louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00971945: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
Official title: Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2009-09-04
Enrollment: 6
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of continued administration of paclitaxel given weekly in subjects considered to need to continue treatment after completion of the preceding "Phase II Clinical Study of Weekly Paclitaxel (BMS-181339) with Advanced Breast Cancer (Protocol No. CA139-371)"


Eligibility criteria: Inclusion Criteria:

* Subjects who were confirmed to have a response after receiving at least two courses of weekly paclitaxel therapy and considered to need to continue the therapy by the investigator/subinvestigator among the patients with advanced or recurrent breast cancer who had met the selection criteria and participated in the preceding phase II clinical study

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: From first dose to end of follow-up period (up to approximately 33 months)
measure: Number of Participants Experiencing Laboratory Tests Abnormalities
timeFrame: From first dose to end of follow-up period (up to approximately 33 months)
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: From first dose to end of follow-up period (up to approximately 33 months)
measure: Duration of Response (DOR)
timeFrame: From first date of Partial Response (in study NCT01023204) to first date of Progressive Disease (in study NCT01023204 or NCT00971945) (up to approximately 37 months)
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Local Institution
state: Aichi
city: Hiroshima-shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Toshima-ku
country: Japan
facility: Local Institution
state: Tokyo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05620745: Comparison of Resilience Between ADHD and Controls.
Official title: Resilience as a Mediator Between Adverse Life Events and Emotional Behavioral Problems in Children and Adolescents and Comparison Between Individuals With Attention-Deficit /Hyperactive Disorder and Controls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ADHD; Resilience; Stress
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: cases ever diagnosed as ADHD; Controls who didn't recieve ADHD diganosis before.

Brief summary: To explore if resilience serves as a mediator between adverse life events and emotional and behavioral problems, and compare the difference of resilience and its mediating effects between children and adolescents with and without ADHD.


Eligibility criteria: Inclusion Criteria:

* ADHD; Control without ADHD

Exclusion Criteria:

* ASD, other major physical and psychiatric diseases

Primary outcomes:
measure: comparison of resilience between ADHD and controls
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan city
country: Taiwan
facility: Chang Gung memorial hospital
Study officials:
References:
Clinical trial NCT01956045: Critically Ill Patient's Capacity
Official title: Critically Ill Patient's Capacity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Decision Making
Critical Illness
Keywords: Intensive Care Units
Judgment
Disability Evaluation
Autonomy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically-ill patients

Brief summary: How to determine the decision-making capacity of critically-ill patients remain unclear. The investigator study the differences between standardised evaluation and subjective medical evaluation.

Detailed description: After written information and consent, an independent, specially trained investigator interviews patients with a standardised test.

After written information and consent, an independent, specially trained investigator interviews residents, doctors and nurses in charge of the patient and ask them how they rates patients capacity.

Eligibility criteria: Inclusion Criteria:

* Caregivers :

Doctors, hospital interns, nurses state of both sexes, aged 18 years or more working in Intensive Care, members of a social security system engaged in a clinic on the day of the assessment

* Patients :

Patients of both sexes, aged 18 years or more hospitalized in Intensive Care, members of a social security system

Exclusion Criteria:

-

Primary outcomes:
measure: correlation between the decision-making capacity and the decision-making capacity assessed by standardized methods
timeFrame: at day 1
Secondary outcomes:
measure: correlation between the global decision-making capacity evaluated by the physician in charge of the patient and the specific decision-making capacity assessed by physician in charge of the patient
timeFrame: at day 1
measure: association between burnout in evaluators and consistency of their decision-making capacity assessments
timeFrame: at day 1
measure: Correlation between the decision-making capacity evaluated by the physician in charge of the patient, the nurse in charge of the patient and a physician not in charge of the patient
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Alexandre LAUTRETTE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736445: Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching
Official title: Evaluating Student Wellness Using a Blended Approach of the Roadmap mHealth App Plus Wellness Coaching
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Health Issue
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Students enrolled at the University of Michigan

Brief summary: In this pilot study, the investigators plan to examine how the combination of wellness coaching and a mobile health app that promotes positive psychology activities can improve the overall well-being of college students. With these tools, the investigators hope to better understand the relationship between digital intervention and coaching and determine how it may improve the mental health of students. The study team also hopes to investigate how mental health can impact academic performance.

Detailed description: Students seeking wellness coaching will have the option to participate in this study. The study will ask participants to:

1. Complete as many sessions of individual wellness coaching as they see fit
2. Install and interact with the Fitbit and Roadmap 2.0 apps on their smartphone
3. Complete longitudinal surveys at baseline, month 1, month 2, and end of study
4. Complete an exit interview at the end of the study
5. Allow the study team to access academic records (optional)

The investigators plan to evaluate the app + coaching influence on mental health outcomes and to determine what can be learned to improve its design for a future, full-scale study, if there is evidence of adoption and sustainability from this pilot study.

Eligibility criteria: Inclusion Criteria:

1. University of Michigan students aged 18 years or older.
2. Students must either be coming to campus for the academic year or taking classes online for the academic year.
3. For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools and be mailed study materials
4. Possess a smartphone (Apple or Android).
5. Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion Criteria:

1. People who are not enrolled in classes at the University of Michigan for the Winter 2023 term.
2. Unwilling or unable to comply with the study procedures.

Primary outcomes:
measure: Wellness Coaching + App Use
timeFrame: 9 months
Secondary outcomes:
measure: Survey Completion
timeFrame: 7 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sung Won Choi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04682145: Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Official title: Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 50
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: All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.

Brief summary: This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.


Eligibility criteria: Inclusion Criteria:

* Participation in the European Haemophilia Safety Surveillance System (EUHASS).

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events.
timeFrame: From start to end of data collection (December 2019 to January 2025)
Secondary outcomes:
measure: Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A
timeFrame: From start to end of data collection (December 2019 to January 2025)
Other outcomes:
Locations:
city: Søborg
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor & Disclosure (2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02785445: Healthy.io Method Comparison & User Performance Study
Official title: A Comparative, Controlled Study to Evaluate the Clinical Accuracy and User Performance of the Dip Home-Based Dipstick Analyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Tract Infection
Kidney Failure
Diabetes
Lead sponsor: Healthy.io Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objectives of the Healthy.io Method Comparison and User Performance Study are:

1. To evaluate the performance of Dip.io Device in comparison to the ACON U500 Mission® U500 Urine Analyzer.
2. To evaluate the user performance of Dip.io Device under actual use conditions (home environment) based on a user questionnaire and rating scale.


Eligibility criteria: Inclusion Criteria:

1. Subject is male or female, 18-80 years of age
2. Subjects who are healthy or pregnant; or
3. Subjects diagnosed with a disease that normally represents itself with an abnormal concentration of one of the following urine analytes; Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Leukocytes, and Nitrite (examples of such diseases include the following):

   * diabetes Type I, Type II, or gestational diabetes (Type III) or,
   * urinary tract infection (UTI)
   * heart disease
   * kidney disease
   * liver disease
   * pregnant women with preeclampsia, gestational diabetes or UTI
   * any pathological findings which might be identified by the urine test (according to the physician discretion)
4. Subject is capable and willing to provide informed consent.
5. Subject has facility with both hands.
6. Subject is capable and willing to adhere to the study procedures
7. Subject is familiar with the use of a smartphone.

Exclusion Criteria:

1. Subject has dementia.
2. Subject has mental disorders.
3. Subject is visually impaired (cannot read the user manual).
4. Subject cannot collect urine in receptacle.
5. Any other reason that might preclude the subject from the study.

Primary outcomes:
measure: Exact and ±1 agreement to compared device
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: User performance
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Garden City
country: United States
facility: AccuMed Research Associates
state: New York
Study officials:
References:
Clinical trial NCT03413345: Effect of Rehabilitation on Ejection Fraction (FE) in Cardiopathic and Non Cardiopathic Patients Undergoing Major Orthopedic Surgery
Official title: Effect of Rehabilitation on Ejection Fraction (FE) in Cardiopathic and Non Cardiopathic Patients Undergoing Major Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Diseases
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-01-29
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the population consists of 188 subjects (94 subjects for the cardiopathic arm and 94 subjects for the non-cardiopathic arm) undergoing to major orthopedic surgery (hip and knee prosthesis)

Brief summary: It is a trial aimed to evaluate the ejection fraction in the preoperative phase and during follow-up in two groups of subjects undergoing major orthopedic surgery: the first consisting of subjects without history of cardiac disease, and the second from subjects with a history of cardiopulmonary disease


Eligibility criteria: Inclusion Criteria:

* Age: \< or equal 18 and \> or equal 85 years
* major orthopedic surgery
* rehabilitation at our site
* a positive history for the cardiopathic group

Exclusion Criteria:

* Age: \> 85 and \< 18
* impossibility to participate to the rehabilitative protocol or come to the follow up visit
* lack of consensus
* previous acute cerebrovascular and / or cardiological events within 6 months prior to enrollment
* previous myocardial (percutaneous and / or surgical) revascularization interventions within the 6 months prior to enrollment
* previous (even in pediatric age) interventions of surgical correction of congenital heart disease
* severe heart failure
* reimplantation of prosthesis

Primary outcomes:
measure: Effect of rehabilitation on the ejection fraction (FE) in cardiopathic and non-cardiac patients undergoing major orthopedic surgery
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Istituto Ortopedico Galeazzi
Study officials:
References:
Clinical trial NCT06483945: Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry (Dexcom Global Registry)
Official title: Dexcom Continuous Glucose Monitoring System Use in aReal-World, Global Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Lead sponsor: DexCom, Inc.
Sponsor class: INDUSTRY
First posted: 2024-07-03
Enrollment: 5000
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The clinical study population will consist of up to 5000 subjects.

Brief summary: "To evaluate the use of the Dexcom CGM System when used according to approved commercial labeling during standard clinical use and its impact on intended users in a real-world setting"

Detailed description: "The Dexcom Global Registry is a non-randomized, open-label, multi-center registry with the goal of collecting Dexcom CGM System data in a real world setting.The registry study involves retrospective and/or prospective data collection associated with Dexcom CGM System use."

Eligibility criteria: Inclusion Criteria:

* Meets Dexcom CGM System Indications for Use (IFU) per approved commercial labeling
* Has at least one HbA1C (Hemoglobin a1c) measurement within three (3) months prior to the Dexcom CGM System use start date that is at least three (3) months after any prior CGM use
* Subject is willing and able to use Dexcom CGM System according to approved product labeling
* Subject is willing and able to complete applicable patient reported outcome assessments/ surveys
* Subject is willing and able to comply with the protocol
* Subject is willing and able to comply with provider requirements for at least two provider encounters per year according to applicable clinical practice guidelines
* Subject or the subject's legally authorized representative must provide written informed consent prior to any study-related data collection or be enrolled under an IRB/EC approved waiver of consent

Exclusion Criteria:

* Is contraindicated for a Dexcom CGM System per approved commercial labeling
* In the Investigator's opinion, the subject is not considered to be a suitable candidate

Primary outcomes:
measure: Patient Reported Outcomes (PROs)
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Stockbridge
country: United States
facility: Institute of Endocrinology Diabetes, Health & Hormones
state: Georgia
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
Study officials:
References:
Clinical trial NCT03012347: Evaluation of a Gel Sunscreen in Controlled Use Conditions (208/2016)
Official title: Evaluation of a Gel Sunscreen in Controlled Use Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-01-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To explore and quantify potential issues with application of a gel sunscreen in Outdoor Use testing, in a controlled indoor environment


Eligibility criteria: Inclusion Criteria:

* Subjects may be male or female.
* Subjects must be adults between 18 and 45 years of age.
* Subjects must have and have had a consistently active lifestyle for at least the previous few years (exercise
* outdoors and in direct sun exposure at least 2 times per week for at least 30 minutes-acceptable activities include tennis, running, jogging, walking, golf, etc.), i.e., outdoor activity should not be a new behavior.
* Subjects must have used a sunscreen with SPF 50 or higher within the previous 9 months.

Exclusion Criteria:

* Subjects who have received or used an Investigational New Drug within the last 30 days.
* Subjects who have been active participants in another clinical or subjective product performance study within the last 30 days.
* Subjects who have a known allergy or sensitivity to sunscreen ingredients or test materials.
* Subjects with respiratory allergies or asthma.

Primary outcomes:
measure: Feeling any discomfort after applying the product assessed by questionnaire
timeFrame: 15 minutes after each application
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
state: Tennessee
Study officials:
References:
Clinical trial NCT01360047: Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Death
Official title: Association Between Low Dose Acetylsalicylic Acid (ASA) and Proton Pump Inhibitors and Risk of Acute Myocardial Infarction or Coronary Heart Disease Death - Nested Case Control Analyses in a Cohort of First-time Users of Low Dose ASA for Secondary Prevention of Cerebrovascular and Cardiovascular Outcomes.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonfatal Myocardial Infarction
Coronary Death
Keywords: MI
low dose aspirin
PPI
epidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-25
Enrollment: 39513
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients aged 50 to 84 years with a first ever prescription of low-dose ASA (defined as 75-300 mg/day) for the secondary prevention of cardiovascular or cerebrovascular events (defined as any previous ischemic cerebrovascular event or ischemic heart disease) from 1 January 2000 to 31 December 2007.

Brief summary: The purpose of this study is to estimate the risk of myocardial infarction (MI)/coronary death associated with use of monotherapy low dose ASA (single antiplatelet) as well as concomitant use of monotherapy low dose ASA and proton pump inhibitors (PPIs) in first- time users of low dose ASA for secondary prevention using a UK primary care database.

Detailed description: Number of Anticipated Subjects: In case-control analysis 5.000-10.000

Eligibility criteria: Inclusion Criteria:

* As above (study population description).
* All individuals aged 50-84 years with at least two year of enrolment with the primary care physician (PCP) and a computerized prescription history of at least one year before the start of the study.

Exclusion Criteria:

* Recorded diagnosis of cancer prior to study start.
* Alcohol abuse or alcohol-related disease prior to study start.
* Patients aged ≥ 70 years with a follow-up longer than one year if having fewer than two recorded consultations with a primary care physician (PCP) during their entire follow-up (proxy for incomplete and invalid data recording) which for some individuals will be close to 8 years.

Primary outcomes:
measure: Nonfatal MI or coronary death
timeFrame: Up to eight years from entry into study cohort
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Research Site
Study officials:
affiliation: CEIFE (Centro Español de Investigación Farmacoepidemiológica)
name: Luis A Garcia Rodriguez
role: PRINCIPAL_INVESTIGATOR
References: