louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04148274: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Ulcerative Colitis
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ulcerative Colitis
Ulcerative Colitis Chronic
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and minors with Ulcerative Colitis

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Ulcerative Colitis

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Ulcerative Colitis

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study
2. Male or female patients of any age.
3. Diagnosis of Ulcerative Colitis

Exclusion Criteria:

1. Refusal to sign informed consent form
2. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
3. Postoperative stoma, ostomy, or ileoanal pouch
4. Participation in any experimental drug protocol within the past 12 weeks
5. Treatment with total parenteral nutrition
6. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
7. Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Disease via Relative Abundance Found in Microbiome Sequencing
timeFrame: One year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: One year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03038074: Plethysmographic and Acoustic Respiration Rate Clinical Data Collection
Official title: Plethysmographic and Acoustic Respiration Rate Clinical Data Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 200
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this clinical investigation is to collect high-resolution pulse oximetry, RRp, and RAM data in pediatric subjects for the purpose of algorithm optimization and to build a database of representative pulse oximetry and respiratory signal profiles for patients in this population.


Eligibility criteria: Inclusion Criteria:

* Age: 0 to 5 years old
* Fully developed skin

Exclusion Criteria:

* Subjects with skin abnormalities at the planned application sites that would interfere with sensor application.
* Subjects with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
* Subjects deemed not suitable for the study at the discretion of the investigator

Primary outcomes:
measure: Collection of high-resolution pulse oximetry and RAM data in pediatric subjects
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: Medical Office of Mohammad T. Bailony
state: California
Study officials:
References:
Clinical trial NCT03117374: Impact of Web-based School Nutrition Intervention to Increase Fruits, Vegetables and Dairy
Official title: The Impact of an Innovative Web-based School Nutrition Intervention to Increase Fruits and Vegetables and Dairy Products in Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2017-04-17
Enrollment: 282
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this study is to evaluate the impact of an innovative web-based school nutrition intervention (Team Nutriathlon) aimed at promoting the consumption of vegetables and fruit and dairy products in high school students and to identify facilitators and/or barriers influencing its success.

Detailed description: Classes of first and second year secondary students (grades 9 and 10) from the Québec City region will be randomized into two groups. Participants in the intervention (Team Nutriathlon) will be asked to increase their consumption of fruits and vegetables and dairy products using an innovative web-based platform, developed for this study, over six weeks. The control group will follow the regular school curriculum. The number of servings of fruits and vegetables and dairy products consumed by students per day and facilitators and barriers influencing the success of the program will be compared between the two groups over the study.

Eligibility criteria: Inclusion Criteria:

* Schools were recruited on a voluntary basis via email invitation and sent across the region of Québec. The selected schools were of medium to high socioeconomic levels according to the Deprivation Index of the Ministry of Education of Québec.

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in fruits and vegetables and dairy products
timeFrame: Before and after the intervention (0 and 6 wk)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chamberland K, Sanchez M, Panahi S, Provencher V, Gagnon J, Drapeau V. The impact of an innovative web-based school nutrition intervention to increase fruits and vegetables and milk and alternatives in adolescents: a clustered randomized trial. Int J Behav Nutr Phys Act. 2017 Oct 16;14(1):140. doi: 10.1186/s12966-017-0595-7.
Clinical trial NCT02731274: Physical Activity and Motor Memory in Pedal Dexterity
Official title: Physical Activity and Motor Memory in Pedal Dexterity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Lead sponsor: Instituto Politécnico de Castelo Branco
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 34
Sex: ALL
Minimum age (years): 65
Maximum age (years): 73
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study was to investigate if a six months period of physical exercise, could improve motor memory consolidation in elderly people on pedal dexterity

Detailed description: 34 subjects of both genders, with a mean age of 71 years old participated in the study. Subjects were divided in two groups: a control group and an experimental one. Before the intervention of physical exercise program, subjects performed a Tapping Pedal Test to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.

Eligibility criteria: Inclusion Criteria:

* individuals not engaged in physical activity;
* persons aged from 65 years.

Exclusion Criteria:

* sensory abnormalities;
* mental abnormalities;
* motor abnormalities;
* other atypical health problems.

Primary outcomes:
measure: Subjects performed a Tapping Pedal Test to measure a performance in motor memory consolidation.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02486874: Clinical Evaluation of PoreSkin
Official title: Clinical Evaluation of PoreSkin: A Human Acellular Dermal Matrix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Treatment
Keywords: Human acellular dermal matrix, burns, wound healing
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PoreSkin, a human acellular dermal matrix (hADM) manufactured by Faculty of Medicine, Chulalongkorn University, is the first human dermal substitute developed in Thailand. It is a permanent dermal substitute aiming to reduce skin contracture. The objective of this study is to assess the safety and ability in achieving durable and cosmetic coverage of PoreSkin.


Eligibility criteria: Inclusion Criteria:

* Male and female patients
* 18-60 years with burn scar contracture and hypertrophic scar

Exclusion Criteria:

* Undergoing immunosuppressive therapy
* Immunocompromise host (DM, HIV infected)
* Evidence of malnutrition
* Active malignancy

Primary outcomes:
measure: The engraftment rate
timeFrame: 1 month
Secondary outcomes:
measure: Any local complications
timeFrame: 1 month
measure: the final cosmetic result
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04664374: Characterizing MyMood Patterns of Use
Official title: Characterizing MyMood Patterns of Use
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Bipolar Disorder
Mood Disorders
Depression
Dysthymia
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal

Brief summary: MyMood is an electronic mood-charting tool available to the general population of Sunnybrook Health Sciences Centre (SHSC). This project aims to characterize duration and frequency of use of MyMood by users characteristics and determine if there is any significant variability in duration and frequency of use attributable to users' age, sex, self-reported diagnosis of a mood disorder, and/or prior treatment.

Detailed description: Mental Health Telemetry (MHT) is a software platform developed at Sunnybrook for collecting real-time self-report symptom-rating questionnaire data using patients' cell phones or other portable, Internet-enabled devices. MHT has previously been used in several funded clinical research studies. The mood-disorders-specific version of MHT, which we have named MyMood, collects information on a variety of items including symptom severity, medication adherence, ER visits / hospital admissions, sleep, relationships, and life events. In our previous project, we made MyMood available to the general population of SHSC by integrating it into Sunnybrook's MyChart personal health record system and collected feedback from users, using the feedback to refine MyMood. In the current project, we aim to characterize long-term patterns of MyMood usage, examining how duration and frequency of use are affected by demographic and clinical characteristics of users (age, sex, present / reported diagnosis of a mood disorder, and/or prior treatment).

Please note that the _only_ route for entry into this study is self-referral: interested individuals who have signed themselves up for MyChart can choose to begin using MyMood on their own. There is no reason to contact the study team regarding recruitment.

Eligibility criteria: Inclusion Criteria:

• Registered user of Sunnybrook Health Sciences Centre "MyChart" electronic patient portal

Exclusion Criteria:

• n/a

Primary outcomes:
measure: MyMood Use
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: David M Kreindler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05966974: GRACE - Study of AGN1 LOEP in Osteopenic and Osteoporotic Patients
Official title: Study of Elective AGN1 LOEP in Osteopenic and Osteoporotic Subjects - a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Keywords: Bone mineral density
Femoral strength
Hip fracture
Local osteo-enhancement procedure
LOEP
Proximal femur
Lead sponsor: AgNovos Healthcare, LLC
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Osteopenic and osteoporotic subjects receiving AGN1 LOEP treatment of the proximal femur.

Brief summary: The study is designed as a retrospective, single-center study for subjects previously treated with the AGN1 LOEP Kit. This will be a non-randomized and non-blinded study. The study will collect retrospective data on the safety and performance of AGN1 LOEP of all subjects treated outside of any other clinical study protocols between September 2019 and November 2022. A prospective questionnaire will be included to evaluate self-reported subject experiences.


Eligibility criteria: Inclusion Criteria:

* Subject has previously received AGN1 LOEP treatment between September 2019 and November 2022.
* Subject has willingness to participate in the study.
* Subject can give written informed consent to allow for data collection.

Exclusion Criteria:

* The subject's AGN1 LOEP treatment was previously performed as part of a prior protocoled clinical study.

Primary outcomes:
measure: Subject satisfaction
timeFrame: Through study completion, an average of 1.1 years
measure: Subject Safety
timeFrame: During the procedure
measure: Subject Safety
timeFrame: Through study completion, an average of 1.1 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: Vitaz
Study officials:
References:
Clinical trial NCT01302574: Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides
Official title: The Role of Sweet Taste Receptor Blockade on Intragastric Liquid Meal-stimulated Secretion of Satiation Peptides in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Taste Disorder, Secondary, Sweet
Keywords: T1R2/T1R3
gastric emptying
gut
lactisole
nutrient sensing
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2011-02-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal tract.

Detailed description: There is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled receptors have been identified in the human gut, including the sweet taste responsive T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for unsaturated long-chain free fatty acids. The functional significance of sweet taste receptors in mixed liquid meal-stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion of a 500 mL mixed liquid meal with or without lactisole (450 ppm)in a double blind, 2-way crossover trial including 16 healthy subjects.

Eligibility criteria: Inclusion Criteria:

* healthy subjects
* BMI of 19.0-24.5
* age 18-40 years old
* stable body weight for at least 3 month

Exclusion Criteria:

* smoking
* substance abuse
* regular intake of medication
* medical or psychiatric illness
* gastrointestinal disorders or food allergies

Primary outcomes:
measure: Gastrointestinal peptide secretion
timeFrame: 2 hours blood sampling
Secondary outcomes:
measure: Appetite perceptions
timeFrame: 4 hours
measure: Gastric emptying rate
timeFrame: 4 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Phase 1 Research Unit
Study officials:
affiliation: Phase 1 Research Unit, University Hospital Basel
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01819974: Effect of Medication Reviews Performed in High Risk Patients
Official title: Effect of Medication Reviews in Hospitalized High-risk Patients - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients in Highest Medication Error Risk
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2013-03-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to examine whether a stratified medication review performed in patients at highest risk of experiencing medication errors have impact on numbers of medication errrors during hospitalization.

Detailed description: Acutely admitted medical patients will be included after admission. After inclusion and randomization the patients will be risk stratified with an existing algorithm according to risk of medication error. The patients in the intervention group will receive a medication review performed by a clinical pharmacist if they are in high medication error risk. Patients in highest medication error risk will recieve a medication review performed by a clinical pharmacologist.

Eligibility criteria: Inclusion Criteria:

* Acutely admitted
* \>17 years
* Patients being treated with at least one drug at admission

Exclusion Criteria:

* Dying patients
* Suicidal patients
* Intoxicated patients

Primary outcomes:
measure: Medication errors
timeFrame: During hospitalization ie. between 8 hours and approximately 20 days
Secondary outcomes:
measure: hospital readmissions (all-cause)
timeFrame: 3 months after discharge
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT00661765: A Single Dose Study Investigating the Absorption and Elimination as Well as the Tolerability of Varenicline Transdermal Delivery System (e.g., a Patch) as Compared to Oral Varenicline in Adult Smokers.
Official title: A Phase I, Open-Label, Randomized, Single Dose, Cross Over Study to Estimate the Relative Bioavailability of a Varenicline (CP-526,555) Transdermal Delivery System to the Chantix Immediate Release Tablet Formulation in Adult Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: varenicline bioavailability transdermal smoking cessation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-18
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 1. To evaluate the absorption and elimination of varenicline Formulation A transdermal delivery system \[TDS (patch)\] compared to varenicline immediate release tablet (CHANTIX®).
2. To evaluate the adhesion of the varenicline Formulation A patch.
3. To evaluate the safety and tolerability of a single application of the varenicline patch and a single oral dose of the varenicline immediate release tablet (CHANTIX®).


Eligibility criteria: Inclusion Criteria:

* healthy adult smokers

Exclusion Criteria:

* Significant blood, kidney, lung, gastrointestinal, heart, liver, psychiatric, or neurologic disease
* Illegal drug usage

Primary outcomes:
measure: Rating Scale for Adhesive Residue (e.g., assesses how well the transdermal delivery system remains adhered to subject's skin)
timeFrame: 24 hours per Arm
measure: Rating Scale for Assessment of Application Site Dermal-Erythema, Edema, and Irritation (assesses skin irritation associated with varenicline transdermal delivery system)
timeFrame: 6 days per Arm
measure: Pharmacokinetic endpoints: plasma varenicline area under the curve (AUClast and AUCinf), maximum plasma concentration (Cmax), terminal half-life (t 1/2) and time of maximum plasma concentration (Tmax)
timeFrame: 6 days per Arm
Secondary outcomes:
measure: Assessment of Adhesidue/Cold Flow Assessment (assesses extent of adhesive residue which remains on the skin at application site as well as the adhesive flow beyond the application site border
timeFrame: 24 hours per Arm
measure: Evaluation of adverse events (including the visual analog scale for nausea), safety laboratory testing, electrocardiogram, vital signs
timeFrame: 6 days per Arm
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Pfizer Investigational Site
state: North Dakota
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03053765: Optimizing Fidelity of Interpersonal Psychotherapy
Official title: Optimizing Fidelity of Interpersonal Psychotherapy for Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depression
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2017-02-15
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study is designed to develop and validate an instrument to measure quality and adherence to IPT for research and training purposes. The measure is now being used to evaluate training in IPT.

Detailed description: The study is a randomized trial comparing 4 different methods of follow-up training in IPT. Following initial 2-day training, participant therapists will be randomized to either individual supervision, group supervision, an internet-based training program, or autodidactic training. Participants will be followed for a year to determine their use of IPT, outcomes with patients, and adherence and quality of IPT in 4 case portfolios. The adherence measure for IPT developed in Phase I of the project is being used as the gold standard measure of IPT fidelity.

Eligibility criteria: Inclusion Criteria:

* Active and licensed therapist conducting psychotherapy treatment; naïve to training in IPT

Exclusion Criteria:

* Inactive or not treating patients

Primary outcomes:
measure: expert evaluation of conduct of IPT using IPT Quality and Adherence Measure
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Scott Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References: