louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02734849: Study to Evaluate Multiple Doses in Patients With Nasal Polyposis
Official title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Study to Evaluate Multiple Doses of AK001 in Patients With Moderate to Severe Nasal Polyposis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nasal Polyposis
Lead sponsor: Allakos Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-12
Enrollment: 40
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: This is a phase 2 study to evaluate multiple doses of AK001 across 2 active doses. Pharmacodynamic activity will also be evaluated.

Detailed description: AK001 is a monoclonal antibody which may be useful in the treatment of patients with moderate to severe nasal polyposis

Eligibility criteria: Inclusion Criteria:

* TPS of ≥5 for both nostrils with presence on endoscopy of nasal polyps of grade ≥2 in each nostril according to the polyp grading scale
* History of sinusitis symptoms
* SNOT-22 ≥30
* No clinically significant Screening 12-lead ECG, vital sign, hematology, chemistry, or urinalysis findings

Exclusion Criteria:

* Use of systemic corticosteroids within 6 weeks of screening
* Chronic use of antibiotic therapy within 3 months prior to Screening
* Nasal surgery (including polypectomy) within 6 months prior to Screening
* Use of investigational drugs or participation in another clinical trial within 30 days prior to Screening or 5 half-lives, whichever is longer

Primary outcomes:
measure: Change in Total Polys Score (TPS)
timeFrame: From Baseline (prior to the first dose) to Week 12 (Day 84)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Investigator site
state: Illinois
city: Boston
country: United States
facility: Investigator site
state: Massachusetts
city: Pittsburgh
country: United States
facility: Investigator site
state: Pennsylvania
city: Houston
country: United States
facility: Investigator site
state: Texas
city: Charlottesville
country: United States
facility: Investigator site
state: Virginia
city: Ghent
country: Belgium
facility: Investigator site
city: Leuven
country: Belgium
facility: Investigator site
city: Dusseldorf
country: Germany
facility: Investigator site
city: Muenster
country: Germany
facility: Investigator site
city: Amsterdam
country: Netherlands
facility: Investigator site
city: Barcelona
country: Spain
facility: Investigator site
city: Jerez de la Frontera
country: Spain
facility: Investigator site
city: Valencia
country: Spain
facility: Investigator
city: Cambridge
country: United Kingdom
facility: Investigator site
city: Manchester
country: United Kingdom
facility: Investigator site
Study officials:
affiliation: University Hospital, Ghent
name: Claus Bachert
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03101449: Analysis of the Effects of Vocal Conditioning Through Semi-occluded Vocal Tract Exercises in Choir Singers
Official title: Analysis of the Effects of Vocal Conditioning Through Semi-occluded Vocal Tract Exercises in Choir Singers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Voice
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aims to evaluate the effects of vocal conditioning through two semioccluded vocal tract exercises (SOVTE) in choir singers.

Detailed description: This research aims to evaluate the effects of vocal conditioning through two semioccluded vocal tract exercises (SOVTE) - Finnish tube and phonation in high strength straw - in vocal parameters, vocal extension profile and maximum phonation time for a period of four months in a group of singers. acoustic analysis will be performed of the average parameters of the fundamental frequency (F0), jitter, shimmer and glottal to Noise Excitation (GNE) by VoxMetria program and perceptual analysis through Consensus Assessment Perceptual Hearing the Voice Protocol (CAPE-V) three times: before the vocal conditioning, after the last meeting of the technical realization and a week after the vocal conditioning period.

Eligibility criteria: Inclusion Criteria:

* signing of the Informed Consent (IC).

Exclusion Criteria:

* voice disorders diagnosed by otolaryngologist physician;
* smokers;
* presence below 75% in the meetings.

Primary outcomes:
measure: Voice quality
timeFrame: 3 months
Secondary outcomes:
measure: Mean fundamental frequency
timeFrame: 3 months
measure: Jitter
timeFrame: 3 months
measure: Shimmer
timeFrame: 3 months
measure: Glottal to Noise Excitation (GNE)
timeFrame: 3 months
measure: Profile vocal range
timeFrame: 3 months
measure: Maximun phonation time
timeFrame: 3 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Science of Porto Alegre
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT05603949: Development of Three-dimensional Deep Learning for Automatic Design of Skull Implants
Official title: Development of Three-dimensional Deep Learning for Automatic Design of Skull Implants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Skull Defect
Keywords: Deep Neural Networks;3D Shape Inpainting
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-11-03
Enrollment: 6
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Take a medical center as the research object

Brief summary: This project aims to develop an effective deep learning system to generate numerical implant geometry based on 3D defective skull models from CT scans. This technique is beneficial for the design of implants to repair skull defects above the Frankfort horizontal plane.

Detailed description: Designing a personalized implant to restore the protective and aesthetic functions of the patient's skull is challenging. The skull defects may be caused by trauma, congenital malformation, infection, and iatrogenic treatments such as decompressive craniectomy, plastic surgery, and tumor resection. The project aims to develop a deep learning system with 3D shape reconstruction capabilities. The system will meet the requirement of designing high-resolution 3D implant numerical models efficiently.

A collection of skull images were used for training the deep learning system. Defective models in the datasets were created by numerically masking areas of intact 3D skull models. The final implant design should be verified by neurosurgeons using 3D printed models.

Eligibility criteria: Inclusion Criteria:

1. Scheduled for cranioplasty
2. Informed consent

Exclusion Criteria:

(1)No informed consent

Primary outcomes:
measure: Number of patients where there is no need to adapt the Patient Specific Implant (PSI) edges
timeFrame: 6 weeks after surgery by standardised questionnaire
measure: Number of patients where there is no need to augment/fill clefts between the Patient Specific Implant (PSI) and patient´s bone
timeFrame: 6 weeks after surgery by standardised questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT05467449: DxFLEX 10C Clinical Study
Official title: DxFLEX ClearLLab 10C US-IVD Clinical Study Protocol - Clinical Laboratory
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Malignancy
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-20
Enrollment: 527
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Intended L\&L population

Brief summary: A multi-center method comparison study is designed per CLSI-EP09 A3. This study compares the qualitative immunophenotype agreement between DxFLEX and Navios EX to demonstrate the accuracy of the DxFLEX-10C system. A series of precision studies will be conducted with each focusing on different aspects of the DxFLEX-10C system.


Eligibility criteria: Inclusion Criteria: Patient specimens targeted for this study will be residual samples with sufficient volume from whole blood, bone marrow, and lymph node meeting the following criteria:

1. Specimens from new cases or follow up patients for myeloid/lymphoid FCI testing.
2. Hematologically abnormal specimens
3. Subjects of any range, ethnicities, and racial backgrounds
4. Specimens from patients with the following medical indications presenting for testing by flow cytometry based on the Bethesda Consensus Guidelines.

Exclusion Criteria:

There are two (2) groups of exclusion criteria to detail the specimens that should not be counted for the study:

1. Pre-analytical/Pre-screen exclusion criteria
2. Post-acquisition exclusion criteria.

Primary outcomes:
measure: Flow immunophenotyped normal and abnormal
timeFrame: immediately after the analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Aliso Viejo
country: United States
facility: NeoGenomics Laboratories
state: California
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Lewisville
country: United States
facility: Quest Diagnostics
state: Texas
city: Seattle
country: United States
facility: PhenoPath Laboratories, PLLC
state: Washington
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Munich
country: Germany
facility: Munich Leukemia Laboratory (MLL)
Study officials:
affiliation: Beckman Coulter, Inc.
name: Guoyan Cheng, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01207349: Type 2 Diabetes Secondary Prevention
Official title: Type 2 Diabetes Secondary Prevention Trial at the Reunion Island
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Secondary prevention
Physical activity
Nutritional education
HbA1c
Reunion island
diabetic patients, both female and male, age >=18 years, able to practise a physical activity, in Saint Pierre (GHSR) and Saint Denis (CHD)
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: Groupe Hospitalier Sud Réunion
First posted: 2010-09-22
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: type 2 diabetic patients

Brief summary: Three hundred and ninety height diabetic patients were educated during a week of hospitalisation (nutritional and physical-activity advices). After that, they were randomized in two groups : frequent follow-up (each three month) by educational nurses and dieteticians, versus no follow-up (control group). All patients were evaluated one year after their inclusion,by HbA1c (primary outcome), anthropometry, other cardiovascular risk factors, nutritionnal and physical-activity behaviours.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes patient aged \>=18 years

Exclusion Criteria:

* incapacity to a moderate physical activity

Primary outcomes:
measure: %HbA1c
timeFrame: at inclusion and at one year
Secondary outcomes:
measure: anthropometry
timeFrame: at inclusion and at one year
Other outcomes:
Locations:
city: Saint Pierre
country: France
facility: GHSR
state: La Réunion
Study officials:
affiliation: GHSR
name: Jean-Claude Schwager, MD
role: STUDY_DIRECTOR
References:
citation: Debussche X, Rollot O, Le Pommelet C, Fianu A, Le Moullec N, Regnier C, Boyer MC, Cogne M, Bakiri F, Schwager JC, Favier F. Quarterly individual outpatients lifestyle counseling after initial inpatients education on type 2 diabetes: the REDIA Prev-2 randomized controlled trial in Reunion Island. Diabetes Metab. 2012 Feb;38(1):46-53. doi: 10.1016/j.diabet.2011.07.002. Epub 2011 Oct 24.
Clinical trial NCT06931249: Turkish Version of The Pediatric Anesthesia Emergency Delirium
Official title: Turkish Version of The Pediatric Anesthesia Emergency Delirium (PAED) Scale: Translation and Cross-Cultural Adaptation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Emergence Delirium, Anesthesia
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 385
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In patients admitted to the Postoperative Anesthesia Recovery Unit (PACU) after general anesthesia for elective pediatric surgery

Brief summary: Emergence delirium (ED) is a mental disorder seen in children during recovery from general anesthesia. The Pediatric Anesthesia Emergence Delirium (PAED) scale is the only valid scale to assess ED in pediatric patients undergoing general anesthesia. The aim of this study is to translate and adapt the PAED scale to Turkish.

A five-stage translation and adaptation process will be performed. The reliability of the Turkish version of the PAED scale was independently assessed by a group of two raters (anesthesiologists or postanesthesia care unit nurses) in pediatric patients after general anesthesia. ED was defined by a cut-off point of ≥ 10 points on the PAED scale


Eligibility criteria: Inclusion Criteria:

1. Parents consented to the study,
2. Transferred to PACU after general anesthesia,
3. Between 2-16 years of age,
4. ASA physical status class I-II,
5. Cognitively intact children.

Exclusion Criteria:

1. Children without parental consent,
2. Children under 2 years of age and over 16 years of age,
3. Children with ASA physical status class III and above,
4. Children who underwent surgery under general anesthesia under emergency conditions,
5. Children with cognitive and behavioral disorders,
6. Children who developed major complications after the operation,
7. Children who are expected to require postoperative mechanical ventilation.

Primary outcomes:
measure: Turkish version of the pediatric anesthesia emergency delirium (PAED) scale
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
Clinical trial NCT04184349: Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of Automatic Implantable Cardioverter Defibrillators (AICDs) and Pacemakers in Pediatric Patients
Official title: Truncal Ultrasound Guided Regional Anesthesia for Implantation and Revision of AICDs and Pacemakers in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia After Pacemaker
AICDS Implantation Pediatrics
Keywords: pacemaker
AICDS
regional anesthesia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 19
Sex: ALL
Minimum age (years): 0
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of truncal blocks for pacemaker and Automatic Implantable Cardioverter Defibrillator implantation in children and to prospectively evaluate whether there is a decrease in amount of narcotic medications need and track complications.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing implantation or revision of pacemaker or AICD in the pediatric cath lab

Exclusion Criteria:

* parent or patient refusal
* use of narcotic medications prior to procedure

Primary outcomes:
measure: Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
timeFrame: From 24 hours after procedure to 48 hours after procedure
measure: Total Narcotic Dose in Milligram Morphine Equivalents (MME) Per Kilogram
timeFrame: up to 24 hours after procedure
Secondary outcomes:
measure: Pain as Measured by the Visual Analog Scale (VAS) Pain Score
timeFrame: up to 1.5 hours post procedure in post anesthesia care unit (PACU)
measure: Pain as Measured by the Visual Analog Scale (VAS) Pain Score
timeFrame: up to 24 hours post procedure
measure: Pain as Measured by the Face, Legs, Activity, Cry, Consolability (FLACC) Pain Assessment Scale
timeFrame: up to 6 hours post procedure in post anesthesia care unit (PACU)
measure: Number of Patients With the Incidence of Pruritis
timeFrame: up to 48 hours after procedure
measure: Number of Patients With the Incidence of Nausea/Vomiting
timeFrame: up to 48 hours after procedure
measure: Number of Patients With Respiratory Depression
timeFrame: up to 48 hours after procedure
measure: Number of Patients With Local Anesthetic Toxicity
timeFrame: up to 48 hours after procedure
measure: Number of Patients With Incidence of Pneumothorax
timeFrame: up to 48 hours after procedure
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Olga Pewelek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06234449: The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
Official title: The Impact of Long-term Pessary Use on Pelvic Organ Prolapse oìduring Covid-19 Pandemic in Patients Attending Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pelvic Organ Prolapse
Vaginal Prolapse
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 200
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with symptomatic and documented POP (stages III and IV) through POPQ examination who opted for reconstructive surgery and managed with pessary until surgery will be included in the cohort.

Brief summary: Patients aged 45 to 80 years with a clinical diagnosis of stage III and IV genital prolapse involving the anterior and/or middle compartments and candidates for surgery will be considered. These will be evaluated to observe whether there is improvement in clinical prolapse with the use of the vaginal pessary during the waiting period for surgery


Eligibility criteria: Inclusion Criteria:

* Pelvic organ prolapse with POP-Q stage \>/= 3 in anterior and/or central compartments
* Women between 45 and 80 years old

Exclusion Criteria:

* Women who refuse to participate in the study
* Patients without baseline POPQ examination documented or with a pessary previously positioned
* Previous pelvic surgeries
* Women with any contraindication for surgery or preference for conservative treatment only (pelvic muscle exercise, vaginal pessary)
* Women who are not successfully fitted with pessaries
* Current genital ulcers/infections
* Active or chronic pelvic infection
* Women who are mentally incapable of completing the questionnaires.

Primary outcomes:
measure: evaluate a change in POPQ points on examination at the time of surgery from baseline evaluation.
timeFrame: At the time of surgery procedure, after at least 6 months after pessary placement
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT03431649: Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Children
Official title: Efficacy of Beraprost in Lowering Pulmonary Arterial Pressure in Pulmonary Arterial Hypertension Children Associated With Left to Right Shunt Congenital Heart Defect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pediatric Pulmonary Hypertension
Lead sponsor: Dr. Soetomo General Hospital
Sponsor class: OTHER_GOV
First posted: 2018-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To analyze the efficacy of beraprost and sildenafil for treatment of pulmonary hypertension in children with left to right shunt.

analyze the efficacy and side effects.

Detailed description: Eligibility criteria:

Inclusion:

1. children aged 1-17 years with left to right shunt, diagnosed as pulmonary hypertension.
2. free from chronic pulmonary disease
3. never performed any cardiac surgical
4. never got any treatment for PH
5. agree to enroll in this study. Exclusion

1. suffer from portal hypertension, HIV and connective tissue disease 2. under interferon therapy.

Outcome measure:

Pulmonary artery pressure

Eligibility criteria: Inclusion Criteria:

* diagnosed as pulmonary hypertension with left to right shunt CHD (VSD, ASD, PDA and combination)
* agree to enroll in this study

Exclusion Criteria:

* suffer from chronic lung disease
* suffer from soft tissue tumor, HIV/AIDS
* under interferon therapy
* already performed any cardiac surgery
* already got anti-PH remedy

Primary outcomes:
measure: Efficacy of Beraprost, Sildenafil and comparison between both drugs in lowering pulmonary arterial pressure
timeFrame: 12 weeks
Secondary outcomes:
measure: Emergent Adverse Events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Surabaya
country: Indonesia
facility: Dr. Soetomo General Hospital
state: East Java
Study officials:
affiliation: Dr. Soetomo General Hospital
name: Mahrus Rachman, MD
role: STUDY_DIRECTOR
References:
citation: Limsuwan A, Pienvichit P, Khowsathit P. Beraprost therapy in children with pulmonary hypertension secondary to congenital heart disease. Pediatr Cardiol. 2005 Nov-Dec;26(6):787-91. doi: 10.1007/s00246-005-0925-4.