louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06477627: The Coastal Exposome: a Study of Sea Air Inhalation and Possible Links to Health
Official title: The Coastal Exposome: a Study of Sea Air Inhalation and Possible Links to Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Immune Suppression
Exposure
Keywords: Oceans and human health
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: three groups: one group that lives at the coast all year round, one group that lives inland all year round and one group that live inland but in the month August lives at the coast (to investigate the change in environment) The participants will not get any treatment, they just have to give samples.
Primary purpose: PREVENTION

Brief summary: The research aims to understand oceans as crucial contributors to human health in coastal environments. Oceans produce marine spray aerosols that contain a mixture of microbiota and natural biological molecules (biogenics).

Detailed description: The primary outcome envisioned consists of 2 goals.

1. In this study, the first objective is to determine whether the microbiota and biogenic molecules found in sea air are also found in the nasal swabs of the participants. In this way, the investigators will gain an understanding of which sea air components are inhaled by humans and how this changes over time.
2. Second, the investigators want to get an idea of whether these inhaled sea air components have an effect on certain pathways in the human body. In the in vitro study with cell lines, effects were already seen of sea air exposure on certain pathways in the body. Now the second goal of this study, is to see if changes in immunity biomarkers (IL-6, TNF-alpha, IL-10) are seen in vivo in humans. The Investigators will do this by taking VAMS blood samples from the participants.

Eligibility criteria: Inclusion Criteria:

* health participants between 18 and 50 years old

Exclusion Criteria:

* people with a medical condition
* people younger than 18 and older than 50

Primary outcomes:
measure: nose swabs: respiratory microbiome and biogenics profile
timeFrame: 4 times during the 8 week study period
measure: VAMS blood samples: cytokines
timeFrame: 4 times during the 8 week study period
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Hannelore Denys
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03803527: Metabolomic Profiling of Eosinophilic Esophagitis
Official title: Metabolomic Profiling of Eosinophilic Esophagitis Patients With Dysphagia for Biomarker Discovery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Eosinophilic Esophagitis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective longitudinal, observational study of adolescent and adults that will identify novel metabolites associated with dysphagia in Eosinophilic Esophagitis (EoE).

Detailed description: In this study, the investigators seek to understand whether a metabolomic profile obtained from esophageal samples correlate with the symptom of dysphagia in adolescent and adults. The investigators hypothesize that intraluminal secreted metabolite(s) will change during episodes of dysphagia. The aim of the study will be to use a novel method of producing esophageal luminal samples, the esophageal string test, to capture esophageal metabolites when a patient is and is not experiencing dysphagia.

Eligibility criteria: Inclusion Criteria:

* Subjects with Eosinophilic Esophagitis (EoE) and seen either at Children's Hospital Colorado or University of Colorado Hospital for scheduled outpatient clinical assessment or upper GI endoscopy

Exclusion Criteria:

* Acute food impaction at time of study
* Recent (within 2 months) use of systemic steroids
* Other known esophageal disease or esophageal injury (e.g. tracheoesophageal fistula, congenital stricture, caustic injury)
* known other inflammatory bowel disease
* inability to swallow the EST

Primary outcomes:
measure: Brief Esophageal Dysphagia Questionnaire
timeFrame: Time of Endoscopic Procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04345627: Japanese Lead Extraction Registry
Official title: Japanese Lead Extraction Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmia, Cardiac
Keywords: Lead extraction
Pacemaker
Defibrillator
Complication
REDCap
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients

Brief summary: Japanese Lead Extraction (J-LEX) Registry is an observational nationwide registry, performed by Japanese Heart Rhythm Society, collaborated with the National Cerebral and Cardiovascular Center. The acute success rate at discharge and the complications associated with transvenous lead extraction will be collected. J-LEX registry will provide a reliable information on indications, methods, the success rate, complications and the prognosis at 30 days prognosis.

Detailed description: Japanese Lead Extraction (J-LEX) Registry is a nationwide, multicenter, observational registry, performed by Japanese Heart Rhythm Society, collaborated with National Cerebral and Cardiovascular Center. This study is a voluntary nationwide registry and data are collected prospectively using a Research Electronic Data Capture (REDCap) system until 30 days after the lead extraction. The investigators will collect the data regarding patient's background and lead characteristic, medical history, details about lead extraction procedure, lead characteristics, and outcomes. The data were anonymized in a linkable manner at each study site before they were sent. Based on the provided information, the annual incidence and predictive factors for outcome will be investigated by the event assessment committee.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing transvenous lead extraction in Japan.

Exclusion Criteria:

* Patients who receive open-chest surgical extraction alone.
* Patients who refused to consent.

Primary outcomes:
measure: Proportion of procedural success
timeFrame: Through discharge from hospital, approximately up to 2 weeks.
Secondary outcomes:
measure: Number of in-hospital deaths
timeFrame: Through discharge from hospital, approximately up to 2 weeks.
measure: Number of patients with procedure-related complications
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
Study officials:
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Kengo Kusano, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04790773: Alexa, What is Eliquis and Xarelto?
Official title: Alexa, What is Eliquis and Xarelto?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Patient Engagement
Patient Satisfaction
Keywords: Technology
Patient Education
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-03-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the effectiveness of providing patient medication education about Eliquis and Xarelto through an Amazon Alexa based voice recording.

Detailed description: Anticoagulants are considered high-risk medications due to the risk of major bleeding. The Federal Drug and Food Administration (FDA) MedWatch reporting system found that anticoagulants had the most adverse drug event (ADE) reports in 2011. Anticoagulants have also been reported as one of the leading drug classes contributing to emergency department visits3. Given the potential for serious adverse events, providing effective education to increase patient knowledge and awareness of those risks are essential. Incorporating technology into health care is becoming increasingly popular and has been shown to be effective for patient education. One reason is that technology can consistently provide complete patient education and is not subject to educator variability in providing this education.

Eligibility criteria: Inclusion Criteria (Patients):

* 18 years of age or older
* Have been prescribed either apixaban or rivaroxaban during their inpatient stay
* Consent to participating in the study

Inclusion Criteria (Nurses):

* Providing direct patient care in select general medicine and orthopedic surgical units
* Consent to participating in the study

Exclusion Criteria:

* Patients will be excluded if they have documented altered mental status, do not speak English, or are being prescribed rivaroxaban or apixaban on discharge only.
* Nurses will be excluded if not providing direct patient care in select general medicine and orthopedic surgical units
* Nurses declining participation

Primary outcomes:
measure: % Change in pre- and post test scores
timeFrame: Within 72 hours of education
Secondary outcomes:
measure: 7-day post-education retention rate
timeFrame: 1 week post discharge
measure: Nursing satisfaction
timeFrame: 72 hours
measure: Patient satisfaction
timeFrame: 72 hours
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
References:
Clinical trial NCT02995473: Efficacy and Safety Study of NP000888 in Subjects With Plaque and Nail Psoriasis
Official title: Multi-center, Randomized, Vehicle-controlled, Investigator-blinded, Parallel Groups Study to Evaluate the Efficacy and Safety of NP000888 in Subjects With Plaque and Nail Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-12-16
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the efficacy and safety of topical application of NP000888 ointment compared to vehicle in plaque and fingernail psoriasis subjects.

Duration of administration: 24 weeks


Eligibility criteria: Inclusion Criteria:

* Subject with a clinical diagnosis of plaque psoriasis defined as an IGA score at least 2 (mild) at Screening and Baseline visits
* Subject with a plaque psoriasis total Body Surface Area (BSA) involvement of at least equal to 3% but less than 20% at Screening and Baseline visits
* Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a fingernail PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits

Exclusion Criteria:

* Subject with guttata, erythrodermic, exfoliative, inverse, pustular or palmo plantar, infected or ulcerated psoriasis or psoriasis involvement \>=20% BSA or an unstable form of psoriasis, defined as at least one flare in the previous month before Screening visit
* Subject with chronic plaque psoriasis who are candidates for systemic therapy at Screening and Baseline visits
* Subject with clinical signs of psoriatic arthritis at Screening and Baseline visits
* Subject with a clinical diagnosis of fingernail psoriasis on at least 1 fingernail with a nail-PGA score from 2 (mild) to 4 (severe) at Screening and Baseline visits.

Primary outcomes:
measure: Success rate in IGA score (clear or almost clear)
timeFrame: Baseline - Week 12
measure: Percent change from baseline in total mtNAPSI scores
timeFrame: Baseline - Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Lincuo
country: Taiwan
facility: Galderma Investigational Site
state: Taoyuan
city: New Taipei
country: Taiwan
facility: Galderma investigational site
city: Taichung
country: Taiwan
facility: Galderma investigational site
city: Tainan
country: Taiwan
facility: Galderma investigational site
city: Taipei
country: Taiwan
facility: Galderma investigational site 1
city: Taipei
country: Taiwan
facility: Galderma investigational site 2
city: Taipei
country: Taiwan
facility: Galderma investigational site 3
city: Taipei
country: Taiwan
facility: Galderma investigational site 4
city: Taipei
country: Taiwan
facility: Galderma investigational site 5
city: Taipei
country: Taiwan
facility: Galderma investigational site 6
Study officials:
References:
Clinical trial NCT01308073: Stability of Middle Molecule Clearance
Official title: Long-time Stability of Middle Molecule Clearance During CI-Ca CVVHD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Continuous Hemodialysis
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care Deutschland GmbH
First posted: 2011-03-03
Enrollment: 15
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 of surgical intensive care unit

Brief summary: The investigators aim to show, whether all middle molecules are included in the clearance and whether this clearance is stable until 72 hours.

Detailed description: A better middle molecule clearance has been shown until 24 hours of duration. The investigators will extend our observations until 72 hours.

Eligibility criteria: Inclusion Criteria:

* informed consent
* age\>18 years
* acute renal insufficiency with indication for continuous hemodialysis, according to RILFE classification F: serum creatinine increase \> 3-fold or serum creatinine \> 4mg/dl with acute increase of \>0,5mg/dl Urine Output \<0,3mg/kg/h for 24 h or anuria for 12 h
* body weight:60-80kg
* anticoagulation with citrate possible and indicated
* Dose for hemodialysis of 2l/h

Exclusion Criteria:

* participation in another clinical trial within on month prior to this study
* pregnancy or brest feeding
* septic shock
* interference with cystatin-C

  1. haemolysis \<1g/dl
  2. Bilirubin\<9mg/dl
  3. Triglyceride \>700mg/dl
  4. rheumatoid factor \> 300kIU/l

Primary outcomes:
measure: Clearance of Urea
timeFrame: up to 72 h
measure: Clearance of Cystatin C
timeFrame: up to 72 h
measure: Clearance of creatinine
timeFrame: up to 72 h
measure: Clearance of Beta2-Microglobulin
timeFrame: up to 72 h
measure: Clearance of Osteocalcin
timeFrame: up to 72 h
measure: Free light chains kappa of Immunoglobulins
timeFrame: up to 72 h
measure: Clearance of albumin
timeFrame: up to 72 h
Secondary outcomes:
measure: Mean arterial pressure
timeFrame: up to 72 h
measure: Vasopressor requirement
timeFrame: up to 72 h
measure: Heart rate
timeFrame: up to 72 h
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Intensivstation ZOM1 Klinik für Anästhesiologie Universitätsklinikum Düsseldorf
Study officials:
affiliation: Klinik für Anästhesiologie Universitätsklinikum Düsseldorf Heinrich-Heine Universität
name: Detlef Kindgen-Milles, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06513273: Observational Study on the Outcome of AML Patients Treated With New Drugs in Real-life (BoxTrial)
Official title: Observational GIMEMA Study on the Outcome of Acute Myeloid Leukemia (AML) Patients Treated With New Drugs in Real-life
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Myeloid Leukemia
AML, Adult
Acute Myeloid Leukemia, Adult
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 397
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: population of adult AML patients treated at Italian GIMEMA centers

Brief summary: This multicenter, prospective and retrospective observational study aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients.

Detailed description: This multicenter, prospective and retrospective observational study (model: case only) aims to evaluate the use and efficacy of new drugs or their combinations in real-life in a population of adult AML patients treated at Italian GIMEMA centers. No additional procedures or visits other than those required by normal clinical practice will be required. every patient will be followed for a minimum of 24 months.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 years or older
2. AML diagnosis according to the ELN guidelines, excluding M3
3. Signed Informed consent, if applicable
4. Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:

   * patients affected by FLT3-mutated AML treated with gilteritinib.
   * patients affected by IDH-mutated AML treated with IDH inhibitors.
   * patients affected by AML in maintenance therapy with oral azacytidine.
   * patients affected by AML treated with glasdegib.
   * patients affected by AML treated with gemtuzumab ozogamicin.
   * other novel drugs or combination for the treatment of AML approved during the study period.

Exclusion Criteria:

Patients included in interventional clinical trials.

Primary outcomes:
measure: New therapies efficacy in terms of Overall survival
timeFrame: at 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Haematology, University of Modena and Reggio Emilia
name: Anna Candoni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02666573: Photodynamic Therapy During Supportive Periodontal Therapy
Official title: Effects of Photodynamic Therapy on Clinical and Immunological Parameters in a Group of Periodontal Patients Undergoing Supportive Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontal Diseases
Chronic Periodontitis
Periodontal Attachment Loss
Keywords: drug therapy
Photosensitizing Agents
therapeutic use
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2016-01-28
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 27 subjects on SPT, each with at least two residual pockets ≥5mm, were recruited for this randomised, split-mouth controlled trial, providing a total of 72 sites. At baseline, probing pocket depth (PPD), recession, clinical attachment level (CAL), plaque and bleeding on probing (BOP) of all sites were examined. Gingival crevicular fluid (GCF) were collected to determine level of cytokines IL-1β, -6, -8, TNF-α and MMP-8 via ELISA. Control sites received subgingival instrumentation and rubber cup polishing with pumice. In addition test sites received a single application of PDT using Fotosan® and photosensitizer consisting of toludine blue O solution. The subjects were recalled three and six months later and re-examined. Site level analysis was performed.


Eligibility criteria: Inclusion Criteria:

1. Good general health with no systemic diseases causing manifestation of periodontal diseases
2. Age ≥ 21 years
3. History of chronic periodontitis
4. At least two residual PPD ≥ 5 mm with or without bleeding on probing
5. Compliant with recalls, i.e. last SPT visit at most 6 months before start of trial
6. Able to give written informed consent

Exclusion Criteria:

1. Pregnant or lactating females
2. Local or systemic antibiotics intake in the past 3 months
3. Systemic conditions which could affect progression of periodontitis
4. Long term use of NSAIDs or immunosuppressive medications
5. Participation in other clinical trials

Primary outcomes:
measure: Difference in percentage change in probing pocket depth
timeFrame: 6 months
Secondary outcomes:
measure: Bleeding on probing
timeFrame: 6 months
measure: Clinical attachment level
timeFrame: 6 months
measure: Recession
timeFrame: 6 months
measure: Cytokines level
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03915873: Evaluation of Bleeding Score in Egyptian Patients With vWD Type I and Correlate it With Laboratory Parameters
Official title: Assessing the Bleeding Severity in Type I Von Willebrand Patients Using the International Society on Thrombosis and Hemostasis Bleeding Assessment Tool ( ISTH-BAT) Questionnaire
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Von Willebrand Disease, Type 1
Keywords: von willebrand
egyptian
questionnaire
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 1 von willebrand egyptian patients

Brief summary: Applying the ISTH-BAT questionnaire on Egyptian patients with type I VWD aiming to correlate the BS with the laboratory findings

Detailed description: The clinical phenotype of the disease is variable and tends to be mild in type 1 vWD, whereas it shows serious bleeding manifestations in types 2 and 3. Overall, the symptoms reported in vWD include easy bruising, epistaxis, gastrointestinal bleeding, excessive menstrual bleeding, postpartum haemorrhage, and excessive bleeding after surgical operation and minor wounds.However, A distinctive bleeding history is a prerequisite for the diagnosis of any bleeding disorder and should guide further laboratory investigations In an attempt to standardize the diagnostic criteria of VWD, a bleeding questionnaire and a bleeding score were developed The combination of a standardized bleeding questionnaire and a well-defined interpretation grid (for the computation of the final (BS) has been referred to as a Bleeding Assessment Tool (BAT).

Eligibility criteria: Inclusion Criteria:

* type 1 vWD patients
* healthy subjects with no known problem with bleeding or bruising were also recruited

Exclusion Criteria:

-

Primary outcomes:
measure: the International Society on Thrombosis and Hemostasis-Bleeding Assessment Tool (ISTH-BAT)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: