louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03260790: Pneumococcal Vaccines in Patients With Asthma
Official title: Immunogenicity of PPSV-23 After PCV-13 Vaccination in Adult Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Vaccine
Pneumococcal
Pneumonia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-08-24
Enrollment: 17
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigators are assessing if patients with asthma respond better to the Pneumovax vaccine if they are given Prevnar initially.

Detailed description: Patients will be randomized into either PCV13 and PPSV23 (Experimental) or PPSV23 alone (Active comparator). At the Week 0 time point, the patients will receive either PCV13 (Experimental) or PPSV23 (Active comparator) and undergo a blood draw of 5ml for assessment of pre-vacation serotype titers. The Active Comparator group will undergo a 5ml draw of blood for assessment of titers at week 8, 16, and 24 following vaccination. The Experimental group will undergo vaccination with PPSV23 at week 8 with 5 ml blood draw for pneumococcal serotype titers as well as a blood draw at week 16 and week 24.

Eligibility criteria: Inclusion Criteria:

- Diagnosis of asthma

Exclusion Criteria:

* Research exemption requested
* History of PCV-13 vaccination
* History of cochlear implant
* Cerebrospinal Fluid (CSF) leak
* Congestive Heart Failure (CHF)
* Diabetes Mellitus (DM)
* Chronic Kidney Disease (CKD)
* Human Immunodeficiency Virus (HIV)
* Common Variable Immune Deficiency (CVID)
* Patients who have received the PPSV23 vaccine in the last 5 years
* Women who are pregnant will also be excluded from the study by performing 2 point of care urine pregnancy tests ( prior to vaccinations)

Primary outcomes:
measure: Total Anti-pneumococcal IgG Levels at Baseline, Week 0, Week 8 and Week 16
timeFrame: Baseline, week 0, week 8, week 16
measure: Sum of Anti-pneumococcal IgG to All Serotypes at Baseline, Week 0, Week 8 and Week 16
timeFrame: Baseline, week 0, week 8, week 16
measure: Sum of Anti-pneumococcal IgG to Serotypes Common to PCV13 and PPSV23 at Baseline, Week 0, Week 8, Week 16
timeFrame: Baseline, week 0, week 8, week 16
measure: Sum of Anti-pneumococcal IgG to Serotypes Unique to PPSV23 at Baseline, Week 0, Week 8 and Week 16.
timeFrame: Baseline, week 0, week 8, week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Avni Y Joshi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03081390: Migraine and CVD Risk in Women
Official title: Mechanisms of Increased Cardiovascular Disease Risk in Women With Migraine
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Migraine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2017-03-16
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are four total groups of participants, stratified according to migraine status (yes/no) and obesity status (yes/no). All undergo the same experimental phenotyping procedures.
Primary purpose: OTHER

Brief summary: The primary goal of this study is to test the effects of a high-fat, high-carbohydrate mixed meal on candidate modulators of cardiovascular disease risk (inflammation, vascular reactivity, sympathetic nervous system tone, and response to pain) in young adult women with migraine compared with healthy young women. This is study enrolling both cases (women with migraine) and controls (women without migraine), with equal numbers of normal weight and obese women in each group. Participants will undergo a telephone screening and a single day in-person study visit.


Eligibility criteria: Inclusion Criteria (all):

* Female 18-35 years of age, inclusive
* BMI 18.5-24.9 kg/m2, inclusive
* BMI ≥30 kg/m2

Inclusion Criteria (cases only):

* Diagnosis of migraine per ICHD-3-beta (1-10 migraine days per month)

Exclusion Criteria (all):

* Smoking (current or former)
* Chronic use of medications, including oral contraceptives
* Major medical or psychiatry illness (e.g. diabetes, fibromyalgia, major depression/anxiety)
* Pregnant or nursing
* Allergies or sensitivity to any of the ingredients of the meal
* Inability to fast for 10 hours and/or abstain from caffeine intake for 24 hours
* Treatment with antibiotics or steroids within the previous 3 months
* Treatment with NSAIDs within the previous 1 week

Exclusion Criteria (controls only):

* Migraine headaches, or headaches other than tension-type headaches with a frequency of 1 or fewer days per month

Primary outcomes:
measure: LPS area under the curve (AUC)
timeFrame: LPS is measured at baseline every 30 minutes for 4 hours.
Secondary outcomes:
measure: Flow-mediated dilation (FMD)
timeFrame: FMD is measured at baseline and 2.5 hours after MMTT.
measure: Sympathetic tone at rest and with painful stimulus
timeFrame: Sympathetic tone at rest and with painful stimulus are measured at baseline and 3 hours after MMTT.
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Shana E McCormack, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01395290: Vitamin D and Staphylococcus Aureus in the Diabetes Study
Official title: Vitamin D and Staphylococcus Aureus in the Diabetes Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection
Keywords: staphylococcus aureus
vitamin D
Lead sponsor: University of Tromso
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 280
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are indications that the vitamin D status of an individual is related to susceptibility to staphylococcal infections. In the present study we will examine nasal colonisation rate in subjects participating in an ongoing vitamin D intervention study ( 20.000 IU cholecalciferol per week vs placebo) for the prevention of type 2 diabetes in subjects with impaired glucose tolerance.


Eligibility criteria: Inclusion Criteria:

* participant in an ongoing intervention study with vitamin D

Exclusion Criteria:

* none specifically for this study

Primary outcomes:
measure: nasal staphylococcus colonisation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
affiliation: University of Tromso
name: Rolf Jorde, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01284790: Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures
Official title: Pitch and Loudness Perception by Cochlear Implant Listeners: Psychophysics and Objective Measures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cochlear Implant Listeners
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2011-01-27
Enrollment: 1
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: Cochlear implants (CIs) have restored some sense of hearing to more than 120 000 people worldwide. While most patients show good scores of speech recognition in quiet, a large majority of them also struggle in more challenging listening situations, such as speech in noise or music. This project aims to understand the basic mechanisms of electrical stimulation of the auditory nerve, in order to identify the important cues that the electrical signal should convey and to possible improve sound perception by CI users.

Detailed description: This study will take place in the ENT department of La Timone hospital in Marseille, where more than 120 adults have been implanted. Our study will comprise several phases, including (1) temporal coding of pitch, (2) spatial coding of pitch, and (3) loudness perception. Eight adult implant users will be recruited for each of these phases.

Eligibility criteria: Inclusion Criteria:

* The adults of more than 18 years old at the beginning of the study without notion of minimal or maximal duration of setting-up(presence).
* The adults WITH cochlear implant listeners .

Exclusion Criteria:

* Presence of intrusive disorders of the personality or mental deficiency. Presence of associated driving disorders. Pregnant or breast-feeding woman.

Primary outcomes:
measure: Identify waveforms aimed to improve sound perception by CI recipients
timeFrame: 2 YEARS
Secondary outcomes:
measure: To correlate the results of our measures psychophysiques with recordings électrophysiologiques of the neuronal activity of the hearing nerve.
timeFrame: 2 YEARS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References:
Clinical trial NCT01106703: The Effects of PG102, a Water Soluble Extract From Actinidia Arguta, on Serum Total IgE Levels
Official title: The Effects of PG102 on Allergy-related Risk Factors: A Randomized, Double Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asymptomatic Subjects With Atopy and Elevated Serum IgE
Keywords: atopy, IgE
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2010-04-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to evaluate the efficacy of PG102 at lowering levels of total IgE in asymptomatic subjects with atopy.


Eligibility criteria: Inclusion Criteria:

* subjects who have atopy but no allergy-related symptoms
* subjects with total IgE levels of 300IU/ml or more
* acquisition of written informed consent prior to commencement of study
* no serious clinical symptoms and normal laboratory test results; in case of abnormal finding, subjects whose conditions are not deemed severe from the judgement of investigators

Exclusion Criteria:

* individuals with normal levels of total serum IgE
* ue of one or more allergic drugs
* serious clinical conditions (such as malignancies, severe cardiovascular disease etc.)
* serious mental disorder
* pregnant woman or woman of childbearing potential within 3 months
* subjects who participated in other clinical trials in the past 6months
* individuals who have a plan to participate in another clinical trials during this trial
* subjects with a history of kiwi allergy
* subjects whose conditions are inappropriate by investigators

Primary outcomes:
measure: serum total IgE level
timeFrame: 8weeks
Secondary outcomes:
measure: serum level of allergy-related factors, such as eosinophilic cation protein(ECP), eotaxin, thymus, and activation-regulated chemokine (TARC), IL-4, IL-5, and IL-13, skin test(atopy score), and adverse reactions
timeFrame: 8weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Soeul National University Bundang Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Up Min, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04907903: RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to COVID-19
Official title: RinasciMENTE, An Internet-Based Self-Help Intervention for People With Psychological Distress Due to Coronavirus-19: Study Protocol of a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychological Disease
Keywords: COVID-19
internet-based intervention
cognitive-behavioral therapy
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
Collaborators: name: Bar-Ilan University, Israel
name: Istituto Auxologico Italiano
name: Linkoeping University
name: Karolinska Institutet
First posted: 2021-06-01
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims is the evaluation of the efficacy and feasibility of RinasciMENTE, the Randomized Controlled Clinical Trial compared with a waiting list control group.

Detailed description: A sample of 128 participants, who experience psychological discomfort due to COVID-19, will be recruited. After initial screening, participants will be randomly assigned to either an experimental group or a waiting list group. Measures will be taken at the baseline (T0), at the end of the treatment (T1) and 12 months follow-up (T2).

Eligibility criteria: Inclusion Criteria:

* 18 years old or over and both gender
* Italian mother-tongue
* Score 14 or less on Patients Health Questionnaire-9 (PHQ-9)
* Internet access and basic informatic ability to navigate the internet platform
* Must be able to complete a phone interview

Exclusion Criteria:

* Having severe and mental impairments, psychiatric condition and neurological disorder
* Not be able to use a computer or do not have internet access
* Not be able to complete a phone interview
* Score 15 or more on PHQ-9

Primary outcomes:
measure: Outcome Questionnaire (OQ-45)
timeFrame: Baseline, 2 months follow-up, 12 months follow-up
Secondary outcomes:
measure: Perceived stress scale (PSS)
timeFrame: Baseline, 2 months follow-up, 12 months follow-up
measure: Emotional regulation questionnaire (ERQ)
timeFrame: Baseline, 2 months follow-up, 12 months follow-up
measure: Depression Anxiety Stress Scales-Short Version (DASS-21)
timeFrame: Baseline, 2 months follow-up, 12 months follow-up
measure: Fear of COVID-19 Scale (FCV-19S)
timeFrame: Baseline, 2 months follow-up, 12 months follow-up
measure: General Self-efficacy Scale (GSES)
timeFrame: Baseline, 2 months follow-up, 12 months follow-up
measure: World Health Organization Quality of Life (WHOQOL)-BREF
timeFrame: Baseline, 2 months follow-up, 12 months follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01560403: A One-Year, Open-Label Study With Teduglutide for Subjects Who Completed Study CL0600-021
Official title: A One-Year, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition-dependent Short Bowel Syndrome Who Completed Study CL0600-021
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Short Bowel Syndrome
Keywords: Parenteral nutrition
TPN
HPN
PN
SBS
Short bowel syndrome
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 14
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 is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in Study CL0600-021.

Detailed description: This study served as a 1-year extension study for those US patients who have completed the CL0600-021 study.

Eligibility criteria: Inclusion Criteria:

* At completion of Study CL0600-021, subjects will be invited to participate in this trial if they meet the following criteria:

  1. Completion of the 24-month study, CL0600-021, regardless if fully weaned from PN/I.V. support
  2. Signed and dated informed consent form (ICF) to participate before any study-related procedures of Study TED-C11-001 are performed

Exclusion Criteria:

* None

Primary outcomes:
measure: Summary of Treatment-emergent Adverse Events
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic & Research Foundation
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Seidner DL, Fujioka K, Boullata JI, Iyer K, Lee HM, Ziegler TR. Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study. Nutr Clin Pract. 2018 Aug;33(4):520-527. doi: 10.1002/ncp.10092. Epub 2018 May 15.
Clinical trial NCT02460003: Physiotherapy Program for Cluster Headache
Official title: Effectiveness of Physiotherapy Program in Patients With Cluster Headache
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cluster Headache
Lead sponsor: AG Clinic
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Hospital Universitario La Paz
name: Hospital Universitario La Paz
First posted: 2015-06-02
Enrollment: 12
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: This study evaluates the effectiveness of physiotherapy program in the treatment of cluster headaches. Half of participants will receive a program of physiotherapy and usual drugs, while the other will receive an exercise program and usual drugs.

Detailed description: Previous studies have shown positive effects of physical therapy in patients with primary headache.

However, so far no study that assessed the effect of a physiotherapy program combined with regular medication in patients with cluster headache.

Eligibility criteria: Inclusion Criteria:

* Cluster headache diagnosed

Exclusion Criteria:

* Other types of headaches.
* Neurostimulator implanted.
* Other chronic pain processes

Primary outcomes:
measure: Pain Scores on the Visual Analog Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: AGClinic
Study officials:
affiliation: Hospital Universitario La Paz. AGClinic
name: Alfonso Gil-Martínez, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT04404803: Motivations and Barriers to Participating in Ophthalmology Research Projects
Official title: Motivations and Barriers to Participating in Ophthalmology Research Projects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Diseases
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-05-28
Enrollment: 1500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All individuals will be considered for inclusion in this study regardless of age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion and belief, sex, and sexual orientation except where the study inclusion and exclusion criteria explicitly state otherwise.

Brief summary: The primary objective of this project is to understand the reasons why patients agree / disagree to take part in ophthalmology research. This will be done by asking participants to complete a Research Questionnaire.


Eligibility criteria: Inclusion Criteria:

* Over 16 years old
* Willing to participate by completing the questionnaire
* Must be able to speak and read English

Exclusion Criteria:

* Under 16 years of age
* Not willing to complete the questionnaire

Primary outcomes:
measure: Assessment of motivations to participating in ophthalmology research.
timeFrame: 5 years
measure: Assessment of barriers in participating in ophthalmology research
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Monika Cien
Study officials:
References:
Clinical trial NCT04261803: FH Detection in Children by Salivary Test
Official title: Familial Hypercholesterolemia Non Invasive Detection in Children by Salivary Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperlipoproteinemia Type II
Keywords: familial hypercholesterolemia
Healthy Volunteers
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Familial Hypercholesterolemia children group Control children group

Brief summary: Familial Hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. Studies on families of Hypercholesterolemia have shown that children with Hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. The difference between Hypercholesterolemia and normal children in their atherogenic profil begin at the age of Nowadays , systematic screening techniques are not well implemented whereas their are clear World health organization guidelines.

International studies show treatment must be initiated early as at the age of eight years old.

In pediatry, Parents can be reluctant to practice blood test on their children. In order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test.

The main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. Furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.


Eligibility criteria: Inclusion Criteria :

* children under 18 years old, with familial hypercholesterolemia
* children under 18 years old, intending surgery
* being able to spit

Exclusion Criteria:

* poor dental health
* for control patients: to have a known cholesterol disease

Primary outcomes:
measure: salivary cholesterol concentration
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon gastro-enterological hepatology and nutrition
Study officials:
affiliation: Hospices Civils de Lyon gastro-enterological hepatology and nutrition
name: Noel PERETTI, MD
role: PRINCIPAL_INVESTIGATOR
References: