louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06979037: Genetic Markers of Diabetic Ulcers and Personalized Treatment Targets Research
Official title: Clinical Investigation of Genetic Markers in Diabetic Ulcers and Their Role in Personalized Treatment Targeting
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Ulcers
Keywords: Diabetic Ulcers
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 712
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of diabetic ulcer patients who visit the The First Affiliated Hospital of University of South China during the trial period and meet the inclusion/exclusion criteria.

Brief summary: This clinical trial involves collecting peripheral blood, ulcer tissue, and fecal samples from diabetic ulcer patients for bioinformatics analysis to screen genetic markers significantly associated with ulcer risk and healing differences. Furthermore, multi-omics data will be integrated to establish a diabetic ulcer risk prediction model. Based on key single nucleotide polymorphisms and their regulatory pathways, potential new drug targets for promoting healing will be explored, providing a genetic basis for personalized treatment.


Eligibility criteria: Inclusion Criteria:

* 1) Subjects who voluntarily participate in this clinical study and sign informed consent;
* 2) Patients with type 2 diabetes and diabetic ulcers;
* 3) Disease duration ≥ 10 years or age ≥ 55 years at enrollment;
* 4) Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study.

Exclusion Criteria:

* 1) Severe vascular occlusion or impairment;
* 2) Patients with congenital heart disease, aortic dissection, or other severe cardiovascular diseases;
* 3) Patients with ulcers caused by factors other than diabetes;
* 4) Patients with severe liver and kidney dysfunction or serious neurological impairment.

Primary outcomes:
measure: Ulcer Healing Time
timeFrame: Three years
Secondary outcomes:
measure: Absolute Change in Ulcer Area
timeFrame: Three years
measure: Number of Amputation Events
timeFrame: Three years
measure: Ulcer Recurrence
timeFrame: Three years
measure: Time to Complete Wound Closure
timeFrame: Three years or wound closure
measure: Number of Foot Infections
timeFrame: Three years
measure: Quality of Life Assessment
timeFrame: Three years
measure: Length of Stay
timeFrame: Three years
Other outcomes:
Locations:
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
Study officials:
References:
Clinical trial NCT05712837: Efficacy of 25% Trichloroacetic Acid Peel Versus 30% Salicylic Acid Peel in Mild to Moderate Acne Vulgaris
Official title: Efficacy of 25% Trichloroacetic Acid Peel Versus 30% Salicylic Acid Peel in Mild to Moderate Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of 25% trichloroacetic acid peel versus 30% salicylic acid peel in mild to moderate acne vulgaris.

Study Design: Randomized Control Trial. Place And Duration of Study: Department of Dermatology, CMH Abbottabad from 01 Jun 2022 to 30th Nov, 2022.

Methodology: A total of 60 patients presented with mild or moderate acne vulgaris were randomized into two groups comprising 30 patients in each group and treated with either the TCA peel or the SA peel at 2-week intervals for 12 weeks. Patients in Group A were treated with 25% TCA peel whereas patients in Group B were treated with 30% SA peel. At the end of therapy after 12 weeks, evaluation of active acne was done by individual lesion counts (comedones, papules and pustules) and calculation of the Michaelsson acne score (MAS).


Eligibility criteria: Inclusion Criteria:

* Patients with mild or moderate facial acne vulgaris presented in dermatology opd

Exclusion Criteria:

* Patients with grade III or IV acne vulgaris
* patients taking any acne medications or had taken oral or topical medications in the past 4 weeks
* pregnant female patients or nursing a baby
* patients with known hypersensitivity to the formulations used in the study or a history of photosensitivity
* hypertrophic scars, keloidal tendency, active or recurrent herpes simplex infection
* active dermatosis
* unrealistic expectations

Primary outcomes:
measure: Effectiveness of 25 % trichloroacetic acid peel versus 30 % salicylic acid peel in the treatment of mild to moderate acne vulgaris
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: Cmh abbottabad
state: Kpk
Study officials:
References:
Clinical trial NCT03998137: Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft
Official title: A Prospective, Controlled, Multi-Center, Post-Approval Trial to Evaluate the Long-term Safety and Effectiveness of AUGMENT® Injectable Bone Graft Compared to Autologous Bone Graft as a Bone Regeneration Device in Foot and Ankle Fusions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ankle and Hindfoot Arthrodesis
Keywords: Ankle Fusions
AUGMENT® Injectable Bone Graft
Autologous Bone Graft
arthritis
ankle pain
foot pain
hindfoot fracture
ankle fracture
Lead sponsor: BioMimetic Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-06-26
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female subjects over the age of 18 years of age, who were randomized and treated as part of the population of the BMTI-2009-01 or BMTI-2010-01 protocol.

Brief summary: The objective of this long-term study is to evaluate the long-term effectiveness and safety of AUGMENT® Injectable Bone Graft vs. autologous bone graft. The study involves evaluation of subjects originally treated under protocol BMTI-2009-01 or BMTI-2010-01 or treated with autograft under protocol BMTI-2006-01.

Subjects will be asked to consent and return to provide long-term follow-up data at or after 60 months (5 years) have elapsed since their original surgery as a subject in protocol BMTI-2009-01 or BMTI-2010-01.

STUDY HYPOTHESIS: The effectiveness and safety profile for AUGMENT® Injectable Bone Graft is maintained and remains comparable to that of autologous bone graft over long-term subject follow-up.

REGULATORY PHASE: Post-approval study


Eligibility criteria: Inclusion Criteria:

1. Must be willing and able to provide informed consent and be available for the planned follow-up evaluations and radiologic tests; and
2. Must have been included in the Augment Injectable propensity score matching population from the Augment Injectable summary of safety and effectiveness data (SSED).

Exclusion Criteria:

1) Subjects that were excluded from the safety analysis in the BMTI-2009-01 or BMTI-2010-01 study. These subjects were consented, but never treated as part of the BMTI-2009-01 or BMTI-2010-01 protocol.

Primary outcomes:
measure: Pain on weight bearing via Visual Analog Scale (VAS)
timeFrame: Visit 1 (Day 0)
Secondary outcomes:
measure: Confirmation of bridging bone via computerized tomography (CT)
timeFrame: Visit 1 (Day 0)
measure: AOFAS (American Orthopaedic Foot & Ankle Society) Hindfoot and Ankle Score
timeFrame: Visit 1 (Day 0)
measure: Foot Function Index, FFI
timeFrame: Visit 1 (Day 0)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01054937: Single Dose Study With 4SC-203 in Healthy Volunteers
Official title: First-in-Man, Randomised, Double-Blind, Placebo-Controlled, Single Dose Escalation Study of the Novel Compound 4SC-203 in Young Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: 4SC-203
Phase I
single dose
healthy volunteers
Lead sponsor: 4SC AG
Sponsor class: INDUSTRY
First posted: 2010-01-22
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years (included), and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening
* Subjects must be able to communicate well with the investigator, to understand and comply with the requirements of the study, and to understand and sign the written informed consent

Exclusion Criteria:

* Evidence of current or previous clinically significant disease, medical condition or finding of the medical examination (including vital signs and ECG), that in the opinion of the investigator would compromise the safety of the subject or the quality of the data
* Current or recent history of significant renal, hepatic, haematological, immunological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease which would interfere with the subject's participation in the trial

Primary outcomes:
measure: Investigation of safety and tolerability of escalating single doses of 4SC-203.
timeFrame: 14 days
Secondary outcomes:
measure: To investigate the pharmacokinetics of single doses of 4SC-203.
timeFrame: 14 days
measure: To assess the pharmacodynamic effect by means of appropriate biomarkers.
timeFrame: 14 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation
Study officials:
affiliation: Charité Research Organisation GmbH, Berlin, Germany
name: Frank Wagner, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04033237: Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Official title: Project 4, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Pregnant Women
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Tobacco Use Disorder
Keywords: Biomarkers of exposure
Compensatory smoking
Nicotine dependence
Reduced nicotine cigarettes
Tobacco withdrawal
Women
Pregnancy
Health disparities
Vulnerable populations
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Food and Drug Administration (FDA)
name: University of Kentucky
First posted: 2019-07-26
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Study 2 will evaluate the effects of extended exposure to cigarettes with varying levels of nicotine in pregnant smokers who have less than an Associate's degree. This study will be limited to two conditions: usual brand vs. 0.4 mg nicotine/g tobacco. After a baseline period in which daily smoking rate and other baseline assessments are completed, participants will be randomly (by chance) assigned to either their usual brand or the very low nicotine content condition and followed for 12 weeks.

Detailed description: Some inclusion/exclusion criteria are purposely omitted at this time to preserve scientific integrity. They will be included after the trial is complete.

Eligibility criteria: Inclusion Criteria:

* Female
* Ages 18-44 years
* Gestational age ≤ 25 weeks

Exclusion Criteria:

* Male
* Under 18 years old
* Over 44 years old
* Gestational age \> 25 weeks

Primary outcomes:
measure: Cigarettes per day
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Sarah H. Heil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01456637: Online Self-Help Intervention for Insomnia: With or Without Feedback
Official title: Online Self-Help Intervention for Insomnia: With or Without Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Insomnia
Keywords: Insomnia
Intervention
Self-help
Internet
Lead sponsor: Utrecht University
Sponsor class: OTHER
First posted: 2011-10-21
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The object of this study is to determine whether feedback added to a self-help protocol for insomnia enhances the treatment effect. In this study all participants receive an online self-help cognitive behavioral therapy (CBT) intervention consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.


Eligibility criteria: Inclusion Criteria:

* Insomnia
* Access to internet
* Dutch citizen

Exclusion Criteria:

* Alcohol or substance abuse
* Being suicidal
* Sleep apnea
* Schizophrenic or having a psychosis disorder

Primary outcomes:
measure: Sleep diary
timeFrame: baseline
measure: Diary
timeFrame: 4-week follow-up
measure: Diary
timeFrame: 6 month follow-up
Secondary outcomes:
measure: Insomnia Severity
timeFrame: baseline
measure: Insomnia severity
timeFrame: 4-week follow-up
measure: Insomnia Severity
timeFrame: 6 month follow-up
measure: Anxiety
timeFrame: baseline
measure: Anxiety
timeFrame: 4-week follow-up
measure: Anxiety
timeFrame: 6-month follow-up
measure: Depression
timeFrame: baseline
measure: Depression
timeFrame: 4-week follow-up
measure: Depression
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: Utrecht University
Study officials:
affiliation: Utrecht University
name: Jaap Lancee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03835637: Single and Multiple Dose Study of ORIC-101 in Adult Healthy Subjects
Official title: A Phase 1 Study of the Oral Glucocorticoid Receptor (GR) Antagonist ORIC-101 in Adult Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: ORIC Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-02-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single centre, open-label, non-randomised study with up to 2 parts, assessing the safety, tolerability, PK and PD of single (Part A) and multiple (Part B; optional) doses of oral GR antagonist ORIC-101.


Eligibility criteria: Inclusion Criteria:

* Healthy males or healthy females of non-child bearing potential
* Age 18 to 65 years of age
* Body mass index of 18.0 to 32.0 kg/m\^2 and weight between 50 kg and 120 kg, inclusive

Exclusion Criteria:

* Subjects who have received any investigational medicinal product (IMP) in a clinical research study within the previous 3 months
* History of any drug or alcohol abuse in the past 2 years
* Current smokers and those who have smoked within the last 12 months
* Females of childbearing potential
* Women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma
* Current disease requiring treatment with systemic corticosteroids
* Serious adverse reaction or serious hypersensitivity to mifepristone, or any other drug, or the formulation excipients

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 96 hours post-final dose
measure: Area under the curve (AUC)
timeFrame: 96 hours post-final dose
measure: Number of participants with adverse events
timeFrame: 96 hours post-final dose
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 96 hours post-final dose
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 96 hours post-final dose
measure: Area under the curve (AUC)
timeFrame: 96 hours post-final dose
measure: Number of participants with adverse events
timeFrame: 96 hours post-final dose
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: 96 hours post-final dose
measure: Maximum plasma concentration (Cmax)
timeFrame: 96 hours post-final dose
measure: Area under the curve (AUC)
timeFrame: 96 hours post-final dose
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Center
Study officials:
References:
Clinical trial NCT02101437: The Relationship of Platelet Micro-RNA Expression and Platelet Reactivity in Patients Under Clopidogrel or Ticagrelor Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PRU
miRNA
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2014-04-02
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: For acute coronary syndrome patients undergoing cardiac catheterization after stenting, we will give dual antiplatelet drugs (dual antiplatelet agents) therapy, the choice of the basis of medical criteria (clinical guidelines) routine as aspirin + clopidogrel or aspirin + ticagrelor, according to medical guidelines currently no other disposal alternative proposal (unless adverse drug tolerance or bleeding can not be administered); idea of this experiment for acute coronary syndrome or conventional cardiac catheterization after stenting, platelet miRNA expression (miR-96 , miR-200b, miR-495, miR-107) after cardiac catheterization and interventional treatment of clopidogrel or ticagrelor acceptance of platelet reactivity (PRU) correlation values (given clopidogrel or ticagrelor determined by the clinician, the patient follow-up experiment to track only and observation), aims to explore under different platelet reactivity (hyper-reactive or hypo-reactive), their differences in miRNA performance.


Eligibility criteria: Inclusion Criteria:

1 under DAPT (dual antiplatelet therapy) of stable angina patients for elective stent implantation.

2. DAPT 24 hours after treatment PRU (platelet activity units) values. (Drug unresponsive patients was defined as PRU\> 235).

Exclusion Criteria:

1.Not suitable for the treatment of patients with DAPT. (Active peptic ulceration or bleeding) 2 patients of aspirin, clopidogrel, ticagrelor, cilostazol medication intolerance.

3 contraindications for aspirin, clopidogrel, ticagrelor, cilostazol drug usage (such as heart failure patients not suitable for use cilostazol).

Primary outcomes:
measure: miRNA
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei city hospital
Study officials:
affiliation: taipei city hospital cardiovascular section
name: chen yueh chung, chieft
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen YC, Lin FY, Lin YW, Cheng SM, Chang CC, Lin RH, Chuang CL, Sheu JS, Chen SM, Tsai CS. Platelet MicroRNA 365-3p Expression Correlates with High On-treatment Platelet Reactivity in Coronary Artery Disease Patients. Cardiovasc Drugs Ther. 2019 Apr;33(2):129-137. doi: 10.1007/s10557-019-06855-3.
Clinical trial NCT06970015: Demographics, Diagnosis, Management, and Outcomes of Non-occlusive Mesenteric Ischemia.
Official title: Demographics, Diagnosis, Management, and Outcomes of Non-occlusive Mesenteric Ischemia: a Substudy of a Prospective Multicenter Observational Study (AMESI)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-Occlusive Mesenteric Ischemia
Lead sponsor: University of Tartu
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study groups

* Patients with non-occlusive mesenteric ischemia.
* Patients with arterial occlusive AMI
* Patients with venous occlusive AMI
* Patients with unclear mechanism of AMI
* Patients with suspected but not confirmed AMI
* Patients with suspected but not confirmed acute mesenteric ischemia
* Patients with suspected but not confirmed acute mesenteric ischemia treated in the ICU

Brief summary: This prospective multicenter observational study, conducted between June , 2022, and April, 2023, is a preplanned analysis of the AMESI study titled 'Demographics, diagnosis, management, and outcomes of non-occlusive mesenteric ischemia,' aiming primarily to describe the demographic profile, clinical presentation, and laboratory findings of patients with non-occlusive mesenteric ischemia (NOMI), and secondarily to identify independent risk factors as well as diagnostic approaches, management strategies, and outcomes-including in-hospital, 90-day, and one-year results.


Eligibility criteria: Inclusion Criteria:

All at least 18-year-old patients with acute mesenteric ischemia or patients suspected of acute mesenteric ischemia that was not confirmed

* Patients with arterial occlusive AMI
* Patients with non-occlusive mesenteric ischemia
* Patients with venous occlusive AMI
* Patients with unclear mechanism of AMI
* Patients with suspected but not confirmed AMI

Exclusion Criteria:

* Patients with other specific form of AMI (e.g dissection)
* Confirmed strangulating bowel obstruction
* Individuals under 18 years of age.
* Consent declined by patient or next of kin
* Chronic mesenteric ischaemia without an acute event

Primary outcomes:
measure: Demographic profile
timeFrame: Baseline
measure: SOFA score
timeFrame: Baseline
measure: Serum Lactate Levels in Patients with Non-Occlusive Mesenteric Ischemia
timeFrame: Baseline
measure: Baseline APACHE II Score
timeFrame: Baseline
measure: Arterial Blood pH in Patients with Non-Occlusive Mesenteric Ischemia
timeFrame: Baseline
Secondary outcomes:
measure: Rate of Patients Diagnosed with Non-Occlusive Mesenteric Ischemia by CT, Endoscopy, or Angiography
timeFrame: Baseline
measure: Management
timeFrame: Baseline
measure: 30-day survival
timeFrame: 30 days after admission
measure: 1-year survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: University of Tartu
Study officials:
References: