louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05944146: Consistency of Carotid Doppler Blood Flow and Thermodilution Technique
Official title: The Consistency of Tracking Changes of Cardiac Output by Carotid Doppler Blood Flow and Thermodilution Technique in Cardiac Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Surgery
Keywords: carotid doppler; hemodynamic
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 200
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: DIAGNOSTIC

Brief summary: Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. By measuring the carotid blood flow, continuous carotid doppler technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, to the best of our knowledge, few study has been reported to evaluate the consistency of this technique in cardiac surgery patients. The aim of this study is to evaluate the tracking ability of CO changes measured by continuous carotid doppler technique in cardiac surgery patients, use the thermodilution technique as the referenced.


Eligibility criteria: Inclusion Criteria:

* adult cardiac surgery patients
* with thermodilution technique monitoring
* mechanical ventilation

Exclusion Criteria:

* life threatening arrhythmia
* severe valve regurgitation
* left ventricular ejection fraction less than 30%
* patients with mechanical circulatory support

Primary outcomes:
measure: cardiac output by thermodilution method
timeFrame: 5 minutes after the patients was sedated
measure: cardiac output by continuous carotid doppler blood flow
timeFrame: 5minutes after the patients was sedated
measure: cardiac output by thermodilution method
timeFrame: 2 minutes after passive leg raising
measure: cardiac output by continuous carotid doppler blood flow
timeFrame: 2 minutes after passive leg raising
measure: cardiac output by thermodilution method
timeFrame: 15 minutes after termination of passive leg raising
measure: cardiac output by continuous carotid doppler blood flow
timeFrame: 15 minutes after termination of passive leg raising
measure: cardiac output by thermodilution method
timeFrame: 30 minutes after dobutamine infusion
measure: cardiac output by continuous carotid doppler blood flow
timeFrame: 30 minutes after dobutamine infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhe Luo
role: STUDY_CHAIR
References:
Clinical trial NCT01933646: Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China
Official title: Burden of Invasive Group B Streptococcal (GBS) Disease in Young Infants in China: Incidence, Case Fatality Rate and Serotype Distribution
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invasive Group B Streptococcal Disease
Keywords: Group B streptococcus
Incidence
Case fatality rate
Serotype distribution
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-09-02
Enrollment: 10
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants (up to and including 90 days of age) born in or treated in a study hospital

Brief summary: Evaluate the burden of invasive group B streptococcal (GBS) disease in young infants (up to 90 days of age) in China, in terms of incidence, case fatality rate and serotype distribution


Eligibility criteria: Inclusion Criteria:

1. Positive culture for GBS from one or more of the following normally sterile sites: blood, cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, suprapubic bladder aspiration or internal body site (e.g., lymph node, brain).
2. ≤90 days old at the time of GBS confirmation.
3. Voluntary written informed consent provided.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Incidence of group B streptococcal (GBS) disease
timeFrame: From birth to 90 days of age
measure: Case Fatality Rate of GBS disease
timeFrame: From birth to 90 days of age
measure: GBS serotype distribution
timeFrame: From birth to 90 days of age
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Site 12
city: Guangzhou
country: China
facility: Site 13
city: Guangzhou
country: China
facility: Site 14
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Heath PT, Schuchat A. Perinatal group B streptococcal disease. Best Pract Res Clin Obstet Gynaecol. 2007 Jun;21(3):411-24. doi: 10.1016/j.bpobgyn.2007.01.003. Epub 2007 Mar 2.
Clinical trial NCT06392646: The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients
Official title: The Effect of a Postoperative Education Programme Based on Swanson's Theory of Caring on the Self-management Behavioural Competence of Elderly Enterostomal Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Enterostomy
Elderly
Self-management
Education
Keywords: Enterostomy
elderly
self-management
education
Lead sponsor: Wuxi No. 2 People's Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this intervention study was to understand the impact of a self-management education program on self-management skills, quality of life, and caregiver burden in older patients with enterostomies. It aims to answer the main question of whether a self-management education program can improve self-management skills, quality of life, and reduce family caregiver burden in elderly patients with enterostomies.


Eligibility criteria: Inclusion Criteria:

* age ≥60 years
* first enterostomy surgery
* informed consent to voluntarily participate in this study.

Exclusion Criteria:

* verbal communication disorder; cognitive dysfunction or history of mental illness;
* visual and manual mobility impairment unable to perform stoma care operations.

Primary outcomes:
measure: self-management
timeFrame: during hospitalization, approximately 5 days and post-discharge, 1month
measure: the quality of life
timeFrame: during hospitalization, approximately 5 days and post-discharge, 1month
measure: Caregiver burden
timeFrame: during hospitalization, approximately 5 days and post-discharge, 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Yan Xue
state: Jiangsu
Study officials:
References:
Clinical trial NCT03567746: Underwater EMR vs. Conventional EMR for Large Non-pedunculated Colonic Polyp
Official title: Efficacy and Safety of Underwater Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection for the Treatment of Large Non-pedunculated Colonic Lesions. Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Polyp
Keywords: Colonic Polyp
Endoscopic mucosal resection
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 356
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: To analyse the efficacy and safety of two standard methods of endoscopic mucosal resection (EMR) for large non-pedunculated colorectal polyps, the investigators will compare submucosal injection-assisted endoscopic mucosal resection (SEMR) versus underwater endoscopic mucosal resection, without submucosal injection (UEMR).

Detailed description: Underwater endoscopic mucosal resection (UEMR) emerges as a variant of traditional resection, in which a submucosal cushion formation is not necessary. This technique was described in 2012 by Kenneth Binmoeller based on the physical floating effect of colonic mucous membrane by filling the colonic lumen using water instead of air. This "floating effect" conditions the natural separation of the colonic wall layers, allowing the distension of the submucosal space without the need to inject substances into it. On the other hand, performing resection in liquid medium conditions could drive the benefit of heat dissipation caused by the current, which would reduces thermal damage caused to the tissues.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients aged \>18 years, diagnosed with a large (\>=20 mm) non-pedunculated colonic polyp, who consent to endoscopic mucosal resection of the polyp and willing to participate in this study.

Exclusion Criteria:

* Polyps showing signs of deep submucosal invasion
* Inflamatory bowel disease with signs of activity
* Known or suspected pregnancy
* Patients unable or unwilling to provide informed consent

Primary outcomes:
measure: Lesion recurrence rate
timeFrame: 1 year
Secondary outcomes:
measure: Technical success rate
timeFrame: 1 hour
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 1 year
measure: En bloc Resection rate
timeFrame: 1 hour
measure: Procedure time
timeFrame: 1 hour
measure: Number of fragments
timeFrame: 1 hour
measure: Lesion size
timeFrame: 1 hour
measure: Thermal artecfacts
timeFrame: 1 hour
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar. Parc de Salut Mar
city: Ciudad Real
country: Spain
facility: Hospital General Universitario de Ciudad Real
Study officials:
References:
Clinical trial NCT02314546: Intranasal Midazolam in Children as a Pre-Operative Sedative
Official title: Intranasal Midazolam in Children as a Pre-Operative Sedative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation, Conscious
Lead sponsor: Bassett Healthcare
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.

Detailed description: Midazolam is often given before surgery to sedate a patient before anesthesia is given. Children are often given a small dose either by mouth or squirted into the nose. Children will often spit out the oral midazolam, making it difficult to know how much medicine, if any, they have received. Giving midazolam into the nose is more reliable, but children may complain of pain, stinging, and may become upset due to the discomfort. Nosebleeds may also occur when midazolam is squirted alone into the nose. The purpose of this study is to see if adding a numbing medicine, xylocaine, to the nasal midazolam makes giving the midazolam easier and more comfortable without affecting how the midazolam works as a sedative.

Eligibility criteria: Inclusion Criteria:

1. Children aged 18 months-7 years, scheduled for a minor otolaryngology (ENT) surgical procedure requiring mask anesthesia
2. American Society of Anesthesiologists (ASA) Class 1 or 2
3. Parent willing and able to provide written informed consent
4. Parent willing and able to complete the OBD VAS

Exclusion Criteria:

1. ASA Class 3 or greater
2. History of allergy to midazolam or xylocaine
3. Presence of acute respiratory infection at time of surgery
4. Parent unwilling or unable to provide informed consent
5. Parent unwilling or unable to complete the OBD VAS

Primary outcomes:
measure: Sedation Scale Score
timeFrame: 10 minutes post-sedation
measure: Sedation Scale Score
timeFrame: 15 minutes post-sedation
measure: Time From Administration to Discharge
timeFrame: Minutes from administration to discharge
Secondary outcomes:
measure: Parental Observed Behavioral Distress Score
timeFrame: 1 minute post-administration
measure: RN Observed Behavioral Distress Score
timeFrame: 1 minute post-administration
measure: Verbal Complaint
timeFrame: At time of administration
measure: Verbal Complaints
timeFrame: 1 minute post-administration
Other outcomes:
Locations:
city: Cooperstown
country: United States
facility: Bassett Healthcare Network
state: New York
Study officials:
affiliation: Bassett Healthcare
name: david Ullman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06873646: Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management
Official title: Wound Dressing Patch with Kelulut Honey-Infused Alginate (Tri-Gnate Alginate) for Effective Wound Care Management
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Diabetic Foot Ulcers
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
Collaborators: name: Ministry of Higher Education, Malaysia
First posted: 2025-03-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this study to effectiveness of dressing patch with Kelulut honey (Tri-Gnate Alginate) in promoting wound healing compared to conventional treatments (standard wound dressing + bactigras) and other types of medicinal honey based product (Manuka honey product). Tri-Gnate alginate is a product produced by researcher team which upgraded from raw honey into a dressing patch. 110 patients with diabetic foot ulcers is expected to enrol in this program. The patients will be assigned randomly into 3 groups namely as Group 1 - patient that will receive Tri-Gnate alginate product in their dressing, Group 2 - patient will receive Manuka honey patch product and group 3 - the patient will receive standard care (bactigras dressing + dermacyn). Prior to the applying of these dressing treatment, all the patient will receive Maggot Debridement Therapy (MDT) to ensure the wound is clean. Patient's wound condition will be monitored 7 times (T0 - T6) on alternate day basis for healing improvement.


Eligibility criteria: Inclusion Criteria:

1. Age 18 and above.
2. present with sloughly diabetes-based foot ulcer
3. Has diabetic foot ulcers more than 2 weeks, less than 1 year.
4. HbA1c reading than 9.0
5. Ankle-brachial index pressure (ABPI) should \> 0.8
6. No more than 1 diabetic foot ulcer per foot.
7. no known allergy to honey of bee products
8. keen on both honey and maggot debridement therapy (MDT)
9. DFU classification: Wagner Grade 2, 3
10. Amputation possibly deferred

Exclusion Criteria:

1. patient in critical state.
2. patient in confuse state.
3. patient do not understand Malay or English.

Primary outcomes:
measure: Wound Size Reduction
timeFrame: Day1 - Day 14
measure: Time to healing
timeFrame: Day1 - Day 14
measure: Patient reported pain
timeFrame: Day1 - Day 14
Secondary outcomes:
measure: Fasting blood sugar (FBS)
timeFrame: Day1 - Day 14
measure: Complete blood counts (CBC)
timeFrame: Day1 - Day 14
Other outcomes:
Locations:
city: Kuantan
country: Malaysia
facility: IIUM Medical Centre
state: Pahang
Study officials:
References:
Clinical trial NCT05110846: A Study of CT-868 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple-Center Study to Evaluate the Efficacy, Safety, and Tolerability of CT-868 Administered for 26 Weeks to Overweight and Obese Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Type2 Diabetes
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-08
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Study to Assess the effect of CT-868 in hemoglobin A1c (HbA1c) in Overweight and Obese Participants with Type 2 Diabetes Mellitus.


Eligibility criteria: Inclusion Criteria:

* Males or Females with T2DM
* BMI of ≥27 kg/m2, inclusive
* 18-75 years old, inclusive
* Stable body weight for 3 months

Exclusion Criteria:

* Significant medical history
* Uncontrolled diabetes
* History of malignancy

Primary outcomes:
measure: Change in hemoglobin A1c (HbA1c)
timeFrame: Baseline up to 12 and 26 weeks
Secondary outcomes:
measure: Change in mean body weight
timeFrame: Baseline up to 12 and 26 weeks
measure: Fasting plasma glucose
timeFrame: Baseline up to 12 and 26 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Carmot Clinical Center US01
state: California
city: Guadalajara
country: Mexico
facility: Carmot Clinical Center MX04
state: Jalisco
city: Monterrey
country: Mexico
facility: Carmot Clinical Center MX01
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Carmot Clinical Center MX02
state: Nuevo Leon
city: Mérida
country: Mexico
facility: Carmot Clinical Center MX05
state: Yucatan
city: Mexico City
country: Mexico
facility: Carmot Clinical Center MX03
Study officials:
affiliation: Carmot Therapeutics, Inc.
name: Michael Elliott
role: STUDY_DIRECTOR
References:
Clinical trial NCT05235646: Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence
Official title: Detection of the Occurrence of Infiltration of Gadolinium Injection in Brain MR Scans Using Artificial Intelligence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing MR brain without and with IV contrast examination as part of their care plan.

Brief summary: The purpose of this research is to develop machine learning algorithms to analyze images from brain MRI to confirm that contrast agent has been correctly administered.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a MR brain without and with contrast examination on any GE or Siemens 1.5T and 3T MRI system within Mayo Clinic, Rochester, as part of their care plan.

Exclusion Criteria:

* None

Primary outcomes:
measure: Detection of Infiltration of Gadolinium contrast agent into tissue and muscle using artificial intelligence model
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: James Pipe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871646: Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314
Official title: A Double-blind, Multi-center, Multi-regional, Randomized Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed With COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19 Pneumonia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 586
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Double-blind, Multi-center, Multi-regional, Randomized controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of CKD-314 in Hospitalized Adult Patients Diagnosed with COVID-19

Detailed description: To evaluate the efficacy and safety of CKD-314 by comparing the study group and control group in hospitalized adult patients diagnosed with COVID-19 pneumonia

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 18 years
2. Patients diagnosed with COVID-19 infection and pneumonia
3. Patients who have voluntarily decided to participate in the study and signed the informed consent form If a patient cannot provide consent on his or her own, informed consent by a legally authorized representative may be obtained.

Exclusion Criteria:

1. Patients with history of hypersensitivity to the study drug
2. Female patients, either who are or may be pregnant or who are breastfeeding, or female patients of child-bearing potential who are unable to use adequate contraception during the study
3. Patients who are deemed to ineligible to participate in the study for other reasons by the investigator

Primary outcomes:
measure: Time to recovery
timeFrame: From day1 to day 28
Secondary outcomes:
measure: Time to clinical improvement: Time to clinical improvement (TTCI)
timeFrame: From day1 to day 28
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Hee Jin Jung, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: