louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03662113: Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy
Official title: Effect of Domperidone on Completion Rate of Vedio Capsule Endoscopy: a Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Capsule Endoscopy
Pediatric Disorder
Keywords: domperidone
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 200
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Video capsule endoscopy (VCE) has become an established technique to investigate the presence of small bowel pathology. But the limited battery life of capsules can lead to incomplete small bowel visualization. There is a rationale to use prokinetic agents prior to VCE reduce the chances of an incomplete small bowel examination via decrease gastric transit time (GTT). Investigators are aimed to prospectively compare the completion rate of VCE in pediatric patients receiving prokinetic with those receiving no prokinetic.

Detailed description: Eligible children were randomly divided into two groups: domperidone prior to VCE and water prior to VCE. The primary outcome measure was the completion rate. Secondary outcome measures included the GTT and SBTT.

Eligibility criteria: Inclusion Criteria:

* Indications of capsule endoscopy;
* Informed consent form obtained.

Exclusion Criteria:

* Contraindication of capsule endoscopy;
* Domperidone allergy;
* Unwilling to participate.

Primary outcomes:
measure: Completion rate of capsule endoscopy
timeFrame: assessed through study completion, an average of 1 year
Secondary outcomes:
measure: Gastric transit time (GTT)
timeFrame: assessed through study completion, an average of 1 year
measure: small bowel transit time (SBTT)
timeFrame: assessed through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's hospital of Fudan university
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Ying Huang, doctor
role: STUDY_DIRECTOR
References:
citation: Mcfarlane M, Liu B, Nwokolo C. Domperidone prolongs oral to duodenal transit time in video capsule endoscopy. Eur J Clin Pharmacol. 2018 Apr;74(4):521-524. doi: 10.1007/s00228-017-2399-8. Epub 2017 Dec 8.
citation: Wu J, Ye Z, Xue A, Huang Y. Can domperidone decrease transit time of pediatric video capsule endoscopy? A randomized controlled trial. Transl Pediatr. 2021 Feb;10(2):344-349. doi: 10.21037/tp-20-273.
Clinical trial NCT06935513: Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations
Official title: Wearable Devices Empowering Active Health Initiatives for High-Risk Stroke Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Diabetes
Atrial Fibrillation
Dyslipidemia
Smoking
Physical Inactivity
Obesity and Overweight
Lead sponsor: Affiliated Hospital of Nantong University
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the control effect of smart wearable devices on key risk factors in the high-risk populations for stroke

Detailed description: A randomized controlled study was conducted on the application of smart wearable devices in the intervention of high-risk populations for stroke, with a focus on whether the functions of smart wearable devices such as medication reminders, heart rate monitoring, and exercise reminders can effectively benefit the improvement of key risk factors for stroke, especially blood pressure, blood glucose, and blood lipids.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with hypertension;
2. Diagnosed with diabetes;
3. Diagnosed with atrial fibrillation;
4. Smoking subjects;
5. Physical inactive subjects；
6. Obesity and overweight subjects;
7. Must be able to use smart wearable devices.

Exclusion Criteria:

1. Diagnosed with malignancies;
2. Diagnosed with psychiatric disorders;
3. Diagnosed with cognitive impairment;
4. Unable to operate smart wearable devices.

Primary outcomes:
measure: medication adherence and risk factor control rates
timeFrame: 6 months
Secondary outcomes:
measure: incident vascular events, including stroke, coronary heart disease (CHD), peripheral vascular disease (PVD), and other related cardiovascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
Study officials:
affiliation: Affiliated Hospital of Nantong University
name: Qiuhong Ji, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01855113: COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
Official title: COMPARISON OF THE PERCEPTION OF PAIN BETWEEN ORTHODONTIC TREATMENT WITH Invisalign ® AND TREATMENT WITH BRACKETS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: PAIN
Keywords: PAIN
ORTHODONTIC TREATMENT
INVISALIGN
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are recruited from the Department of Orthodontics at the University of Montreal.

Brief summary: This study aims to compare the pain experienced by patients undergoing orthodontic treatment with Invisalign ® corrective aligners with that of patients undergoing orthodontic treatment with conventional braces. Because the aligners are removable, nearly invisible and don't involve metal that can irritate teeth and gums, we are expecting less pain in the Invisalign Treatment and less affectation of the quality of life.

Detailed description: The aims of the study are to determine:

the presence of pain, the magnitude of pain, the duration of pain, and the location of pain.

The hypotheses of this study are:

* Treatment with Invisalign ® aligners result in less pain than the braces
* Treatment with Invisalign ® aligners result in less irritation to the soft tissues with braces
* Pain should increase each time the aligners are put in the mouse and decrease until disappearing on the third day.
* The quality of life will be most affected by treatment with braces than with Invisalign ®.
* Null Hypothesis: There is no difference at all points between the two treatments.

Eligibility criteria: Inclusion Criteria:

* In permanent dentition;
* Age less than 30 years;
* No medical contraindications or presence of systemic diseases (including nervous system disorders);
* No missing teeth except the third molars;
* Orthodontic treatment without extraction.
* Relationship skeletal cl. I (or slightly cl. II or cl. III)
* Speak and understand French without help.

Exclusion Criteria: lack of compliance with appointments.

-

Primary outcomes:
measure: PAIN DURING INVISALIGN TREATMENT
timeFrame: 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: clinique d'orthodontie de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Université de Montreal
name: Hicham EL-Khatib, DMD,MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03494413: Transpharyngeal Doppler Sonography for Cerebral Perfusion Monitoring
Official title: Evaluation of Transpharyngeal Doppler Sonography as a Cerebral Monitoring Tool in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Perfusion
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

Brief summary: This prospective interventional study investigates transpharyngeal sonography (TPS) as an additional neuromonitoring strategy to assess cerebral perfusion during cardiovascular surgery. In the first part of the study the investigators will investigate the feasibility of TPS for visualization of aortic arch branches including the innominate and the carotid arteries in patients undergoing cardiac surgery with cardiopulmonary bypass. In the second part the investigators plan to adopt the investigators previous experiences on TPS to a selected population of patients undergoing ascending aortic and/or arch repair in hypothermic circulatory arrest (HCA).


Eligibility criteria: Inclusion Criteria:

* Cardiovascular Surgery
* Age \> 18 yrs
* Informed Consent

Exclusion Criteria:

* Contraindication for TPS
* Carotid artery stenosis

Primary outcomes:
measure: Accuracy of cerebral flow velocity measurement
timeFrame: intraoperative phase, expected to be ca. 4 hours
Secondary outcomes:
measure: Hypothermic Circulatory Arrest
timeFrame: intraoperative phase, expected to be ca. 4 hours
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern, University of Bern
Study officials:
References:
Clinical trial NCT02124213: A Study To Evaluate D1 Receptor Occupancy (RO) Following Single Dose of PF-06412562 In Healthy Male Volunteers
Official title: Open Label Adaptive Design Study To Evaluate D1 Receptor Occupancy (ro) Following Single Dose Of Pf-06412562, Using Positron Emission Tomography (Pet) With Ligand [11c]sch23390 In Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Receptor Occupancy
PET
D1 Receptor Agonist
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-28
Enrollment: 5
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate D1 Receptor Occupancy (RO) following a single dose of PF-06412562 In healthy male volunteers


Eligibility criteria: Inclusion Criteria:

Healthy Male Volunteers

Exclusion Criteria:

Evidence or history of clinically significant hepatic, renal, cardiovascular, endocrine, hematologic, gastrointestinal, pulmonary, neurologic, oncologic, psychiatric, or allergic disease Any condition possibly affecting drug absorption A positive urine drug screen

Primary outcomes:
measure: PF-06142562 plasma exposure and RO in the striatum
timeFrame: Day 1
Secondary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day 1
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day 1
measure: Area under the plasma concentration-time profile from time zero to the last plasma measurement at 4 hours (AUC0-4)
timeFrame: Day 1
measure: Average plasma concentration over 4 hours (Cav,0-4)
timeFrame: Day 1
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska Trial Alliance (KTA) M62
state: Stockholm
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04048213: The Becoming of Children With Doose Syndrome
Official title: The Becoming of Children With Doose Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Doose Syndrome
Epileptic Syndromes
Learning Disabilities
Keywords: doose syndrome
Epileptic Syndromes
Learning Disabilities
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: University Hospital, Lille
name: University Hospital, Rouen
First posted: 2019-08-07
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: During this study, parents of children with Doose syndrome will receive a questionnaire regarding learning disabilities, quality of life and epilepsy of their children. Children with doose syndrome diagnosed between ages 1 and 6 and with normal development until onset of seizures will be included in this study.

Brief summary: Doose syndrome is a rare epileptic syndrome that can lead to learning difficulties and a poor quality of life. The goal of this study is to evaluate the evolution of epilepsy and its consequences on cognitive development and learning issues in children with Doose syndrome.

Detailed description: Doose syndrome is a rare epileptic syndrome beginning between ages two and five, characterized by myoclonic-astatic seizures which can be associated with myoclonic seizures, astatic seizures, absences and generalized tonic-clonic seizures. These seizures can be difficult to treat effectively and may lead to learning difficulties. During this study, parents of children with Doose syndrome will receive a questionnaire regarding learning disabilities, quality of life and epilepsy of their children.

Eligibility criteria: Inclusion Criteria:

* children with doose syndrome diagnosed between ages 1 and 6
* normal development until onset of seizures

Exclusion Criteria:

* unconfirmed diagnoses
* abnormal diagnoses
* abnormal psychomotor development before onset of seizures
* cerebral MRI abnormalities
* other child epileptic syndromes

Primary outcomes:
measure: disease effects on the learning ability of children with doose syndrome
timeFrame: day of inclusion
Secondary outcomes:
measure: Evolution of epilepsy in children with doose syndrome based on pathological symptoms
timeFrame: day of inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHRU LILLE
name: Sylvie Nguyen, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rouen
name: Axel Lebas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05396313: Prediction of Mortality After CIED Implantation (PM-CIED)
Official title: Development and Validation of Predictive Models for Mortality After CIED Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure, Systolic
Sudden Cardiac Death
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 1618
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: The patients who received CRT/ICD implantation for heart failure or high risk of sudden cardiac death (SCD).

Brief summary: The study aims to develop and validate predictive models for the mortality of patients receiving CIED (including CRT and ICD) implantation.

Detailed description: The study aims to develop and validate predictive models for the mortality of patients receiving cardiovascular implantable electronic devices (CIED) \[including cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator (ICD)\] implantation, with traditional statistical analysis and machine learning algorithms.

Eligibility criteria: Inclusion Criteria:

* all patients who received implantation of CRT/ICD

Exclusion Criteria:

* patients who received generator placement of CRT/ICD

Primary outcomes:
measure: All-cause mortality
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Yixiu Liang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04811313: Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy
Official title: Impact of Tranexamic Acid Use on Blood Loss and Transfusion Rates After Hip Reconstruction in Children, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intraoperative Blood Loss
Pediatric
Orthopedic Disorder
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 400
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.

Detailed description: the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited.

We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.

Eligibility criteria: Inclusion Criteria:

* ASA I - II
* Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.

Exclusion Criteria:

* Patient's guardian refusal to participate in the study.
* Children known to have pre-existing bleeding or coagulation disorders.
* Children with anemia; defined according to (WHO ) cutoffs as Hb level\<11g/dl for girls and \<12g/dl for boys
* History of epilepsy.
* History of renal insufficiency or failure

Primary outcomes:
measure: amount of intraoperative blood loss
timeFrame: 24 hours
Secondary outcomes:
measure: Rate of blood transfusion
timeFrame: 24 hours
measure: Incidence of adverse effects or complications of TXA
timeFrame: 24 hours
measure: length of hospital stay
timeFrame: 24 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Amr M Sleem, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03148613: Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit
Official title: Carbon Monoxide Breath Sensor System (COBSS) Performance, Human Factors, and Usability Assessment in a Single Visit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Tobacco
Lead sponsor: Pivot Health Technologies Inc.
Sponsor class: INDUSTRY
Collaborators: name: UserWise, LLC
First posted: 2017-05-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects experience device use compared to a control device (predicate).
Primary purpose: OTHER

Brief summary: Prospective, open label, single center clinical study enrolling 70 subjects to study Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System (COBBS)

Detailed description: Performance:

* Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study subjects using two different types of measurement devices.
* Assess the correlation between the measured CO levels (in parts per million, or ppm) of the study CO breath sensor (Carrot Sense) and the predicate CO breath sensor (Bedfont).

Human Factors and Usability:

* Ensure that representative intended users are able to operate the COBSS independently.
* Validate appropriate mitigations of use related hazards identified in risk management documentation.
* Uncover previously unforeseen use errors.

NOTES:

* The study design allows for the assessment of a performance endpoint and human factors endpoint in a single study.
* Each participant will complete the study in a single visit which will include the consent process, entry into the study, the study session, and conclusion of the study. The study session is completed on a single day requiring up to 90 minutes.

Eligibility criteria: Subject who self-report smoking 2 or more cigarettes each day

Inclusion Criteria:

* 18-80 years of age
* English speaking
* Owns and uses a smartphone
* Willing to sign the Informed Consent Form

Exclusion Criteria:

• Pregnancy

Primary outcomes:
measure: Performance Variable - Correlation of Carbon Monoxide (CO) Measurements Between COBSS and Predicate Devices
timeFrame: 1 minute
measure: Human Factors - User Performance in Use Scenarios Assessment With Observer Ratings
timeFrame: 1 minute for each question; up to 90 minutes for study session
Secondary outcomes:
measure: User Documentation Assessment With Questionnaire With Observer Ratings
timeFrame: Up to 90 minutes
measure: Number of Participants Answering "No" for the Subjective Feedback With Questionnaire
timeFrame: Up to 90 minutes
measure: Participant Assessment With Questionnaire Rating Scales
timeFrame: Up to 90 minutes
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Carrot Sense
state: California
Study officials:
affiliation: Pivot Health Technologies Inc.
name: David Utley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522313: Influence of Perioperative Kidney Function on Postoperative Outcome
Official title: Retrospective Data Analysis of the Impact of Perioperative Kidney Function on Postoperative Outcome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Insufficiency
Acute Kidney Injury
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 39369
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: Retrsospective analysis of electronic charts of all patients that underwent anesthesia between January 2006 - June 2012 in the Department of Anesthesiology at the Charité - University Medicine Berlin, Campus Charité Mitte und Campus Virchow Klinikum.

Brief summary: This study investigates the influence of perioperative changes in serum creatinine on hospital length of stay and mortality.


Eligibility criteria: Inclusion Criteria:

* all patients anesthetized between January 2006 - June 2012

Exclusion Criteria:

* end stage renal disease
* pre-anesthesiologic need of renal replacement therapy
* patients undergoing nephrectomy or kidney transplantation

Primary outcomes:
measure: hospital length of stay
timeFrame: 1 year
Secondary outcomes:
measure: all cause in-hospital mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia D Spies, MD Prof.
role: PRINCIPAL_INVESTIGATOR
References: