louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03173183: Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis
Official title: Clinical Research on Treatment of Functional Dyspepsia With Genuine Regional Rhizoma Atractylodis: a Randomized Double-blind Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Efficiency of Genuine Regional and Non-genuine Regional Rhizoma Atractylodis in Treating FD
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2017-06-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The research is designed by randomized, double-blind, placebo and parallel clinical control.
Primary purpose: TREATMENT

Brief summary: This is a randomized double-blind placebo controlled trial aim to compare the efficiency of genuine regional and non-genuine regional Rhizoma Atractylodis in treating functional dyspepsia. This study will also observe the clinical safety of genuine regional Rhizoma Atractylodis.The trial will be conducted in Xiyuan Hospital of China Academy of Chinese Medicine Sciences and Dongzhimen Hospital of Beijing University of Chinese Medicine.


Eligibility criteria: Inclusion Criteria:

1. Meeting the FD Rome Ⅲ diagnosis standard;
2. Meeting TCM differentiated diagnosis standard of the spleen deficiency with dampness pattern;
3. Without taking any medicines affecting gastric motility in the recent 14 days;
4. Between 18 and 65 years old;
5. Voluntary participation in the trial and signing informed consent.

Exclusion Criteria:

1. Combined irritable bowel syndromes; combined peptic ulcer, erosive gastritis, atrophic gastritis, abdominal surgery history, gastric mucosa with severe dysplasia or pathological diagnosis of suspected malignant transformation; combined gastroesophageal reflux disease, irritable bowel syndrome with overlapping syndromes.
2. Patient whose differentiation is not clear or who doesn't belong to the spleen deficiency with dampness pattern.
3. Women in pregnancy, breastfeeding or have fertility plans recently; the legally disabled (blind, deaf, dumb, mental retardation, mental disorders, physical disability)
4. Patients with endocrine and metabolic diseases such as connective tissue diseases, diabetes, menopausal syndromes; patients combined with heart rate disorder, severe diseases in cardiovascular, brain, liver, lung, kidney and hematopoietic systems, acute and chronic infectious diseases, malignant tumors, mental illness.
5. Allergy to the trial drug.
6. With suspected or definite alcohol, drug abuse history.

Primary outcomes:
measure: disappearance rate of dyspepsia
timeFrame: Eight weeks
Secondary outcomes:
measure: The Short-Form Leeds Dyspepsia Questionnaire, SF-LDQ
timeFrame: Eight weeks
measure: Nepean Dyspepsia Index, NDI
timeFrame: Eight weeks
Other outcomes:
Locations:
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Yanming Xie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01377883: Clown Care for Botulinum Toxin (BTX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Pain
Keywords: Needle, Anxiety, Pain, Clowns
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2011-06-22
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Children with cerebral palsy (CP) undergo multiple painful procedures such as Botulinum toxin (BTX) injections that are administered several times a year. While clown care reduces preoperative anxiety, its effect on painful procedures has not been assessed. We hypothesized that medical clowning reduces pain and anxiety during BTX injections.

Detailed description: PATIENTS AND METHODS: Twenty five children with CP (mean age 7.4±4.8 years; 19 boys), enrolled in this randomized controlled study underwent BTX injections (3±1.7 muscles per procedure). Prior to treatment each child was assigned to receive either medical clown intervention (study) or standard care (control). Outcome measure was the Visual Analogue Scale (VAS) as reported by the child (n =14) or parent (n =11) prior and subsequent to each procedure.

Eligibility criteria: Inclusion Criteria:

* Children with CP for whom BTX treatment was indicated

Exclusion Criteria:

* Children with minimal communication skills (n =1)
* Autistic spectrum disorders (n =1)
* Severe anxiety requiring general anesthesia (n =1)

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: sevral minutes before and after BTX injections
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ben-Pazi H, Cohen A, Kroyzer N, Lotem-Ophir R, Shvili Y, Winter G, Deutsch L, Pollak Y. Clown-care reduces pain in children with cerebral palsy undergoing recurrent botulinum toxin injections- A quasi-randomized controlled crossover study. PLoS One. 2017 Apr 17;12(4):e0175028. doi: 10.1371/journal.pone.0175028. eCollection 2017.
Clinical trial NCT03018483: Mechanical Ventilation- Weaning and Thoracic Impedance Tomography
Official title: Comparison Between Automated Pressure Support Ventilation, Variable Pressure Support Ventilation and Non-variable Pressure Support Ventilation in Weaning From Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Weaning From Mechanical Ventilation
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 342
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: The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.

This study is a multicenter randomized controlled open trial comparing variable, non-variable pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation for more than 24 hours who are able to be weaned.

The aim of the study is to determine the duration of weaning from mechanical ventilation for each one of the above mentioned weaning methods


Eligibility criteria: Inclusion Criteria:

* age≥18 years
* duration of controlled mechanical ventilation≥ 24 h
* temperature≤ 39°C
* hemoglobin≥ 6 g/dl
* ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction - PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O
* ability of the patient to breathe spontaneously
* informed consent

Exclusion Criteria:

* patient participated in another interventional trial within the last four weeks before enrollment
* peripheral neurological disease associated with impairment of the respiratory pump
* muscular disease associated with impairment of the respiratory pump
* unstable thorax with paradoxical chest wall movement
* planned surgery under general anesthesia within 72 hours
* difficult airway or intubation
* existing tracheotomy at ICU admission
* expected survival\<72 hours
* home mechanical ventilation or on chronic oxygen therapy
* suspected or confirmed pregnancy

Primary outcomes:
measure: weaning time
timeFrame: within 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: University of Naples
Study officials:
References:
Clinical trial NCT04006483: Meta-analysis of Stannous Fluoride and the Effects on Dental Plaque
Official title: A Review of Meta-Analyses on Bioavailable Stannous Fluoride Dentifrices: Effects on Dental Plaque
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Plaque
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2019-07-05
Enrollment: 2359
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This meta-analysis includes healthy adult male and females.

Brief summary: The aim of this 18 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) dentifrices when used up to 3 months on dental plaque relative to a positive or negative control dentifrice.


Eligibility criteria: Subjects were excluded from this study for the following reasons;

* pregnancy,
* rampant caries,
* severe periodontitis,
* at discretionary of the Principal Investigator.

Primary outcomes:
measure: Dental Plaque Scores
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Multiple P&G Investigation Clinical Sites
state: Ohio
Study officials:
References:
Clinical trial NCT04001361: Laser Cell Therapy for Knee Cartilage Repair
Official title: Combined Effect of IPG Medical Charlie Laser and Bone Marrow Grafting on Cartilage Defects of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Endocellutions
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Blinded trial. Three groups. Sham, laser only, laser plus marrow. Stage 2 and 3 OA of one or both knees
Primary purpose: TREATMENT

Brief summary: Laser pulsed energy will be delivered over an optical fiber to create channels into damaged cartilage of the knee or knees. The channels have a diameter of approximately 100 microns or less and an approximate depth of 1 millimeter or less. Bone marrow aspirate will then be delivered into the damaged joint.

Detailed description: The creation of micro-channels into damaged knee cartilage will facilitate the movement of fluid into and out of the tissue to allow for more efficient nutrient diffusion. The addition of bone marrow aspirate will provide additional growth factor enriched nutrition to the tissue. The goal of this combination therapy is to facilitates the body's own reparative processes leading to improved patient well being.

Eligibility criteria: Inclusion Criteria:

Kellergren grading scale of 2 or 3 in at least one compartment of either or both knees with no compartment representing a stage 4 in either knee.

No significant MCL or LCL tear or laxity

No significant meniscal tear. ( i.e. bucket handle)

Exclusion Criteria:

* Injection with the past 6 weeks
* Stage 4 osteoarthritis in either knee
* Uncontrolled Diabetes or any other metabolic syndrome
* BMI greater than 28
* Significant lower extremity deformity
* Bilateral or tri compartmental Knee OA
* Adults unable to consent
* Individuals who are not yet adults (infants, children, and teenagers, age \< 18)
* pregnant women
* Prisoners
* Stage 4 osteoarthritis in either knee
* Subjects, who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Primary outcomes:
measure: MRI
timeFrame: one year
measure: VAS Score
timeFrame: one year
measure: KOOS score
timeFrame: one year
measure: Treadmill Test
timeFrame: one year
measure: Swiss Ball wall squat test
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Steubenville
country: United States
facility: Trinity Sports Medicine
state: Ohio
Study officials:
affiliation: Trinity Sports Medicine
name: Michael Scarpone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156583: Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
Official title: Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systolic Heart Failure
Keywords: Ventricular Assist Device
Skeletal Muscle
Frailty
Older adults
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Thoratec Corporation
name: National Skeletal Muscle Research Center
name: Greater New York Geriatric Cardiology Consortium
First posted: 2014-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive heart failure patients 60 years old or older undergoing left ventricular assist device implantation.

Brief summary: This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.


Eligibility criteria: Inclusion Criteria:

* 60 years old or older
* Scheduled to undergo left ventricular assist device implantation at Thomas Jefferson University

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Unable to complete baseline frailty assessment

Primary outcomes:
measure: Change in frailty following left ventricular assist device implantation
timeFrame: Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively
Secondary outcomes:
measure: Skeletal muscle size as measured by ultrasonography
timeFrame: Baseline (prior to surgery); 10 days and 3 months postoperatively
Other outcomes:
measure: Cognitive function measured by the Montreal Cognitive Assessment
timeFrame: Baseline; 3 and 6 months post-operatively
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Gordon R Reeves, MD, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maurer MS, Horn E, Reyentovich A, Dickson VV, Pinney S, Goldwater D, Goldstein NE, Jimenez O, Teruya S, Goldsmith J, Helmke S, Yuzefpolskaya M, Reeves GR. Can a Left Ventricular Assist Device in Individuals with Advanced Systolic Heart Failure Improve or Reverse Frailty? J Am Geriatr Soc. 2017 Nov;65(11):2383-2390. doi: 10.1111/jgs.15124. Epub 2017 Sep 21.
Clinical trial NCT01974583: Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting
Official title: Wound-healing Improvement by Resurfacing Split-Thickness Skin Donor Sites With Thin Split-thickness Grafting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Graft Disorder
Disorder of Skin Donor Site
Wound Healing Disturbance of
Keywords: the split-thickness skin graft （STSG） donor site
regraft
wound healing
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2013-11-01
Enrollment: 192
Sex: ALL
Minimum age (years): 5
Maximum age (years): 56
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study cohort included 192 participants, who were randomly selected from patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University.

Brief summary: Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.

Detailed description: Background：Split-thickness skin grafting remains fundamental treatment of patients with deep burns and other traumatic injuries. However, the split-thickness skin graft (STSG) donor site dressing has been controversial until now. Our study here aimed to assess patient comfort and wound-healing efficacy with the application of thin split-thickness grafting on STSG donor sites.

Methods: 192 consecutive patients undergoing split-thickness skin grafting were included in the study and the participants were randomly divided into three groups: Group A was regrafted with thin STSG, while, Group B and Group C were covered with the occlusive hydrocellular dressing and paraffin gauze, respectively. The three groups were compared regarding to the time of epithelialization, pain sensed by the patients and the scar formation.

Eligibility criteria: Inclusion Criteria:

* patients who continuously received an STSG from January 2002 to December 2010 in Department of Burn and Plastic Surgery, Tangdu Hospital, Fourth Military Medical University

Exclusion Criteria:

* The patients who were significant psychiatric, hypersensitive to silver, and not be followed up were excluded

Primary outcomes:
measure: The time of epithelialization
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Pain sensed by the patients
timeFrame: up to 6 months
Other outcomes:
measure: Scar formation of skin donor site
timeFrame: 1 year
Locations:
Study officials:
affiliation: specify Unaffiliated
name: Yongqian Bian, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04886583: Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
Official title: Preliminary Multi-centric Clinical Study Assessing the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for the Continuous Monitoring and Recording of Vital Physiological Parameters on Infants and Young Children by Comparison of Simultaneous Polysomnographic Recording During Standard of Care Hospitalisation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Oxygen Desaturations
Sleep-Disordered Breathing
Lead sponsor: Gabi SmartCare
Sponsor class: INDUSTRY
First posted: 2021-05-14
Enrollment: 99
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 5 years old who need to undergo a polysomnographic exam, as per standard of care, and admitted in the PSG paediatrics service for at least 1 night after proper medical examination and diagnostic by a qualified physician.

Brief summary: During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep. After the test, data from the device and from the PSG (HR, SpO2, BR) will be saved and analysed in the aim to assess the actual accuracy of the GBB with golden standard values (ECG, Oximeter, belly belt). In a second analysis, the aim is to improve the accuracy of the GBB algorithm.


Eligibility criteria: Inclusion Criteria:

* Infants and children under 5 years of age
* PSG is required per standard of care
* Signature of consent form

Exclusion Criteria:

* Children having already done the PSG wearing GBB for this study
* Epileptic children (due to high motion/artifacts during sleep)
* Weight below 2.5 kg

Primary outcomes:
measure: to improve the calibration, the correctness and reproducibility of the SpO2 (%) measurements reported by the GBB
timeFrame: 12 hours
Secondary outcomes:
measure: to improve the calibration, the correctness and reproducibility of the measurements of the BR (breathing rate; cycle/min) reported by the GBB
timeFrame: 12 hours
measure: to improve the calibration, the correctness and reproducibility of the measurements of the HR (heart rate; beat/min or bpm) reported by the GBB
timeFrame: 12 hours
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Hopital Universitaire Des Enfants Reine Fabiola
state: Brussels
city: Charleroi
country: Belgium
facility: CHU Marie Curie
state: Hainaut
city: Liège
country: Belgium
facility: CHC Montlégia
Study officials:
References:
Clinical trial NCT06584461: Interest of Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia
Official title: Lidocaine in Children with Upper Airway Infection Undergoing General Anesthesia: Interventional Controlled Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Upper Respiratory Tract Infections
Perioperative Respiratory Complications
Keywords: upper respiratory tract infections
IV lidocaine
General anesthesia
children
laryngospasm
bronchospasm
cough
perioperative respiratory complications
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 102
Sex: ALL
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to determine whether intravenous (IV) lidocaine reduces the incidence of perioperative respiratory complications (PRCs) in children with upper respiratory tract infections undergoing general anesthesia. The study will also evaluate the safety of IV lidocaine in this population. The main questions it aims to answer are:

1. Does IV lidocaine lower the incidence of perioperative respiratory complications (e.g., laryngospasm, cough, desaturation) compared to a placebo?
2. What are the side effects associated with the administration of IV lidocaine in these children? Researchers will compare IV lidocaine to a placebo to assess its effectiveness in reducing PRCs.


Eligibility criteria: Inclusion Criteria:

* Children aged 1 to 14 years.
* American Society of Anesthesiologists (ASA) Physical Status Classification I, II, or III.
* Scheduled or urgent surgery or radiological exploration under general anesthesia.
* Upper respiratory tract infection (URTI) symptoms present for less than 15 days.

Exclusion Criteria:

* Refusal of participation by parents.
* Children on long-term corticosteroid or bronchodilator therapy.
* Contraindications to the use of lidocaine or other drugs used in the protocol.
* Patients who did not adhere to the study protocol.

Primary outcomes:
measure: Incidence of Perioperative Respiratory Complications
timeFrame: Within the first 2 hours post-operation.
Secondary outcomes:
measure: Incidence of Side Effects Related to IV Lidocaine
timeFrame: Within the first 24 hours post-operation.
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Bechir Hamza Children's Hospital
Study officials:
References: