louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06921902: Glycemic Metrics and Patterns in People With and Without Prediabetes
Official title: Observation and Identification of Glycemic Metrics and Patterns in People With and Without Prediabetes (PREMAP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pre Diabetes
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2025-04-10
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be stratified into groups, including male and female sex, race, age and Body Mass Index. Approximately 25 evaluable subjects will be enrolled into each group.

Brief summary: The FreeStyle Libre 3 Continuous Glucose Monitoring (FSL3) System is used to characterize the glycemic profiles of people with and without a prediabetes diagnosis.

Detailed description: This is a non-pivotal, non-randomized, multi-center, prospective, non-significant risk to evaluate the glycemic profiles of people with and without a prediabetes diagnosis using continuous glucose monitoring. Up to 2000 subjects will be enrolled in up to 20 sites. Approximately 50% of evaluable subjects will have a prediabetes diagnosis.

Eligibility criteria: Inclusion Criteria:

* Subject must be at least 18 years of age.
* Subject must be willing and able to provide written signed and dated informed consent.

Exclusion Criteria:

* Subject has a diagnosis of type 1 diabetes, type 2 diabetes, or gestational diabetes.
* Subject is known to be currently practicing a low-carbohydrate or ketogenic diet at the time of enrollment.
* Subject is known to be pregnant at the time of enrollment.
* Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
* Subject is currently on any form of treatment indicated for the treatment of diabetes.
* Subject is currently on any form of medication indicated for weight loss.

Primary outcomes:
measure: Characterize the glycemic profiles of people with and without a prediabetes diagnosis.
timeFrame: up to 50 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bend
country: United States
facility: Diabetes and Obesity Care
state: Oregon
Study officials:
affiliation: Abbott Diabetes Care
name: Shridhara Karinka, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05489302: Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE)
Official title: Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE) Alt-RAMEC vs Conventional Rapid Palatal Expansion Randomized Controlled Trial -CBCT Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Maxillary Protraction in Class III Adolescent After Using (MSE)
Keywords: Expansion
maxillary protraction
class III
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 42
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT)


Eligibility criteria: Inclusion Criteria:

* Class3 Patients suffering maxillary collapse with a skeletal background
* Patients with retrognathic maxilla.
* Patients with anterior cross-bite or incisor end-to-end relationship
* Patients with unilateral or bilateral posterior crossbite.
* Patients with no periodontal disease.
* Patients with good oral hygiene and general health.
* No systemic diseases that may affect bone quality or interfere with orthodontic treatment.
* Patients with no previous orthodontic treatment.

Exclusion Criteria:

* previous orthodontic treatment.
* Craniofacial syndrome.

Primary outcomes:
measure: amount of maxillary protraction
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mohamed Shendy
state: Nasr City
Study officials:
References:
citation: Liou EJ, Tsai WC. A new protocol for maxillary protraction in cleft patients: repetitive weekly protocol of alternate rapid maxillary expansions and constrictions. Cleft Palate Craniofac J. 2005 Mar;42(2):121-7. doi: 10.1597/03-107.1.
Clinical trial NCT00345202: Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects
Official title: Short Term Effects of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: HMG-COA reductase inhibition
GFR
RPF
FE
CL
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: We wanted to test the shortterm effects of HMG-CoA reductase inhibition (atorvastatin) on renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Both men and women
* Age: Between 20-50
* BMI\<30

Exclusion Criteria:

* Cl. signs or history of disease of heart, lungs, kidneys or endocrine organs.
* Abnormal lab. tests( haemoglobin, pl. sodium, pl. potassium, pl.creatinine, pl.bilirubin, pl.ALAT, pl. cholesterol, blood glucose)
* Albuminuria or glucosuria
* Cancer
* Art. hypertension
* Alcohol abuse
* Med. treatment, except oral contraceptives
* Pregnancy or breast feeding
* Blood donation less than 1 month before study

Primary outcomes:
measure: GFR
measure: RPF
measure: FEna
measure: FELi
measure: CLna
measure: CLli
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Medical research unit, Department of medicin, Holstebro Sygehus
state: Ringkøbing countie
Study officials:
affiliation: Holstebro Sygehus
name: Erling B. Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01305902: Substance Use and Fitness
Official title: Substance Use and Fitness: A Pilot Study of Contingency Management in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Exercise
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-03-01
Enrollment: 45
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to estimate the effect size of a contingency management procedure that reinforces walking at rates consistent with the American College of Sports Medicine recommendations of 10,000 or more steps per day in older adults. We expect that participants randomized to the contingency management intervention will increase walking to a greater degree than those assigned to a standard care condition.


Eligibility criteria: Inclusion Criteria:

* age 55 - 75 years
* currently not physically active
* willing and physically able as determined by physician approval to walk 10,000 steps per day
* blood pressure of 120-159 mmHg systolic or 80-99 mmHg diastolic
* willing to meet with research staff weekly for 12 weeks

Exclusion Criteria:

* psychiatric or physical illness that could interfere with participation

Primary outcomes:
measure: number of days on which participants walked the recommended number of steps
timeFrame: Weeks 1-12
Secondary outcomes:
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
Study officials:
affiliation: University of Conncecticut Health Center
name: Nancy M Petry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05373602: LARS for Chinese Patients
Official title: The Incidence and Risk Factors of Low Anterior Resection Syndrome: Basing on Data of Chinese Patients From a Single Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incidence and Risk Factors of Low Anterior Resection Syndrome
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2022-05-13
Enrollment: 261
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rectal cancer patients

Brief summary: Low anterior resection syndrome (LARS) frequently occurs in patients undergoing low anterior resection (LAR). However, the incidence, exact mechanism and risk factors of major LARS largely variate in different studies. Considering varieties and differences of patient characteristics between Chinese patients and the western ones, this retrospective study aims to investigate the incidence of LARS in Chinese patients undergoing laparoscopic LAR, and to explore perioperative risk factors that might be associated with major LARS. Consequent patients undergoing laparoscopic LAR and free from disease recurrence from January 2015 to May 2021 were issued with LARS questionnaire. Incidence of LARS and patient data were collected and analyzed.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed as rectal cancer and underwent radical laparoscopic LAR and straight colorectal/coloanal anastomosis (with or without a protective stoma) by a same surgical team

Exclusion Criteria:

either local or distal recurrence, severe complications such as postoperative anastomotic leakage, failure of protective stoma closure, data missed and no responding to LARS questionnaire

Primary outcomes:
measure: incidence of LARS
timeFrame: at least 1 months postoperatively
measure: incidence of major LARS
timeFrame: at least 1 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05650684: Factors Associated With Continuation of Exclusive Breastfeeding Until the Post-natal Visit
Official title: Factors Associated With Continuation of Exclusive Breastfeeding Until the Post-natal Visit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breastfeeding
Keywords: exclusive breastfeeding
postnatal visit
factors associated
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2022-12-14
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mother initiating exclusive breastfeeding after birth

Brief summary: Breastfeeding promotes the health of mother and her child, and remains the reference in terms of infant nutrition. World Health Organization recommends exclusive breastfeeding for the first six months. This recommended duration is not respected in France with a median duration of breastfeeding in France at 3 months.

Detailed description: The aim is to study factors associated with continuation of exclusive breastfeeding until the post-natal visit.

Eligibility criteria: Inclusion Criteria:

* primiparous and multiparous women
* women who have initiate breastfeeding
* women aged 18 and more
* agreeing to participate in the study

Exclusion Criteria:

* women whose newborn has been in intensive care unit
* women with a multiple pregnancy

Primary outcomes:
measure: breastfeeding
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04446884: Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells
Official title: Treatment of Stress Urinary Incontinence in Women With Autologous Adipose-derived Mesenchymal Stem Cells Mixed With Collagen Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Stress Urinary Incontinence
Keywords: Stress Urinary Incontinence
Mesenchymal stem cells
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
First posted: 2020-06-25
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of women with stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

Detailed description: During the implementation of the project, method for the treatment of women stress urinary incontinence using injection of autologous adipose-derived mesenchymal stem cells mixed with collagen was developed.

Effectiveness of MSCs is due to the following:

* the ability of MSCs to stimulate tissue regeneration
* positive results of preclinical studies of the method of treatment of stress urinary incontinence (SUI) in animals (female rats).

After gynecological examination, diagnosis of SUI, MSCs were isolated from adipose tissue, cultured and then transplanted back to directly under mucosa of urethra by three point injection in one third distal from the urethral neck at 3, 6 and 9 o'clock and to the paraurethral area.

Injected volume was 3 ml per patient. For injection MSCs (6\*10\^6 cells) were mixed with collagen solution (3,5% w\|w).

Follow up patients monitoring was mperformed at 2, 4, 6 and 12 months after injection.

Eligibility criteria: Inclusion Criteria:

* Stress urinary incontinence
* absence of acute inflammatory manifestations in the genitourinary system

Exclusion Criteria:

* urethral or bladder malformations
* acute and chronic infectious diseases: HIV, viral hepatitis, tuberculosis
* mental disorders

Primary outcomes:
measure: Number of cured patients
timeFrame: 3 months
measure: Number of patients with treatment-related adverse events
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hrodna
country: Belarus
facility: Hrodna City Clinical Hospital
Study officials:
affiliation: Head of the Lab of Institute of Biophysics and Cell Engineering
name: Igor D Volotovski, Prof
role: STUDY_DIRECTOR
affiliation: Associate Professor of Department of Surgical Diseases
name: Alexander Nechiporenko, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT06636084: Vertical and Horizontal Mandibular Ridge Augmentation Techniques
Official title: Vertical and Horizontal Mandibular Ridge Augmentation Techniques: a Randomized Controlled Clinical Trial Comparing Customized CAD/CAM Titanium Mesh Versus Reinforced Perforated PTFE Mesh
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vertical Ridge Deficiency
Horizontal Ridge Deficiency
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare alveolar ridge augmentation outcomes of two types of membranes for vertical and horizontal mandibular ridge augmentation: Customized CAD/CAM Titanium Mesh versus Reinforced Perforated PTFE Mesh (RPM).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Physical status according to the American Society of Anesthesiology (ASA) I or II, which includes patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
* Subjects having at least one free end saddle edentulous area of the posterior area of the mandible with moderate horizontal and vertical bone defects \>≥3mm.
* Capacity to understand and accept the written conditions of the study.

Exclusion Criteria:

* Insufficient oral hygiene.
* Smoking habit of \>10 cigarettes/day (self-reported).
* Abuse of alcohol or drugs.
* Pregnancy or individuals attempting to get pregnant (self-reported).
* Acute local or systemic infections.
* Uncontrolled diabetes or other metabolic disease.
* Severe hepatic or renal dysfunction.
* Autoimmune disorders.
* Patients who underwent radiotherapy in the last 5 years.
* Patients undergoing immunosuppressive therapy or who are immunocompromised.
* Any other contraindications for undergoing surgery.

Primary outcomes:
measure: Ridge width changes in mm
timeFrame: 6 months
measure: Ridge height changes in mm
timeFrame: 6 months
Secondary outcomes:
measure: Change in the mucosal thickness in mm
timeFrame: 6 months
measure: Histological outcomes of the augmented bone
timeFrame: 6 months
measure: The volumetric bone gain of the grafted area in mm3
timeFrame: 6 months
measure: Rate of complications
timeFrame: 6 months
measure: Cost analysis
timeFrame: 6 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Dentistry
state: Michigan
Study officials:
affiliation: Department of Periodontics and Oral Medicine, University of Michigan
name: Hom-Lay Wang, DDS MSD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02034084: A Comparison of Left and Right Radial Approach for Percutaneous Coronary Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transradial Approach,
Coronary Angiography,
Percutaneous Coronary
Keywords: Transradial approach,
Coronary angiography
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 1400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previous studies have shown that the transradial cardiac catheterization has decreased not only bleeding complications related to the access site and procedural discomfort but also morbidity and hospitalization as compared to transfemoral approach. At present, the right radial approach (RRA) is the first choice routinely for coronary angiography and interventions in daily clinical practice despite more marked subclavian artery tortuosity than left radial approach (LRA). Although LRA has been thought to be more direct access to the ascending aorta similar to transfemoral approach and may reduce fluoroscopy time and cerebrovascular complications compared with RRA, the application of LRA for coronary intervention is still low. Moreover, several studies have also obtained conflicting results showing no difference in procedural success rate compared LRA and RRA using Judkins catheters. To date, it remains unclear whether LRA is superior to RRA in term of safety and feasibility for coronary angiography and interventions in real world practice and few data of randomized control trial are available.

The aim of this study was to randomly investigate and compare the safety and feasibility of LRA compared with RRA for coronary diagnostic angiography in Chinese subjects.

The investigators will enroll consecutively for 2 years all patients undergoing coronary diagnostic procedures through trans radial approach.

The primary outcome was total procedural duration. Secondary outcomes included fluoroscopy time, dose of radiation including cumulative air kerma and dose area product, contrast volume and the incidence of vascular complications.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients who undergo to diagnostic coronary procedures

Exclusion Criteria:

* Acute ST-elevation myocardial infarction
* Previous coronary artery bypass graft surgery
* Hemodynamic instability

Primary outcomes:
measure: Total procedural duration
timeFrame: 1 day
Secondary outcomes:
measure: Fluoroscopy time
timeFrame: 7 days
measure: Dose of radiation
timeFrame: 7 days
measure: Contrast volume
timeFrame: 7 days
Other outcomes:
measure: Vascular complications
timeFrame: 7 days
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Buxing Chen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00337584: A Pre-Operative Screening Questionnaire (AMS-Q) for Ambulatory Orthopedic Surgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ambulatory Surgery
Keywords: out patient surgery
quality improvement
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2006-06-16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: We are studying whether providing patients undergoing day surgery the opportunity to have their medical history reviewed by an hospital internist before surgery leads to better results after surgery. These doctors are internal medicine specialists who are experienced in assessing patients going to surgery, making sure they are "fine-tuned" before their operation. We believe this will ensure the safest and best surgical outcomes. The study involves the patient filling out a 3 page questionnaire for review by the internist prior to surgery. Additionally, patients will receive a follow-up phone call one week after surgery asking about the experience at the hospital and a questionnaire in the mail three months later to see if the patient had any medical problems after leaving the hospital.


Eligibility criteria: Inclusion Criteria:

* All patients having ambulatory surgery performed by one of our participating surgeons during the study period.

Exclusion Criteria:

* Patients who speak neither English nor Spanish.
* Patients who have had any surgery in the previous 6 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Lisa A Mandl, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: