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Showing 20 of 27881 trials
Characterization of High-Level Cognitive Impairments in Patients With Neuropsychiatric Disorders
NCT07295652
Recruiting
Conditions Neurologic Disorders, Schizophrenia, Bip...
Phase NA
Enrollment 600
Locations 3 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Cognitive assessment
  • Brain MRI (optional)
  • Electroencephalography (optional)
  • Magnetoencephalography (optional)

Primary Outcomes

  • Performance scores on validated computerized neuropsychological tasks assessing high-level cognitive domains
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-03-12
Completion: 2039-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 600 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier St Anne
Collaborators: Paris Brain Institute (ICM)
Principal Investigators:
  • Pierre BOURDILLON, Dr (PRINCIPAL_INVESTIGATOR) - Hôpital Fondation Adolphe de Rothschild
Contact Information
Study Contact:
Jacob DHOTE, Dr
+33 145658177
j.dhote@ghu-paris.fr
Fabien VINCKIER, Pr
F.VINCKIER@ghu-paris.fr
Interventions
  • Cognitive assessment
  • Brain MRI (optional)
  • Electroencephalography (optional)
  • Magnetoencephalography (optional)
Study Locations (3 sites)
Departement of Adult Psychiatry, GH Pitié Salpétrière, Paris, 75013 France
Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences, Paris, 75014 France
Hôpital Fondation Adolphe de Rothschild, Paris, France
Eligibility Criteria
Inclusion Criteria: For patients: * Aged over 18 years * Diagnosed with a psychiatric disorder according to ICD-10 by a psychiatrist (F10-F98) or diagnosed with a neurological disorder according to ICD-10 by a neurologist (G00-G99) * Provided written informed consent * Affiliated with a social security scheme For healthy volunteers: * Aged over 18 years * Provided written informed consent * Affiliated with a social security scheme Exclusion Criteria: For healthy volunteers: * Current diagnosis of a psychiatric disorder according to ICD-10 (F20-F98) or current prescription of a psychotropic medication, or diagnosis of a neurological disorder according to ICD-10 (G00-G99) * History of depression (F32) * Substance use disorder (excluding tobacco) * Neurological history (e.g., stroke, coma, epilepsy, neuroinflammatory or neurodegenerative disease) or identified cognitive disorder * Inability to complete cognitive testing (e.g., due to motor or sensory impairment) For participants undergoing MRI (without contrast agent): * Presence of MRI contraindications: non-MRI-compatible pacemaker, heart valve, implant, or metallic foreign body * Pregnancy at the time of MRI
Survivors Uniting for Remote Guided Exercise
NCT07290309
Recruiting
Conditions Cancer, Cancer (Colon Cancer, Breast Can...
Phase NA
Enrollment 300
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

  • Virtually Supervised Exercise Sessions
  • Asynchronous Group

Primary Outcomes

  • Change in accelerometer measured moderate to vigorous physical activity from baseline to 3- and 6-month follow-up
  • Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 3 and 6 month follow-up
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-02-06
Completion: 2030-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Colorado State University
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Heather J Leach, PhD (PRINCIPAL_INVESTIGATOR) - Colorado State University
Contact Information
Study Contact:
Heather J Leach, PhD
(970) 491-8951
heather.leach@colostate.edu
Elena M Lancioni, MPH
elena.lancioni@colostate.edu
Interventions
  • Virtually Supervised Exercise Sessions
  • Asynchronous Group
Study Locations (1 sites)
Human Performance Clinical Research Lab, Fort Collins, Colorado 80523 United States
Eligibility Criteria
Inclusion Criteria: * Able to speak/read English, * Diagnosed with any type of cancer within the last 5 years * Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy, surgery) with no planned treatment within the next nine months. This does not include long-term or chronic therapies such as anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation therapy, immunotherapies) Exclusion Criteria: * Existing participation in ≥150 minutes per week of at least moderate intensity aerobic exercise * Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device) * Current or planned participation in another structured program or intervention intended to encourage participation in exercise or physical activity.
Research on New Methods and New Models of Rehabilitation Intervention for Cancer Patients Based on Exercise and Psychological Intervention
NCT07317765
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 200
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

  • Natural Psychotherapy
  • Receive routine psychotherapy and read popular science materials related to breast cancer.

Primary Outcomes

  • SAS score
  • SDS score
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2025-03-17
Completion: 2025-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beijing HuiLongGuan Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Natural Psychotherapy
  • Receive routine psychotherapy and read popular science materials related to breast cancer.
Study Locations (1 sites)
San Huan Cancer Hospital, Beijing, Beijing Municipality China
Eligibility Criteria
Inclusion Criteria: * Patients with pathologically confirmed breast cancer, no distant metastasis, who have completed the perioperative period and not received subsequent treatment; * Aged 18-59 years with an expected survival period of ≥ 1 year; * Breast cancer patients with a self-reported depression score of ≥ 53 and/or anxiety score of ≥ 50 on self-rating scales (e.g., Self-Rating Depression Scale \[SDS\], Self-Rating Anxiety Scale \[SAS\]); * Voluntarily participating in the study after providing informed consent and signing the informed consent form. Exclusion Criteria: * Patients with advanced breast cancer (stage IV with distant metastasis); * Patients receiving other psychological interventions besides this study (e.g., individual counseling, group therapy); * Patients with severe mental illness (e.g., schizophrenia), cognitive impairment (MMSE score \< 24), heart disease, severe physical illness, other cancers, or complications; * Patients who are unable to cooperate with psychological interventions, questionnaires, or interviews; patients who request or voluntarily withdraw from this study.
Effects of Environmental Fungal Exposure on Bronchial Asthma, ABPA and Bronchiectasis
NCT07313904
Recruiting
Conditions Environmental Exposure, Asthma, Bronchie...
Phase Not Applicable
Enrollment 125
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Respiratory fungi
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-07-23
Completion: 2026-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 125 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: First Affiliated Hospital of Ningbo University
Contact Information
Study Contact:
Chao Cao
+86-0574-87089878
caocdoctor@163.com
Shiyi He
+86-0574-87089878
shiyihii@163.com
Interventions
N/A
Study Locations (1 sites)
The First Affiliated Hospital of Ningbo University, Ningbo, Zhejiang Recruiting, Ningbo, Zhejiang 315010 China
Eligibility Criteria
Inclusion Criteria: 1. Age range of 18-80 years old (including 18 and 80 years old), gender and race are not limited; 2. No history of asthma, ABPA, or other chronic respiratory diseases. 3. No history of allergic diseases, such as allergic rhinitis, eczema, or food allergies. 4. Pulmonary function is normal or close to the normal range. 5. Laboratory testing: 1\. Blood routine: High sensitivity C-reactive protein, white blood cells, neutrophils, lymphocytes, and monocytes are all within the normal range. Allergen testing: IgE levels for common allergens such as dust mites, cat hair, dog hair, cockroaches, mold, and pollen are normal or close to the normal range. Exclusion Criteria: 1. Suffering from bronchial asthma ABPA、 Bronchiectasis or other respiratory diseases: chronic obstructive pulmonary disease, active pulmonary tuberculosis, pulmonary embolism, lung cancer, pneumothorax, hemoptysis, pulmonary arterial hypertension, interstitial lung disease, etc; 2. Cancer patients who suffer from serious other systemic diseases, such as myocardial infarction, stroke, hypertensive crisis or refractory hypertension, severe arrhythmia, heart failure, aortic aneurysm, liver failure, renal failure, hematological disorders, etc., and have recently been discovered or are currently receiving treatment; 3. Four weeks prior to enrollment, systemic use of antibiotics, antifungal drugs, immunosuppressants, cytotoxic agents, hormones, etc; 4. Other individuals with contraindications for induced sputum testing:
Optimizing a Sensor-Enabled mHealth Intervention for Adolescents With Suboptimal Asthma Control
NCT07301060
Recruiting
Conditions Asthma (Diagnosis)
Phase NA
Enrollment 160
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control
  • mHealth standard of care control condition

Primary Outcomes

  • Feasibility of Recruitment
  • Retention
  • Engagement
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-12-22
Completion: 2028-01-15
Eligibility
Age: 13 Years
Sex: ALL
Volunteers: false
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Kansas
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Contact Information
Study Contact:
Christopher C. Cushing, Ph.D.
785-864-0713
christopher.cushing@ku.edu
Interventions
  • Sensor-Enabled mHealth Intervention for Adolescents with Suboptimal Asthma Control
  • mHealth standard of care control condition
Study Locations (2 sites)
Nemours Children's Health, Jacksonville, Florida 32207 United States
University of Kanas, Lawrence, Kansas 66045 United States
Eligibility Criteria
Inclusion criteria for adolescents are: 1) they are between 13-17 years-old; 2) they have a physician-verified diagnosis of persistent asthma for at least 6 months; 3) they have suboptimal asthma control as defined by national asthma guidelines;5 4) they have a daily inhaled corticosteroid prescription that is compatible with the ReACT sensor; and 5) the adolescent-caregiver dyad speak and read English. Exclusion criteria are: 1) the adolescent is currently involved in an asthma management intervention beyond usual care; 2) the adolescent has a comorbid chronic health condition that may impact lung function (e.g., cystic fibrosis); 3) the adolescent has significant cognitive impairment or developmental delay that interferes with study completion, and 4) the adolescent does not have their own smart phone. Consistent with national asthma guidelines, we define suboptimal as control as a score of ≤19 on the Asthma Control Test (ACT) or by endorsing one or more of the following symptoms of on \>4 days in the past 2 weeks: (a) use of any short-acting beta-agonist medication, (b) experiencing asthma symptoms (i.e., wheezing, tightness of chest, coughing) during the day or night, (c) nighttime awakening due to asthma, or (d) activity limitation or school absence due to asthma.
Comparative Effects of Buteyko Versus Pilates Breathing Combined With McKenzie Neck Exercises on Lung Function and Chest Expansion in Asthmatic Patients With Forward Head Posture
NCT07289789
Recruiting
Conditions Asthma
Phase NA
Enrollment 22
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

  • Pilates Breathing Combined with McKenzie Neck Exercises
  • McKenzie Neck Exercises with Buteyko Breathing

Primary Outcomes

  • Chest Expansion
  • Lung Functions
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-08-20
Completion: 2026-02-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 22 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Foundation University Islamabad
Contact Information
Study Contact:
Arzoo Bashir Awan, DPT
03215770272
arzoobashir66@gmail.com
Sana Bashir, MS-CPPT
03218529475
drsana.bashir@fui.edu.pk
Interventions
  • Pilates Breathing Combined with McKenzie Neck Exercises
  • McKenzie Neck Exercises with Buteyko Breathing
Study Locations (1 sites)
Foundation University College of Physical Therapy, Islamabad, 44000, Islamabad, 44000 Pakistan
Eligibility Criteria
Inclusion Criteria: * Age group 18-40years * Both males and females * Individuals clinically diagnosed with asthma that is well controlled (Level 1 and Level 2) with FHP * Not participated in any structured exercise regime for improving lung function during the past 6 months. * Individuals well tolerated with a current exercise plan of combination exercises. (Buteyko breathing/Pilate breathing and McKenzie neck exercises Exclusion Criteria: * -Level 3 and 4 asthma or status asthmatics. * Any congenital deformity of the chest wall * Any active infections like fever, TB * Those with any contraindication to exercise testing or training. * Recent history of any chest wall trauma * Any abdominal or cardio thoracic surgery * Any psychiatric illness * Unstable Cardiopulmonary disease i.e. unstable angina, heart failure, recent MI. * Unstable hemodynamic parameters (arterial pressure \>140mmhg systolic and \>90mmhg for diastolic * Pregnancy * Previous or parallel participation in interventional programs.
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
NCT07285044
Recruiting
Conditions Amyloidosis, Basal Cell Carcinoma, Bilia...
Phase PHASE2
Enrollment 27
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

  • Cancer Therapeutic Procedure
  • Cancer Therapeutic Procedure
  • Questionnaire Administration

Primary Outcomes

  • Patient preferences regarding location of cancer treatment delivery
  • Adverse Events Related to Location of Treatment
  • Incidence of avoidable acute care visits, emergency room visits, and hospitalizations
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-12-18
Completion: 2026-12-18
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 27 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Principal Investigators:
  • Roxana S. Dronca, MD (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
Study Contact:
Clinical Trials Referral Office
855-776-0015
mayocliniccancerstudies@mayo.edu
Interventions
  • Cancer Therapeutic Procedure
  • Cancer Therapeutic Procedure
  • Questionnaire Administration
Study Locations (1 sites)
Mayo Clinic in Florida, Jacksonville, Florida 32224-9980 United States
Eligibility Criteria
Inclusion Criteria: * Patient has had adequate tolerability of their clinical standard of care treatment, in the opinion of their treating physician, and no clinically significant drug-related reactions occurred prior to consent * Participant must be receiving a standard-of-care treatment regimen listed in this protocol that is being used in accordance with standard medical practice. Specifically, it must be either a) Food and Drug Administration (FDA)-approved for the participant's disease indication, or b) recommended in nationally recognized professional guidelines (e.g. National Comprehensive Cancer Network \[NCCN\], American Society of Clinical Oncology \[ASCO\], American Society of Hematology \[ASH\], etc.) as standard of care for the disease indication. Off-label use is permitted only if supported by such guidelines * A social stability screener, used per standard of care, indicates patient is appropriate to participate in the CCBW program * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3 at the discretion of the treating physician * Female or male patients age \>= 18 years at the time of consent * Willing and able to comply with the study protocol in the investigator's judgement * Patients with histologically confirmed malignancy who are currently receiving treatment with one of the eligible treatment regimens. Patients with hepatocellular carcinoma (HCC) are eligible based on imaging diagnosis alone: histologic confirmation is not required. * Note: patients diagnosed with any of the following disease types may receive any of the eligible regimens listed. Additionally, patients receiving hormonal or immunotherapy, such as nivolumab or pembrolizumab, may receive these infusions in home supplemental to any of the regimens identified. Co-administration with hormonal agents such as anti-androgens, poly(ADP-ribose) polymerase (PARP) inhibitors, oral gonadotrophin releasing hormone (GnRh) antagonists, estrogens, selective estrogen receptor modulators (SERMs), or aromatase inhibitors are allowed, however combinations of oral regimens only are not permitted. Patients may receive any combination of any listed medications or regimens * Eligible disease cancer types: * Amyloidosis * Basal cell carcinoma * Biliary * Bladder * Breast * Cervical * Colorectal * Endometrial * Fallopian tube * Gastroesophageal * Glioblastoma * Head and neck * Hepatocellular * Hodgkin lymphoma * Lung * Mantle cell lymphoma * Merkle cell carcinoma * Multiple myeloma * Melanoma * Myelodysplastic syndrome * Ovarian * Pancreatic * Peritoneal * Prostate * Renal cell carcinoma * Squamous cell carcinoma * Urothelial carcinoma * Eligible regimens * Atezolizumab +/- bevacizumab * Avelumab * Bevacizumab * Bortezomib * Cemiplimab * Daratumumab +/- bortezomib * Darbepoetin alpha * Degarelix * Denosumab (Xgeva) * Durvalumab * Fluorouracil +/- bevacizumab * Fulvestrant * Goserelin * Ipilimumab +/- Nivolumab * Lanreotide * Leuprolide * Nivolumab * Nivolumab + relatlimab * Octreotide * Pembrolizumab * Pertuzumab +/- trastuzumab * Trastuzumab +/- pertuzumab * Zoledronic acid (Zometa) * Willingness to follow birth control requirements for females and males of reproductive potential * Resides within the Florida Panhandle and surrounding area serviced by the at-home healthcare supplier utilized for the study and a paramedic network * Patient's residence has an existing Wi-Fi connection or can be connected using using a mobile Wi-Fi device provided as part of the program so as to enable a reliable connection with the remote CCBW Command Center at Mayo Clinic * Patients who, according to documentation from their treating provider, plan to continue the eligible treatment regimen they are currently prescribed for \>= 12 weeks from the time of registration * Provide written informed consent * Ability to complete questionnaire(s) by themselves or with assistance * Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study) Exclusion Criteria: * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Receiving any investigational agent which would be considered as a treatment for the primary neoplasm. * Note: oral concomitant medications for oncologic indications will be maintained per standard of care treatment and not considered part of the trial. Any nononcologic medication, regardless of route of administration will be maintained per standard of care treatment and also not considered part of the trial; therefore, patients receiving oral anti-cancer or other medications per standard of care treatment in addition to any of the medications listed are considered eligible for this trial * Individuals who require continuous (24/7) assistance with daily living and are unable to independently manage the technology required for study participation, unless a caregiver is available and willing to provide consistent support throughout the study * Current inpatient hospitalization (excluding admission to the Advanced Care at Home program)
A Comparison of Effectiveness, Safety, and Cost-effectiveness of Dapagliflozin and Empagliflozin in Patients With Type 2 Diabetes Mellitus and High Body Mass Index (BMI)
NCT07311551
Not yet recruiting
Conditions Type 2 Diabetes
Phase PHASE4
Enrollment 112
Locations 0 sites
Compensation reimbursement available
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Dapagliflozin (10Mg Tab) along with standard medical therapy
  • Empagliflozin (25 Mg Tab) along with standard medical therapy

Primary Outcomes

  • Change in HbA1c from baseline at 6 months
  • Change in weight from baseline at 6 months
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Not yet recruiting
Start Date: 2025-12-24
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 112 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Bhavya Bhavya, MD
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Dapagliflozin (10Mg Tab) along with standard medical therapy
  • Empagliflozin (25 Mg Tab) along with standard medical therapy
Eligibility Criteria
Inclusion Criteria: Adults aged 18 years or older with a diagnosis of type 2 diabetes mellitus (T2DM) who have been on stable background therapy for at least three months were eligible for inclusion. Participants were required to have an HbA1c level between 7% and 10% while receiving Metformin with or without other oral hypoglycemic agents, and there had to be a clear clinical indication to initiate an SGLT2 inhibitor. Individuals with a body mass index (BMI) of 23 kg/m² or higher and who were willing to provide written informed consent were included in the study. Exclusion Criteria: Patients were excluded if they had uncontrolled diabetes with an HbA1c level greater than 10.0% or if they had used SGLT2 inhibitors, insulin, or GLP-1 receptor agonists within 90 days prior to randomization. Individuals with a history of bariatric surgery or those planning such surgery during the study period were not eligible. Current alcohol consumption of ≥140 g/week in women or ≥210 g/week in men-equivalent to at least 14 or 21 standard drinks per week, respectively-was also an exclusion criterion. Acutely ill patients visiting the OPD, those receiving medications known to cause hepatic steatosis (such as amiodarone, valproate, tamoxifen, methotrexate, or steroids), and individuals with an eGFR \<45 mL/min/1.73 m² were excluded. Patients with contraindications to SGLT2 inhibitor use, including a history of recurrent urinary or genital infections, current or previous gangrene, known hypersensitivity to the drug, or a history of diabetic ketoacidosis, were also not included. Pregnant or breastfeeding women were excluded from participation.
Personalized Cancer Vaccine (PCV) Strategy in Triple Negative Breast Cancer Patients
NCT07300475
Not yet recruiting
Conditions Triple Negative Breast Cancer
Phase PHASE1
Enrollment 30
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Paclitaxel
  • Carboplatin
  • Pembrolizumab
  • Doxorubicin
  • Cyclophosphamide

Primary Outcomes

  • Treatment-emergent adverse events (TEAEs)
  • Treatment-related adverse events (TRAEs)
  • Serious adverse events (SAEs)
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: 2026-08-01
Completion: 2035-04-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Washington University School of Medicine
Principal Investigators:
  • William Gillanders, MD (PRINCIPAL_INVESTIGATOR) - Washington University School of Medicine
Contact Information
Study Contact:
William Gillanders, MD
314-747-0072
gillandersw@wustl.edu
Katherine Clifton, M.D.
314-273-3712
k.clifton@wustl.edu
Interventions
  • Paclitaxel
  • Carboplatin
  • Pembrolizumab
  • Doxorubicin
  • Cyclophosphamide
Study Locations (1 sites)
Washington University School of Medicine, St Louis, Missouri 63110 United States
Eligibility Criteria
Step 0 Inclusion Criteria: * Newly diagnosed, previously untreated, locally advanced non-metastatic triple negative breast cancer (as defined by the most recent ASCO/CAP guidelines). Permissible staging per AJCC is as follows: * T1c, N1-N2 * T2, N0-N2 * T3, N0-N2 * At least 18 years of age. * Adequate tissue available for nucleic acid isolation/PCV design or willing to undergo biopsy if adequate tissue is not available. * Adequate cardiac function per treating physician and a candidate for the KEYNOTE 522 regimen (or receiving the KEYNOTE 522 regimen for no more than one month). Note that patients who are already receiving the KEYNOTE 522 regimen at the time of screening must have adequate archival tissue for nucleic acid isolation/PCV design (biopsy will not be permitted). * TIL percentage \< 10% (performed on SOC biopsy). * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. Step 0 Exclusion Criteria: * Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial. * Received prior chemotherapy, targeted therapy, or radiation therapy within the past 12 months. * Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another co-inhibitory T-cell receptor. * Currently receiving any other investigational agents. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in the study. * Received a live vaccine within 30 days of the first dose of pembrolizumab. * Active autoimmune disease that has required systemic treatment in the past 2 years. * Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab. * History of (non-infectious) pneumonitis that required steroids, or current pneumonitis. * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better. * Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 7 days of study entry. * Known history of active TB (bacillus tuberculosis). * Known history of HIV. * Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection. * History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection. Step 1 Inclusion Criteria: * ECOG performance status ≤ 1 within 10 days of initiation of PCV * Adequate bone marrow and organ function within 28 days of initiation of PCV as defined below: * Absolute neutrophil count ≥ 1.0 K/cumm * Platelets ≥ 100 K/cumm * Hemoglobin ≥ 8.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN * Creatinine clearance \> 30 mL/min by Cockcroft-Gault * The effects of the PCV on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after last dose of PCV. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately. * Received at least 4 months of the KEYNOTE 522 regimen. Step 1 Exclusion Criteria: * Currently receiving any other investigational agents. * Pregnant and/or breastfeeding. * Experiencing ongoing AEs related to the SOC KEYNOTE 522 regimen that have not resolved to \< grade 3. Patients may be permitted to enroll with a grade 3 AE with approval of the PI and treating physician. * QTcF \> 470 msec.
The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
NCT07290842
Recruiting
Conditions Hypertension, CKD - Chronic Kidney Disea...
Phase NA
Enrollment 20
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

  • Beetroot Juice - Active
  • Beetroot juice placebo

Primary Outcomes

  • Changes in 24 h systolic blood pressure
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-12-08
Completion: 2030-01-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Gødstrup Hospital
Contact Information
Study Contact:
Kezia T McWhan, MD
004578436580
kezmcw@rm.dk
Interventions
  • Beetroot Juice - Active
  • Beetroot juice placebo
Study Locations (1 sites)
University Clinic in Nephrology and Hypertension, Gødstrup Regional Hospital and Aarhus University, Herning, 7400 Denmark
Eligibility Criteria
Inclusion Criteria: * Hypertension, treated with a maximum of 2 antihypertensive drugs and unattended office BP \< 150/95 mmHg at the screening visit, or newly diagnosed without antihypertensive treatment by 24-hour BP or home BP measurement (above 130/80 or 135/85 respectively), and unattended office BP \< 160/100 mmHg. * CKD I-III based on hypertensive kidney injury. Patients, who previously met the criteria for CKD I within the last 5 years, but no longer has proteinuria after relevant treatment, can also be included. Diagnosis of CKD I can be based on eGFR and either urine albumin/creatine ration or urine-dipstick test with presence of protein. * Albumin/creatinine ratio \< 500 mg/g * eGFR \> 30 ml/min/1,73m2 * Body Mass Index (BMI) ≤ 35 kg/m2 * Able to adhere to dietary regimen * Fertile women must use safe contraception (oral contraceptive pill, hormonal or copper intrauterine device, vaginal ring, contraceptive implant, transdermal contraceptive patch or contraceptive injections) or abstinence. Excluded from this are postmenopausal woman without menstrual bleeding for at least 12 months before inclusion, surgically sterilized women and women with surgically sterilized partner. Exclusion Criteria: * • Diagnosis of heart failure, NYHA II-IV * Diagnosis of liver failure * Diabetes mellitus (all types) * Current malignant disease (other than non-melanoma skin cancer) * Indicators of other aetiologies of CKD than hypertensive kidney injury, e.g. through kidney biopsy or biochemistry. * Previous kidney transplant recipient * History of stroke or transient cerebral ischemic attack * Current indication of untreated cardiovascular disease, e.g. planned work-up for ischemia. * History of myocardial infarction, apart from non-STEMI more than 1 year prior to the study, if the subject is currently revascularized and relevantly medicated. Organic nitrate treatment Diagnosed secondary hypertension other than renal parenchymal hypertension (i.e. renal artery stenosis, primary hyperaldosteronism, low renin hypertension etc.) * Pregnancy or lactation * Alcohol abuse (intake above the recommended guidelines from Danish Health Authorities) * Conditions treated with medication that investigator finds may interfere with the effect parameters, and cannot be discontinued during the trial (e.g. atrial fibrillation treated with betablockers) * If, according to the investigator's assessment, the participant is considered unsuitable to participate.
[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer
NCT07314073
Recruiting
Conditions Stage III Breast Cancer
Phase PHASE2
Enrollment 85
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Fluoroestradiol (18F)

Primary Outcomes

  • Patient based detection rate of qualitative [18F]FES PET/CT evaluation for distant metastases
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-12-24
Completion: 2029-12-31
Eligibility
Age: 19 Years
Sex: ALL
Volunteers: false
Enrollment: 85 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Asan Medical Center
Principal Investigators:
  • Hyehyun Jeong (PRINCIPAL_INVESTIGATOR) - Asan Medical Center
Contact Information
Study Contact:
Sangwon Han
+82-2-3010-0657
hswon87@amc.seoul.kr
Jaeeun Kim
+82-2-3010-4572
kje0216@amc.seoul.kr
Interventions
  • Fluoroestradiol (18F)
Study Locations (1 sites)
Asan Medical Center, Seoul, South Korea
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged ≥19 years, regardless of race/ethnicity 2. Patients newly diagnosed with invasive breast cancer within 90 days prior to screening, with documented histopathological confirmation. 3. Patients diagnosed with histologically confirmed estrogen receptor-positive, histologic grade 1 or 2 primary breast cancer 4. Patients with clinical stage IIIA-IIIC disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM staging system 5. Patients who have undergone, or are scheduled to undergo chest computed tomography (CT), abdominal CT, and bone scintigraphy within 90 days prior to screening before the 18F-FES PET/CT scan 6. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤2 Exclusion Criteria: * The subject or the subject's legally authorized representative has not signed the informed consent form * Subjects who are currently receiving systemic therapy for breast cancer (e.g., neoadjuvant chemotherapy, hormonal therapy) * Subjects with a history of another invasive malignancy within the past 2 years (except for non-melanoma skin cancer) * Subjects diagnosed with distant metastases on chest CT, abdominal CT, or bone scintigraphy performed within 90 days prior to screening or before the 18F-FES PET/CT scan * Subjects for whom neither biopsy nor ≥6 months of follow-up imaging has been performed for lesions suspicious for distant metastases * Pregnant or breastfeeding women. The following cases are considered not at risk of pregnancy: (1) physiologically postmenopausal (no menses for ≥2 years), (2) surgically sterile (history of bilateral oophorectomy or hysterectomy), (3) women of childbearing potential with a documented negative serum or urine pregnancy test within 24 hours prior to 18F-FES administration, and who agree to use effective contraception during the trial. * Subjects with serious and/or uncontrolled and/or unstable medical conditions (e.g., congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic kidney disease, or chronic liver disease) * Subjects who are relatives or students of the investigator, or otherwise in a dependent relationship with the investigator * Subjects who, in the judgment of the investigator, are unable to provide complete data for the clinical trial due to personal circumstances or other reasons
Endocrine Therapy Base on 21-gene RS
NCT07311122
Not yet recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 4000
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Oncotype DX

Primary Outcomes

  • invasive disease-free survival
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: 2026-01-01
Completion: 2028-12-31
Eligibility
Age: 20 Years
Sex: ALL
Volunteers: false
Enrollment: 4000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Gangnam Severance Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Oncotype DX
Eligibility Criteria
Inclusion Criteria: 1. Histologically confirmed breast cancer. 2. Age ≤50 years at initial diagnosis. 3. Premenopausal at diagnosis, defined as any of the following: A. History of menstruation within 6 months prior to diagnosis. B. Serum FSH \< 30 mIU/mL. C. If criteria A or B are unavailable, women aged ≤50 years are considered premenopausal. 4. Underwent curative-intent breast cancer surgery between January 2012 and December 2021. 5. Pathologic tumor stage pT1-pT3 after surgery. 6. Pathologic nodal stage pN0-pN1 after surgery. 7. Hormone receptor-positive disease by immunohistochemistry (IHC): estrogen receptor (ER) and/or progesterone receptor (PR) positive (≥1% positive cells or Allred score ≥3). 8. HER2-negative disease per ASCO/CAP guidelines: IHC 0 or 1+; if IHC 2+, in situ hybridization (FISH or SISH) negative. 9. Oncotype DX® performed, meeting one of the following Recurrence Score (RS) ranges: A. pN0: RS 11-25. B. pN1: RS ≤25. Exclusion Criteria: 1. Evidence of distant (systemic) metastasis at diagnosis. 2. Postmenopausal status at diagnosis, defined as any of the following: A. Prior bilateral oophorectomy before the breast cancer diagnosis (considered postmenopausal). B. Prior unilateral oophorectomy alone is not considered postmenopausal (classified as premenopausal). C. Bilateral oophorectomy performed after breast cancer surgery for therapeutic purposes is not an exclusion; such patients will be categorized as having received ovarian function suppression (OFS). D. Serum FSH ≥ 30 mIU/mL. 3. Hormone receptor-negative or HER2-positive disease. 4. Insufficient or unclear data regarding the type of adjuvant therapy received. 5. History of another malignancy treated before the breast cancer diagnosis, except for thyroid cancer and non-melanoma skin cancer. 6. Bilateral breast cancer. 7. Receipt of neoadjuvant systemic therapy prior to surgery.
Quality of Life After Glaucoma Surgery: Evaluating the Patient Perspective Across Surgical Options
NCT07303257
Recruiting
Conditions Glaucoma Eye, Open-angle Glaucoma, Close...
Phase Not Applicable
Enrollment 132
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).

Primary Outcomes

  • Quality of life score from the NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
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: 2026-02-23
Completion: 2027-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 132 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hospices Civils de Lyon
Contact Information
Study Contact:
Victor VERMOT-DESROCHES, MD
426109431
victor.vermot-desroches@chu-lyon.fr
Christelle SZATANEK
426732724
christelle.szatanek@chu-lyon.fr
Interventions
  • NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25).
Study Locations (1 sites)
Service d'Ophtalmologie, Hôpital de La Croix Rousse, Hospices Civils de Lyon, Lyon, 69317 France
Eligibility Criteria
Inclusion Criteria: * Patient aged ≥ 18 years with an indication for glaucoma surgical treatment * Eligible surgical procedures: Preserflo™ MicroShunt with mitomycin C, Trabeculectomy with mitomycin C or non-penetrating deep sclerectomy with mitomycin C * Unilateral or bilateral glaucoma, open-angle or angle-closure, at early, moderate, or advanced stages * Pseudoxexfoliative or pigmentary glaucoma * Secondary glaucoma, including: uveitic glaucoma, Steroid-induced glaucoma, traumatic glaucoma * Written informed consent obtained prior to study participation Exclusion Criteria: * Congenital glaucoma * Refractory glaucoma with a history of multiple previous surgeries * Ophthalmologic surgery within 6 months prior to inclusion * Severe visual co-morbidities (age-related macular degeneration, severe diabetic retinopathy, retinal degeneration, or similar conditions) * Expected difficulty with follow-up including poor anticipated compliance, planned travel or prolonged absence during the follow-up period * Illiteracy, inability to speak French or impaired cognitive capacity preventing adequate understanding of the study * Patients with a significant pre-existing impairment in quality of life attributable to a progressive physical illness or a neuropsychiatric disorder. * Patients under curatorship or guardianship * Pregnant women
A Study of KT-621 Administered Orally to Adult Participants With Moderate to Severe Eosinophilic Asthma
NCT07323654
Recruiting
Conditions Eosinophilic Asthma
Phase PHASE2
Enrollment 264
Locations 58 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

  • KT-621
  • Placebo

Primary Outcomes

  • Change from baseline in pre-bronchodilator FEV1
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-01-28
Completion: 2027-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 264 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kymera Therapeutics, Inc.
Contact Information
Study Contact:
Kymera Medical Director
857-285-5300
clinicaltrials@kymeratx.com
Interventions
  • KT-621
  • Placebo
Study Locations (58 sites)
Kymera Investigative Site, Lancaster, California 93534 United States
Kymera Investigative Site, Long Beach, California 90815 United States
Kymera Investigative Site, Northridge, California 91324 United States
Kymera Investigative Site, Redding, California 96001 United States
Kymera Investigative Site, Upland, California 91786 United States
Kymera Investigative Site, Loxahatchee Groves, Florida 33470 United States
Kymera Investigative Site, Miami, Florida 33126 United States
Kymera Investigative Site, Miami, Florida 33173 United States
Kymera Investigative Site, Miami Lakes, Florida 33014 United States
Kymera Investigative Site, Tampa, Florida 33607 United States
Eligibility Criteria
Inclusion Criteria: * Must be 18 years old (or the legal age of consent in the jurisdiction in which the study is taking place) to 75 years of age, inclusive, at the time of signing the ICF. * Must have a physician diagnosis of asthma for at least 1 year prior to the Screening visit. * Must be on a stable regimen of medium- to high- dose inhaled corticosteroid (ICS), in combination with a long-acting β2-agonist (LABA). The regimen may include additional controller medications used for at least 12 weeks, at a stable dose and regimen, with no change in the dose or frequency of administration for at least 4 weeks prior to the Screening visit and between the Screening and Baseline visits. * Must have a pre-bronchodilator FEV1 40 to 80% of predicted normal at the Screening and Baseline visits, prior to randomization. * Must have an ACQ-5 score ≥ 1.5 at the Screening and Baseline visits, prior to randomization. * Must have a FeNO level of ≥ 25 ppb at the Screening and Baseline visits. * Must have a demonstrated evidence of reversible airway obstruction by post-bronchodilator (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL at Screening. * Must have an absolute blood eosinophil count must be ≥ 0.30 × 10\^9/L at Screening. * Must have a documented history of at least 1 asthma exacerbation requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening within the past 52 weeks prior to Screening. * Must agree to contraceptive requirements in compliance with the clinical study and local requirements. * Must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, other study-related procedures, and questionnaires, including completing the electronic diary (e-diary), for the duration of the study as required by the study protocol. Exclusion Criteria: * Must not have any clinically significant pulmonary disease other than asthma. * Must not have had an asthma exacerbation, requiring either treatment with systemic corticosteroids (intramuscular, intravenous, or oral) and/or hospitalization or an emergency/urgent medical care visit for acute asthma worsening, at any time from 4 weeks prior to the Screening visit up to and including the Baseline visit. * Must not have any other clinically significant disease, condition, or medical history that, in the opinion of the Investigator, would interfere with participant safety, study evaluations, and/or study procedures. * Must not be pregnant or breastfeeding; must not be a woman planning to become pregnant or breastfeed during the study. * Must not have results from clinical laboratory safety tests that are outside the local reference range at Screening. * Must not have been dosed with any investigational drug or device in a clinical study within 8 weeks or 5 half-lives (whichever is longer) of KT-621 administration. * Must not have any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results. * Must not be a current smoker of nicotine/tobacco as well as non-nicotine products, have a smoking history of ≥ 10 pack years, or use vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack years and users of vaping or e-cigarette products must have stopped for at least 26 weeks prior to the Screening visit. * Must not have a known sensitivity to any of the components of KT-621. * Must not be a member of the investigational team or his/her immediate family.
Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
NCT07285382
Recruiting
Conditions HR Positive HER2 Negative Advanced Breas...
Phase PHASE2
Enrollment 120
Locations 2 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

  • Dalpiciclib 125mg
  • Dalpiciclib 150mg
  • Letrozole 2.5mg

Primary Outcomes

  • Progression - Free Survival (PFS)
  • Duration of Response (DoR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-06-25
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: wanghaibo
Contact Information
Study Contact:
haibo Wang
18661805787
hbwang66@126.com
Interventions
  • Dalpiciclib 125mg
  • Dalpiciclib 150mg
  • Letrozole 2.5mg
Study Locations (2 sites)
The Second Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116027 China
Qingdao University Affiliated Hospital, Qingdao, Shandong 266000 China
Eligibility Criteria
Inclusion Criteria: * Female patients aged ≥18 years and ≤75 years, who are postmenopausal or premenopausal/perimenopausal, and meet one of the following conditions: 1. Have undergone bilateral oophorectomy in the past, or be aged ≥60 years; or 2. Aged \<60 years, in a natural postmenopausal state (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), with E2 and FSH at postmenopausal levels; or 3. Premenopausal or perimenopausal female patients can also be enrolled, but must be willing to receive LHRH agonist treatment during the study period * Patients with breast cancer confirmed by pathological examination to be HR-positive and HER2-negative, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiotherapy with the goal of cure, and without clinical indications for chemotherapy. 1. ER-positive and/or PR-positive is defined as: the proportion of tumor cells with positive staining among all tumor cells is ≥1% (reviewed and confirmed by the investigator at the participating trial center); 2. HER2-negative is defined as: standard immunohistochemistry (IHC) test result is 0/1+; ISH test shows that the HER2/CEP17 ratio is less than 2.0 or the HER2 gene copy number is less than 4 (reviewed and confirmed by the investigator at the participating trial center) * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 * Have not previously received any systemic antineoplastic treatment for focal recurrent or metastatic disease * Have measurable lesions in line with RECIST 1.1 criteria or only bone metastatic lesions (including osteolytic lesions or mixed osteolytic/osteoblastic lesions) * Have sufficient organ and bone marrow function * Women of childbearing potential must be willing to use a medically approved highly effective contraceptive method during the study period and within 3 months after the last administration of the study drug * All acute toxic effects of previous antineoplastic treatment have resolved to grade 0-1 (according to NCI-CTCAE Version 5.0) or to the level specified in the inclusion/exclusion criteria. Except for other toxicities such as alopecia that the investigator deems to pose no safety risk to the patient * Have given informed consent and signed the informed consent form, and be willing and able to comply with the planned visits, study treatment plan, laboratory tests and other trial procedures Exclusion Criteria: * Previously diagnosed with HER2-positive breast cancer by pathological examination * Inflammatory breast cancer * Disease progression or recurrence at 12 months or within 12 months after completion of previous neoadjuvant or adjuvant endocrine drug treatment * Patients judged by the investigator to be unsuitable for endocrine treatment. Including advanced patients with symptoms, disseminated to internal organs, and at risk of life-threatening complications in the short term (including those with uncontrollable large effusions \[pleural, pericardial, peritoneal\], lymphangitis of the lung, and patients with more than 50% liver involvement) Confirmed to have brain metastatic lesions by cranial CT or MRI examination * Have previously received any CDK4/6 inhibitor drug treatment * Underwent major surgery, chemotherapy, radiotherapy, any investigational drug or other anticancer treatment within 2 weeks before entering the study Diagnosed with any other malignant tumor within 3 years before entering the study, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that have undergone radical treatment Human Immunodeficiency Virus (HIV) infection or known to have Acquired Immunodeficiency Syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection of the analytical method), or co-infection with hepatitis B and hepatitis C * Within 6 months before entering the study, the following occurred: myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, persistent arrhythmia of grade ≥2 (according to NCI-CTCAE Version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism) * Complicated with severe infection within 4 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment norms), or unexplained fever \>38.5℃ during the screening period/before the first administration * Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption * Known allergy to the study drug or any excipients * Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation * Known history of psychiatric drug abuse or drug addiction * Patients currently participating in other studies * Have other serious physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study, interfere with the study results, and are deemed unsuitable for participating in this study by the investigator
Evaluation of BRUDYGLAUCO (DHA + Citicoline) in Patients With Glaucoma
NCT07322965
Recruiting
Conditions Glaucoma, Primary Open Angle Glaucoma (P...
Phase NA
Enrollment 108
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

  • BrudyGlauco
  • Placebo

Primary Outcomes

  • Change from baseline in visual function assessed by Mean Deviation (MD) at 12 months
  • Change from baseline in visual function assessed by Visual Field Index (VFI) at 12 months
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-01
Completion: 2027-05-30
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 108 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institut Catala de Retina
Collaborators: Hospital de la Esperanza
Contact Information
Study Contact:
Alfonso Antón Lopez Antón Lopez, Prof MD PhD
+34 93 4340553
alfonso.anton@icrcat.com
Estela del Mar Sánchez Sotano, Biomedical science
93 253 16 47
estela.sanchez@icrcat.com
Interventions
  • BrudyGlauco
  • Placebo
Study Locations (2 sites)
Institut Català de Retina, Barcelona, Barcelona 08022 Spain
Hospital del Mar | Centre Esperança, Barcelona, Barcelona 08024 Spain
Eligibility Criteria
Inclusion Criteria: 1. Patients with chronic glaucoma (primary or secondary, open-angle or closed-angle) diagnosed in at least one eye, meeting the following criteria: Structural damage: Thinning of the neuroretinal rim, peripapillary hemorrhage, or reduction in the nerve fiber layer, confirmed by OCT or color fundus photography. Functional damage: At least 3 contiguous abnormal points outside the 95% confidence limit in the pattern deviation map of the visual field. 2. At least 4 reliable visual field (VF) tests before study enrollment. 3. Age between 50 and 75 years. 4. If both eyes meet the inclusion criteria, the eye with the worst Mean Deviation (MD) will be selected as the study eye. Exclusion Criteria: 1. Use of any vitamin or nutraceutical supplement in the month prior to screening. 2. Any condition that could alter visual field testing, including: Neurological diseases. Retinal diseases. Advanced cataracts. Treatment with Lyrica (Pregabalin) due to its effect on visual fields. 3. Hypersensitivity to acetylsalicylic acid (aspirin) (cross-reactivity risk with citicoline). 4. Ocular surgery or laser treatment in the 3 months prior to enrollment or planned during the study. 5. Mean Deviation (MD) of the visual field worse than -20 dB or better than -3 dB.
ENV-294 for Moderate-to-Severe Asthma: A 12-Week Study in Adults
NCT07301255
Recruiting
Conditions Asthma
Phase PHASE2
Enrollment 50
Locations 14 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

  • ENV-294
  • Placebo

Primary Outcomes

  • Incidence and Severity of Adverse Events
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-01-09
Completion: 2027-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Enveda Therapeutics
Principal Investigators:
  • Gurpreet Ahluwalia, PhD (STUDY_DIRECTOR) - Enveda Therapeutics, Inc.
Contact Information
Study Contact:
Clinical Operations
env-294.clinicaltrials@enveda.com
Interventions
  • ENV-294
  • Placebo
Study Locations (14 sites)
Enveda Investigative Site, Birmingham, Alabama 35209 United States
Enveda Investigative Site, Los Angeles, California 90025 United States
Enveda Investigative Site, San Jose, California 95117 United States
Enveda Investigative Site, Colorado Springs, Colorado 80907 United States
Enveda Investigative Site, Hialeah, Florida 33012 United States
Enveda Investigative Site, Albany, Georgia 31707 United States
Enveda Investigative Site, Owensboro, Kentucky 42301 United States
Enveda Investigative Site, Southfield, Michigan 48075 United States
Enveda Investigative Site, St Louis, Missouri 63141 United States
Enveda Investigative Site, Clackamas, Oregon 97015 United States
Eligibility Criteria
Inclusion Criteria: * Able to read, understand, and sign an informed consent form before any study procedures * Male or female adults aged 18 to 75 years with a physician diagnosis of moderate to severe asthma for at least 12 months * Receiving stable treatment with an inhaled corticosteroid (ICS) plus a long-acting beta₂-agonist (LABA) for at least 2 months before screening * Pre-bronchodilator FEV₁ between 50% and 80% of predicted normal at screening and baseline * Demonstrated bronchodilator reversibility * ACQ-5 score ≥1.25 to ≤3.0 at screening and baseline * History of at least one asthma exacerbation in the past 12 months requiring systemic corticosteroids or hospitalization/emergency care Exclusion Criteria: * Recent moderate or severe asthma exacerbation (within 4 weeks before screening) * History of life-threatening asthma * Other significant pulmonary disease * Recent bronchial thermoplasty (within 2 years) * Uncontrolled current or recurrent concomitant illness * Recent use of biologic therapies for asthma (within 6 months or 5 half-lives) * Require immunosuppressive medications or frequent systemic corticosteroids * Current smokers or former smokers with significant smoking history * Uncontrolled hypertension * Significant hepatic impairment
Efficacy Evaluation of Glimepiride in Patients With Type 2 Diabetes Mellitus and Chronic Heart Failure With Reduced Ejection Fraction.
NCT07288749
Not yet recruiting
Conditions Type 2 Diabetes Mellitus (T2DM), Chronic...
Phase PHASE3
Enrollment 1484
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

  • Glimepiride (oral)
  • Placebo

Primary Outcomes

  • A composite endpoint of cardiovascular death, heart transplantation, or worsening heart failure (defined as rehospitalization for heart failure or an emergency heart failure visit requiring intravenous therapy).
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: 2026-01-01
Completion: 2031-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1484 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tongji Hospital
Collaborators: Shanghai Zhongshan Hospital, Nanjing Medical University, Second Xiangya Hospital of Central South University, Huaxi Hospital, Zhongnan Hospital, Xiangya Hospital, Beijing Anzhen Hospital, The First Affiliated Hospital of Air Force Medicial University, Chinese Academy of Medical Sciences, Fuwai Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Xinjiang Medical University, Anhui Provincial Hospital, Southwest Medical University, First Hospital of China Medical University, Wuhan Central Hospital, Tianjin Medical University
Contact Information
Study Contact:
Dao Wen Wang
+86-027-6937-8422
dwwang@tjh.tjmu.edu.cn
Li Ni
+86-027-8366-2479
nili@tjh.tjmu.edu.cn
Interventions
  • Glimepiride (oral)
  • Placebo
Study Locations (1 sites)
Tongji Hostipal, Wuhan, Hubei 430030 China
Eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 80 years old at the time of enrollment; gender is not restricted. 2. Patients diagnosed with type 2 diabetes according to the "Chinese Diabetes Prevention and Management Guidelines (2024 Edition)" issued by the Chinese Medical Association Diabetes Branch, with a confirmed diagnosis at least three months prior. 3. According to the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2024 Edition)" issued by the Chinese Society of Cardiology, the diagnosis is heart failure with reduced ejection fraction (HFrEF) or heart failure with mildly reduced ejection fraction (HFmrEF), confirmed at least three months prior. 4. NYHA heart failure classification stage II-IV; 5. Within 12 months prior to enrollment, left ventricular ejection fraction (LVEF) was \< 50%, as determined by echocardiography, nuclear ventriculography, angiography, or cardiac magnetic resonance imaging. 6. NT-proBNP levels ≥ 600 pg/mL in patients with no recent hospitalization for heart failure; NT-proBNP levels ≥ 400 pg/mL within the past 12 months due to heart failure hospitalization; NT-proBNP levels ≥ 900 pg/mL in patients with heart failure complicated by atrial fibrillation/flutter. 7. Patients must have experienced stable heart failure symptoms for at least three months prior to enrollment and must have received standardized chronic heart failure therapy and guideline-directed diabetes management for no less than two weeks before enrollment, with no dose adjustments during this period. 8. Participation is voluntary and requires signing an informed consent form; follow-up can extend beyond three years. Exclusion Criteria: 1. Heart failure caused by valvular disease, congenital heart conditions, pericardial diseases, arrhythmias, or non-cardiogenic illnesses; as well as heart failure resulting from failure of vital organs such as renal or hepatic failure; and right-sided heart failure due to pulmonary origin or other definitive causes. 2. Currently experiencing acute decompensated heart failure (ADHF) or hospitalized for ADHF within the previous four weeks before enrollment. 3. Patients scheduled to undergo coronary artery revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) or cardiac resynchronization therapy following randomization, or who have received cardiac resynchronization therapy within 12 weeks prior to enrollment. 4. Any conditions other than cardiovascular diseases, including but not limited to malignancies with an expected survival of less than three years, severe mental disorders, hematologic diseases, neuroendocrine disorders, elevated liver transaminases and alkaline phosphatase levels exceeding three times the upper limit of normal (ULN), renal impairment indicated by serum creatinine greater than 2 mg/dL (176.82 µmol/L), and hyperkalemia with serum potassium levels exceeding 5.5 mmol/L. 5. Chronic kidney disease stage 3b or more advanced renal impairment (i.e., estimated glomerular filtration rate \[eGFR\]/creatinine clearance \[CrCl\] \<45 ml/min); 6. Left ventricular outflow tract obstruction, acute or fulminant myocarditis, aortic aneurysm, aortic dissection, or significant hemodynamic changes caused by unrepaired valves; 7. Cardiac shock, uncontrollable malignant arrhythmias, second-degree or higher sinus or atrioventricular block without pacemaker therapy, progressive unstable angina pectoris, or acute myocardial infarction; 8. Uncontrolled hypertension with systolic blood pressure (SBP) ≥180 mmHg and/or diastolic blood pressure (DBP) ≥110 mmHg; or SBP \<90 mmHg and/or DBP \<60 mmHg; 9. Female patients who are pregnant, planning to become pregnant, or breastfeeding; 10. Patients who have participated in any other investigational medicinal product clinical trial within the past 4 weeks; 11. Patients with a history of allergies or hypersensitivity to glimepiride or its derivatives; 12. Received glimepiride treatment within 8 weeks prior to enrollment or previously demonstrated intolerance to glimepiride; 13. Patients refusing to comply with study requirements to complete the research; 14. Conditions where the investigator deems the patient unable to understand and/or comply with study medications, procedures, or any other circumstances that may prevent completion of the study; 15. Any other reason deemed inappropriate for inclusion by the study physician.
Effect of Meditation as an Adjunct to Cardiac Rehabilitation
NCT07310992
Not yet recruiting
Conditions High Blood Pressure (& [Essential Hypert...
Phase NA
Enrollment 80
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

  • Meditation
  • Standard Cardiac Rehabilitation

Primary Outcomes

  • Quality of Life Scores (EuroQol EQ-5D Visual Analogue Scale)
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: 2026-01-15
Completion: 2028-01-15
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 80 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Instituto Dante Pazzanese de Cardiologia
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Meditation
  • Standard Cardiac Rehabilitation
Eligibility Criteria
Inclusion Criteria: * Patients of both sexes, aged 18 years or older. * Newly enrolled in the Phase II Cardiac Rehabilitation Program. * Clinically stable condition with medical clearance to perform aerobic and resistance exercises. * Diagnosis of cardiovascular disease (e.g., coronary artery disease, post-myocardial infarction, post-cardiac surgery, or stable heart failure) warranting rehabilitation. * Willingness and cognitive ability to provide written informed consent. * Availability to attend the twice-weekly sessions for the 12-week duration of the study. Exclusion Criteria: * Current regular practice of meditation, yoga, or other mind-body techniques (defined as formal practice more than once a week in the previous 3 months). * Current participation in other psychological or behavioral intervention clinical trials. * Severe cognitive impairment or psychiatric disorders that preclude understanding of the meditation instructions or group participation (e.g., dementia, untreated psychosis). * Unstable clinical conditions such as unstable angina, uncontrolled arrhythmias, or decompensated heart failure that contraindicate physical exercise. * Significant orthopedic or neurological limitations that prevent the performance of the exercise protocol. * Refusal to participate in the randomization process.
Safety and Efficacy of PA9159 Inhalation Aerosol for the Treatment of Adult Bronchial Asthma
NCT07326995
Recruiting
Conditions Bronchial Asthma
Phase PHASE2
Enrollment 60
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

  • PA9159 Metered-Dose Inhaler, 60 μg per day for 28 days
  • PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days
  • PA9159 Metered-Dose Inhaler, 240 μg per day for 28 days
  • Placebo Metered-Dose Inhaler without PA9159, Twice daily for 28 days

Primary Outcomes

  • Evaluation the change in morning pre-dose forced expiratory volume in one second (FEV1) from baseline to week 4 of treatment.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-02-24
Completion: 2026-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Anhui Palo Alto Pharmaceuticals, Inc.
Principal Investigators:
  • Wei Zuo (PRINCIPAL_INVESTIGATOR) - The First Affiliated Hospital of Nanchang University
Contact Information
Study Contact:
Mengli Kan
86-15618775927
kanmengli@paloaltopharma.com
Chunping Lu
86-15921612878
luchunping@paloaltopharma.com
Interventions
  • PA9159 Metered-Dose Inhaler, 60 μg per day for 28 days
  • PA9159 Metered-Dose Inhaler, 120 μg per day for 28 days
  • PA9159 Metered-Dose Inhaler, 240 μg per day for 28 days
  • Placebo Metered-Dose Inhaler without PA9159, Twice daily for 28 days
Study Locations (1 sites)
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330006 China
Eligibility Criteria
Inclusion Criteria: * Aged 18 to 75 years inclusive, regardless of gender; * According to the definition in the Chinese "Guidelines for Prevention and Treatment of Bronchial Asthma (2020 Edition)," subjects diagnosed with bronchial asthma, including those with an initial diagnosis of asthma, or those diagnosed with asthma during childhood or adolescence with stable condition who have not received long-term treatment but exhibit significantly more pronounced symptoms in adulthood and/or recently compared to the past; * Pre-randomization, pulmonary function tests show 60% ≤ FEV1% predicted ≤ 85%; * Any objective test result indicating variable airflow limitation conducted within 1 year prior to screening is positive, or the bronchodilator test during the screening period is positive, i.e., an increase in FEV1 ≥ 12% and an absolute increase in FEV1 ≥ 200 mL 15-30 minutes after inhaling 400 μg salbutamol (if the bronchodilator test result does not meet the positive threshold, a repeat bronchodilator test is allowed within 14 days after the test \[excluding the test day\]); or the bronchial provocation test is positive, i.e., a decrease in FEV1 ≥ 20% after inhaling a provocant (methacholine or histamine); or the average daily diurnal variability of peak expiratory flow (PEF) (calculated as the sum of daily PEF diurnal variability over 7 consecutive days divided by 7) \> 10%; * Voluntarily sign the informed consent form. Exclusion Criteria: * Subjects who are unable to correctly use a nebulizer, cannot tolerate nebulized inhalation administration, or fail inhalation administration training; * Subjects with other pulmonary diseases, including chronic obstructive pulmonary disease, bronchiectasis, pulmonary fibrosis, tuberculosis, etc., for which, in the investigator's judgment, asthma remains the dominant condition; * Coexistence of other clinically significant conditions that may affect lung function, including but not limited to pleural diseases, mediastinal diseases, diaphragmatic disorders, myasthenia, thoracic deformities, etc.; * History of severe cardiovascular diseases, such as congestive heart failure, coronary artery disease, myocardial infarction, arrhythmia, uncontrolled hypertension (resting seated systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on two or more consecutive measurements), etc., which, in the investigator's judgment, would put the subject at risk or may affect the interpretation of study results; * Subjects with hyperthyroidism, assessed by the investigator as unsuitable for participation in this trial; * History of severe hematologic, hepatic, psychiatric, renal, or other diseases that, in the investigator's judgment, would put the subject at risk or may affect the interpretation of study results; * History of malignancy within the past five years (excluding cured cervical intraepithelial neoplasia, thyroid cancer, or basal cell carcinoma of the skin diagnosed and cured within 5 years); * Subjects who have undergone or are expected to undergo solid organ or bone marrow transplantation within the next year; * Hypokalemia (serum potassium \< 3.5 mmol/L during screening); * Type I diabetes or poorly controlled Type II diabetes (fasting blood glucose \> 11.1 mmol/L during screening); * Known or pre-randomization examination revealing oral, pharyngeal, or esophageal candidiasis; * Abnormal liver or kidney function during screening (ALT and/or AST \> 2× upper limit of normal; Scr \> 1.5× upper limit of normal); * Positive hepatitis B surface antigen or hepatitis B core antibody with HBV DNA ≥ 2000 IU/mL, positive hepatitis C antibody with HCV RNA ≥ 1000 IU/mL, positive human immunodeficiency virus antibody, or history of acquired immunodeficiency syndrome; * Known allergy to any component of inhaled corticosteroids or salbutamol preparations; * Respiratory tract infection, sinus infection, or acute otitis media within 4 weeks before screening or during the run-in period, which, in the investigator's judgment, would lead to changes in asthma treatment or affect the subject's asthma status; * Asthma exacerbation requiring systemic corticosteroid treatment within 4 weeks before screening or during the run-in period, or asthma requiring oral corticosteroid therapy, or other conditions requiring systemic corticosteroid treatment; * Use of strong CYP3A4 enzyme inhibitors (e.g., ritonavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin, etc.) within 4 weeks before dosing, or need for concomitant use of strong CYP3A4 inhibitors during the trial; * Smoking cessation \< 1 year at screening (including cigarettes, cigars, pipe tobacco, e-cigarettes, etc.), or previous smoking history \> 10 pack-years \[pack-years = number of packs per day × years of smoking, where 1 pack = 20 cigarettes\]; * History of drug abuse, substance abuse, or alcoholism within 2 years before screening \[alcoholism defined as average daily alcohol intake \> 2 units (1 unit = 360 mL beer, or 45 mL of 40% alcohol liquor, or 150 mL wine)\]; * Pregnant or lactating women, or women planning pregnancy during the trial; * Subjects who have participated in other clinical trials within 1 month before screening; * Any other reason considered by the investigator to make the subject unsuitable for participation in the trial.