louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02084472: Accessible and Affordable Moisturizers for Atopic Eczema
Official title: Accessible and Affordable Moisturizers for Atopic Eczema: the 2am Atopic Eczema Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Atopic Dermatitis
Keywords: atopic eczema
moisturisers
alternatives
affordable
Lead sponsor: Red Cross War Memorial Childrens Hospital
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Aqueous (EUA) cream, cetomacrogol (CMG) and emulsifying ointment (HEB) are in South Africa's essential drug list (EDL) but are not available to most rural patients. To assess whether accessible moisturizers can be used as alternatives in atopic eczema (AD), a randomized controlled trial of patients with mild-to-moderate AD, aged 1-12 years was conducted. Two separate sub-studies were conducted using a randomized controlled single (assessor) blind trial design. Study 1 compared UEA vs. liquid paraffin (unscented baby oil) for baths, all patients used HEB as moisturiser. In Study 2, 4 moisturisers were compared -HEB, CMG, petroleum jelly and petroleum jelly/Glycerine (2:1). Assessments (SCORAD, POEM, NESS and IQDOL) carried out at baseline, week 4, 8 and 12. Routine topical steroids and antihistamines were continued as prescribed.


Eligibility criteria: Inclusion Criteria:

* Patients with Atopic dermatitis as defined by the united kingdom (UK) Working party Diagnostic Criteria
* Atopic Dermatitis patient with mild to moderate stable atopic eczema with parents/guardians willing and able to apply study moisturizers as directed and commit to attend all visits.

Exclusion Criteria:

* Less than 1 year of age
* Patients with atopic dermatitis treated with systemic preparations

Primary outcomes:
measure: Change in the validated SCORing Atopic Dermatitis(SCORAD)
timeFrame: Baseline, week 4, 8 and week 12
Secondary outcomes:
measure: Change in the patient quality-of-life as measured by the infants dermatitis quality of life (IDQOL) index at each visit.
timeFrame: Baseline, week 4, 8,12
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Red Cross War Memorial Children's Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Nonhlanhla Khumalo, MD, PhD
role: STUDY_DIRECTOR
affiliation: Red Cross War Memorial Children's Hospital
name: Carol Hlela, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04497272: Assesment of the Metabolomic Signature in COVID-19 Patients
Official title: Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID 19
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2020-08-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient with COVID-19 disease
Primary purpose: DIAGNOSTIC

Brief summary: Metabolomics is the analysis of small molecules in a biological sample (cells, tissues or biological fluids). It can potentially detect very sensitively any change related to a pathology or exposure to a toxic agent. The analyses are fast, inexpensive and therefore applicable in routine, particularly in health care. Given the emergence of this new disease, COVID-19, there is a real need to better understand the pathophysiological mechanisms of SARS-CoV-2 infection. In this context, metabolomics could have a place and could lead to the development of interesting diagnostic or prognostic tools. The objective of this study is to identify, through the analysis of biological samples (blood and urine), whether there is a metabolomic signature in patients with COVID-19.


Eligibility criteria: Inclusion Criteria:

* patient over 18 years of age
* affiliated to a social security scheme
* consultant in the emergency department and/or being hospitalized for suspected SARS CoV infection
* confirmation, after medical examination, of the need for a biological examination (this will negate the need for additional venipuncture)

Exclusion criteria:

* Patient who do not meet inclusion criteria
* Person subject to a guardianship order
* Opposition to the use of the data or samples (withdrawal of non-opposition) / Sponsor's or investigator's decision

Primary outcomes:
measure: Identifying the metabolomic signature
timeFrame: Enrollment
Secondary outcomes:
measure: Identification of the metabolomic profile according to clinical severity.
timeFrame: Enrollment
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de nice
state: Alpes-Maritimes
Study officials:
affiliation: Néphrologie, CHU de Nice
name: OCCELLI Céline
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00463372: Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
Official title: A Phase I, Investigator And Subject-Blind (Sponsor Unblinded), Placebo-Controlled Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-02545920 After Multiple Oral Dose Administration In Subjects With Stable Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Schizo-affective Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with schizophrenia or schizo-affective disorder who are currently clinically stable and to evaluate the serum and urine pharmacokinetics of PF-02545920 and the N-desmethyl metabolite, PF-01001252, after multiple doses of PF-02545920 administered orally.


Eligibility criteria: Inclusion Criteria:

* Subjects with DSM-IV diagnosis of schizophrenia or schizo-affective disorder for whom antipsychotic monotherapy is indicated.
* Subjects must be free from an acute exacerbation of psychosis for at least 3 months prior to screening.
* Current Clinical Global Impression (CGI) of Severity of Illness score ≤ 3.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence or history of a primary DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder.
* Any condition possibly affecting drug absorption (e.g., gastrectomy).

Primary outcomes:
measure: Safety endpoints: physical and neurological examination, adverse event reports, clinical laboratory tests, vital signs, and 12-lead ECGs throughout the conduct of the study.
measure: Pharmacokinetic endpoints: Primary: AUCtau, Tmax and Cmax of PF-02545920 and PF-01001252 on Days 1 and 13.
Secondary outcomes:
measure: Secondary efficacy endpoints include: PANSS, CGI-S, CGI-I, CDSS, CNSVS VS-M cognitive battery, ESRS-A and SSS change from baseline to day 12.
measure: Secondary PK endpoints include AUClast, t1/2, Cavg, Cmax/Cmin ratio on Day 13, and urinary excretion parameters (renal clearance and amount excreted over the dosing interval) of PF-02545920 and PF-01001252 as data permit.
Other outcomes:
Locations:
city: George
country: South Africa
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02479672: Comparison of the VividTrac® Videolaryngoscope to Direct Laryngoscopy in Adults Under Manual Inline Stabilization
Official title: Comparison of the VividTrac® Videolaryngoscope to Direct Laryngoscopy in Adults Under Manual Inline Stabilization
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Endotracheal Intubation
Keywords: breathing tube placement
VideoTrac® laryngoscope
direct laryngoscopy
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective randomized clinical study to be performed in adult patients ages 18 and older who are undergoing surgical procedures requiring endotracheal intubation. Adult patients will be randomized to either the VideoTrac® laryngoscope or direct laryngoscopy and the time to intubation will be compared and recorded. Patients in both treatment arms will receive manual inline stabilization. The study hypothesis is that the time to endotracheal intubation will be decreased in the VividTrac® video laryngoscope group when compared to direct laryngoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients will be 18 years old and older requiring endotracheal intubation

Exclusion Criteria:

* Patients with increased pulmonary risk;
* Prior documentation of difficult endotracheal intubation;
* elevated intracranial pressure;
* those who lack legal representative consent

Primary outcomes:
measure: Time to Intubation
timeFrame: day of surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02764372: Telerehabilitation Upper Extremity for Neurological Disorders
Official title: Serious Games for Upper Extremity Rehabilitation for Patients With Neurological Disorders: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Stroke
Keywords: Arm rehabilitation
Serious games
stroke
Multiple sclerosis
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
Collaborators: name: University of Bremen
First posted: 2016-05-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aims of the present study were to:

* Investigate the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services.
* Provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with MS.

Main results suggest that the serious games approach was positively received in terms of user experience and motivation to use, with the participants showing also improvements in functional abilities of the treated arm.

Detailed description: The objective of this pilot study was to assess the feasibility of using a therapeutic gaming system (REHAB@HOME), based on Kinect, to augment upper extremity neurorehabilitation services. A secondary objective was to provide preliminary evidence of clinical efficacy of the approach in increasing arm activity and health related quality of life of persons post stroke or with multiple sclerosis (MS).

A pilot single-blind randomized controlled trial was carried out in an inpatient and ambulatory care at a rehabilitation center. Twenty persons with multiple sclerosis (n=16) or chronic poststroke (n=4) receiving rehabilitation at the center, able to flex shoulder and elbow at least 45 degrees, participated in the study.

An intervention group received Serious Games-based upper extremity therapy for a total of 12 sessions (4-5 sessions, lasting 40 minutes, per week) and the control played the same amount of time with commercial exergames of the Wii. Both groups received their usual rehabilitation services as well as game playing.

Eligibility criteria: Inclusion Criteria:

* Persons Post stroke or with MS with resultant upper extremity motor deficits.
* Range of motion of shoulder and elbow equal or higher than 45 degrees.
* Able to comprehend and follow directions.

Exclusion Criteria:

* Wearing pace maker
* Comorbidities affecting arm use
* Not able to comprehend and follow directions

Primary outcomes:
measure: 9 Hole peg test
timeFrame: 10 months
measure: Box and Block test
timeFrame: 10 months
Secondary outcomes:
measure: Short Form 12
timeFrame: 10 months
measure: the EQ-5D visual analogue scale (EQ-VAS)
timeFrame: 10 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06331572: Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression
Official title: Exploring Blood Plasma Metabolomics: Unraveling the Metabolic Landscape in Treatment-Resistant Adolescent Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychiatric Disorder
Major Depressive Disorder
Metabolic Disorder
Keywords: adolescent MDD
treatment-resistant depression
metabolomic
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 162
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: FEDN-MDD: 53 patients with MDD who had a first episode and had not been treated with antidepressants TRD: 53 patients who had been on medication for at least 6 weeks or more and were not responding to antidepressant therapy HC: 56 healthy subjects

Brief summary: This study contributes new evidence for the identification of adolescent TRD and sheds light on differing pathophysiologies by delineating distinct plasma metabolic profiles between adolescent TRD and FEDN-MDD.


Eligibility criteria: Inclusion Criteria:

FEDN-MDD：

1. Age 12-18 years
2. Meet the diagnostic criteria for MDD according to the DSM-5
3. First-episode and drug-naive
4. HAMD-17 score \> 17

TRD:

1. Age 12-18 years
2. Meet the diagnostic criteria for MDD according to the DSM-5
3. HAMD-17 score \> 13
4. Currently or previously taking a standard therapeutic dose of antidepressant for at least 6 weeks, and they had at least one historical failure to an antidepressant (reduction in depressive symptoms \<50%)

HC:

1. age 12-18 years
2. HAMD-17 score \< 7
3. HCs without a personal history of a mental illness or family history in a first-degree relative

Exclusion Criteria:

FEDN-MDD、TRD：

1. the presence or past history of severe medical, neurological or psychiatric disorders (other than MDD in patients)
2. anxiety comorbidity was not considered an exclusion criterion provided that MDD was the main diagnosis and the primary reason for seeking assistance
3. substance abuse, head trauma, or loss of consciousness
4. Chronic physical diseases that significantly affect peripheral metabolism or neurological function
5. Pregnant and lactating women

HC:

1. the presence or past history of severe medical, neurological or psychiatric disorders
2. substance abuse, head trauma, or loss of consciousness
3. Chronic physical diseases that significantly affect peripheral metabolism or neurological function
4. Pregnant and lactating women

Primary outcomes:
measure: 17 items Hamilton Depression Scale
timeFrame: baseline
Secondary outcomes:
measure: Hamilton Anxiety Scale
timeFrame: baseline
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Province
Study officials:
References:
Clinical trial NCT03676868: Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations
Official title: Biology of Cerebral Arteriovenous Malformations : Study of the Link Between Blood Biomarkers and the Haemorrhagic Prognosis of Cerebral Arteriovenous Malformations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Arteriovenous Malformations
Ruptured or Unruptured Cerebral Arteriovenous Malformations
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2018-09-19
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with a cerebral arterioveinus malformation for which an intervention (endovascular treatment or surgery) or only clinical monitoring is planned

Brief summary: The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.

The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.

The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient with a cerebral AVM for which an intervention (endovascular treatment or surgery) or only clinical monitoring
* Express consent to participate in the study

And

* children
* Free informed and express consent of both holders of the minor patient's parental authority, or, by way of derogation and only if the other holder of parental authority cannot give his or her consent within a time limit compatible with the methodological requirements specific to the conduct of the research with regard to its purposes, of one of the two holders of parental authority

Exclusion Criteria:

* Patient benefiting from a legal protection measure
* Pregnant or breast feeding woman

Primary outcomes:
measure: Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic
timeFrame: 6 months
measure: Associaton between dosage of platelet and the arteriovenous malformation pronostic
timeFrame: 6 months
measure: Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic
timeFrame: 6 months
measure: Associaton between neo-angiogenesis activation markers and the arteriovenous malformation pronostic
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Rotschild
Study officials:
References:
Clinical trial NCT03641768: Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
Official title: Risk Prediction for Alzheimer Dementia With Brain Imaging and Genetics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alzheimer Dementia
Posttraumatic Stress Disorder
Traumatic Brain Injury
Keywords: Alzheimer Dementia
PTSD
MRI
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn about how trauma, posttraumatic stress disorder (PTSD), and mild traumatic brain injury that can occur during deployment affect the brain. The investigators also want to learn how PTSD and mild traumatic brain injury can affect the chance of developing Alzheimer disease later in life. The investigators will study this by using magnetic resonance imaging and positron emission tomography scans to obtain pictures of the brain.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65
* Previously enrolled in studies of OEF/OIF veterans by the same investigators
* Free of implanted metal objects or mental shards in eyes
* Fluent in English and capable of consenting

Exclusion Criteria:

* Axis I disorders other than Major Depressive Disorder or PTSD
* Current substance abuse or lifetime substance dependence (other than nicotine)
* High risk for suicide
* Claustrophobia
* Neurological disorders
* Learning disability or developmental delay
* Major medical conditions

Primary outcomes:
measure: Cortical thickness as measured by MRI scans
timeFrame: Baseline
measure: Beta amyloid plaques as measured by PET scans
timeFrame: Baseline
measure: Tau proteins as measured by PET scans
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA
state: North Carolina
Study officials:
affiliation: Duke University
name: Rajendra Morey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00515268: Endotoxin Challenge Study For Healthy Men and Women
Official title: A Double Blind, Placebo Controlled, Repeat Dose Study to Compare the Effectiveness of Two Doses of GSK256066 With Placebo in Reducing Lung Inflammation Following Segmental LPS Challenge in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: LPS challenge,
Healthy volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-08-13
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females (contraception restrictions),
* 18-50yrs,
* BMI 19-31kg/m2,
* Non-smokers,
* FEV1 \>/= 80% predicted

Exclusion Criteria:

* Abnormal troponin and/or CK MB,
* Participated in any GSK study involving the administration of COA for \>/= 21 days.

Primary outcomes:
measure: Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure
timeFrame: 24 hours
Secondary outcomes:
measure: Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8
timeFrame: Day 1,Day 7&DAY 8
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: GSK Investigational Site
state: Niedersachsen
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: