louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00564304: NPD Measurement in Infants
Official title: Nasal Potential Difference Measurement in Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: Nasal Potential Difference
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children below age of 6 years who suspected for Cystic Fibrosis

Brief summary: Nasal Potential Difference measurements (NPD) have been performed in Israel since 1996. NPD measurements are used to assess the voltage across nasal epithelium, which correlates with the transport of sodium and chloride across cell membranes. NPD was first demonstrated to be abnormal in Cystic Fibrosis (CF) in 1981 and the technique has since been used to increase our understanding of this condition. It is now established as an important diagnostic tool and more recently has been used to assess the effectiveness of new treatments such as gene and alternative therapy (Knowles 1995; Wilschanski 2003).

The nasal cavity is accessible which makes it a good site to examine the ion transport characteristics of airway epithelia. Less than a centimetre into the nose the squamous ("skin type") epithelium becomes ciliated pseudocolumnar epithelium, characteristic of the proximal airways.

The change in NPD with the perfusion of different solutions is demonstrated. By employing NPD protocols with perfusion of different solutions and drugs, different aspects of the nasal ion transport characteristics can be examined. In CF, this ion transport profile is abnormal and the NPD measurement has a number of features that differentiate CF from non-CF. This methodology is well established for measurements in subjects over 6 years of age.

Measurements on smaller children and infants have been very difficult to perform. We propose a new method using smaller, single lumen catheters with much lower perfusion rates (0.2 ml/min compared to up to 5 ml/min with the adult method) .Perfusion measurements will be possible in newly born infants. Obviously this opens up the potential for using NPD as a diagnostic test in babies. This is important as the diagnosis of CF is often difficult to make or refute in babies because of the problems in collecting enough sweat. This may be the ideal diagnostic test for CF in the neonatal nursery in infants with meconium plug syndrome.


Eligibility criteria: Inclusion Criteria:

* Age below 6 years
* Patients who suspected for CF due to pulmonary and/or gastrointestinal symptoms

Exclusion Criteria:

* Age over 6 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Michael Wilschanski, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01690104: The Effect of PXR Activation on Blood Pressure Regulation
Official title: The Effect of PXR Activation on Blood Pressure Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blood Pressure Regulation
Keywords: rifampicin
pregnane X receptor
blood pressure
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
First posted: 2012-09-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: We are investigating the effects of pregnane X receptor (PXR) activation on the regulation of blood pressure in healthy volunteers. Rifampicin (an antibiotic and also an efficient PXR activator) and placebo will be given for a week to volunteers and blood pressure is measured 24 hours using an ambulatory blood pressure monitor. Blood pressure regulating hormones will be measured in blood. Our hypothesis is that PXR is involved in the regulation of blood pressure.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers
* BMI 19-30 kg/m2
* Age 18-40 years
* Systolic blood pressure 95 - 140 mmHg

Exclusion Criteria:

* Any continuous medication
* Any significant medical condition as judged by the study physician
* Diastolic blood pressure over 90 mmHg
* Sensitivity to rifampicin
* Pregnancy and lactation
* Difficult venipuncture
* Abuse of alcohol or medications, or drug use.
* Participation in other trial with medications in previous 30 days

Primary outcomes:
measure: Systolic ambulatory blood pressure
timeFrame: On day 8 of each arm
measure: Diastolic ambulatory blood pressure
timeFrame: On day 8 of each arm
Secondary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: On day 9 of each arm
measure: Pulse (ambulatory)
timeFrame: On day 8 of each arm
measure: Plasma renin activity
timeFrame: On day 9 of each arm
measure: Serum aldosterone
timeFrame: On day 9 of each arm
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Janne Hukkanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rahunen R, Kummu O, Koivukangas V, Hautajarvi H, Hakkola J, Rysa J, Hukkanen J. Pregnane X Receptor-4beta-Hydroxycholesterol Axis in the Regulation of Overweight- and Obesity-Induced Hypertension. J Am Heart Assoc. 2022 Mar 15;11(6):e023492. doi: 10.1161/JAHA.121.023492. Epub 2022 Mar 1.
Clinical trial NCT02597504: Development of a Neurocognitive Screening Test
Official title: Development of a Neurocognitive Screening Test
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Concussion
Mild Cognitive Impairment
Lead sponsor: ImPACT Applications, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 1600
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This research study will evaluate a standalone software application and is designed to standardize and validate new neurocognitive screening testing for children aged 6 through 11, and adolescents and adults ages 12 through 75.

The purpose of this study is to evaluate recently developed computerized tasks sensitive to changes in neurocognitive performance after a concussion. These tests were designed to help measure the effects of concussion on cognitive processes (e.g., memory, attention, brain speed) and visual functioning.


Eligibility criteria: Inclusion Criteria:

* Age: 12-75 (Adult version), 6-11 (pediatric version)
* Primary English speaking or fluent in English.
* No known special education diagnosis excluding a 504 designation.
* Currently not suffering from a concussion or being treated for a concussion.\*
* No known physical or psychological impairment that would affect their ability to perform the test.

Exclusion Criteria:

* Documentation of a known special education diagnosis other than a 504 designation.
* English is not their primary language nor are they proficient in the English language.
* Currently suffering from a concussion or being treated for a concussion.\*
* Any known physical or psychological impairment that would affect their ability to perform the test.

  * Note: Unless specifically required by the particular study (i.e., a discriminant validity study differentiating concussed versus non-concussed individuals).

Primary outcomes:
measure: Reliability will be established through a test-retest to establish results should be stable over time
timeFrame: 12 Months
measure: Validity established through correlation studies with well-known measures of memory and processing speed and ANOVA.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: FastMed Urgent Care
state: Arizona
city: Fayetteville
country: United States
facility: University of Arkansas
state: Arkansas
city: Crofton
country: United States
facility: Head First
state: Maryland
city: Pittsburgh
country: United States
facility: Jim Gyurke
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01248104: Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
Official title: Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Bypass
Keywords: Cardiac Surgery
Antifibrinolytic agents
Blood transfusion
epsilon aminocaproic acid
tranexamic acid
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-11-25
Enrollment: 100
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: We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.

Detailed description: Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.

Eligibility criteria: Inclusion Criteria:

1. Is the subject 18 years of age or older?
2. Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?
3. Is the subject more than 30 kg ( 66 lbs)?
4. Does subject understand English?

Exclusion Criteria:

1. Does the subject have existing coagulation defects (INR \> 1.5, platelets \< 100 ?
2. Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?
3. Does the subject have severe liver disease (AST \& ALT\> 3x normal) ?
4. Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?
5. Is the subject having any procedure where CPB is not anticipated?
6. Is the patient weight greater than 150 kg?

Primary outcomes:
measure: Total Transfusion Amounts
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
affiliation: Loma Linda University Medical Center
name: Jason Gatling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04334304: Evaluation of Standard and Robot Assisted Total Knee Arthroplasty with a Bicrucatie Retaining Prosthesis
Official title: Evaluation of Standard and Robot Assisted Total Knee Arthroplasty with a Bicrucatie Retaining Prosthesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Total Knee Arthroplasty
Robot
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 47
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: Posterior Stabilized TKA without robot Arm 2: Posterior Stabilized TKA with robot Arm 3: Bicruciate retaining TKA without robot Arm 4: Bicruciate retaining TKA with robot
Primary purpose: TREATMENT

Brief summary: The first study goal is to compare the outcomes between Posterior Stabilized and Bicruciate Retaining TKA. Additionally, the second goal is to evaluate the effect of robot assisted surgery in both Posterior Stabilized and Bicruciate Retaining TKA.


Eligibility criteria: Inclusion Criteria:

* End stage osteoarthritis of the knee joint with failed conservative treatment

Exclusion Criteria:

* Previous ligament trauma
* Previous fracture of femur or tibia
* Fixed flexion contracture \> 10°
* Flexion \< 110°
* Coronal deformity \> 15°
* Previous infection of the knee joint
* Ligament insufficiency
* Neurologic conditions

Primary outcomes:
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Patient reported outcome measures
timeFrame: Preoperative
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
measure: Change in patient reported outcome measures
timeFrame: Postoperatively at 6 weeks, 6 months, 1 year and 2 years.
Secondary outcomes:
measure: Alignment
timeFrame: Preoperative and postoperatively at 6 weeks and 6 months.
measure: Knee laxity
timeFrame: Preoperative and postoperatively at 1 year.
measure: Knee laxity
timeFrame: Preoperative and postoperatively at 1 year.
measure: Knee kinematics in 3D after squat, knee flexion/extension, stair ascend and descend.
timeFrame: Postoperatively at 1 year.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: UZ Ghent
name: Jan Victor, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03155204: Comparison of the Pharmacokinetics of Tiotropium Delivered From Test Inhaler Products With A Reference Product
Official title: Phase I Randomised, Five-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With Spiriva Respimat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: inhalation
LABA
corticosteroid
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2017-05-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the absorption of four different inhalation products with the reference product in healthy volunteers.

Detailed description: Healthy subjects will be enrolled and will receive single doses of 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.

Eligibility criteria: Inclusion Criteria:

* Healthy Volunteer
* Willing and able to give informed consent
* Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
* Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration

Exclusion Criteria:

* Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
* Any presence or history of a clinically significant allergy including any adverse reaction to study drug
* History of drug or alcohol abuse within the past 2 years
* Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
* Donation or loss of greater than 400 mL of blood within the previous 3 months
* Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
* Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
* Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
* If female, nursing, lactating or pregnant
* Regular alcohol consumption in males \>21 units per week and females \>14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 24 hr
Secondary outcomes:
measure: Adverse events
timeFrame: 24 hr
measure: Area Under the Plasma Concentration vs Time Curve (AUC)
timeFrame: 24 hr
Other outcomes:
Locations:
city: Loughborough
country: United Kingdom
facility: 3M Health Care
Study officials:
affiliation: 3M
name: Victoria Sessions, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05469204: Effect of Estrogen Treatment on Drug Metabolism and Transport
Official title: Effect of Gender-Affirming Estrogen Therapy on Drug Metabolism, Transport, and Gut Microbiota
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Transgender Persons
Keywords: hormone therapy
estrogen treatment
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2022-07-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This project will evaluate the effect of estrogen treatment on how other medications are processed by the body.

Detailed description: Estradiol is prepared as a medication that patients may take to increase hormone levels. Changes in estradiol concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how estradiol therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm estradiol treatment does not affect natural bacterial in the gut.

Eligibility criteria: Inclusion Criteria:

* Self-identified trans\* adult 18-55 years of age.
* Not taking estradiol treatment currently.
* Planning to start injectable estradiol or estradiol tablets for gender-affirming medical care.

Exclusion Criteria:

* Unwilling/unable to return for project follow-up visits.
* Unwilling/unable to provide written informed consent.

Primary outcomes:
measure: midazolam AUC ratio (treatment/control)
timeFrame: 0-6 hours
measure: digoxin renal clearance (treatment/control)
timeFrame: 0-48
Secondary outcomes:
measure: midazolam Cmax ratio (treatment/control)
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References:
Clinical trial NCT04260204: Effect of Retrograde Autologous Blood Priming on Pulmonary Mechanics in Pediatric Cardiac Surgery
Official title: Effect of Retrograde Autologous Blood Priming of Cardiopulmonary Bypass on Hemodynamic Parameters and Pulmonary Mechanics in Pediatric Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: retrograde autologous priming pulmonary mechanics
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 124
Sex: ALL
Minimum age (years): 12
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were included in the study if they had left to right shunt due to volume or pressure overload
Primary purpose: PREVENTION

Brief summary: The present study hypothesized that beyond its hemodynamic affects,retrograde autologus blood priming of cardiopulmonary bypass (RAP) has a positive impact on hemodynamics and pulmonary mechanics subjected to cardiac surgery.

Detailed description: This prospective randomized study analyzed the clinical records of 124 children subjected to cardiac surgery for congenital heart diseases with left to right shunt. They comprised 64 patients with RAP and 60 patients conventional cardiopulmonary bypass priming. The preoperative, intraoperative and postoperative data of the studied patients were reported.

Eligibility criteria: Inclusion Criteria:

* children complained of congenital heart disease with left to right shunt pressure or volume load

Exclusion Criteria:

* cyanotic heart disease

Primary outcomes:
measure: Comparison of postoperative peak air way pressure between the studied groups
timeFrame: 1 hour after surgery
measure: Comparison of postoperative air way resistance between the studied groups
timeFrame: 1 hour after surgery
measure: Comparison of postoperative Plateau pressure between the studied groups
timeFrame: 1 hour after surgery
measure: Comparison of postoperative Lung compliance between the studied groups
timeFrame: 1 hour after surgery
measure: Comparison of postoperative Tidal volume between the studied groups
timeFrame: 1 hour after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ain shams university faculty of medicine
name: Hamdy Singab, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04076904: Cesarean Niche Examination by Transvaginal us
Official title: Cesarean Niche Examination by us to Assess Its Integrity and Dehescence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section; Dehiscence
Lead sponsor: Aljazeera Hospital
Sponsor class: OTHER
First posted: 2019-09-04
Enrollment: 110
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: In 2015, WHO displayed and reveled a systematic review of the research studies in the scientific literature to evaluate and asses the linkage and connection between cesarean section rates and maternal,

Brief summary: The developed uterine scar developing due to cesarean section is usually clinically evaluated and visualized by transvaginal sonography (TVS) and saline infusion sonography (SIS) or Gel installation sonography (GIS)

Detailed description: In 2015, WHO displayed and reveled a systematic review of the research studies in the scientific literature to evaluate and asses the linkage and connection between cesarean section rates and maternal

Eligibility criteria: Inclusion Criteria:

- women with secondary infertility

Exclusion Criteria:

* obstructed labor, pregnant women having chronic diseases;

Primary outcomes:
measure: The number of women who will have dehesent scar
timeFrame: within a week
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Algazeerah and Kasralainy hospital
city: Giza
country: Egypt
facility: Algazeerah
Study officials:
affiliation: Algezeera hospitaland National Research Centre ,Egypt
name: Mahmoud Alalfy, PhD
role: STUDY_CHAIR
References:
citation: Alalfy M, Osman OM, Salama S, Lasheen Y, Soliman M, Fikry M, Ramadan M, Alaa D, Elshemy S, Abdella R. Evaluation of the Cesarean Scar Niche In Women With Secondary Infertility Undergoing ICSI Using 2D Sonohysterography Versus 3D Sonohysterography and Setting a Standard Criteria; Alalfy Simple Rules for Scar Assessment by Ultrasound To Prevent Health Problems for Women. Int J Womens Health. 2020 Nov 3;12:965-974. doi: 10.2147/IJWH.S267691. eCollection 2020.