louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00465413: Bronchodilatation Effects of a Small Volume Spacer Used With a Metered-Dose Inhaler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: metered-dose inhalers (MDI)
forced expiratory volume in 1 second (FEV1)
forced expiratory flow rate (FEF25-75%)
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2007-04-25
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations.

Detailed description: Administration of bronchodilator drugs with metered-dose inhalers (MDIs) is difficult for some patients because the timing of the spray and the inhalation must be coordinated exactly. Use of spacers seems to improve delivery in these patients. It is not clear, however, if there is any advantage to a spacer for patients who are able to use an MDI with correct technique.

The purpose of the present study is to determine whether use of a small volume spacer is associated with better bronchodilatation in an unselected population of patients with documented reversible airflow limitations. The intervention in the first part of the study is use of an MDI with or without a spacer to deliver a bronchodilator (2 puffs, 0.4 mg of fenoterol). Spirometry is performed before and after the inhalation.

The second part of the study is conducted identically to the first with the same conditions and variables but with the addition of rinsing the mouth with 100 mL of water after inhaling the bronchodilator but before the second spirometry measurement.

The outcome to be measured is the increase in forced expiratory volume in 1 second (FEV1) and forced expiratory flow rate (FEF25-75%).

Eligibility criteria: Inclusion Criteria:

* age \> 6 years old,
* subjects known to have reversible airway limitation with demonstrated response to bronchodilators on spirometry.

Exclusion Criteria:

* refusal to participate,
* negative bronchodilator test,
* poor performance of pulmonary function testing.

Primary outcomes:
measure: forced expiratory volume in 1 second (FEV1)
measure: forced expiratory flow rate (FEF25-75%)
Secondary outcomes:
Other outcomes:
Locations:
city: Tamshui
country: Taiwan
facility: Mackay Memorial Tamshui Branch Hospital
state: Taipei
city: Taitung
country: Taiwan
facility: Mackay Memorial Taitung Branch Hospital
Study officials:
affiliation: Mackay Memorial Taitung Branch Hospital
name: Ching-Lung Liu, MD
role: STUDY_CHAIR
affiliation: Mackay Memorial Tamshui Branch Hospital
name: Yen-Ta Lu, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu CL, Lu YT. Bronchodilatation effects of a small volume spacer used with a metered-dose inhaler. J Asthma. 2009 Sep;46(7):637-41. doi: 10.1080/02770900802492111.
Clinical trial NCT00291213: Levetiracetam Treatment of Tardive Dyskinesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tardive Dyskinesia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: UCB Pharma
First posted: 2006-02-13
Enrollment: 50
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 placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.


Eligibility criteria: Inclusion Criteria: meet Glazer Morgenstern criteria for TD -

Exclusion Criteria: none

-

Primary outcomes:
measure: Abnormal Involuntary Movement Scale (AIMS) Total Score
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Scott W Woods, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Woods SW, Saksa JR, Baker CB, Cohen SJ, Tek C. Effects of levetiracetam on tardive dyskinesia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2008 Apr;69(4):546-54. doi: 10.4088/jcp.v69n0405.
Clinical trial NCT02100813: Safety and Efficacy of Doses of LEO 43204 Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
Official title: Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Full Balding Scalp in Subjects With Actinic Keratosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Actinic Keratosis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 220
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: To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle


Eligibility criteria: Inclusion Criteria:

* Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp.
* Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the full balding scalp

Exclusion Criteria:

* Location of the treatment area

  * within 5 cm of an incompletely healed wound
  * within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
* Prior treatment with ingenol mebutate gel on the treatment area
* Lesions in the treatment areas that have

  * atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
  * recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Primary outcomes:
measure: Part 1: Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
timeFrame: From Day 1 up to and including Day 8
measure: Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Lesion Count
timeFrame: From baseline to Week 8
Secondary outcomes:
measure: Part 2: Participants With Complete Clearance of AKs
timeFrame: From baseline to Week 8
measure: Part 2: Participants With Partial Clearance of AKs
timeFrame: From baseline to Week 8
Other outcomes:
Locations:
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
Study officials:
affiliation: Gwinnett Clinical Research Center, Inc.
name: Jonathan Weiss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586013: the Effect Site Equilibration Time of Propofol is Age Dependant
Official title: Importance of Age as Covariable in the Requirements to Determine the Drug Plasma -Site Effect Equilibration Time for TCI Propofol Pharmacokinetic Models
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: propofol
pharmacodynamic
age
ke0
Lead sponsor: Universidad del Desarrollo
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study obtains an effect site model for White (Modified Marsh) pharmacokinetic propofol model. The plasma effect-site rate constant (ke0) obtained is affected by age.

Detailed description: In the Target Controlled Infusion pumps the first order plasma-effect-site steady-state rate constant (ke0) links the pharmacokinetics (PK) and pharmacodynamics (PD) for a given drug and it is used to predict the course of the effect and to calculate a theoretical drug concentration at the effect site. The PK model for propofol recently published by White et al. (derived from the Marsh model used by the Diprifusor®) include covariate as age and gender to describe the pharmacokinetics but does not incorporate a ke0.

Methods: 45 healthy adult patients will be scheduled for elective surgery with standard monitoring and BIS XP (Aspect) will received a White PK model-driven plasma target controlled infusion of propofol ( 12 ugml-1 or 10 ugml-1 over 65 years) to be reached in 4 min. After reaching the target, the infusion will be stopped obtaining a complete effect curve upon patient awakening. Calculated plasma concentration and EEG data were stored every one second. Loss (LOC) and recovery (ROC) of consciousness were assessed and recorded. The dynamic relationship between propofol Ce and its effect as measured by BIS will be modeled with an inhibitory Emax model using a population PK/PD approach with NONMEM V.

the Study take around 12 min.

Eligibility criteria: Inclusion Criteria:

* ASA 1-2

Exclusion Criteria:

* less than 70% or more than 130% ideal body mass index,
* neurologic disorders,
* pregnancy,
* psychoactive medication intake during last 48 hours

Primary outcomes:
measure: pharmacodynamic model for the White propofol pharmacokinetic
timeFrame: Bispectral index
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Clinica Alemana
Study officials:
affiliation: Clinica Alemana Universidad del Desarrollo
name: Pablo O Sepulveda, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: White M, Kenny GN, Schraag S. Use of target controlled infusion to derive age and gender covariates for propofol clearance. Clin Pharmacokinet. 2008;47(2):119-27. doi: 10.2165/00003088-200847020-00005.
Clinical trial NCT04002713: Comparison of Choosing Free ALT or Free PMT for Reconstruction With Head and Neck Cancer
Official title: Comparison of the Outcome of Choosing Free Anterolateral Thigh or Free Posterolateral Thigh Flap for Reconstruction in Patients With Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reconstructive Surgery
Head and Neck Cancer
Keywords: Anterolateral thigh (ALT)
anteromedial thigh (AMT)
free flap reconstruction
microsurgery
head and neck cancer
outcomes
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 1590
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective study was performed on adult trauma patients from the registered free flap database and electric medical records of Kaohsiung Chang Gung Memorial Hospital, a 2,686-bed medical center in Southern Taiwan.

Brief summary: This study was designed to compare the outcome of the anteromedial thigh (AMT) and anterolateral thigh (ALT) flaps in head and neck cancer reconstruction.

Detailed description: To compare the results of the AMT and ALT flaps, this study aimed to compare their outcomes in head and neck cancer reconstruction under the condition of attenuating baseline patient and operative characteristics with the selection of propensity score-matched patient cohorts.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent ALT or AMT free flap reconstruction after head and neck cancer surgery between March 1, 2008 and February 28, 2017.

Exclusion Criteria:

* Patients whose data were missing will be excluded.

Primary outcomes:
measure: survival or failure
timeFrame: up to 6 months
Secondary outcomes:
measure: Complications
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT04452513: A Prospective Clinical Study of Phenylketonuria (PKU)
Official title: A Prospective Clinical Study of Phenylketonuria (PKU)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phenylketonurias
Keywords: PKU
Phenylketonuria
PAH Deficiency
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-06-30
Enrollment: 32
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PKU Patients 14 years or older with uncontrolled plasma Phe levels

Brief summary: This is a study for adults and children ≥ 14 years old who have Phenylketonuria (PKU) with uncontrolled plasma Phe levels. No clinical intervention or study drug is provided by BioMarin in this study.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency
* Ability and willingness to maintain dietary protein intake consistent with baseline intake
* Willingness and capable per investigator opinion to comply with study procedures and requirements
* Plasma Phe Levels \> 600umol/L

Exclusion Criteria:

* Clinically significant liver dysfunction or disease
* Prior treatment with gene therapy
* Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study

Primary outcomes:
measure: Change in Plasma Phe Levels
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Change in dietary protein intake from medical and intact food
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hosptial of Colorado
state: Colorado
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Chilren's Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Riley Hospital for Children
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Strasburg
country: United States
facility: Clinic for Special Children
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
city: Wauwatosa
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT05924113: A Study of Latin Dance for Post- Lung Transplant
Official title: Efficacy of Latin Dance for Promoting Wellbeing in Post Lung Transplant Recipients as Measured by Several Functional Measures, in the Outpatient Setting
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Transplant
Well-Being, Psychological
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 52
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: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to see if participating in Latin dance for 12 sessions can improve wellbeing in several areas including balance, fear of movement, anxiety, depression and spirometry.


Eligibility criteria: Inclusion Criteria:

- Ambulatory with or without assisting devices (not on supplemental oxygen is not exclusionary), who have completed outpatient cardiopulmonary rehab and good pain control.

Exclusion Criteria:

- Tracheostomy, Hemodialysis, gastro-jejunal tubes, nasogastric tubes, wound vacs, chest tube, high levels of oxygen supplementation (mask vs nasal canula), recent falls.

Primary outcomes:
measure: Change in anxiety
timeFrame: Baseline, 12 weeks
measure: Change in depression
timeFrame: Baseline, 12 weeks
measure: Change in Tampa Kinesophobia Scale
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Change in gait
timeFrame: Baseline, 12 weeks
measure: Change in Forced Expiratory Volume in one second (FEV1)
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Teresa Padro, DNP, APRN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07020013: Evaluation of the Effectiveness of Day Hospital Care for Adolescents With Anxious School Refusal
Official title: Evaluation of the Effectiveness of Day Hospital Care for Adolescents With Anxious School Refusal
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: School Phobia
Keywords: School phobia
Anxious school refusal
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of patients followed in day hospital for anxious school refusal

Brief summary: The objective of the study is to evaluate the benefit of day care in a child psychiatric hospital on the return to school and on the development of child psychiatric disorders associated with Anxious Social Refusal.

Detailed description: This is a prospective, longitudinal, single-center observational cohort study carried out on a population of patients followed in a day hospital for anxious school refusal.

Participating physicians will have the opportunity to recruit their patients over a 12-month period. All enrolled patients will be followed for a minimum of 10 months. The study will be completed as soon as the last enrolled patient has completed a final assessment.

Aside from the baseline visit, each patient will be assessed only once at 10 months. During each patient visit with the investigating physician, the physician will complete an assessment on the electronic CRF.

Eligibility criteria: Inclusion Criteria:

* Patients aged 12 to 18 years
* Patients with anxious school refusal, defined by a score ≥ 41 on the SCREEN scale
* Patients receiving day hospital care
* Patients who have been informed and whose parents (or holder(s) of parental authority) have agreed to their participation in the study and have not objected to the use of their health data

Exclusion Criteria:

* Patients with a mental disability or any other reason that may hinder the understanding or strict application of the protocol
* Patients not affiliated with the French social security system
* Patients under guardianship

Primary outcomes:
measure: Anxious school refusal
timeFrame: Month 10
Secondary outcomes:
measure: Obsessive-compulsive disorder assessment
timeFrame: Month 10
measure: Anxiety disorder assessment
timeFrame: Month 10
measure: depressive disorder assessment
timeFrame: Month 10
measure: Post traumatic Stress disorder assessment
timeFrame: Month 10
measure: Attention Deficit Hyperactivity disorder assessment
timeFrame: Month 10
measure: Schooling method
timeFrame: Month 10
Other outcomes:
Locations:
city: La Penne-sur-Huveaune
country: France
facility: Clinique des 3 cyprès
Study officials:
References:
Clinical trial NCT03724513: High Altitude Area- A Risk Factor For Gastric Perforation?
Official title: High Altitude Area- A Risk Factor For Gastric Perforation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Perforation
Keywords: High Altitude
Gastric Antrum Perforation
Mucosal Atrophy
Intra Luminal Pressure
Lead sponsor: 403 Military Field Hospital, India
Sponsor class: OTHER_GOV
First posted: 2018-10-30
Enrollment: 5
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young soldiers located in High Altitude Area

Brief summary: This is an original case series on soldiers evacuated from HAA(High Altitude Area) over last one year(Sept 2017- Aug 2018) , of which 100% cases were found to have gastric antrum perforation. This is a deviation from the usual trend that is being noted in Indian subcontinent where duodenal perforations are commonest.

Detailed description: INTRODUCTION : This is an original case series on soldiers evacuated from HAA(High Altitude Area) over last one year(Sept 2017- Aug 2018) , of which 100% cases were found to have gastric antrum perforation. This is a deviation from the usual trend that is being noted in Indian subcontinent where duodenal perforations are commonest.

DISCUSSION : High altitude associated dyspepsia is a common phenomenon and some studies done in high altitude population have recorded high incidence of antral gastritis and mucosal atrophy on histo-pathological evaluation. This is also supported by high incidence of H.pylori infection. The presence of atrophic gastric mucosa associated with antral gastritis, when exposed to hypobaric hypoxemic conditions faced by soldiers posted to heights above 15000ft , may leads to increased intra-luminal pressure and ischemia which probably predisposes individuals for gastric antrum perforations.

CONCLUSION : This is a relatively untouched topic as we have not found studies on high altitude related gastric perforations and probably this is the first case series of its kind. The acknowledgement of this phenomenon may pave way for further studies for defining the role of high altitude in gastric perforations.

Eligibility criteria: Inclusion Criteria:

* Individuals located in High Altitude Area (\>10,000ft).
* presented as perforation peritonitis.
* intra-operatively found to be perforated peptic ulcers.

Exclusion Criteria:

* Not located in High Altitude Area.
* intra-operatively perfoarations sites other then stomach and duodenum.

Primary outcomes:
measure: Assessment of site of perforated peptic ulcers by intra-operative observation in cases evacuated from High Altitude Area.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Leh
country: India
facility: 403 Military Field Hospital
state: Jammu AND Kashmir
Study officials:
affiliation: 403 MILITARY FIELD HOSPITAL
name: Aditya Pawar, MS
role: PRINCIPAL_INVESTIGATOR
References: