louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02284347: NuVent™ Revision Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Lead sponsor: Medtronic Surgical Technologies
Sponsor class: INDUSTRY
First posted: 2014-11-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).


Eligibility criteria: Inclusion Criteria:

1. Subject is at least 18 years of age.
2. Subject has chronic rhinosinusitis unresponsive to medical therapy and previous sinus surgery.
3. Subject has sinus surgery planned on at least one of the frontal, sphenoid or maxillary sinus ostia.
4. Subject has scarred, granulated or previously surgically altered tissue for which an image-guided balloon tool may be feasible, in the opinion of the Investigator.
5. Subject is willing and able to comply with protocol requirements.

Exclusion Criteria:

1. Subject is pregnant or breastfeeding.
2. Subject is not healthy enough to undergo endoscopic sinus surgery based on the opinion of the Investigator.
3. Subject has sinonasal tumors.
4. Subject is participating in another investigational device, biologic, or drug study and has not completed the primary endpoint(s) or if there is a potential for clinical interference beyond the primary endpoint.
5. Subject lacks capacity to consent to participation in this research himself/herself.

Primary outcomes:
measure: Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium
timeFrame: At time of surgery
measure: Device-related Adverse Event Point Estimate
timeFrame: 2 weeks
Secondary outcomes:
measure: Device Safety Profile as Measured by the Overall Adverse Event Rate
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01139047: Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
Official title: Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% vs Finacea® (Azelaic Acid) 15% in Subjects With Healthy Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Manifestations
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-06-08
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the tolerability of MetroGel® 1% to Finacea® 15% in subjects with healthy skin applied according to product labeling for three weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults (ages 18 years or older)
* Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions
* Subjects with known allergy to one of the components of the study drugs (refer to the package inserts for MetroGel® 1% and Finacea® Gel 15%)
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis, rosacea, or other topical conditions on the area to be treated
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)

Primary outcomes:
measure: Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3
timeFrame: baseline to week 3
Secondary outcomes:
measure: Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22
timeFrame: day 22
measure: 6 Question Subject Preference Survey at Week 3
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Thomas J. Stephens & Associates, Inc.
state: Colorado
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00156247: Acitretin and Etanercept in Psoriasis
Official title: Pilot, Single-Arm Study of the Effect of Adding Acitretin to Etanercept Therapy in Patients With Moderate to Severe Psoriasis Who Fail to Respond to Etanercept Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: psoriasis
etanercept
acitretin
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Connetics Corp.
First posted: 2005-09-12
Enrollment: 10
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: TREATMENT

Brief summary: To determine whether acitretin plus etanercept is more effective than etanercept alone in clearing psoriasis plaques in adults.

Detailed description: This study will include patients with moderate to severe psoriasis who have been taking etanercept 50 mg/week for at least 3 months (12 weeks) and have not achieved PASI 75. They will be given acitretin 25 mg/day. The combined treatment will occur over 6 months. Subjects' progress will be assessed monthly, based on the improvement of their PASI and PGA scores.

Eligibility criteria: Inclusion Criteria:

* Adults (aged 18 to 80 years old) with moderate to severe psoriasis (defined as having a physician global assessment score of 3 \[moderate\] or higher) who are on etanercept 50 mg SQ once weekly and have not achieved PASI 75 after 12 weeks or more of treatment with etanercept
* All patients on etanercept have been tested for TB before initiation of etanercept

Exclusion Criteria:

* Patients \< 18 years old or \> 80 years old
* Patients who are not on etanercept 50 mg SQ once weekly
* Women of childbearing potential (Note: women of non-childbearing potential, meaning surgically sterile \[bilateral oophorectomy, hysterectomy, and/or bilateral tubal ligation\] or post-menopausal for at least 2 years, are eligible)
* Inability to understand consent or comply with study requirements
* Uncontrolled hypertriglyceridemia
* Patients with severely impaired hepatic function
* Patients without health insurance or who are not willing to pay out-of-pocket for etanercept and laboratory tests
* Systemic psoriasis therapies or PUVA within the past 2 weeks
* UVB or topical psoriasis therapies (other than emollients/moisturizers and OTC shampoos) within the past 1 week
* Patients with epilepsy or multiple sclerosis

Primary outcomes:
measure: Percent of Patients Achieving PASI 75 at 6 Months After the Addition of Acitretin Therapy
timeFrame: 6 months
Secondary outcomes:
measure: Percent of Patients Achieving PASI 50 at 6 Months After the Addition of Acitretin Therapy
timeFrame: 6 months
measure: Percent of Patients Achieving a PGA of Clear or Almost Clear at 6 Months After the Addition of Acitretin Therapy
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Melissa A. Magliocco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224977: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.
Official title: Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 4.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthmatic Patients
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
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 main objectives of the study are:

1. To unravel the importance of molecular phenotyping in predicting the response to antimicrobial therapy with potential anti-inflammatory potency

The investigators have developed a non-invasive technique based on mRNA analysis of induced sputum that enables us to study airway inflammation in detail. This technique forms the basis for our current project based on the following hypotheses:

1. Different molecular asthma phenotypes exist: a Th2 phenotype and a non Th2 phenotype as reported by Woodruff and colleagues (Woodruff PG et al). Sputum mRNA cytokine levels can be used to diagnose Th2 asthma and discriminate this from non-Th2 asthma.
2. Based on our previous research and preliminary data that non-Th2 asthma can be further divided in Th17 asthma and Th1+Th2 asthma; besides these, a fourth group without Th2, Th17 or Th1 characteristics also exist.
3. These subgroups have different responses to anti-microbial therapy with potential anti-inflammatory potency (macrolides).


Eligibility criteria: Inclusion Criteria:

* severe asthmatics (GINA step 4 or step 5 (without anti-IgE))

Exclusion Criteria:

* viral/fungal/bacterial infection +fever (\<1 month)
* asthma exacerbation (\<3 months)
* other respiratory disease (CF, ciliary dyskinesia,bronchiectasis)

Primary outcomes:
measure: sputum cytokine mRNA
timeFrame: 3 months
Secondary outcomes:
measure: responsiveness to the medication
timeFrame: 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
state: Vlaams-Brabant
Study officials:
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Dominique MA Bullens, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lab of clinical immunology, O&N I Herestraat 49 - bus 811, 3000 Leuven, België
name: Sven F Seys, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT03316677: Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
Official title: Intraoperative Testing of Colorectal Anastomosis - Air or Water (Methylene Blue)?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ColoRectal Cancer
Colonic Diverticulitis
Anastomotic Leak
Anastomotic Complication
Anastomosis
Keywords: anastomotic leak
colorectal
anastomosis testing
Intraoperative testing
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A leak from a colorectal anastomosis is a post-operative complication surgeons fear the most, following colonic resection. Over the years, there have been multiple suggestions for intraoperative tests for the integrity of the colorectal anastomosis.

Two of the most common tests that are performed routinely are:

1. Air tight leak test - filling the pelvis with saline and insufflating air trans anal - looking for air bubbles in the saline filled pelvis.
2. Injecting diluted dye (methylene blue) trans anal, and looking for blue dye stains on gauze pads covering the outer side of anastomosis.

The aim of the study is to compare the two methods, and to assess if there is a superior method. A secondary aim is to establish standards to perform the test, mainly to assess the appropriate pressure to apply on the anastomosis.

In this prospective study patients scheduled to undergo colonic resection of their distal part of the colon/ rectum with colorectal anastomosis, will have both testing methods performed sequentially and will be followed post-operative to assess the yield and sensitivity of the testing methods.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 undergoing elective colonic resection of their distal part of the colon/ rectum with colorectal anastomosis in a laparoscopic or open approach for a benign or malignant colonic disease.

Exclusion Criteria:

* Emergent colonic resections,
* Colonic resections with no colorectal anastamosis

Primary outcomes:
measure: the predictive value of intraoperative anastomosis testing on anastomotic leak.
timeFrame: 30 days
Secondary outcomes:
measure: The sensitivity of the 2 methods of intraoperative anastomosis testing.
timeFrame: Both findings will be obvious (if present) immediately after the test is performed
Other outcomes:
Locations:
Study officials:
affiliation: Meir Medical Center, Israel
name: Shmuel Avital, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudnicki Y, White I, Tiomkin V, Lahav L, Raguan B, Avital S. Intraoperative evaluation of colorectal anastomotic integrity: a comparison of air leak and dye leak tests. Tech Coloproctol. 2021 Jul;25(7):841-847. doi: 10.1007/s10151-021-02453-4. Epub 2021 Apr 27.
Clinical trial NCT02058277: A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy Volunteers
Official title: An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Dose Of Aprepitant, A Moderate CYP3A Inhibitor On Bosutinib Administered Orally To Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: bosutinib
aprepitant
drug interaction
healthy volunteers
pharmacokinetics
chronic myelogenous leukemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-02-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. The primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single oral dose of bosutinib in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects with an informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol .
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.

Primary outcomes:
measure: Area under the Concentration-Time Curve (AUC)
timeFrame: 96 hours
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 96 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 96 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 96 hours
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 96 hours
measure: Apparent Oral Clearance (CL/F)
timeFrame: 96 hours
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 96 hours
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Hsyu PH, Pignataro DS, Matschke K. Effect of aprepitant, a moderate CYP3A4 inhibitor, on bosutinib exposure in healthy subjects. Eur J Clin Pharmacol. 2017 Jan;73(1):49-56. doi: 10.1007/s00228-016-2108-z. Epub 2016 Oct 7.
Clinical trial NCT03102177: Effect of Age, Weight and Sex on Levothyroxine Pharmacokinetics
Official title: Hypothyroidism Treatment in Aging and Thyroid Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypothyroidism Primary
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 41
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label prospective study
Primary purpose: OTHER

Brief summary: This study was a prospective, single-center, open-label, non-randomized, pharmacokinetic study using stable isotope carbon-13 labeled levothyroxine

Detailed description: Setting The study was conducted on the clinical research unit of an academic medical center.

Participants Adults of any age being treated with levothyroxine for hypothyroidism were studied.

Interventions A single dose of 13C- LT4 was administered to hypothyroid subjects taking levothyroxine replacement.

Main Outcomes and Measures Eighteen serial plasma samples were collected. One sample was obtained before the 13C- LT4 dose and the remainder over the 312-hour period post-dosing. 13C- LT4 concentration was quantified using validated liquid chromatography tandem mass spectrometry methods. Pharmacokinetic analysis was conducted using linear log trapezoidal non-compartmental analysis using Phoenix 6.4.

Eligibility criteria: Inclusion Criteria:

* age \>21 years at the time of consent
* euthyroidism while undergoing treatment with LT4
* no other serious illness
* ability to give written informed consent.

Exclusion Criteria:

* baseline hematocrit lower than 28.0%
* TSH greater than 4.5 mIU/L
* kidney dysfunction
* concomitant use of drugs that affect thyroidal axis interactions

Primary outcomes:
measure: CL/F
timeFrame: 120 hours
measure: V/F
timeFrame: 120 hours
measure: t-half
timeFrame: 120 hours
Secondary outcomes:
measure: CL/F analysed by age groups
timeFrame: 120 hours
measure: V/F analysed by age groups
timeFrame: 120 hours
measure: t-half by age groups
timeFrame: 120 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01003977: Registry Experience at the Washington Hospital Center, DES - Xience V
Official title: REWARDS (Registry Experience at the Washington Hospital Center, DES - Xience V)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2009-10-29
Enrollment: 6069
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a Xience V, everolimus-eluting, Stent at the Washington Hospital Center.

Brief summary: Single center registry of patients who have received a Xience V everolimus-eluting stent at the Washington Hospital Center, with the primary objective to assess clinical success and safety at 30 days, 6 months and 1 year post-implantation.

Detailed description: Interventional cardiology was revolutionized by the invention of stents, initially with the bare-metal stents (BMS) and recently with the drug-eluting stents (DES). The everolimus eluting, Xience V stents have shown very promising results in randomized clinical trials, demonstrating a reduction of clinical and angiographic restenosis in comparison to BMS, and comparable clinically-driven target lesion revascularization rates in comparison with sirolimus-eluting stents. While registry data is available from outside of the United States, it will be important to collect "real-world" data regarding the stent usage and outcomes in the United States. In this study we propose to follow patients who received at least one Xience V® Stent for at least 1 year post initial stent implantation.

Eligibility criteria: Inclusion Criteria:

* Patients, male or female, \>18 years of age
* Patients who received at least one Xience V drug-eluting stent at the Washington Hospital Center

Exclusion Criteria:

* Patients who received another type of DES (other than Xience V) or a bare metal stent at the time of initial Xience V stent implantation

Primary outcomes:
measure: Evaluation of Major Adverse Cardiac Events (MACE) post Xience V implantation
timeFrame: Follow Up
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
Study officials:
affiliation: Medstar Research Institute/Cardiovascular Research Institute
name: Ron Waksman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04234347: Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access
Official title: Long Versus Short Axis Approach for Ultrasound Guided Peripheral Intravenous Access: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Venous Access
Lead sponsor: Temple University
Sponsor class: OTHER
First posted: 2020-01-21
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare a long axis approach versus short axis when placing peripheral IVs using ultrasound guidance.

Detailed description: Patients needing an USGPIV will be randomized into long or short axis orientation. Emergency Medicine residents will place the IV using an ultrasound.

Eligibility criteria: Inclusion Criteria:

* Hemodynamically stable patients requiring placement of an USGPIV.

Exclusion Criteria:

* Hemodynamically unstable
* Unable to consent

Primary outcomes:
measure: First pass success
timeFrame: 1 day
measure: Number of attempts
timeFrame: 1 day
measure: Overall success
timeFrame: 1 day
measure: Time to completion
timeFrame: 1 day
Secondary outcomes:
measure: Complications
timeFrame: 1 day
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Lewis Katz School of Medicine at Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Ryan C Gibbons, MD
role: PRINCIPAL_INVESTIGATOR
References: