louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05998915: A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer
Official title: A Multi-center Study on Human Microecology Assisted Diagnosis of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Microecology；Colorectal Disease；Auxiliary Diagnosis
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 5
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 2500

Brief summary: As for this research，we want to find whether the intestinal microecology (flora, peptidoglycan fragments) have certain distribution characteristics in colorectal diseases; whether it can predict the development of disease/as a prognostic indicator.

Detailed description: We even want to find whether it can predict the development of disease/as a prognostic indicator.

Eligibility criteria: Inclusion Criteria:

* people who is going to get the colonoscopy examination

Exclusion Criteria:

* people who was diagnosed as one cancer，expect for CRC; who has had the antibiotics or the medicine that treats for colorectal disease, except for medical probiotics, in one month; who has had the laxative and the colonscopy in one week; who had a operation in three month.

Primary outcomes:
measure: collect specimen before colonscope
timeFrame: Baseline (before colonscope)
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT00646815: Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Official title: Insulin Sensitivity and Substrate Metabolism Before and After Treatment in Patients With Growth Hormone Deficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Growth Hormone Deficiency
Keywords: insulin sensitivity
substrate metabolism
fatty liver
intramyocellular lipids
growth hormone deficiency
Growth hormone deficiency (Adult)
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2008-03-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intrahepatic-intramyocellular lipids in patients with growth hormone deficiency (GHD).


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Must be of legal age and competent
* Age: \>18 and \<60 years old
* Presently diagnosed with growth hormone deficiency; if panhypopituitary, the patient must be sufficiently substituted in the other axis´s, for at least 3 months before inclusion in the study

Exclusion Criteria:

* Alcohol consumption \>21 units per week
* Malignant disease
* Pregnancy
* Magnetic implants or material in the body
* Claustrophobia
* BMI \>30
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.

Controls are matched on age, gender and BMI

Inclusion Criteria:

* Written informed consent
* Must be of legal age and competent

Exclusion Criteria:

* Alcohol consumption \>21 units per week
* Malignant disease
* Pregnancy
* Magnetic implants or material in the body
* Claustrophobia
* Heart disease (NYHA \>2)
* Uncontrolled hypertension
* Manifest diabetes mellitus
* Change in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial

Primary outcomes:
measure: insulin sensitivity
timeFrame: before and after 3 months treatment with growth hormone
Secondary outcomes:
measure: substrate metabolism
timeFrame: before and after 3 months of growth hormone treatment
measure: intrahepatic lipid content
timeFrame: before and after 3 months of growth hormone treatment
measure: intramyocellular lipid content
timeFrame: before and after 3 months of growth hormone treatment
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical department M (Endocrinology and Diabetes), Aarhus University Hospital, Aarhus Sygehus, Denmark.
city: Aarhus
country: Denmark
facility: Medical Department M, Aarhus University Hospital
Study officials:
affiliation: Medical Department M, Aarhus University Hospital, Aarhus, Denmark
name: Jens OL Jorgensen, Professor MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03261115: Effects of Benzocaine 20% Topical Anesthetic and no Topical Agent on Pain Perception During Intra-oral Injections
Official title: Efficacy of Topical Benzocaine in Anterior Maxilla: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Keywords: Pain, Benzocaine, Clinical trial
Lead sponsor: CMH Lahore Medical College and Institute of Dentistry
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia against the use of no topical agent during buccal infiltration in maxillary anterior teeth. The rationale behind this comparison is to evaluate the practical, clinical outcome of not using any topical agent if in fact topical anesthesia does not reduce pain as reported by various studies and if consequently its usage was to be discontinued.

Detailed description: The clinical implication of topical anesthesia and placebo being the same is to not use either of them prior to LA administration in dentistry. This clinical approach has rarely been studied and this study aims to compare the effects of the use of topical anesthesia against the use of no topical agent prior to buccal infiltration in maxillary anterior teeth.

Eligibility criteria: Inclusion Criteria:

* Above the age of 18
* Males and females both
* Participants requiring extraction of maxillary anterior teeth
* Intact or minimally restored anterior teeth
* Patients with American Society of Anesthesiologists physical status of 1 or 2

Exclusion Criteria:

* Participants with physical American Society of Anesthesiologists physical status of 3 or 4
* Showing signs of inflammation in the area to be injected
* Having known allergy to any of the agents used in the study
* Used anti- anxiety drugs or sedatives in the past two weeks
* Have taken analgesics on the day of data collection

Primary outcomes:
measure: Pain score on needle penetration
timeFrame: Immediately
measure: Pain score on local anesthesia deposition
timeFrame: Immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: CMH Lahore Medical College and Institute of Dentistry
Study officials:
affiliation: CMH Lahore Medical College and Institute of Dentistry
name: Nurain Rehman
role: PRINCIPAL_INVESTIGATOR
affiliation: CMH Lahore Medical College and Institute of Dentistry
name: Samir Qazi, FFDRCSI
role: STUDY_DIRECTOR
References:
citation: Rehman N, Qazi SR. Efficacy of Topical Benzocaine in Maxilla: A Randomized Controlled Trial. Anesth Prog. 2019 Spring;66(1):24-29. doi: 10.2344/anpr-66-01-01.
Clinical trial NCT03885115: Lace Up and Move: Structured After School Intervention for Hispanic and African American Youth
Official title: Lace Up and Move: Structured After School Exercise Intervention for Hispanic and African American Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Childhood Obesity
Obesity
Physical Activity
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: United Health Foundation
First posted: 2019-03-21
Enrollment: 600
Sex: ALL
Minimum age (years): 9
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the efficacy of Lace Up and Move (LUAM), a structured after-school exercise intervention, designed to increase moderate-to-vigorous physical activity (MVPA) and enhance sleep quality among Hispanic and African American (AA) boys and girls.

Detailed description: This study uses a randomized comparison-group pre-post-test design. Overall objectives of LUAM are to: (1) to increase the percentage of youth who meet 60 minutes of daily MVPA per week; (2) to improve the quality of sleep patterns (i.e., sleep efficiency and duration); and (3) to reduce percent body fat (%BF). It is hypothesized that compared to the control group (CG) participants, the experimental group (EG) participants will exhibit: (a) greater increase in percentage of children who meet 60 minutes of daily MVPA per week; (b) greater increase of sleep efficiency and duration; and (c) greater decrease in sleep latency and (d) greater decrease in %BF.

Eligibility criteria: Inclusion Criteria:

* child and at least their mother \[or one member of the family\] must be of Hispanic or African American descent
* child must have no physical disability or medical conditions that interfere with their participation in the exercise program

Exclusion Criteria:

* neither child nor parental guardians is of Hispanic or African American descent
* child is not between the ages of 9-14 years
* child is pregnant or physically unable to participate in the exercise program.

Primary outcomes:
measure: Child Physical Activity
timeFrame: pre & post intervention at Week 12
Secondary outcomes:
measure: Sleep
timeFrame: pre & post intervention at Week 12
measure: Sleep Quality
timeFrame: pre & post intervention at Week 12
measure: Body fat percentage
timeFrame: pre & post intervention at Week 12
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Norma Olvera
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00801515: A Compassionate Access Protocol For Those Patients Who Have Completed A4001029
Official title: A Compassionate Access Protocol For Those Patients Who Have Completed A4001029
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: HIV
Keywords: Compassionate
HIV
CCR5
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-12-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This is a compassionate study to provide continued access to maraviroc for only those subjects completing study A4001029 who are showing clinical benefit. Assessments of safety and tolerability of maraviroc when added to OBT will be continued.


Eligibility criteria: Inclusion Criteria:

* Patients having completed study A4001029 in Canada and still deriving clinical benefit.

Exclusion Criteria:

* None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00661115: To Investigate the Efficacy and Safety of Vardenafil in Men With Erectile Dysfunction.
Official title: A Randomised, Double Blind, Placebo Controlled, Multi-center, Fixed Dose, Parallel Group Study to Investigate the Efficacy and Safety of Vardenafil (BAY 38-9456) in Men With Erectile Dysfunction .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Sexual Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 173
Sex: MALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of vardenafil in men with erectile dysfunction.


Eligibility criteria: Inclusion Criteria:

* Men 21 years or above with ED for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months
* having at least a 50% failure rate of sexual intercourse attempts during the run-in phase

Exclusion Criteria:

* Subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded.
* Diabetic subjects with hemoglobin A1c (HbA1c) more than 12% were also excluded.
* Subjects could not be on androgens/anti-androgens or alpha blockers.

Primary outcomes:
measure: Erectile function (EF) domain score of the International Index of Erectile Function (IIEF)calculated as the sum of scores from Questions 1 to 5 and 15
timeFrame: At Week 12 using the Last Observation Carried Forward (LOCF) method to account for dropouts.
Secondary outcomes:
measure: Success in penetration and maintenance as recorded in subject diaries
timeFrame: At Weeks 4, 8 and 12 (as observed and at LOCF)
measure: Scores for questions 3 and 4 of the IIEF
timeFrame: At Weeks 4, 8 and 12 (as observed and at LOCF)
measure: Other IIEF domain scores
timeFrame: At Week 12 (observed and at LOCF)
measure: Global Assessment Question (GAQ) responses
timeFrame: At Weeks 4, 8 and 12 (as observed and at LOCF)
measure: Rates of premature termination, adverse events, laboratory abnormalities, ECG abnormalities, and concomitant medication use.
timeFrame: At Weeks 4, 8 and 12 (as observed and at LOCF)
Other outcomes:
Locations:
city: Bangalore
country: India
state: Karnataka
city: Bangalore
country: India
state: Karnataka
city: Belagum
country: India
state: Karnataka
city: Mumbai
country: India
state: Maharashtra
city: Mumbai
country: India
state: Maharashtra
city: Madurai
country: India
state: Tamilnadu
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04956315: Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing ACL Rupture
Official title: Accuracy and Stability of a New Automatic Knee Arthrometer in Diagnosing Anterior Cruciate Ligament Rupture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Ligament; Laxity
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beihang University
First posted: 2021-07-09
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: one healthy subject was tested with both devices for ten consecutive days to estimate examiner effect； 20 healthy subjects were tested with both devices to determine the method effect； 200 medicine students volunteered as healthy subjects; each with pain-free knees in the last three months, and without a history of knee injury； 200 patients with ACL rupture from our institution were also included.

Brief summary: We introduced an automatic knee arthrometer (AKA) and aimed to evaluate the repeatability and effectiveness thereof in diagnosing ACL rupture compared with the KT-2000.

Detailed description: The AKA was compared to the KT-2000 at 134 N in this study, the anterior displacement and difference of both knees of every subject were measured. The first protocol was designed to evaluate examiner effect (level of experience) and contralateral-side effect (left or right knee) in a single healthy subject, ten times, on ten consecutive days. The second was to compare the stability in 20 healthy subjects, with a single experienced examiner. Third, we recruited 200 ACL rupture and 200 healthy subjects as contrast to compare the accuracy of the devices in diagnosing ACL rupture.

Eligibility criteria: Inclusion Criteria:

* patients with ACL rupture from our institution were included. All patients were diagnosed by sports medicine specialists based on clinical manifestation, combined with imaging examinations, and hospitalized for further surgery.

Exclusion Criteria:

* Patients aged \<18 or \>45 years, with combined multiple knee ligament injury combinations, and/or limited range of motion of the knee (unable to flex to 20-30°)

Primary outcomes:
measure: Side-to-side difference （SSD）
timeFrame: within 3 months after ACL rupture
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: yingfang ao, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT01849315: Effects of Physical Activity on Disease Risk Factors
Official title: Effects of an Empirically-Based Physical Activity Intervention on Chronic Disease Risk Factors in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2013-05-08
Enrollment: 13
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Obesity is associated with increased risk of heart disease and diabetes (Kim et al., 2010). Appalachian children in Athens County, Ohio, experience higher rates of obesity compared to the national average (20.9% vs. 15.4%), which increases their risk of obesity-related diseases (Montgomery-Reagan, Bianco, Heh, Rettos, \& Huston, 2009). Although physical activity (PA) is known to improve fitness and adiposity (Gutin \& Owens, 2011; Yin et al., 2009), very little is known about the effects of PA on the progression of chronic disease risk factors (biomarkers) for obesity-related diseases in children, such as inflammatory markers, lipids, and glucose/insulin. This lack of knowledge is due to a limited understanding of the number of calories burned during children's free-play PA. This study will assess the impact of a PA program (ACT) of known energy cost on obesity-related disease markers in 2nd-4th grade children compared to a sedentary control group (SED). The study will recruit children from an after-school program in Athens County elementary schools. Baseline and posttest data will include measures of height, weight, body composition, blood pressure, and physical activity levels. Following baseline measures, children will be randomized into either the ACT or SED group for 8 weeks. The ACT group will play recess-type games previously determined to expend ≥100 calories in 30 minutes. The SED group children will play sedentary-type activities during the same time period. It is hypothesized that the ACT group children will demonstrate significant improvements in PA after 8 weeks compared to the SED group children and that these improvements will be related to positive changes in body weight and body composition.


Eligibility criteria: Inclusion Criteria:

* Attends participating after school program

Exclusion Criteria:

* cardiorespiratory, metabolic, and neurological disorders and physical impairments that would prevent them from being physically active, and were not taking any medications that would affect metabolism

Primary outcomes:
measure: Daily Physical Activity Levels
timeFrame: 8 weeks
Secondary outcomes:
measure: body composition
timeFrame: 8 weeks
measure: biomarkers for cardiometabolic disease
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00870415: Breast-Conserving Surgery Techniques in Treating Women With Breast Cancer
Official title: Multicenter (Phase II) Study of Oncoplastic Surgical Techniques for Breast Conservation in Breast Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIC breast cancer
ductal breast carcinoma
invasive ductal breast carcinoma
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2009-03-27
Enrollment: 263
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery.

PURPOSE: This phase II trial is studying different breast-conserving surgery techniques in treating women with breast cancer.

Detailed description: OBJECTIVES:

Primary

* Evaluate the percentage of histologically healthy margins maintained during resection in women with breast cancer.

Secondary

* Evaluate local recurrence at 5 years.
* Evaluate aesthetic results.
* Evaluate quality of life using the QLQC30 and BR23 questionnaires.

OUTLINE: This is a multicenter study.

Patients undergo oncoplastic conservative surgery according to defined modalities across the various centers.

Quality of life is assessed periodically.

After completion of study treatment, patients are followed every 6 months for 2 years and then for at least 3 years.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets 1 of the following criteria:

  * Diagnosis of intraductal breast cancer requiring a wide local resection
  * Diagnosis of infiltrating ductal breast cancer within range
  * Diagnosis of invasive breast cancer that has not responded well to neoadjuvant treatment
* No multicentric tumor
* No gigantomastia
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* No patients subject to a measure of legal protection or unable to express consent
* No patients deprived of liberty by judicial or administrative decision or hospitalized without patient consent
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the diseased breast
* No prior adjuvant treatment
* No concurrent participation in another clinical research study

Primary outcomes:
measure: Percentage of histologically healthy margins maintained during resection
timeFrame: From inclusion to end of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Study officials:
affiliation: Institut du Cancer de Montpellier - Val d'Aurelle
name: Philippe Rouanet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: