louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04182048: Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
Official title: Remote Study of an Electronic Means to Characterize Bowel Movements in Adult Populations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Irritable Bowel Syndrome
Healthy
Lead sponsor: HealthMode Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-02
Enrollment: 843
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US resident participants downloading the HealthMode Stool application from the Apple AppStore.

Brief summary: A remote study to find out if a mobile phone application (HealthMode Stool) can serve as a useful tool to track and characterize daily bowel movements. The application provides participants with a single place to record their bowel movements either as a part of their general health self-monitoring, or because they may be dealing with a bowel movement condition. The minimal study duration is 1 month, and participants can continue using the application up to 2 years.


Eligibility criteria: Inclusion Criteria:

* Females and males over 18 years old
* Willing to use their own/personal mobile phone (iPhone 6 or higher, running iOS 11 or higher) for participation
* Willing to share demographic data with the sponsor of the study
* Willing to follow app use instructions during the course of the study
* Willing to log the bowel movement events on a daily basis with manual input of additional characteristics
* Willing to complete survey instruments as described in study procedures
* Willing to provide electronic informed consent
* Able to read and understand the english language well enough to complete electronic informed consent

Exclusion Criteria:

* New to HealthMode Stool application:
* No additional exclusion criteria.

OR

* Current HealthMode Stool User:
* Is an active participant in any other study using HealthMode Stool app in its protocol.

Primary outcomes:
measure: Dataset completeness
timeFrame: 28 days
Secondary outcomes:
measure: Daily bowel movement characteristics and fluctuation
timeFrame: 28 days
measure: Daily bowel movement characteristics and fluctuation
timeFrame: 28 days
measure: Daily bowel movement characteristics and fluctuation
timeFrame: 28 days
measure: Usability of the application
timeFrame: 28 days
Other outcomes:
measure: Sensitivity and specificity of models for automatic determination of bowel movement characteristics
timeFrame: 28 days
Locations:
city: Bronx
country: United States
facility: Virtual Facility
state: New York
Study officials:
References:
Clinical trial NCT05816148: Leisure Physical Activity and Barriers to Physical Activity
Official title: Leisure Physical Activity and Barriers to Physical Activity Among Members and Users of APF France Handicap
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Disabled Persons
Keywords: Exercise
Cross sectional studies
Social inclusion
Lead sponsor: Institut de Sante Parasport Connecte Synergies
Sponsor class: OTHER
Collaborators: name: Association des Paralysees de France (APF)
First posted: 2023-04-18
Enrollment: 769
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members or users of APF France handicap.

Brief summary: People with disabilities are less physically active than the general population. Currently, the level of leisure physical activity of people who are members or users of APF France handicap and their barriers to physical activity are unknown. The APF France handicap association is a national movement for the defense and representation of people with disabilities and their families. It represents all types and severities of disability.

The objective of this study is to describe the level of leisure physical activity of people who are members or users of APF France handicap and their barriers to physical activity.

Detailed description: This is a national transversal study aiming at studying the level of leisure physical activity among people with disabilities, members or users of APF France handicap.

The study is based on a survey by questionnaire to the APF France handicap community. The survey is distributed between April and June 2023 through a public communication campaign (emails, posters, website, social networks, etc.). Data on leisure physical activity, barriers to physical activity and quality of life will be collected.

The questionnaire has been translated in simplified French to facilitate its understanding.

This is a survey that collects data anonymously and follows the MR004 methodology.

Eligibility criteria: Inclusion Criteria:

* Members or users of APF France handicap
* People with disability
* Agreeing to participate in the survey

Exclusion Criteria:

* None

Primary outcomes:
measure: Physical activity level
timeFrame: Baseline
Secondary outcomes:
measure: Barriers of physical activity
timeFrame: Baseline
measure: Quality of life
timeFrame: Baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: ISPC Syngergies
Study officials:
affiliation: ISPC Synergies
name: Vincent Carpentier, MD-MSc
role: STUDY_CHAIR
affiliation: ISPC Synergies
name: François Genêt, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04149548: Placental Assessment in Diabetic Mothers
Official title: Placental Assessment in Early and Late Pregnancy in Diabetic Women
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic and non diabetic pregnanrt women attending for ANC

Brief summary: Diabetes mellitus is one of the major heath problems

Detailed description: Maternal and fetal effects are edpected to be more than in diabetic mothers

Eligibility criteria: Inclusion Criteria:

* in control group A non diabetic pregnant women

Exclusion Criteria:

* Diabetic pregnant women

And the reverse in group B

Primary outcomes:
measure: The number of diabetic fetuses who will have undesirable effects
timeFrame: within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera
name: Mahmoud Alalfy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05822648: Evaluating a Type 2 Diabetes Prevention Program
Official title: Evaluating a Brief Type 2 Diabetes Prevention Program With Greater Scalability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
PreDiabetes
Keywords: prevention
Type 2 Diabetes
prediabetes
group intervention
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-04-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to test the effectiveness of a Type 2 Diabetes (T2D) prevention program for individuals who have been diagnosed with prediabetes compared to a T2D educational control group. Project health is an obesity prevention program and has produced a 42% to 53% reduction in future onset of overweight/obesity and also produced greater reductions in negative affect compared to assessment-only controls that persisted. Project Health has been adapted to prevent onset of T2D among individuals with prediabetes. The study aims to test the effectiveness of Project Health at reducing BMI, HbA1c levels, increase physical activity and improve glucose control.


Eligibility criteria: Inclusion Criteria:

1. Between the ages of 18 and 65
2. Overweight (BMI between 25 and 40 kg/m2)
3. Diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).

Exclusion Criteria:

1. Not between the ages of 18 and 65
2. Not overweight (BMI between 25 and 40 kg/m2)
3. Not diagnosed with prediabetes, defined as having elevated HbA1c (5.7-6.4%).

Primary outcomes:
measure: Body Mass Index (BMI) - Post-Test
timeFrame: post-test (immediately after completion of 6 week intervention)
measure: Body Mass Index (BMI) - 3-Month Follow-Up
timeFrame: 3-month follow-up
measure: HbA1c at 3-month Follow-up
timeFrame: 3-month follow-up
measure: Fasting Plasma Glucose
timeFrame: 3-month follow-up
measure: Percent Body Fat - Post-Test
timeFrame: post-test (immediately after completion of 6 week intervention)
measure: Percent Body Fat - 3-Month Follow-Up
timeFrame: 3-month follow-up
measure: Percent Lean Body Mass - Post-Test
timeFrame: post-test (immediately after completion of 6 week intervention)
measure: Percent Lean Body Mass - 3-Month Follow-Up
timeFrame: 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Eric Stice, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03863548: French Observational Study of Complications Associated With Anticoagulants and Antiplatelet Treatment in Retina/Vitreous Surgery
Official title: French Observational Study of Complications Associated With Anticoagulants and Antiplatelet Treatment in Retina/Vitreous Surgery (CLOT Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patients Undergoing Retina/Vitreous Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgery

Brief summary: Anticoagulants and antiplatelet treatments are frequently prescribed treatments to prevent or treat thromboembolic complications and reduce morbidity and mortality related to cardiovascular risk factors. In retina/vitreous surgery, there are rare but potentially serious risks of hemmorrhagic complication resulting in irreversible loss of visual acuity. There is no clear consensus on how to proceed during the perioperative period with regard to the continuation or discontinuation of anticoagulant and antiplatelet treatments in these types of surgery. the purpose of the study is to identify complications at 1 month depending on the type of surgery with or without discontinuation of antithrombotic treatments. Practitioners are not asked to change their modus operandi. The hypothesis is that there is no excess risk of peri- or post-operative hemorrhage in retino-vitreous surgery in patients treated with antithrombotic compared to untreated patients and that therefore discontinuation of these treatments before surgery is not necessary.


Eligibility criteria: Inclusion Criteria:

* person who has expressed willingness to participate
* person over 18 years of age
* person with a retinal-vitreous condition requiring scheduled surgery (epi-retinal membrane surgery, vitreous traction surgery, macular hole surgery).

Exclusion Criteria:

* person subject to legal protection (curatorship, guardianship)
* person deemed mentally incompetent
* pregnant, parturient or breastfeeding woman
* adult unwilling or unable to consent
* patient who has already participated in the study
* person with a physical or mental disability that does not allow participation.
* a person who has participated in any study of an experimental medical product within the previous 3 months
* person who experiences any of the following during the ophthalmological examination:

  * severe or proliferating diabetic retinopathy
  * intra-vitreal hemorrhage
  * tractional retinal detachment
  * subretinal or retrohyaloidal hematoma.

Primary outcomes:
measure: Occurrence of intra-operative and postoperative hemorrhagic complications in retina/vitreous surgery
timeFrame: Through study completion, an average of 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU dijon Bourgogne
Study officials:
References:
Clinical trial NCT02390648: Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting
Official title: Efficacy of Ginger as an Adjunctive Prophylaxis for Chemotherapy-induced Nausea and Vomiting: Randomised Double-blind Placebo-control Cross Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-induced Nausea and Vomiting
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Breast cancer patient receiving AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) who has nausea score from 40/100 VAS or vomiting after the first or second cycle of chemotherapy is recruited. The patient who meets the eligibility criteria and provides informed consent is randomised to receive either Ginger capsule (500 mg) or placebo taking twice a day by mouth during the first 5 days of chemotherapy cycle. The study drug will be switched on the subsequent cycle (i.e. the patient who received Ginger capsule will receive placebo and vice versa). The primary outcome is the nausea score and vomiting during the first 5 days of each chemotherapy cycle when receiving the study drug.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer patient
* Received AC regimen chemotherapy (Doxorubicin + Cyclophosphamide) and has nausea score at least 40/100 VAS or has vomiting
* Expect to receive at least 2 further cycles of AC regimen chemotherapy
* Provide informed consent

Exclusion Criteria:

* Pregnancy or lactation
* Has nausea or vomiting during 24 hours before chemotherapy
* Has other causes of nausea or vomiting eg. brain metastasis, gut obstruction, hepatitis or recent abdominal or pelvic irradiation within 1 week before chemotherapy
* Received any chemotherapy regimen other than AC regimen
* Allergic or intolerance to ginger

Primary outcomes:
measure: Nausea score
timeFrame: The first 5 days of chemotherapy cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
affiliation: Lecturer
name: Nopadol Soparattanapaisarn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02706548: Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence
Official title: Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Medication Adherence
Chronic Disease
Keywords: occupational therapy
medication adherence
intervention studies
Lead sponsor: University of Wisconsin, Milwaukee
Sponsor class: OTHER
First posted: 2016-03-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Unfortunately, current interventions for medication nonadherence are not very effective. This objective of this study is to test a new intervention, the Integrative Medication Self-management (IMedS) intervention to improve medication adherence in adults with chronic health conditions.

Detailed description: Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Objective: The purpose of this study was to perform a phase I feasibility study to understand if an integrated occupational therapy intervention could help people with chronic health conditions improve their adherence to medications. Method: Using a small-N design, we report single-subject analyses of the medication adherence, behavior counts, and perceptions of medication adherence of participants before and after either an occupational therapy intervention or standard of care intervention. We used a multiple baseline approach with inter-subject replication, and blinding.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with a chronic health condition
* Live in the community
* A medication regimen of 5 or more medications a day recommended by a health care professional
* Independently manage medications
* Difficulty taking medications as prescribed
* Live in the Milwaukee area

Exclusion Criteria:

* Significant cognitive impairment

Primary outcomes:
measure: Medication Adherence
timeFrame: 4 Weeks
measure: Self-perceived improvements in ability to mange medications
timeFrame: 4 weeks
Secondary outcomes:
measure: Strategies used to manage medications
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Schwartz JK, Smith RO. Benefits of Student Engagement in Intervention Research. Am J Occup Ther. 2015 Sep-Oct;69 Suppl 2:6912185050p1-6912185050p10. doi: 10.5014/ajot.2015.018200.
citation: Schwartz JK, Smith RO. Intervention Promoting Medication Adherence: A Randomized, Phase I, Small-N Study. Am J Occup Ther. 2016 Nov/Dec;70(6):7006240010p1-7006240010p11. doi: 10.5014/ajot.2016.021006.
Clinical trial NCT05877248: Preoperative Clear Liquid Diet Fasting; Survey Among Medical School Physician
Official title: The Knowledge and Practice of Preoperative Clear Liquid Diet Fasting Among Medical Staff in a Medical School Hospital.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting Before Operation
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 273
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: physician who have opportunity to order fasting for surgical patient.

Brief summary: To determine knowledge and practice about liquid diet fasting among physicians in a Quaternary-care academic center

study decide: questionnaire based study to ask concerning and knowledge and practice about liquid diet fasting and other diet fasting.


Eligibility criteria: Inclusion Criteria:

* physician who have opportunity to order fasting for surgical patient.

Exclusion Criteria:

* none

Primary outcomes:
measure: Score of multiple-choice question test about fasting before operation in physician of medical school.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine Siriraj hospital, Mahidol University
city: Bangkok
country: Thailand
facility: faculty of medicine Siriraj hospital
Study officials:
References:
Clinical trial NCT01169948: 320 Multidetector Computed Tomography Prior to Coronary Artery Bypass Surgery
Official title: 320 Multidetector Computed Tomography in the Preoperative Assessment for Coronary Artery Bypass Graft Surgery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Disease
Keywords: Coronary disease
Coronary artery bypass
Cardiac surgery
Computed tomography
Coronary angiography
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2010-07-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Outpatients awaiting cardiac surgery.

Brief summary: Recent advances in technology have resulted in the development of scanners that can n image the heart arteries within 10 to 20 minutes but without the need for admission to hospital or insertion of catheters. This means that coronary heart disease may be more readily identified (or ruled out) and allow better diagnosis and treatment of patients with symptoms suggesting coronary heart disease. Here, we propose to assess the latest and most powerful scanners to see if it can accurately diagnose the extent of coronary artery disease and facilitate the planning of heart surgery.


Eligibility criteria: Inclusion Criteria:

* patients who have undergone conventional coronary angiography and have been referred for coronary artery bypass surgery or valve replacement

Exclusion Criteria:

* age less than 18
* pregnancy or breast feeding
* inability to undergo computed tomography scanning
* inability to give informed consent
* severe renal failure (serum creatinine \>250umol/l or estimated glomerular filtration rate \<15ml/min)
* known allergy to iodinated contrast

Primary outcomes:
measure: Coronary artery stenosis defined qualitatively by trained observers and quantitatively by computer software
timeFrame: 1 month
Secondary outcomes:
measure: Myocardial perfusion defects defined qualitatively by trained observers and quantitatively by computer software
timeFrame: 1 month
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: David E Newby, PhD BM DM
role: PRINCIPAL_INVESTIGATOR
References: