louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05665517: Chat-based Instant Messaging Support Health Education Program
Official title: User Evaluation of a Chat-based Instant Messaging Support Health Education Program for Chronic Kidney Disease: Effectiveness and Gender Differences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease
Chatbot
Push notification
Users' evaluation
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 55
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: At the first meeting, the participants completed the pre-test of the CKD patient's simple health literacy evaluation and were invited to use the "Chatbot Little K Nurse", which was an intervention of CKD chat-based instant messaging support health education system.

After the first week, the first System Usability Scale (SUS) measurement was completed, whereas the second SUS measurement was completed in the fourth week. After completing the intervention in the 12th week, the participant's health literacy was reassessed through a post-test, and the third SUS assessment was performed.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to explore the effectiveness of a CKD-specific chatbot-based instant messaging support health education (CIM-SHE) program and determine its user evaluation by CKD patients.

A pre- and post-study design was employed and 60 patients were invited to join a three-month program for chronic kidney disease health education; 55 successfully completed the intervention. Data were collected from April to November, 2020, using a structured questionnaire. Paired t-tests and generalized equation estimation were used to examine the intervention effectiveness and users' evaluation.


Eligibility criteria: Inclusion Criteria:

1. adults over 20 years old
2. diagnosed chronic kidney disease
3. the ability to operate technologies
4. intact cognition

Exclusion Criteria:

Who was undergoing kidney dialysis, unconsciousness, dementia, or any other mental illness.

Primary outcomes:
measure: Chronic kidney disease subjects' health literacy and disease knowledge
timeFrame: 12 weeks
measure: System usability scale was developed to subjectively evaluate the user's operating system to understand and ensure its usability and quality.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University,
Study officials:
affiliation: National Taiwan Normal University
name: Jong-Long Guo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01934517: Validity of Digital Models Obtained With iTero® and Lava Digital® in Comparison With Plaster Models.
Official title: Validity, Reliability and Reproducibility of Digital Models Obtained With iTero® (AlignTech) and Lava Digital® (3M) in Comparison With Plaster Models.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentition/Teeth Measurement
Lead sponsor: Université de Montréal
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 25
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring an orthodontic treatment from the Orthodontics clinic of the University of Montreal

Brief summary: The purpose of this study is to evaluate the validity, reliability and reproducibility of digital models obtained from iTero® and Lava Digital® in comparison with traditional plaster models.

Detailed description: The primary objective of this study is to evaluate the validity, reliability and reproducibility of the dental measurements obtained on the digital models with iTero® in comparison with those obtained on the plaster models (gold standard) and on the digital models with Lava Digital®.

The secondary objective is to compare two different impression materials (i.e. alginate and polyvinylsiloxane (PVS)) and determine whether the impression material used affects the accuracy of the measurements.

Statistical analysis:

* Intraclass correlation coefficient (ICC) will be used to evaluate the intra- and inter-operator reliability of the measurements for each method, i.e. the plaster models and the digital models.
* A paired t-test will be used to determine the validity of the digital measurements with iTero®, and to compare the impression materials (alginate and PVS).
* A Bland-Altman plot will also be used to compare the two digital methods (Lava Digital® et iTero®) with the plaster models.
* Dahlberg coefficient will be used to evaluate the technical error associated with the measurements that will be made.

Eligibility criteria: Inclusion Criteria:

* Aged between 12 and 30 years old (male or female)
* complete permanent dentition from first molar to the other first molar
* no interproximal modifications (e.g. decay, large restorations, abnormal tooth morphology) which could affect the mesio-distal width of the teeth

Exclusion Criteria:

* Dentition with severe crowding (that could therefore affect the mesio-distal width of the teeth)

Primary outcomes:
measure: Overjet
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: University of Montreal, Faculty of Orthodontics
state: Quebec
Study officials:
affiliation: University of Montreal, department of Orthodontics
name: Vincent-Claude Peloquin, resident
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Normand Bach, D.M.D., M.Sc., F.R.C.D.(c)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04101617: Improving Dental Health Among Toddlers in the Dominican Republic
Official title: Cooperation Between Dentists and Pediatricians to Improve Dental Health Among Toddlers in the Dominican Republic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries in Children
Dental Caries
Lead sponsor: Universidad Iberoamericana
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Borrow Foundation
name: Hospital General Plaza de la Salud
name: Colgate Palmolive
First posted: 2019-09-24
Enrollment: 306
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Caries prevalence in the Dominican Republic (DR) seems high, although recent information is lacking. In DR there is a growth and development program for all children from the age of 0 to 5.Even though there is a mandatory educational health program for children and parents in this program, where periodically pediatricians examine them, this program does not include oral health education/prevention. Thus, it is proposed A) to devise materials to be used by pediatricians to share relevant information about caries control to parents of toddlers, and B) to evaluate the impact of such material on caries prevention for groups of toddlers over a 1.5-year period. Educational material will be developed for parents, and the pediatricians will deliver this material to 10-months-old children randomly selected at Plaza de la Salud Hospital. The PI will train the pediatricians in caries prevention and how to deliver the information to the parents in a clear manner. A total of 306 will be allocated into two groups. The experimental group (128 children) will receive the devised educational materials at 10 months, follow-up information will be provided at growth and development visits when the child is 18-, and 24 months old. The second group will be considered as the control group and will not receive any educational materials (178 children). All the enrolled children will receive fluoride containing toothpaste and tooth brushes. After 18 months when the children will be about 3 years old they will be examined to assess dental caries status. A sample mortality rate of 40% is expected during the two-year follow-up. Differences in caries status between the two groups will be examined using Welch's independent t-tests for unequal variances.


Eligibility criteria: Inclusion Criteria:

* Healthy children
* Parents agreed to participate in the program

Exclusion Criteria:

-

Primary outcomes:
measure: Dental caries status
timeFrame: Up to ten months
Secondary outcomes:
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Hospital General Plaza de la Salud
state: Distrito Nacional
Study officials:
affiliation: The University of Copenhagen
name: Kim Ekstrand, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02012517: Antibiotic Prophylaxis in Prosthetic Breast Reconstructions
Official title: Antibiotic Prophylaxis in Prosthetic Breast Reconstructions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Surgical Site Infections
Keywords: surgical site infection
breast reconstruction
drains
prophylaxis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-12-16
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. Patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. Patients will be closely followed up to one year after surgery. The number of surgical site infections according to the NNIS criteria and loss of breast implants will be compared between the two groups.


Eligibility criteria: Inclusion Criteria:

All criteria should be present:

1. Signing an informed consent form
2. Reconstructive breast surgery
3. One drain or more remained after surgery -

Exclusion Criteria:

Age \< 18 years Active infection at the surgical site at the operation time or in close proximity to the surgical site Immune deficiency state

-

Primary outcomes:
measure: surgical site infection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Department of plastic surgery, Sheba medical center
Study officials:
affiliation: Sheba Medical Center
name: Yasmin Maor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00486317: Pharmacokinetics/Pharmacodynamics of Oral Salmon Calcitonin in Patients With Osteoarthritis
Official title: SMC021A - Absorption, Efficacy and Tolerance in Patients With Osteoarthritis. A Placebo-Controlled 14-Days Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Keywords: Osteoarthritis, oral salmon calcitonin, tolerability, biomarkers
Lead sponsor: Nordic Bioscience A/S
Sponsor class: INDUSTRY
Collaborators: name: Novartis
First posted: 2007-06-14
Sex: ALL
Minimum age (years): 52
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to expose patients with OA to calcitonin and to determine plasma calcitonin levels after administration of 0.6 mg and 0.8 mg oral calcitonin and 200 IU nasal calcitonin. Also the purpose is to assess the effect of different doses of oral calcitonin (0.6 mg and 0.8 mg oral) and 200 IU nasal calcitonin compared to placebo on serum CTX-I and CTX-II. Finally to assess the tolerance profile of different doses/formulations of oral calcitonin compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Medical history and symptoms of knee osteoarthritis

Exclusion Criteria:

* Any other disease or medication affecting the bone or cartilage.
* Any clinical signs or laboratory evidence diseases, which in the Investigator's opinion would preclude the participant from adhering to the Protocol or completing the trial.

Primary outcomes:
measure: Number of adverse events
Secondary outcomes:
measure: Changes in Urine CTX-I and CTX-II
measure: Changes in serum osteocalcin
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: CCBR A/S
Study officials:
affiliation: Nordic Bioscience A/S
name: Bente J Riis, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05136417: Study of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device
Official title: Safety and Feasibility of Intra-Cardiac Echocardiography in Guiding Left Atrial Appendage Occlusion With the Watchman Device: The ICE WATCHMAN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Left Atrial Appendage Occlusion
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to to assess the feasibility and safety of left atrial appendage (LAA) occlusion with the WATCHMAN FLX™ device using a standardized intra-procedural intracardiac echocardiography (ICE) protocol under moderate sedation for procedural guidance.


Eligibility criteria: Inclusion Criteria:

* The patients is eligible to undergo WATCHMAN device implant procedure.
* The patient is eligible for short term anticoagulation therapy.
* Ability to tolerate the procedure without the need for general anesthesia as assessed by the treating physician(s).
* Ability to give informed consent for the procedure.
* The patient is able and willing to undergo the procedure under moderate sedation.
* The patient is able and willing to return for required 45-day transesophageal echocardiogram (TEE).

Exclusion Criteria:

* Patient has contraindication for short term anticoagulation.
* The patient has history of a hypercoagulable state per medical record documentation.
* Pregnancy or planning to get pregnant during the investigation.

Primary outcomes:
measure: Successful Implantation of WATCHMAN FLX Device
timeFrame: 45 days post procedure
measure: Major Complications
timeFrame: up to 7 days post procedure
Secondary outcomes:
measure: Procedure Conversion to General Anesthesia
timeFrame: baseline
measure: Iatrogenic Atrial Septal Defect
timeFrame: 45 days post procedure
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Pacific Heart Institute
state: California
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mohamad Adnan Alkhouli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05712317: The Effectiveness of an Exergame-based Intervention
Official title: Evaluation of the Effectiveness of Regular Training in the ExerCube - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Pressure
Physical Inactivity
Keywords: Exergaming
Blood pressure
Endurance performance
Pulse wave analysis
Exercise
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized control trial aims to compare the effects of a regular exergame-based intervention and a regular moderate-intensity endurance exercise in healthy individuals. The main questions it aims to answer are:

• Is regular exergame-based training an effective intervention to improve different health and performance parameters in healthy adults? Can the exergaming intervention improve health and performance parameters similar to a moderate-intensity endurance exercise intervention? Throughout the intervention period (8 weeks), participants will participate in regular training sessions (3x/week) in an exergame called the ExerCube.

Researchers will compare the effects to a control group who participates in regular (3x/week) moderate-intensity endurance exercise to see if the exergaming intervention induces similar effects on health and performance parameters.


Eligibility criteria: Inclusion Criteria:

* Healthy female and male adults
* Aged 18-60 years
* Free from acute and chronic diseases
* Free from movement restrictions or injuries to the musculoskeletal system
* Provided written informed consent

Exclusion Criteria:

* Underlying health condition that could compromise the safety of the physical exercise
* Were taking cardiovascular medications

Primary outcomes:
measure: Changes from baseline in maximum oxygen consumption at week 8
timeFrame: Baseline and week 8
Secondary outcomes:
measure: Changes from baseline in pulse wave velocity at week 8
timeFrame: Baseline and week 8
measure: Changes from baseline in systolic blood pressure at week 8
timeFrame: Baseline and week 8
measure: Changes from baseline in diastolic blood pressure at week 8
timeFrame: Baseline and week 8
Other outcomes:
measure: Changes from baseline in body mass index at week 8
timeFrame: Baseline and week 8
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Sascha Ketelhut, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03317717: Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers
Official title: Phase 1 Study to Determine the Pharmacodynamic and Safety of MEDITOXIN®(Clostridium Botulinum Toxin Type A) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2017-10-23
Enrollment: 25
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Male adults aged between 20 and 45
* Satisfying baseline nerve conduction criteria in below at screening visit CMAP M-wave amplitude of EDB ≥ 4.0mV CMAP M-wave amplitude of AH ≥ 5.0mV CMAP M-wave amplitude of ADQ ≥ 5.0mV

Exclusion Criteria:

* Have history of childhood botulism
* Have a pacemaker or any other heart device
* Have peripheral neuropathy or accessary peroneal nerve
* Have history of lower limb myotomy or denervation surgery

Primary outcomes:
measure: CMAP(Compound Muscle Action Potential) amplitude of the EDB(Extensor Digitorum Brevis) muscle
timeFrame: day 14, 30, 60, 90
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Paul's Hospital
Study officials:
References:
Clinical trial NCT05005117: Laparoscopic Approach for Emergency Colon Resection
Official title: Laparoscopic Approach for Emergency Colon Resection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Laparoscopic Surgery
Colorectal Cancer
Colorectal Disorders
Emergencies
Complication of Surgical Procedure
Long-term Effects of Cancer Treatment
Keywords: Laparoscopic surgery
Emergency surgery
Colorectal
Lead sponsor: Joint Authority for Päijät-Häme Social and Health Care
Sponsor class: OTHER
Collaborators: name: Kanta-Häme Central Hospital
First posted: 2021-08-13
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized controlled multicenter trial
Primary purpose: TREATMENT

Brief summary: This is a randomized, controlled, parallel, multicenter trial to compare post-operative complications and long-term results between open and laparoscopic technique in emergency colorectal surgery.

Detailed description: Laparoscopic technique in elective colorectal surgery has been shown to be advantageous for patients compared to open technique. However, the feasibility and potential benefits of laparoscopic colorectal surgery in emergency setting has not been evaluated sufficiently.

The aim of this study is to compare laparoscopic and open technique in emergency colon resections. Primary outcome is the immediate recovery after operation and secondary outcome is long-term overall and cancer-specific survival.

Eligibility criteria: Inclusion Criteria:

* all patients in need of emergency colon resection

Exclusion Criteria:

* age \< 18 year
* trauma patients
* reoperations
* acute pancreatitis

Primary outcomes:
measure: postoperative morbidity
timeFrame: 30 days
Secondary outcomes:
measure: Surgical site infections
timeFrame: 30 days
measure: Long-term Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Lahti
country: Finland
facility: Marie Grönroos-Korhonen
Study officials:
affiliation: Päijät Häme Central Hospital
name: Marie T Grönroos-Korhonen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01268917: The Effects of Preoperative Aspirin on Graft Patency and Cardiac Events in Off-pump Coronary Artery Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Coronary Artery Disease
Off-pump Coronary Artery Bypass
Aspirin
Keywords: coronary artery disease
off-pump coronary artery bypass
aspirin
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2010-12-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Antiplatelet therapy is critical in the management of coronary artery disease.For patients undergoing off-pump coronary artery bypass graft,controversy remains regarding the safety of preoperative antiplatelet therapy.And there is little study about the effect of continuing aspirin until the surgery day on graft patency.So we would like to perform this study to evaluate the effects of preoperative aspirin on graft patency and cardiac events in off-pump coronary bypass.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective, off-pump coronary artery bypass with at least two grafts
* patient able to give informed consent

Exclusion Criteria:

* on-pump CABG
* combined with the valve surgery
* Preoperative use of clopidogrel and warfarin
* allergy to aspirin
* History of severe liver disease
* History of bleeding diathesis,significant GI bleed
* Patient has known renal failure or contraindication for Cardiac CT Angio
* Redo CABG

Primary outcomes:
measure: graft patency examined by CT scan
timeFrame: one week after surgery
Secondary outcomes:
measure: Bleeding, transfusion, re-exploration
timeFrame: perioperative
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
References:
citation: Chen S, Wu H, Yang T, Li B, Hu Y, Sun H. Does Early Graft Patency Benefit from Perioperative Statin Therapy? A Propensity Score-Matched Study of Patients Undergoing Off-Pump Coronary Artery Bypass Surgery. Cardiovasc Ther. 2019 Aug 6;2019:1582183. doi: 10.1155/2019/1582183. eCollection 2019.