louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06204653: Effect of High-flow Nasal Oxygenation on Gastric Insufflation in Children
Official title: The Effect of High-flow Nasal Oxygenation Versus Mask Ventilation on Gastric Insufflation in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Induction of General Anesthesia
Keywords: High flow nasal oxygenation
Facemask ventilation
Gastric insufflation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 70
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized controlled study to compare the incidence of gastric insufflation when using high-flow nasal oxygenation and facemask ventilation in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 1 to 6 years
* American Society of Anesthesiologists physical classification 1 or 2
* Scheduled for general anesthesia

Exclusion Criteria:

* Patients expected to have difficulty with mask ventilation
* Patients with oropharyngeal facial deformity
* Obese patients (BMI\>30 kg/m2)
* Patients with an upper respiratory tract infection
* Patients with a history of abdominal surgery

Primary outcomes:
measure: Incidence of gastric insufflation
timeFrame: From the start of anesthesia induction to 3 minutes after anesthesia induction
Secondary outcomes:
measure: Gastric insufflation detected by ultrasound
timeFrame: 3 minutes after anesthesia induction
measure: Gastric insufflation detected by auscultation
timeFrame: From the start of anesthesia induction to 3 minutes after anesthesia induction
measure: gastric antrum longitudinal diameter (D1)
timeFrame: 3 minutes after anesthesia induction
measure: gastric antrum anteroposterior diameter (D2)
timeFrame: 3 minutes after anesthesia induction
measure: gastric antral cross-sectional area (CSA)
timeFrame: 3 minutes after anesthesia induction
Other outcomes:
measure: MAP
timeFrame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
measure: HR
timeFrame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
measure: SpO2
timeFrame: Every 1 minute during intervention (baseline, 1, 2, 3 min after induction)
measure: TV
timeFrame: Every 1 minute during intervention (1, 2, 3 min after induction)
measure: PIP
timeFrame: Every 1 minute during intervention (1, 2, 3 min after induction)
measure: ETCO2
timeFrame: Every 1 minute during intervention (1, 2, 3 min after induction) and just after intubation
measure: Lowest SpO2
timeFrame: From the start of anesthesia induction to completion of tracheal intubation
Locations:
Study officials:
References:
Clinical trial NCT04974853: Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation
Official title: Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation: Feasibility Study on Patients With Mild-to-moderate Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: Ayurveda
Cholesterol
Cardiovascular Diseases
Hyperlipidemia
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
Collaborators: name: Aarogyam UK
First posted: 2021-07-23
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this feasibility study was to assess the lipid-lowering effects and safety of a Ayurveda formulation containing Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer)

Detailed description: The COVID-19 related lockdowns severely affected the healthcare in India, specially in second wave of COVID-19. This research presents the applicability of Ayurveda formulation to analyze the impact on lipid profile during the lockdown.

Patients with hyperlipidemia who referred to Gyansanjeevani were recruited. All participants were enrolled in the study after a complete physical examination and medical history remotely over the virtual secure platform.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 65 years
* BMI between 18.5 and 40 kg/m2
* Total Cholesterol \>180 mg/dl
* No clinically significant medical history
* Willing to participate to the study by complying with the protocol
* Able to provide written informed consent

Exclusion Criteria:

* Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder,
* Severe chronic disease
* History of ischemic cardiovascular event,
* Uncontrolled hypertension
* Under treatment or dietary supplement which could affect study parameter

Primary outcomes:
measure: Reduction of LDL-cholesterol
timeFrame: Change from baseline to 2 weeks
Secondary outcomes:
measure: Reduction of total cholesterol
timeFrame: Changes from baseline to 2 weeks
measure: Increase of HDL cholesterol
timeFrame: Change from baseline to 2 weeks
measure: Reduction of Triglycerides
timeFrame: Change from baseline to 2 weeks
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Gyansanjeevani
state: Rajasthan
Study officials:
affiliation: NMP Medical Research Institute, India
name: Prashanna T Chockalingam
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Abhijit Venu
role: STUDY_CHAIR
affiliation: NMP Medical Research Institute, India
name: Skanthesh Lakshmanan
role: STUDY_DIRECTOR
References:
Clinical trial NCT01999153: Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
Official title: Evaluation of the Analgesic Effect of Ropivacaine in Topical Use at the Thin Skin Graft Donor Site
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Graft Pain
Keywords: skin graft
donor site
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-12-03
Enrollment: 88
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 the study is to Evaluate of the analgesic effect of ropivacaine in topical use at the thin skin graft donor site.

For Patient needing a thin skin graft \< 320 cm2, randomization will be done in 2 groups, one receiving the standard treatment (20 mL of physiologic serum) during the surgical intervention in topical use to recover an alginate dressing (Algosteril)and the other receive 20 mL of Naropein during the surgical intervention on alginate dressing.

The hypothesis of the study is the administration of ropivacaine will decrease the post-operative pain compared to physiologic serum


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient needing a thin skin graft \< 320 cm2 and which is possible on the thigh
* Patient who read the information letter and signed the informed consent
* Patient affiliated at a social security system
* Effective contraceptive method for more than 3 months for women of childbearing age

Exclusion Criteria:

* Contraindication to one of the medicine used (allergy, intolerance, potential drug interaction)
* Treatment by classII or III of analgesics or analgesic dose of aspirin(\>500mg per day) at the inclusion or randomization time
* Preoperative EVA\>0 at the skin graft donor site on the thigh
* Sensory disturbances of the lower limbs
* Cognitive disturbances not allowing investigations
* Pregnant or lactating women
* People deprived of discernment
* People deprived of their liberty by judicial or administrative authority
* Protected adult (guardianship or trusteeship)

Primary outcomes:
measure: Class II analgesic consumption between the 2 arms
timeFrame: 5 days post-operative
Secondary outcomes:
measure: Class II antalgic consumption between the 2 arms
timeFrame: Day 90
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: day 90
Other outcomes:
Locations:
city: Rouen
country: France
facility: UHRouen
Study officials:
affiliation: University Hospital, Rouen
name: Dorothée COQUEREL-BEGHIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815553: Cardiac Tumors Interventional （Radio Frequency/Laser Ablation）Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Tumors
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Currently, surgical removal remains the main clinical treatment for cardiac tumor patients. However, part of tumors are hard to completely resect. Also, as thoracoscopic surgeries induce great operation trauma, some patients cannot tolerate or do not will to take the operation. Therefore, new methods and techniques are in urgent need.

Our center have a 12-year experience of intervention treatment for solid tumors and has conducted several animal experiments to verify the effectiveness of transthoracic puncture ablation and radiofrequency ablation for ventricular muscle.

The purpose of this study is to conduct new method of direct transthoracic cardiac tumor-targeted Radiofrequency Ablation (RFA) or Laser induced Interstitial Thermotherapy (LITT), make minimally invasive treatment plans for cardiac tumor patients, and verify the safety and validity of intervention treatment in long term.


Eligibility criteria: Inclusion Criteria:

* Cardiac tumors not suitable for surgical removal
* Subject has significant clinical symptoms or obstruction (or progressive obstruction increase) in inflow or outflow tracts shown in imaging evidence
* Cardiac tumors in ventricular chambers, myocardium, or pericardium
* Subject who cannot tolerate thoracoscopic removal or volunteer for the operation
* Subject Over 12 years old

Exclusion Criteria:

* Subject who has other cardiac diseases must receive surgical removal
* Subject has end-stage heart failure
* Subject has poor physical conditions and cannot tolerate the operation

Primary outcomes:
measure: Mortality
timeFrame: 24 months
measure: Tumor size
timeFrame: 24 months
measure: Quantification of obstructive severity
timeFrame: 24 months
Secondary outcomes:
measure: Quantification of cardiac function
timeFrame: 24 months
measure: Quantification of tumor blood perfusion
timeFrame: 24 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Ultrasonic Diagnosis Department of Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT05672953: Biogeography of the Oral Microbiome
Official title: Biogeography of the Oral Microbiome Using Metatranscriptomic Analyses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Microbiome
Lead sponsor: Viome
Sponsor class: INDUSTRY
First posted: 2023-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study population includes anyone that meets the inclusion criteria and does not have any exclusion criteria.

Brief summary: A cross-sectional study to metatranscriptomically analyze and compare the oral microbiome in different environmental niches within the oral cavity.

Detailed description: This study will collect samples from participants meeting the eligibility criteria over the span of 3 months. Samples will be collected from multiple locations within the oral cavity and metatranscriptomically analyzed.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older

Exclusion Criteria:

* Positive SARS-CoV-2 test result, if performed
* Antibiotic use in the previous 30 days
* Mouthwash use in the previous 6 months

Primary outcomes:
measure: Species richness in multiple oral locations
timeFrame: 3 months
Secondary outcomes:
measure: KO richness of multiple oral locations
timeFrame: 3 months
Other outcomes:
Locations:
city: Bothell
country: United States
facility: Viome Life Sciences
state: Washington
Study officials:
affiliation: Viome
name: Momchilo Vuyisich
role: PRINCIPAL_INVESTIGATOR
affiliation: Viome
name: Guruduth Banavar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03986853: Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
Official title: Exploration of Angiogenesis in Decompensated Developmental Venous Abnormalities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Developmental Venous Anomaly
Lead sponsor: Hopital Foch
Sponsor class: OTHER
Collaborators: name: Collège de France
First posted: 2019-06-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of our study is to demonstrate by blood samples in situ in the vascular lesion (performed during any cerebral catheterization for an embolization of arteriovenous malformation) the existence of angiogenic growth factors and inflammatory factors that would confirm the decompensation of venous ischemia.


Eligibility criteria: Main Inclusion Criteria:

* Presenting a DVA requiring hyperselective catheterization
* Having sign an informed consent form

Exclusion Criteria:

* Presenting a contraindication to the realization of hyperselective cathterism

Primary outcomes:
measure: Assessment of angiogenic and inflammatory growth factors
timeFrame: 1 day
measure: Assessment of angiogenic and inflammatory growth factors
timeFrame: 1 day
measure: Assessment of angiogenic and inflammatory growth factors
timeFrame: 1 day
measure: Assessment of angiogenic and inflammatory growth factors
timeFrame: 1 day
measure: Assessment of angiogenic and inflammatory growth factors
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Georges Rodesch
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00849953: FinESS Registry Study
Official title: FinESS Registry Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinosinusitis
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who in the investigator's opinion, require trans-antral treatment of the maxillary sinus ostium and ethmoid infundibulum to remodel the bony sinus outflow tract using balloon displacement of adjacent bone and paranasal sinus structures using FinESS Sinus Treatment.

Brief summary: A prospective, post-approval registry study assessing subject rhinosinusitis symptomatic status over time following treatment with FinESS Sinus Treatment using self-administered quality of life survey data.


Eligibility criteria: Inclusion Criteria:

* adults 18 years or older undergoing balloon dilation with FinESS Sinus Treatment and have provided voluntary consent to participate in Registry

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: South Denver ENT and Allergy
state: Colorado
city: Panama City
country: United States
facility: Gulf Coast Facial Plastics and ENR
state: Florida
city: Grand Blanc
country: United States
facility: Gensys Regional Medical Center
state: Michigan
city: Maple Grove
country: United States
facility: Paparella Group
state: Minnesota
city: St Cloud
country: United States
facility: St. Cloud Ear Nose and Throat
state: Minnesota
city: Lee's Summit
country: United States
facility: Lee's Summit Ear, Nose and Throat Center
state: Missouri
city: Sioux Falls
country: United States
facility: Midwest Ear, Nose and Throat
state: South Dakota
city: Dickson
country: United States
facility: Dickson Ear, Nose and Throat PLC
state: Tennessee
city: Austin
country: United States
facility: Austin Ear, Nose and Throat Clinic
state: Texas
city: Austin
country: United States
facility: Capital Otolaryngology
state: Texas
city: Boerne
country: United States
facility: Texas Sinus Center
state: Texas
city: Houston
country: United States
facility: Medical Center ENT Associates of Houston
state: Texas
city: Richmond
country: United States
facility: Advanced Otolaryngology, PC
state: Virginia
city: Milwaukee
country: United States
facility: Advanced Ear, Nose and Throat Specialists
state: Wisconsin
Study officials:
affiliation: Entellus Medical
name: Jeff Grebner
role: STUDY_DIRECTOR
References:
Clinical trial NCT05802953: Quality of Life in Temporomandibular Joint Dysfunction
Official title: Investigation of the Relationship of Individual, Physical and Psychosocial Characteristics With Quality of Life in Temporomandibular Joint Dysfunction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: Temporomandibular Joint Dysfunction Syndrome
Quality of Life
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be conducted in Afyonkarahisar Health Science University Faculty of Dentistry. 18-85 aged patients with TMD will be included.

Brief summary: It is planned to examine the relationship between quality of life in patients with temporomandibular joint dysfunction and the patient's individual, physical and psychosocial characteristics.

Detailed description: A recent study showed that individuals with TMD have a lower quality of life than healthy controls. In addition, it was determined in the study that investigating the quality of life is insufficient. Future studies should search for psychosocial aspects related to TMD. The aim of this study is to individual the physical and psychosocial characteristics of individuals with Axis I TMD and examine their relationship with quality of life.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65,
* Being in group I according to RDC/TMD Axis I,

Exclusion Criteria:

* Any treatment for temporomandibular joint dysfunction (TMD) in the last six months
* Having dental problems
* Having any disorder and/or disease involving structures and/or masticatory muscles associated with TMD
* Having a history of trauma in the head and neck region,
* Having previously undergone temporomandibular joint surgery,
* Using corticosteroid and anticonvulsant drugs
* Patients who have received physiotherapy and rehabilitation related to the temporomandibular joint in the last six months

Primary outcomes:
measure: Quality of life scores
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Emel Taşvuran Horata
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: EMEL TAŞVURAN HORATA, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05788653: Comparison of Different Massages Tecniques on Chronic Pelvic Pain
Official title: Comparison of the Effectiveness of Transverse Friction Massage and Thiele Massage in Female Patients With Chronic Pelvic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Lead sponsor: Atlas University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 20
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate and compare the effectiveness of transverse friction and Thiele massage on pain, quality of life and sexual functions in female patients with chronic pelvic pain. The study will be performed on 20 female patients with pelvic floor muscle tenderness, who applied to the Urology Clinic in Istanbul and were diagnosed with chronic pelvic pain.


Eligibility criteria: Inclusion Criteria:

Clinical Diagnosis of Pelvic floor muscle tenderness, Clinical Diagnosis of Chronic Pelvic Pain Syndrome

Exclusion Criteria:

Neurological pathologies ( such as hemiplegia, epilepsy, multiple sclerosis and parkinson's disease) Urogynecological surgery in the last 6 months, Severe pelvic prolapse, Pelvic malignancy and pelvic radiotherapy.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 4 weeks
measure: McGill Melzack Pain Questionnaire (MMPQ)
timeFrame: 4 weeks
measure: Notthingam Health Profile Questionnaire (NHP)
timeFrame: 4 weeks
measure: Female Sexual Function Index (FSFI)
timeFrame: 4 weeks
measure: Bristol Female Lower Urinary System Symptom Index (BFLUSSI)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medicine Hospital
state: Bağcılar
Study officials:
References: