louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01754233: Evaluation of the 755nm Alexandrite for the Treatment of Epidermal and Dermal Pigmented Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermal and Epidermal Pigmented Lesions
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to assess treatment for facial dermal and epidermal pigmented lesions using the 755nm Alexandrite laser.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old
2. Has unwanted dermal and/or epidermal pigmented lesions or desires skin toning and wishes to undergo laser treatments.
3. Is willing to consent to participate in the study.
4. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.
5. Has Fitzpatrick skin types III to IV.

Exclusion Criteria:

1. The subject is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
2. The subject is hypersensitive to light exposure OR takes photo sensitized medication.
3. The subject has active or localized systemic infections
4. The subject has any condition which, in the investigator's opinion, would make it unsafe for the subject to participate in this research study.
5. The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within 3 months prior to entering this study.
6. The subject has used Accutane within 6 months prior to enrollment.
7. The subject has the need to be exposed to artificial tanning devices or excessive sunlight during the trial.
8. The subject has had prior treatment with parenteral gold therapy (gold sodium thiomalate).
9. The subjects had prior treatment with laser or other devices in the treatment area within 3 months.
10. The subject has a history of keloids or hypertrophic scarring.
11. The subject has evidence of compromised wound healing.
12. The subject has a history of squamous cell carcinoma or melanoma
13. The subject has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
14. Is allergic to topical lidocaine or topical steroids.

Primary outcomes:
measure: Photographic Evaluation
timeFrame: up to 4 months post last treatment
Secondary outcomes:
measure: Reporting of Adverse Events
timeFrame: up to 4 months post last treatment
measure: Satisfaction Questionnaire
timeFrame: up to 4 months post treatment
Other outcomes:
Locations:
city: Chestnut Hill
country: United States
facility: Skin Care Physicians
state: Massachusetts
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT03644433: Impact of Uterine Closure Techniques on the Cesarean Scar Thickness After Repeated Cesarean Section
Official title: Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cesarean Section, Repeated
Cesarean, Uterine Scar Thickness
Cesarean, Residual Myometrial Thickness
Cesarean Section Complications
Cesarean Section; Complications, Wound, Dehiscence
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2018-08-23
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean.


Eligibility criteria: Inclusion Criteria:

* previous two or three cesarean
* gestational weeks \>=36 weeks

Exclusion Criteria:

* risk of obstetric haemorrhage
* suspicion or diagnosis placenta previa or accrete syndrome
* chorioamnionitis
* uterine myoma in the anterior uterine segment
* hysterotomy other than lower segment uterine incision at previous cesarean

Primary outcomes:
measure: residual myometrial thickness
timeFrame: 6 months after cesarean
Secondary outcomes:
measure: residual myometrial thickness
timeFrame: 6 weeks after cesarean
measure: Healing ratio
timeFrame: 6 months after cesarean
measure: Healing ratio
timeFrame: 6 weeks after cesarean
measure: Existence of cesarean scar defect
timeFrame: 6 months after cesarean
measure: Existence of cesarean scar defect
timeFrame: 6 weeks after cesarean
measure: Operation time
timeFrame: 10 minute after cesarean completed
measure: Change in hemoglobin
timeFrame: 48 hours after cesarean
measure: Blood product transfusion
timeFrame: One week after cesarean
measure: Maternal infectious morbidity
timeFrame: six weeks after cesarean
measure: Length of hospitalization
timeFrame: One month after cesarean
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk Üniversitesi araştırma Hastanesi
Study officials:
References:
Clinical trial NCT05732233: RITUAL Ultivision AI CADe Randomized Controlled Trial
Official title: Randomized Clinical Trial of the Ultivision AI Artificial Intelligence System for Colorectal Cancer Screening or Surveillance in Colonoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Adenoma
Polyp of Colon
Adenoma Colon
Keywords: Screening
Surveillance
Artificial Intelligence
Colonoscopy
Lead sponsor: Satisfai Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial USA Inc.
First posted: 2023-02-16
Enrollment: 137
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel trial design
Primary purpose: DIAGNOSTIC

Brief summary: Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).

Ultivision AI CADe is indicated for white light colonoscopy only.

Detailed description: Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).

The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.

Eligibility criteria: Inclusion Criteria:

1. Age 45 to 75 years;
2. Screening or surveillance colonoscopy.
3. Iinformed consent

Exclusion Criteria:

1. Colorectal cancer;
2. Inflammatory bowel disease, including Crohn's disease or ulcerative colitis;
3. Polyposis syndrome including Familial Adenomatous Polyposis, Cowden syndome, Linch syndrome, Peutz-Jeghers syndrome, MUITYH associated polyposis, familial Colorectal Cancer type X;
4. Positive Fecal Immunochemical Test;
5. Use anti-platelet agents or anticoagulants that prevent polyps removal;
6. Colon resection, not including the appendix;
7. Subject is pregnant or lactating.

Primary outcomes:
measure: Adenoma per Colonoscopy (APC)
timeFrame: During the procedure/surgery
measure: Adenoma Per Extraction (APE).
timeFrame: During the procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine
state: California
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Montréal (Québec)
country: Canada
facility: University of Montreal Research Center (CRCHUM)
state: Montreal
city: Milano
country: Italy
facility: Humanitas Research Hospital
Study officials:
References:
citation: Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18.
Clinical trial NCT03413033: Immediate Effects of Two Semi-occluded Vocal Tract Exercises
Official title: Immediate Effects of Two Semi-occluded Vocal Tract Exercises on Laryngeal Activity of Individuals With Constant Vocal Effort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Voice
Keywords: Semi-occluded vocal tract
resonance tubes
tongue trill
voice therapy
Lead sponsor: Universidad Nacional de Colombia
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 43
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy university teachers despite constant vocal effort, without past voice training or therapy.

Brief summary: This study aims to observe the physiological effects of two different Semi-occluded vocal tract (SOVT) exercises in the larynx when they are executed by individuals with constant vocal effort and without vocal pathology.

Detailed description: SOVT is a voice education or rehabilitation method that involves different postures which partially occlude or elongate the vocal tract. It causes a change in the vibration pattern of the vocal folds. SOVT postures have been postulated to produce changes in contact quotient (CQ), measured with electroglottograph (EGG). This study aims to observe the physiological effects of two different SOVT exercises in larynx when they are executed by people with constant vocal effort and without vocal pathology. In order to do so, EGG will be performed before and after 43 volunteers execute two SOVT exercises (tongue trill and resonance tubes). The following parameter will be captured: CQ. A t-paired test will be performed to compare pre and post-test information. Furthermore, a generalized estimating equation will be fit to find the effects of each exercise in the subjects.

This protocol was modified due to different administrative issues related to the use of the stroboscopy (one of the assesment tools previosly considered), so that stroboscopy was removed from the protocol.

Eligibility criteria: Inclusion Criteria:

* No current or past history of voice disorders.
* No current or past voice training or therapy.
* Vocal use larger than 20 hours per week.

Exclusion Criteria:

* Laryngeal pathology during execution of stroboscopy.
* Flu-like symptoms during measures.
* Trouble with execution of semi-occluded vocal tract exercises.
* Allergy to electrodes.

Primary outcomes:
measure: Contact quotient (CQ)
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Universidad Nacional de Colombia
Study officials:
affiliation: Universidad Nacional de Colombia
name: Luisa F Ángel Gordillo
role: STUDY_DIRECTOR
References:
Clinical trial NCT01239433: Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions
Official title: Pathophysiologic Changes in the Respiratory System During Therapeutic Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 25
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: Patients in the Intensive Care Unit (ICU) on mechanical ventilation where daily endotracheal suctioning is performed to remove secretions.

Most of the patients have ARDS/ ALI.

Brief summary: Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation.

Detailed description: Airway pressures change during fiberoptic bronchoscopy and endotracheal suctioning. In this study such pressure changes are examined in a mechanical lung model and in a population of ICU patients on mechanical ventilation. A systematic recording of airway pressures, tidal volumes and blood gases are carried out during ordinary therapeutic procedures requested by the staff physician. No additional study interventions are carried out.

The aim of the project is to examine negative effects of pressure/volume changes.

Eligibility criteria: Inclusion Criteria:

* \> 18 years of age
* on mechanical ventilation
* daily endotracheal suctioning performed

Exclusion Criteria:

* \< 18 years of age
* non-invasive ventilation

Primary outcomes:
measure: Intrabronchial airway pressure
timeFrame: 2013
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital - Ulleval
Study officials:
affiliation: Oslo University Hospital - Ulleval, Norway
name: Espen R Nakstad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ullevaal University Hospital
name: Helge Opdahl, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03106233: Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction
Official title: The Lateral Thigh Perforator (LTP) Flap for Autologous Breast Reconstruction: A Prospective Analysis of 138 Flaps
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast reconstruction
Perforator flap
Microsurgery
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 86
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All female patients who opted for autologous breast reconstruction but who required an alternate flap than the deep inferior epigastric artery perforator (DIEP) flap.

Brief summary: The lateral thigh perforator (LTP) flap was previously introduced as an alternative flap for autologous breast reconstruction when the abdomen is not suitable as a donor site. In this prospective study all LTP flap breast reconstructions that have been performed since September 2012 are analyzed. In addition, the surgical refinements that were introduced over the years are reported.


Eligibility criteria: Inclusion Criteria:

* Lateral thigh region suitable as a donor site
* Abdomen not suitable as donor site
* Informed consent

Exclusion Criteria:

* Pre-operative imaging showing no suitable perforators

Primary outcomes:
measure: Recipient- and donor-site complications
timeFrame: Through study completion up to an average of 12 months post-operatively
Secondary outcomes:
measure: Flap re-explorations
timeFrame: Through study completion up to an average of 12 months post-operatively
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: Maastricht University Medical Center
name: Stefania Tuinder, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00263133: Modulation of Visually Evoked Potentials by an Antidepressant
Official title: Modulation of Visually Evoked Potentials by an Antidepressant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
SSRI
Sertraline
synaptic plasticity
visually evoked potentials
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2005-12-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 12 normal healthy controls will be treated with 50 mg sertraline once daily for three weeks. Early amplitudes of visually evoked potentials will be examined at day 0, 10 and 21 and statistically compared. This study aims to examine a putative modulation of synaptic transmission and plasticity by an antidepressant and is part of a series of studies in healthy individuals and depressed patients.


Eligibility criteria: Inclusion Criteria:

* healthy individuals 18-65 years

Exclusion Criteria:

* history of affective oder other psyhiatric disorder
* severe medical condition
* pregnancy or ineffective contraception
* active illicit drug use

Primary outcomes:
measure: Amplitudes and latencies of early visually evoked potentials.
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Dept. of Psychiatry, University of Freiburg
Study officials:
affiliation: Dept. of Psychiatry, University of Freiburg
name: Claus Normann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06729333: A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China
Official title: A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Premature Birth of Newborn
Retinopathy of Prematurity (ROP)
Low Birthweight Infant
Keywords: retinopathy of prematurity
incidence rate
screening
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary hospital

Brief summary: The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.


Eligibility criteria: Inclusion Criteria:

From December 2024 to May 2025, preterm infants (gestational age \<37 weeks) or low birth weight infants (birth weight \<2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.

Exclusion Criteria:

1. Death before the first screening;
2. Death or loss to follow-up before complete retinal vascularization;
3. Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;
4. Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;
5. Poor systemic condition preventing fundus examination;
6. History of ocular trauma or surgery (excluding treatments for ROP);
7. Poor-quality fundus images;
8. Other conditions deemed exclusionary by the investigators.

Primary outcomes:
measure: The incidence rate of ROP
timeFrame: 6 months after the first screening
measure: Gestational age at which treatment-requiring ROP develops
timeFrame: 6 months after the first screening
measure: Birthweight at which treatment-requiring ROP develops
timeFrame: 6 months after the first screening
Secondary outcomes:
measure: Gestational age of infants developing any ROP lesion
timeFrame: 6 months after the first screening
measure: Birthweight of infants developing any ROP lesion
timeFrame: 6 months after the first screening
measure: Postmenstrual age (PMA) at which ROP lesions occur
timeFrame: 6 months after the first screening
measure: PMA at which treatment-requiring ROP occurs
timeFrame: 6 months after the first screening
measure: Screening and treatment costs
timeFrame: 6 months after the first screening
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Study officials:
References:
Clinical trial NCT02157233: Post-exercise Food Intake Regulation in a Hot Environment
Official title: Post-exercise Food Intake Regulation in a Hot Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy and Physically Active Young Men
Lead sponsor: University of the French West Indies and French Guiana
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The potential of physical activity and other non-medicinal methods for the care and prevention of metabolic and cardiovascular disorders has been insufficiently used. There is a potential influence of environmental heat in energetic balance regulation. However, the existing knowledge is insufficient to optimize physical activity programs based on the impact of exercise on energy intake regulation in hot climates. The aim of the present study is to define the major physiological determinants of short-term food intake regulation in young active and healthy men, when exposed to different levels of metabolic activity and environmental temperatures. We will thus explore the biological mechanisms related to post-exercise relative energy intake. Post-rest and post-exercise energetic compensation will be analysed in these different environmental conditions, with a special focus on the effect of the birth weight. This study should open interesting ways to define adequate nutritional and exercising programs in hot environments.


Eligibility criteria: Inclusion Criteria:

* healthy and physically active men aged 18-30 years

Exclusion Criteria:

* any physical or medical problem liable to limit the subjects' ability to perform the exercise testing in safe conditions,
* ear troubles

Primary outcomes:
measure: Relative post-exercise and post-rest energy intake
timeFrame: 11 months
Secondary outcomes:
measure: Appetite hormones
timeFrame: 13 months
measure: Heart rate variability
timeFrame: 11 months
measure: Tympanic temperature
timeFrame: 11 months
measure: Peak exercise capacity
timeFrame: 11 months
measure: Appetite visual analogic scale
timeFrame: 11 months
measure: metabolic markers
timeFrame: 13 months
measure: vascular biomarkers
timeFrame: 13 months
measure: comfort visual scale
timeFrame: 11 months
Other outcomes:
Locations:
city: Les Abymes
country: France
facility: CREPS
state: Guadeloupe
Study officials:
References:
citation: Faure C, Charlot K, Henri S, Hardy-Dessources MD, Hue O, Antoine-Jonville S. Effect of heat exposure and exercise on food intake regulation: A randomized crossover study in young healthy men. Metabolism. 2016 Oct;65(10):1541-9. doi: 10.1016/j.metabol.2016.07.004. Epub 2016 Jul 11.