louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00917579: Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet
Official title: An Open Label, Randomized, Single Dose, Two-Way Crossover Bioequivalence Study Comparing A New 10 Mg Atorvastatin Tablet To A 10 Mg Atorvastatin Commercial Tablet In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Bioequivalence, pharmacokinetics, atorvastatin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: • To determine whether new 10 mg atorvastatin tablets are bioequivalent to 10 mg commercial atorvastatin tablets (Lipitor®).


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years
* Body Mass Index (BMI) of 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening.
* Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC Infinity)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Secondary outcomes:
measure: Time to Reach Maximum Plasma Concentration (Tmax)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
measure: Plasma Elimination Half-life (t1/2)
timeFrame: 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 10, 12, 24, 36, 48, 72 hours post dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05315479: Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Official title: A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety and Pharmacokinetics of N1539 in Children 2 to <17 Years of Age Following Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: meloxicam
pediatric
Lead sponsor: Baudax Bio
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 19
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is an open-label, multicenter evaluation of Safety and Pharmacokinetics of N1539 in postoperative Pediatric subjects aged 2 to \<17 years.


Eligibility criteria: Inclusion Criteria:

* Male or female 2 to \<17 years of age before dosing on Day 1
* Eligible for elective surgery that will be performed according to standard surgical technique under appropriate anesthesia
* Be premenarche or have confirmed negative urine pregnancy testing before surgery on Day 1, if an adolescent female of childbearing potential
* Willing and able to cooperate with all the requirements of the study; including providing appropriate informed consent/assent

Exclusion Criteria:

* Have a known allergy or hypersensitivity to meloxicam, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), or any excipient of N1539
* Have a known bleeding disorder that may be worsened with the administration of an NSAID
* Be undergoing cardiothoracic surgery
* Has used meloxicam within 7 days before the surgical procedure on Day 1
* Has any clinically significant medical history or clinical manifestations of significant disease or any other condition that increases the risk associated with the subject's participation in the study or compromises the scientific objectives of the study.

Primary outcomes:
measure: Number of Subjects Experiencing an AE
timeFrame: Through study completion, approximately 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: Research Center
state: Alabama
city: Bakersfield
country: United States
facility: Research Center
state: California
city: Salt Lake City
country: United States
facility: Research Center
state: Utah
Study officials:
References:
Clinical trial NCT05249179: Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices
Official title: Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices on the Transition to Full Oral Feeding in Infants With a Gestational Age of 26-32 Weeks
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature
Nutrition Disorders
Sucking Behavior
Keywords: Sucking
Oral stimulation
Premature baby
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 140
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Non-oral feeding methods are frequently used in babies born prematurely since sucking and sucking-swallowing coordination have not yet developed. While some premature babies gain the sucking and swallowing reflexes faster, some of them cannot develop this reflex for a long time, so the length of hospital stay is prolonged. All infants who can be fed completely enterally (PMA \>29 weeks) will be randomized into 4 groups as oral stimulation (group 1), pacifier (group 2), oral stimulation + pacifier (group 3), and control group by using a stratified blocked randomization method with a block size of 4. Stratification on GA (26-27, 28-29, 30-32 weeks GA) was used to ensure that the groups had similar gestational age distribution. The time of the patients to start breastfeeding and the length of hospital stay (days) will be compared.


Eligibility criteria: Inclusion Criteria:

* Preterm babies born between 26-32 weeks (including 26 and 32 weeks)

Exclusion Criteria:

* Babies with congenital anomalies
* Babies born with asphyxia
* Babies with major GIS anomalies
* Babies who have undergone major GIS surgery

Primary outcomes:
measure: Full oral feeding time (postmenstruel week)
timeFrame: 2 years
measure: Hospital stay (days)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Bilkent Central Hospital, Neonatal Unit
name: Nilgün Altuntas, Proff
role: STUDY_DIRECTOR
affiliation: Ankara Bilkent Central Hospital, Neonatal Unit
name: Suna S Oguz, Proff
role: STUDY_DIRECTOR
affiliation: Ankara Bilkent Central Hospital, Neonatal Unit
name: Mustafa S Akin, Specialist
role: STUDY_DIRECTOR
References:
Clinical trial NCT00627679: Safety and Blood Level Study of Unit Dose Budesonide
Official title: A Randomized, Double Blind, Active Controlled, Single Dose, 4 Arm, 4 Period Crossover, Phase 1 Study Investigating the Tolerability and Pharmacokinetics of MAP0010
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: Pediatric asthma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
name: Q-Pharm Pty Limited
First posted: 2008-03-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers, aged 18-50 years
* BMI less than 30 kg/m2
* Non smoker (currently and \<10 pack years total if ex-smoker)

Exclusion Criteria:

* Any use of corticosteroid in previous 4 weeks
* Pregnancy/lactation
* Significant blood donation (or testing) in previous 8 weeks

Primary outcomes:
measure: Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010
timeFrame: 8 hours
measure: Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
timeFrame: 8 hours
measure: AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010
timeFrame: 8 hours
measure: AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
timeFrame: 8 hours
measure: Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Q-Pharm Pty Limited
state: Queensland
Study officials:
affiliation: Q-Pharm Pty Limited
name: Joanne Marjason, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02753179: Covert-saccades, Dynamic Visual Acuity and Quality of Life
Official title: Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Diseases
Keywords: Bilateral vestibular hypofunction
Video Head Impulse Test
Covert-saccades
Quality of life
Dynamic visual acuity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.


Eligibility criteria: Inclusion Criteria:

* Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria

  * Mean peak slow phase velocity of 5°/s or less in bilateral bithermal (30 and 44°C) caloric irrigations
  * Pathologic Head-impulse test
  * VOR gain of \<0.25 on rotatory chair tests
* Disorder present for over 6 month
* Comprehension of the experiments instructions
* Patient consent

Exclusion Criteria:

* Corrected Visual Acuity lower than 5/10
* Other conditions leading to oscillopsia or ataxia
* Oculomotor palsy, ocular instability in primary position
* Cervical rachis pathology with instability
* Cochlear Implants
* Non-stabilized medical disease
* Pregnant women
* Patients under tutelage

Primary outcomes:
measure: Frequency of covert-saccades
timeFrame: Day 0
Secondary outcomes:
measure: Quality of life assessed with the Dizziness Handicap Inventory
timeFrame: Day 0
measure: Dynamic visual acuity
timeFrame: day 0
measure: Oscillopsia severity questionnaire score
timeFrame: day 0
measure: Latency of covert-saccades
timeFrame: Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Unité de Neuro-Ophtalmologie Hôpital Neurologique
Study officials:
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Caroline TILIKETE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04214379: Management of Severe Congenital Blepharoptosis
Official title: Evaluation of Polytetrafluoroethylene (Ptose-up) in Management of Severe Congenital Blepharoptosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharoptosis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-01-02
Enrollment: 15
Sex: ALL
Minimum age (years): 11
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Frontalis sling surgery was carried out using Ptose-up under general anaesthesia for patients with severe congenital ptosis.

Detailed description: Frontalis sling surgery was carried out using Ptose-up for patients with severe congenital ptosis in 23 eyes of 15 patients and they followed up for at least 6 months to detect the success rate and if there is any postoperative complications.

Eligibility criteria: Inclusion Criteria:

* Severe congenital blepharoptosis
* Poor levator muscle function
* No previous ptosis surgery

Exclusion Criteria:

* Patients with Jaw winking phenomenon
* Blepharophimosis syndrome
* Congenital myasthenia

Primary outcomes:
measure: Improvement of ptosis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
state: Minia
Study officials:
affiliation: Minia University
name: Mohamed F Ibrahiem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06315179: Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
Official title: Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inflammatory Bowel Diseases
Crohn Disease
Ulcerative Colitis
Indeterminate Colitis
Functional Abdominal Pain Syndrome
Functional Bowel Disorder
Esophageal Diseases
Gastroduodenal Disorder
Bowel Dysfunction
Gallbladder Diseases
Sphincter of Oddi Dysfunction
Anorectal Disorder
Keywords: IBD
DGBI
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Allen Institute
First posted: 2024-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals who meet inclusion criteria will be approached.

Brief summary: This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.

Detailed description: Research procedures will coincide with clinical visits at institutional standards. As part of their clinical disease evaluation, participants will have blood, stool, and tissue collected as indicated by their disease course. Additional research samples or data will be collected during these visits. Participants will be asked to collect urine samples specifically for research.

Eligibility criteria: Inclusion Criteria:

* Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)

Exclusion Criteria:

* Evidence of Other Complicating Medical Issues:
* Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
* Pregnancy
* Tobacco, alcohol, or illicit drug abuse

Primary outcomes:
measure: Bio-repository sample collection for spatial transcriptomics
timeFrame: 3 years
Secondary outcomes:
measure: Paris Classification of Crohn's Disease
timeFrame: Baseline
measure: Montreal Classification of Crohn's disease
timeFrame: Baseline
measure: Paris Classification of Ulcerative Colitis/Indeterminate Colitis
timeFrame: Baseline
measure: Montreal Classification of Ulcerative Colitis/Indeterminate Colitis
timeFrame: Baseline
measure: Disorder of Gut-Brain Interaction classification
timeFrame: Baseline
measure: Physician's Global Assessment (PGA)
timeFrame: 3 years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital, University of Washington
name: Betty (Hengqi) Zheng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03353779: The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients
Official title: The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Percutaneous Coronary Intervention
Coronary Artery Disease
Keywords: Percutaneous coronary intervention
antiplatelet
platelet function
prognosis
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 1440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with complex PCI were defined as having at least 1of the following features :3 vessels treated,≥3 stents implanted, ≥3 lesions treated,bifurcation with 2stents implanted ,total stent length \>60 mm or chronic total occlusion.

Brief summary: To identify the optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China

Detailed description: This study will observe the relationship between platelet function testing and clinical outcomes. Meanwhile we aim to identify optimal cut-off values in different platelet function testing, including IPF, TEG and VerifyNow, to predict MACCE during12-months in complex PCI patients.

Eligibility criteria: Inclusion Criteria:

* Documented undergoing complex PCI in 1 year prior to enrollment.

Exclusion Criteria:

* Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, alcohol or drug abuse).
* Presence of serious/severe co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year).
* Current participation in a blinded randomized clinical trial.

Primary outcomes:
measure: Optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China
timeFrame: Within 12 months of patient enrolled
Secondary outcomes:
measure: Effectiveness and sensitivity of predicting between different platelet function testing
timeFrame: Within 12 months of patient enrolled
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yida Tang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06751979: Probiotic Treatment of Orthodontic Patients
Official title: Effect of the Probiotic Strain Streptococcus Salivarius M18 on de Novo Formation and Composition of Dental Biofilm in Orthodontic Patients: A Randomized Double-blind Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dental Plaque
Dental Caries
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Bluestone Pharma
First posted: 2024-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This clinical trial applies a randomized double-blind placebo-controlled design with two parallel arms.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the effect of treatment with a lozenge containing the probiotic strain S. salivarius M18 on the formation, composition and virulence of dental plaque and in healthy orthodontic patients, compared to placebo control.


Eligibility criteria: Inclusion Criteria:

1. Generally healthy males and females ≥ 10 years of age.
2. Able to read and receive a copy of the signed informed consent form.
3. Have at least 20 natural teeth.
4. Have been undergoing orthodontic treatment with fixed orthodontic appliances in the upper and/or lower jaw \> 6 months.
5. An average plaque score of \> 2 according to the Modified Orthodontic Plaque Index (MOPI) at the screening appointment.

Exclusion Criteria:

1. Significant oral soft tissue pathology based on a visual examination.
2. History of allergy or significant adverse events following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
3. History of allergies to milk proteins.
4. History of allergies towards probiotics.
5. Self-reported as pregnant or nursing.
6. Self-reported serious medical conditions.
7. Antibiotic or anti-inflammatory medication within 30 days of screening visit.
8. Acute sinusitis or severe oral-pharyngeal infections.
9. Smoker.

Primary outcomes:
measure: Planimetric plaque quantification
timeFrame: 6 weeks
Secondary outcomes:
measure: Prevalence of S. salivarius
timeFrame: Immediately after intervention
measure: Gingivitis
timeFrame: Immediately after intervention
measure: Plaque pH
timeFrame: Immediately after intervention
Other outcomes:
measure: Microbiome composition
timeFrame: Immediately after intervention
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department of Dentistry and Oral Health
Study officials:
References: