louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05878470: Reducing Self-stigma Using Brief Video Intervention
Official title: Reducing Self-stigma Using Brief Video Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stigma, Social
Mental Health Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 1214
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stigma is a profound obstacle to care. Self-stigma decreases sense of self-competency, as well as healthcare seeking and treatment adherence and creates barriers to pursuing employment, independent living, and fulfilling social life. For example, people with mental disorders avoid, delay, or drop out of treatment due to a fear of labeling and discrimination or experience treatments as ineffective or disrespectful. Therefore, reducing self stigma can reduce self-blame, improve self-confidence and provide support for people living with mental illness.

In a prior study, the investigators developed a short video intervention to reduce self-stigma among people with schizophrenia. The investigators would like to test the efficacy of this video using Prolific (a crowdsourcing platform). Specifically, the investigators are interested in recruiting 1,200 Prolific participants, ages 18-35, who mentioned in their profile while enrolling to Prolific that they have a mental health condition, and randomized them into watching the newly developed video to reduce self-stigma or participate in the non-intervention control arm. Participants will be invited to participate in a follow-up survey 30 days after completing the first survey.

Detailed description: The primary objective of this study is to test the video efficacy in reducing self stigma among 1,200 Prolific users who mentioned in their profile while enrolling to Prolific that they have a mental health condition (600 in an intervention group, and 600 in a non-intervention control group). The study participants will be invited to participate in a 30-day follow up questionnaire. The investigators hypothesize finding a reduced level of self-stigma among those who watch the intervention video.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* 18-35-year-old
* US residents
* Those who answered yes to "Do you have or have you had a diagnosed, ongoing mental health/illness/condition?"

Exclusion Criteria:

* Non English-speaking
* Non US residents
* Age younger than 18 or older than 35
* People who replied no to the question on ongoing mental health

Primary outcomes:
measure: Self-stigma
timeFrame: Baseline
measure: Self-stigma
timeFrame: Post (immediately after the intervention and for the control immediately after doing the baseline survey)
measure: Self-stigma
timeFrame: 30 day follow up
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References:
Clinical trial NCT03305770: DD T2 Daily Disposable Registration Trial
Official title: DD T2 Daily Disposable Registration Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Refractive Errors
Keywords: soft contact lenses
vision
eyesight
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2017-10-10
Enrollment: 107
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: The purpose of this study is to evaluate the performance of the investigational verofilcon A contact lens compared to the commercially available delefilcon A contact lens, by assessing visual acuity as the primary variable.

Detailed description: Enrolled participants will be randomized (2:1) to receive either verofilcon A (test) contact lenses or delefilcon A (control) contact lenses for wear in both eyes and attend 7 office visits: Baseline, Dispense, 1-week follow-up, 2-week follow-up, 1-month follow-up, 2-month follow-up and 3-month follow-up/Exit.

Eligibility criteria: Inclusion Criteria:

* Successful wear of spherical soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Best corrected VA 20/25 or better in each eye.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

* Any current or prior wear experience with DT1 lenses.
* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Monocular Visual Acuity (VA) With Contact Lenses at Each Visit (Snellen)
timeFrame: Dispense, Week 1, Week 2, Month 1, Month 2, Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Alcon Investigative Site
state: California
city: Longwood
country: United States
facility: Alcon Investigative Site
state: Florida
city: Maitland
country: United States
facility: Alcon Investigative Site
state: Florida
city: Bloomington
country: United States
facility: Alcon Investigative Site
state: Illinois
city: Brentwood
country: United States
facility: Alcon Investigative Site
state: Tennessee
city: Memphis
country: United States
facility: Alcon Investigative Site
state: Tennessee
Study officials:
affiliation: Alcon, a Novartis Division
name: Alcon, a Novartis Division
role: STUDY_DIRECTOR
References:
Clinical trial NCT05114070: Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy
Official title: Build a Decision Aid Tool to Help Emergency Intensive Care Specialists in the Context of Hypoxic Ischemic Encephalopathy. NEWBORN NEURO-DIGITAL STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Encephalopathy
Keywords: Full Term Newborn
EEG
HIE
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 106
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Babies born within a context of HIE (Hypoxic Ischemic Encephalopathy)

Brief summary: The project aims at designing a machine learning solution able to recognize characteristics signals patterns of brain damages in full term babies born within a context of Hypoxic Ischemic Encephalopathy (HIE)

Detailed description: Retrospective study based on a digital EEG signal library intending to design, train and test an efficient AI solution for hypothermia protocol start indications.

The output of the Project is to make available to pediatric resuscitation units an adequate tool to guide them in the decision of hypothermia protocol start in a general context of neurophysiologist competence scarcity. EEG signal that would allow the algorithm design will be based on several parameters of the conventional EEG and not only on signal amplitude

Eligibility criteria: Inclusion Criteria:

* Full term (\> 36 weeks)
* HIE context
* EEG recording before 6 hours of life

Exclusion Criteria:

-Opposition of parental authority holders of a patient born after 2015

Primary outcomes:
measure: Decision of hypothermia protocol start
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital TROUSSEAU
Study officials:
References:
Clinical trial NCT03528070: A Clinical Study of Tranilast in the Treatment of Sarcoidosis
Official title: A Clinical Study of Tranilast in the Treatment of Sarcoidosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Sarcoidosis
Keywords: Sarcoidosis
Tranilast
skin
lung
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 56
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: 56 patients with sarcoidosis will be selected to receive treatment of tranilast.The investigators can analyse the changes in the thickness and area of skin lesions before and after treatment as well as other involved organs nodule size changes to determine the efficacy and safety of drugs.

Detailed description: 56 patients with sarcoidosis will be selected. After the signing of the informed consent ,participants will be collected the initial lesions photos, the size of the lump by ultrasound, the forced vital capacity(FVC), and chemical examinations including blood routine examination, routine urine test, liver function, renal function. During tranilast treatment (0.1g each time, three times a day) , participants need regular follow-up (1 per month) including liver and kidney function, blood glucose level monitoring, every three months to retest ultrasound and the forced vital capacity(FVC). With 3 month as a time point, participants were observed for four points(one point if only skin invasion ).After the experiment, the experimental data will be arranged and the data will be statistically processed (t test) to determine whether it is meaningful.

Eligibility criteria: Inclusion Criteria:

* (1)patients with diagnosed sarcoidosis, the skin pathology showed non necrotic granuloma and negative staining of fungi and atypical mycobacterium; (2)No corticosteroids and immunosuppressants were used for nearly 1 months.

Exclusion Criteria:

* 1)with a liver or kidney disease, or accompanied by a tumor or a severe infection ; (2)with mental disease.

Primary outcomes:
measure: Changes in the size of the pulmonary nodule by ultrasound
timeFrame: 12 months
measure: Changes of the forced vital capacity(FVC)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00627770: Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance
Official title: Validation of a Procedure Using Bioimpedance to Measure the Edema of Lower Leg of Patients After Total Knee Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Keywords: Physical Therapy - Therapeutics - Edema
Arthroplasty replacement knee
Treatment outcome
Lead sponsor: Haute Ecole de Santé Vaud
Sponsor class: OTHER
Collaborators: name: University of Applied Sciences of Western Switzerland
name: University of Lausanne Hospitals
First posted: 2008-03-03
Enrollment: 34
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty

Detailed description: Current measurement techniques of edema are not adapted or not convenient for assessment in the post surgical environment. Developement of a convenient, quick and reliable method could be useful to facilitate edema evaluation in this context.

Eligibility criteria: Inclusion Criteria:

* knee replacement surgery

Exclusion Criteria:

* pacemaker
* cardiac defibrillator
* other metallic implant than knee arthroplasty

Primary outcomes:
measure: bioimpedance ratio right/left
timeFrame: presurgery, 2 and 8 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Département de l'Appareil Locomoteur - CHUV
Study officials:
affiliation: Haute Ecole de Santé Vaud
name: Claude A Pichonnaz, physiother.
role: PRINCIPAL_INVESTIGATOR
affiliation: Département de l'Appareil Locomoteur - CHUV + Faculté des sciences et techniques de l'ingénieur (STI) - EPFL
name: Brigitte M Jolles, PhD MER MSc
role: STUDY_DIRECTOR
affiliation: Haute Ecole Vaudoise d'Ingénierie et de Gestion
name: Correvon Marc, Engineer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pichonnaz C, Bassin JP, Lecureux E, Currat D, Jolles BM. Bioimpedance spectroscopy for swelling evaluation following total knee arthroplasty: a validation study. BMC Musculoskelet Disord. 2015 Apr 25;16:100. doi: 10.1186/s12891-015-0559-5.
Clinical trial NCT03245970: Impedance Cardiography to Decrease the Risk of Preeclampsia
Official title: Use of Impedance Cardiography to Decrease the Risk of Preeclampsia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Chronic Hypertension Complicating Pregnancy (Diagnosis)
Preeclampsia
Lead sponsor: University of Tennessee Medical Center
Sponsor class: OTHER
First posted: 2017-08-10
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 51
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to treatment or non treatment group
Primary purpose: PREVENTION

Brief summary: To determine if the use of impedance cardiography can identify appropriate medications for use in treating chronic hypertensive patients to decrease the risk of preeclampsia.

Detailed description: Impedance cardiography helps determine whether vasoconstriction or an elevated cardiac output is occurring. The test is easy to perform and non invasive. The treatment for an elevated cardiac output in pregnancy is a beta-blocker while a vasodilator is used for vasoconstriction. If a beta-blocker is given to someone that vasoconstricted, this might make the cardiovascular parameters worse, leading to no improvement in future pregnancy issues. Likewise, if a vasoconstricting drug is given to someone with an elevated cardiac output, it could potentially make the cardiovascular parameters worse.

All centers in the United States that choose to prescribe an antihypertensive medication for use in pregnancy do so by trial and error, whereas impedance cardiography can help the clinician choose the best medication from the start. Many pregnant patient patients have chronic hypertension and this population is at increased risk for superimposed preeclampsia and other pregnancy complications. The current recommendation for pregnancy is to NOT treat mild hypertension because studies have not shown any benefit. These studies, have also not shown any harm. Prior studies that have shown no benefit to treatment of mild hypertension in pregnancy may be hampered by choosing the wrong antihypertensive medication, thereby not improving the rate of superimposed preeclampsia and other pregnancy related complications.

Eligibility criteria: Inclusion Criteria:

Pregnant patients 18-51 years old Less than 20 weeks gestation with mild chronic hypertension - Not on antihypertensive medications

Exclusion Criteria:

Patients with an allergy to antihypertensive medication or contraindication for their usage such as certain cardiac or neurologic disorder during pregnancy Patients who have a blood pressure 140/90 or greater -

Primary outcomes:
measure: Rates of preeclampsia in chronically hypertensive pregnant women
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Knoxville
country: United States
facility: HIgh Risk Obstetrical Consultants
state: Tennessee
Study officials:
affiliation: University of Tennessee Medical Center
name: Kimberly Fortner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01570270: Cheese Intake and Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Endocannabinoids
Lead sponsor: Azienda Ospedaliera Brotzu
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in alpha-lipoic acid (ALA), conjugated linoleic acid (CLA) and vaccenic acid (VA), would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects.


Eligibility criteria: Inclusion Criteria:

* 42 adult volunteers (19 male and 23 female) with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL),
* 30-60 years of age

Exclusion Criteria:

* Pregnant (or those planning to become pregnant during the study period) and lactating women were excluded;
* also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit.
* In addition, those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening, were not enrolled.
* Volunteers with the following characteristics were also excluded:

  * total cholesterol ≥ 300 mg/dL,
  * serum triglycerides ≥ 250 mg/dL or ≤ 200 mg/dL,
  * HDL ≥ 70mg/dL,
  * BMI ≥ 30, or
  * uncontrolled hypertension (systolic blood pressure ≥ 160 mm Hg or
  * diastolic blood pressure ≥ 100 mm Hg) at screening.

Primary outcomes:
measure: modification of LDL-cholesterol levels
timeFrame: baseline and 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02818270: Evaluation of Aerosolized Drugs Deposition During Mechanical Ventilation
Official title: Evaluation of Aerosolized Drugs Deposition Delivered Through a Mechanical Ventilator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chang Gung University
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
First posted: 2016-06-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. The objective of this study was to evaluate inhaled bronchodilator and mucolytic agents delivered through a ventilator system.

Detailed description: Aerosolized medication is used widely to patients with respiratory illness and admitted in the intensive care unit, and includes bronchodilators, steroids, mucolytics, and antibiotics. Aerosol delivery through a ventilator is influenced by numerous factors from ventilator-related, circuit-related to device-related factors. Aerosolized drug delivery through a ventilator system was studied on bench model with albuterol, yet the results were often overestimated. Only few clinical trials on aerosol delivery deposition were published in the last decades. In addition, inhaled bronchodilators, mucolytics, antibiotics, and steroids are often administered to ventilated patients in the intensive care units in Taiwan, but they are never studied. Therefore, the aim of this study was to evaluate inhaled bronchodilator and mucolytics (acetylcystine) delivered by a jet nebulizer through a ventilator system to intubated patients.

Eligibility criteria: Inclusion Criteria:

* Mechanical ventilated patients with an endotracheal tube intubated
* Receiving aerosol therapy with salbutamol or acetylcystine
* On relatively stable medical condition

Exclusion Criteria:

* Pregnant
* Unstable hemodynamic status (e.g. blood pressure \<100/60 mmHg, under Intra-aortic balloon pump)
* Infected with airborne pathogens (e.g. tuberculosis or Influenza virus)
* Poor oxygenation (fraction of inspiratory oxygen \>0.8, under high frequency oscillatory ventilation, or extracorporeal membrane oxygenation)

Primary outcomes:
measure: Inhaled drug dose
timeFrame: Inhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes
Secondary outcomes:
measure: exhaled drug dose
timeFrame: Exhaled drug dose was collected Immediately after each nebulization, expected average of 20 minutes
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Chiayi Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung University
name: Hui-Ling Lin, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02403570: Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
Official title: Rotating Frame Relaxation Imaging in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Keywords: Multiple Sclerosis, MRI, rotating frame
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2015-03-31
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MS patients with relapsing-remitting or secondary progressive MS will be recruited from amongst the MS patients in the neurological outpatient policlinics in the Hospital District of Southwestern Finland.

Brief summary: The aim of this study is to develop novel magnetic resonance imaging (MRI) protocols suitable for patients with multiple sclerosis using advanced MRI such as rotating frame relaxation imaging. In addition, the investigators want to study the correlation between advanced MRI parameters and clinical disease progression.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of relapsing remitting MS made according to the Poser, McDonald's or revised McDonald's criteria (Group I) before participating in the study
* Initial MS diagnosis of relapsing remitting form of the disease according to the criteria as mentioned above, and conversion into the secondary progressive phase of the disease as evaluated by the referring neurologist according to the clinical evaluation and confirmed by the study physician (Group II).
* Mental status: Patients must be able to understand the meaning of the study
* Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff

Exclusion Criteria:

* Any other autoimmune disease than MS requiring immunomodulatory or immunosuppressive medication
* High-dose corticosteroid treatment within 30 days before participating in the study
* Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease
* Any psychiatric condition that compromises the subject's ability to participate in the study
* Infections: Patient must not have an uncontrolled serious infection
* No contraindications for MRI (cardiac pacemaker, intracranial clips etc)

Primary outcomes:
measure: MR relaxation values 0
timeFrame: Baseline
measure: MR relaxation values 1
timeFrame: One year
Secondary outcomes:
measure: MR relaxation values and clinical markers 0
timeFrame: Baseline
measure: MR relaxation values and clinical markers 1
timeFrame: One year
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Division of Clinical Neurosciences, Turku University Hospital
Study officials:
affiliation: Turku University Hospital, Department of Diagnostic Radiology
name: Hannu Aronen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: