louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02540278: Evaluation of the Positive Prevention PLUS Program
Official title: Evaluation of the Positive Prevention PLUS Program Teen Pregnancy Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy in Adolescence
Lead sponsor: California State University, San Bernardino
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2015-09-03
Enrollment: 4267
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to determine if the Positive Prevention PLUS teen pregnancy prevention program has an impact on abstinence, birth control use, and likelihood of becoming pregnant.

Detailed description: A clustered randomized controlled trial (CRCT) was employed where participating high school sites were randomly assigned either to a treatment group that implemented the Positive Prevention PLUS program or a control group. Students completed a self-administered survey at baseline (prior to program implementation) and a 6 month follow-up survey (post program implementation). Eligible students in the sample included all male and female 9th-grade students from 21 high schools enrolled in mandatory 9th-grade health, science, or physical education classes, to which the district assigns students randomly. Of the 7,042 eligible students, 4,267 received parental consent and were enrolled in the study. Outcome variables include initiation of sexual activity, ever been pregnant, and birth control use.

Eligibility criteria: Inclusion Criteria:

* Must have parental consent and be in the eligible school sites.

Exclusion Criteria:

-

Primary outcomes:
measure: Ever had sex (Yes/No)
timeFrame: 6 months
measure: Ever been pregnant (Yes/No)
timeFrame: 6 months
measure: Sex without using birth control in prior 3 months (Yes/No)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Bernardino
country: United States
facility: CSUSB
state: California
Study officials:
References:
Clinical trial NCT02429778: Relaxation Treatment for Anxiety in Adults Aged 60 or Older
Official title: Reducing Late-Life Anxiety and Improving Functioning With Self-Directed Relaxation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: VA Palo Alto Health Care System
name: Brain & Behavior Research Foundation
First posted: 2015-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral Intervention (relaxation, breathing, activity engagement)
Primary purpose: TREATMENT

Brief summary: The PI developed a self-directed program to treat late-life anxiety called Breathing, Relaxation, and Education for Anxiety Treatment in the Home Environment (BREATHE). This program consists of weekly video lessons that participants watch on digital video disc (DVD) along with weekly telephone check-ins. In BREATHE participants will learn two behavioral interventions: diaphragmatic breathing and progressive muscle relaxation (PMR). The purpose of the study is to examine whether the self-directed BREATHE program is superior to a wait list control in reducing anxiety in older adults with anxiety disorders. For those assigned to wait list control, they will be offered opportunity to participate in BREATHE treatment after 8 weeks of wait list.


Eligibility criteria: Inclusion Criteria:

* Participants have a diagnosis of an anxiety disorder, specifically, Generalized Anxiety Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder or Anxiety Disorder Unspecified/Other Specified).
* Participants speak English.

Exclusion Criteria:

* Diagnosis of Dementia
* Probable presence of significant cognitive impairment according to a brief cognitive screen
* Serious mental illness (schizophrenia, psychosis, bipolar disorder)

Primary outcomes:
measure: Change in Anxiety Symptoms
timeFrame: Change from baseline to 8 weeks
measure: Change in Activity Engagement
timeFrame: Change from baseline to 8 weeks
Secondary outcomes:
measure: Change in Depressive Symptoms
timeFrame: Change from baseline to 8 weeks
measure: Change in Somatic Symptoms
timeFrame: Change from baseline to 8 weeks
Other outcomes:
measure: Change in Heart Rate
timeFrame: Change from baseline to 8 weeks
measure: Change in Blood Pressure
timeFrame: Change from baseline to 8 weeks
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto/Stanford University
name: Christine E Gould, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04222478: Interest of Auriculotherapy in the Treatment of Xerostomia
Official title: Interest of Auriculotherapy in the Treatment of Xerostomia.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Xerostomia
Keywords: Auriculotherapy
Xerostomia
ENT cancer
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 68
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 aim of the study is to show that auriculotherapy is effective in the treatment of xerostomia


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old;
* Complain about xerostomia after cervical irradiation in the context of ENT cancer;
* End of radiotherapy\> 3 months
* Covered by a national healthcare insurance
* Consent form signed.

Non inclusion Criteria:

* Pregnant or breastfeeding women;
* Local counterindication to auriculotherapy;
* With anticoagulant treatment;
* History or existing of hemophilia;
* Valvular prosthesis;
* Ear's pavilion infection;
* Treatment by auriculotherapy or acupuncture in this indication in the previous 12 months;
* Having started in the 48 hours preceding the first auriculotherapy session, any new management of xerostomia and likely to interfere with the study (specific medication and/or complementary therapeutic management);
* Difficulty to comply with the treatment, questionnaires or study protocol;
* Being deprived of liberty or under guardianship.

Primary outcomes:
measure: Number of patients with improvement of salivation after 3 month of treatment (Real Auriculotherapy group compared to Sham Auriculotherapy group)
timeFrame: 3 months
Secondary outcomes:
measure: Assess the effect of auriculotherapy on the subjective improvement of salivation
timeFrame: 3 months
measure: Assess the effect of auriculotherapy on the subjective improvement of clinical status
timeFrame: 3 months
measure: Assess the effect of auriculotherapy on the dysgeusia, dysphagia, pain or burning sensations
timeFrame: 3 months
measure: Assess the effect of auriculotherapy on anxiety and depression
timeFrame: 3 months
measure: Assess the effect of auriculotherapy on quality of life
timeFrame: 3 months
measure: Assess the effect of auriculotherapy on the wish to continue treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan
state: Bretagne
city: Férolles-Attilly
country: France
facility: Hôpital Forcilles
city: Paris
country: France
facility: GHP Saint Joseph
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hopital Foch
name: Mireille Michel-Cherqui, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01771978: Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
Official title: Effects of Diltiazem and/or N-Acétylcystéine Versus Placebo on hémodynamiques and Biological Repercussions of the Ischaemia-réperfusion During the Coronary Surgery With Beating Heart
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ischaemia-reperfusion Injury
Keywords: ischaemia-reperfusion injury
cardiac surgery
oxidative stress markers
troponin
diltiazem
acetylcystein
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Less oxidative stress occurs during off-pump than on-pump coronary artery bypass graft (CABG) surgery but warm ischaemia-reperfusion injury may occur following transient coronary artery clamping. The aim of this study was to compare the preventive effects of diltiazem and N-acetylcysteine (NAC), alone or in combination, on biomarkers of myocardial damage and oxidative stress during off-pump CABG surgery.


Eligibility criteria: Inclusion Criteria:

* Age included between 60 and 80 years

Exclusion Criteria:

* Age \< 60 or \> 80 years
* Pregnancy
* The allergy in used medicines (N-acétylcystéine, Diltiazem)
* Presence of a pathology valvulaire associated
* Urgency
* Unstable angor
* Bypass as a matter of urgency
* Recours peropératoire to a CEC
* FE \< 0,40
* BAV of the 2nd and 3rd not sailed degree
* fibrillation or flutter little finger.

Primary outcomes:
measure: Reduce the percentage 40% of patients operated on a beating heart to 10% as a result of treatment with diltiazem and N-acetylcysteine
timeFrame: during ischaemia-reperfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Department of Anaesthesiology
Study officials:
affiliation: Strasbourg University Hospital, France
name: Annick Steib, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05965778: Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
Official title: Comparison of the Performance and Safety of T2769 Versus Vismed® Multi in the Treatment of Moderate to Severe Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2023-07-28
Enrollment: 226
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: To demonstrate the non-inferiority of T2769 compared to Vismed® Multi in terms of total ocular surface staining (Oxford score) after 35 days of treatment.

To evaluate the performance and safety of T2769 versus Vismed® Multi.


Eligibility criteria: Inclusion Criteria:

* Informed consent signed and dated (obtained prior to initiating any procedures).
* Patient aged ≥18 years old.
* Known dry eye syndrome requiring artificial tears for at least the last 3 months prior to screening visit.
* Surface Disease Index (OSDI) Score ≥ 23.
* Ocular discomfort evaluated by VAS ≥ 40 mm.

Exclusion Criteria:

* Far best-corrected visual acuity (BCVA) ≥+0.7 LogMar (e.g., ≤0.2 in decimal value or ≤20/100 Snellen equivalent or ≤50 (ETDRS) letters Early Treatment Diabetic Retinopathy Study).
* Severe blepharitis according to the judgment of the investigator
* Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.

Primary outcomes:
measure: Change from baseline (Day 1) in total ocular surface staining grade according to Oxford 0-15 grading scheme.
timeFrame: Oxford 0-15 grading scheme: is assessed at Day 1 and Day 36
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Gabriel-Montpied University Hospital
Study officials:
affiliation: Individual Practice for Specialized Ophthalmology Care
name: Frédéric CHIAMBARETTA, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771078: Expanded Access Protocol (EAP) for Participants Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Official title: Expanded Access Protocol (EAP) for Patients Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Multiple Myeloma
Keywords: BB2121
Multiple Myeloma
Expanded Access
idecabtagene vicleucel
nonconforming
CAR T
EAP
Pre-Approval Access
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-02-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This study is designed to evaluate the safety and efficacy of nonconforming idecabtagene vicleucel (ide-cel) in participants with multiple myeloma per the approved prescribing information. This is an expanded access protocol (EAP) to be conducted at Risk Evaluation and Mitigation Strategies (REMS) qualified sites approved for commercial administration of idecabtagene vicleucel and where the EAP is authorized to be conducted for use of nonconforming idecabtagene vicleucel.

Non-conforming idecabtagene vicluecel is idecabtagene vicleucel that does not meet commercial release specifications but may be acceptable for use as an investigational product in the Expanded Access Protocol setting.


Eligibility criteria: Inclusion Criteria:

* Had a participant-specific batch of Idecabtagene vicleucel (ide-cel) manufactured intended for commercial treatment; however, the final manufactured product was nonconforming and did not meet commercial release criteria
* Remanufacturing is deemed not feasible or clinically inappropriate per assessment of the treating physician in discussion with the participant
* Clinically stable

Exclusion Criteria:

* Has a hypersensitivity to the active substance or to any of the excipients
* No experience of a significant worsening in clinical status that would, in the opinion of the treating physician, either increase the risk of Adverse Events associated with lymphodepleting chemotherapy, or exclude them from treatment with nonconforming Idecabtagene vicleucel (ide-cel)
* Has any condition and/or laboratory abnormality that places the participant at unacceptable risk if he/she were to participate in the Expanded Access Protocol based on the Investigator's judgement

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05916378: Achieving Equity in Genomic Testing for Breast Cancer Through Partner-Led Strategies and Policies
Official title: Achieving Equity in Genomic Testing for Breast Cancer Through Partner-Led Strategies and Policies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Genomic Testing
Precision Breast Cancer Care
Precision Medicine
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: The Latino Cancer Institute
First posted: 2023-06-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We expect to recruit 150 participants for enrollment in phase 1. These participants will include 100 patients diagnosed with breast cancer and 50 caregivers. In phase 2, we expect to recruit 55 of our phase 1 survey participants to complete a one-time one-on-one in-depth interview.

Brief summary: The purpose of this study is to identify the barriers, and the extent of said barriers, to genomic testing for breast cancer patients among low-income and minority populations, particularly throughout Northern California. The investigators have created a survey that is available online for any patient with cancer to fill out voluntarily regarding their experiences to date. The survey is available at: https://stanforduniversity.qualtrics.com/jfe/form/SV_7VElf8oesWcB3bE

Detailed description: The study has two main data-collecting phases. In phase 1, the investigators will engage multilevel stakeholders to respond to a survey assessing experience with and perceptions of genomic testing and its accessibility for patients with breast cancer in California. In phase 2, selected and interested survey participants who voluntarily provide their contact information on the survey will be asked to participate in an in-depth 1:1 semi-structured interview to explore disparities in genomic testing for breast cancer more closely. The investigators will then utilize their findings from both phases to present aggregate findings to an Expert Panel and Community Advisory Board and work together to develop policy recommendations. The policy recommendations will then be presented to policy makers, with the aim of identifying sustainable solutions that address breast cancer treatment and outcome disparities throughout Northern California.

Eligibility criteria: Inclusion Criteria:

* The patients must be 18 years or older.
* Patients who opt in to complete the survey.
* Patients must have the capacity to verbally consent for the interview.

Exclusion Criteria:

* Patients who under the age of 18 years old.

Primary outcomes:
measure: Number of participants who fill out the survey and participate in the semi-structured interviews. [ Time Frame: 12 Months ]
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
References:
Clinical trial NCT06502678: AUTOANTIBODIES AND SYSTEMIC SCLEROSIS
Official title: Systemic Sclerosis: the Role of Autoantibodies and Their Blockade in the Disease Pathogenesis. In Vitro and in Vivo Experimental Models
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Understand Pathogenicity of SSc-specific Antibodies in SSc and the Effect of Antibody Blockade in Vitro
Lead sponsor: IRCCS Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: systemic sclerosis patients characterised by the autoantibody positivity

Brief summary: Established in vitro assays, combined with state-of-the-art multi-omics approaches and innovative in vitro experimental models, will gain insights into the mechanistic bases underlying Systemic Sclerosis (SS) pathogenesis and will dissect the consequences of treatment with Efgartigimod on functional and phenotypic cell behaviors. Healthy microvascular endothelial cells, fibroblasts and monocytes will be challenged with serum and autoantibodies prior to or upon treatment with Efgartigimod in order to assess both the prevention and the recovery capacity of the FcR blocker. The putative modulatory effect of Efgartigimod on vascular remodeling, endothelial-to-mesenchymal transition, fibroblast-to-myofibroblasts transition and monocyte behavior will be evaluated in in-vitro consolidated assays. Integrated Omics analyses will support and complement the in vitro findings by unveiling potential prognostic signatures and by identifying specific treatment-related profiles that might guide the modulation of the drug usage in order to maximize its beneficial effects.


Eligibility criteria: Inclusion Criteria:

* positivity of autoantibodies

Exclusion Criteria:

* pregnant

Primary outcomes:
measure: Verify if Fcblocker can block the pathogenic activity of autoantibodies
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04293978: Virtual Reality Relaxation for Addiction Inpatients
Official title: Virtual Reality Relaxation at an Adolescent Addiction Inpatient Ward: A Single-arm Pilot Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Addiction
Keywords: Virtual Reality
Relaxation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm University
First posted: 2020-03-03
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, with immediate effects of interest. Varying number of intervention uses across participants.
Primary purpose: TREATMENT

Brief summary: This trial examines the immediate session effect of Virtual Reality (VR) relaxation, when used at an addiction inpatient ward for adolescents.

Detailed description: Past research has revealed that Virtual Reality nature environments can be used to induce relaxation, yet this type of intervention has not yet been evaluated in a clinical setting. This trial examines whether VR relaxation can be used as a digital equivalent of a (physical) comfort room at an an addiction inpatient ward for adolescents.

Eligibility criteria: Inclusion Criteria:

* Patient at Maria Ungdom inpatient ward.
* Sufficient grasp of Swedish to understand terms of study participation and intervention instructions.

Exclusion Criteria:

* Self-reported stereoscopic vision or balance problems hindering VR experience.
* Self-reported history of repeated violent outbursts when using technology.

Primary outcomes:
measure: Change from baseline in general well-being
timeFrame: Change from baseline (start of session) to immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Maria Ungdom Heldygnsvård
Study officials:
affiliation: Karolinska Institutet
name: Philip Lindner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lindner P, Miloff A, Hamilton W, Carlbring P. The Potential of Consumer-Targeted Virtual Reality Relaxation Applications: Descriptive Usage, Uptake and Application Performance Statistics for a First-Generation Application. Front Psychol. 2019 Feb 4;10:132. doi: 10.3389/fpsyg.2019.00132. eCollection 2019.