louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01839812: Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
Official title: Adrenal Responsiveness During the Perioperative Period in Children Undergoing Congenital Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Adrenal Cortex Diseases
Infant Morbidity
Keywords: Cardiopulmonary bypass
Cortisol
Dexamethasone
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 35
Sex: ALL
Maximum age (years): 365
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our objective was to determine whether a standard 1mg/kg intraoperative dose of dexamethasone results in similar drug levels for all patients and to characterize the relationship between these drug levels and the innate stress response following infant Cardiopulmonary Bypass (CPB). The investigators hypothesized that postoperative dexamethasone levels are highly variable, and that the infant stress response is inversely related to the amount of dexamethasone measured in the blood. To test this theory the investigators simultaneously measured blood levels of dexamethasone and cortisol at critical time points during the perioperative period for infants undergoing CPB for CHD surgery.

Detailed description: We conducted a single center prospective trial of infants (≤ 365 days of age) who presented to a single institution for congenital cardiac surgery.

Blood was collected from study participants at 7 time points; 1) post-anesthesia induction, 2) post-CPB/pre-MUF, 3) Intensive care unit (ICU) arrival, 4) post-op hour 4, 5) post-op hour 8, 6) post-op hour 12, and 7) post-op hour 24. At each of the 7 time points blood was analyzed for levels of the following; dexamethasone, cortisol, ACTH, Interleukin (IL) 10, IL 8, and IL 6. In addition, the innate stress response was evaluated with a cosyntropin stimulation test. Each patient received a 1 mcg/1.73 m2 intravenous dose of cosyntropin at; anesthesia induction, prior to dexamethasone (time 1), ICU arrival (time 3), and 24 hours after ICU arrival (time 7). Cortisol levels were measured before (time 1, 3, and 7) and 30 minutes after cosyntropin administration (time 1a, 3a, and 7a).

Eligibility criteria: Inclusion Criteria:

* less than 365 days of age
* Congenital cardiac surgery that requires cardiopulmonary bypass

Exclusion Criteria:

* Corticosteroids within 24 hours prior to enrollment
* Less than 36 weeks gestational age at time of surgery
* pre-operative mechanical circulatory support (ECMO)

Primary outcomes:
measure: Cortisol level
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sheri S Crow, MD,MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01665612: The Clinical and Subjective Performance of Three Different MPDS With Silicon Hydrogel Lenses
Official title: The Evaluation of the Clinical and Subjective Performance of Three Different Contact Lens Care Solutions With Silicon Hydrogel Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Reaction to Contact Lens Solution
Keywords: Contact lens
Care solution
MPDS
comfort
Lead sponsor: Finnsusp Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the clinical investigation is to assess the clinical and subjective performance of three novel multipurpose disinfecting solutions (MPDS) in daily wear with two silicone hydrogel contact lenses (Lotrafilcon B and Comfilcon A).


Eligibility criteria: Inclusion Criteria:

* age above 18
* experienced contact lens user
* good health (self-reported)

Exclusion Criteria:

* eye disease or eye operations
* pregnancy
* medication that can affect sight

Primary outcomes:
measure: Clinical performance
timeFrame: 1 month
Secondary outcomes:
measure: Subjective performance
timeFrame: 1 month
Other outcomes:
Locations:
city: Raisio
country: Finland
facility: Raision Näkökulma
Study officials:
affiliation: University of Turku, Finland; Finnsusp Ltd, Finland
name: Riikka Järvinen, PhD
role: STUDY_DIRECTOR
affiliation: Turku University Hospital
name: Hanna Vaahtoranta-Lehtonen, Dr. Ophth.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390712: Mirror-image Study of Paliperidone Palmitate and Risperidone Long-acting Injection
Official title: Mirror-image Study Exploring Relapse and Resource Utilization of Paliperidone Palmitate and Risperidone Long-acting Injection in Vitalité Health Network Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: Paliperidone palmitate
Risperidone long-acting injection
mirror-image
Lead sponsor: Réseau de Santé Vitalité Health Network
Sponsor class: OTHER
Collaborators: name: Janssen Inc.
First posted: 2018-01-04
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients initiated on long-acting injectable anipsychotics from the regional hospitals under the direction of the Vitalité health network.

Brief summary: The primary objective of this single-center multi-site retrospective chart review is to determine if paliperidone palmitate and/or risperidone long-acting injection can decrease the number of psychiatric relapses following their initiation in an inpatient acute psychiatric unit compared to oral antipsychotic therapy and determine if one treatment is superior to the other in this regard. This study will utilize a mirror-image design and incorporate up to a 3 years of follow-up following the index admission. Secondary objectives of this study will be to determine the change in hospital resource utilization for psychiatric reasons following treatment initiation, and to determine the difference in time to relapse.


Eligibility criteria: Inclusion Criteria:

• Patients who were initiated on either Risperidone long-acting injection or Paliperidone palmitate during an acute psychiatric admission for schizophrenia or other psychotic related disorders.

Exclusion Criteria:

* Patients who had their long-acting injection stopped prior to the discharge date of their index admission.
* Patients who received a long-acting injection in the year prior to the index admission.
* Patients who had a psychiatric admission to a forensic, rehabilitation or high dependency unit during the observation period prior to or following their index admission.

Primary outcomes:
measure: Psychiatric Relapse
timeFrame: up to 3 years
Secondary outcomes:
measure: Hospital Resource utilization for psychiatric reasons
timeFrame: up to 3 years
measure: Time to relapse
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Bathurst
country: Canada
facility: Chaleur Regional Hospital
state: New Brunswick
city: Campbellton
country: Canada
facility: Campbellton Regional Hospital
state: New Brunswick
city: Edmundston
country: Canada
facility: Edmundston Regional Hospital
state: New Brunswick
city: Moncton
country: Canada
facility: Dr. George-L.-Dumont University Hospital Center
state: New Brunswick
Study officials:
References:
Clinical trial NCT02794012: Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
Official title: Periodontal Inflammation and Immunity in Preclinical Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Periodontal Disease
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Rheumatology Research Foundation
First posted: 2016-06-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include: subjects at-risk for RA, subjects with early RA, and healthy controls \>40 years old.

Brief summary: The purpose of this study is to evaluate the association of Rheumatoid Arthritis (RA)-related antibodies and periodontal inflammation in subjects at-risk for Rheumatoid Arthritis. Subjects will undergo periodontal and joint examinations, as well as collection of body fluids to measure Rheumatoid Arthritis-related antibodies.


Eligibility criteria: Inclusion Criteria:

* Rheumatoid Arthritis-antibody positivity (anti-CCP) in the absence of arthritis or
* Early RA \<36 months since diagnosis

Exclusion Criteria:

* Pregnancy
* Antibiotic use prior to dental procedures or cleanings
* Wear dentures
* \<18 years old

Primary outcomes:
measure: Degree of periodontal disease by oral examinations according to the American Academy of Periodontology (AAP) guidelines
timeFrame: 1 day
Secondary outcomes:
measure: Frequency of bacterial communities of the periodontium by bacterial diversity (e.g. Shannon Diversity Index) and bacterial load (qPCR)
timeFrame: 1 day
measure: Frequency of Rheumatoid Arthritis-related antibodies in blood and mucosal sites using Rheumatoid Factor and Anti-Citrullinated Protein Antibody assays
timeFrame: 1 day
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Lindsay B Kelmenson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00724412: Evaluate Artificial Tear Efficacy in Moderate to Severe Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Keywords: Dry Eye
Corneal Staining
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-29
Enrollment: 279
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: Comparison of two Dry Eye products


Eligibility criteria: Inclusion:

* Have a score of at least 2 ("some of the time") on the subject-assessed Symptom Eligibility question; see Section 8.5.1.
* Have a sodium fluorescein corneal staining sum of ≥ 3 in either eye; see Section 8.5.10.
* Have a best-corrected visual acuity of 0.6 log MAR or better in each eye as assessed using an ETDRS chart; see Section 8.5.7.

Exclusion:

* Have a history or current evidence of the following: epithelial herpes simplex keratitis (dendrictic keratitisis); vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular rosacea; acute or chronic bacterial disease of the cornea and/or conjunctiva and/or eyelids; mycobacterial infection of the eye; and/or fungal disease of the eye.
* Use of Restasis® (cyclosporine ophthalmic emulsion, 0.05%) within 30 days of Visit 1.
* Use of systemic medications that may contribute to dry eye if the dosing regimen has not been stable for at least 30 days prior to Visit
* Additionally, the dosing regimen must remain stable throughout the study period. Medications known to contribute to dry eye include, but are not limited to, cold and allergy treatments, tricyclic antidepressants, and hormone replacement therapies.
* Presence of ocular conditions such as active acute blepharitis, conjunctival infections, iritis, or any other ocular condition that may preclude the safe administration of the test article.
* Unwilling to discontinue contact lens wear at least 7 days prior to Visit 1 and during the study period.
* Current punctal occlusion of any type (e.g., collagen plugs, silicone plugs).

Primary outcomes:
measure: Tear Break-up time
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04759612: Is Self-action Observation More Effective Than Observing Another Person's Action?
Official title: Is Self-action Observation More Effective Than Observing Another Person's Action During Upper Extremity Functions?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Adults
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
Collaborators: name: Izmir Katip Celebi University
First posted: 2021-02-18
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of the study is to compare the possible effects of self-action observation and observation of another person's action on upper extremity functionality, cognitive functions and reaction times.


Eligibility criteria: Inclusion Criteria:

* \>18 years old
* willingness

Exclusion Criteria:

* any kind of neurological or musculoskeletal problems
* sight problems
* pain in the upper limb

Primary outcomes:
measure: Change in upper extremity functionality
timeFrame: The outcome will be assessed at baseline and immediately after the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Katip Celebi University
Study officials:
References:
Clinical trial NCT04234412: Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
Official title: Treatment of Osteoarthritic Knee With High Tibial Osteotomy and Implantation of Allogenic Human Umbilical Cord Blood-derived Stem Cells.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis, Knee
Keywords: osteoarthritis
knee
high tibial osteotomy
umbilical cord blood stem cell
cartilage regeneration
Lead sponsor: Uijeongbu St. Mary Hospital
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical results after implantation of human umbilical cord blood-derived mesenchymal stem cells(hUCB-MSCs) and High tibia osteotomy in patients with medial compartment osteoarthritis(MCOA) as well as varus deformity of the knee joint.

This study will prospectively evaluate 10 knees after hUCB-MSCs implantation and High Tibial Osteotomy(HTO) in the medial compartment osteoarthritis and varus deformity of the knee joint.

Clinical outcomes will be evaluated using the International Knee Documentation committee(IKDC), Visual analogue scale(VAS), Western Ontario and McMaster Universities Arthritis Index(WOMAC), and patients satisfaction with the surgery.


Eligibility criteria: Inclusion Criteria:

* age older than 30 years,
* full-thickness cartilage lesion measuring at least 2 cm2,
* femoro-tibial angle (varus or valgus) 5°\< in the mechanical axis

Exclusion Criteria:

* ligament injuries (such as injuries of the anterior cruciate ligament and posterior cruciate ligament),
* metabolic arthritis
* infectious condition
* psychosis
* serious medical illness
* pregnancy

Primary outcomes:
measure: International Cartilage Repair Society (ICRS) grade improvement
timeFrame: at 24, 48, 96 weeks after surgery, score changes will be observed.
Secondary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: at 24, 48, 96 weeks after surgery, score changes will be observed.
measure: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
timeFrame: at 24, 48, 96 weeks after surgery, score changes will be observed.
measure: International Knee Documentation Committee (IKDC score)
timeFrame: at 24, 48, 96 weeks after surgery, score changes will be observed.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00340912: Use of Biopsy Punch for Skin Biopsies for Fibroblasts Culturing
Official title: Use of Biopsy Punch for Skin Biopsies for Fibroblasts Culturing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroblasts
Keywords: Skin Biopsy
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no

Brief summary: Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes. Firstly, to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics. Secondly, to look for biochemical markers of diabetes or obesity in Pimas employing two dimensional electrophoresis techniques.

Detailed description: Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes: 1) to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics; and 2) to look for biochemical markers of diabetes or obesity in Pimas employing two-dimensional electrophoresis techniques.

Eligibility criteria: * INCLUSION CRITERIA:

We will include Pima Indians who do not meet any of the exclusion criteria.

EXCLUSION CRITERIA:

We will exclude any seriously ill individuals, any known to have a bleeding diathesis or to be immunosuppressed or subjects who are carriers of HIV or HBV.

Children will be excluded, as the age range for this study's participants is 18-50.

Pregnant women will be excluded on the basis of a urinary pregnancy test.

All other subjects are potentially included.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: NIDDK, Phoenix
state: Arizona
Study officials:
References:
Clinical trial NCT01204112: Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
Official title: A Phase 1, Open Label, Fixed-Sequence Study To Estimate The Effect Of Repeat-Dose Rifampin On The Pharmacokinetics Of CP-690,550 In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug-Drug Interaction
Tasocitinib (CP-690
550)
Rifampin
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The current study is designed to estimate the effect of rifampin (600 mg orally every 24 hours for 7 days) on pharmacokinetics of single 30 mg dose (CP-690,550) in normal healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects (of non-childbearing potential)

Exclusion Criteria:

* Clinically significant disease or condition
* Recent serious infection

Primary outcomes:
measure: AUCinf of tasocitinib (CP-690,550)
timeFrame: 9 days
measure: Cmax of tasocitinib (CP-690,550)
timeFrame: 9 days
Secondary outcomes:
measure: AUClast, Tmax, t1/2 of tasocitinib (CP-690,550)
timeFrame: 9 days
measure: Safety: clinical laboratory abnormalities, AE reporting, and vital signs (blood pressure/pulse rate).
timeFrame: 9 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06820112: Comparison of Respiratory Support for Acute Pulmonary Edema
Official title: This Study Retrospectively Collected Relevant Patient Data to Compare the Effects of Different Respiratory Support Modalities in Patients With Acute Pulmonary Edema.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pulmonary Edema - Acute
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with acute pulmonary edema

Brief summary: This study is a retrospective study. The demographic and vital signs of patients with acute pulmonary edema are retrospectively collected to compare the prognosis of patients after receiving different respiratory support.


Eligibility criteria: Inclusion Criteria:

* diagnosis of acute pulmonary edema

Exclusion Criteria:

* Under 18 years old

Primary outcomes:
measure: death rate
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: