louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06317961: Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools
Official title: Pilot Study on the Use of iENTER, iCONSENT and iPARTICIPATE E-tools
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: Vall d'Hebron Institute of Oncology
name: The Netherlands Cancer Institute
First posted: 2024-03-19
Enrollment: 30
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 enrolled in the CCE BoB trial

Brief summary: Precision oncology is the future of fighting cancer. Cancer Core Europe (CCE) developed a precision medicine trial, i.e. the Basket of Basket (BoB) study, to provide personalised treatment to a large number of patients by incorporating a molecular profiling platform. The EU-funded CCE_DART project, developed within the CCE Consortium, is aimed at improving efficiency and transform platform trials into data-rich translational research programmes. Within the CCE_DART project working area D "Patient involvement through information and partnership" three interconnected web e-tools were developed aimed at promoting patient information, recruitment, and involvement as well as facilitating adherence to the CCE BoB trial: 1) iENTER: informative web site addressed to potential BoB trial participants, their caregivers, patients' advocates, and the public; 2) iCONSENT: web app for remote management of the informed consent process in the CCE BoB trial.3) iPARTICIPATE: web app allowing remote access to BoB trial patients trial visits calendar, medications list and posology, to upload documents and download reports, messaging between patients and clinical staff. The main objective of this study is to carry out field testing and assess usability of the e-tools iENTER, iCONSENT and iPARTICIPATE. The study is also addressed at collecting patients' suggestions for improvements of the e-tools.


Eligibility criteria: Inclusion Criteria:

* Cancer patients, or their informal caregivers, candidates to precision oncology trials. Patients or caregivers able to surf the internet and to fill in a simple online form.

Exclusion Criteria:

* People with clinically evident cognitive impairment.

Primary outcomes:
measure: SUS questionnaire
timeFrame: 31-1-2025
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
References:
Clinical trial NCT05479461: Technology-enabled Management Versus Usual Care for Blood Pressure
Official title: A Two-arm Parallel Randomized Clinical Trial of Implementation of Technology-enabled Management Versus Usual Care for Blood Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: High blood pressure
Digital Health Mobile Technology
Cardiovascular risk
Clinical Research
Medications
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized open label
Primary purpose: PREVENTION

Brief summary: Two arm parallel randomized clinical trial

Detailed description: Patients will be randomized 1:1 to receive mobile technology intervention versus usual care. Half of patients from a clinician team will receive the intervention and half will receive usual care. We aim to recruit at least 200 patients, 100 in each arm.

Eligibility criteria: Inclusion Criteria:

* Age 30-90 yrs.
* Smartphone ownership
* Office SBP: ≥ 140 mm Hg
* ≤ 2 current anti-HTN meds
* Able to add or dose-increase at least 2 of the following classes of medications: ACE-I/ARB, diuretic, calcium channel blocker, beta-blocker, mineralocorticoid receptor antagonists (i.e., at least 2 classes are available for addition or dose- increases after excluding intolerant medications and medications currently at maximum dose)
* English or Spanish-speakers

Exclusion Criteria:

* Heart failure with reduced ejection fraction (EF \< 40%)
* ESRD (GFR \<15)
* Renal replacement therapy
* Pregnant
* Myocardial infarction or stroke within preceding 6 months
* Hospitalization for hypertensive emergency or malignant hypertension within preceding 6 months
* Prior solid organ transplantation
* At the clinical discretion of the investigators
* Enrolled in another clinical study

Primary outcomes:
measure: Defined Daily Dose (DDD)
timeFrame: Visit 1 (Baseline), Visit-3 (6 Month follow up)
Secondary outcomes:
measure: Systolic Blood Pressure (SBP)
timeFrame: Visit-1 (Baseline), Visit-3 (6 Month follow up)
measure: Diastolic blood pressure (DBP)
timeFrame: Visit-1 (Baseline), Visit-3 (6 Month follow up)
measure: Antihypertensive Drugs
timeFrame: Visit-1 (Baseline), Visit-3 (6 Month follow up)
measure: Systolic Blood Pressure (SBP)
timeFrame: Visit-1 (Baseline), Visit -2 (3 Month follow up)
measure: Physician Survey
timeFrame: Visit 1 (Baseline), Visit-3 (6 Month follow up)
measure: Clinician inertia
timeFrame: Visit 1 (Baseline), Visit-3 (6 Month follow up)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Health Care
state: California
Study officials:
affiliation: Stanford University
name: Paul J Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01227161: New Formula for Selection of Proper Size of Endotracheal Tube (ETT) in Children: Ultrasonographic Examination
Official title: New Formula for Selection of Proper Size of ETT in Children: Ultrasonographic Examination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Urological Surgery
Keywords: ASA I-II children between the age 0-7
general anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-10-25
Enrollment: 215
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Sampling method: PROBABILITY_SAMPLE
Study population: University Hospital (Severance Hospital, Seoul, S.Korea)

Brief summary: Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will results in soft tissue injury to trachea by means of the pressure, insufficient ventilation, and aspiration, therefore choosing the adequate ETT size has very important clinical aspect.

Detailed description: Choosing the adequate size of endotracheal tube(ETT) in pediatric patients is important in all anesthesiologists, pediatricians, and critical care specialists. Inadequate ETT size will results in soft tissue injury to trachea by means of the pressure, insufficient ventilation, and aspiration, therefore choosing the adequate ETT size has very important clinical aspect.

Subglottis is the narrowest portion of upper airway. Thus, ETT size should be determined according to the subglottic diameter. Several conventional methods are available to determine ETT size. These methods are based on the demographic data of patient, such as age, weight, height, but could not be customized for each patient. Ultrasonography (US) is one of the most accurate method to measure the subglottic diameter. Also, US is quick, easy to perform, and non-invasive measure. The investigators tried to measure the exact subglottic diameter with US and analyze the correlation of the diameter and demographical data. Furthermore, the investigators will try to develop the equation that could determine the adequate ETT size based on demographical data, instead of actually measuring the subglottic diameter using US.

Eligibility criteria: Inclusion Criteria:

* children undergoing elective urological surgeries

Exclusion Criteria:

* children with anatomical airway problem or prematurely delivered children

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03884361: Does Elective Amniocentesis Change Vaginal Microbiome?
Official title: Does Elective Amniocentesis Change Vaginal Microbiome?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Microbiome
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-03-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: the aim of this study is to check if elective amniocentesis change vaginal microbiome


Eligibility criteria: Inclusion Criteria:

* pregnant women between 18-45 years old , pregnant week is 16-24 , and a signle pregnant.

Exclusion Criteria:

* infection in the Uterus

Primary outcomes:
measure: Vaginal Microbiome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe medical center
Study officials:
affiliation: Hillel Yaffe medical center, Hadera, Israel
name: Gabbay Gabbay Ben-Ziv, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06684561: EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET
Official title: EARLY FEASIBILITY STUDY: SAFETY AND EFFICACY OF PHOTON INFUSION SET
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Infusion sets
insulin pumps
AID system
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study 1:

The purpose of this study is to evaluate safety and efficacy of Photon infusion sets (PIS) with new PFAS-free cannula (catheter) in adult patients with Type 1 diabetes for up to 10 days and 6 hours.

This is a 1-center, prospective, open-label, 1-arm study with type 1 patients with diabetes on 780G insulin pump therapy with Guardian™ 4 Continuous Glucose Monitoring (CGM). All subjects will be instructed to change infusion sets every 246 hours (10 days \& 6 hours) or at set failure. Each subject is required to wear the CGM device continuously.

After completing 2 sets, the subjects have an optional office visit to download pump and CGM data and will continue to additional two wears. At day 40 or after using 4 completed wears of infusion sets (Note: early infusion set failure with wear time of \<6 hours due to insertion failure will be reported, yet not accounted as completed wear), the patients will return to a visit, download pump and CGM data, and end the study.

Photon infusion sets with 6-mm and 9-mm cannula length will be supplied for this study, with selection based on subjects' needs and doctor's recommendation. Subjects will change insulin reservoirs at least every 7 days (the labelled wear duration of the Extended reservoir). The infusion set(s) or reservoir(s) can be replaced independent of each other. The date and time of each infusion set insertion will be recorded in a Daily Log (Diary) which will include the causes of early removal, if occurs.

Study 2: If Study 1 is successful, the same study designed as illustrated in Figure 1 may be performed on the current on-market Extended infusion set (EIS) for comparison of clinical performance with the PIS, using the same cohort of pump users.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of type 1 diabetes for at least one year
2. Using a MiniMed™ 780G Insulin pump with Guardian sensor
3. Age 18 to 80 years
4. Hemoglobin A1c level less than or equal to 10%
5. Not currently known to be pregnant, nor planning pregnancy during the study.
6. Willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

1. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
2. Pregnant or lactating females
3. Subject has Glycosylated hemoglobin (HbA1c)\< 10 % at time of screening.

Primary outcomes:
measure: Primary Effectiveness Endpoint
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03101761: Characteristics and the Future of the City Chilblains
Official title: Characteristics and the Future of the City Chilblains
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chilblains
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: every patient consulting for chilblains between 2012 and 2014

Brief summary: Chilblains are cutaneous lesions affecting extremities (foot and fingers) with erythemic papules, evolving by painful relapse due to cold and sudden reheating.

This pathology is currently poorly understood while it's frequent.

The aim of the study is to evaluate all the characteristics of this pathology by reporting clinical and biological data of patient consulting for chilblains; and the other point is to assess the evolution of these patients.

Detailed description: Investigators are going to collect data on patient medical report to fill up a case report form. And in a second time they call patient by phone to ask him/her about the evolution of their pathology.

Eligibility criteria: Inclusion Criteria:

* patient consulting for chilblains
* diagnostic of chilblain during the consultation

Exclusion Criteria:

* patients consulting for other reason than chilblains
* patient who can't reply by telephonic call

Primary outcomes:
measure: Évaluation of chilblains' topography
timeFrame: Day 1
Secondary outcomes:
measure: Questionnaire of assessment of chilblains' evolution
timeFrame: 2 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Groupe Hospitalier Paries St JOSEPH
name: Pascal PRIOLLET, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01168661: Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout
Official title: Yoga, Mindfulness and Cognitive Psychotherapy as Treatment for Stress and Burnout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Burnout, Professional
Anxiety
Depression
Keywords: Stress
Burnout
Anxiety
Depression
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2010-07-23
Enrollment: 90
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate if treatment with yoga or mindfulness has a more profound and longstanding effect on stress and burnout than treatment with cognitive psychotherapy alone.


Eligibility criteria: Inclusion Criteria:

* On sick leave at least 50% at the beginning of the study.
* Sick leave for a maximum of 1 year if on full-time sick leave at the beginning of the study or for a maximum of 3 years if on part-time sick leave at the beginning of the study.
* Speak Swedish well enough to participate in the study interventions.
* Body mass index (BMI) of between 18 and 30.
* Meet the diagnostic criteria for burnout syndrome from the Swedish National Board of Health and Welfare.

Exclusion Criteria:

* Medication, including all medication or topical skin preparations with cortisone in any form. Exceptions: Antidepressants, contraceptives, hormone replacement therapy for hypothyroidism if hormone levels were within the normal range, and hormone replacement therapy to treat menopausal symptoms. To receive an exception for medication, a participant had to take the same medication at the same dose at both blood tests.

Primary outcomes:
measure: Reduced stress measured by qualitative questionnaires
timeFrame: 5 months after start of treatment
Secondary outcomes:
measure: Reduced cortisol secretion
timeFrame: 5 months after start of treatment
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
state: Huddinge
Study officials:
affiliation: Karolinska Institutet
name: Astrid M Grensman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Bikash Dev Acharya, MSc Psyc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grensman A, Acharya BD, Wandell P, Nilsson GH, Falkenberg T, Sundin O, Werner S. Effect of traditional yoga, mindfulness-based cognitive therapy, and cognitive behavioral therapy, on health related quality of life: a randomized controlled trial on patients on sick leave because of burnout. BMC Complement Altern Med. 2018 Mar 6;18(1):80. doi: 10.1186/s12906-018-2141-9.
Clinical trial NCT03431961: Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment
Official title: Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Allergic Asthma
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2018-02-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.

Detailed description: Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.

Eligibility criteria: Inclusion Criteria:

* allergic rhinitis + mild asthma

Exclusion Criteria:

* other respiratory disease
* any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.

Primary outcomes:
measure: Cellular inflammation
timeFrame: 24 hours after nasal allergen challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Cardio- Respiratory Research Laboratory, Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: McMaster University
name: Gail M Gauvreau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04862611: Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)
Official title: Tracking Attempts of CSE, Epidural and Spinal Insertions (TRACES)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuraxial Anesthesia Charting
Keywords: neuraxial attempts
anesthetic charting
anesthetic documentation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 220
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must meet the inclusion criteria, and give verbal consent to being watched. Providers must give verbal consent to being watched

Brief summary: The goal of this study is to compare observed neuraxial (Epidural, spinal, combined spinal-epidural) insertion attempts with actual documented attempts in anesthesia providers (staff, residents and fellows) at one maternal hospital. Trained research staff will document the number of neuraxial attempts before the operation, and compare this with the attempts recorded in the patient's chart. The definition of a neuraxial attempt will be determined before the study begins through a thorough literature review.


Eligibility criteria: Inclusion Criteria:

* Healthy parturients receiving any neuraxial procedure

Exclusion Criteria:

* Patient refusal of observation
* Provider refusal of observation

Primary outcomes:
measure: Percent accuracy of recorded neuraxial attempts
timeFrame: 1 day post-operatively
Secondary outcomes:
measure: Percent accuracy of recorded neuraxial redirections
timeFrame: 1 day post-operatively
measure: Define a neuraxial attempt
timeFrame: 1 month before recruitment starts
measure: Define a neuraxial redirection
timeFrame: 1 month before observations start
measure: Departmental consensus on a neuraxial attempt
timeFrame: One week after observations conclude
measure: Completeness of documentation
timeFrame: 1 day post-operatively
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anthony Chau, MD
role: PRINCIPAL_INVESTIGATOR
References: