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Showing 20 of 29277 trials
PirfenidoneVsPlacebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following HFRT in Breast Cancer Patients
NCT05704166
Recruiting
Conditions Acute Lung Injury, Prevention
Phase PHASE2
Enrollment 214
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Pirfenidone/Placebo

Primary Outcomes

  • Changes in lung injury grading on chest computerized tomography within 3 months after radiotherapy
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Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2023-03-16
Completion: 2026-05-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 214 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fujian Medical University Union Hospital
Collaborators: Beijing Continent Pharmaceutical Co, Ltd.
Principal Investigators:
  • Yong Yang, Doctor (PRINCIPAL_INVESTIGATOR) - Director of the radiotherapy department
Contact Information
Study Contact:
Yong Yang, Doctor
18813019084
dr_yangyong1983@163.com
Daxin Huang, Master
13655913399
1660579075@qq.com
Interventions
  • Pirfenidone/Placebo
Study Locations (1 sites)
Fujian Medical University Union Hospital, Fuzhou, Fujian China
Eligibility Criteria
Inclusion Criteria: * To be enrolled in this study, patients must meet all of the following inclusion criteria: 1. Breast invasive carcinoma or ductal carcinoma in situ or lobular carcinoma in situ confirmed by histology; 2. Age 18-75, female; 3. The physical state score of the Eastern Tumor Cooperative Group (ECOG) was 0-2; 4. Patients meeting the indications of postoperative radiotherapy and neoadjuvant chemotherapy: clinical stage 3 or above or postoperative ypT3-T4 or N+; Non-neoadjuvant chemotherapy patients: postoperative pathological staging of pT3-T4 or pN2 or above, or positive for upper and lower clavicle and lymph nodes in the internal milk region, or positive for clinical consideration; For patients with pT1-2N1, postoperative adjuvant radiotherapy should be determined based on the patient's age, tumor grade, incisal margin, number of positive lymph nodes, molecular typing, past complications, and patient's intention. 5. Radiotherapy regimen was chest wall + supraclavicular 40Gy/15f after root modification, or whole milk ± upper and lower clavicular 40Gy/15f after breast preservation, tumor bed simultaneous supplement 50Gy/15f; 6. All screening period laboratory tests should be performed in accordance with protocol requirements and within 28 days prior to enrollment. The values of laboratory tests performed by screening must meet the following criteria: blood routine check all meet the following criteria: A. Hb≥90g/L; B. ANC≥1.5×109/L; C. PLT≥70×109/L; biochemical examination all meet the following criteria: TBIL \< 1.5× upper limit of normal range (ULN); ALT and AST≤2.5 x ULN; Serum Cr≤1.25×ULN or endogenous creatinine clearance ≥45 mL/min (Cockcroft-Gault formula) 7. Women who are at risk of becoming pregnant must undergo a negative serum pregnancy test within 7 days before the first dose and be willing to use a highly effective method of contraception during the trial period and 120 days after the last dose of the test drug. Male subjects with a partner of a woman of reproductive age should be surgically sterilized or consent to a highly effective method of contraception during the trial period and 120 days after the last test drug administration; 8. The subjects voluntarily joined the study, signed the informed consent, had good compliance, and cooperated with follow-up. Exclusion Criteria: * Patients with any of the following criteria were not enrolled in this study 1. History and complications A. male breast cancer patients; B. Did not meet the conditions of large segmentation radiotherapy (upper and lower clavicular lymph node metastasis, internal milk lymph node metastasis, the patient refused large segmentation radiotherapy); C. The subject has any active, known, or suspected autoimmune disease. To admit subjects who are in a stable state and do not require systemic immunosuppressive therapy; D. The patient is participating in another clinical study or less than 4 weeks after the end of the previous clinical study; E. Patients with a known or highly suspected history of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; F. A history of other malignant tumors; Except in patients who have had potentially curable therapy and have not had disease recurrence for 5 years since treatment began; G. Pregnant women and patients with mental illness; H. Prior treatment with radiotherapy, chemotherapy, etc.; I. Patients with active tuberculosis should be excluded; J. Severe acute or chronic lung infections requiring systemic treatment; K. Patients with obvious blood coughing or daily hemoptysis of half a teaspoon (2.5ml) or more in the 2 months before randomization; L. Patients with heart failure (New York Heart Association standard Class III or IV), poor coronary artery disease control or arrhythmia, or a history of myocardial infarction in the 6 months prior to screening despite receiving appropriate medication. 2. Physical examination and laboratory examination A. A known history of testing positive for human immunodeficiency virus (HIV) or a known history of acquired immunodeficiency syndrome (AIDS); B. untreated active hepatitis (hepatitis B: HBsAg positive with HBV DNA≥ 500 IU/mL; Hepatitis C: HCV RNA positive and abnormal liver function); Combined with hepatitis B and hepatitis C co-infection. 3. As determined by the investigator, the patient may have other factors that may lead to the termination of the study, such as other serious diseases or serious abnormalities in laboratory tests or other factors that may affect the safety of the subjects, or family or social factors such as the collection of test data and samples.
Targeted Assessment in High-Risk paTients With dIAbetes to ideNtify Undiagnosed Heart Failure
NCT05705869
Active, positions filled
Conditions Heart Failure, Diabetes Mellitus, Type 1...
Phase NA
Enrollment 706
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • NT-proBNP

Primary Outcomes

  • Diagnosis of heart failure within 6 months
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2022-12-22
Completion: 2032-12
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 706 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: NHS Greater Glasgow and Clyde
Collaborators: AstraZeneca
Principal Investigators:
  • Mark C Petrie, MbChB (PRINCIPAL_INVESTIGATOR) - University of Glasgow
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • NT-proBNP
Study Locations (2 sites)
Glasgow Royal Infirmary, Glasgow, Scotland G4 0SF United Kingdom
Queen Elizabeth University Hospital, Glasgow, Scotland G51 4TF United Kingdom
Eligibility Criteria
Inclusion Criteria: * Male or female ≥40 years of age * Informed consent * An established diagnosis of diabetes (type 1 or type 2) * At least one additional risk factor for heart failure: 1. Coronary artery disease (either a previous documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery \[\>50% left main or \>70% left anterior descending, circumflex or right coronary artery\]) 2. Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation) 3. Previous ischemic or embolic stroke 4. Peripheral arterial disease (previous surgical or percutaneous revascularisation or a documented stenosis greater than 50% of a major peripheral arterial vessel). 5. Chronic kidney disease (defined as an estimated glomerular filtration rate \<60mL/min/1.73m2 or eGFR 60-90mL/min/1.73m2 and UACR \>300mg/g). 6. Regular loop diuretic use (any dose at any dosing interval) for \>30 days. 7. COPD (evidenced by one of the following; PFTs showing airway obstruction, diagnosis by respiratory physician, CT scan reporting presence of emphysema or treatment with national guideline-advocated COPD therapy). Exclusion Criteria: * Inability to give informed consent e.g., due to significant cognitive impairment. * Previous documented diagnosis of heart failure. * Echocardiogram or NT-proBNP interpreted as excluding heart failure within 12 months. * Currently receiving scheduled renal replacement therapy. * Anyone who, in the investigators' opinion, is not suitable to participate in the trial for other reasons e.g., a diagnosis which may compromise survival over the study period
Brief Cognitive Behavioural Therapy for Insomnia Versus Sleep Hygiene for Sleep Difficulties in Early Pregnancy
NCT05710991
Recruiting
Conditions Sleep Disturbance, Perinatal Anxiety, Pe...
Phase NA
Enrollment 102
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Sleep Hygiene Workshop
  • Cognitive Behavioural Therapy for Insomnia Workshop

Primary Outcomes

  • Insomnia Severity Index (ISI)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-08-10
Completion: 2025-09
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 102 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: St. Joseph's Healthcare Hamilton
Contact Information
Study Contact:
Sheryl Green, C.Psych
905-522-1155
sgreen@stjoes.ca
Interventions
  • Sleep Hygiene Workshop
  • Cognitive Behavioural Therapy for Insomnia Workshop
Study Locations (1 sites)
St. Joseph&#39;s Healthcare Hamilton, West 5th Campus, Hamilton, Ontario L9C 0E3 Canada
Eligibility Criteria
Inclusion Criteria: 1. ≥18 years 2. First, second, or third trimester of pregnancy (up to 34 weeks gestation) to allow for early/proactive benefit of sleep intervention. 3. Subjective difficulties with sleep (a score of 8 or higher on the Insomnia Severity Index) 4. Fluent in English. Exclusion Criteria: 1. Severe depression/active suicidal ideation or psychotic 2. Unstable general medical condition 3. Current use of sleep aids or if taking a prescriptive medication, it remains stable in dose and type for study duration 4. a sleep disorder other than insomnia (e.g., restless leg syndrome).
Intermittent Theta Burst Stimulation for Maintenance Therapy in Depression
NCT05732311
Recruiting
Conditions Depression
Phase NA
Enrollment 60
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

  • intermittend theta burst stimulation

Primary Outcomes

  • relapse (number of patients who have a relapse for depression)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-04-25
Completion: 2026-02-28
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Berthold Langguth, MD, Ph.D.
Principal Investigators:
  • Berthold Langguth, Prof. (PRINCIPAL_INVESTIGATOR) - University Hospital of Regensburg, Department of Psychiatry and Psychotherapy at the Bezirksklinikum
Contact Information
Study Contact:
Martin Schecklmann, Prof.
+49-941-941-2054
martin.schecklmann@medbo.de
Mohamed Abdelnaim, Dr.
+49-941-941-1256
mohamed.abdelnaim@medbo.de
Interventions
  • intermittend theta burst stimulation
Study Locations (1 sites)
Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, 93055 Germany
Eligibility Criteria
Inclusion Criteria: * adult women and men aged 18 to 70 years with an ICD-10 diagnosis of a depressive episode of depressive disorder (F32), recurrent depressive disorder (F33), or bipolar disorder (F31) * moderate or severe current episode prior to initial open iTBS treatment (HAMD-21 \>16 points) * response to iTBS treatment (either reduction in HAMD score by 50% or score at the end of treatment \<11 points) * no concomitant psychotic symptoms. * no other relevant psychiatric disorder as assessed by the study physician * residence in Germany and German speaking that allows understanding of the information provided * patient is capable of giving consent Exclusion Criteria: * fulfillment of the general contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps). * severe neurological diseases (e.g., cerebrovascular events, neurodegenerative diseases, epilepsy, malformations of the brain, severe head injury in the history) * current harmful use or dependence on alcohol, amphetamines, cocaine, benzodiazepines, anticonvulsants, or opiates * acute suicidality * pregnancy * current participation in another study
Using Exercise-testing to Explore Patient Differences in Severe Asthma
NCT05733143
Active, positions filled
Conditions Asthma
Phase Not Applicable
Enrollment 64
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • cardiopulmonary exercise stress test (CPEST)

Primary Outcomes

  • OBJECTIVES AND OUTCOME MEASURES
Interested in this trial?
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Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2023-07-18
Completion: 2025-11-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: Not specified
Enrollment: 64 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Queen's University, Belfast
Collaborators: Belfast Health and Social Care Trust
Principal Investigators:
  • Liam G Heaney, MD (PRINCIPAL_INVESTIGATOR) - Queens University Belfast
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • cardiopulmonary exercise stress test (CPEST)
Study Locations (1 sites)
Queen's University Belfast, Belfast, Northern Ireland United Kingdom
Eligibility Criteria
Inclusion Criteria All participating patients will be attending the Regional Severe Asthma Service of Belfast Trust and will be: 1. Age ≥ 18 and ≤ 80 years at screening visit 2. Able and willing to provide written informed consent and to comply with the study protocol 3. Severe asthma confirmed after assessment by an asthma specialist as per GINA guidelines (1) 4. Diagnosed with asthma at least 12 months prior to screening and on GINA Step 4/5 treatment including those who are on biologic therapy 5. On optimal medical management as determined by clinician Exclusion criteria Exclusion criteria will be: 1. Any absolute contraindication to CPEST (Acute myocardial infarction (3-5 days), unstable angina uncontrolled arrhythmia causing symptoms or haemodynamic compromise, syncope, active endocarditis, acute myocarditis/pericarditis, symptomatic severe aortic stenosis, uncontrolled heart failure, suspected dissecting or leaking aortic aneurysm, uncontrolled asthma, arterial desaturation at rest on room air \<85%) (15) 2. Acute exacerbation requiring oral corticosteroids in previous 4 weeks before first visit 3. History of current alcohol, drug, or chemical abuse or past abuse that would impair or risk the participant's full participation in the study, in the opinion of the investigator 4. Treatment with an investigational agent within 30 days of assessment (or five half-lives of the investigational agent, whichever is longer) 5. Female participants who are pregnant or lactating 6. Other clinically significant medical disease or uncontrolled concomitant disease despite treatment that is likely, in the opinion of the investigator, to impact the patient's ability to participate in the study
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin in Patients With StablE Diabetes II
NCT05702463
Recruiting
Conditions Platelet Aggregation, Type 2 Diabetes, A...
Phase PHASE1
Enrollment 30
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Aspirin 81Mg Ec Tab twice daily for 7 days
  • Aspirin 40Mg Chew Tab twice daily for 7 days
  • Aspirin 162 mg EC Tab once daily for 7 days

Primary Outcomes

  • Describe the screening rate to evaluate the feasibility of a larger scale randomized controlled trial.
  • Describe the enrollment rate by the proportion of referred participants who are eligible to evaluate the feasibility of a larger scale randomized controlled trial.
  • Describe the enrollment rate by the proportion of eligible participants who consent to evaluate the feasibility of a larger scale randomized controlled trial.
Interested in this trial?
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Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2023-06-13
Completion: 2027-07-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Montreal Heart Institute
Collaborators: Heart and Stroke Foundation of Canada
Principal Investigators:
  • Guillaume Marquis Gravel, MD, MSc (PRINCIPAL_INVESTIGATOR) - ICM Co. Ltd.
Contact Information
Study Contact:
Guillaume Marquis Gravel, MD, MSc
514-376-3330
guillaume.marquis.gravel@umontreal.ca
Marie Lordkipanidzé B. Pharm, Ph.D.
514-376-3330
marie.lordkipanidze@umontreal.ca
Interventions
  • Aspirin 81Mg Ec Tab twice daily for 7 days
  • Aspirin 40Mg Chew Tab twice daily for 7 days
  • Aspirin 162 mg EC Tab once daily for 7 days
Study Locations (1 sites)
Montreal Heart Institute, Montreal, Quebec H1T 1C8 Canada
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years; 2. Participant must be naïve to ASA, defined as absence of chronic treatment with ASA within the previous 3 months, and of any ASA use within the previous 2 weeks; 3. Type 2 diabetes, based on at least one of the following criteria: (5) * Chronic treatment with oral antihyperglycemic agents or insulin therapy; * Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L) (fasting is defined as no caloric intake for at least 8h); * 2-h Plasma Glucose (2h-PG) ≥ 200 mg/dL (11.1 mmol/L) during the oral glucose tolerance test (OGTT); * A1C ≥ 6.5% (48 mmol/ml); 4. Willing to attend all study visits of both the run-in and randomized phases of the trial. Exclusion Criteria: 1. Definitive indication for ASA, including any evidence of clinical atherosclerotic disease, previous or current; 2. Known hypersensitivity to ASA; 3. Patient requiring dialysis; 4. Severe hepatic insufficiency or ALT \> 3 x ULN; 5. High-risk GI bleeding features, such as known H. pylori infection, past or present ulcer, history of bleeding from the GI tract; 6. Bleeding diathesis; 7. Platelet count or hemoglobin levels outside of the normal reference range; 8. Planned major surgical procedure or dental procedure during the course of the study; 9. Chronic inflammatory disease requiring regular anti-inflammatory treatment; 10. Chronic treatment with an oral anticoagulant, an antiplatelet agent, NSAIDs or systemic steroids; 11. Active cancer; 12. History of hematological malignancy or myelodysplasia; 13. Pregnant or lactating women;
TEZSPIRE (Tezepelumab) Asthma Japan Post-Marketing Study (PMS)
NCT05729711
Active, positions filled
Conditions Bronchial Asthma (Only the Patients With...
Phase Not Applicable
Enrollment 416
Locations 33 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: 2023-04-04
Completion: 2029-11-16
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 416 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Principal Investigators:
  • Toshimitsu Tokimoto (STUDY_DIRECTOR) - AstraZeneca KK
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
N/A
Study Locations (33 sites)
Research Site, Aichi, Japan
Research Site, Akita, Japan
Research Site, Aomori, Japan
Research Site, Chiba, Japan
Research Site, Fukui, Japan
Research Site, Fukuoka, Japan
Research Site, Gifu, Japan
Research Site, Gunma, Japan
Research Site, Hiroshima, Japan
Research Site, Hokkaido, Japan
Eligibility Criteria
Inclusion Criteria: * The evaluable patients are those treated with Tezspire for the first time due to "Bronchial asthma (only the patients with severe or intractable bronchial asthma which could not be controlled with the existing therapy) Exclusion Criteria: None
A Study of Hansoh (HS)-10502 in Patients With Advanced Solid Tumors
NCT05740956
Recruiting
Conditions Ovarian Cancer, Breast Cancer, Pancreati...
Phase PHASE1
Enrollment 318
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

  • HS-10502

Primary Outcomes

  • Maximum tolerated dose (MTD) of HS-10502(Stage 1)
  • Maximum applicable dose (MAD) of HS-10502(Stage 1)
  • Efficacy of HS-10502: Objective response rate (ORR)(Stage 2)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2023-06-09
Completion: 2026-10-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 318 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact Information
Study Contact:
Lingying Wu, Medical PhD
13910865483
wulingying@csco.org.cn
Interventions
  • HS-10502
Study Locations (1 sites)
Cancer Hospital Chinese Acedemy of Medical Sciences, Beijing, Beijing Municipality 100020 China
Eligibility Criteria
Inclusion Criteria: 1. Males or females aged 18 - 75 years (inclusive). 2. Having at least one target lesion per the RECIST v1.1. 3. For the phase Ia Cohort A: advanced solid tumor carrying HRR gene mutation with failure or intolerance or not available to the currently available Standard of care (SoC). 4. For the phase Ib study: Cohort B: patients with HRD positive recurrent ovarian cancer with failure or intolerance or not available to SoC Cohort C: patients with HRR gene mutation advanced Human epidermal growth factor receptor 2 (HER2)-negative breast cancer with failure or intolerance or not available to SoC Cohort D: patients with HRR gene mutation advanced pancreatic cancer with failure or intolerance or not available to SoC Cohort E: patients with HRR gene mutation mCRPC with failure or intolerance or not available to SoC Cohort F: patients with HRR gene mutation colorectal cancer with failure or intolerance or not available to SoC Cohort G: patients with other HRR gene mutation or HRD positive advanced solid tumors with failure or intolerance or not available to SoC 5. Eastern cooperative oncology group (ECOG) performance status was 0-1. 6. Minimum life expectancy \> 12 weeks. 7. Females should be using adequate contraceptive measures and should not be breastfeeding Males should be using adequate contraceptive measures. 8. Have signed Informed Consent Form. Exclusion Criteria: 1. Received or are receiving the following treatments: 1. Previous or current treatment with two or more Poly(ADP-ribose) polymerase (PARP) inhibitors. 2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study treatment. 3. Cytotoxic chemotherapeutic drugs, investigational drugs or other systematic anti-tumor therapies within 3 weeks before the first dose of study treatment; Nitrosourea or Mitomycin C within 6 weeks prior to the first dose of study treatment. 4. Local radiotherapy within 2 weeks prior to the first dose of study treatment; more than 30% of bone marrow radiotherapy or large-area irradiation within 4 weeks before the first dose of study treatment. 5. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion. 6. Major surgery within 4 weeks prior to the first dose of study treatment. 2. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy. 3. History of other primary malignancies. 4. Known and untreated, or active central nervous system metastases. 5. Inadequate bone marrow reserve or hepatic and renal functions. 6. Myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML), or with features suggestive of MDS or AML. 7. Severe, uncontrolled or active cardiovascular disorders. 8. Diabetic ketoacidosis or hyperosmolar hyperglycemic state within 6 months prior to the first dose of study treatment; glycosylated hemoglobin ≥ 7.5%. 9. Serious or poorly controlled hypertension. 10. Any life-threatening hemorrhagic event or events requiring blood transfusion within 120 days prior to the first dose of study treatment. Clinically significant hemorrhagic symptoms or obvious hemorrhagic tendency. 11. Serious infection within 4 weeks prior to the first dose of study treatment, or presence of uncontrollable active infection in the screening period. 12. Having serious neurological or mental disorders. 13. A history of hypersensitivity to any of the active or inactive ingredients of HS-10502 or drugs with a similar chemical structure to HS-10502 or in the same class as HS-10502. 14. Patients who may have poor compliance with the procedures and requirements of the study, as judged by the investigator. 15. Patients with any condition that jeopardizes the safety of the patient or interferes with the assessment of the study, as judged by the investigator.
Effect of Partial Dietary Replacement From Animal to Plant-Based Protein for Type 2 Diabetes Management
NCT05706155
Recruiting
Conditions Type 2 Diabetes, Overweight, Obesity
Phase NA
Enrollment 146
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

  • Control Diet
  • Plant-based Diet

Primary Outcomes

  • Change in Glycated Hemoglobin
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-11-01
Completion: 2027-12-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 146 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hospital de Clinicas de Porto Alegre
Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico
Principal Investigators:
  • Fernando Gerchman, PhD (PRINCIPAL_INVESTIGATOR) - Hospital de Clínicas de Porto Alegre
Contact Information
Study Contact:
Fernando Gerchman, PhD
+555133596246
fgerchman@hcpa.edu.br
Interventions
  • Control Diet
  • Plant-based Diet
Study Locations (1 sites)
Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul Brazil
Eligibility Criteria
Inclusion Criteria: * Adults (≥18 and ≤65 years old) * Diagnosis of Type 2 Diabetes; * Glycated hemoglobin from 7% to 11%; * Overweight or obesity (BMI ≥25 kg/m² and \<40 kg/m²); * Use of any hypoglycemic and insulin; * Stable weight (maximum variation of approximately 5%) for at least 12 weeks before screening; * Not having undergone dietary intervention in the last 6 months; * Have the ability to understand and be able to adhere to intervention proposals; * Able and willing to provide an informed consent form for written and to comply with the requirements of the study protocol; Exclusion Criteria: * Type 1 diabetes mellitus; * Retinopathy with vision deficit that limits the activities proposed in the interventions; * Chronic kidney disease with estimated glomerular filtration \< 30 mL/min per 1.73m²; * Liver failure, chronic viral hepatitis; * Grade III or IV heart failure * Active or progressive neurodegenerative disease; * Prior stroke that has caused sequelae; * Use of medications that affect glucose metabolism (e.g. corticosteroids or immunosuppressants) or cause weight loss; * Chronic treatment with oral or parenteral corticosteroids (\>7 days consecutive treatment) within 4 weeks prior to screening; * Treatment with weight-reducing agents (eg, orlistat, sibutramine, topiramate, bupropion, liraglutide, semaglutide) within the last 12 weeks before screening; * Treatment with thyroid hormone that was not maintained at a stable dose in last 12 weeks before screening; * History of active substance abuse (including alcohol) within the last year; * Thyroid Stimulating Hormone (TSH) outside the normal range; * Fasting triglycerides ≥ 600 mg/dL; * Tumor diagnosed and/or treated (except basal cell skin cancer, carcinoma in situ of the cervix, or prostate cancer in situ) within the last 5 years; * Severe psychiatric illness; * Predisposition or diagnosis of eating disorders; * Women who are pregnant, intend to become pregnant during the study period, or who are currently breastfeeding; * Hyperglycemia characterized by acute symptoms: polyuria, polydipsia and/or weight loss in the last 3 months; * Metabolic and acute complications of diabetes such as ketoacidosis or hyperosmolar coma; * Potentially unreliable patients and those deemed by the investigator to be unsuitable for the study; * Night workers who work after 10pm; * Being on a vegetarian, vegan or flexitarian diet at the time of recruitment; * Having undergone bariatric surgery; * Carriers of the human immunodeficiency virus (HIV); * Any other medical condition/disorder that the investigators consider that are likely to: interfere with the patient's ability to complete the entire study period or participate in study activities; * Participants who require any treatment that could affect the interpretation, reliability or safety of data during the study intervention.
Amygdala Neurofeedback for Depression - Large Scale Clinical Trial
NCT05703256
Recruiting
Conditions Major Depressive Disorder
Phase NA
Enrollment 200
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

  • Amygdala real-time fMRI neurofeedback
  • Sham feedback

Primary Outcomes

  • Beck Depression Inventory (BDI-II)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-06-01
Completion: 2028-04-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 200 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kymberly Young
Collaborators: National Institute of Mental Health (NIMH)
Principal Investigators:
  • Kymberly Young, PhD (PRINCIPAL_INVESTIGATOR) - University of Pittsburgh
Contact Information
Study Contact:
Kymberly Young, PhD
412-648-6179
youngk@pitt.edu
Lisa Stupar
412-383-8100
stuparlm@upmc.edu
Interventions
  • Amygdala real-time fMRI neurofeedback
  • Sham feedback
Study Locations (1 sites)
University of Pittsburgh, Pittsburgh, Pennsylvania 15261 United States
Eligibility Criteria
Inclusion Criteria: * ages 18 - 55 * primary diagnosis of MDD and are currently depressed * able to give written informed consent prior to participation * unmedicated OR are stable on an antidepressant regime (at least 4 weeks to ensure symptoms are stable). Effective medications will not be discontinued for the purposes of the study. Exclusion Criteria: * clinically significant or unstable cardiovascular, pulmonary, endocrine, neurological, gastrointestinal illness or unstable medical disorder * Current severe DSM-V alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild or moderate alcohol or substance use would also interfere with the effects of the intervention. * history of traumatic brain injury * unable to complete MRI scan due to claustrophobia or general MRI exclusions (e.g., shrapnel inside body) * currently pregnant or breast feeding * unable to complete questionnaires written in English * current (within 3 weeks of testing) use of any antipsychotics, anticonvulsants, stimulants, benzodiazepines, beta-blockers, or other medications (except antidepressants) likely to influence cerebral blood flow. Effective medications will not be discontinued for the purposes of the study. * diagnosis of psychotic or organic mental disorder, bipolar I or II disorder. * eye problems or difficulties in corrected vision.
FES BPET-DBT in Newly Diagnosed Breast Cancer
NCT05659797
Recruiting
Conditions Breast Cancer
Phase EARLY_PHASE1
Enrollment 20
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

  • BPET/DBT imaging
  • 18F-FES

Primary Outcomes

  • Uptake of FES on BPET
  • Image quality
  • Image artifacts
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Recruiting
Start Date: 2023-10-02
Completion: 2028-01
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Abramson Cancer Center at Penn Medicine
Principal Investigators:
  • Christine Edmonds, MD (PRINCIPAL_INVESTIGATOR) - Abramson Cancer Center at Penn Medicine
Contact Information
Study Contact:
Erin o Schubert
2155736569
erin.schubert@pennmedicine.upenn.edu
Hannah Straughn
hannah.straughn@pennmedicine.upenn.edu
Interventions
  • BPET/DBT imaging
  • 18F-FES
Study Locations (1 sites)
University of Pennsylvania, Philadelphia, Pennsylvania 19130 United States
Eligibility Criteria
Inclusion Criteria: 1. Participants will be ≥ 18 years of age. 2. Known ER positive (by immunohistochemistry) breast cancer. 3. At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. mammogram, ultrasound, MRI, CT, FDG-PET/CT). Only one type of imaging is required to show a lesion. 4. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: 1. Females who are pregnant or breast feeding will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to PET imaging.. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician. 3. Currently taking tamoxifen or raloxifene 4. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
PBI for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment
NCT05663294
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 150
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

  • external beams radiotherapy
  • brachytherapy

Primary Outcomes

  • Local Control rate
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: 2023-01-09
Completion: 2029-12
Eligibility
Age: 41 Years
Sex: FEMALE
Volunteers: false
Enrollment: 150 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Istituto Clinico Humanitas
Collaborators: Mediolanum Cardio Research
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • external beams radiotherapy
  • brachytherapy
Study Locations (1 sites)
IRCCS Istituto Clinico Humanitas, Rozzano, Milano 20089 Italy
Eligibility Criteria
Inclusion Criteria: * Age \>40 * Pathologically confirmed DCIS: 1. low risk (lesions of ≤3 cm diameter, resection margins of at least 2 mm, nuclei grade: G1, G2) 2. intermediate risk (lesions of ≤1 cm diameter, resection margins of at least 2 mm, nuclei grade: 3) * Written informed consent Exclusion Criteria: * Prior thoracic radiation therapy * Preoperative systemic treatments (i. e., chemotherapy, endocrine therapy); * Autoimmune disease, vasculitis, collagenopathy or scleroderma that may predispose to late sequelae * No other cancers in the last 5 years
Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study
NCT05667701
Recruiting
Conditions Wheezing, Asthma in Children
Phase PHASE2
Enrollment 65
Locations 2 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Soy isoflavone
  • matching placebo

Primary Outcomes

  • T2 endotype
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-09-18
Completion: 2028-12-31
Eligibility
Age: 2 Months
Sex: ALL
Volunteers: true
Enrollment: 65 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Rajesh Kumar
Collaborators: Northwestern University, University of South Florida, University of Colorado, Denver, National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigators:
  • Rajesh Kumar, MD (PRINCIPAL_INVESTIGATOR) - Ann & Robert H Lurie Children's Hospital of Chicago
Contact Information
Study Contact:
Sarah Godley, RN
312 227 6010
sgodley@luriechildrens.org
Interventions
  • Soy isoflavone
  • matching placebo
Study Locations (2 sites)
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago, Illinois 60611 United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois 60611 United States
Eligibility Criteria
Inclusion Criteria: 1. Parent/guardian must be an adult (≥18 years of age) and able to understand and provide informed consent. 2. Age: Term infants (≥37 weeks gestational age) less than 12 months of age at recruitment 3. High risk of asthma: As determined by one or more of the following: 1. A history of uni- or bi-parental asthma with onset in childhood by parent self report, OR 2. Uni- or bi-parental asthma with onset after childhood along with the presence of one or more other comorbid atopic condition including allergic rhinitis, atopic dermatitis, or food allergy, OR 3. atopic dermatitis in the child determined by parent report of a physician diagnosis 4. Genotype: Either homozygous or heterozygous for the PAI-1 risk allele (i.e. 4G4G or 4G5G). 5. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the SIRA Manual of Operations (MOP). 1. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion. Exclusion Criteria: 1. 1\. Inability or unwillingness of a parent or guardian to give written informed consent or comply with study protocol. 2. Parents who will not include either a puree or some form of bottle feeding such that the infant would be able to take the investigational product in a puree or a liquid (expressed breast milk, supplemental formula, or a small amount of water). 3. Currently on a soy based formula. 4. Breastfeeding mothers who are taking soy supplements or soy enriched foods more than 2 times a week and will not stop this level of ingestion while breastfeeding. 5. On treatment for recurrent wheezing such as regular inhaled steroids. 6. The infant may not have the following specific contraindications: known congenital thyroid disease, or a history of estrogen sensitive clinically relevant mutations in the family (such as BRCA1). 7. Medication use 1. Maternal use of tamoxifen in pregnancy or if breastfeeding 2. Use of immunomodulatory medications such at methotrexate, mycophenolate, azathioprine, or other immunomodulatory agent in the mother if breastfeeding or in the infant. 8. Use of another investigational agent in the last 30 days prior to randomization. 9. Current, parent reported, diagnosis of mental illness or current, diagnosed or self-reported drug or alcohol abuse (in the primary caregiver) that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements. 10. Known allergy to soy protein (either by reported allergy or skin testing to soy prior to randomization) or reported allergy to NovaSoy, from which the investigational product is compounded. 11. The infant is currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to enrollment. 12. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study. 13. Infant requiring intubation prior to screening. 14. Infant requiring \> 3 hospitalizations for asthma symptoms/ wheezing illness prior to screening. 15. Infant requiring \> 3 five day bursts of oral steroid at least 14 days apart from each other prior to screening. 16. Any chronic condition requiring use of systemic corticosteroids or another immunomodulating agent at screening or before randomization, and during the course of the study. 17. Non-adherence: 1. Inability / unwillingness of the parents to induce the infant to swallow study medication 2. Unwillingness of the parents to allow the staff to perform baseline measurements 18. Living with a foster parent as a ward of the state. 19. Caregiver does not have access to a phone (needed for scheduling appointments or responding to questionnaires). 20. Plan(s) for the family to move from the area during the study period. 21. The infant's caretaker does not primarily speak English or Spanish. In order to be eligible to continue in the study following screening visit A (V1) , an individual must meet all of the following additional randomization criteria: 1. Must be ≥4 months and \<12 months of age at randomization 2. Must have either 4G/4G or 4G/5G genotype 3. Cannot have had a severe wheezing exacerbation requiring ICU admission between screening (V1) and randomization (V3) 4. Cannot have had more than two wheezing / "asthma" episodes (separated from each other by at least 14 days), each requiring at least a 5 day course of oral steroids in the time between screening visit A (V1) and randomization (V3).
Symptom-driven ICS/LABA Therapy for Adolescent Patients With Asthma Non-adherent to Daily Maintenance Inhalers
NCT05689983
Active, positions filled
Conditions Asthma in Children, Nonadherence, Medica...
Phase PHASE1, PHASE2
Enrollment 40
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

  • Maintenance ICS and Symptom Driven SABA
  • Symptom-driven budesonide/formoterol combination

Primary Outcomes

  • Adherence to inhaler strategy delineated using an electronic inhaler sensor
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2022-04-01
Completion: 2025-12-01
Eligibility
Age: 12 Years
Sex: ALL
Volunteers: false
Enrollment: 40 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Washington University School of Medicine
Collaborators: National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
Principal Investigators:
  • James Krings, MD MSc (PRINCIPAL_INVESTIGATOR) - Washington University School of Medicine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Maintenance ICS and Symptom Driven SABA
  • Symptom-driven budesonide/formoterol combination
Study Locations (1 sites)
Washington University in St. Louis School of Medicine, St Louis, Missouri 63110 United States
Eligibility Criteria
Inclusion Criteria: 1. Able to understand and provide informed consent. 2. Age 18-75 at the time of study enrollment. 3. Provider diagnosed mild or moderate persistent asthma and prescribed maintenance ICS treatment and as needed SABA for at least 6 months prior to enrollment. 4. Suboptimal adherence to prescribed maintenance ICS therapy defined as missing at least expected 2 ICS refills in the prior 6 months based on examination of pharmacy records or a Medication Adherence Report Scale for Asthma (MARS-A) score \<4.5. 5. An Asthma Control Test (ACT) score at enrollment greater than or equal to 12 but less than or equal to 20 indicating partially controlled or moderately uncontrolled asthma. 6. iPhone or Android smartphone with an active data plan and willingness to use the Adherium device. Exclusion Criteria: 1. Relevant comorbid pulmonary diseases including, but not limited to a diagnosis of chronic obstructive pulmonary disease (COPD), cystic fibrosis, or alpha 1 anti-trypsin deficiency. 2. Current use of a biologic medication or investigational treatment for asthma. 3. History of asthma requiring ICU admission in the last year. 4. Unwillingness to use or pay for an inhaler that is compatible with the Adherium sensor (fluticasone propionate or budesonide/formoterol). Of note, fluticasone and budesonide/formoterol are formulary tier 1-2 for Missouri Medicaid and most commercial insurances and are believed to be equally or less expensive as alternative inhalers for most patients. 5. Any clinically significant abnormalities on physical exam, laboratory testing, or baseline diagnostic testing that the study team believes will make the study unsafe. 6. Patients who do not complete at least 70% of the twice-daily texts during the two weeks after screening.
The PIVOT Trial: Project on EHR-Integrated Lifestyle Interventions for Adults Aged Fifty and Older
NCT05654142
Active, positions filled
Conditions CARDIOMETABOLIC CONDITIONS, Obesity, Pre...
Phase NA
Enrollment 1029
Locations 3 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Base intervention
  • Augmented Intervention

Primary Outcomes

  • Assess change in weight from baseline to 52 weeks
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: 2023-04-17
Completion: 2026-12-31
Eligibility
Age: 50 Years
Sex: ALL
Volunteers: false
Enrollment: 1029 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of Illinois at Chicago
Collaborators: Washington University School of Medicine, University of Pittsburgh
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Base intervention
  • Augmented Intervention
Study Locations (3 sites)
Department of Medicine, Vitoux Program on Aging and Prevention, Chicago, Illinois 60608 United States
Washington University School of Medicine in St Louis, St Louis, Missouri 63110 United States
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania 15213 United States
Eligibility Criteria
Inclusion Criteria: * Age 50 - 74 years (inclusive) * Confirmed body mass index (BMI) ≥27.0 based on: * Weight measured by participant at home using the study-provided wireless weight scale * Height documented in the EHR during at least 2 separate ambulatory care encounters within the past 2 years * Diagnosis of 1 or more cardiometabolic condition (prediabetes, metabolic syndrome, type 2 diabetes, hypertension, dyslipidemia) in the EHR * Willing and able to accept randomization, and provide written informed consent and HIPAA authorization * Willing and able to participate in all aspects of the data collection and intervention protocols, including remote monitoring with a study-provided wireless weight scale and activity tracker and the use of a study tablet for access of MyChart, REDCap, and Fitbit apps Exclusion Criteria: * Unable to speak, read, understand English sufficiently for informed consent * No reliable Wi-Fi Internet access at home * Self-report of current active weight loss treatment, including research-based commercial weight loss programs (e.g., Weight Watchers, Jenny Craig, HMR, Omada, TOPS), other weight loss or related behavioral health or wellness programs led by trained personnel (professional or lay) at the recruiting clinic or in the local community, and prescription weight loss medications * Screen positive for active eating disorder (bulimia nervosa or binge eating disorder) using PHQ- eating disorder module * Planned or prior bariatric surgery within the last 2 years (Note: patients who are more than 2 years post bariatric surgery can participate if otherwise eligible) * Unable to pass the Revised Physical Activity Readiness Questionnaire (PAR-Q) or obtain physician medical clearance to participate * Presence of any significant safety concerns or contraindications related to serious physical or mental health issues based on the EHR or self-report (e.g., type 1 diabetes or insulin dependence, myocardial infarction, stroke, cancer diagnosis (other than non-melanoma skin cancer) within the past 12 months and/or actively receiving cancer treatment, end-stage organ failure, bipolar disorder, psychosis, life expectancy \<12 months) * Cognitive impairment based on the Callahan 6-item screener * Active alcohol or substance use disorder (including prescription drugs) based on the CAGE Questionnaire Adapted to Include Drugs (CAGE-AID) * Discontinued health care at the recruiting site, or plan to discontinue in the next 12 months * Participation in other behavioral, medical or surgical treatment studies by self-report that conflict with the primary weight loss outcome of this study. * Family/household member of an already enrolled participant or of a study team member * Investigator discretion for clinical safety or protocol adherence reasons
A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of MN-08 Tablets
NCT05660863
Not yet recruiting
Conditions Pulmonary Arterial Hypertension
Phase PHASE1
Enrollment 16
Locations 0 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

  • MN-08 24 mg/day
  • MN-08 60 mg/day

Primary Outcomes

  • Incidence and severity of TEAEs and SAEs
  • Incidence and severity of treatment-related adverse events
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: 2025-09-01
Completion: 2026-06-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 16 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Guangzhou Magpie Pharmaceuticals Co., Ltd.
Contact Information
Study Contact:
Roy Feng, Doctor
412-509-7201
fengrentian@hotmail.com
Interventions
  • MN-08 24 mg/day
  • MN-08 60 mg/day
Eligibility Criteria
Inclusion Criteria: Subjects must meet all the following criteria to be included in the study: 1. Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 45 years of age, with body mass index (BMI) \> 18.0 and \< 30.0 kg/m2 , and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females. 2. Healthy as defined by: 1. the absence of clinically significant illness and surgery within 4 weeks prior to the first dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator. 2. the absence of a clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease. 3. Female subjects must not be pregnant, breastfeeding, or at risk to become pregnant during study participation. Female subjects must have a negative serum pregnancy test at screening (within 72 hours of the first dose of study medication) if of childbearing potential, or be of non-childbearing potential. Non-childbearing potential is defined as: 1. post-menopausal female (absence of menses for 12 months prior to the first study drug administration, or having had a bilateral oophorectomy, or hysterectomy with bilateral oophorectomy at least 6 months prior to the first study drug administration); or 2. surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration). 4. Female subjects of childbearing potential (childbearing potential defined as not post menopausal nor surgically sterile) must agree to use a reliable method of birth control (see below for details) or remain abstinent during the study, starting with the screening visit until at least 90 days after the last study drug administration. 5. Male subjects who have not been vasectomized for at least 6 months, and who are sexually active with a female partner of childbearing potential must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration: 1. simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks prior or intra-uterine contraceptive device placed since at least 4 weeks prior to study. 2. simultaneous use of a male condom and, for the female partner, a diaphragm or cervical cap with intravaginally applied spermicide. 6. Male subjects (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first study drug administration until at least 90 days after the last study drug administration. 7. Male subjects must be willing not to donate sperm until 90 days following the last study drug administration 8. Capable of signing the informed consent form. Exclusion Criteria: Subjects to whom any of the following applies will be excluded from the study: 1. Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening. 2. Subjects with any following clinical illness at screening, including but not limited to respiratory, circulatory, digestive, hematological, endocrine, immunological, dermatological, and ENT abnormalities. 3. Subjects with digestive, liver, or kidney diseases which could affect the pharmacokinetics of drugs. 4. Positive urine drug screen, alcohol breath test, or urine cotinine test at screening. 5. History of allergic reactions to MN-08 or other related drugs, or to any excipient in the formulation. 6. Positive pregnancy test at screening. 7. Clinically significant ECG abnormalities or vital sign abnormalities, including: systolic BP lower than 90 or over 139 mmHg, diastolic BP lower than 60 or over 89 mmHg, or HR less than 55 or over 100 bpm; orthostatic BP: decrease in systolic blood pressure of 20 mmHg or higher, decrease in diastolic blood pressure of 10 mmHg or higher, or increase in heart rate of 30 bpm or higher within 2 to 3 minutes after passing from a supine to a standing position at screening. 8. History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week \[1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol\]). 9. History of significant drug abuse within 1 year prior to screening, or use of soft drugs (such as marijuana) within 3 months prior to the screening visit, or hard drugs (such as cocaine, phencyclidine \[PCP\], crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening. 10. Subjects drinking excessive amounts of tea, coffee, or caffeinated beverages (more than 8 cups,1 cup = 250 mL) every day before the screening, or those who cannot agree to prohibit drinking tea, coffee, and/or products containing caffeine, grapefruit, or poppy 24 hours before dosing and during the study period. 11. Smoking history of 5 cigarettes per day within 3 months before the study, or those who cannot stop smoking 24 h before dosing and during the study period. 12. Have undergone major surgery 6 months before the study, or plan to have surgery during the study. 13. Have been vaccinated within 3 months prior to the study. 14. Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration. 15. Use of medications for the time frames specified below, except for medications prescribed by the Investigator on a case-by-case basis because they have been judged unlikely to affect the pharmacokinetic profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption): 1. Prescription medications within 14 days prior to the first dosing. 2. Over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing, except for the occasional use of acetaminophen (up to 2 g daily). 3. Depot injection or implantation of any drug within 3 months prior to the first dosing. 4. Any drugs known to induce or inhibit hepatic drug metabolism (including St. John's Wort) within 30 days prior to the first dosing. 16. Donation of plasma within 7 days prior to dosing. Donation or blood loss (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing. 17. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study. 18. Breastfeeding subject. 19. Any history of suicidal ideation or suicidal behavior (within 2 years prior to screening), as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS; baseline version).
Feasibility of a Telemonitoring Program for Pregnant Women at High-Risk for Preeclampsia in Pakistan
NCT05662696
Recruiting
Conditions Preeclampsia, Pregnant With Complication
Phase NA
Enrollment 50
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

  • Raabta Telemonitoring Program (Mobile Application)

Primary Outcomes

  • Acceptability
  • Demand
  • Practicality
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-08-04
Completion: 2027-03-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University Health Network, Toronto
Collaborators: Jinnah Postgraduate Medical Centre, Aga Khan University, University of Toronto
Principal Investigators:
  • Emily Seto, PhD (PRINCIPAL_INVESTIGATOR) - University of Toronto
Contact Information
Study Contact:
Emily Seto, PhD
416-669-9295
emily.seto@utoronto.ca
Anam Shahil Feroz, MSc
6478676702
anam.shahil@mail.utoronto.ca
Interventions
  • Raabta Telemonitoring Program (Mobile Application)
Study Locations (1 sites)
Jinnah Postgraduate Medical Centre, Karachi, Sindh 75510 Pakistan
Eligibility Criteria
Inclusion Criteria: * Pregnant women at high-risk for preeclampsia (HRPE) who are either in their first or second trimester of pregnancy. The definition of HRPE will follow that of the NICE guidelines that define pregnant women at HRPE as those who have one high-risk factor or more than one moderate risk factor for preeclampsia. * Participants who can speak and read (at least at a rudimentary level with help from a caregiver) the Urdu language for ease of communication with the research team and to be able to use the telemonitoring system. * Partners (almost always male husbands in the Pakistani culture) and/or other caregivers (e.g., mother and mother-in-law) of pregnant women \[for post-study interviews\] * Clinicians and nurses involved in the implementation of the telemonitoring program \[for post-study interviews\] Exclusion Criteria: * Pregnant women at high-risk for preeclampsia who are admitted to hospital for the management of their preeclampsia condition
Prenatal Aspirin and Postpartum Vascular Function
NCT05653973
Recruiting
Conditions Preeclampsia, Microvascular Function
Phase EARLY_PHASE1
Enrollment 60
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

  • Acetylcholine
  • Endothelin-1

Primary Outcomes

  • microvascular endothelial function
  • microvascular endothelin-1-mediated constriction
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: Recruiting
Start Date: 2023-01-03
Completion: 2027-07-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Anna Stanhewicz, PhD
Contact Information
Study Contact:
Anna Reid-Stanhewicz, PHD
319-467-1732
anna-stanhewicz@uiowa.edu
Interventions
  • Acetylcholine
  • Endothelin-1
Study Locations (1 sites)
University of Iowa, Iowa City, Iowa 52242 United States
Eligibility Criteria
Inclusion: * 18 years or older, * 12 weeks to 5 years postpartum * and one of the following: 1. women who had a normal pregnancy and did not use low does aspirin (LDA) during pregnancy, 2. women who had a normal pregnancy and used LDA during pregnancy, 3. women who had preeclampsia and did not use LDA during pregnancy, 4. women who had preeclampsia and used LDA during pregnancy. Exclusion: * current daily aspirin use, * skin diseases, * current tobacco use, * diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR \< 60 mL/min/1.73m2, * statin or other cholesterol-lowering medication, * current antihypertensive medication, * history of hypertension prior to pregnancy, * history of gestational diabetes, * current pregnancy, * body mass index \<18.5 kg/m2, * allergy to materials used during the experiment.(e.g. latex), * known allergies to study drugs.
Motivational Multicomponent Lifestyle Interventions as a Supportive Treatment for Depression in Primary Health Care
NCT05681767
Recruiting
Conditions Depression
Phase NA
Enrollment 210
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

  • Motivational multicomponent lifestyle intervention + Treatment as usual
  • Treatment as usual

Primary Outcomes

  • Change in Beck Depression Inventory (BDI) scores
  • Change in the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS) scores
  • Change in 15D scores
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2022-11-21
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 210 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Kuopio University Hospital
Collaborators: University of Eastern Finland, City of Kuopio, University of Oslo
Principal Investigators:
  • Pekka Mäntyselkä (PRINCIPAL_INVESTIGATOR) - University of Eastern Finland
Contact Information
Study Contact:
Pekka Mäntyselkä
+35850449436
pekka.mantyselka@uef.fi
Ulla Mikkonen
ulla.mikkonen@uef.fi
Interventions
  • Motivational multicomponent lifestyle intervention + Treatment as usual
  • Treatment as usual
Study Locations (1 sites)
Kuopio Health Center, Kuopio, Finland
Eligibility Criteria
Inclusion Criteria: * adults ≥ 18 years * depression (ICD-10, F32-F33) * Beck Depression Inventory (BDI-1A) ≥ 10 points * the initiation of treatment in a primary health care center Exclusion Criteria: * bipolar disorder * psychosis * substance abuse * pregnancy or lactation * a long-term rehabilitative psychotherapy.
REgistry of Pulmonary Arterial Hypertension Associated With CONNECTIVE Tissue Diseases (RECONNECTIVE)
NCT05665556
Recruiting
Conditions Pulmonary Arterial Hypertension, Connect...
Phase Not Applicable
Enrollment 170
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • To characterize the clinical clinical course of Pulmonary Arterial Hypertension (PAH) associated with Connective Tissue Diseases (CTD) in a register of Mexican patients from the first visit and at every 6 months.
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: 2022-12-15
Completion: 2027-12
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 170 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Principal Investigators:
  • Jose Luis Hernandez Oropeza, PhD (PRINCIPAL_INVESTIGATOR) - Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Contact Information
Study Contact:
Jose Luis Hernandez Oropeza, PhD
+52 55 5487 0900
elinternista@hotmail.com
Jose de Jesus Rodriguez Andoney, M.Sc.
+52 55 5487 0900
andoneyjjr@hotmail.com
Interventions
N/A
Study Locations (1 sites)
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, 14080 Mexico
Eligibility Criteria
Inclusion Criteria: * Incident and prevalent patients diagnosed with Group I associated with Connective Tissue Diseases (CTD) * Incident and prevalent patients diagnosed with Group IV Pulmonary Arterial Hypertension (PAH) associated with Connective Tissue Diseases (CTD) with evidence of a chronic thromboembolic pulmonary disease by ventilation/perfusion pulmonary gammagraph or computed tomography pulmonary angiogram with at least three months of total anticoagulation therapy. * Patient diagnosed with a connective tissue disease according to the classification criteria of the American College of Rheumatology. * Precapillary pulmonary hypertension confirmed by right heart catheterization (RHC): Mean pulmonary arterial pressure (mPAP) \>20 mm Hg with a pulmonary arterial wedge pressure ≤ 15 mm Hg and Pulmonary vascular resistance (PVR) ≥ 2.0 Wood units Exclusion Criteria: * Patients who meet the criteria for another group of pulmonary hypertension (Groups II, III or V).