louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00963027: Effect of Esomeprazole on the Pharmacokinetics of Oral Treprostinil
Official title: An Evaluation of Single Dose UT-15C SR (Treprostinil Diethanolamine) Pharmacokinetics Following Repeated Dosing With the Proton Pump Inhibitor Esomeprazole in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Keywords: Hypertension, Pulmonary
Treprostinil
Pharmacokinetics
Treprostinil Diethanolamine
Pulmonary Arterial Hypertension
Esomeprazole
Lead sponsor: United Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-08-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics.

Detailed description: This open-label study will evaluate the effect of esomeprazole, a proton pump inhibitor, on treprostinil pharmacokinetics following a single 1 mg oral dose of UT-15C SR in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Subject is healthy and between the ages of 18 and 55 years, inclusive, at Screening.
* Female subjects must weigh between 45 and 100 kg, inclusive, with a BMI between 19.0-29.9 kg/m2, inclusive at Screening. Male subjects must weigh between 50 and 120 kg, inclusive, with a BMI between 19.0-32.0 kg/m2, inclusive at Screening.
* Subject has a medical history, physical examination, vital signs, ECG and clinical laboratory results within normal limits or considered not clinically significant by the Investigator at Screening.

Exclusion Criteria:

* Subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ECG, or laboratory examinations.
* Subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug.
* Subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary, and/or musculoskeletal disease; glaucoma; a psychiatric disorder, or any other chronic disease, whether controlled by medication or not.

Primary outcomes:
measure: Treprostinil pharmacokinetics in healthy volunteers following a single oral dose of a 1 mg treprostinil diethanolamine sustained release tablet before and after repeated dosing with esomeprazole.
timeFrame: Within 10 minutes prior to through 36 hours post treprostinil diethanolamine dosing
measure: Adverse event monitoring
timeFrame: Time Frame: From the first dose of treprostinil diethanolamine through study end (Study Day 9/10)
Secondary outcomes:
measure: Clinical laboratories
timeFrame: Study Days 0 and 9
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development
state: Texas
Study officials:
affiliation: PPD Development, LP
name: Aziz Laurent, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06861127: Role of MRI in Diagnosis of Postpartum Neurological Disorders
Official title: Role of MRI in Diagnosis of Postpartum Neurological Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Role of MRI in Diagnosis of Postpartum Neurological Disorders
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50

Brief summary: Role of MRI in diagnosis of postpartum neurological disorders


Eligibility criteria: Inclusion Criteria:

1. Female gender.
2. Age more than 18 years old.
3. Patients presented with neurological complaint in 3 months following childbirth.

Exclusion Criteria:

1. Male gender.
2. Female younger than 18 years old
3. Contraindication to perform MRI examination. These include:- Cardiac pacemaker.- Metallic aneurysm clips.

Primary outcomes:
measure: Distribution of MRI Abnormalities in Postpartum Neurological Cases
timeFrame: 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT00935727: Elastographic Imaging of Renal Transplants
Official title: Pilot Study to Define Parameters of Elastography Compared to Color Flow Doppler Ultrasound in Renal Transplants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Renal Transplant
Keywords: renal transplant
ultrasound
elastography
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Hospital
First posted: 2009-07-09
Enrollment: 10
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: The study was developed to acquire images of normal, then abnormal, then unknown diagnosis for transplanted kidneys in order to determine whether the elastography imaging modality, a type of ultrasound imaging, can provide data useful for diagnosis of renal transplant abnormalities.

The specific aims of this study are:

1. To define normal elastography imaging by correlation with clinical findings.
2. To define specific abnormal elastography images by correlation with clinical findings.
3. To determine whether elastography could be useful in early diagnosis of abnormalities of renal transplants, especially in early rejection.

Detailed description: The study is collecting standard ultrasound and elastographic images of transplanted kidneys in order to perfect the imaging technique to get the best pictures, and to evaluate these images for characteristics that may be of diagnostic value.

Eligibility criteria: Inclusion Criteria:

* Adult (over 18) male or female renal transplant patient
* normally functioning
* or being evaluated for a possible problem

Exclusion Criteria:

* unwilling or unable to give informed consent

Primary outcomes:
measure: Identification of features of a set of elastography images that can be characterized as those of a normally functioning transplanted kidney, or those of specific abnormalities
timeFrame: after up to 50 "normal" images are collected
Secondary outcomes:
measure: Assessment of the value of renal transplant imaging by elastography compared to standard ultrasound
timeFrame: by the time up to 100 images are obtained
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Alan M Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Jonathan Ophir, PhD
role: STUDY_DIRECTOR
References:
citation: Weitzel WF, Kim K, Rubin JM, Xie H, O'Donnell M. Renal advances in ultrasound elasticity imaging: measuring the compliance of arteries and kidneys in end-stage renal disease. Blood Purif. 2005;23(1):10-7. doi: 10.1159/000082005.
Clinical trial NCT03560427: Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine
Official title: Duloxetine Potentiates the Analgesic Efficacy of Intrathecal Morphine in Major Abdominal Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-06-18
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. Duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. There are few studies examining its effect for acute pain. The objective of this study is to evaluate the analgesic effect of duloxetine combined with intrathecal morphine for patients subjected to major abdominal cancer surgery


Eligibility criteria: Inclusion Criteria:

* adult patients, subjected to major abdominal cancer surgery

Exclusion Criteria:

* patients on chronic opioid therapy
* patients allergic to study drugs (duloxetine+morphine)
* patients have uncontrolled hypertension and or ischemic heart disease

Primary outcomes:
measure: time to first analgesic request
timeFrame: 48 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Diab
state: Assuit
Study officials:
affiliation: Lectuere of anesthesia and pain management
name: Diab Hetta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01031927: N-methyl Glycine (Sarcosine) for the Treatment of Obsessive Compulsive Disorder (OCD)
Official title: Sarcosine as Primary or Adjunctive Therapy in Obsessive Compulsive Disorder: A Prospective, Open-label Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive Compulsive Disorder
Keywords: obsessive compulsive disorder
sarcosine
glycine transporter I
NMDA receptor
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Taipei City Hospital
First posted: 2009-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Several lines of evidence implicate glutamatergic dysfunction in the pathophysiology of obsessive compulsive disorder (OCD). Sarcosine, also known as N-methylglycine, is an endogenous antagonist of glycine transporter-I (GlyT-I), which potentiates glycine's action at the glycine site of N-methyl-D-aspartate (NMDA) receptors. In this 10-week open-label trial, we examined the efficacy and safety of sarcosine treatment in OCD patients.


Eligibility criteria: Inclusion Criteria:

* a primary OCD according to DSM-IV
* at least 1 year's duration of OC symptoms and a minimum severity score of ≥16 on Yale-Brown Obsessive Compulsive Scale
* drug naïve at study entry or
* being free from psychotropic medication for at least 8 weeks at study entry,or
* inadequately responded to ongoing psychotropic medications at study entry (defined by a Y-BOCS score of ≧16 despite treatment with maximum tolerated dose of a SRI medication for at least 8 weeks)

Exclusion Criteria:

* patients with moderate to severe depression defined by a 21-item Hamilton Depression Rating Scale score of \>17,
* a history of bipolar disorder, schizophrenia, schizoaffective disorder, or other psychosis as defined by DSM-IV, or if they were at significant risk of suicide, and
* with clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, metabolic, or renal disease

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale
timeFrame: week0, 2, 4, 6, 8, and 10
Secondary outcomes:
measure: Hamilton Anxiety Rating scale
timeFrame: week0, 2, 4, 6, 8, and 10
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: Department of Psychiatry, Harbor-UCLA Medical Center, California, U.S.A
name: Guochuan E Tsai, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01353027: Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus
Official title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6002 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ebola Hemorrhagic Fever
Lead sponsor: Sarepta Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2011-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.

Detailed description: Ebola hemorrhagic fever (EHF) is a rare human disease caused by Ebola Virus (EBOV), a filamentous single-stranded, negative-sense RNA virus. Since 1976 several Ebolavirus outbreaks have occurred with fatality rates ranging from 57% to 90%, with most of these outbreaks traced to single EBOV species; EBOV-Z. No effective therapy is currently available for Ebolavirus.

AVI-6002 is an experimental combination of 2 phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically target viral messenger RNA encoding 2 Ebolavirus proteins thought to be important in viral replication and host immune suppression. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-6002 in healthy human subjects.

Eligibility criteria: Inclusion Criteria:

* Male or female and between the ages of 18 and 50 years in good general health
* Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
* Volunteers must be willing to undergo a urine screen for drugs of abuse

Exclusion Criteria:

* Pregnancy or breastfeeding.
* Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
* Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 28 Days
Secondary outcomes:
measure: Drug concentration in plasma
timeFrame: 28 days
measure: Drug concentration in urine
timeFrame: 28 days
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research - Knoxville
state: Tennessee
Study officials:
affiliation: New Orleans Center for Clinical Research-Knoxville
name: William B Smith, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarepta Therapeutics, Inc.
name: Alison Heald, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05864027: Oral Health Recovery Group
Official title: Oral Health Recovery: A Peer-Delivered Oral Health Intervention for Individuals With Psychiatric Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Health
Dental Care
Psychiatric Diagnosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2023-05-18
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the study is to test a brief, peer-led group-based oral health educational intervention - called the "Oral Health Recovery Group" - designed for individuals with psychiatric disabilities.

Detailed description: Participants at each site will obtain either: a) a Peer-led Oral Health Recovery educational group, representing the primary intervention; or b) viewing of an educational video about oral health, representing the comparison intervention. After participating in either condition, an onsite Peer staff member will offer to help the participant make a dentist appointment. They will follow up with the participant as needed for a two-month period to help arrange dental care and follow up on any dental self-care goals established by the participant, such as purchasing toothpaste with fluoride.

Eligibility criteria: Inclusion Criteria:

* An adult member/consumer with the selected site (JIMHO or Washtenaw CMH)
* Ability to understand and willingness to read a consent terms handout and discussion
* Participant must understand/read/speak English

Exclusion Criteria:

* Not a member/consumer with the site
* Not able to understand and/or not willing to read consent terms handout
* Does not understand/read/speak English

Primary outcomes:
measure: Average subject-level change between pre- and post-surveys
timeFrame: 2 months
Secondary outcomes:
measure: Odds ratio of participants who reported seeking dental care
timeFrame: 2 months
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Justice in Mental Health Organization (JIMHO)
state: Michigan
city: Ypsilanti
country: United States
facility: Community Mental Health (Towner)
state: Michigan
Study officials:
affiliation: University of Michigan Medical School, Psychiatry
name: Adrienne Lapidos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06094127: Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
Official title: A Post-market Clinical Follow up Study on Cook Medical Zenith® Alpha Thoracic Endovascular Grafts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thoracic Aortic Aneurysm
Penetrating Aortic Ulcer
Keywords: Aneurysm
Thoracic
Descending
Aorta
Stent-graft
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a (ZTA) since January 2019through 1 year follow-up from index placement procedure.

Brief summary: This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft \[ZTA\]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.

Detailed description: Per local regulations, this study includes both retrospective and prospective patients. Patients can be included retrospectively if they are treated with the study device from 01 January 2019 until the study site is eligible for prospective enrollment.

Eligibility criteria: Inclusion Criteria:

* Patient has been treated/was intended to be treated with ZTA according to the clinical practice from Jan 2019 until site initiation
* The patient is willing to participate in the study and provide written informed consent for study participation or express non-objection or give written consent per local requirements prior to data collection of any data from medical records.

Exclusion Criteria:

* A patient treated with a custom-made fenestrated and/or branched endovascular graft in conjunction with ZTA either during the same procedure or in a staged procedure.
* A patient whose follow-up data collection is not possible (e.g. due to living abroad).

Primary outcomes:
measure: Freedom from aneurysm-related mortality
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Le Plessis-Robinson
country: France
facility: Hopital Marie Lannelongue Groupe Hospitalier Pairs St Joseph
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: München
country: Germany
facility: Universitätsklinikum der LMU München
city: Münster
country: Germany
facility: St. Franzikus Hospital Munster
city: Bologna
country: Italy
facility: IRCCS-University Hospital Sant'Orsolo Polyclinic
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud UMC
Study officials:
affiliation: Klinikum der Universitat Munchen
name: Nikolaos Tsilimparis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00695227: Screening for Barrett's Esophagus in Otolaryngology Patients
Official title: Screening for Barrett's Esophagus in Otolaryngology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extraesophageal Symptoms
Cough
Throat Clearing
Hoarseness
Difficulty Swallowing
Keywords: laryngopharyngeal reflux
extraesophageal reflux symptoms
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: Oregon Health and Science University
First posted: 2008-06-11
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to develop an accurate method to identify patients that suffer from acid reflux, but may not present with classic reflux symptoms (such as heart burn). Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR. Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed up through the esophagus and may affect the vocal cords and upper respiratory tract.

It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus similar to that found in a population with typical reflux symptoms. We propose to systematically test this hypothesis using the USE.

This project is designed to improve the methods of identifying patients with a form of acid reflux that is often undetected, and thus untreated. If this project is successful then more patients with Barrett's esophagus will be identified; furthermore, screening and treatment for this pre-cancerous condition will be improved.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* Prior anti-reflux surgery, laryngeal surgery, trauma to larynx Esophageal diverticulum Pregnancy Anticoagulation therapy Esophageal varices ENT malignancy History of recurrent epistaxis

Primary outcomes:
measure: The primary aim of the study is to establish that patients with symptoms of LPR who are referred to an otolaryngology clinic have a prevalence of Barrett's metaplasia equivalent to that of a population with GERD symptoms.
timeFrame: One time
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Joshua Schindler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nason KS, Murphy T, Schindler J, Schipper PH, Hoppo T, Diggs BS, Sauer DA, Shaheen NJ, Morris CD, Jobe BA; Barrett's Esophagus Risk Consortium (BERC). A cross-sectional analysis of the prevalence of Barrett esophagus in otolaryngology patients with laryngeal symptoms. J Clin Gastroenterol. 2013 Oct;47(9):762-8. doi: 10.1097/MCG.0b013e318293d522.