louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02100553: Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women
Official title: A Phase 1, Open Label, Two Period, Fixed Sequence, Parallel Group Study To Estimate The Effects Of Multiple Dose Administration Of Itraconazole On The Single Dose Pharmacokinetics Of Conjugated Estrogens/Bazedoxifene In Non Obese (Bmi <30 Kg/m2) And Obese (Bmi ≥30 Kg/m2) Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Postmenopausal Women
Obese
Non-obese
Drug Interaction with Itraconazole
Pharmacokinetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-01
Enrollment: 24
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess if itraconazole will affect the blood levels of Duavee when they are given together. This study will also assess if a subject's body size affects the blood levels of Duavee.


Eligibility criteria: Inclusion Criteria:

* Generally healthy postmenopausal women, aged 40-64. Intact Uterus

Exclusion Criteria:

* The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin.
timeFrame: up to 96 hours
measure: Maximum Observed Plasma Concentration (Cmax) for BZA, total estrone adjusted for baseline and total equilin.
timeFrame: up to 96 hours
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.
timeFrame: up to 96 hours
measure: Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.
timeFrame: up to 96 hours
measure: Apparent Oral Clearance (CL/F) for all analytes.
timeFrame: up to 96 hours
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes.
timeFrame: up to 96 hours
measure: Apparent Volume of Distribution (Vz/F) for all analytes.
timeFrame: up to 96 hours
measure: Terminal Phase Elimination Half-Life (t1/2) for all analytes.
timeFrame: up to 96 hours
Other outcomes:
Locations:
city: Miami
country: United States
facility: SeaView Research, Inc. (Screening Office)
state: Florida
city: Miami
country: United States
facility: SeaView Research, Inc.
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01510353: Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization
Official title: Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radiation Monitoring
Radiation Protection
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2012-01-16
Enrollment: 505
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria:

* None

Primary outcomes:
measure: Radiation exposure of the operator
timeFrame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
Secondary outcomes:
measure: Radiation exposure of the patient
timeFrame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
Other outcomes:
Locations:
city: Dallas
country: United States
facility: VA North Texas Health Care System
state: Texas
Study officials:
affiliation: North Texas Veterans Healthcare System
name: Emmanouil S. Brilakis, MD, PhD
role: STUDY_CHAIR
affiliation: North Texas Veterans Healthcare System
name: Subhash Banerjee, MD
role: STUDY_DIRECTOR
References:
citation: Christopoulos G, Papayannis AC, Alomar M, Kotsia A, Michael TT, Rangan BV, Roesle M, Shorrock D, Makke L, Layne R, Grabarkewitz R, Haagen D, Maragkoudakis S, Mohammad A, Sarode K, Cipher DJ, Chambers CE, Banerjee S, Brilakis ES. Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study. Circ Cardiovasc Interv. 2014 Dec;7(6):744-50. doi: 10.1161/CIRCINTERVENTIONS.114.001974. Epub 2014 Nov 25.
Clinical trial NCT00185653: Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors For The Treatment Of Multiple Myeloma
Official title: Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors for the Treatment of Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.

Detailed description: The primary objective of the protocol is to evaluate the toxicity and tolerability of this mixed chimerism matched unrelated donor allogeneic transplant approach for patients with multiple myeloma. Response, toxicity, survival and graft-versus-host disease will be evaluated.

Eligibility criteria: Inclusion Criteria:a) Multiple myeloma which is responsive to therapy. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease. Patients who have relapsed following autologous transplantation may be eligible for this protocol.

b) Age \<= 60 years. c) No prior therapy which would preclude the use of low-dose total body irradiation.

d) Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or amyloidosis will be excluded from this study.

e) Patients must have a Karnofsky performance status \> 70%. f) DLCO \>= 60% predicted. g) ALT and AST must be \< 2X normal. Total bilirubin less than 2 mg/dl. h) Serum creatinine \< 2.0 or 24-hour creatinine clearance \>= 50 ml/min. i) Patients must be HIV negative. j) Pregnant or lactating women will not be eligible to participate. k) Patients must provide signed, informed consent. Exclusion Criteria:a) Severe psychological or medical illness b) Patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study.

c) Patients who have an HLA-identical sibling donor will be excluded

Primary outcomes:
measure: Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants.
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Robert Lowsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01843153: Continuous Versus Intermittent Sciatic Block for Total Knee Arthroplasty
Official title: Continuous Versus Intermittent Sciatic Block Combined With a Continuous Femoral Block for Patients Undergoing Total Knee Arthroplasty: a Prospective, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Total Knee Arthroplasty
Pain
Keywords: pain score
Lead sponsor: Kreiskrankenhaus Dormagen
Sponsor class: OTHER
First posted: 2013-04-30
Enrollment: 140
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: The role of a sciatic block in addition to a femoral block remains controversial. The study addresses this topic by comparing a continuous block versus an injection on demand.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for total knee arthroplasty

Exclusion Criteria:

* failure to establish femoral and sciatic block
* insufficient analgesic effect of the block
* patient declines to participate

Primary outcomes:
measure: pain score (VRS)
timeFrame: 4 days
Secondary outcomes:
measure: frequency of injections into the sciatic catheter
timeFrame: 4 days
Other outcomes:
Locations:
city: Dormagen
country: Germany
facility: KKH Dormagen
Study officials:
References:
citation: Soltesz S, Meiger D, Milles-Thieme S, Saxler G, Ziegeler S. Intermittent versus continuous sciatic block combined with femoral block for patients undergoing knee arthroplasty. A randomized controlled trial. Int Orthop. 2016 Sep;40(9):1861-7. doi: 10.1007/s00264-016-3117-3. Epub 2016 Jan 25.
Clinical trial NCT05978453: Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-22cm)
Official title: Blood Pressure Monitor#Model#BP7# Clincial Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Lead sponsor: Andon Health Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-08-07
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal blood pressure and hypertensive patients over 12 years old

Brief summary: The purpose of this study is to verify the accurancy of the blood pressure monitor device.

Cuff size of arm circumference: 13.5cm- 22cm.


Eligibility criteria: Inclusion Criteria:

* Normal blood pressure and hypertensive patients over 12 years old

Exclusion Criteria:

* Patients with serious arrhythmias or a high frequency of arrhythmias
* pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial

Primary outcomes:
measure: blood pressure monitor accurancy
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjin
Study officials:
References:
Clinical trial NCT04967053: Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study.
Official title: Outcomes of Sleeve Gastrectomy in Obese Patients, Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbid Obesity
Keywords: morbid obesity
sleeve gastrectomy
bariatric surgery
weight loss
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: both males and females, age from 18 to 65 yrs complain of obesity with body mass index ≥ 40 kg/m2 or body mass index ≥ 35 kg/m2 with comorbidities diseases.

Brief summary: This study will be a retrospective study in which we will review patients who underwent laparoscopic sleeve gastrectomy at Sohag University Hospital in the period from january 2017 to May 2018.Assessment of outcomes as Effects on weight, Effects on co-morbidities and Post operative complications.


Eligibility criteria: Inclusion Criteria:

* age from 18 to 65 years old
* body mass index ≥ 35 kg/m2 with comorbidities disease or body mass index ≥ 40 kg/m2, with failure of non operative attempts to lose weight
* a minimum 2-year follow-up at our outpatient clinic.

Exclusion Criteria:

* secondary causes of obesity (e.g. endocrine diseases)
* patients unable to participate in medical follow-up;
* associated comorbidities or diseases impacting on weight loss.

Primary outcomes:
measure: Effects on weight reported as percentage of excess weight loss
timeFrame: minimum 2-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT02006953: Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
Official title: Bolus Versus Continuous Feeding Regimens Post Gastrostomy Tube Placement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Enteral Nutrition
Enteral Feeding
Gastrostomy Tube
Keywords: gastrostomy
enteral
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
First posted: 2013-12-10
Enrollment: 97
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the best way to feed children after they have a gastrostomy tube placed. The study compares bolus feeding to continuous feeding.

Detailed description: This study will consist of a prospective, randomized comparison of bolus versus continuous enteral feeding protocols in pediatric patients with gastrostomy tubes

Eligibility criteria: Inclusion Criteria:

* Less than 18 years of age
* Admitted for gastrostomy tube placement, with or without Nissen Fundoplication

Exclusion Criteria:

* Immunocompromised patients
* Short Bowel Syndrome (SBS)

Primary outcomes:
measure: Rate of gastrostomy tube leakage
timeFrame: 8 weeks
Secondary outcomes:
measure: Emesis
timeFrame: 8 weeks
measure: Retching
timeFrame: 8 weeks
measure: Venting beyond recommendations
timeFrame: 8 weeks
measure: Feeding changes
timeFrame: 8 weeks
measure: Unscheduled clinic/ER visits/calls
timeFrame: 8 weeks
measure: G-tube infection
timeFrame: 8 weeks
measure: Weight
timeFrame: 8 weeks
measure: Time to goal feeds
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, CS Mott Children's Hospital
state: Michigan
city: Toledo
country: United States
facility: Mercy Children's Hospital
state: Ohio
Study officials:
affiliation: University of Michigan
name: Steven W Bruch, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332953: Sensory Perception of Sweet Flavors in E-Cigarette
Official title: Sensory Perception of Sweet Flavors in E-Cigarette
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Oregon State University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Despite the explosive popularity of sweet flavored electronic cigarettes, there is little empirical evidence regarding how "sweet" flavors interact with different levels of nicotine to reduce its perceived bitterness and harshness, and thereby increase its appeal and additive potential. This study will serve to fill this knowledge gap through empirical psychophysical data that will determine the association between sweet flavor and nicotine and its link to the acceptance and rejection of vaped nicotine.

Detailed description: We will recruit current, healthy e-cigarette users between the ages of 18-35.This study will require 1 visit to the Oregon State University campus to partake in a 1 hour (approximate) testing session. During the testing session, participants will be asked to puff commercial e-cigarettes containing 9 commercially available e-liquid preparations.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between 18-35 years of age; have been vaping for at least 1 month; currently use an e-cigarette that contains nicotine; have used an e-cigarette with medium (9-12 mg/mL) or high (18 to 36 mg/mL) nicotine strength at some point in their e-cigarette using history.

Exclusion Criteria:

* Do not have mouth or throat problems that would keep subject from vaping comfortably; do not have health problems that would keep subject from tasting or smelling normally; do not have any food ingredient allergies and have never had an allergic reaction to propylene glycol or vegetable glycerin; do not have any respiratory allergies (i.e., frequent sneezing, nasal congestion, nasal discharge); do not have a history of pulmonary disease or asthma; are not in the process of trying to quit vaping; are not pregnant, breast feeding, or trying to become pregnant.

Primary outcomes:
measure: Hedonic and Intensity Ratings
timeFrame: Until July 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Oregon State University
state: Oregon
Study officials:
affiliation: Oregon State University
name: Juyun Lim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01242553: Clinical Validation Study for iVue
Official title: Clinical Validation Study for iVue
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal and Ocular Pathology
Lead sponsor: Optovue
Sponsor class: INDUSTRY
First posted: 2010-11-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Volunteers with various ocular pathology or no ocular pathology.

Brief summary: To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.


Eligibility criteria: Inclusion Criteria:

* Normal: Normal results from clinical exam and free of ocular pathology.
* Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
* Cornea: Clinical exam results consistent with cornea pathology.
* Retina: Clinical exam results consistent with retina pathology

Primary outcomes:
measure: thickness of ocular structures
Secondary outcomes:
Other outcomes:
Locations:
city: Daly City
country: United States
facility: Pacific Eye Specialists
state: California
city: Denver
country: United States
facility: Colorado Retina Center
state: Colorado
Study officials:
affiliation: Pacific Eye Specialists
name: Michael Hee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado Retina Center
name: Nalin Mehta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Optovue
name: Michael Sinai, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04846153: Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images
Official title: Comparing Human and Computer-based Quantification of Airway Stenosis From Bronchoscopic Images
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Airway Obstruction
Keywords: Airway Stenosis
Stenosis Index Quantification
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-04-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Physicians enrolling the study are exclusively assigned to Human-based Quantification.
Primary purpose: OTHER

Brief summary: This is a pilot study to assess the utility of the automatic stenosis index quantification using 3D Slicer software (Computer-based Quantification). We will recruit three physicians to perform a similar analysis using video images of the same bronchoscopes images (Human-based Quantification). This study relates to the latter data collection.


Eligibility criteria: Inclusion Criteria:

* Physicians who are trained in bronchoscopy.
* Physicians who are willing and able to understand the scope of the study.

Exclusion Criteria:

* Physicians who are not trained in bronchoscopy.
* Physicians who are unwilling and unable to understand the study procedure
* Employees under the direct supervision of the investigators conducting the research

Primary outcomes:
measure: Stenosis index quantified [0-100%]
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: