louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05244343: I VACCIN Hospitalization of COVID-19 Patients
Official title: Impact of Vaccination on Medical and Intensive Care Hospitalization of COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
COVID-19
Keywords: COVID-19
Vaccination
Hospitalization
Lead sponsor: Eshmoun Clinical Research Center
Sponsor class: NETWORK
First posted: 2022-02-17
Enrollment: 1096
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized due to COVID-19 in ICU or medical units, who are ≥ 18 years old during the period extended from January 1st to March 3rd.

Brief summary: A REALLIFE evaluation of rate of hospitalized patients in Intensive Care Units and in medical Units of non -vaccinated patients vs vaccinated patients

Detailed description: Transversal National multicenter non interventional on the COVID-19 vaccines

* Period of hospitalization: from January 1st to March 3rd, 2022
* Recruitment duration: 37 days
* Total study duration: 44 days

Eligibility criteria: Inclusion Criteria:

* Male and Female ≥ 18 years
* Confirmed COVID-19 patients hospitalized in ICU and Medical Units during the period of the study from January 1st to March 3rd.

Exclusion Criteria:

* Subjects vaccinated outside Tunisia
* Subjects \<18 years
* Not confirmed COVID-19
* Not hospitalized patients

Primary outcomes:
measure: Rate of COVID-19 not vaccinated patients hospitalized in ICU
timeFrame: From January 1st to February 15th
measure: Rate of COVID-19 not fully vaccinated patients hospitalized in ICU
timeFrame: From January 1st to February 15th
Secondary outcomes:
measure: Rate of COVID-19 not vaccinated patients hospitalized in Medical Units
timeFrame: From January 1st to February 15th
measure: Rate of COVID-19 not fully vaccinated patients hospitalized in Medical Units
timeFrame: From January 1st to February 15th
measure: Rate of COVID-19 vaccinated patients hospitalized in Medical Unit by type of vaccine
timeFrame: From January 1st to February 15th
Other outcomes:
Locations:
city: Ariana
country: Tunisia
facility: Abderrahmen Mami Hospital
Study officials:
affiliation: Eshmoun Clinical Research Center
name: Mariem Melliti
role: STUDY_DIRECTOR
References:
Clinical trial NCT06535243: Evaluation of the Efficacy of "Lifespan Integration" (LI) Therapy in Patients With Complex Post-Traumatic Stress Disorder
Official title: Evaluation of the Efficacy of "Lifespan Integration" Therapy in Patients With Complex Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-Traumatic Stress Disorder Complex
Psychiatric Disorder
Abuse Neglect
Abuse Physical
Abuse, Sexual
Abuse Domestic
Abuse Verbal
Keywords: Lifespan Integration Therapy
Psychotrauma type II
Abuse
Victims
Complex Post-traumatic Stress Disorder
Psychotherapy
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: eligible candidates to be included in this cohort should be

* older than 18 yo
* French speaking
* with a diagnosis of complex PTSD as confirmed by 1/clinical interview with a trained psychiatrist and 2/ scores for the International Trauma Questionnaire (ITQ), clinical tool based on the ICM 11 criteria
Primary purpose: OTHER

Brief summary: The study aims to evaluate the efficacy of a relatively new type of psychotherapy called Lifespan Integration (LI) in patients suffering of complex PTSD


Eligibility criteria: Inclusion Criteria:

* patients diagnosed with complex PTSD
* French speaking
* first time following an LI type of therapy
* psychotropic treatment is allowed

Exclusion Criteria:

* no other parallel psychotherapy is accepted (if the patient underwent recently any other type of psychotherapy, a "wash out " period of minimum 4 weeks is required )
* no active manic episode at the time of inclusion
* no active psychotic episode at the time of inclusion
* no chronic psychotic disorder diagnosis
* no autistic spectrum disorder diagnosis ,
* no intellectual deficit

Primary outcomes:
measure: change of the scores of International Trauma Questionnaire
timeFrame: maximum one year
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS) Score
timeFrame: maximum one year
Other outcomes:
measure: Rosenberg Self - Esteem Scale (RSES) (Rosenberg, 1965)
timeFrame: maximum one year
Locations:
city: Paris
country: France
facility: CHU St Anne
state: Ile De France
Study officials:
affiliation: GHU Paris Hôpital St Anne
name: Alexandru GAMAN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01519843: Post Stroke Motor Learning
Official title: Post-stroke Procedural Learning: From Neural Substrates to Therapeutic Modulation by Non-invasive Brain Stimulation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Stroke
Hemiparesis
Keywords: stroke
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
First posted: 2012-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Noninvasive brain stimulations (NIBS) will be used in chronic stroke patients to improve motor learning.

Functional magnetic resonance imaging will be used to evaluate the mechanisms underlying motor learning in healthy volunteers and in chronic stroke patients.

Detailed description: transcranial direct current stimulation will be used for NIBS

Eligibility criteria: Inclusion Criteria:

* stroke with at least slight deficit

Exclusion Criteria:

* epilepsy
* contraindication to tDCS and/or to fMRI
* presence of metal in the head
* inability to understand / complete behavioral tasks
* chronic intake of alcohol or recreational drugs
* major health condition
* presence of pacemaker (for the fMRI part only)
* pregnancy

Primary outcomes:
measure: Motor learning improvement with tDCS
timeFrame: Improvement on motor learning were recorded from baseline to 4 weeks after the intervention
Secondary outcomes:
measure: Neuroimaging
timeFrame: before motor learning, during motor learning and after (immediately, 30,60min) motor learning (with or without tDCS)
measure: Neurophysiological outcome measure
timeFrame: start of session 5min before motor learning, just at the end of the motor learning, after 30 min of motor learning, after 60 min of motor learning, Recall test at 1,2,3,4 weeks after the day of intervention (with or without tDCS)
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: Department of Neurology, CHU Mont-Godinne
state: Namur
Study officials:
References:
citation: Riga A, Gathy E, Ghinet M, De Laet C, Bihin B, Regnier M, Leeuwerck M, De Coene B, Dricot L, Herman B, Edwards MG, Vandermeeren Y. Evidence of Motor Skill Learning in Acute Stroke Patients Without Lesions to the Thalamus and Internal Capsule. Stroke. 2022 Jul;53(7):2361-2368. doi: 10.1161/STROKEAHA.121.035494. Epub 2022 Mar 21.
citation: Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Clinical trial NCT05188443: Radiological Imaging in Patients Tested for COVID-19
Official title: Radiological Imaging in Patients Tested for COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Coronary Artery Disease
Cardiovascular Diseases
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Positive RT-PCR test for COVID-19 with radiological imaging available within the last 3 years.

Brief summary: It has become apparent that patients with co-morbidities have an increased risk of mortality from coronarvirus disease 2019 (COVID-19). However, the impact of subclinical respiratory and cardiovascular disease on the outcome of patients with COVID-19 is currently unknown. This observational study will assess the impact of incidental cardiovascular calcification on radiological imaging on the outcomes of patients with COVD-19.

Detailed description: It has become apparent that patients with co-morbidities have an increased risk of mortality from coronarvirus disease 2019 (COVID-19). However, the impact of subclinical respiratory and cardiovascular disease on the outcome of patients with COVID-19 is currently unknown.

Subclinical respiratory and cardiovascular disease can be identified on radiological imaging. For example, calcification in blood vessels can identify cardiovascular disease, intra-thoracic and intra-abdominal fat is associated with coronary artery disease, and lung diseases can be identified on CT and x-ray. The impact these radiological features on the outcomes of patients with COVID-19 is currently unknown.

This study aims to assess the radiological imaging of patients tested for COVID-19 in order to identify the presence of co-existing respiratory and cardiovascular disease and assess their impact on clinical outcomes.

All patients tested for COVID-19 with current or previous (last 3 years) radiological imaging will be included in this study. Radiological images will be de-identified and assessed for the presence of cardiovascular calcification. Information on COVID-19 tests and clinical factors will be obtained from routinely collected data. Additional clinical information will be obtained from electronic health records as required.

Eligibility criteria: Inclusion Criteria:

* One or more positive RT-PCR test for COVID-19.
* One or more CT or chest x-ray available performed within the last 3 years

Exclusion Criteria:

* No available radiological imaging within the last 3 years

Primary outcomes:
measure: All cause mortality
timeFrame: 1 month
Secondary outcomes:
measure: Cardiovascular mortality
timeFrame: 1 month
Other outcomes:
measure: Myocardial infarction
timeFrame: 1 month
Locations:
city: Edinburgh
country: United Kingdom
facility: University of Edinburgh
state: Scotland
Study officials:
References:
Clinical trial NCT06844643: The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study
Official title: The Disease Progression of Chinese Axial Spondyloarthritis in a Real-word Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Axial Spondyloarthritis
Ankylosing Spondylitis (AS)
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 2250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with axial spondyloarthritis

Brief summary: An observational, ambispective cohort to learn about the disease progression of axial spondyloarthritis (axSpA) according to the changes from baseline in measures of disease activity, function, and imaging.

Detailed description: This is an observational cohort study of Chinese patients (≥18 years of age) diagnosed with axSpA. Patients are followed at 4-6 month intervals. Data will be collected at baseline and at every follow-up time points. Primary outcomes are the structural damage measured with imaging(Conventional radiography, low-dose CT and MRI) and the disease activity measured with the Ankylosing Spondylitis Disease Activity Scale (ASDAS) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Secondary outcomes are inflammatory markers, Bath ankylosing spondylitis functional index (BASFI) and Bath ankylosing spondylitis metrology index (BASMI).

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older and diagnosed with the Assessment of Spondyloarthritis International Society axial spondyloarthritis criteria.

Exclusion Criteria:

* Patients with serious disease in cardiovascular, kidney and blood and endocrine system; history of schizophrenia or epilepsy; pregnant or in lactation period.

Primary outcomes:
measure: ASDAS-CRP
timeFrame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
measure: ASDAS-ESR
timeFrame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
measure: BASDAI
timeFrame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
measure: Modified stoke ankylosing spondylitis spinal score (mSASSS)
timeFrame: 2-year interval
measure: The Spondyloarthritis Research Consortium of Canada (SPARCC) scoring system.
timeFrame: From enrollment to 16 weeks，1 year; after 1year on a an average of 6 months until study completion.
Secondary outcomes:
measure: BASFI
timeFrame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
measure: BASMI
timeFrame: From enrollment to 16 weeks, 28 weeks, 1 year; after 1year on a an average of 6 months until study completion.
Other outcomes:
measure: CT Syndesmophyte Score
timeFrame: 2-year interval
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
References:
Clinical trial NCT00665743: Study Evaluating the Bioavailability of Naproxen 500 mg in Three Formulations
Official title: An Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Naproxen 500 mg Administered as PN 400 (Naproxen / Esomeprazole), as the [Active Comparator 1], or as [Active Comparator 2] in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Arthritis
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 30
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: We will evaluate the bioavailability of naproxen 500 mg administered as three dfferent formulations.


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female subjects between 18-55 years of age as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

* Standard exclusion criteria for a study of this nature

Primary outcomes:
measure: To assess and compare the pharmacokinetics and relative bioavailability of a single oral dose of naproxen 500 mg administered in 3 formulations
timeFrame: 72-hour PK
Secondary outcomes:
measure: To evaluate the safety of the 3 treatments
timeFrame: entire study duration
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
References:
Clinical trial NCT01449643: The Influence of Inspiratory Muscular Training (IMT) on Diaphragmatic Mobility in Morbidly Obese
Official title: The Influence of Inspiratory Muscular Training on Diaphragmatic Mobility, Lung Function and Quality of Life in Obese Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Diaphragm
Inspiratory muscular training
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2011-10-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is whether an inspiratory muscle training protocol would be associated with an improvement in of the diaphragm mobility, an increase in pulmonary function values , gain strength and endurance of respiratory muscles and improving quality of life.

Detailed description: Few studies have investigated the effects of an inspiratory muscle training in obese patients on the diaphragmatic mobility and thickness. Obesity, especially morbid, triggers changes in the respiratory system, which can affect the work activities and daily life of individuals with this multifactorial syndrome. These functional changes in mechanical ventilation may be linked to weakness and poor respiratory muscle strength, so by promoting rehabilitation of these muscles can minimize the losses that come with obesity

Eligibility criteria: Inclusion Criteria:

* BMI \> 40 kg/m²
* Absence of acute or chronic lung disease

Exclusion Criteria:

* Acute or chronic inflammatory process
* Thyroid disorders

Primary outcomes:
measure: Ultrasound evaluation of the diaphragm mobility
timeFrame: 3 months
Secondary outcomes:
measure: Pulmonary function test
timeFrame: 3 months
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Maria S Brasileiro-Santos, D.Sc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tenorio LH, Santos AC, Camara Neto JB, Amaral FJ, Passos VM, Lima AM, Brasileiro-Santos Mdo S. The influence of inspiratory muscle training on diaphragmatic mobility, pulmonary function and maximum respiratory pressures in morbidly obese individuals: a pilot study. Disabil Rehabil. 2013;35(22):1915-20. doi: 10.3109/09638288.2013.769635. Epub 2013 May 7.
Clinical trial NCT05510843: A Study to Evaluate THB001 in Adult Patients With Chronic Cold Urticaria
Official title: An Open-label, Multicenter Study to Assess the Safety, Pharmacokinetics and Pharmacodynamic Effects of THB001 in Adult Patients With Chronic Cold Urticaria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Cold Urticaria
Lead sponsor: Third Harmonic Bio, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1b, open label, non-randomized, sequential dose-escalation, multicenter trial in adult patients with chronic cold urticaria.


Eligibility criteria: Key Inclusion Criteria:

1. Women and Men ages 18-75
2. Diagnosed with chronic, cold inducible urticaria for at least 3 months prior to starting the study and refractory to antihistamine treatment
3. Positive cold stimulation test assessed by TempTest® at the Screening and Baseline visits
4. Considered healthy as assessed by medical evaluation including review of medical history, physical examination, vital signs, laboratory tests and ECG recording
5. Willing and able to participate in all visits, undergo all study procedures and adhere to study restrictions

Key Exclusion Criteria:

1. A diagnosis of acute urticaria or non-cold chronic inducible urticaria
2. Ongoing treatment with immunosuppressant drugs (corticosteroids, cyclosporine, azathioprine, methotrexate, omalizumab, dupilumab, sulfasala-zine, dapsone or others)
3. A positive test for pregnancy, HIV, Hepatitis B or Hepatitis C
4. Clinical laboratory values outside of the normal ranges at the Screening visit
5. History of any clinically significant abnormality that would contraindicate participation

There are additional criteria that your study doctor will review with you to confirm you are eligible for the study.

Primary outcomes:
measure: Safety as assessed by the incidence and severity of adverse events
timeFrame: From Day 1 through Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Institute of Allergology
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
References:
Clinical trial NCT06870643: Parabiotics Use with Nutritional Management in Pediatric Celiac Patients
Official title: Effect of Parabiotics As an Adjuvant in Nutritional Management of Pediatric Celiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease in Children
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a sequential study to evaluate the effect of parabiotics as an adjuvant therapy with gluten restriction on quality of life in children with Celiac disease.


Eligibility criteria: Inclusion Criteria:

• Celiac cases diagnosed either by non-biopsy approach {serology based: high IgA antibodies against transglutaminase ≥10 times the upper limit of normal with positive endomysial antibodies or diagnosed by biopsy using March classification

Exclusion Criteria:

* Immunocompromised patients
* Patients taking immunosuppressant drugs or antibiotics within the last 4 weeks or during the study

Primary outcomes:
measure: Evaluate the effect of parabiotics as an adjuvant on celiac patients' quality of life .
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
References: