louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05272137: Evoke Data Collection Study Germany
Official title: Prospective Data Collection to Evaluate the Feedback Control of the Saluda Medical's Evoke Spinal Cord Stimulation System in the Treatment of Patients With Chronic Pain of the Trunk and/or Limbs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Saluda Medical Pty Ltd
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 2
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: Male and female patients, age ≥ 18 years, suffering from chronic pain in the trunk and/or limbs, whom are implanted with the Saluda Medical Evoke SCS system.

Brief summary: The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.


Eligibility criteria: Inclusion Criteria:

* Patient approval for data collection and transfer of de-identified data to sponsor.

Exclusion Criteria:

* No further exclusion criteria.

Primary outcomes:
measure: ECAP Measurement in Microvolts
timeFrame: through 6 months post-implant
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Universität Düsseldorf
state: North Rhine-Westphalia
Study officials:
References:
Clinical trial NCT02513537: Postoperative Delirium - European Society of Anaesthesiology Survey
Official title: Postoperative Delirium - European Society of Anaesthesiology Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-07-31
Enrollment: 564
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: Anaesthesists , nursing statt and students (Members of the European Society of Anaesthesiology)

Brief summary: The ESA is currently preparing a guideline on the management of postoperative delirium (POD), which attempts to reduce the impact of postoperative delirium and provide recommendations for prevention, diagnostics and treatment of delirium outside the intensive care unit. The guidelines are going to be published during 2015.

While the guideline provides recommendations for daily practice, assessment of current practice and knowledge is of utmost importance, because the implementation and the measurement of a change in clinical practice will be dependent on these measurements.

This Survey has been approved by the Scientific and Research Committees of the European Society of Anaesthesiology (ESA), the Media Committee of the ESA, as well as the institutional ethical committee of Charité - Universitätsmedizin Berlin.


Eligibility criteria: Inclusion Criteria:

* Anaesthesists, nursing staff, which are invited to the online - Survey of the European Society of Anaesthesiology

Primary outcomes:
measure: Status of diagnosis of delirium
timeFrame: Up to 6 months
measure: Status of prevention of delirium
timeFrame: Up to 6 months
measure: Status of therapy of delirium
timeFrame: Up to 6 months
Secondary outcomes:
measure: Status of diagnosis of delirium
timeFrame: Up to one, two and five years
measure: Status of prevention of delirium
timeFrame: Up to one, two and five years
measure: Status of therapy of delirium
timeFrame: Up to one, two and five years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anaesthesiolgy and Intensive Care Medicine CVK/CCM, Charité - Univeristy Medicine Berlin
city: Ancona
country: Italy
facility: Italian National Research Centres On Aging
city: Valladolid
country: Spain
facility: Department of Anaesthesiology, Faculdad de medicina de Valladloid, Hospital Universitario Rio Hortega
city: London
country: United Kingdom
facility: Department of Anaesthesia, Imperial College NHS Healthcare Trust
Study officials:
affiliation: Charité - Univeristy Medicine Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06496737: Effects of Moderate-Intensity Interval Training (MIIT) on Mental Toughness, Sports Motivation, Athlete Burnout, Perceived Stress, Unforced Errors and Performance of Competitive Badminton Players in China
Official title: Effects of Moderate-Intensity Interval Training (MIIT) on Mental Toughness, Sports Motivation, Athlete Burnout, Perceived Stress, Unforced Errors and Performance of Competitive Badminton Players in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout，Motivation，Stress，Mental Toughness
Keywords: Burnout，motivation，stress and mental toughness of badminton players
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 171 people tested were randomly divided into 3 groups of 57 each during the intervention phase, with two groups carrying out a intervention
Primary purpose: TREATMENT

Brief summary: The objective of this observational study was to assess whether moderate intensity training (MIIT) intervention has positive effects on Mental Toughness, Sports Motivation, Athlete Burnout and Perceived Stress of badminton players in Yunnan Province. And reduce the error rate of badminton players


Eligibility criteria: Inclusion Criteria:

* 1. Participants were between the ages of 18 to 30

  2. Male or female

  3. At least 3 years' experience in amateur badminton training. This includes current players who are training with the Province badminton team. Or has been selected by the Kunming badminton team in Yunnan Province. Or have participated in domestic or foreign provincial, municipal or higher's competitions.

Exclusion Criteria:

- 1. Participants who are currently injured. 2. Participants who have not participated in any provincial badminton competition.

3. Participants who refuse to give consent to participate in the study.

Primary outcomes:
measure: Reduce the error rate of badminton players
timeFrame: week 12
Secondary outcomes:
measure: Change from mental toughness questionnaire (MTQ)
timeFrame: week 12
measure: Change from athlete burnout questionnaire (ABQ)
timeFrame: week 12
measure: Change from sport motivation scale-6 (SMS-6）
timeFrame: week 12
measure: Change from Perceived Stress Questionnaire（PSQ）
timeFrame: week 12
measure: Heart rate variability (HRV) Heart rate variability (HRV)
timeFrame: week 12
measure: Blood oxygen saturation (SaO2)
timeFrame: week 12
Other outcomes:
Locations:
city: Kota Bharu
country: Malaysia
facility: Universiti Sains Malaysia
state: Kelantan
Study officials:
References:
Clinical trial NCT06733337: A Study to Learn About the Safety of TALZENNA in People With Prostate Cancer.
Official title: Special Investigation of TALZENNA Capsules - Study on BRCA Mutation-Positive Metastatic Castration-Resistant Prostate Cancer -
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prostate Cancer
Keywords: BRCA mutation-positive
metastatic castration-resistant prostate cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-12-13
Enrollment: 104
Sex: MALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who satisfy the inclusion criteria

Brief summary: The purpose of this study is to learn about the safety of TALZENNA in patients with BRCA mutation-positive metastatic castration-resistant prostate cancer. BRCA mutation positive means any changes to the BRCA gene. Metastasis means the cancer that has spread to other parts of the body. Castration-resistant prostate cancer means the prostate cancer that keeps growing even when the amount of male sex hormone in the body is reduced to very low levels. Prostate is a male sex organ.

The study is seeking for participants:

* with BRCA mutation-positive metastatic castration-resistant prostate cancer
* who have not used this study medicine before. All patients in this study will receive TALZENNA according to the prescriptions.

Patients will be followed up to 52 weeks (12 months) from the day of start of treatment start (Day 1). However, in cases where treatment has been completed or stopped less than 52 weeks (12 months) after the start of giving study medicine, the participants will be checked until completion (discontinuation) of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with BRCA mutation-positive metastatic castration-resistant prostate cancer
* No history of previous use of this drug

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of adverse drug reactions
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03589937: Ocular Development and Refractive Error Changes Among Children and Adolescent - A Longitudinal Study
Official title: A Longitudinal Study on Ocular Development and Refractive Error Changes Among children-and Adolescent
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myopia
Keywords: refractive error
ocular structural parameters
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 7050
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7)

Brief summary: The study aims to observe the ocular development and refractive error changes among school children and adolescents

Detailed description: This study aims to observe the refractive error changes of school children and adolescents for 3 years, and to collect data of ocular structural parameters, family history and environmental factors so as to understand the natural course and internal laws of myopia progression.

Eligibility criteria: Inclusion Criteria:

* School children and adolescent at the age of 3(Junior Kindergarten), 6(Grade 1), 9(grade 4), 12(grade 7).
* No allergy to tropicamide or topical anesthetics
* written informed consent is obtained from guardian
* Be willing to cooperate with the relevant ophthalmological examination and complete the questionnaire.

Exclusion Criteria:

* No history of eye diseases
* Receiving or has been received treatment of myopia control such as atropine eye drops, corneal contact lens or myopic glasses
* A history of allergy to topic amide or topical anesthetics
* Have severe systemic disease
* Missing ability to give informed consent

Primary outcomes:
measure: spherical equivalent change
timeFrame: examine every 12 months, follow up for 3 years
Secondary outcomes:
measure: Axial length
timeFrame: examine every 12 months, follow up for 3 years
measure: Anterior chamber depth
timeFrame: examine every 12 months, follow up for 3 years
measure: lens thickness
timeFrame: examine every 12 months, follow up for 3 years
measure: Vitreous length
timeFrame: examine every 12 months, follow up for 3 years
measure: Environmental factor
timeFrame: examine every 12 months, follow up for 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zengcheng
state: Guangdong
city: Guangzhou
country: China
facility: Zengcheng
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-san University
name: Yizhi LIU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01866137: Copeptin During a Standardized Psychological Stress Test
Official title: Copeptin During a Standardized Psychological Stress Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress
Keywords: Copeptin
psychological stress
The Trier Social Stress Test (TSST)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adults

Brief summary: The aim of the PsyCo Study is to determine whether psychological Stress has an influence on copeptin levels.

Detailed description: healthy volunteers undergo the TSST and stress hormones as cortisol and copeptin are measured

Eligibility criteria: Inclusion Criteria:

•Aged over 18 years

Exclusion Criteria:

* Intake of any kind of medication (except birth control pill)
* BMI \>30 kg/m2
* Evidence of any acute illness
* History of chronic illness
* Baseline glucose level \>7 mmol/l Baseline sodium level \<135 mmol/l or \>145 mmol/l

Primary outcomes:
measure: Changes in copeptin levels after a psychological stress test in healthy volunteers
timeFrame: 30min before, at time point 0, +10, +20, +40, +60 after the psychological stress test
Secondary outcomes:
measure: Changes in copeptin levels after a psychological stress test in patients with central diabetes insipidus
timeFrame: Timpepoint 0, +10, +20, +40, +60 after the psychological stress test
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
name: Mirjam Christ-Crain, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04150237: Using Simulation to Ensure Basic Competence in Gastroscopy
Official title: Using Simulation to Ensure Basic Competence in Gastroscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopy
Simulation
Education
Gastroscopy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The medical students will be recruited after passing their anatomy exam at the University of Southern Denmark. The endoscopy nurses will be recruited at Odense University Hospital. Medical doctors in medical gastroenterology and surgery will be recruited at the Odense University Hospital, Denmark.

Brief summary: The main purpose of this study is to develop and gather validity evidence for a simulation-based test to ensure learning basic competence in gastroscopy.


Eligibility criteria: Inclusion Criteria:

* Medical students enrolled at the University of Southern Denmark who have passed their anatomy exam.
* Experienced endoscopy nurses, who have assisted to more than 100 gastroscopies and with no prior self-performed gastroscopies.
* Experienced medical doctors in medical gastroenterology or surgery, who have self-performed more than 500 gastroscopies.

Exclusion Criteria:

* None

Primary outcomes:
measure: Simulation gastroscopy test score
timeFrame: 1-hour test
Secondary outcomes:
measure: Total time for the diagnostic exercises
timeFrame: 1-hour test
measure: Total time for the tool exercises
timeFrame: 1-hour test
measure: Total landmark and pathology recognition for the diagnostic exercises
timeFrame: 1-hour test
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT06928337: Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.
Official title: CHLOE Oocyte Data Collection Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fertility Disorders
Lead sponsor: Fairtility
Sponsor class: INDUSTRY
First posted: 2025-04-15
Enrollment: 350
Sex: FEMALE
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: Oocyte donors

Brief summary: This data collection protocol is aimed to allow the reliable and robust development (training, verification, and validations) of CHLOE technology-based applications as well as improve the machine learning stage of released devices/applications. Additionally, a simulated use assessments will be conducted to ensure the correct and easy use of the CHLOE applications.

Detailed description: The CHLOE-OQ Data Collection Protocol is designed to support the reliable and robust development of the CHLOE technology-based application, ensuring their accuracy and effectiveness in assessing oocyte quality. This protocol facilitates the entire AI model development lifecycle, including training, verification, and validation, to enhance the performance and reliability of machine learning algorithms integrated into the CHLOE application.

Additionally, the protocol aims to refine the machine learning stage of the already released OQ applications by incorporating new data and improving model performance over time. A key component of this process includes simulated use assessments, which are conducted to evaluate the usability, accuracy, and overall functionality of CHLOE applications in real-world clinical settings by means of a questionnaire for embryologist using CHLOE. These assessments ensure that the technology is not only scientifically sound but also user-friendly, making it easier for embryologists to integrate CHLOE applications into their workflow efficiently.

By adhering to this structured data collection protocol, the CHLOE application can continuously evolve, maintaining high standards of performance and usability in the assessment of oocyte quality.

Eligibility criteria: Inclusion Criteria:

* Women at least 18 years of age.
* Embryos or eggs cultured in a time-lapse incubator connected to CHLOE Embryo Viewer.

Exclusion Criteria:

* Women with autologous eggs

Primary outcomes:
measure: Area under the curve (AUC) will be quantified using logistic regression to assess CHLOE OQ's prediction of blastulation.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: The World Egg and Sperm Bank
state: Arizona
Study officials:
affiliation: klaus.wiemer@fairtility.com
name: Klaus Wiemer, 704 9079714
role: STUDY_CHAIR
References:
Clinical trial NCT03764137: Imaging with [89Zr]Panitumumab-PET/MRI in Patients with Newly Diagnosed Colorectal Cancer
Official title: Imaging with [89Zr]Panitumumab-PET/MRI in Patients with Newly Diagnosed Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Metastatic Colon Cancer
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This clinical study will investigate the utility of PET imaging with \[89Zr\]Panitumumab for imaging of EGFR expression in newly diagnosed colon cancer patients to assess lymph node involvement. If promising, this data will be used to design larger trials.


Eligibility criteria: Inclusion Criteria:

* Be at least 19 years of age.
* Diagnosis of colon cancer
* Scheduled to undergo surgical resection

Exclusion Criteria:

* Inability to provide informed consent
* Pregnancy
* Inability to lie still for the imaging study
* Weight over 350 lbs., due to the scanner bore size
* Contraindication for MRI study (e.g. non-removable metal implants or certain tattoos)
* Inability to receive Omnipaque (iohexol) iodinated contrast
* Inability to receive glucagon
* Inability to receive Eovist (gadoxetate disodium) gadolinium based contrast agent
* Allergy to contrast imaging agents
* Finding or suspicion of distant metastases on CT

Primary outcomes:
measure: Image Quality
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Suzanne Lapi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03530137: Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness
Official title: Collaboration to Promote Early Childhood Well Being in Families Experiencing Homelessness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Families Experiencing Homelessness With Children Under 48 Months of Age
Keywords: homelessness
homeless children
homeless families
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to help us learn what are the best services to promote young children's healthy development for families who are experiencing homelessness. Participants may participate in three programs: 1. Healthy Home: four weekly, one-hour group sessions on health topics; 2. Attachment and Biobehavioral Catch-up (ABC): 10, one-hour parenting with parent and child; 3. Healthy Steps: helps families identify, understand and manage parenting challenges completed at well child visits. Participants will be asked to complete surveys, participate in focus groups, and interviews about the experiences with the services offered. Questionnaires about understanding health issues and surveys about parenting behaviors and self-efficacy will also be completed. Study duration is approximately 10 - 12 weeks. Programs may be continued once families move into permanent housing.


Eligibility criteria: Inclusion Criteria:

* Head of household of families living at FMF with at least one child under 48 months.
* All subjects must be English speaking and able to give legally effective consent.

Exclusion Criteria:

* Non-English speaking subjects

Primary outcomes:
measure: Feasibility of the intervention as measured by a composite of satisfaction surveys and focus groups with families and staff.
timeFrame: up to 12 months
measure: Changes in parent and child functioning as measured by composite of observation and self-report.
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Sustainability as measured by focus groups of staff
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Families Moving Forward
state: North Carolina
Study officials:
affiliation: Duke University
name: Alison H Edie, DNP
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Karen A Carmody, PhD
role: PRINCIPAL_INVESTIGATOR
References: