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Showing 20 of 28375 trials
Use of Preoperative Postbiotic Supplementation in Colorectal Cancer Surgery
NCT07268846
Recruiting
Conditions Cancer (Colon Cancer, Breast Cancer, Lym...
Phase NA
Enrollment 164
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

  • Postbiotic
  • Placebo

Primary Outcomes

  • Postoperative complications within 30 days (Clavien-Dindo grade II or higher)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-06-01
Completion: 2027-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 164 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AC Camargo Cancer Center
Principal Investigators:
  • Samuel A Junior, MD, PhD (PRINCIPAL_INVESTIGATOR) - A.C.Camargo Cancer Center
Contact Information
Study Contact:
Samuel A Junior, MD, PhD
+5511 2189-5020
samuel.aguiar@accamargo.org.br
Bruna E Catin Kupper, PhD
+5511 2189-5010
bruna.catin@accamargo.org.br
Interventions
  • Postbiotic
  • Placebo
Study Locations (1 sites)
A.C.Camargo Cancer Center, São Paulo, São Paulo 01509-010 Brazil
Eligibility Criteria
Inclusion Criteria: * Individuals diagnosed with malignant neoplasm of the large intestine, specifically adenocarcinoma. * Patients over 18 years of age, of both sexes. * Patients who agree to participate in the study and sign the informed consent form. Exclusion Criteria: * Emergency or urgent surgeries. * Cytoreductive surgeries involving intraoperative intraperitoneal chemotherapy. * Extended surgeries for the treatment of recurrent tumors.
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
NCT07235176
Recruiting
Conditions Advanced ER+/HER2- Breast Cancer
Phase PHASE1, PHASE2
Enrollment 300
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

  • QLS1304 tablet+Fulvestrant or QLC1401
  • QLS1304 tablet+Fulvestrant,AI or QLC1401+CDK4/6i

Primary Outcomes

  • Recommended Phase II Dose (RP2D) of QLS1304 in combo therapy
  • objective response rate(ORR)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Recruiting
Start Date: 2026-01-16
Completion: 2031-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Qilu Pharmaceutical Co., Ltd.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • QLS1304 tablet+Fulvestrant or QLC1401
  • QLS1304 tablet+Fulvestrant,AI or QLC1401+CDK4/6i
Study Locations (1 sites)
Fudan University Cancer Hospital, Shanghai, China
Eligibility Criteria
Inclusion Criteria: 1. Volunteer to participate in this study, sign an informed consent form and have good compliance; 2. Age ≥ 18 years old, Male or female 3. ECOG score: 0-1 4. Expected survival ≥ 12 weeks 5. Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology; 6. Failed to at least one therapy line of endocrine therapy ; 7. Baseline presence of at least one measurable lesion according to the RECIST v1.1; 8. The functional level of important organs is basically normal, meeting the requirements of the scheme; 9. Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication; 10. Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation. 11. Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent. Exclusion Criteria: 1. Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug. 2. Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug. 3. Subjects require long-term or high-dose use of non-steroidal drugs. 4. Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1. 5. Subjects have a known or suspected severe allergy to the investigational drug or any of its components. 6. Subjects have other active malignant tumors within 3 years before the first use of the investigational drug. 7. Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease. 8. Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment. 9. Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption. 10. Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug. 11. Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.
Postpartum Education Via Artificial Intelligence for Recovery and Loneliness: A Randomized Controlled Trial
NCT07223736
Not yet recruiting
Conditions Pelvic Floor Disorder, Loneliness, Postp...
Phase NA
Enrollment 130
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Generative artificial intelligence (genAI) postpartum chatbot
  • Standard of Care (SOC)

Primary Outcomes

  • Prolapse and incontinence knowledge
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-11-10
Completion: 2026-11-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of California, San Diego
Contact Information
Study Contact:
Alexandra C Nutaitis, DO
858-657-7344
anutaitis@health.ucsd.edu
Cecile Ferrando, MD, MPH
(858) 657-1238
cferrando@health.ucsd.edu
Interventions
  • Generative artificial intelligence (genAI) postpartum chatbot
  • Standard of Care (SOC)
Study Locations (1 sites)
University of California San Diego, La Jolla, California 92093 United States
Eligibility Criteria
Inclusion Criteria: 1. Has the capacity to provide informed consent 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Postpartum persons, aged \>18 years old 4. Primiparous 5. Vaginal or cesarean delivery 6. English Speaking 7. Internet access and proficiency of internet access 8. Access to a smartphone 9. Postpartum 2-6 weeks Exclusion Criteria: 1. Multiparous 2. Major neonatal anomaly 3. Delivery \< 34 weeks gestational age 4. Intrauterine fetal demise (IUFD) 5. Enrollment in any interfering studies 6. Unanticipated NICU admission 7. Discharge home without live baby 8. Surrogates/gestational carrier 9. Birthing individuals with baby placed for adoption 10. Currently pregnant 11. Psychiatric history requiring psychiatric hospitalization prior to delivery 12. Other psychiatric conditions needing immediate attention and intervention as determined by study team and/or treatment team
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
NCT07219173
Recruiting
Conditions Asthma
Phase PHASE2
Enrollment 531
Locations 121 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

  • Brenipatide
  • Brenipatide
  • Placebo

Primary Outcomes

  • Annualized Asthma Exacerbation Rate Over 52 Weeks 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: 2025-10-22
Completion: 2028-06
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 531 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Eli Lilly and Company
Principal Investigators:
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-45 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) (STUDY_DIRECTOR) - Eli Lilly and Company
Contact Information
Study Contact:
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
317-615-4559
LillyTrials@Lilly.com
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Interventions
  • Brenipatide
  • Brenipatide
  • Placebo
Study Locations (121 sites)
AMR Clinical, Tempe, Arizona 85281 United States
NewportNativeMD, Inc., Newport Beach, California 92663 United States
California Medical Research Associates, Northridge, California 91324 United States
Peninsula Research Associates, Rolling Hills Estates, California 90274 United States
Asthma & Allergy Associates - Colorado Springs, Colorado Springs, Colorado 80907 United States
AMR Clinical, Doral, Florida 33172-2514 United States
Renstar Medical Research, Ocala, Florida 34470 United States
Avanza Medical Research Center, Pensacola, Florida 32503 United States
USF Health, Tampa, Florida 33613 United States
Axis Clinical Trials - Westchester, Westchester, Illinois 60154 United States
Eligibility Criteria
Inclusion Criteria: * Physician-diagnosed asthma who have received a physician-prescribed asthma controller medication for at least 12 months prior to screening visit. * Participants must have an asthma control questionnaire-6 (ACQ-6) score of ≥1.5 on 2 out of 3 visits before randomization. * History of 1 severe asthma exacerbation that led to systemic glucocorticoid treatment in the last 12 months prior to screening visit. Exclusion Criteria: * Participants are excluded from the study if any of the following criteria apply: * An established diagnosis of occupational asthma * Known pre-existing, clinically important lung condition other than asthma, including but not limited to: * chronic respiratory infection * bronchiectasis * pulmonary fibrosis * allergic bronchopulmonary aspergillosis * emphysema * chronic bronchitis * eosinophilic granulomatosis with polyangiitis * chronic obstructive pulmonary disease, and * other mimics of asthma, that is, vocal cord dysfunction. * Have a current or recent acute, active infection. For at least 30 days before screening visit and up to the randomization visit.
Link Between Reduction of Suicide Ideation by Esketamine in Add-On and Initial Levels of Psychological Pain and Anhedonia
NCT07199179
Active, positions filled
Conditions Depression - Major Depressive Disorder, ...
Phase Not Applicable
Enrollment 456
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Anhedonia
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: 2024-11-24
Completion: 2025-11-24
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 456 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University Hospital, Montpellier
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (1 sites)
Chu Montpellier, Montpellier, France
Eligibility Criteria
Inclusion Criteria: * patients who participated in the ASPIRE I (NCT03039192) and ASPIRE II (NCT03097133) Exclusion Criteria: * Not applicable
Building on Trust: Navigating Preventive Lung, Breast, and Prostate Cancer Screenings at Community Resource Spots
NCT07231159
Recruiting
Conditions Breast Cancer, Lung Cancer (Diagnosis), ...
Phase Not Applicable
Enrollment 200
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

  • referral for definitive diagnosis based on their cancer screening results
  • Engagement

Primary Outcomes

  • The categorization of the RE-AIM model dimensions of Reach, Effectiveness, Adoption, Implementation, and Maintenance,
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: 2025-11-17
Completion: 2026-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AdventHealth
Collaborators: Florida Department of Health
Principal Investigators:
  • Mark Socinski, MD (PRINCIPAL_INVESTIGATOR) - AdventHealth
Contact Information
Study Contact:
Patricia Robinson, PhD
407-303-3286
patricia.robinson@adventhealth.com
Interventions
  • referral for definitive diagnosis based on their cancer screening results
  • Engagement
Study Locations (1 sites)
Adventhealth, Orlando, Florida 32804 United States
Eligibility Criteria
Inclusion Criteria: 1. Adult aged 18 or older 2. Seeking care at a CRS or emergency department 3. Meets criteria for lung, breast, and/or prostate cancer screening, as outlined below: 1. Lung cancer: Adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years 2. Breast cancer: Women aged 40 to 74 years 3. Prostate cancer: Men aged 55 to 69 years 4. Receives a positive screening result for lung, breast, and/or prostate cancer at a study site Exclusion Criteria: 1. Displays behavior disruptive to other patients or staff 2. Refusal to accept screening for breast, lung, and/or prostate cancers
Clinical Trial in Hypertensive Patients Comparing Two Cardiorespiratory Exercise Protocols, Low-volume Sprint Interval Training (SIT) Versus Moderate-intensity Continuous Training (MICT), to Evaluate Decreases in Ambulatory Blood Pressure and Other Clinical Variables.
NCT07229196
Recruiting
Conditions Hypertension (HTN)
Phase NA
Enrollment 20
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.
  • MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session.

Primary Outcomes

  • To evaluate the differences between both exercise protocols in 24-hour systolic ambulatory blood pressure (ABPM) values after the 12-week programmed exercise
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-04-29
Completion: 2027-01
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Unidad Enfermedades Cardiometabolicas- Hospital Interzonal General Agudos San Martin de La Plata
Principal Investigators:
  • Walter Espeche (PRINCIPAL_INVESTIGATOR) - Hospital Interzonal General San Martin
  • Julian Minetto, Physican (PRINCIPAL_INVESTIGATOR) - Hospital interzonal general agudos San Martin de La Plata
  • Matias Santamaria (PRINCIPAL_INVESTIGATOR) - Hospital interzonal general agudos San Martin de La Plata
Contact Information
Study Contact:
Julian Minetto, Physican
+542214835429
jjminetto@hotmail.com
Walter Espeche, Doctor (PH)
wespeche@gmail.com
Interventions
  • SIT group: 2-4 maximal 20-30-second cycling sprints (≥100% VO₂max) with recovery intervals (2-4 min), total duration ≤15 minutes per session.
  • MICT group: Continuous cycling at 50-70% of VO₂max, 15-30 minutes per session.
Study Locations (1 sites)
Hospital Interzonal General San Martin La Plata, La Plata, Buenos Aires 1900 Argentina
Eligibility Criteria
Inclusion Criteria: * Patients of both sexes between 30-59 years of age who meet the definition of hypertension. Hypertension will be defined as: 1. Those patients who report a history of hypertension and are under pharmacological treatment for it (Angiotensin Converting Enzyme Inhibitors/Angiotensin II Receptor Antagonists/Calcium Channel Blockers/Thiazide Diuretics/Beta Blockers) at the time of the evaluation. OR 2. Patients who report a history of hypertension during the evaluation and who, without pharmacological treatment, have average levels ≥140/90 mmHg will also be considered hypertensive. Exclusion Criteria: * Extreme body mass index (BMI) \<18.5 and ≥35. * Patients with office blood pressure readings ≥160/100 mmHg. * Patients with high cardiovascular risk conditions such as type II diabetes, chronic kidney disease (\<60 milliseconds), history of cerebrovascular disease, coronary artery disease, peripheral arterial disease, or heart failure (Framingham Criteria clinical diagnosis). * Pregnant or postpartum women up to 3 months old. * Patients with psychophysical limitations that make exercise difficult. * Patients with a history of active malignant neoplastic disease under treatment. Elimination Criteria -Patients whose pharmacological treatment is initiated or modified during the follow-up after 3 months.
Trial of Neoadjuvant THP vs TCHP for HER2-Amplified/Positive Breast Cancer
NCT07220135
Recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 100
Locations 8 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

  • Carboplatin
  • Docetaxel
  • Trastuzumab (or biosimilar)
  • Pertuzumab (or biosimilar)

Primary Outcomes

  • Pathologic complete response (pCR) rate in the breast and axilla in the two treatment arms
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2025-11-14
Completion: 2031-05-14
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Kansas Medical Center
Principal Investigators:
  • Yiduo Hu, MD (PRINCIPAL_INVESTIGATOR) - University of Kansas Medical Center
Contact Information
Study Contact:
KUCC Navigation
913-588-3671
kucc_navigation@kumc.edu
Interventions
  • Carboplatin
  • Docetaxel
  • Trastuzumab (or biosimilar)
  • Pertuzumab (or biosimilar)
Study Locations (8 sites)
The University of Kansas Cancer Center (KUCC), Fairway, Kansas 66205 United States
The University of Kansas Cancer Center - Westwood, Kansas City, Kansas 66205 United States
KUCC - Indian Creek, Overland Park, Kansas 66211 United States
KUCC - Overland Park, Overland Park, Kansas 66215 United States
KUCC - Briarcliff, Westwood, Kansas 66205 United States
KUCC - Olathe, Westwood, Kansas 66205 United States
The University of Kansas Cancer Center - North, Kansas City, Missouri 64154 United States
KUCC - Lee's Summit, Lee's Summit, Missouri 64064 United States
Eligibility Criteria
Inclusion Criteria: * Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent * 18 years of age or older * Histologically confirmed cT2-T3 N0-N2, cT1 N1-N2, or cTX N1-N2 HER2 positive breast cancer (The invasive tumor must be HER2-positive based on the current ASCO-CAP guidelines; Patients are eligible regardless of estrogen receptor (ER) or progesterone receptor (PR) expression status. However, percentage of both ER and PR positivity must be documented in the pathology report.) * No previous ipsilateral breast surgery for the current breast cancer * No previous chemotherapy, anti-HER2 therapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer * ECOG Performance Status 0-1 documented within 28 days prior to the start of study treatment (Appendix A) * Breast and axillary imaging (including mammogram, ultrasound and/or MRI, per standard of care) within 49 days (7 weeks) prior to treatment initiation * Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic confirmation of disease status with image-guided biopsy or fine needle aspiration unless deemed medically unsafe * Co-enrollment in the PRO-HER2 (HSC #160944) observational registry protocol * Archival breast tumor tissue has been obtained or has been requested for use, which should include either a formalin-fixed paraffin-embedded (FFPE) block, or sixteen slides (fourteen 5-micron uncharged unstained slides plus either two H\&E slides or two 5-micron charged unstained slides) - from primary breast tumor only. * Subjects with bilateral synchronous HER2 positive breast cancer are eligible if they meet other eligibility criteria * Neuropathy: No baseline grade 2 or above neuropathy * Not pregnant, not breastfeeding, and at least one of the following applies: Not a woman of reproductive potential as defined by institutional standards; A woman of reproductive potential who agrees to follow contraceptive guidelines per institutional standards * Adequate organ function, defined as follows: Hematologic (assessed ≤ 21 days of treatment initiation): Absolute neutrophil count ≥ 1,500/μL (with the exception of patients with documented Fy(a-/b-) (Duffy null) immunophenotype, in which case absolute neutrophil count ≥1,200/uL is allowed), Platelets ≥ 100,000/μL, Leukocytes ≥ 3,000/μL, Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L (must be met without erythropoietin dependency and without erythrocyte transfusion within the last two weeks); Hepatic (assessed ≤ 21 days of treatment initiation): Total bilirubin ≤ 1.5x ULN, AST(SGOT) and ALT(SPGT) ≤ 2x ULN, Serum albumin ≥ 3.0 g/dL; Cardiac (assessed ≤ 49 days of treatment initiation): Normal baseline echocardiogram or MUGA scan including LVEF ≥ 50%, per standard of care Exclusion Criteria: * Current or anticipated use of other investigational agents while participating in this study * Clinically or radiographically detected metastatic disease * Inflammatory breast cancer * Prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen. Note: Patients with squamous cell or basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ (CIS) of the uterine cervix who have undergone definitive therapy are not excluded from participation * History of allergic reactions attributed to carboplatin, docetaxel, trastuzumab, or pertuzumab * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the subject's participation for the full duration of the study, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator * Pregnancy, breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment. There is a potential for congenital abnormalities and for this regimen to harm breastfeeding infants.
IMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition
NCT07197138
Recruiting
Conditions Depressive Disorder, Post-Acute COVID-19...
Phase NA
Enrollment 42
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS

Primary Outcomes

  • Change in immunophenotypic marker CRP from baseline to post-treatment
  • Change in immunophenotypic marker TNF from baseline to post-treatment
  • Change in immunophenotypic marker IL-1ß from baseline to post-treatment
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-09-11
Completion: 2027-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 42 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Max-Planck-Institute of Psychiatry
Principal Investigators:
  • Angelika Erhardt-Lehmann, MD, Prof. (PRINCIPAL_INVESTIGATOR) - Max-Planck-Institute of Psychiatry
Contact Information
Study Contact:
Alexandros Balaskas, MD
0049-089-30622-1402
Ambulanz@psych.mpg.de
Angelika Erhardt-Lehmann, MD, Prof.
Interventions
  • Intermittent theta-burst stimulation (iTBS) using PowerMAG 100 ppTMS
Study Locations (1 sites)
Max-Planck-Institute of Psychiatry, Munich, Bavaria 80804 Germany
Eligibility Criteria
Inclusion Criteria: * Age 18-65 years * Capacity to consent (legally competent, written informed consent including data protection) * Diagnosis of depression (at least moderate severity, BDI-II ≥ 20), including major depressive episode in bipolar disorder * Comorbid diagnosis of Post-COVID-19 condition (WHO definition) * Insufficient improvement of depressive symptoms under psychopharmacological treatment * Stable psychopharmacological medication for at least 4 weeks prior to start of iTBS Exclusion Criteria: * Age \<18 years or \>65 years * Pregnancy, planned pregnancy, or breastfeeding * Legal guardianship or cognitive impairment preventing valid informed consent * Severe developmental disorder or intellectual disability * Acute or chronic substance abuse (alcohol, prescription drugs, or illicit drugs) * Current treatment with benzodiazepines or Z-substances * Acute suicidality * Psychotic symptoms * Severe neurological disorder (e.g., major brain injury, neurodegenerative disease) * Ongoing treatment with another neurostimulation method (ECT, TMS, VNS) * Contraindications to TMS, including: Intracranial metal, implants, shunts, Cochlear implant, pacemaker, implantable defibrillator, History of seizures or epileptiform EEG * Severe general medical illness (e.g., anemia requiring transfusion, severe arrhythmias, cardiomyopathy)
A Randomized Trial of Surgical Decision-Making Guided by TDTP-RECIST
NCT07208526
Not yet recruiting
Conditions Intrahepatic Cholangiocarcinoma (Icc), C...
Phase NA
Enrollment 270
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • GOLP regimen
  • Surgery
  • TDTP-RECIST

Primary Outcomes

  • Overall survival
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-12-01
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 270 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Shanghai Zhongshan Hospital
Collaborators: Shanghai Geriatric Medical Center, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai 10th People's Hospital, Oriental Hepatobiliary Surgery Hospital Affiliated to Naval Military Medical University
Principal Investigators:
  • Jia Fan, MD&PhD (STUDY_CHAIR) - Shanghai Zhongshan Hospital
Contact Information
Study Contact:
Xiao-Yong Huang, MD
+8615021519215
huang.xiaoyong@zs-hospital.sh.cn
Guo-Ming Shi, MD
+8613916969578
shi.guoming@zs-hospital.sh.cn
Interventions
  • GOLP regimen
  • Surgery
  • TDTP-RECIST
Study Locations (1 sites)
Zhongshan hospital, Shanghai, Shanghai, 200032 China
Eligibility Criteria
Inclusion Criteria: \- Subjects eligible to participate in this study must meet all of the following criteria: 1. Male or female aged 18-75 years; 2. Patients must provide signed informed consent prior to enrollment, demonstrating the ability to understand and willingness to sign the written informed consent form; 3. Pathologically confirmed diagnosis of intrahepatic cholangiocarcinoma; 4. Locally advanced disease, failure to achieve R0 resection, and absence of distant metastasis; 5. At least one measurable lesion; 6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0; 7. Child-Pugh class A liver function; Exclusion Criteria: \- Subjects who meet any of the following exclusion criteria are not permitted to enroll in this study: 1. Pathologically diagnosed hepatocellular carcinoma, combined hepatocellular-cholangiocarcinoma, or other non-cholangiocarcinoma malignant components; 2. Patients with postoperative recurrence, or those who have previously received PD-1/PD-L1 antibodies, CTLA-4 antibodies, lenvatinib, or chemotherapy; 3. History or current diagnosis of other malignancies; 4. Active tuberculosis infection; 5. Active, known, or suspected autoimmune disease; 6. History of interstitial lung disease, or non-infectious pneumonitis requiring steroid treatment; 7. Significant clinically significant bleeding symptoms within 3 months prior to enrollment, or clear bleeding tendency; 8. Suspected allergy to the investigational drug(s).
A Study of Meaning-Centered Therapy for Mexican Adults With Advanced Cancer
NCT07225309
Recruiting
Conditions Breast Cancer, Prostate Cancer, Colorect...
Phase NA
Enrollment 300
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Meaning-Centered Psychotherapy for Latinos /MCP-L

Primary Outcomes

  • Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
  • Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-05-01
Completion: 2029-04-13
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Principal Investigators:
  • Rosario Costas Muniz, PhD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
Study Contact:
Rosario Costas Muniz, PhD
646-888-8062
costasmr@mskcc.org
Francesca Gany, MD, MS
646-888-8054
ganyf@mskcc.org
Interventions
  • Meaning-Centered Psychotherapy for Latinos /MCP-L
Study Locations (2 sites)
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
Instituto Nacional de Cancerología (INCan), Mexico City, Mexico
Eligibility Criteria
Patient Eligibility Criteria: A patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener and suicide risk assessment. Inclusion Criteria: EMR Criteria \- Documentation of Disease * Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis) * Definition of Disease \[or Measurable Disease\] * Diagnosed with stages III or IV * Prior Treatment * Receiving ambulatory care at INCan Self-Report Criteria * Age ≥ 18 years * Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No" * Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention * Providing care (or services) to Mexican cancer patients at INCan * Has access to internet and an electronic device * Agrees to be audio-recorded Exclusion Criteria: EMR Criteria * Prior Treatment * Received psychological or psychiatric care at INCan in the last 3 months * In the judgment of the treating physician, protocol investigators, and/or study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and/or study participation * Diagnosed with a serious psychiatric condition Self-Report Criteria * Received psychological or psychiatric care outside of INCan in the last 3 months * Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale * Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?" Provider Eligibility Criteria: Inclusion Criteria Self-Report Criteria * Age ≥ 18 years * Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No" * Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention * Providing care (or services) to Mexican cancer patients at INCan * Has access to internet and an electronic device * Agrees to be audio-recorded
Cofrogliptin and Linagliptin as add-on Therapy to Insulin in Type 2 Diabetes
NCT07198932
Not yet recruiting
Conditions Type 2 Diabetes
Phase Not Applicable
Enrollment 594
Locations 7 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Cofrogliptin add to insulin
  • Linagliptin add to insulin

Primary Outcomes

  • Change in HbA1c
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: 2025-10-01
Completion: 2027-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 594 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Yanbing Li
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Cofrogliptin add to insulin
  • Linagliptin add to insulin
Study Locations (7 sites)
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang China
Affiliated Hospital of Hebei University, Baoding, China
Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing, China
the First Medical Center of Chinese PLA General Hospital, Beijing, China
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University, Shanghai, China
Shanghai Changzheng Hospital, Shanghai, China
Xi'an International Medical Center Hospital, Xi'an, China
Eligibility Criteria
Inclusion Criteria: 1. Sign the informed consent form. 2. Aged ≥18 years. 3. Diagnosed with type 2 diabetes mellitus (meeting the 1999 WHO diagnostic criteria). 4. Recently tested HbA1c 7%-9% and FPG ≤11 mmol/L, with stable treatment using insulin ± OADs for at least 12 weeks prior to enrollment. Insulin regimens are limited to: basal insulin once daily or once weekly, premixed insulin once or twice daily, or IDegAsp once or twice daily. OAD classes are limited to metformin, SGLT2 inhibitors, and α-glucosidase inhibitors and with no more than three agents in total. 5. Willing to start or have already initiated cofrogliptin or linagliptin treatment (at the physician's discretion in accordance with clinical practice). The treatment decision is independent of study enrollment, must be made before signing the informed consent, and cofrogliptin or linagliptin initiation must occur either within 2 weeks before or within 2 weeks after signing the informed consent. Exclusion Criteria: 1. Allergic to the study drug. 2. Diagnosed with type 1 diabetes. 3. Unable to comply with study-specific procedures. 4. Current or planned pregnant, or currently breastfeeding. 5. With any other situation judged by the investigator, that is unsuitable for participation in this trial.
A Trial of SHR-4658 in Healthy Volunteers or Volunteers With Elevated Blood Pressure
NCT07230145
Not yet recruiting
Conditions Heart Failure
Phase PHASE1
Enrollment 48
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • SHR-4658 Injection.
  • SHR-4658 Placebo Injection

Primary Outcomes

  • Adverse events (AEs)
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: 2025-11
Completion: 2026-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 48 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Beijing Suncadia Pharmaceuticals Co., Ltd
Contact Information
Study Contact:
Miao Guo
+86-0518-82342973
miao.guo.mg19@hengrui.com
Shuai Jiang
+86-0518-82342973
shuai.jiang.sj5@hengrui.com
Interventions
  • SHR-4658 Injection.
  • SHR-4658 Placebo Injection
Study Locations (1 sites)
Beijing Anzhen Hospital Capital Medical University, Beijing, Beijing Municipality 100029 China
Eligibility Criteria
Inclusion Criteria: 1. Able and willing to provide a written informed consent. 2. Blood pressure as defined in the protocol. 3. Male or female,aged 18 to 55 years (inclusive). 4. Meet the weight standard. Exclusion Criteria: 1. Known history or current clinically significant disease. 2. Protocol-defined risk factors for disease. 3. Participated in clinical trials of other drugs or medical devices. 4. Pregnant or nursing women.
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
NCT07232056
Not yet recruiting
Conditions Breast Cancer, Hormone Receptor Positive...
Phase NA
Enrollment 452
Locations 0 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • GOAL-AI
  • CST-AI

Primary Outcomes

  • Change in pain severity and interference as measured by the Brief Pain Inventory - Short Form
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: 2026-06-01
Completion: 2030-11-30
Eligibility
Age: 65 Years
Sex: FEMALE
Volunteers: false
Enrollment: 452 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Duke University
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Rebecca Shelby, PhD (PRINCIPAL_INVESTIGATOR) - Duke University
Contact Information
Study Contact:
Smrithi Divakaran, MBBS, MSPH
919-681-7695
smrithi.divakaran@duke.edu
Michael W Willis, BA
919-681-8437
michael.w.willis@duke.edu
Interventions
  • GOAL-AI
  • CST-AI
Eligibility Criteria
Inclusion Criteria: * Female, age ≥65 years * HR+ non-metastatic breast cancer * Within 12 months of starting AI therapy * English-speaking * Able to provide consent Exclusion Criteria: * Age \<65 years * Metastatic cancer * Cognitive impairment preventing consent * Receiving care at multiple participating sites
CALM Study: Can A Prebiotic Fibre bLend Improve Stress, Mood, and Anxiety?
NCT07201909
Recruiting
Conditions Stress
Phase NA
Enrollment 156
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Prebiotic fibre blend
  • Maltodextrin powder

Primary Outcomes

  • Perceived Stress
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-10-02
Completion: 2026-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 156 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Myota GmbH
Collaborators: University of Reading
Contact Information
Study Contact:
Caitlin Hall, PhD, RD
07830709854
caitlin@myotahealth.com
Interventions
  • Prebiotic fibre blend
  • Maltodextrin powder
Study Locations (1 sites)
CALM Study Site, London, EC2A 4BQ United Kingdom
Eligibility Criteria
Inclusion Criteria: * Aged 18-50 years of age * Capacity to give informed consent to participate in the study * Able to comply with study requirements and visits * Meet the range required for mild-severe stress levels (as assessed by DASS-42 stress subscale) * Normal or corrected to normal vision and/or hearing Exclusion Criteria: * Current smoker * Having food allergies and/or intolerances * Diagnosis of Type 1 or 2 diabetes or cardiovascular disease or psychiatric or neurological conditions (e.g. schizophrenia, dementia) including eating disorders * Current or previous diagnosis of depression in past 6 months * Receiving medications that lower cholesterol, blood pressure, blood glucose levels, or improve insulin sensitivity * Receiving antidepressant or anti-anxiety medications or treatments * Receiving hormonal birth control * Perimenopause or menopause * Pregnancy, lactation, or an intent to become pregnant during the course of the study * Continuous antibiotic use for \> 3 days within 1 month prior to enrolment * Continuous use of weight-loss drug for \> 1 month before screening * Major change in dietary intake in past month (e.g. excluding whole food groups) * Currently consuming daily prebiotic or probiotic supplements * Prior use (\< 6 months) of any blood glucose or cholesterol lowering medication * Any significant GI condition affecting GI absorption including (but not limited to) inflammatory bowel disease, weight loss surgery, irritable bowel disease. * End stage renal disease * Active cancer, or treatment for any cancer, in last 3 years * Consuming more than 20g of fibre a day as assessed by the 18-item FiberScreen
This Study Explores the Mental Health Impact of Two Akashic Records Sessions.
NCT07219914
Active, positions filled
Conditions Resilience, Connectedness, Depression, A...
Phase NA
Enrollment 117
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Akashic Records Session

Primary Outcomes

  • DASS-21 (Depression, Anxiety, Stress) Clinical Scale
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2024-06-21
Completion: 2026-01-22
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 117 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Rasa Healing Inc
Principal Investigators:
  • Candice S Rasa, LCSW (PRINCIPAL_INVESTIGATOR) - Rasa Healing Inc
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Akashic Records Session
Study Locations (1 sites)
Virtual/ No Physical Facility, Palm City, Florida 34990 United States
Eligibility Criteria
Inclusion: * 18 years old and over * Ability and willingness to provide written, informed consent in English prior to initiation of any study-related procedures and adhere to all study requirements * Willingness to engage in discussion about past life patterns and emotions * Self-report of anxiety, depressive or stress symptoms in the last 12 months Exclusion: * Inability to provide consent due to cognitive impairment, mental health disorders, or other conditions that impact their ability to understand the nature, risks, and benefits of the study. * History of alcohol or substance use disorder within 12 months * History of hypomania or psychotic episode within 12 months * Prior history (lifetime diagnosis) of schizophrenia spectrum, or other psychotic disorders * Experiencing any other serious mental or physical health issues that would impact their ability to engage in the research study * Has either attempted suicide, has documented medical history of suicidal ideation, or been hospitalized due to suicide risk within 1 year prior to prescreening. * Previous Akashic Record Session with Interventionist, Candice S. Rasa, LCSW or previous Akashic Record Session with any other provider within 6 months. * Any form of medicinal therapy should be stable 3 months prior to screening with no plan to start, stop or alter the use of any prescribed medications, supplements or other therapies from informed consent * Any form of non-medical therapy should be stable 3 months prior to pre-screening with no plan to start, stop or alter use of psychotherapy, acupuncture, hypnosis, or other similar therapy from the time of providing informed consent.
Virtual Reality Intervention to Improve Psychological Symptom Burden for Cancer Patients Undergoing Treatment
NCT07221409
Recruiting
Conditions Adjustment Disorder, Anxiety Disorder, D...
Phase NA
Enrollment 24
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Questionnaire Administration
  • Virtual Reality (VR) Intervention

Primary Outcomes

  • Successfully complete the virtual reality (VR) intervention (Feasibility)
  • Absence of major issues during administration (Feasibility)
  • Acceptability
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-10-08
Completion: 2027-10-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 24 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Mayo Clinic
Principal Investigators:
  • Juan C. Cardenas Rosales, MD (PRINCIPAL_INVESTIGATOR) - Mayo Clinic
Contact Information
Study Contact:
Wendi Lehman
904-953-8742
lehman.wendi@mayo.edu
Telly Coney
904-953-3725
coney.telleso@mayo.edu
Interventions
  • Questionnaire Administration
  • Virtual Reality (VR) Intervention
Study Locations (1 sites)
Mayo Clinic in Florida, Jacksonville, Florida 32224-9980 United States
Eligibility Criteria
Inclusion Criteria: * History of cancer * Age between 18 to 90 years * Undergoing in-patient chemotherapy, bone marrow transplant (BMT), chimeric antigen receptor (CAR)-t, \& out-patient chemotherapy Exclusion Criteria: * History of bipolar disorder, major depression, bipolar disorder, anxiety disorder, post traumatic stress disorder (PTSD), obsessive compulsive disorder (OCD), psychotic disorder, schizophrenia, personality disorder, substance use disorder other than caffeine or tobacco. History of suicidal ideation or attempt * History of treatment resistant depression, psychiatric hospitalization, syncope, transient ischemic attack (TIA), stroke, epilepsy, electroconvulsive therapy, benign positional vertigo, Meniere's disease
Gut Microbiota, Diet-INDuced Obesity and Type 2 Diabetes in New Caledonia - MIND
NCT07205913
Not yet recruiting
Conditions Diabetes Mellitus, Type 2, Obesity
Phase Not Applicable
Enrollment 270
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • 25 ml blood sample
  • Urine sample
  • Stools
  • 40 ml blood sample

Primary Outcomes

  • Describe and characterise the faecal microbiota of patients to investigate the relationships between microbiota composition with bioclinical parameters
  • Describe and characterise the faecal microbiota and metabolome of patients to investigate the relationships between microbiota composition with bioclinical parameters
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: 2026-02-15
Completion: 2027-02-15
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 270 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Institut Pasteur
Collaborators: RIKEN Center for Integrative Medical Sciences
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • 25 ml blood sample
  • Urine sample
  • Stools
  • 40 ml blood sample
Eligibility Criteria
Inclusion Criteria: * Aged between 18 and 60 years. * Ability to understand and provide informed consent. * Ability and willingness to meet the required schedule and study interventions. * Willingness to share their community belonging * Benefit from a social security system. For obese and diabetic patients : * IMC ≥ 30 kg/m² with type 2 diabetes * Fasting plasma glucose (FPG) ≥7 mM (=1.26g/l) or * Patients with HbA1c ≥ 6.5% (48 mmol/mol) * All stages of albuminuria For obese patients without type 2 diabetes * IMC ≥ 30 kg/m² * Weight stable for at least 2 months * Patients with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and an HbA1c \< 6.5 % * No treatment (diabetic or weight loss) * Match age (±5years), sex and self-reported community to the patients from the1 group. For control group : * BMI between 18.5-24.9 kg/m² * Match age (±5years), sex and self-reported community to the patients from the 1 and 2 groups. * Participants with normal glucose tolerance (NGT), impaired glucose tolerance (IGT) and/or impaired fasting glucose (IFG) and an HbA1c \< 6.5 % Exclusion Criteria: All participants : * Treatment that may alter gastrointestinal motor function, acidity, microbial population, or immunosuppressants * Altered anatomy of the esophagus, stomach, small intestine, or large intestine due to gastrointestinal surgery (except appendectomy or cholecystectomy) * Chronic or acute inflammatory bowel disease or infections * Abdominal or pelvic radiation therapy or abdominal cancer, colorectal cancer * Dysphagia, eosinophilic esophagitis, esophageal stricture, or other swallowing disorders * Organ transplantation and patients receiving immunosuppressive therapy * Severe renal failure and/or patients undergoing dialysis * Cardiovascular, endocrine, renal, or other chronic disease that may affect motility. * Preparation for colon cleansing within the last month * \< 3 bowel movements per week * Women who are pregnant or breastfeeding
Double-blind, Placebo-controlled Study in Adults With Major Depressive Disorder
NCT07226661
Recruiting
Conditions Major Depressive Disorder (MDD)
Phase PHASE2
Enrollment 230
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

  • SPN-821 2400 mg
  • Placebo

Primary Outcomes

  • Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-01-19
Completion: 2027-01-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 230 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Supernus Pharmaceuticals, Inc.
Contact Information
Study Contact:
Gianpiera Ceresoli-Borroni, PhD
301-838-2521
gceresoliborroni@supernus.com
Interventions
  • SPN-821 2400 mg
  • Placebo
Study Locations (1 sites)
Collaborative Neuroscience Network, Garden Grove, California 92845 United States
Eligibility Criteria
Inclusion Criteria: * Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI * Duration of current MDE of at least 8 weeks * MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit * CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit * Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered. Exclusion Criteria: * MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit * History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE * History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit * Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion * Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I/II disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study * Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening. * History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion * Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function. * Requires treatment with a medication or other substance that is prohibited by the protocol.
Efficacy of Psilocybin and Trazodone Combination in Treatment-resistant Depression: a Randomized Controlled Proof-of-concept Study (PSILOTRAZ)
NCT07210112
Not yet recruiting
Conditions Depression - Major Depressive Disorder, ...
Phase PHASE2
Enrollment 112
Locations 1 sites
Compensation compensation available
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Psilocybin 25 mg per os
  • Trazodone 5mg
  • Trazodone 30 mg
  • Placebo of psilocybin
  • Placebo of trazodone

Primary Outcomes

  • Change from Baseline in the mean score of Montgomery-Åsberg Depression Rating Scale (MADRS) at 1 month
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: 2025-10-08
Completion: 2030-06-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 112 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Centre Hospitalier St Anne
Principal Investigators:
  • Lucie BERKOVITCH, MD (PRINCIPAL_INVESTIGATOR) - GHU Paris Psychiatrie and Neurosciences - Neuromodulation Institute
Contact Information
Study Contact:
Lucie BERKOVITCH, MD
+33 145657481
l.berkovitch@ghu-paris.fr
Interventions
  • Psilocybin 25 mg per os
  • Trazodone 5mg
  • Trazodone 30 mg
  • Placebo of psilocybin
  • Placebo of trazodone
Study Locations (1 sites)
GHU Paris Psychiatrie and Neurosciences, Paris, 75014 France
Eligibility Criteria
Inclusion Criteria: * Patient with major depressive episode without psychotic features according to DSM-5 criteria; * Treatment-resistant depressive episode, i.e. failure to respond to at least two lines of antidepressant medication at an adequate dose and for a sufficient period of time (6 weeks according to the MGH-ATRQ); * MADRS ≥ 20; * Written signed informed consent; * Patient covered by the social security system. Exclusion Criteria: Psychiatric comorbidities known from medical history or identified during inclusion assessment: * Bipolar disorder; * Schizophrenia and psychosis; * Personal or family history of psychotic disorder; * History of personality disorder; * Post-traumatic stress disorder, obsessive-compulsive disorder, eating disorders; * Alcohol or substance use disorder in past 12 months or positive urine toxins at time of assessment; * Significant suicide risk, as defined by: (a) suicidal ideation as indicated by items 4 or 5 on the C-SSRS within the past six months, at Screening, during the Screening Period, or at Baseline (b) demonstrating suicidal behaviors in the past six months, or; (c). clinical assessment of significant suicidal risk or risk of self-injury during participant interview; * Patient with a psychiatric decompensation following a previous use of psychedelic substance like LSD; Comorbidities or somatic specificities: * Pregnancy and breastfeeding women; * Cardiovascular history (myocardial infarction, stroke, heart rhythm disorder, uncontrolled hypertension, QT interval prolongation, tachycardia and poor cardiovascular health); * Uncontrolled diabetes; * Uncontrolled thyroid disorder; * Epilepsy; * Parkinson's disease treated by selegiline or levodopa; * HIV treated by ritonavir and indinavir; * Active infection treated by erythromycin; * Fungal infection treated by ketoconazole and itraconazole; * Contraindications to MRI; Concomitant therapies: * 5-HT antagonist treatment2A (including quetiapine, olanzapine, aripiprazole); * Lithium treatment; * Treatment with buprenorphine or opioids, clonidine, methyldopa, digoxin, Monoamine oxidase inhibitors (MAOI), aldehyde dehydrogenase (ALDH) inhibitors and alcohol dehydrogenase (ADH) inhibitors, St. John's Wort, or warfarin should be discontinued completely before study drug administration; * Use of electroconvulsive therapy and/or transcranial magnetic stimulation, during the current depressive episode; or lifetime vagus nerve stimulation, deep brain stimulation, and/or ablative neurosurgery; * Use of psychedelics (psilocybin, lysergic acid, ayahuasca, mescaline and derivatives) during current episode; Legal status: * Persons deprived of their liberty by judicial or administrative decision, persons under compulsory psychiatric care; * Persons under legal protection or unable to give consent; Other: \- Any clinical manifestation which, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk to the participant if he or she participates in the study.