louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01668147: Efavirenz and Ritonavir on Human Brain P-Glycoprotein
Official title: Influence of Efavirenz and Ritonavir on Human Brain P-Glycoprotein Activity Using PET Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Drug Effects
Keywords: PET Imaging
Efavirenz
Ritonavir
[11C] desmethyl-loperamide
Healthy volunteers
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: To determine the effects of ritonavir and efavirenz on the activity of P-glycoprotein in human brain.

Detailed description: Sequential crossover using tracer 11C-desmethylloperamide, a substrate for brain P-glycoprotein, and positron emission tomography (PET), administered after nothing (control), oral ritonavir (3d), and oral efavirenz (14d) with washout in between

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female, 18-40 yr old
* Good general health with no remarkable medical conditions
* BMI \< 33
* Provide informed consent

Exclusion Criteria:

* Known history of liver or kidney disease
* History of major medical conditions
* HIV seropositive
* Fasting blood glucose \> 110 mg/dl
* Family history of type 2 diabetes
* Use of prescription or non prescription medications, herbals or foods known to be metabolized by or altering P-glycoprotein or CYP3A activity (hormonal birth control medications are acceptable if alternative means of contraception are used)
* Females who are pregnant or nursing
* Females taking hormonal contraceptives who are unwilling to use alternative means of contraception
* Contraindications to MRI
* Contraindications to PET scanning

Primary outcomes:
measure: Cerebral [11C]dLop Distribution Volume
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Evan Kharasch, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01314547: Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort
Official title: Impact of Environmental Factors on Disease Activity in Spondyloarthritis (SPA): Results of the Prospective Co-Env Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylarthritis
Primary Systemic Vasculitis
Keywords: Environment
spondylarthritis
vasculitis
stress
life event
vaccine
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with SPA disease

Brief summary: Susceptibility to SPA has been shown to be largely genetically determined. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

Detailed description: Susceptibility to SPA has been shown to be largely genetically determined but the contribution of environmental factors to disease evolution has not yet been elucidated. The objective of this study was to prospectively investigate the impact of several environmental factors on disease activity.

Eligibility criteria: Inclusion Criteria:

* 18 years SPONDILARTHRITIS: modified New York criteria Systemic vasculitis: ACR criteria

Exclusion Criteria:

no internet access

Primary outcomes:
measure: Score on a disease activity rating scale
timeFrame: Six years
Secondary outcomes:
measure: Ancillary studies will be possible with the available database
timeFrame: six years
Other outcomes:
Locations:
city: Boulogne
country: France
facility: hopital ambroise Pare
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: THOMAS HANSLIK, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06159647: Consumer Responses to Alcohol Warnings
Official title: Consumer Responses to Alcohol Warnings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 2522
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The primary objective is to evaluate whether alcohol warnings about different topics elicit higher perceived message effectiveness than control messages. The secondary objective is to evaluate whether alcohol warnings about different topics elicit higher reactance than control messages.

Detailed description: Participants will complete a within-subjects online randomized experiment in which they will view and rate messages on the risk of alcohol consumption. Participants will view and rate 12 messages total: 10 warning messages and 2 control messages. They will rate each message on perceived message effectiveness (primary outcome) and message reactance (secondary outcome). The 10 warning messages will be about 5 different warning topics (i.e., 2 messages per topic) and the 2 control messages will be about 1 control topic (2 messages per topic). In this within-subjects experiment, the survey will present the topics in random order and the messages within each topic in random order.

Eligibility criteria: Inclusion Criteria:

* Age 21 and older
* Reside in the United States
* Able to complete a survey in English

Exclusion Criteria:

* Under 21 years of age
* Reside outside the United States
* Unable to complete a survey in English

Primary outcomes:
measure: Perceived message effectiveness
timeFrame: The survey will take up to 20 minutes.
Secondary outcomes:
measure: Reactance
timeFrame: The survey will take up to 20 minutes.
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Online study
state: California
Study officials:
affiliation: Assistant Professor
name: Anna Grummon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01083147: Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment
Official title: Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Keywords: Intermediate AMD
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2010-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: intermediate AMD

Brief summary: The purpose of this study is to evaluate the compliance of the Foresee Home device in intermediate AMD patients.

Detailed description: This is a non-randomized cohort, multi-center study. The eligible subjects will be asked to use the FORESEE HOME device daily and the tests results will be automatically transmitted to the Data Monitor Center for analysis.

Eligibility criteria: Inclusion Criteria:

* Subjects who successfully completed participation in ForeseeHome-US2 study
* Patients with ability to comprehend and sign the informed consent/authorization

Exclusion Criteria:

* Subjects who failed to complete participation in ForeseeHome-US2 study

Primary outcomes:
measure: Subject compliance with Foresee HomeTM device
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of the Telemedicine infrastructure
timeFrame: 6 months
Other outcomes:
Locations:
city: Tom's river
country: United States
facility: Vitreos retina center
state: New Jersey
Study officials:
affiliation: Vitreos retina center - NJ
name: Daniel Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00765947: Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
Official title: A Twenty-four Week, Open-label, Non-comparative, Multi-center Study to Assess the Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Essential Hypertension ( Mild to Moderate)
Keywords: Essential Hypertension ( mild to moderate)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 256
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 study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure \[msSBP\] ≥ 140 mmHg and \< 180 mmHg and/or mean sitting Diastolic Blood Pressure \[msDBP\] ≥ 90 and \<110 mmHg).


Eligibility criteria: Inclusion Criteria:

* Outpatients ≥ 18 years of age
* Patients with a diagnosis of mild to moderate hypertension at Visit 1
* All patients must have a msSBP ≥ 140 mmHg and \< 180 mmHg and/or msDBP ≥ 90 mmHg and \< 110 mmHg mmHg at Visit 3

Exclusion Criteria:

* Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg
* Secondary form of hypertension
* Current diagnosis of heart failure (NYHA Class II-IV)
* Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates)
* Second or third degree heart block without a pacemaker
* Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.
timeFrame: 24 weeks
measure: Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP]
timeFrame: Baseline and Week 24
measure: Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP]
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Investigative Site
city: Budapest
country: Hungary
facility: Investigative Site
city: Bucharest
country: Romania
facility: Investigative Site
city: Bratislava
country: Slovakia
facility: Investigative Site
Study officials:
References:
Clinical trial NCT03443947: Modified Mallampati Scoring Technique for Airway Assessment
Official title: Modified Mallampati Scoring Technique for Airway Assessment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intubation;Difficult
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: comparing a new technique for airway assessment using tongue depressor versus conventional mallampati scoring system. Using tongue depressor to improve airway score is suggested to increase reliability of airway assessment model


Eligibility criteria: Inclusion Criteria:

* all patients scheduled for elective surgery

Exclusion Criteria:

* known difficult airway trismus cases maxillofacial anomalies

Primary outcomes:
measure: assessment of airway difficulty
timeFrame: before intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Al Manşūrah
country: Egypt
facility: Mansoura university
state: Dkahleya
city: Mansourah
country: Egypt
facility: Gastroenterology center
Study officials:
References:
Clinical trial NCT04337047: Distress in Crisis Situations During COVID-19
Official title: Distress During the COVID-19 Pandemic in France: a National Assessment of At-risk Populations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stress, Psychological
Lead sponsor: Wefight
Sponsor class: INDUSTRY
First posted: 2020-04-07
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Vik's users in France

Brief summary: There are many scales for screening or assessing the impact of a disease. These scales are generally used to diagnose or assess the severity of a disease and are carried out at the request of a physician by the patient. Conversational agents could make it possible to administer these questionnaires remotely, analyse them and use the results on a large scale, without prior medical intervention.

The main objective of this study is to quantify and qualify the distress of a large population in times of pandemic crisis.

Detailed description: The Peritraumatic Distress Inventory is the standard tool designed to assess distress in times of crisis. It consists of 13 questions.

Questions will be submitted to the participants from the Vik chatbot. Responses will be analysed and compared according to the demographics and pathologies encountered.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old

  * Collection of the subject's non-opposition
  * Patient registration on Vik breast, Vik asthma, Vik migraine, Vik depression

Exclusion Criteria:

* Patient unable to formulate non-opposition

Primary outcomes:
measure: quantify and qualify distress over a large population in times of pandemic crisis.
timeFrame: 1 month
Secondary outcomes:
measure: qualify demographic data vs distress over a large population in times of pandemic crisis.
timeFrame: 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Wefight
Study officials:
References:
citation: Chaix B, Delamon G, Guillemasse A, Brouard B, Bibault JE. Psychological distress during the COVID-19 pandemic in France: a national assessment of at-risk populations. Gen Psychiatr. 2020 Nov 26;33(6):e100349. doi: 10.1136/gpsych-2020-100349. eCollection 2020.
Clinical trial NCT04080947: The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis
Official title: The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Steatohepatitis, Nonalcoholic
Lead sponsor: Sadat City University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to evaluate the safety and efficay of Montelukast in treatment of patients with fatty liver disease.


Eligibility criteria: Inclusion Criteria:

- The inclusion criteria were adult patients (age \>18 years old) of both sexes, overweight/obese subjects with presence of evidence of hepatic steatosis by imaging (increased liver echogenicity, stronger echoes in the hepatic parenchyma, vessel blurring, and narrowing of the lumen of the hepatic veins). Patients with mild to moderate elevation in aminotransferase activities (\> 2 but \<5 times upper limit of normal), hepatic steatosis index (HIS) \>36, Fibro-scan score \>7 kpa and \<12.5 kpa (F0-F3), and HAIR score of 2 or 3 were included in the study.

Exclusion Criteria:

- The exclusion criteria included smokers, patients with secondary hepatic fat accumulation which results from using steatogenic medications or hereditary disorders. Alcohol consumers, patients with Wilson's disease, hemochromatosis, viral hepatitis, decompensated liver disease, inflammatory diseases, diabetes, depression and patients with other comorbid conditions that elevate transaminases (congestive heart failure and malignancy) pregnancy and lactating women were excluded

Primary outcomes:
measure: Fibro-scan score
timeFrame: At baseline and after 12 weeks of intervention
measure: Liver Panel
timeFrame: after 12 weeks of intervention
Secondary outcomes:
measure: HOMA-IR
timeFrame: after 12 weeks of intervention
measure: 8-OHdG
timeFrame: after 12 weeks of intervention
measure: TNF-Alpha
timeFrame: after 12 weeks of intervention
measure: hyaluronic acid
timeFrame: after 12 weeks of intervention
measure: TGF-β1
timeFrame: after 12 weeks of intervention
measure: Assessment of drugs tolerability: Side effects
timeFrame: after 12 weeks of intervention
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine
state: Menoufia
Study officials:
References:
citation: Abdallah MS, Eldeen AH, Tantawy SS, Mostafa TM. The leukotriene receptor antagonist montelukast in the treatment of non-alcoholic steatohepatitis: A proof-of-concept, randomized, double-blind, placebo-controlled trial. Eur J Pharmacol. 2021 Sep 5;906:174295. doi: 10.1016/j.ejphar.2021.174295. Epub 2021 Jun 30.
Clinical trial NCT00638547: Intrathecal Enzyme Replacement for Hurler Syndrome
Official title: Intrathecal Enzyme Replacement Therapy For Patients With Mucopolysaccharidosis Type I (Hurler Syndrome)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hurler Syndrome
Keywords: Hurler Syndrome
mucopolysaccharidosis type I
Iduronidase deficiency
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 26
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol will examine whether the enzyme alpha-L-iduronidase (Laronidase), delivered into the spinal fluid of patients with Hurler syndrome at intervals before and after bone marrow transplant, is a safe and effective approach to slow the neurologic degeneration seen in Hurler patients undergoing transplantation.

Detailed description: Subjects will receive an infusion of Laronidase into his/her spinal fluid approximately 12 weeks before, 2 weeks before, 100 days after and 6 months after transplant. This procedure is done by lumbar puncture (also called a "spinal tap").

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of MPS IH (Hurler syndrome) are candidates for this protocol if they are being considered for hematopoietic stem cell transplantation according the University of Minnesota guidelines.

Exclusion Criteria:

* Patients are less than 6 months old, or older than 3 years of age.
* There is a history of clinically-severe hypersensitivity to Laronidase.
* There is a contraindication for repeated lumbar puncture.
* The family is not willing to undergo the necessary procedures and evaluations inherent in the study.
* Consent has not been signed for participation in the 2004-09 study of intravenous Laronidase administration.

Primary outcomes:
measure: To demonstrate the efficacy of intrathecally delivering alpha-L-iduronidase in patients with mucopolysaccharidosis type I in decreasing neurodevelopmental deterioration
timeFrame: 1 year
Secondary outcomes:
measure: To determine the safety and toxicity of intrathecally delivering alpha-L-iduronidase in patients with mucopolysaccharidosis type I
timeFrame: 1 year
measure: To determine brain changes with magnetic resonance imaging
timeFrame: 1 and 2 years
measure: To determine neurocognitive changes present in patients with Hurler syndrome
timeFrame: 6, 12, and 24 months
measure: To determine cerebral spinal fluid levels of glycosaminoglycans, cytokines and antibodies to Laronidase at baseline and at each point CSF is obtained
timeFrame: through 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Fairview
state: Minnesota
Study officials:
affiliation: University of Minnesota Medical Center
name: Paul Orchard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03319147: Effect of Amino Acid on Muscle Damage
Official title: Effect of Leucine-enriched Essential Amino Acid on Integrated Muscle Protein Synthesis and Muscle Recovery After Resistance Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: exercise
recovery
muscle
protein
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2017-10-24
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to determine the impact of essential amino acids on integrated muscle protein synthesis over 4 days after resistance exercise.

In addition, the secondary objective is to determine the effect of essential amino acids on satellite cell regulation and inflammatory responses during this prolonged recovery period.


Eligibility criteria: Inclusion Criteria:

* Healthy, male, recreationally-active participants
* Healthy will be defined as screened by the PAR-Q+ (The Physical Activity Readiness Questionnaire for everyone; Appendix. B). Active will be defined as being in the top 20% of age specific scores on iPAQ (the International Physical Activity Questionnaire; Appendix.C).
* Participants are required not to engage in lower limb RT (resistance training) for at least 6 months prior to the study.
* Participants will be 18-35 years old.
* Participants are willing to abide by the compliance rules of this study

Exclusion Criteria:

* Female
* Inability to adhere to any of the compliance rules judged by principle investigator or medical doctor
* Self-reported regular tobacco use
* Self-reported illicit drug use (e.g. growth hormone, testosterone, etc.)
* The individual who has allergy for milk

Primary outcomes:
measure: Muscle protein synthesis
timeFrame: 4 hours
Secondary outcomes:
measure: exercise performance
timeFrame: 4 days
measure: Muscle soreness
timeFrame: 4 days
measure: Muscle damage
timeFrame: 4 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Goldring Centre for High Performance Sport
state: Ontario
Study officials:
References: