louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06957626: Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
Official title: Development and Validation of Microbiota and Metabolite-based Prediction Model for Recurrence of High-risk Colorectal Polyps After Polypectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Polyp
Colorectal Cancer Recurrent
Colorectal Adenoma
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with high-risk colorectal polyps

Brief summary: The characteristics of the intestinal microbiota in high-risk colorectal polyp recurrence and their relationship with disease pathogenesis have not yet been fully elucidated. This study aims to analyze the microbial community characteristics in the intestinal mucosal tissue of patients after polypectomy with recurrence of colorectal polyps. Additionally, this research holds significant importance for understanding the etiology of adenoma recurrence and develop a microbiota and metabolite-based predicting tool.


Eligibility criteria: Inclusion Criteria:

* patients aged 40-75 years who undergo the colonoscopy with at least 1 high-risk colorectal polyp

Exclusion Criteria:

* patient with severe physical diseases that prevented them from adhering to the examination requirements,
* patient with coagulopathy or other contraindications for biopsy or polypectomy,
* patient with previous surgical procedures on the gastrointestinal tract,
* presence of colorectal cancer or other malignant tumor at baseline
* presence of inflammatory bowel disease or hereditary polyposis syndromes (such as family adenomatous polyposis or Lynch syndrome)
* within 1 month before enrollment, oral antibiotics and probiotics were taken;
* inability to provide informed consent or refusal to participate in the study.

Primary outcomes:
measure: The characteristics of the intestinal microbiota in patients with high-risk colorectal polyp recurrence
timeFrame: 24 months
Secondary outcomes:
measure: Development and validation of Microbiota and metabolite-based model predicting recurrence of high-risk colorectal polyps after polypectomy
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, 1 Shuaifuyuan, Dongcheng District, Beijing, China
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jing nan Li, MD, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01690026: Facilitating Adolescent Self-Change for Alcohol Problems
Official title: Facilitating Adolescent Self-Change for Alcohol Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Underage Drinking
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-09-21
Enrollment: 1209
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This present multi-site investigation compares a voluntary brief intervention for adolescent alcohol problems to an educational comparison condition. Measures are taken at intake and at 4 and 12 weeks post intake to determine effectiveness of the intervention to promote personal change efforts and arrest progression of alcohol problems. This study tests cognitive mechanisms of change and treatment characteristics and processes associated with youth self-regulation to reduce or stop hazardous drinking.


Eligibility criteria: Inclusion Criteria:

* All 9th-12th graders at six schools from 3 sites across the country are eligible to participate, regardless of alcohol experience

Exclusion Criteria:

* exclusion prior to 9th grade and after 12th grade

Primary outcomes:
measure: Alcohol use and problems
timeFrame: one year
Secondary outcomes:
measure: Cognitive mediators
timeFrame: one year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Drug Free Youth in Town
state: Florida
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Portland
country: United States
facility: Reed College
state: Oregon
Study officials:
References:
Clinical trial NCT01030926: A Trial Investigating the Concentration in the Blood of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
Official title: A Trial Investigating the Pharmacokinetic Properties of NN1250 in Children, Adolescents and Adults With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-12-14
Enrollment: 39
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial was conducted in Europe. The aim of this clinical trial was to look into the concentration of NN1250 (insulin degludec/insulin 454) in the blood after one injection of NN1250 in children, adolescents and adults with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 6-65 years (both inclusive)
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index for children: 15.0-20.0 kg/m\^2 (both inclusive), for adolescents: 18.0-28.0 kg/m\^2 (both inclusive) and for adults maximum 30.0 kg/m\^2

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Not able or willing to refrain from smoking during the inpatient period
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods

Primary outcomes:
measure: Area under the NN1250 concentration-time curve after single dose
timeFrame: 0-72 hours after dosing
Secondary outcomes:
measure: Maximum observed NN1250 concentration after single dose
timeFrame: 0-72 hours after dosing
measure: Time to maximum observed NN1250 concentration after single dose
timeFrame: 0-72 hours after dosing
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Biester T, Blaesig S, Remus K, Aschemeier B, Kordonouri O, Granhall C, Sondergaard F, Kristensen NR, Haahr H, Danne T. Insulin degludec's ultra-long pharmacokinetic properties observed in adults are retained in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Feb;15(1):27-33. doi: 10.1111/pedi.12116.
Clinical trial NCT01054157: Expression and Localization of FP Prostaglandin Receptor in Human Ocular Tissues
Official title: Expression and Localization of FP Prostaglandin Receptor in Human Ocular Tissues
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malposition of the Lower Lid
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery

Brief summary: to approve the expression of PGF2α receptors in hair follicle in ocular skin tissue, explaining the hypertrichotic effect of PG analogues as intraocular pressure lowering treatment.

Detailed description: 50 hair follicle dissection - human lower lid skin and lashes will be derived from lateral tarsal strip (LTS) dissected routinely in ectropion repair surgery, the skin strip is dissected routinely in this surgery , without any relation to our study. The study will be planned according to Helsinki declaration for Paraffin embedded LTS tissue sections (4 µ) will be processed and examined in immunohistochemistry lab. FP receptor proteins expression, using subtype-specific polyclonal antibodies, will be detected by the light microscopic level, according to manufacturer instruction.

Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* malposition of lower eyelid

Exclusion Criteria:

* age \< 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center
name: halah el naddaf, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06438757: Trial of JYB1904 in Patients With Allergic Asthma
Official title: Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Allergic Asthma
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2024-06-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.


Eligibility criteria: Inclusion Criteria:

* Able to provide written informed consent voluntarily;
* Aged 18-75 years, weight ≥ 40 kg, male or female;
* Diagnosed Allergic asthma.

Exclusion Criteria:

* Prior exposure to anti-IgE therapy within 1 year;
* Allergic to anti-IgE biologics;
* Current smokers, or quit smoking within 1 year;
* Combined with other non-allergic diseases that cause IgE elevation；
* History of malignancy, autoimmune diseases, Immune complex mediated diseases, Hypereosinophilic syndrome;
* Other conditions unsuitable for the trial judged by the investigator.

Primary outcomes:
measure: Serum concentrations of JYB1904
timeFrame: Baseline through 337 days post-dose
measure: Serum concentrations of IgE
timeFrame: Baseline through 337 days post-dose
measure: Adverse Events(AEs)
timeFrame: Baseline through 337 days post-dose
Secondary outcomes:
measure: Times of protocol-defined asthma exacerbations during the 24-week treatment period
timeFrame: Baseline through 168 days post-dose
measure: Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks
timeFrame: Baseline through 24 weeks post-dose
measure: Serum concentrations of anti-drug antibody (ADA)
timeFrame: Baseline through 337 days post-dose
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai General Hospital
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Min Zhang
role: STUDY_CHAIR
References:
Clinical trial NCT02311257: Survey on Supplement Use in Mitochondrial Disease
Official title: Survey on Supplement Use in Mitochondrial Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitochondrial Disease
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-12-08
Enrollment: 162
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited through the NAMDC Clinical Registry and RDCRN Contact Registry. Additional means of recruitment may be used to direct patients to join the NAMDC or RDCRN registries.

Brief summary: The purpose of this study is to learn about the use of nutritional supplements in patients with mitochondrial disease.

Detailed description: Our goal is to better assess which nutritional supplements are prescribed to patients with mitochondrial disorders, the monitoring obtained and whether any subjective improvements are noted by the patients or their caregivers.

Eligibility criteria: Inclusion Criteria:

* NAMDC Clinical Registry or RDCRN Contact Registry participant
* Diagnosis of a mitochondrial disease confirmed by either electron transport chain abnormalities or molecular testing.

Exclusion Criteria:

* Lack of participation in NAMDC or RDCRN registries
* Diagnosis of mitochondrial disorder not confirmed by ETC studies or molecular diagnosis

Primary outcomes:
measure: Assessment of nutritional supplement use in patients with mitochondrial disease.
timeFrame: Up to one year after study activation.
Secondary outcomes:
measure: Assess the attitudes of patients and parents towards use of nutritional supplements in patients with mitochondrial disease
timeFrame: Upt to one year after study activation.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: The Cleveland Clinic
name: Sumit Parikh, MD
role: STUDY_CHAIR
affiliation: Massachussetts General Hospital
name: Amel Karaa, MD
role: STUDY_CHAIR
affiliation: Columbia University
name: Michio Hirano, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02020057: Comparison of Highly Cross-Linked and Conventional Polyethylene in Total Knee Arthroplasty
Official title: Comparison of Highly Cross-Linked and Conventional Polyethylene in Posterior Cruciate-Substituting Total Knee Arthroplasty in the Same Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2013-12-24
Enrollment: 319
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To our knowledge, there has been no information on in vivo clinical results of posterior cruciate-substituting arthroplasties using highly cross-linked polyethylene. We evaluated whether the clinical and radiographic results, incidence of post fracture of the tibial polyethylene insert, failure of the locking mechanism of the tibial polyethylene insert, and the incidence of osteolysis would be similar between posterior cruciate-substituting total knee prostheses using conventional and highly cross-linked polyethylene.


Eligibility criteria: Inclusion Criteria:

* osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Exclusion Criteria:

* inflammatory arthritis
* osteoarthritis of the hip causing pain or restricted mobility
* a foot or ankle disorder which limited walking
* dementia or a neurological disorder including a past history of stroke which affected mobility

Primary outcomes:
measure: knee society knee score
timeFrame: 3 months, 1 year, and yearly thereafter the operation, until 15 years after the operation
Secondary outcomes:
measure: range of motion
timeFrame: preoperative, 3 months, 1 year, and yearly thereafter the operation until 15 years
Other outcomes:
Locations:
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Young-Hoo Kim, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02486757: Investigation of Female Reproductive Hormone Dynamics During Adolescence
Official title: Investigation of Female Reproductive Hormone Dynamics During Adolescence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Menstruation Disturbances
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 9
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Irregular menstrual cycles are common in girls for several years after their first menstrual period. The cause of abnormal menstrual cycles during this time is not well-understood. The purpose of this study is to: 1) monitor girls during a menstrual cycle (with blood and urine sampling and serial pelvic ultrasounds) to identify those girls who do not ovulate (release of an egg from the ovary), and 2) determine whether cycles can be corrected by treating girls with a short course of low-dose estrogen and progesterone.


Eligibility criteria: Inclusion Criteria:

* no more than 3 ½ years postmenarchal

Exclusion Criteria:

* Subjects currently on or previously treated with medications that may affect reproductive hormones (eg birth control pills).
* Subjects with severe acne or hirsutism
* Subjects who exercise excessively (running \> 20 miles/week or its equivalent)
* Subjects with any of the following medical conditions: diabetes, hypertension, hyperlipidemia, valvular heart disease, lupus, rheumatoid arthritis, migraine headaches with aura, undiagnosed breast mass, inflammatory bowel disease, gallbladder disease, sickle cell disease, or thrombophilia.
* Current smoker
* History of deep venous thrombosis or pulmonary embolism in subject or first-degree relative

Primary outcomes:
measure: Ovulation in Cycle 2
timeFrame: 20-40 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Reproductive Endocrine Unit, Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Janet Hall, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ortega MT, Carlson L, McGrath JA, Kangarloo T, Adams JM, Sluss PM, Lambert-Messerlian G, Shaw ND. AMH is Higher Across the Menstrual Cycle in Early Postmenarchal Girls than in Ovulatory Women. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1762-71. doi: 10.1210/clinem/dgaa059.
citation: Sun BZ, Kangarloo T, Adams JM, Sluss P, Chandler DW, Zava DT, McGrath JA, Umbach DM, Shaw ND. The Relationship Between Progesterone, Sleep, and LH and FSH Secretory Dynamics in Early Postmenarchal Girls. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2184-2194. doi: 10.1210/jc.2018-02400.
citation: Sun BZ, Kangarloo T, Adams JM, Sluss PM, Welt CK, Chandler DW, Zava DT, McGrath JA, Umbach DM, Hall JE, Shaw ND. Healthy Post-Menarchal Adolescent Girls Demonstrate Multi-Level Reproductive Axis Immaturity. J Clin Endocrinol Metab. 2019 Feb 1;104(2):613-623. doi: 10.1210/jc.2018-00595.
Clinical trial NCT01943357: Improving Self Management Skills of Older Adults With Diabetes
Official title: Improving the Self Management Skills of Older Adults With Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Diabetes
Keywords: diabetes
patient education
self management
health improvement
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: HealthCore, Inc.
First posted: 2013-09-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study will help determine if the Better Choices Better Health Diabetes program (community-based or online, also known as the Diabetes Self-Management Program) improves the hbA1C of people with Type-II diabetes. The investigators will also examine 1) symptoms (fatigue, sleep, low blood sugar symptoms, depression, shortness of breath), 2) healthy behaviors (blood sugar monitoring; taking medications as prescribed; getting eye, foot, kidney and cholesterol exams; and activity), 3) the use of health care services. This project is a translational study to demonstrate the effectiveness of the intervention in the context of a major insurer.

Detailed description: Self-report questionnaires and hbA1c capillary blood collection kits will be administered at baseline (prior to the intervention), six-months and twelve-months. Differences between baseline and followup scores will be used to determine if participants have benefited from the intervention, using intent-to-treat methodology. Subgroups and delivery method (small-group or on-line) will be compared using repeated measures and analyses of covariance.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* WellPoint insurance or medicare supplement plan participant
* 18 years or older

Exclusion Criteria:

* Treatment for cancer in past year
* Pregnant
* Under 18
* Previously taken a Stanford self-management program

Primary outcomes:
measure: Metabolic control HbA1C
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Symptom:fatigue
timeFrame: Baseline to 12 months
measure: symptom: sleep
timeFrame: Baseline to 12 months
measure: symptom: PHQ-8 depression
timeFrame: Baseline to 12 months
measure: symptoms: hypoglycemic index
timeFrame: Baseline to 12 months
measure: health behavior: blood glucose monitoring
timeFrame: Baseline to 12 months
measure: health behavior: medication adherence
timeFrame: baseline to 12 months
measure: Health behavior: communication with physician
timeFrame: baseline to 12 months
measure: health behavior: exercise
timeFrame: baseline to 12 months
measure: health behavior/utilization: frequency of exams
timeFrame: baseline to 12 months
measure: Health care utilization
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford School of Medicine
name: Kate Lorig, DPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01830257: Explore Active Surveillance Mode of the Community's Adverse Event Following Immunization(AEFI)
Official title: Phase 4 Study of MR and APDT Vaccine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Adverse Reaction to Drug
Lead sponsor: Beijing Center for Disease Control and Prevention
Sponsor class: OTHER_GOV
First posted: 2013-04-12
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators would remind the guardians of observation after immunization via sending short message and collect the information of AEFI by two ways, short message/telephone and website questionnaire.

Detailed description: The investigators will compare the rate between active and inactive surveillance of AEFI

Eligibility criteria: Inclusion Criteria:

* According with the regular vaccination
* Immunization the acellular pertussis diphtheria tetanus vaccine and Measles and rubella combined vaccine

Exclusion Criteria:

* Disapproval the AEFI information

Primary outcomes:
measure: Incidence about AEFI
timeFrame: 1.5years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Chaoyang District Centers for Disease Control and Prevention
name: Zhaoyun Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: