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Showing 20 of 28810 trials
Safety, Tolerability and Pharmacokinetics Study of L608 in Healthy Adults
NCT06429930
Recruiting
Conditions Healthy Adult Participants
Phase PHASE1
Enrollment 40
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

  • L608 Liposomal inhalation suspension
  • Placebo Solution

Primary Outcomes

  • Percentage of participants with DLT
  • Percentage of participants with TEAEs and SAEs
  • Frequency and severity of TEAEs and SAEs
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-04-11
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Pharmosa Biopharm Inc.
Collaborators: Novotech (Australia) Pty Limited
Contact Information
Study Contact:
Pei Kan, PhD
+886-2-2782-7561
peikan@pharmosa.com.tw
Sydney Chuang
+886-2-2782-7561
sydney@pharmosa.com.tw
Interventions
  • L608 Liposomal inhalation suspension
  • Placebo Solution
Study Locations (1 sites)
NZCR Ltd (New Zealand Clinical Research), Christchurch, 8011 New Zealand
Eligibility Criteria
Key Inclusion Criteria: 1. Men and women aged between 18 and 65 (inclusive) at the time of Screening visit. 2. Participants with Body Mass Index (BMI) of ≥18.5 and ≤32.0 kg/m2 and weight of at least 50 kg at Screening. 3. Non-smokers or former smokers who have smoked ≤ 100 cigarettes in their lifetime and have not consumed any tobacco or tobacco-containing products for at least 3 months prior to Screening. 4. Females must not be pregnant or lactating and must use acceptable, highly effective double contraception from Screening until 3 months after the last dose of the Investigational product. Key Exclusion Criteria: 1. Participants with contraindications or sensitivity to any components of the study treatment. 2. Participants with histories or active conditions of unexplained bleeding events, hemoptysis, abnormal bleeding tendencies, and/or coagulation disorders. 3. Participants with histories or active conditions of asthma, sleep apnea, chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, bronchiectasis, bronchospasm, and/or reactive airway. Subjects who have had childhood asthma which have resolved as deemed by the PI can be considered. 4. Participants with histories or active conditions of myocardial infarction (MI), cerebrovascular accident (CVA), coronary artery disease (CAD), unstable angina, heart failure, significant cardiac arrhythmias, congenital or acquired valvular heart disease with clinically insignificant symptom, suspected lung congestion, and/or pulmonary arterial hypertension (PAH) causing by venous thromboembolism. 5. Cohorts A1 and B1: Participants with systolic blood pressure \< 90 mmHg or \> 140 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg at Screening or check-in visit. Cohorts B2, B3, C1 and C2: Participants with systolic blood pressure \< 110 mmHg or \> 140 mmHg and/or diastolic blood pressure \< 50 mmHg or \> 95 mmHg at Screening, check-in visit or predose on Day1. 6. Participants with FEV1 less than 80% predicted, FVC ˂ 80% predicted, or resting oxygen saturation less than 95% at Screening or check-in visit. 7. Participants with histories of drug or alcohol abuse within 1 year prior to subject check-in (Day -1). Regular alcohol consumption defined as \> 14 standard drinks per week for female and \> 21 standard drinks per week for male. 8. Consumption of products containing caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hours before dosing and products containing grapefruit and/or pomelo (shown to inhibit cytochrome P450 \[CYP\] 3A4 activity) within 10 days prior to drug administration, and/or participants unwilling to refrain from consumption of alcohol from 48 hours before dosing to Day 14. 9. Receipt of blood products within 2 months prior to dosing. 10. Positive results of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and pregnancy test. 11. Blood donation or significant blood loss (\>480 ml) within 3 months prior to Screening. 12. Participants unwilling to refrain from strenuous exercises from 7 days prior to dosing until the EOS visit. 13. Participants planning to receive a tattoo, body piercing, or undergo any invasive procedure during the study period.
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
NCT06429761
Recruiting
Conditions BREAST CANCER
Phase PHASE4
Enrollment 100
Locations 6 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

  • Trastuzumab deruxtecan

Primary Outcomes

  • To assess the safety of trastuzumab deruxtecan in adult Indian patients
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2025-01-02
Completion: 2026-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
  • Trastuzumab deruxtecan
Study Locations (6 sites)
Research Site, Bangalore, 560017 India
Research Site, Delhi, 110029 India
Research Site, Kochi, 682041 India
Research Site, Mumbai, 400012 India
Research Site, Pune, 411028 India
Research Site, Varanasi, 221005 India
Eligibility Criteria
Inclusion Criteria: 1 Participant must be \>18 years of age inclusive, at the time of signing the informed consent. 2 Patients who are willing and capable of giving signed informed consent as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3 Participants with pathologically documented breast cancer that: * is unresectable or metastatic * HER2-positive expression (IHC 3+ or IHC 2+ with ISH positive) as confirmed by laboratory assessment within last 1 year of study enrolment. * was previously treated with an anti HER-2 based regimen 4 Adequate bone marrow function, within 14 d before enrolment, defined as: a. Absolute neutrophil count ≥ 1.5 × 109/L (granulocyte colony-stimulating factor administration is not allowed within 1 wk prior to Screening assessment); b. Platelet count ≥ 100 × 109/L (Platelet transfusion is not allowed within 1 wk prior to Screening assessment); c. Hemoglobin level ≥ 9.0 g/dL (Red blood cell transfusion is not allowed within 1 wk prior to Screening assessment). 5 Adequate renal function within 14 d before enrolment, defined as: * Creatinine clearance ≥ 30 mL/min, as calculated using the Cockcroft-Gault equation (CLcr (mL/min) = \[140 - age (years)\] × weight (kg) {× 0.85 for females}; 72 × serum creatinine (mg/dL) 6 Adequate hepatic function within 14 d before enrolment, defined as: * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) if no liver metastases or \< 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline, and * Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 3 × ULN 7 Adequate blood clotting function within 14 d before enrolment, defined as: * International normalized ratio/prothrombin time ≤ 1.5 × ULN and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5 × ULN 8 Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 mo after the last dose of trastuzumab deruxtecan. Male subjects must agree to inform all potential female partners that they are participating in a clinical trial of a drug that may cause birth defects. Male subjects must also agree to either avoid intercourse or that they and/or any female partners of reproductive/childbearing potential will use a highly effective form of contraception during and upon completion of the study and for at least 4.5 mo after the last dose of trastuzumab deruxtecan. Methods considered as highly effective methods of contraception include: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: o Oral o Intravaginal o Transdermal * Progestogen-only hormonal contraception associated with inhibition of ovulation: o Oral o Injectable o Implantable * Intrauterine device * Intrauterine hormone-releasing system * Bilateral tubal occlusion * Vasectomized partner * Complete sexual abstinence defined as refraining from heterosexual intercourse during and upon completion of the study and for at least 7 mo for female subjects (4.5 mo for male subjects) after the last dose of trastuzumab deruxtecan. True abstinence must be in line with the preferred and usual lifestyle of the subject. Periodic abstinence (calendar, symptothermal, postovulation methods) is not an acceptable method of contraception. Non-childbearing potential is defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 mo of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone \> 40 mIU/mL and estradiol \< 40 pg/mL \[\< 147 pmol/L\] is confirmatory). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use 1 of the contraception methods outlined for women of childbearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 wk will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their postmenopausal status, they can resume use of HRT during the study without use of a contraceptive method. 9 Male subjects must not freeze or donate sperm throughout the study period beginning at Cycle 1 Day 1 and for at least 4.5 mo after the last dose of trastuzumab deruxtecan or Preservation of sperm should be considered prior to enrollment in this study. 10 Female subjects must not donate ova or retrieve them for their own use from the time of Screening and throughout the study treatment period, and for at least 7 mo after the last dose of trastuzumab deruxtecan Exclusion Criteria: 1. Prior treatment with T-DXd 2. Uncontrolled or significant cardiovascular disease, including any of the following: 1. History of myocardial infarction within 6 months before enrolment 2. History of symptomatic congestive heart failure (New York Heart Association Class II to IV); 3. Corrected QT interval (QTc) prolongation to \> 470 ms (females) or \>450 ms (male); 4. LVEF \< 50% within 28 d prior to treatment initiation. 3. Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening. 4. Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. * Subjects with clinically inactive brain metastases may be included in the study. * Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 wk must have elapsed between the end of whole brain radiotherapy and study enrollment. 5. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product or to other mAbs. 6. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. 7. Known human immunodeficiency virus (HIV) infection or active hepatitis B or C infection. 8. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the investigator after consultation with the Sponsor Medical Monitor or designee (eg, Grade 2 chemotherapy-induced neuropathy). 9. Therapeutic radiation therapy or major surgery within 4 wk before enrolment or palliative stereotactic radiation therapy within 2 wk before enrolment. 10. Systemic treatment with anticancer therapy (immunotherapy \[non-antibody-based therapy\], retinoid therapy, or hormonal therapy) within 3 wk before enrolment; antibody-based-anticancer-therapy within 4 wk before enrolment; or treatment with nitrosoureas or mitomycin C within 6 wk before randomization; or treatment with small-molecule targeted agents within 2 wk or 5 half-lives before enrolment, whichever is longer. 11. Participation in a therapeutic clinical study within 3 wk before enrolment (for small-molecule targeted agents, this non-participation period is 2 wk or 5 half-lives, whichever is longer), or current participation in other investigational procedures. 12. Pregnant, breastfeeding, or planning to become pregnant. 13. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any un
Triage Survey for Cardiovascular, Obesity, and Related Endocrine Trial Eligibility
NCT06412536
Recruiting
Conditions Cardiovascular Diseases, Obesity, PreDia...
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Blood work

Primary Outcomes

  • Number of participants who are interested in industry-sponsored clinical research
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: 2024-05-30
Completion: 2029-04-17
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Brooklyn Clinical Research
Principal Investigators:
  • Ammara Mushtaq, MD (PRINCIPAL_INVESTIGATOR) - Brooklyn Clinical Research
Contact Information
Study Contact:
Ammara Mushtaq, MD
929-203-5879
amushtaq@brooklynclinicalresearch.com
Katherine Azer, MS
929-332-7848
kazer@brooklynclinicalresearch.com
Interventions
  • Blood work
Study Locations (1 sites)
Brooklyn Clinical Research, Brooklyn, New York 11226 United States
Eligibility Criteria
Inclusion Criteria: 1. Participant or Legally Authorized Representative has signed an ICF prior to study-specific procedures being performed. 2. Participant is at least 18 years old. Exclusion Criteria: 1. Participant is pregnant, breast-feeding, or planning to become pregnant. 2. History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results. 3. Moderate or severe substance use disorder within 90 days prior to screen 4. Any condition that in the investigator's opinion makes a participant unsuitable for the study. 5. Currently employed by Swift Clinical Research Group, Inc. or any of its subsidiaries, including Brooklyn Clinical Research, or a first-degree relative of an employee.
Comparative-effectiveness of a Healthy Lifestyle and Asthma Management Program, In-person vs. ONline
NCT06432790
Recruiting
Conditions Overweight, Childhood, Obesity, Childhoo...
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

  • CHAMPION

Primary Outcomes

  • Change in Child Body Mass Index (BMI)
  • Change in Child BMI z-score
  • Change in Asthma Control Test
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-07-17
Completion: 2028-07-31
Eligibility
Age: 4 Years
Sex: ALL
Volunteers: false
Enrollment: 500 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Massachusetts General Hospital
Collaborators: Patient-Centered Outcomes Research Institute
Contact Information
Study Contact:
Lauren Fiechtner, MD
617-726-8705
lfiechtner@mgb.org
Sheila Kelly, MPH
skelly45@mgh.harvard.edu
Interventions
  • CHAMPION
Study Locations (1 sites)
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Eligibility Criteria
Caregiver-proxies will be 18 years old or older, English or Spanish speaking, and a primary caregiver of a child meeting the following criteria: Inclusion criteria * Age 4-17.9 years at time of screening * BMI ≥ 85th percentile * Asthma or reactive airway disease diagnosis, per child's Electronic Health Record (EHR) documentation and caregiver report Exclusion criteria * Diagnosis of anorexia nervosa, per child's EHR or caregiver report * Pregnant, per child's EHR * Plan to change pediatricians in the next year, per caregiver report * Opted out of research, per child's EHR * Sibling currently enrolled in the research trial, per enrollment log or caregiver report
Potts-shunt for the Treatment of Pediatric Patients With Severe Pulmonary Hypertension
NCT06429579
Recruiting
Conditions Pulmonary Artery Hypertension
Phase NA
Enrollment 120
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

  • Comprehensive therapy combined Potts-shunt procedure and conventional drug therapy
  • Only conventional drug therapy

Primary Outcomes

  • Mortality or Lung transplantation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-04-23
Completion: 2029-04-23
Eligibility
Age: 6 Months
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: China National Center for Cardiovascular Diseases
Contact Information
Study Contact:
Shoujun Li, MD
+8613501071589
drlishoujunfw@163.com
Interventions
  • Comprehensive therapy combined Potts-shunt procedure and conventional drug therapy
  • Only conventional drug therapy
Study Locations (1 sites)
Pediatric cardic surgical center, Fuwai Hospital, Beijing, Beijing Municipality 100037 China
Eligibility Criteria
Inclusion Criteria: 1. 6 months \&lt; age ≤ 18 years; 2. ESC 2022 Group I PAH; 3. Have received standardized drug therapy for at least 6-9 months and still remain at intermediate to high/high-risk status of the criteria of ESC2022; 4. Presenting with significant clinical manifestations (i.e., progressive symptoms/syncope history/growth and development restriction, etc); 5. Informed consent form signed by the patient and their guardian. Exclusion Criteria: 1. ESC 2022 Group II-V PAH; 2. Poor right ventricular function: RVEF \&lt; 25% or RVFAC \&lt; 20%; 3. Deteriorated general condition: requiring ICU resuscitation or ECMO assistance; 4. Pulmonary artery pressure/main arterial pressure ratio \&lt; 0.7; 5. Six-minute walk distance \&lt; 150 meters (only applicable to patients aged 8 and above); 6. No significant improvement in RVEF under triple drug therapy.
Combination Short-Acting BroNchodilator and Inhaled Corticosteroid Rescue Therapy on Health Outcomes in Routine Care
NCT06422689
Active, positions filled
Conditions Asthma
Phase PHASE4
Enrollment 1511
Locations 11 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

  • Albuterol and budesonide inhalation aerosol

Primary Outcomes

  • Asthma exacerbation
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Active, positions filled
Start Date: 2024-05-10
Completion: 2027-02-03
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 1511 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Collaborators: Premier HealthCare Solutions Inc.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Albuterol and budesonide inhalation aerosol
Study Locations (11 sites)
Research Site, North Hollywood, California 91602 United States
Research Site, Walnut Creek, California 94598 United States
Research Site, Louisville, Kentucky 40217 United States
Research Site, Boston, Massachusetts 02111 United States
Research Site, Ann Arbor, Michigan 48109 United States
Research Site, Flint, Michigan 48532 United States
Research Site, Minneapolis, Minnesota 55425 United States
Research Site, Asheville, North Carolina 28803 United States
Research Site, Greenville, North Carolina 27834 United States
Research Site, DuBois, Pennsylvania 15801 United States
Eligibility Criteria
Inclusion Criteria: 1. Adults aged 18 years and above as of enrollment date. 2. At least 1 diagnosis of asthma prior to the enrollment date documented in patient record. 3. At least 1 prescription filled for Short-acting beta-agonist (SABA)-only inhaler (i.e., albuterol-only or levalbuterol only inhalers) within 12 months before enrollment date. 4. At least 1 severe asthma exacerbation within 12 months before enrollment date. 5. Had both medical and pharmacy insurance coverage (e.g., Medicare, Medicaid, and commercial insurance) for at least 12 months before enrollment date and without foreseeable plans to discontinue insurance coverage within 12 months after enrollment date. 6. Participants also need to meet each of the following inclusion criteria: 1. Willingness to use albuterol and budesonide as rescue as instructed by their physician, prescribing information, and United States instruction for use (USIFU). 2. Willingness to respond to quarterly safety inquiries. 3. Willingness to participate in quarterly electronic patient-reported outcome (PRO) surveys via email or text. 4. Physician decision that participant is eligible for treatment with albuterol and budesonide as rescue according to the approved United States prescribing information (USPI). Exclusion Criteria: 1. Conditions with major respiratory diagnoses including chronic obstructive pulmonary disease (COPD), cystic fibrosis, pulmonary fibrosis, bronchiectasis, respiratory tract cancer, bronchopulmonary dysplasia, sarcoidosis, lung cancer, interstitial lung disease, pulmonary hypertension, and tuberculosis in 12 months before the enrollment date. 2. Inpatient admission or emergency department or urgent care visit due to asthma in the 10 days before enrollment date, or self-reported use of systemic corticosteroid for the treatment of asthma in the 10 days before enrollment date. Participants who were screen-failed due to this criterion may be re-screened once the participant is more than 10 days post asthma-related inpatient admission, emergency department or urgent care visit, or systemic corticosteroid use. 3. Chronic use of oral corticosteroids (for any condition) within 3 months before enrollment date. Chronic use of oral corticosteroids is defined as: daily or every other day use for 21 days or longer. 4. History of albuterol and budesonide as rescue use within 12 months before enrollment date. 5. History of any malignancy (except non-melanoma neoplasms of skin) in 12 months before the enrollment date. 6. For females only - currently pregnant or breastfeeding on enrollment date. Participants are excluded from the study if any of the following criteria apply.
Fasenra Pediatric Japan Post-Marketing Study(PMS)
NCT06427876
Active, positions filled
Conditions Bronchial Asthma
Phase Not Applicable
Enrollment 40
Locations 11 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Incidence of ADRs
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2024-07-16
Completion: 2028-12-31
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 40 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Principal Investigators:
  • Shunsuke Hiroki (STUDY_DIRECTOR) - AstraZeneca
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (11 sites)
Research Site, Aichi, Japan
Research Site, Chiba, Japan
Research Site, Hiroshima, Japan
Research Site, Hokkaido, Japan
Research Site, Hyōgo, Japan
Research Site, Ibaraki, Japan
Research Site, Kumamoto, Japan
Research Site, Mie, Japan
Research Site, Okayama, Japan
Research Site, Osaka, Japan
Eligibility Criteria
Inclusion Criteria: The evaluable patients in children aged ≥6 years to \<15 years are those treated with Fasenra for the first time due to "Bronchial asthma (only the patients with intractable bronchial asthma which could not be controlled with the existing therapy) Exclusion Criteria: none
FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion
NCT06416163
Not yet recruiting
Conditions Interstitial Lung Disease, Fibrosis Lung...
Phase Not Applicable
Enrollment 160
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

  • Prospective

Primary Outcomes

  • Change in 6-minute walk distance
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2024-07-01
Completion: 2029-07-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
Principal Investigators:
  • Alex West, MBBS (PRINCIPAL_INVESTIGATOR) - Guys and St. Thomas NHS Foundation Hospital
Contact Information
Study Contact:
Alexandra Lawrence, MBBS
02071887188
alexandra.lawrence@gstt.nhs.uk
Gillian Radcliffe, BSc
07395285492
gillian.radcliffe@gstt.nhs.uk
Interventions
  • Prospective
Study Locations (1 sites)
Guy's & St Thomas' NHS Foundation Trust, London, SE1 9RT United Kingdom
Eligibility Criteria
Inclusion Criteria: 1. Patients aged 18 year and over 2. Tertiary MDT diagnosis of FILD with \>10% fibrosis on CT chest as determined by the investigator. Underlying diagnoses to include but not limited to: idiopathic pulmonary fibrosis (IPF), non-specific interstitial pneumonitis (NSIP), chronic hypersensitivity pneumonitis (CHP), connective tissue disease-related interstitial lung disease (CTD-ILD), fibrotic organising pneumonia (FOP) and pulmonary sarcoidosis. 3. Able to provide informed written consent Exclusion Criteria: 1. The use of or any indication for long-term oxygen therapy (LTOT) 2. Known moderate or severe obstructive sleep apnoea with an apnoea/hypopnoea index (AHI) or oxygen desaturation index (ODI) over 15 events per hour 3. Radiological predominance of emphysema compared with fibrosis on CT chest 4. Inability to complete all health status questionnaires as set out in this protocol, with appropriate support 5. A confirmed diagnosis of pulmonary hypertension 6. Significant cardiovascular comorbidity including severe, uncontrolled hypertension, uncontrolled arrhythmia, recent acute coronary syndrome within 30 days prior to study enrolment, that could mean exercise testing poses a risk to patient health, in the opinion of the investigator 7. Musculoskeletal comorbidity that will preclude the participant's ability to reliably complete the complete 6-minute walk test (6MWT) 8. Participation in another research project which may confound this study's research findings
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
NCT06428396
Active, positions filled
Conditions Metastatic Breast Cancer
Phase PHASE2
Enrollment 120
Locations 41 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

  • Belzutifan
  • Fulvestrant
  • Everolimus
  • Exemestane

Primary Outcomes

  • Progression-free Survival (PFS)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2024-11-27
Completion: 2028-12-25
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 120 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Merck Sharp & Dohme LLC
Principal Investigators:
  • Medical Director (STUDY_DIRECTOR) - Merck Sharp & Dohme LLC
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Belzutifan
  • Fulvestrant
  • Everolimus
  • Exemestane
Study Locations (41 sites)
City of Hope - Phoenix ( Site 0006), Goodyear, Arizona 85338 United States
Cedars Sinai Medical Center ( Site 0012), Beverly Hills, California 90211 United States
Moores Cancer Center at UC San Diego Health ( Site 0025), La Jolla, California 92093 United States
USC/Norris Comprehensive Cancer Center ( Site 0013), Los Angeles, California 90033 United States
USC Norris Oncology Hematology Newport Beach ( Site 0029), Newport Beach, California 92663 United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011), Marietta, Georgia 30060 United States
Southeastern Regional Medical Center ( Site 0010), Newnan, Georgia 30265 United States
CHRISTUS Highland ( Site 0005), Shreveport, Louisiana 71105 United States
Renown Regional Medical Center ( Site 0018), Reno, Nevada 89502 United States
MD Anderson Cancer Center at Cooper ( Site 0024), Camden, New Jersey 08103 United States
Eligibility Criteria
Inclusion Criteria: * Has a diagnosis of estrogen receptor positive (ER+)/human epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent * Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET) * Provides additional tissue from the same sample used to determine ER and HER2 status locally * Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4/6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4/6 inhibitor where the CDK 4/6 inhibitor was discontinued due to intolerance * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has Breast cancer amenable to treatment with curative intent * Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane) * Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass * Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications * Has active, bleeding diathesis, or on oral anti-vitamin K medication * Has history of noninfectious pneumonitis/interstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis/interstitial lung disease * Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting * Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting * Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced/metastatic setting * Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention * Is currently receiving either a strong inhibitor or inducer of CYP3A4 that cannot be discontinued for the duration of the study * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention * Has concurrent active Hepatitis B and Hepatitis C virus infection * Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure * Has not adequately recovered from major surgery or have ongoing surgical complications
Longitudinal Study of Gene Expression in the Human Placenta During First-trimester and Full-term Pregnancy at the Single Cell Level
NCT06427408
Recruiting
Conditions Pregnancy Related
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Non applicable

Primary Outcomes

  • Analysis of the cellular transcriptomic trajectory of the human placenta
  • Analysis of the cellular transcriptomic trajectory of the human placenta
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: 2026-03-25
Completion: 2029-02
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Collaborators: Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
Principal Investigators:
  • Céline MÉHATS, PHD (STUDY_DIRECTOR) - Institut National de la Santé Et de la Recherche Médicale, France
  • Hélène COLLINOT, MD (PRINCIPAL_INVESTIGATOR) - APHP
Contact Information
Study Contact:
Vassilis TSATSARIS, MD PHD
00331 58 41 38 71
vassilis.tsatsaris@aphp.fr
Marie BENHAMMANI-GODARD
0033158411190
marie.godard@aphp.fr
Interventions
  • Non applicable
Study Locations (1 sites)
Maternité Port-Royal, Cochin hospital, Paris, IDF 75014 France
Eligibility Criteria
Inclusion Criteria: * Age 18 to 50 * Progressive monofoetal pregnancy between 11 and 15 weeks of amenorrhea * Patient with prenatal medical indication and requesting chorionic villus biopsy with cytogenetic analysis or molecular genetics * Patient scheduled for delivery at Port-Royal Maternity Hospital Exclusion Criteria: * Minor patient * Multiple pregnancy * Patient's objection * Without health insurance * Patient under guardianship or curatorship
QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer
NCT06404736
Not yet recruiting
Conditions Early Breast Cancer, Neoadjuvant Therapy...
Phase PHASE2
Enrollment 73
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

  • Bispecific antibody (bsAb) targeting PD-1 and CLTA-4
  • Albumin-bound paclitaxel
  • Carboplatin

Primary Outcomes

  • Total Pathological complete response (tpCR) rate using the definition of ypT0/Tis, N0
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Not yet recruiting
Start Date: 2024-05-07
Completion: 2030-11-07
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 73 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fudan University
Contact Information
Study Contact:
Zhi-Ming Shao, MD, PhD
+86-021-64175590
zhi_ming_shao@163.com
Li Chen, MD
+86-021-64175590
Interventions
  • Bispecific antibody (bsAb) targeting PD-1 and CLTA-4
  • Albumin-bound paclitaxel
  • Carboplatin
Study Locations (1 sites)
Zhimin Shao, Shanghai, Not US/Canada 200032 China
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily join this study and sign the informed consent form; 2. Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO/CAP guidelines, histopathologically confirmed TNBC breast cancer, histological grade II, TNM stage T1cN1-cN2 or T2-T4, cN0-cN2; 3. According to RECIST 1.1, there is at least one measurable lesion; 4. ECOG score: 0\~1; 5. Tumor tissue specimens that can be used for biomarker detection; The function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication): Inclusion Criteria: 1. Voluntarily join this study and sign the informed consent form; Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO/CAP guidelines, histopathologically confirmed ER+/HER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2; 2. According to RECIST 1.1, there is at least one measurable lesion; ECOG score: 0\~1; Tumor tissue specimens that can be used for biomarker detection; The function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication): (1) Absolute neutrophil count ≥1.5×109/L; (2) Platelets ≥100×109/L; (3) Hemoglobin ≥90 g/L; (4) Serum albumin ≥30 g/L; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy). Exclusion Criteria: 1. The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; 2. Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 3. Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \>10 mg/day prednisone or other effective hormones), and are still using it within 2 weeks before enrollment; 4. Severe allergic reactions to other monoclonal antibodies; Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 5. Those with known central nervous system metastasis; 6. Suffered from other malignant tumors in the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical cancer in situ); 7. Suffering from high blood pressure that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); the above parameters are allowed to be achieved through the use of antihypertensive treatment; there has been a hypertensive crisis or high blood pressure in the past Hypertensive encephalopathy; 8. Have cardiac clinical symptoms or diseases that cannot be well controlled, such as (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc\>450ms (male); QTc\>470ms (female); 9. Those who are receiving thrombolysis or anticoagulation therapy are allowed to use low-dose aspirin and low-molecular-weight heparin prophylactically; 10. Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive during the baseline period, it can be re-examined. If it is still positive after the reexamination, a gastroscopy is required; 11. The tumor invades important blood vessels, or the researcher determines based on imaging that there is a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding; 12. Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage; 13. Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 14. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia patients, coagulation disorders, etc.); 15. Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment; 16. Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount \>1.0 g; 17. Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count \>15×109/L; 18. Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU/ml, or hepatitis C virus antibody positive; Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period; 19. In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient's safety.
Association of Pembrolizumab Infusion Time and Efficacy in Patients With Non-metastatic Triple-negative Breast Cancer (TNBC) Treated With Neoadjuvant Chemotherapy and Immunotherapy
NCT06418139
Not yet recruiting
Conditions Non-Metastatic Breast Carcinoma
Phase Not Applicable
Enrollment 450
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • No intervention

Primary Outcomes

  • Residual cancer burden class (RCB)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2024-05
Completion: 2026-09
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 450 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Assistance Publique - Hôpitaux de Paris
Contact Information
Study Contact:
Sylvie Giacchetti, Dr
+33142499785
sylvie.giacchetti@aphp.fr
Jérôme Lambert, Pr
+33142499742
jerome.lambert@u-paris.fr
Interventions
  • No intervention
Eligibility Criteria
Inclusion Criteria: * Female sex * Age ≥ 18 years-old * Previously untreated histologically proven triple-negative breast cancer (RE \< 10%, RP \< 10%, Her-2 negative) * No metastatic * Having at least one injection of pembrolizumab associated with chemotherapy * Pembrolizumab injection schedule correctly reported by the nurse in charge of the patient Exclusion Criteria: • Metastatic disease
REBECCA-3 Study, Research on Breast Cancer Induced Chronic Conditions Supported by Causal Analysis of Multi-source Data
NCT06435091
Active, positions filled
Conditions Cancer Related Fatigue
Phase Not Applicable
Enrollment 40
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Evaluation of the average REBECCA system usage rate throughout the monitoring period.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2023-12-15
Completion: 2025-06
Eligibility
Age: 19 Years
Sex: MALE
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Helse Stavanger HF
Principal Investigators:
  • Svein Skeie, PhD (STUDY_DIRECTOR) - Helse Stavanger HF
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Stavanger University Hospital, Stavanger, 4067 Norway
Eligibility Criteria
Inclusion Criteria: * Prostate cancer patients with histologically detectable M0 prostate cancer requiring primary surgery or primary radiation therapy followed by hormone therapy at least and no more than 3 months of initiation prior to study start * Male prostate cancer patients under 80 years of age. * Patients who have an increased life expectancy beyond the first 3 months after starting treatment. * Patients who have the ability to understand the protocol and can participate in the follow-up plan. * Patients who have the absence of psychological, familial, sociological, or geographic condition potentially hindering compliance with the study protocol and follow-up schedule. * Patients who have a smart phone. Exclusion Criteria: * Patients who do not consent to the study protocol. * Patients with a previous cancer diagnosis (except skin cancer treated only by surgery). * Patients who have previously been treated with any form of chemotherapy/radiotherapy. * Foreign-language patients without sufficient Norwegian understanding * Patients who do not have a smartphone
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer
NCT06434064
Recruiting
Conditions Anatomic Stage III Breast Cancer AJCC v8...
Phase PHASE2
Enrollment 30
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

  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography
  • Magnetic Resonance Imaging

Primary Outcomes

  • Overall response rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-03-03
Completion: 2028-11-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Roswell Park Cancer Institute
Principal Investigators:
  • Sheheryar Kabraji (PRINCIPAL_INVESTIGATOR) - Roswell Park Cancer Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Biopsy
  • Biospecimen Collection
  • Computed Tomography
  • Echocardiography
  • Magnetic Resonance Imaging
Study Locations (1 sites)
Roswell Park Cancer Institute, Buffalo, New York 14263 United States
Eligibility Criteria
Inclusion Criteria: * Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines of therapy in the metastatic setting * Patients must have a confirmed eligible TP53 genomic alteration, as determined by the Roswell Park Oncomine™ Precision Assay (OPA) or similar CLIA-approved assay, using either an archival metastatic tumor sample or, if unavailable, a fresh biopsy. Uncertainty about the eligibility of the TP53 genomic alteration for this study can be resolved by discussion with the study PI * Patients must have ERα (estrogen receptor alpha) and PgR (progesterone receptor) status assessed using current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Patients are eligible if the tumor staining is ERα low/negative (ER ≤ 10%) and PgR negative by ASCO/CAP guidelines * The tumor must be HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative * Patients must be ≥ 18 years of age * Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Absolute neutrophil count (ANC) ≥ 1500/ μL * Hemoglobulin (hb) ≥ 9 g/dL * Platelet count ≥ 100,000/ μL * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x ULN * Creatinine clearance \> 60 mL/min (Cockroft-Gault Equation) * Left ventricular ejection fraction (LVEF) assessment must be performed within 30 days prior to enrollment. (LVEF assessment performed by 2-D echocardiogram is preferred; however, multigated acquisition scan \[MUGA\] scan may be substituted based on institutional preferences). The LVEF must be ≥ 50% regardless of the cardiac imaging facility's lower limit of normal * Patients must be able to swallow oral medications * Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Patients must not have any known contraindications to endocrine therapy, in the opinion of the treating investigator * Participants who have had chemotherapy, hormonal/endocrine therapy, immunotherapy, biologics or radiotherapy (as well as any other investigational agents/devices) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C), or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier * Have a known history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or any of its excipients * Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, transient ischemic attack (TIA), or pulmonary embolism * Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness * Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimen. This includes angina pectoris, arrhythmias except for benign premature ventricular contractions, a history of myocardial infarction, documented congestive heart failure (CHF) or cardiomyopathy * Patients with cirrhosis or severe hepatic impairment * Patients must not have a condition or an uncontrolled intercurrent illness including, but not limited to any of the following: ongoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection (UTI), or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant or nursing female participants * Unwilling or unable to follow protocol requirements * Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request
NCT06415266
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 264
Locations 9 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Quality of life questionnaire (QLQ)
  • Satisfaction survey
  • Assessment of patient needs in the field of oncosexology

Primary Outcomes

  • Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-08-09
Completion: 2028-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 264 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Principal Investigators:
  • Véronique D'HONDT, Dr (PRINCIPAL_INVESTIGATOR) - Institut du Cancer de Montpellier (ICM)
Contact Information
Study Contact:
Aurore MOUSSION
04 67 61 31 02
DRCI-icm105@icm.unicancer.fr
Emmanuelle TEXIER
04 67 61 31 02
DRCI-icm105@icm.unicancer.fr
Interventions
  • Quality of life questionnaire (QLQ)
  • Satisfaction survey
  • Assessment of patient needs in the field of oncosexology
Study Locations (9 sites)
Institut de Cancérologie de l'Ouest, Saint-Herblain, Saint Herblain 44805 France
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy 54519 France
Centre Léon Bérard, Lyon, 69008 France
ICM Val d'Aurelle, Montpellier, 34298 France
Centre Antoine Lacassagne, Nice, 06189 France
CHU de Nîmes, Nîmes, 30029 France
Institut Curie, Paris, 75005 France
IUCT - Oncopole, Toulouse, 31100 France
Institut Gustave Roussy, Villejuif, 94800 France
Eligibility Criteria
Inclusion Criteria: * Woman or man at least 18 years old * Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor * Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously * Patient with sufficient command of the French language to be able to answer the questionnaires * Patient having given informed, written and express consent. * Affiliation to the French Social Security System * Willingness and ability to comply with scheduled visits, treatment plan and other study procedures Exclusion Criteria: * Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments) * Metastatic disease * Patient under guardianship, curatorship or safeguard of justice
Evaluation of Efficacy and Safety of Combination Therapy of Henagliflozin Proline, Retagliptin and Metformin in New Diagnosed Type 2 Diabetes Patients
NCT06417489
Not yet recruiting
Conditions Type 2 Diabetes
Phase PHASE4
Enrollment 160
Locations 0 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

  • Combination therapy
  • Sequential treatment group

Primary Outcomes

  • Proportion of subjects with HbA1c<7% at 12w
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: 2024-05-31
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 160 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Peking University First Hospital
Contact Information
Study Contact:
Junqing Zhang
8613611167278
nan.gu@pkufh.cn
Interventions
  • Combination therapy
  • Sequential treatment group
Eligibility Criteria
Inclusion Criteria: 1. Untreated newly diagnosed T2DM patients; 2. Age ≥ 18 years old; 3. 8.0% ≤ HbA1c\&lt;11.0%; 4. 19 kg/m2 ≤ BMI\&lt;35 kg/m2; 5. eGFR ≥ 60 ml/min1.73m2; 6. Voluntarily participate and sign an informed consent form Exclusion Criteria: 1. Pregnant and lactating women, as well as women of childbearing age who are unwilling to take reliable contraceptive measures; 2. Individuals who are known to be allergic to Henggliflozin, Regagliptin, or Metformin; 3. Other types of diabetes except type 2 diabetes; 4. Type 2 diabetes with a history of ketoacidosis (DKA) in the last 6 months; 5. NYHA cardiac grade IV patients; 6. Within 30 days prior to the screening visit, admission due to acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery; Or plan to undergo percutaneous coronary intervention or cardiac surgery within 3 months. 7. Confirmed respiratory system diseases (such as chronic obstructive pulmonary disease, pulmonary arterial hypertension, etc.); 8. History of acute or chronic pancreatitis; 9. Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (average of three supine blood pressure measurements) during screening visits; 10. Patients with orthostatic hypotension and/or systolic blood pressure\&lt;90 mmHg at visit 0 or visit 1, or clinically diagnosed as having low blood volume; 11. Diagnosed malignant tumor patients with an expected life expectancy of less than 1 year; 12. Patients with a history of recurrent urinary and reproductive tract infections (judged by clinical doctors); 13. Patients who participate in other clinical trials within 3 months; 14. Alcohol or drug addiction. 15. In addition to the above, the researchers determined that patients who are not suitable to participate in this clinical trial.
Clinical Trial Protocol: Randomized Placebo-Controlled Pilot Study of GcMAF (Soloways TM) in Patients With Metastatic Breast Cancer
NCT06434077
Not yet recruiting
Conditions Breast Cancer
Phase PHASE3
Enrollment 60
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

  • GcMAF injections (100 ng)
  • placebo

Primary Outcomes

  • Change in Serum Nagalase Levels
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: 2025-08-20
Completion: 2026-12-20
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: S.LAB (SOLOWAYS)
Collaborators: Center of New Medical Technologies
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • GcMAF injections (100 ng)
  • placebo
Study Locations (1 sites)
Center of New Medical Technologies, Novosibirsk, Novosibisk Region 630090 Russia
Eligibility Criteria
Inclusion Criteria: * Diagnosis: * Histologically or cytologically confirmed metastatic breast cancer. * Evidence of metastatic disease, confirmed by imaging studies (CT, MRI, or PET scans) and/or biopsy. 2. Prior Treatment: * Patients must have completed at least one line of systemic therapy (e.g., chemotherapy, hormone therapy, targeted therapy) for metastatic breast cancer. * A minimum of 4 weeks must have elapsed since the last chemotherapy, targeted therapy, or radiotherapy before starting the study treatment. 3. Age: * Female patients aged 18 to 70 years. 4. Performance Status: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5. Life Expectancy: * Estimated life expectancy of at least 6 months. 6. Laboratory Values: * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥ 100 x 10\^9/L, and hemoglobin ≥ 9 g/dL. * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver metastases). * Adequate renal function: Serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 60 mL/min/1.73 m\^2 (calculated using the Cockcroft-Gault formula). 7. Contraception: * Women of childbearing potential must agree to use effective contraception (e.g., hormonal contraceptives, intrauterine device, barrier methods, or abstinence) during the study and for at least 6 months after the last dose of study treatment. 8. Informed Consent: * Ability to understand and willingness to sign a written informed consent document. 9\. Compliance: * Willingness and ability to comply with the study protocol, including scheduled visits, treatment plans, laboratory tests, and other study procedures. 10. Nagalase Levels: • Elevated serum nagalase levels above the normal range, indicating active tumor burden. Exclusion Criteria: * Concurrent Malignancies: * Presence of other active malignancies (excluding adequately treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix). 2. Severe Comorbid Conditions: * Severe uncontrolled concurrent illness, such as significant cardiovascular disease (e.g., uncontrolled hypertension, recent myocardial infarction), severe pulmonary conditions (e.g., uncontrolled asthma, chronic obstructive pulmonary disease), or active infections requiring systemic therapy. 3. Pregnancy and Lactation: * Pregnant or breastfeeding women. 4. Previous GcMAF Treatment: * Previous treatment with GcMAF. 5. Allergies and Sensitivities: * Known hypersensitivity to any component of the study drug or its formulation.
Non-invasive BCI and Application Verification for Depressed People
NCT06417437
Recruiting
Conditions Depression, Major Depressive Disorder, B...
Phase PHASE4
Enrollment 400
Locations 1 sites
Compensation incentive available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • SSRI
  • rTMS
  • Neuro-Feedback
  • Game Regulation

Primary Outcomes

  • EEG power in alpha band between the depression patient group and healthy controls.
  • EEG power in beta band between the depression patient group and healthy controls.
  • MRI imaging of DLPFC between the depression patient group and healthy controls.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE4
Status: Recruiting
Start Date: 2023-07-01
Completion: 2027-07-31
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: true
Enrollment: 400 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Mental Health Center
Collaborators: The Fourth People's Hospital of Chengdu, Shanghai Jiao Tong University School of Medicine, University of Electronic Science and Technology of China, East China Normal University
Principal Investigators:
  • Zhenghui Yi, chief physician (STUDY_CHAIR) - Shanghai Mental Health Center
Contact Information
Study Contact:
Zhenghui Yi, chief physician
18017311007
yizhenghui1971@163.com
Qinyu Lv, chief physician
18616550357
lvqinyu_louis@163.com
Interventions
  • SSRI
  • rTMS
  • Neuro-Feedback
  • Game Regulation
Study Locations (1 sites)
Shanghai Mental Health Center, Shanghai, Shanghai Municipality 200030 China
Eligibility Criteria
Inclusion Criteria: * ≥ 12 years old, male or female, right-handed, Han ethnicity * Meets the DSM-5 diagnostic criteria for depression, with HAMD-17 scores greater than 17 and YMRS scores less than 6; * Primary school education or above, able to understand the research content, willing to participate in this study and sign an informed consent form Exclusion Criteria: * Concomitant or previous history of organic brain disease or severe traumatic brain injury, personal or family history of epilepsy; * Severe abnormalities in heart, liver, and kidney function; * Patients with severe physical illnesses; * History of substance dependence or abuse (alcohol, cocaine, drugs, etc.); * Patients with mental disorders caused by organic diseases, drug or alcohol induced mental disorders, and other mental disorders; * Pregnancy or lactation period; * Within six months, physical therapy such as MECT and TMS should be used; * Implants of vegetative nerve stimulation; * Individuals who have implanted electronic or metal instruments (such as pacemakers, defibrillators, stents, orthopedic plates, etc.) and undergo ventriculoperitoneal shunt surgery; * Obvious visual and auditory impairment, unable to cooperate in completing neuropsychological and scale assessments.
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer
NCT06407401
Not yet recruiting
Conditions ER+ Breast Cancer, HER2-negative Breast ...
Phase PHASE3
Enrollment 399
Locations 0 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

  • Duloxetine 60 MG
  • Furosemide 40 mg
  • Booklet for healthy behaviors

Primary Outcomes

  • Endocrine therapy related musculoskeletal pain
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: 2024-12
Completion: 2028-11-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 399 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Contact Information
Study Contact:
EORTC HQ
+3227741611
eortc@eortc.org
Interventions
  • Duloxetine 60 MG
  • Furosemide 40 mg
  • Booklet for healthy behaviors
Eligibility Criteria
Inclusion criteria: * Female (both pre- and postmenopausal) or male patients * Age ≥18 years * Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III * Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction * Present endocrine therapy related MSK pain (arthralgia and/or bone pain and/or myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit: * Grade 2: moderate pain; limiting instrumental activities daily living (ADL) * Grade 3: severe pain; limiting activities self-care ADL * Previous chemotherapy is allowed if completed at least 3 months before enrolment * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 * Adequate organ function * Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module) * Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment. Note: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons. * Patients of childbearing / reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation. * Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment. Exclusion criteria: * Current history of moderate/severe depression and/or anxiety, both defined as grade≥2 CTCAE V5.0 * History of suicide-related events * Current use of diuretics, antidepressants and/or phytoestrogens * Current use of prescribed or natural medicines with known interactions with furosemide and/or duloxetine * Contraindications to duloxetine: * Severe renal impairment (creatinine clearance \&lt; 30 mL/min) * Uncontrolled hypertension * Hepatic impairment Child Pugh Class B or C * Contraindications to furosemide: * Symptomatic hypotension, hypovolemia, or dehydration * Severe renal impairment (creatinine clearance \&lt; 30 mL/min) * Severe hypokalaemia and/or severe hyponatremia * Addison's disease * Porphyria * Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. * Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction/motility disorder, malabsorption syndrome, or prior gastric bypass * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial. * Participation in another interventional study with drugs.
An Innovative Master Platform for Clinical Trials in Mood Disorders
NCT06408012
Recruiting
Conditions Mood Disorders, Depressive Disorder, Bip...
Phase Not Applicable
Enrollment 2200
Locations 9 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Rate of participation in the master trial platform
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2023-10-17
Completion: 2029-03-31
Eligibility
Age: 16 Years
Sex: ALL
Volunteers: true
Enrollment: 2200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: St. Joseph's Healthcare Hamilton
Collaborators: Unity Health Toronto, Centre for Addiction and Mental Health, Queen's University, University of Ottawa, University of British Columbia, University of Calgary, McGill University, Nova Scotia Health Authority, University of Michigan, Simon Fraser University, University Health Network, Toronto
Principal Investigators:
  • Benicio N Frey (PRINCIPAL_INVESTIGATOR) - St. Joseph's Healthcare Hamilton
Contact Information
Study Contact:
Saba Khoshroo
905-522-1155
skhoshro@stjoes.ca
Interventions
N/A
Study Locations (9 sites)
University of Calgary, Calgary, Alberta T2N 4Z6 Canada
University of British Columbia, Vancouver, British Columbia V6T 2A1 Canada
Nova Scotia Health Authority, Halifax, Nova Scotia B3H 2E2 Canada
McMaster University, Hamilton, Ontario L8P 3B6 Canada
Queen's University, Kingston, Ontario K7L4X3 Canada
University of Ottawa, Ottawa, Ontario K1Z 7K4 Canada
University Health Network, Toronto, Ontario M5T 2S8 Canada
Centre for Addiction and Mental Health, Toronto, Ontario M6J 1H4 Canada
Ontario Shores Centre for Mental Health Sciences, Whitby, Ontario L1N 5S9 Canada
Eligibility Criteria
Inclusion Criteria Patients: 1. 16 years of age or older. 2. Meet criteria for bipolar or depressive disorders as defined by DSM-5. 3. Fluency in English, sufficient to complete the interviews and self-report questionnaires. Inclusion Criteria Healthy Comparison (HC) Participants: 1. 16 years of age or older. 2. No history of psychiatric disorders (according to DSM-5) or significant unstable medical conditions. 3. Fluency in English, sufficient to complete the interviews and self-report questionnaires.