at least 12 months prior to Screening plus serum FSH ≥40 mIU/mL and estradiol \<30 pg/mL at screening 4. Male subjects, are not enrolled into this study 5. Medically healthy on the basis of medical history, and physical examination (including but not limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, and central nervous systems), as determined by the Investigator at Screening and each Check-In Visit Key Exclusion Criteria: 1. Females who are pregnant, lactating, or likely to become pregnant during the study 2. History and/or recent evidence within 6 months prior to Screening of alcohol or drug/substance abuse disorder 3. Subjects with a history of hypersensitivity to Zanamivir or any component of study medication 4. History of clinically significant allergies including drug allergies or allergic bronchial asthma or related bronchospastic conditions 5. Subjects who have history of unexplained syncope or fainting or a condition that predisposes them to syncope, such as hypotension, orthostatic hypotension, bradycardia or dehydration
Precision Physical Exercise for Personalized Onco-Hematology.
NCT07286539
Not yet recruiting
Conditions Hematologic Cancer, Colon Cancer, Breast...
Phase NA
Enrollment 150
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Supervised Intervention
  • Home-based Intervention

Primary Outcomes

  • Functional physical condition
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-04-01
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Salamanca
Contact Information
Study Contact:
Carlos Martin-Sanchez, PhD
+34646774655
carlos_ms@usal.es
Interventions
  • Supervised Intervention
  • Home-based Intervention
Eligibility Criteria
Inclusión criteria: * Adult patients (≥18 years), capable of signing the informed consent and willing to participate in the study. * Performance status (ECOG) 0-2. * Specific inclusion criteria are defined for each cohort involved in the study as follows: Lung cancer: Patients diagnosed with non-small cell lung carcinoma in metastatic stage, eligible for combined immunotherapy and chemotherapy, with active treatment. Colorectal cancer: Patients with stage II, III, or IV resected colorectal cancer undergoing adjuvant chemotherapy. Breast cancer: Female patients with histologically confirmed hormone receptor-positive/HER2-negative breast cancer, receiving active hormonal therapy (tamoxifen, aromatase inhibitor, or fulvestrant) in either adjuvant or stable metastatic phase. Chronic lymphocytic leukemia (CLL): Patients diagnosed with CLL who have not received and are not in need of pharmacological treatment. Multiple myeloma (MM): Patients with a confirmed new diagnosis of MM under active first line treatment and non-candidates to autologous transplantation. Exclusion criteria: * Presence of unstable bone metastases or extensive bone involvement associated with a high risk of fracture. * Uncontrolled cardiovascular, respiratory, musculoskeletal, or metabolic diseases that contraindicate physical exercise at the investigator's discretion. * Explicit medical contraindication to exercise training. * Documented poor adherence (\<80%). * Treatment discontinuation, disease progression, intolerance, or any other medical, personal, or logistical circumstance that, in the opinion of the investigators, may compromise participant safety or the integrity of the study.
Vitamin D for Preventing Recurrent Preeclampsia in Pregnant Women
NCT07288801
Recruiting
Conditions Pre-eclampsia, Pregnancy, Vitamin D
Phase PHASE4
Enrollment 146
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

  • Vitamin D
  • Placebo and standard of care

Primary Outcomes

  • Pre-eclampsia
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-08-09
Completion: 2026-02-08
Eligibility
Age: 20 Years
Sex: FEMALE
Volunteers: false
Enrollment: 146 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nishtar Medical University
Principal Investigators:
  • Mehnaz K Professor, FCPS (STUDY_CHAIR) - Nishtar Medical University and Hospital
Contact Information
Study Contact:
Tehseen A Principal Investigator, MBBS
+92 303 7832417
tehseenaslam451@gmail.com
Interventions
  • Vitamin D
  • Placebo and standard of care
Study Locations (1 sites)
Nishtar Medical University and Hospital, Multan, Punjab Province 60000 Pakistan
Eligibility Criteria
Inclusion Criteria: * Gestational age ≥ 20-weeks (on LMP method) ' - Past medical history of pre-eclampsia Exclusion Criteria: * Pre-existing hypertension, cardiac diseases, renal disease, thyrotoxicosis (on history and medical record) * Women presenting with intra-uterine death of the fetus.
Comparison of Outcome Between Grisotti Flap Versus Reverse Mirror Grisotti Flap for Central Quadrant Breast Tumors
NCT07293052
Active, positions filled
Conditions Breast Cancer, Breast Reconstruction
Phase NA
Enrollment 106
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

  • Grisotti Flap
  • Reverse Mirror Grisotti Flap

Primary Outcomes

  • Flap viability
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2025-11-04
Completion: 2026-05-04
Eligibility
Age: 25 Years
Sex: FEMALE
Volunteers: false
Enrollment: 106 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mayo Hospital Lahore
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Grisotti Flap
  • Reverse Mirror Grisotti Flap
Study Locations (1 sites)
King Edward Medical University, Lahore, Punjab Province 54000 Pakistan
Eligibility Criteria
Inclusion Criteria: 1. Diagnosed cases of breast cancer patients 2. Gender: Females 3. Age: 25-70 years 4. T1 (\<2cm) and T2 (2-5cm) tumors with or without prior systemic therapy 5. Tumor located in the NAC or located within 2 cm of the edge of the areola Exclusion Criteria: 1. Metastatic breast cancer 2. Inflammatory breast cancer 3. Patients not willing for post-operative radiotherapy 4. High tumour-breast ratio
CGM-Based Glycemic Analysis After ESI
NCT07280780
Not yet recruiting
Conditions Type 2 Diabetes (T2DM), Hyperglycemia, R...
Phase Not Applicable
Enrollment 36
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Epidural Steroid Injection
  • Continuous Glucose Monitoring

Primary Outcomes

  • Change in Daily Mean Glucose
  • Change in Time in Range (TIR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-04-20
Completion: 2026-12-31
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 36 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Korea University Anam Hospital
Collaborators: The Korean Pain Society
Principal Investigators:
  • Sunmin Kim, M.D. (STUDY_DIRECTOR) - Korea University Anam Hospital
Contact Information
Study Contact:
Sunmin Kim, M.D.
+82-2-920-5632
k05790@korea.ac.kr
Interventions
  • Epidural Steroid Injection
  • Continuous Glucose Monitoring
Study Locations (1 sites)
Korea University Anam Hospital, Seoul, Seoul 02841 South Korea
Eligibility Criteria
Inclusion Criteria: * Adults aged 20 to 60 years. * Patients scheduled for cervical or lumbar epidural steroid injection at the pain clinic. * Patients capable of understanding and using a Continuous Glucose Monitoring (CGM) device. Exclusion Criteria: * Patients currently taking or administering steroid medications. * Patients with Type 1 Diabetes Mellitus. * Patients with Cushing's disease. * Patients who have received an epidural steroid injection within the last 3 months. * Patients with a known allergy to contrast media. * Patients taking anticoagulants or antiplatelet agents. * Patients unable to use a Continuous Glucose Monitoring (CGM) device.
IMB-Based Sleep Hygiene Education for Menopausal Women: Effects on Sleep Quality and Depression
NCT07299903
Recruiting
Conditions Insomnia, Depressive Symptoms
Phase NA
Enrollment 500
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

  • Sleep Hygiene Education

Primary Outcomes

  • Sleep Quality
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-01-01
Completion: 2026-06-30
Eligibility
Age: 45 Years
Sex: FEMALE
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ankara Yildirim Beyazıt University
Principal Investigators:
  • Ayten ARIÖZ DÜZGÜN (STUDY_DIRECTOR) - Ankara Yildirim Beyazıt University
Contact Information
Study Contact:
Busra Karagol
+90 544 574 56 95
busrakaragol22@gmail.com
Interventions
  • Sleep Hygiene Education
Study Locations (1 sites)
Ankara Atatürk Sanatorium Training and Research Hospital, Ankara, Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Being in menopause * Being between 40 and 60 years of age * Having a low sleep quality score according to the Menopause-Specific Sleep Quality Scale. * Being willing to participate in the study. * Having no physical or mental disabilities that would hinder communication. * Having technology (smartphone, tablet, or computer) with internet access and the ability to participate in online training. Exclusion Criteria: * Having a history of receiving psychological support. * Having been diagnosed with a chronic psychiatric illness (previously diagnosed depression, anxiety disorder, etc.). * Having a neurological or chronic systemic illness that may affect sleep quality. * Being treated for a sleep disorder (receiving medication or psychotherapy). * Receiving hormone replacement therapy (HT). * Having received sleep hygiene training/therapy within the last 6 months.
A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
NCT07292246
Recruiting
Conditions Breast Cancer, BRCA 1 Gene Mutation, BRC...
Phase NA
Enrollment 15
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

  • Endoscopic nipple sparing mastectomy
  • HandX endoscopic instrument

Primary Outcomes

  • Technical success
  • Surgical Safety
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-09
Completion: 2029-10
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Vasileios Kalles
Principal Investigators:
  • Vasileios Kalles, MD, MSc, PhD, FEBS (PRINCIPAL_INVESTIGATOR) - Mediterraneo Hospital
Contact Information
Study Contact:
Vasileios Kalles, MD, MSc, PhD, FEBS
00306973746477
vassilis_kalles@yahoo.gr
Interventions
  • Endoscopic nipple sparing mastectomy
  • HandX endoscopic instrument
Study Locations (1 sites)
Mediterraneo Hospital, Glyfada, Attica 16675 Greece
Eligibility Criteria
Inclusion Criteria: * Female sex * Age ≥ 18 years old * Indication for therapeutic or prophylactic (risk-reducing) mastectomy for: 1. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing primary surgery 2. early invasive breast cancer (Clinical Stage I-II at diagnosis) undergoing surgery post systemic (neoadjuvant) therapy with clinical evidence of partial or complete response 3. ductal carcinoma in situ (DCIS), or 4. BRCA or other breast cancer - related genetic mutation carriers, or 5. high risk for development of breast cancer. * Breast volume: cup sizes A to C as defined by underwear size, expected implant volume \<550cc and glandular ptosis not exceeding Grade I Regnault's classification. * ECOG / WHO Performance Status \<2 * Subject with signed and dated informed consent form Exclusion Criteria: * Chest wall or skin invasion * Extended lymph node involvement at diagnosis (cN2) * Inflammatory breast cancer * Tumor distance from nipple - areola complex \<1cm on imaging studies * Active smoking/nicotine use within 4 weeks pre-op (combustible tobacco, vaping, nicotine pouches, NRT) * BMI \>35 * High risk patients with severe and poorly controlled co-morbid conditions (including but not limited to diabetes, heart disease, renal failure or liver dysfunction) * Pregnancy or breastfeeding * Psychiatric, addictive, or any disorders which compromise the ability to give informed consent for participation in this study * Subject without signed and dated informed consent form
Behavioral Pain Intervention for Older Cancer Patients
NCT07300995
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 168
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

  • Pain Coping Skills Training (PCST)

Primary Outcomes

  • Pain severity as measured by the Brief Pain Inventory (BPI)
  • Pain interference as measured by the Brief Pain Inventory (BPI)
  • Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Physical Function
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-06-30
Completion: 2027-06-01
Eligibility
Age: 55 Years
Sex: FEMALE
Volunteers: false
Enrollment: 168 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Duke University
Collaborators: National Institute on Aging (NIA)
Contact Information
Study Contact:
Tamara Somers, PhD
919-416-3408
tamara.somers@duke.edu
Interventions
  • Pain Coping Skills Training (PCST)
Study Locations (1 sites)
Duke Cancer Network, Durham, North Carolina 27713 United States
Eligibility Criteria
Inclusion Criteria: * Receiving cancer care at a Duke Cancer Network (DCN) clinic * Stage I-IV breast cancer * Self-reported pain on at least 10 days in the last month and pain rating of worst pain of 4 or greater on a 0-10 scale in the last week * Biologically female * Greater than or equal to 55 years old * Ability to speak and read English * Hearing and vision that allows for successful completion of videoconferencing and phone session Exclusion Criteria: * Participation in the last 6 months in a pain coping skills training program
Closed-Loop Transcranial Alternating Current Stimulation for the Treatment of Major Depressive Disorder
NCT07282678
Not yet recruiting
Conditions Depression - Major Depressive Disorder, ...
Phase NA
Enrollment 214
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Closed-loop tACS
  • Sham Comparator

Primary Outcomes

  • Hamilton Depression Rating Scale (HDRS) score reduction, Phase 1 Evaluation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-12
Completion: 2028-01
Eligibility
Age: 22 Years
Sex: ALL
Volunteers: false
Enrollment: 214 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Pulvinar Neuro, LLC
Principal Investigators:
  • Mark George, MD (PRINCIPAL_INVESTIGATOR) - Medical University of South Carolina
Contact Information
Study Contact:
James McCall, PhD
910-447-6576
james.mccall@pulvinarneuro.com
Interventions
  • Closed-loop tACS
  • Sham Comparator
Eligibility Criteria
Inclusion Criteria: 1. ≥ 22 years of age; 2. with at least moderate symptom severity (HAM-D17 ≥ 17); 3. who are currently in a depressive episode; 4. who have used at least 1 antidepressant in the current or previous episode, but have not found adequate symptom relief or who were not able to tolerate medication side effects; 5. who, for 6 weeks prior to enrollment, are either; * not taking antidepressant medication, or: * are taking a stable psychiatric medication regimen with one or more stable antidepressant medication dose(s) 6. if currently engaged in depression-focused psychotherapy, have maintained stable frequency of therapy for at least 8 weeks prior to enrollment and agree to continue the same regimen throughout study participation; 7. are able and willing to comply with the protocol and follow up schedule and protocol, in the opinion of the investigator; 8. who understand English and are able to provide written informed consent; 9. who are currently under the care of a psychiatric clinician or a primary care physician for major depressive disorder, and who agree to promptly inform the study staff of any change of psychiatric or mental health providers during study participation; 10. who agree to allow any and all forms of communication between the investigators/study staff and their current or past (within 2 years) healthcare providers; 11. who agree to provide the names and verifiable contact information (email and mailing addresses, mobile and/or land-line phone numbers, as applicable) for at least two persons (≥ age 18) who reside within a 60-minute drive of their residence and whom the research staff are at liberty to contact, as they deem necessary, to ensure participant safety for the duration of study participation; Exclusion Criteria: 1. Subjects with current / past six months use of an external stimulation device for MDD, including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain or cranial nerve stimulation; 2. Subjects with (lifetime) history of failure to response to an adequate trial of ECT, TMS, or implanted vagus nerve stimulation; 3. Subjects who currently receive esketamine, ketamine, or psilocybin treatment 4. Subjects who are pregnant or of childbearing potential and not using adequate contraception, as determined by the investigator; 5. Subjects who are breastfeeding. 6. Subjects whose current depressive episode had onset within 6 months post-partum; 7. Presence of active skin disorder on the forehead that could be exacerbated by stimulation electrodes in the opinion of the investigator. 8. Subjects with clinical or historical features which, in the opinion of the investigator, make them an inappropriate candidate for participation in this trial; 9. Subjects whose current depressive episode has not responded to 3 or more adequate trials of FDA approved antidepressant medications; 10. Subjects with current suicidal ideation with plan or intent, or suicidal behavior or preparation in the past 3 months, as determined by CSSRS assessment or by the Investigator; 11. Subjects with a history of epilepsy or unexplained seizures, as determined by the Investigator; 12. Subjects with a diagnosis or clinical history suggestive of bipolar disorder, hypomania, mania, or psychosis, as determined by the Investigator. 13. Subjects currently participating, or intending to participate (during the next 3 months) in another study involving an investigational drug or device treatment that, in the opinion of the investigator, could impact symptoms of MDD or use of the investigational device; 14. Subjects with a history of intracranial surgery; 15. Subjects with implanted neurostimulators, nonremovable or implanted electrical devices or intracranial metal objects, with the exception of dental metal; 16. Subjects with cognitive impairment or memory disorders, which, in the opinion of the investigator, could impact their ability to comply with study requirements; 17. Subjects currently meeting diagnostic criteria for obsessive compulsive disorder; 18. Subjects who meet DSM-V criteria for moderate/severe alcohol use disorder or other substance use disorders (except tobacco/nicotine) within the past 6 months as confirmed by the DIAMOND interview; 19. Subjects who meet DSM-V criteria for moderate/severe cannabis use disorder (CUD) within the past 6 months as confirmed by the DIAMOND interview. Subjects with recreational or prescription use (including medical marijuana cards) not considered moderate to severe CUD will be included. 20. Subjects with a current neurological condition or disease which, in the opinion of the investigator, is likely to manifest a depressive syndrome or symptoms that would substantially confound the diagnosis or serial assessment of major depressive disorder.
24-hour Effect of Rocklatan Compared With Latanoprost in Open Angle Glaucoma and Ocular Hypertension Patients
NCT07325240
Recruiting
Conditions Open Angle Glaucoma, Ocular Hypertension
Phase PHASE4
Enrollment 30
Locations 1 sites
Compensation Phase 4: Typically $100-$500
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
  • Latanoprost 0.005% Ophthalmic Solution

Primary Outcomes

  • Change in mean Intraocular Pressure (IOP)
  • Change in mean IOP
  • Change in mean IOP
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-11-21
Completion: 2027-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Collaborators: Alcon Research
Principal Investigators:
  • Arthur J Sit, MD, MS (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
Study Contact:
Bridgette Halder
507-422-2780
Halder.Bridgette@mayo.edu
Interventions
  • Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
  • Latanoprost 0.005% Ophthalmic Solution
Study Locations (1 sites)
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Eligibility Criteria
Inclusion Criteria * Diagnosis of OHT or mild-to-moderate OAG in both eyes (OAG in one eye and OHT in the fellow eye is acceptable) based on VF, OCT and dilated fundus examination within one year of the screening visit. * Both eyes must qualify for the study with an IOP of ≥18 mmHg but ≤34 mmHg on history or at the screening visit * Be able and willing to provide signed informed consent and follow study instructions * Ability to cooperate with the examinations required for the study and be able to attend all study visits * If a contact lens wearer, willing to remove contact lenses at least 24 hours prior to each of the study visits. * Best-corrected visual acuity (BCVA) using ETDRS chart of +0.4 logMAR units (Snellen equivalent \~ 20/50) or better in each eye Exclusion Criteria Ocular: * Subjects with narrow angles (3 quadrants with Grade 2 or less according to Shaffer Scale), angle closure or a history of angle closure, or peripheral iridotomy in either eye * Severe glaucomatous damage * Difference in IOP between eyes \> 4 mmHg (unmedicated) at any baseline time point * Use of more than two ocular hypotensive medications within 30 days of screening * Chronic or recurrent inflammatory eye diseases in either eye * Ocular infection or ocular inflammation in the past 3 months in either eye * Ocular trauma other than corneal abrasion within the past 6 months in either eye * Clinically significant retinal disease (e.g., severe diabetic retinopathy, exudative or severe non-exudative macular degeneration, macular edema, retinal vein or artery occlusion) in either eye * Cornea pathologic changes preventing reliable measurement (e.g., scarring, opacity, edema, keratoconus) in either eye * Myopia greater than -6.00D, or hyperopia greater than +2.00D in either eye * Central corneal thickness less than 480 μm or greater than 620 μm in either eye * Previous intraocular surgery other than routine uncomplicated cataract surgery in either eye * Previous glaucoma intraocular surgery or glaucoma laser procedures (except SLT performed more than 6 months ago) in either eye * Unilateral intraocular surgery or glaucoma laser procedures * Previous corneal refractive surgery in either eye (eg, radial keratotomy, PRK, LASIK, corneal cross-linking, etc.) * Severe dry eye in either eye * Use of ocular medications in either eye within 30 days of screening, with the exception of IOP-lowering medications (which must be washed out according to the provided schedule), and lubricating drops for dry eye (which may be used throughout the study) * Known hypersensitivity to any component of the formulation (eg, benzalkonium chloride, etc.), or to topical anesthetic Systemic: * Clinically significant systemic diseases which might interfere with the study * Participation in any interventional study within 30 days prior to screening visit * Changes of systemic medication that could have an effect on IOP within 30 days prior to screening, or anticipated during the study including, β-adrenergic antagonists, α-adrenergic agonists and antagonists, angiotensin converting enzyme (ACE) inhibitors, angiotensin II receptor blockers * Recent change in medications that are known to affect IOP within 30 days prior to the screening visit and during the study including: systemic/inhaled steroids, calcium channel blockers, diuretics, and vasodilators * Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. An adult woman is considered to be of childbearing potential unless she is one year post-menopausal or three months post-surgical sterilization. All females of childbearing potential must have a negative pregnancy test result at the screening examination and must not intend to become pregnant during the study * Subjects with a known hypersensitivity or contraindications to any of the ingredients in the study medications
ADO-5030 in Bronchoconstriction Challenge, Phase 1b
NCT07281274
Not yet recruiting
Conditions Asthma (Diagnosis)
Phase PHASE1
Enrollment 36
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • ADO-5030

Primary Outcomes

  • Change from baseline in PC20 AMP.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2026-01-01
Completion: 2026-07-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 36 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Adovate
Collaborators: University of Virginia
Contact Information
Study Contact:
Deborah Murphy, BSN
434-982-3510
ddm9q@uvahealth.org
Interventions
  • ADO-5030
Study Locations (1 sites)
University of Virginia, Charlottesville, Virginia 22904 United States
Eligibility Criteria
Inclusion Criteria: 1. Males and females ages 18-65 years, inclusive 2. History of well-controlled mild or moderate persistent asthma for at least 6 months prior to screening. 3. Well controlled asthma demonstrated by asthma control test (ACT) score ≥20 at Visit 1. 4. Reactivity to AMP, as determined in Protocol 19512 (Screening Protocol of Asthmatic, Allergic Rhinitic, or Control Participants for Experimental Challenges). Reactivity is defined as having a PC20 AMP at or before 80mg/mL. 5. Two replicable (within 2 dose doublings) AMP challenges. The two AMP challenges must occur within 28 days of each other. 6. Pre-bronchodilator FEV1 ≥ 60% of predicted at screening. 7. Normal or not clinically significant (NCS) safety laboratory results from Visit 1 prior to Visit 2. 8. Negative pregnancy test for females who have not had a hysterectomy with oophorectomy or who have not been amenorrheic for 12 months or more. 9. Willing to abstain from caffeine for 24 hours prior to each AMP challenge. 10. Willing and able to give informed consent. Exclusion Criteria: 1. Any chronic medical condition considered by the PI as a contraindication to participation in the study including significant cardiovascular disease, uncontrolled diabetes, chronic renal disease, uncontrolled chronic thyroid disease, history of chronic infections or immunodeficiency. 2. Inability to refrain from using inhaled corticosteroids (ICS), cromolyn, long-acting-beta-agonists (LABA), and leukotriene modifiers (LT) for 48 hours. 3. Pregnancy or nursing a baby. 4. A positive history for HIV, TB, HBV, or HCV. 5. Any asthma exacerbation requiring oral corticosteroids within 12 months of screening or that resulted in overnight hospitalization or an urgent care visit requiring additional treatment for asthma. 6. Uncontrolled asthma at enrollment Visit 1 defined as ACT score \<20. 7. Current smokers or a smoking history of ≥ 10 pack years. A subject may not have used any inhaled tobacco products in the 12-month period preceding Visit 1. 8. Known allergy/sensitivity to theophylline. 9. Any acute infection requiring antibiotics within 4 weeks or fever of unknown origin within 4 weeks of screening. Subjects having an intercurrent respiratory infection during the study will be permitted to reenroll. 10. Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. 11. Unwillingness to use reliable contraception if sexually active (IUD, birth control pills/patch).
IMT in Asthma: Activity, Coping, Self-Management
NCT07320066
Recruiting
Conditions Qualitative Research
Phase Not Applicable
Enrollment 15
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • other

Primary Outcomes

  • Patient-reported experiences of inspiratory muscle training (IMT) assessed by semi-structured in-depth interviews (study-specific interview guide)
  • Experience of exercising using telerehabilitation assessed by semi-structured in-depth interviews (study-specific interview guide)
  • Changes in physical activity in daily life assessed by semi-structured in-depth interviews (study-specific interview guide)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2026-01-05
Completion: 2027-12-19
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 15 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Istanbul Esenyurt University
Contact Information
Study Contact:
Esra PEHLİVAN, PhD
+90 216 777 96 00
fztesrakambur@yahoo.com
Interventions
  • other
Study Locations (1 sites)
Istanbul Esenyurt University, Istanbul, Istanbul 34890 Turkey (Türkiye)
Eligibility Criteria
Inclusion Criteria: * Being between the ages of 18-65 * Having been diagnosed with severe persistent, non-allergic asthma by a pulmonologist in accordance with the Global Initiative for Asthma (GINA) guideline criteria, * Patients with type 2 inflammation markers. According to accepted standards; peripheral eosinophils \<150/µL and/or negative skin prick test and/or total IgE \<30 kU/L * Bronchodilator response (\>12% or 200 mL improvement in FEV1% predicted following inhalation of 400 mg salbutamol) * Diagnosis-follow-up period: Patients diagnosed at least 6 months prior, under follow-up and treatment, and/or with controlled asthma * Having completed the pulmonary rehabilitation program * Completion of 8 weeks of inspiratory muscle training (IMT) * Patients who have read, understood, and signed the informed consent form Exclusion Criteria: * Having recently had a respiratory tract infection recently (within the last month), * Having a smoking history of more than 10 pack-years or having a history of smoking within 6 months after quitting smoking * Having received oral corticosteroid treatment in the last 4 weeks, * Having a Body Mass Index \>35, * Eosinophilic Granulomatosis Polyangiitis (EGPA) and Allergic Bronchopulmonary Aspergillosis (ABPA), * Vasculitis, * History of malignancy, * Pregnancy, * Previous lung surgery, use of long-term oxygen therapy * Having accompanying restrictive lung diseases (advanced kyphoscoliosis, ankylosing spondylitis) and neuromuscular diseases (myastania gravis, muscular dystrophies, myopathies) that will prevent healthy respiratory function testing and rehabilitation. * Cognitive dysfunction, mental retardation, dementia, or other conditions that make it difficult to follow the protocol, * Unwillingness to continue participating in the study, * Communication difficulties or intellectual deficiencies
Lakota Family Acceptance Project
NCT07326748
Recruiting
Conditions LGBTQ, Racial Disparities, Family Relati...
Phase NA
Enrollment 28
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

  • Adapted Lakota Family Acceptance Program

Primary Outcomes

  • Suicidality (Youth and Caregivers)
  • Depression (Youth and Caregivers)
  • Anxiety (Youth and Caregivers)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-01-20
Completion: 2027-01-31
Eligibility
Age: 13 Years
Sex: ALL
Volunteers: true
Enrollment: 28 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Michigan
Collaborators: National Institute of Mental Health (NIMH)
Principal Investigators:
  • Katie Edwards, PhD (PRINCIPAL_INVESTIGATOR) - University of Michigan
Contact Information
Study Contact:
Katie Edwards (Principal Investigator), PhD
734-647-8812
edkatie@umich.edu
Interventions
  • Adapted Lakota Family Acceptance Program
Study Locations (2 sites)
Wahwala Iyohlogya/Peaceful Means, Pine Ridge, South Dakota 57770 United States
University of Michigan/Rapid City, Rapid City, South Dakota 57701 United States
Eligibility Criteria
Youth Inclusion Criteria: * Identify as 2SLGBTQ+ (and their identity must be known to their participating caregiver) * Identify as Indigenous (multiracial youth who are also Indigenous are eligible) * Youth should be between the ages of 13 and 18 years * Read and speak English * Report moderate to high levels of caregiver/family rejection (as evidenced by agreement on items that assess the presence and frequency of specific family rejecting behaviors \[includes ambivalent and moderately and highly rejecting caregivers\] * Report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their caregiver Participating Caregiver Inclusion Criteria: * Caregivers are broadly defined and may include a biological parent, stepparent, grandparent, aunt/uncle, or other adult who provides care to the Indigenous 2SLGBTQ+ youth * Must be over the age of 18 * Read and speak English * Be aware of the SGM identity of their Indigenous 2SLGBTQ+ youth * report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their teen Exclusion Criteria: * We will exclude Indigenous 2SLGBTQ+ youth and caregivers at imminent risk for suicide and/or who are experiencing current psychosis symptoms as determined by results on the safety items screener.
Bronchial Thermoplasty for Adults With Severe Asthma in the Biologic Era
NCT07292805
Recruiting
Conditions Asthma Exacerbations, Severe Asthma, Bro...
Phase NA
Enrollment 90
Locations 2 sites
Compensation reimbursement available
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Bronchial thermoplasty

Primary Outcomes

  • Exacerbation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-04-09
Completion: 2029-04-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 90 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
Contact Information
Study Contact:
P Bonta, Md PhD
+31 (0)20-7329509
p.i.bonta@amsterdamumc.nl
Interventions
  • Bronchial thermoplasty
Study Locations (2 sites)
amsterdam UMC, Amsterdam, Netherlands
UMCG, Groningen, Netherlands
Eligibility Criteria
Inclusion Criteria: * adult (\>18 years) * severe uncontrolled asthma (defined as ACQ above 1.5) despite optimal medical therapy (GINA treatment step 5; alternative diseases excluded, therapy compliance and adequate inhalation technique confirmed) * 1 or more trials of treatment with a biologic or ineligible for biologic treatment * 2 or more severe asthma exacerbations in the previous year (defined as the need for a course of OCS or doubling dose of maintenance OCS for at least 3 consecutive days) * FEV1 ≥ 50% predicted after 400μg inhaled salbutamol or equivalent Exclusion Criteria: * chronic OCS therapy at a dose \>20 mg/day prednisone equivalent * 1 or more ICU admission for mechanical or endotracheal intubation for * asthma in the previous year. * anti-coagulation therapy that cannot be stopped temporarily * pregnancy * body mass index ≥35 * current or ex-smokers with \>20 pack years * DLCOc \<70% * Subject has a known sensitivity to medications required to perform bronchoscopy * Subject is using immunosuppressant therapy other than oral steroid therapy that impact on BT * Subject has bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/mm2 or known coagulopathy * Comorbidities that are a contra-indication for BT such as severe heart failure and other respiratory diseases including bronchiectasis, interstitial lung disease, emphy-sema, cystic fibrosis, mechanical upper airway obstruction, Churg-Strauss syndrome, and allergic bronchopulmonary aspergillosis (ABPA) * Subject uses an internal or external pacemaker or cardiac defibrillator..
VENTURI (VENTilation Using Respiratory Imaging)
NCT07282886
Recruiting
Conditions Asthma
Phase PHASE2
Enrollment 20
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

  • Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI
  • Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder

Primary Outcomes

  • Evaluate the effect of extrafine beclomethasone dipropionate/formoterol fumarate /glycopyrrolate compared with non-extrafine fluticasone furoate/ umeclidinium/vilanterol on ventilation defect percentage utilizing 129Xenon MRI.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-03-15
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Alabama at Birmingham
Contact Information
Study Contact:
Elizabeth Plan, RRT
205-975-5294
epkennedy@uabmc.edu
Surya Bhatt, MD, MSPH
205-934-5555
sbhatt@uabmc.edu
Interventions
  • Beclomethasone Dipropionate/Formoterol Fumarate/Glycopyrrolate pMDI
  • Fluticasone Furoate/Umeclidinium/Vilanterol 100 MCG/1 ACTUATION-62.5 MCG/1 ACTUATION-25 MCG/1 ACTUATION Inhalation Powder
Study Locations (1 sites)
The University of Alabama at Birmingham, Birmingham, Alabama 35233 United States
Eligibility Criteria
Inclusion Criteria: * Subject's written informed consent obtained prior to any study-related procedure. * Patients aged ≥ 18 and ≤ 75 years * Confirmed diagnosis of asthma (patients must have a documented history of asthma for at least 1 year with diagnosis before the age of 40 and/or pre-bronchodilator FEV1 between 50-80% of their predicted normal value, after appropriate washout from bronchodilators) * Symptomatic on ICS/LABA treatment with ACT \<20 * No exacerbations in the past 3 months requiring treatment with systemic corticosteroids or emergency department visit/ in-patient hospitalization * The ability to be trained and correctly use a pressurized Meter Dose Inhaler (pMDI) and Dry Powder Inhaler (DPI) * To have a cooperative attitude and the ability to perform the required outcomes measurements (e.g. spirometry maneuvers in sitting and supine position) and the ability to understand the risks involved * WOCBP fulfilling one of the following criteria: 1. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signature of the informed consent and until the follow-up visit or 2. WOCBP with physician confirmed non-fertile male partners (contraception is not required in this case). * Female patients of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile, e.g. amenorrheic for ≥12 consecutive months without alternative medical cause). Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges). Exclusion Criteria: * Pregnant or lactating female * Patients who had an exacerbation, defined as a sustained and acute deterioration of subject's symptoms and signs (dyspnea, cough and/or sputum production/purulence) that was either moderate, i.e. require treatment with systemic (oral/IV/IM) corticosteroids and/or antibiotics, or severe, i.e. require hospitalization, if their associated treatment/hospitalization occurred within 3 months prior to V1 * Inability to carry out pulmonary lung function testing, to comply with study procedures or with study treatment intake * History of near fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the Investigator, may have placed the patient at undue risk * Patients using systemic corticosteroid medication in the 4 weeks or slow-release corticosteroids in the 12 weeks, prior to screening * Patients who suffer from COPD as defined by the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) document * History of a diagnosis of cystic fibrosis, bronchiectasis or alpha-1 antitrypsin deficiency, or any other significant lung disease which may have interfered with study evaluations * Current smokers or current use of electronic cigarettes or ex-smokers with total cumulative exposure equal or more than 10 pack-years or having stopped smoking one year or less prior to screening visit * Patients who had clinically significant cardiovascular condition according to investigator's judgement, such as but not limited to: congestive heart failure (NYHA class \>2), acute ischemic heart disease in the last year prior to study screening, history of sustained cardiac arrhythmias or sustained and non-sustained cardiac arrhythmias diagnosed in the last 6 months (sustained meant lasting more than 30 seconds or ending only with external action, or led to hemodynamic collapse; non-sustained meant \>3 beats \<30 seconds, and or ending spontaneously, and or asymptomatic), high degree impulse conduction blocks (\>2nd degree atrioventricular block type 2). Similarly, patients affected by persistent, long standing or paroxysmal AF were not considered for enrollment * Patients who are unable to undergo imaging procedures for CT scans or MRI or demonstrate intolerance to Xenon gas * Patients who have participated in a recent therapeutic trial (within past 6 months) * Patients who have a milk protein allergy
The Impact of Mobile Application-Supported Monitoring on Treatment Compliance and Success in Lifestyle Changes in Hypertensive Patients
NCT07299266
Not yet recruiting
Conditions Hypertension
Phase NA
Enrollment 40
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Mobile App-Supported Blood Pressure Monitoring

Primary Outcomes

  • Change from Baseline in Systolic and Diastolic Blood Pressure at Month 3
  • Change from Baseline in "Scale for Assessment of Treatment Adherence and Lifestyle Change Success in Hypertensive Individuals" Total Score at Month 3
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-01-01
Completion: 2026-12-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Gaziantep
Principal Investigators:
  • Özlem Ovayolu, Prof. Dr. (STUDY_DIRECTOR) - https://www.gaziantep.edu.tr/
Contact Information
Study Contact:
Mehmet Ali Bozkurt, PhD Student
+905535680466
mehmetali1903.mab@gmail.com
Özlem Ovayolu, Prof. Dr.
+905462101692
drovayolu@gmail.com
Interventions
  • Mobile App-Supported Blood Pressure Monitoring
Eligibility Criteria
Inclusion Criteria: * Diagnosed with hypertension at least 6 months prior. * Willingness to voluntarily participate in the study. * Aged 18 years or older. * Ability to use a smartphone. * Ability to read and write (literate). Exclusion Criteria: * Patients with other serious cardiovascular diseases (e.g., heart failure, cardiac arrhythmia). * Inability to use a smartphone (for the intervention group). * Pregnancy. * Withdrawal of consent or request to leave the study. * Presence of any diagnosed psychiatric disorder.
GCAR1, a Chimeric Antigen Receptor (CAR) T-CELL Therapy for Relapsed/Refractory GPNMB-Expressing Solid Tumours
NCT07297667
Recruiting
Conditions Alveolar Soft Part Sarcoma, Renal Cell C...
Phase PHASE1
Enrollment 30
Locations 2 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Fludarabine
  • Cyclophosphamide
  • GCAR1

Primary Outcomes

  • To determine the recommended phase II dose (RP2D), defined as the next lower dose below the maximum administered dose, of GPNMB directed CAR T cell therapy
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2026-06-30
Completion: 2033-09-01
Eligibility
Age: 15 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Canadian Cancer Trials Group
Collaborators: University of Calgary, Canadian Institutes of Health Research (CIHR), BioCanRx
Principal Investigators:
  • Mona Shafey (STUDY_CHAIR) - Tom Baker Cancer Centre, Calgary, Alberta, Canada
Contact Information
Study Contact:
Laura Pearce
613-533-6430
lpearce@ctg.queensu.ca
Mariam Jafri
613-533-6430
mjafri@ctg.queensu.ca
Interventions
  • Fludarabine
  • Cyclophosphamide
  • GCAR1
Study Locations (2 sites)
Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta T2N 5G2 Canada
University Health Network, Toronto, Ontario M5G 2M9 Canada
Eligibility Criteria
Inclusion Criteria: * Archival tumour specimen must be positive for GPNMB with high expression by immunohistochemistry (central laboratory testing). * Histologically and/or cytologically confirmed diagnosis of one of the following tumours that is advanced/ metastatic/ recurrent or unresectable, for which no curative therapy exists. * alveolar soft part sarcoma * renal cell carcinoma (excluding clear cell) * triple negative breast cancer (ER, PR and HER-2 negative as defined by ASCO/CAP criteria) * Must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block. * Presence of radiologically documented disease. * Measurable disease as defined by RECIST 1.1. * ASPS participants ≥ 15 years of age. * TNBC and RCC participants ≥ 18 years of age. * ECOG performance status of 0 or 1 or Karnofsky or Lansky \> 60. * Anticipated life expectancy of ≥ 6 months. * Must have received prior systemic therapy as shown below; * ASPS - completed all systemic therapy available that has been shown to improve survival (unless contraindicated). * TNBC 1. Progressive disease following at least one line of systemic treatment for metastatic disease which must include an ADC (all participants) and an ICI (participants whose tumours express PD-L1). 2. ≤3 lines of treatment for metastatic disease. 3. Must have had at least 1 prior line of cytotoxic chemotherapy for breast cancer, in any setting, which must have included an anthracycline and a taxane (unless contraindicated). * RCC - must have progressive disease following at least one line of systemic treatment for metastatic disease that must have included an ICI and a VEGFR targeted agent (unless contraindicated). * Participants must have recovered to ≤ grade 1 from all reversible toxicity related to prior therapies. * Adequate washout must be followed per protocol. * Previous major surgery is permitted ≥21 days prior to enrollment * Prior external beam radiation is permitted ≥28 prior to enrollment. Concurrent radiotherapy is not permitted. * Adequate hematologic and biochemical parameters. * Consent and assent, when applicable, must be appropriately obtained in accordance with applicable local and regulatory requirements. Each participant or their parent/ legal guardian (if applicable) must sign a consent form prior to screening onto the trial to document their willingness to participate. * Fit for leukapheresis and has adequate venous access for cell collection. * Must be accessible for treatment and follow up at the participating centre for a minimum of 12 months or for as long as is deemed necessary by the treating physician. * Participants of childbearing potential must have agreed to use a highly effective contraceptive method. Exclusion criteria * Participants on active anticancer therapy for other advanced or metastatic malignancies. * Concurrent treatment with other anti-cancer therapy * Prior therapy with a gene therapy product or any adoptive T cell therapy or prior GPNMB targeting therapy. * Live attenuated vaccination administered within 30 days prior to or planned within 30 days after GCAR1 therapy. * Primary immunodeficiency or history of severe autoimmune disease (including: Crohn's disease, rheumatoid arthritis, systemic lupus) requiring immunosuppressive agents/ systemic disease modifying agents within 2 years of enrollment. * Active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the participant to be managed according to the protocol including but not limited to: * Hepatitis B or C virus (HBV or HCV). For participants with previous HBV or HCV infection who are currently on treatment, they are eligible if they have an undetectable viral load via quantitative PCR and/or nucleic acid testing * HIV positive by serology and PCR * Uncontrolled fungal, bacterial, viral or other infection * Current infection with HTLV-1 * Tuberculosis * Syphilis * West Nile Virus * Untreated and/or uncontrolled cardiovascular conditions and/or symptomatic cardiac dysfunction (including cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects) or unstable angina congestive heart failure or myocardial infarction within the previous year. * Known sensitivity or allergy to fludarabine, cyclophosphamide or any of their components, or to GCAR1 or any of its components. * Active intracerebral metastases or leptomeningeal disease. Participants who have received definitive treatment, are clinically stable and do not require corticosteroids are eligible to participate in the trial. * Pregnant or breastfeeding women.
Breast Cancer Study Tracking Risk Awareness of Alcohol Consumption and Improving Knowledge in Young Adult Women
NCT07320664
Recruiting
Conditions Behavior, Risk
Phase NA
Enrollment 500
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

  • Alcohol and Breast Cancer Risk Messages
  • Skin Cancer Risk Messages

Primary Outcomes

  • Alcohol Consumption
  • Daily Alcohol Consumption
  • Intentions to Reduce Alcohol Consumption
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-03-19
Completion: 2027-07-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ohio State University Comprehensive Cancer Center
Collaborators: Breast Cancer Research Foundation
Principal Investigators:
  • Darren Mays, MPH, PhD (PRINCIPAL_INVESTIGATOR) - Ohio State University Comprehensive Cancer Center
Contact Information
Study Contact:
The Ohio State University Comprehensive Cancer Center
800-293-5066
OSUCCCClinicaltrials@osumc.edu
Interventions
  • Alcohol and Breast Cancer Risk Messages
  • Skin Cancer Risk Messages
Study Locations (1 sites)
Ohio State University Comprehensive Cancer Center, Columbus, Ohio 43210 United States
Eligibility Criteria
Inclusion Criteria: * Assigned female at birth. * Age 18-25 at enrollment. * Report drinking alcohol at least once in the past 30 days. * Not pregnant or intending to become pregnant by self-report. * Reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey. * Willing to complete procedures. * Able to complete procedures a, b, or c: 1. Can read, write, and converse in English. 2. Has a personal mobile smartphone with texting capabilities to receive text messages that may contain text and images. 3. For the subsample who will wear the BACTrack sensor, they must have an iPhone. At the time of this protocol, the BACTrack skyn app is only compatible with iPhones. If this expands to Android phones over the course of the study, Android phones will be eligible. Exclusion Criteria: * Assigned male at birth * Ages \<18 or \>25 at enrollment * Do not report drinking alcohol at least once in the past 30 days * Pregnant or intending to become pregnant by self-report. * Do not reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey. * Not willing to complete procedures. * Unable to complete procedures.
FMT in Triple Negative Breast Cancer Guided by ctDNA
NCT07292142
Not yet recruiting
Conditions Breast Cancer
Phase PHASE1, PHASE2
Enrollment 125
Locations 3 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Fecal Microbiota Transplantation (FMT)
  • No Intervention.

Primary Outcomes

  • To evaluate the safety of combining Fecal Microbial Transplantation (FMT) using intestinal bacteria existing in the stool of healthy donors with immunotherapy/chemotherapy in triple-negative breast cancer patients.
  • Feasibility of giving FMT is triple negative breast cancer patients treated with chemotherapy / immunotherapy prior surgery.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Not yet recruiting
Start Date: 2026-02
Completion: 2031-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 125 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Jewish General Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Fecal Microbiota Transplantation (FMT)
  • No Intervention.
Study Locations (3 sites)
London Health Sciences Center, London, Ontario Canada
The Ottawa Hospital Cancer Centre, Ottawa, Ontario Canada
Jewish General Hospital, Montreal, Quebec H3T 1E2 Canada
Eligibility Criteria
Inclusion Criteria: PHASE 1 * Patients must be 18 years old or older. * Patients must have a confirmed diagnosis of TNBC (defined as estrogen receptor expression 0-10%, progesterone receptor expression 0-10%, and HER-2/neu negative (immunohistochemistry 0, 1+, or 2+ and fluorescent in-situ hybridization negative for HER-2 gene amplification) and are about to start neoadjuvant chemotherapy. * Patients with ECOG performance of 0-2. * Patients who are willing to provide serial stool and blood samples. * Patients must be able to provide written informed consent * Patients with available primary tumor biopsy tissue for molecular analysis PHASE 2 * Patients must be 18 years old or older. * Patients must have a confirmed diagnosis of TNBC (defined as estrogen receptor expression 0-10%, progesterone receptor expression 0-10%, and HER-2/neu negative (immunohistochemistry 0, 1+, or 2+ and fluorescent in-situ hybridization negative for HER-2 gene amplification) and are about to start neoadjuvant chemotherapy-immunotherapy. * Patients with ECOG performance of 0-2. * Patients must be able to provide written informed consent and understand the infectious risks associated with FMT administration. * Ability to ingest capsules. * Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (\>10 mg prednisone daily or equivalent). Exclusion Criteria: PHASE 1 * Clinical or radiological evidence of metastatic disease. * Known infection with HIV or hepatitis. * Pregnant woman. PHASE 2 * Previous anti-PD-1 treatment. * Patient with a secondary malignancy. * Pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. * Current exposure to high-dose oral or intravenous corticosteroids (\>10 mg of prednisone daily or equivalent). Patients who require intermittent use of bronchodilators or local steroid injections are not excluded from the study. * Absolute neutrophil count \<1.0 within 48 hours of planned FMT administration * Has a diagnosis of immunodeficiency (for example, HIV or transplantation) or any other form of immunosuppressive therapy before trial treatment. * Ongoing use of antibiotics or previous use of antibiotics one week before the FMT procedure. * Probiotic supplements and food products labeled as containing probiotics must be discontinued a minimum of 24 hours before FMT administration and are not permitted during the course of neoadjuvant immunotherapy treatment. * Presence of a chronic intestinal disease (for example, celiac, malabsorption, and colonic tumor). * Presence of absolute contraindications to FMT administration, including toxic megacolon, severe dietary allergies (for example, shellfish, nuts, or seafood), and inflammatory bowel disease. * Expected to require any other form of systemic or localized anti-neoplastic therapy other than those proposed by the study while on study. * Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo, type I diabetes, or resolved childhood asthma/atopy are exceptions to this rule. * A history of recent (\<30 days) (non-infectious) pneumonitis that required steroids or current pneumonitis. * Has serious concomitant illnesses, such as uncontrolled cardiovascular disease (congestive heart failure, uncontrolled hypertension, active evidence of cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders. This includes HIV or AIDS-related illness or active hepatitis B or C virus. * Has an active infection requiring systemic therapy. * Patient has received a live vaccine within 4 weeks before the first dose of treatment. Note that seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (for example, FluMist) are live attenuated vaccines and are not allowed. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.