louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05896891: San Raffaele EoE Biobank
Official title: San Raffaele EoE Biobank: New Horizons From Etiopathogenesis and Physiopathology
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Eosinophilic Esophagitis
Keywords: eosinophilic
disorders
translational
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every male or female patient \> 16 years pertaining to IRCCS San Raffaele Hospital in Milan

Brief summary: Eosinophilic Esophagitis (EoE) is a immuno-mediated disease, characterised by a Th-2 food-antigen driven chronic inflammatory response of the esophagus. Main symptoms are dysphagia and food bolus impaction, frequently overlapping with most atypical and general symptoms like heartburn or regurgitation and difficulty to thrive in children. Overall incidence and prevalence of EoE are rapidly increasing. The complete comprehension of pathogenetic and molecular mechanism underlying this complex and relatively new disease is still to be conquered. For this reason, we created this EoE Biobank, in order to collect blood, oral and esophageal tissue samples of proven EoE patients to further exploit new insights of this disease.

Detailed description: Every EoE patient pertaining to the EoE Unit of San Raffaele Hospital in Milan from 1st June 2023 will be enrolled in the EoE Biobank protocol after being adequately informed and after having signed the informed consent during a preliminary visit where also different clinical and demographic variable of each patient will be taken and stored in an anonymus database. Every patient, during the endoscopic examination performed according to clinical practice guideline for his management, will be asked to provide a sample of oral saliva, 5 mL of blood sample (directly withdraw from the previously placed venous catheter) and additional esophageal biopsies from the esophagus, normally performed for the diagnosis or the follow-up of the disease. The collected samples will be stored in Biological Resources Centre (BRC) of the host organization. These sample will later be analyzed "in vitro" in the context of dedicated protocols

Eligibility criteria: Inclusion Criteria:

* EoE diagnosis proven histologically with clinical activity
* Age \> 16 years

Exclusion Criteria:

* Not signed informed consent
* No definite EoE diagnosis

Primary outcomes:
measure: Molecular characterization of eosinophilic esophagitis
timeFrame: June 1st 2023 to June 1 st 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
state: Milano
Study officials:
References:
Clinical trial NCT03103191: Diagnostic Value of KL-6 in ILD
Official title: Diagnostic Value of KL-6 in Interstitial Lung Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Fibrosis
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects over 18 years of age attending the outpatient clinic at Hospital de la Santa Creu i Sant Pau.

Brief summary: KL-6 may be a useful biomarker in patients with interstitial lung disease, but there is limited information in non-Asian populations. Therefore, it is necessary to carry out studies in other populations to confirm the diagnostic values of the biomarker and its prognostic implication.

Hypothesis KL-6 may be a useful biomarker in the management of interstitial lung diseases. But it is necessary to know more about its utility in the European population.

Study Objectives:

* To determine the concentration of KL-6 in serum of patients with pulmonary fibrosis at the time of diagnosis compared to patients without pulmonary fibrosis
* Diagnostic yield of KL-6 in patients with pulmonary fibrosis.
* Correlation of KL-6 values with functional and radiological parameters of disease severity at diagnosis.
* Correlation of serum KL-6 values with the evolution of the disease.


Eligibility criteria: Inclusion Criteria:

1. Subjects older than 18 years.
2. Chronic respiratory diseases )including Fibrotic interstitial lung disease, asthma or COPD) related or not to a connective tissue disease.
3. Acceptance of the patient to participate in the study by signing the informed consent after having discussed with the researchers the objectives, risks and potential benefits.

Exclusion Criteria:

1. Absence of informed consent
2. Psychiatric disorder or limitation of collaboration (including language, socio-cultural problem, etc.).

Primary outcomes:
measure: Serum KL-6 levels in patients with pulmonary fibrosis at the time of diagnosis.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT00639691: A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
Official title: A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab)in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma, Anti-immunoglobin E, omalizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-03-20
Enrollment: 48
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study has the objective of providing compassionate use access to omalizumab (Xolair) and to evaluate the Safety of Xolair in subjects with severe allergic asthma who remain symptomatic despite optimal therapy according to GINA step 4 treatment guidelines.


Eligibility criteria: Inclusion Criteria:

* male or female, ≥ 6years of age;
* who have a diagnosis of allergic asthma ≥ 1 year duration according to American Thoracic Society (ATS) criteria;
* severe persistent allergic asthma who remain symptomatic despite optimal therapy (as per Canadian Asthma Consensus Report (1999));
* Subjects having successfully completed one of the following protocols: CIGE025A011E3, CIGE025A2425, CIGE025AIA05;
* elevated immunoglobin E levels

Exclusion Criteria:

* significant systemic disease
* pregnancy or lactation
* an active lung disease other than allergic asthma (eg: cystic fibrosis, bronchiestasis);
* history of food or drug related severe anaphylactoid or anaphylactic reaction(s);
* current treatment with warfarin (Coumadin®), immunomodulatory therapy (e.g., methotrexate, gold, cyclosporine), or antiplatelet therapy.

Primary outcomes:
measure: Serious Adverse Events from first visit until end of study
Secondary outcomes:
measure: To evaluate reasons for premature discontinuation.
measure: All adverse events, duration of study participation.
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
Study officials:
References:
Clinical trial NCT05086601: A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer
Official title: A Cohort of Molecular Characteristics and Prognosis of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Surgery
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 15000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients pathologically diagnosed as colorectal cancer, and receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery

Brief summary: This study aims to establish a colorectal cancer cohort, collect clinicopathological information, collect biological samples for multi-omics testing, and perform relevant analysis, to predict the prognosis of colorectal cancer, guide the diagnosis and treatment of colorectal cancer and the formulation of health policies.

Detailed description: In this study, the investigators will establish a database to collect clinical pathological information, based on the medical data system of participating medical centers. The investigators will also collect corresponding tumor specimens and perform multiple omics tests such as genome, transcriptome, and proteome. The investigators will aggregate these data into a special database, and use appropriate methods to conduct big data analysis, to predict prognosis, guide diagnosis and treatment, and assist in formulating health policies.

Eligibility criteria: Inclusion Criteria:

* Pathologically diagnosed as colorectal cancer
* Receiving any surgery of primary tumor, including palliative resection, simple enterostomy and exploratory surgery

Exclusion Criteria:

* The patient refused to join the study
* The patient refused to collect the biological sample
* The patient refused to follow up

Primary outcomes:
measure: Disease-free survival time
timeFrame: 2 yeas after surgery
Secondary outcomes:
measure: Overall survival time
timeFrame: 2 yeas after surgery
measure: Pathological TNM stage
timeFrame: 1 month after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT05384301: Effects of Urban Afforestation Activity on Mood, Stress, and Anxiety
Official title: Effects of an Urban Afforestation Activity on Mood, Stress, and Anxiety of Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Green spaces
Nature-based activities
Urban afforestation
Horticultural therapy
Mental health
Mood
Stress
Anxiety
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2022-05-20
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single-group pretest-posttest clinical trial aims to evaluate the effects of a single-session afforestation activity on mood, stress, and anxiety in a sample of adults.

Detailed description: The participants will perform an afforestation activity for a single session of 90 minutes. The therapist will direct the participants' attention to the visual, auditory, olfactory, and tactile features of the surrounding environment.

Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 65 years.
* Any sex and gender.

Exclusion Criteria:

* Intake of any psychotropic medication.
* Other severe or medically unstable diseases that may interfere with participation.
* Severe cognitive impairment (Mini-Mental State Examination score \< 17 out of 30 points).
* Severe mental disorders in the acute phase or symptomatic phase.
* Severe intellectual disability.
* Behavioural alterations as this may interfere with their participation.

Primary outcomes:
measure: Mood
timeFrame: Change from baseline the total mood disturbance after 90 minutes.
Secondary outcomes:
measure: State stress
timeFrame: Change from baseline state stress after 90 minutes.
measure: State anxiety
timeFrame: Change from baseline state anxiety after 90 minutes.
Other outcomes:
Locations:
city: Granada
country: Spain
facility: University of Granada, Faculty of Health Sciences
state: Andalusia
Study officials:
affiliation: Associate Professor
name: José Manuel PÉREZ-MÁRMOL, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00976001: Follow-up Pilot Study After a First Stroke
Official title: Open, Randomized Follow-up Pilot Study After a First Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Follow-up after stroke
Lead sponsor: Skaraborg Hospital
Sponsor class: OTHER_GOV
First posted: 2009-09-14
Enrollment: 163
Sex: ALL
Maximum age (years): 84
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized follow-up study after discharge from a stroke unit after a first stroke. The patients are randomized either to follow-up at a special out-patient stroke unit or with their general practitioners. The hypothesis is that follow-up with specialists is superior to follow-up with general practitioners. Endpoints are mortality, recurrent stroke and handicap measured with different scales.


Eligibility criteria: Inclusion Criteria:

* first stroke (ischemic or hemorrhagic)
* age below 85 years
* living at home before the stroke

Exclusion Criteria:

* modified Rankin scale 5 points
* other severe disease
* expected survival less than one year
* severe dementia
* drug or alcohol abuse

Primary outcomes:
measure: Total mortality
timeFrame: 3.5 years
Secondary outcomes:
measure: Recurrent stroke
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Lidkoping
country: Sweden
facility: Stroke unit, Department of Medicine, Lidkoeping hospital
Study officials:
References:
Clinical trial NCT00488501: Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM)
Official title: Clinical Usefulness and Efficacy of Intrathoracic Impedance Monitoring Using the OptiVol Patient Alert(TM) in Medtronic(R) ICD's for Early Detection of Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: intrathoracic impedance
cardiac resynchronization therapy
heart failure
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2007-06-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who have been implanted a biventricular pacemaker ICD equipped with impedance monitoring and who are known with chronic heart failure of any cause

Brief summary: In this study we investigate the clinical value and efficacy of OptiVol (TM) impedance measurements by Medtronic (R) ICD's. We aim to determine sensitivity and positive predictive value for detecting heart failure. We also investigate if left ventricular filling pattern measured by echocardiography and/or brain natriuretic peptide (BNP) level can be used to improve the positive predictive value of the Optivol alert

Detailed description: Patients who have a Medtronic (R) ICD equipped with the Optivol (TM) impedance monitoring will be included in your study after informed consent. The OptiVol (TM) feature will be activated and at baseline data is collected (blood sample including BNP, electrocardiography, echocardiography, chest X-ray and ICD check-up). During follow-up patients will be re-assessed in case of an OptiVol alert or in case of heart failure.

Eligibility criteria: Inclusion Criteria:

* chronic heart failure of any cause
* implanted Medtronic ICD with OptiVol impedance monitoring

Exclusion Criteria:

* inability to receive informed consent

Primary outcomes:
measure: clinical efficacy and value of ambulatory intrathoracic impedance measurement of the Optivol alert as an indicator of decompensated heart failure reflected by sensitivity and positive predictive value
timeFrame: end of follow-up
Secondary outcomes:
measure: influence of left ventricular filling pattern and brain natriuretic level on the positive predictive value of the Optivol alert
timeFrame: end of follow-up
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: P Houthuizen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Catharina Ziekenhuis Eindhoven
name: A Meijer, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT07004101: Effect of Virtual Reality Combined With Balance Training on Biodex Balance System in Female With Fibromyalgia
Official title: Effect of Virtual Reality-based Therapy Combined With Balance Training on Biodex Balance System in Female Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Virtual Reality
Lead sponsor: Badr University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Is there an effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .

Detailed description: PURPOSE: To Study the Effect of virtual reality based therapy combined with balance training using biodex balance system on female patients with fibromyalgia .

BACKGROUND: Fibromyalgia (FM) is a chronic disorder defined by report of chronic widespread pain including axial pain and presence of multiple tender points on physical exam . Beyond the defining criteria.A recent survey reported balance problems as one of the top 10 most debilitating symptoms with prevalence of 45%. Balance or postural stability is a very complex task that involves the integration of multiple sensory inputs to execute appropriate neuromuscular activity needed to maintain balance .

Biodex balance system is a relatively new instrument that can be used for the assessment and management of balance dysfunction. Preliminary studies reported positive effects of balance training on Biodex balance system for the improvement of balance function.

Virtual reality based therapy (VRBT) could be effective as a non-pharmacological alternative intervention to reduce pain in women with FM. It improves dynamic balance, as it is an active therapy that requires engaging in physical activities during the sessions.VRBT requires autonomous movement of different body parts that can increase muscle tone and the perception of pain-free movement favoring the elimination of restrictions to movement included in the cerebral body scheme due to continued pain.

Eligibility criteria: Inclusion Criteria:

* Women patients from age 35 to 50 years old
* All patients describe a history of pain spreading in all quadrants of the body for at least three months and pain is caused by digital pressure in at least 11 out of 18 allogenic points, called tender points

Exclusion Criteria:

* Old neglected fracture
* Malignant diseases
* Neurological diseases.
* Uncontrolled diabetes

Primary outcomes:
measure: BIODEX BALANCE ASSESMENT
timeFrame: pre and post treatment 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT04619901: Palliative Care in Maternity and Neonatology
Official title: How Parents (and Their Child if They Continue Their Life) Fare After a Decision of Palliative Care Has Been Taken in the Neonatal Period
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Critical Care
Keywords: Palliative care
Maternity
newborn
parents
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-11-06
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children and parents followed in pediatric unit whom a decision of palliative care has been made in the neonatal period

Brief summary: Palliative care is now an accepted principle in most maternity and neonatology wards, however not much is known about its psychological and social consequences on families. Some children continue their life after a palliative care decision has been taken. In France, quality of life and the neuro-developmental evolution of newborns who continue their life after a palliative care decision has been taken, have never been studied.


Eligibility criteria: Inclusion Criteria:

* Father and/or Mother of a child, who is alive or not, for whom a decision of palliative care has been made in the neonatal period
* Under the care of one of the Level 3 Maternity Centers in the North and Pas-de-Calais departments (Arras, Lens, Lille, Valenciennes) since 2018
* Written consent of the two legal guardians of the child allowing the collection of data concerning the child
* Written consent of the parent(s) participating to this study by completing the parental questionnaires

Exclusion Criteria:

* Medico-legal complaint underway
* Parents who do not understand French
* Parents or children who are under legal protection (guardianship, curatorship)
* Parents or children who are not Social Security beneficiaries

Primary outcomes:
measure: Semi Structured interview
timeFrame: 24 months after palliative care decision
Secondary outcomes:
measure: Ages and Stages Questionnaire (ASQ) - Clinical Examination of Child
timeFrame: 24 months after palliative care decision
measure: Semi Structured Interview
timeFrame: 24 months after palliative care decision
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 24 months after palliative care decision
measure: Intolerance to Uncertainty Scale (EEI)
timeFrame: 24 months after palliative care decision
measure: Brief COPE
timeFrame: 24 months after palliative care decision
Other outcomes:
Locations:
city: Arras
country: France
facility: CH ARRAS
city: Lens
country: France
facility: CH LENS
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
city: Valenciennes
country: France
facility: CH Valenciennes
Study officials:
affiliation: University Hospital, Lille
name: Laurent Storme, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: