louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06825351: A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial
Official title: A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 27
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: his feasibility study aims to compare the effectiveness of Psychological First Aid (PFA) and Dialectical Behavior Therapy (DBT) interventions in reducing suicide risk among undergraduate students. The study employs a crossover randomized controlled trial design, allowing participants to experience both interventions at different times.

Detailed description: Suicide risk among undergraduate students is a pressing mental health concern, exacerbated by academic pressures and social isolation. Psychological First Aid (PFA) is a supportive intervention designed to reduce distress and foster coping in the immediate aftermath of a crisis. Conversely, Dialectical Behavior Therapy (DBT) is a structured, evidence-based therapy that focuses on emotional regulation, interpersonal effectiveness, and distress tolerance. This study explores the feasibility and effectiveness of these two interventions in a university setting.

Eligibility criteria: Inclusion Criteria:

Participants in this feasibility study must be undergraduate students aged 18-25 years who are identified as at risk for suicide based on a validated screening tool. They must be currently enrolled in a degree program, able to provide informed consent, and proficient in English.

Exclusion Criteria:

Individuals with severe mental illnesses (e.g., schizophrenia, bipolar disorder), those in acute crisis requiring immediate intervention, current substance abuse issues, significant cognitive impairments, prior experience with DBT or similar therapies within the last year, and physical health conditions that could complicate participation.

Primary outcomes:
measure: Suicidal Ideation Attributes Scale
timeFrame: 3 months
measure: The Attitudes Toward Seeking Professional Psychological Help-Short Form
timeFrame: 3 months
measure: Perception of Academic Stress Scale
timeFrame: 3 months
measure: The Brief Resilience Scale
timeFrame: 3 months
measure: The Self-Compassion Scale
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley Committee
Study officials:
References:
Clinical trial NCT00608751: A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy
Official title: A Feasibility Study of Adaptive Intensity-Modulated Radiation Therapy in the Definitive Treatment of Head-and-Neck Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Head and Neck Cancer
Keywords: Newly Diagnosed head and neck cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 5
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: Patients with head and neck cancer and are schedule to receive standard radiation therapy known as IMRT to treat cancer

Detailed description: In this study, we will plan additional measurements of the position of the patient's organs weekly during radiation treatment. We will analyze these measurements in order to evaluate whether we need to adjust our treatment procedures for the remainder of the treatments. We might adjust the dose of radiation received to specific organs in order to try to minimize the amount of radiation the healthy tissue receives.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Karnofsky Performance Status of \>= 60
* New diagnosis of head-and-neck cancer, all subsites included (i.e. nasopharynx, oropharynx, oral cavity, hypopharynx, larynx.)
* All stages with measurable gross disease (\>= 1.0 cm) by CT imaging
* Pathologic confirmation of squamous cell carcinoma by biopsy or cytology
* Signed study-specific consent form
* Sequential or concurrent chemotherapy is allowed but not mandated. (no chemotherapy is allowed if patient is judged not to be a candidate for chemotherapy by the medical oncologist)

Exclusion Criteria

* Age \< 18
* Karnofsky Performance Status \< 60
* Radiographic or pathologic evidence of distant metastatic disease (i.e. other than cervical lymph nodes)
* Prior radiation therapy to the head-and-neck region

Primary outcomes:
measure: Feasibility of adaptive radiation therapy in the definitive treatment (MLC-based IMRT or helical tomotherapy)
timeFrame: 7 weeks
Secondary outcomes:
measure: Measure additional time required by physician and ancillary staff for the process of adaptive IMRT
timeFrame: 7 weeks
measure: Identify a subset of patients in whom adaptive IMRT would be recommended
timeFrame: 7 weeks
measure: Measure acute and late toxicity
timeFrame: Until patient death
measure: Local, regional, and distant recurrence
timeFrame: Until recurrence
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Wade Thorstad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02196051: Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.
Official title: Lipid and Carbohydrate Metabolism: Effects of Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: Insulin resistance
Exercise
de novo lipogenesis
NAFLD
Magnetic Resonance Spectroscopy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-07-21
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.

Detailed description: In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46 years) and healthy, lean elderly individuals (65-90 years) underwent 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis was determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies were performed in 2 sets: Study Part 1: Resting, Study Part 2: After 1 bout of 45 minutes exercise.

The study has been completed and published as two papers: August 16, 2011 and July 24, 2012.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index \< 29 kg/m2
* No regular exercise routine
* Non-smokers
* Absence of systemic and organ disease.

Exclusion Criteria:

* Hematocrit \< 35 vol%
* History of claustrophobia
* Ferromagnetic implants
* Regular exercise regimen
* Not weight stable
* Any significant hematological, neurological, musculoskeletal or endocrine disease (including diabetes mellitus)
* Any significant cardiovascular condition, including confirmed CAD and prior cardiovascular events
* Taking coumadin as anticoagulant therapy.

Primary outcomes:
measure: change in de novo lipogenesis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: YCCI/YNNH Hospital Research Unit
state: Connecticut
Study officials:
affiliation: Yale University
name: Kitt Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rabol R, Petersen KF, Dufour S, Flannery C, Shulman GI. Reversal of muscle insulin resistance with exercise reduces postprandial hepatic de novo lipogenesis in insulin resistant individuals. Proc Natl Acad Sci U S A. 2011 Aug 16;108(33):13705-9. doi: 10.1073/pnas.1110105108. Epub 2011 Aug 1.
citation: Flannery C, Dufour S, Rabol R, Shulman GI, Petersen KF. Skeletal muscle insulin resistance promotes increased hepatic de novo lipogenesis, hyperlipidemia, and hepatic steatosis in the elderly. Diabetes. 2012 Nov;61(11):2711-7. doi: 10.2337/db12-0206. Epub 2012 Jul 24.
Clinical trial NCT04029051: Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the Emergency Department
Official title: Focus Thoracic Ultrasound for Dyspnea Diagnosis in Elderly Patient in the ED: Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyspnea
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 84
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patient consulting in the emergency department for acute onset dyspnea

Brief summary: Brief Summary: The aim of this study is to analyze in elderly patients with undifferentiated dyspnea, the concordance of diagnosis before and after a focus thoracic ultrasound in comparison with the reference one established by an adjudication committee

Detailed description: Dyspnea is associated with a variety of etiology whose diagnosis is challenging especially in elderly patients with unconventional symptoms. Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound. It has already demonstrated its ability to reduce diagnosis uncertainty in emergency patients with dyspnea. However, adequacy of diagnosis before and after thoracic ultrasound has not been investigated in such patients.

In this population, after clinical examination and use of any resource deemed necessary, the physician states its hypothesis in closed list. An emergency physician then realizes a thoracic ultrasound exam. An adjudication committee with all the patient's file will state the reference hypothesis.

Eligibility criteria: Inclusion Criteria:

* Acute onset dyspnea in patient over 74 years old consulting at the emergency department

Exclusion Criteria:

* Need for ICU
* Need for a mechanical ventilation
* Less than 24 hours hospital stay
* Inability to consent

Primary outcomes:
measure: main objective
timeFrame: 3 years
Secondary outcomes:
measure: Frequency
timeFrame: 3 years
measure: mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
References:
citation: De Carvalho H, Javaudin F, Le Bastard Q, Boureau AS, Montassier E, Le Conte P. Effect of chest ultrasound on diagnostic workup in elderly patients with acute respiratory failure in the emergency department: a prospective study. Eur J Emerg Med. 2021 Jan 1;28(1):29-33. doi: 10.1097/MEJ.0000000000000732.
Clinical trial NCT03107351: Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography
Official title: Validation Study of Cardiac Linear and Torsional Contractility Measurements With a New Technology: Multi Dimensional Kineticardiography (MKCG)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2017-04-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double blind randomized crossover active vs placebo
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aims to validate the possibility to track cardiac contractility changes with a new technology called 'Heart Kinetic' (HK). HK measurements will be realized and compared echocardiography.


Eligibility criteria: Inclusion Criteria:

* Adult between 18 and 50 years old.
* Healthy without medical cardiac conditions history.
* Non smoker.
* Does not take any drugs or medications.
* Does not participate in other clinical study or trial.
* BMI (Body Mass Index) in between 20 and 25 kg/m2.

Exclusion Criteria:

* Being younger than 18 or older than 50 years old.
* Having had previous cardiac conditions or present disease.
* Being a regular smoker.
* Taking any drugs or medications
* Taking part in another clinical study or trial.
* BMI (Body Mass Index) lower than 20 or higher than 25 kg/m2.

Primary outcomes:
measure: HK reproducibility validation
timeFrame: day 1
measure: Cardiac contractility tracking with HK
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Hôpital Erasme
state: Anderlecht
Study officials:
References:
citation: Hossein A, Rabineau J, Gorlier D, Pinki F, van de Borne P, Nonclercq A, Migeotte PF. Effects of acquisition device, sampling rate, and record length on kinocardiography during position-induced haemodynamic changes. Biomed Eng Online. 2021 Jan 6;20(1):3. doi: 10.1186/s12938-020-00837-5.
Clinical trial NCT04677751: Clinical and Electrographic Changes in Responsive Neurostimulation System (RNS) Patients with Acupuncture Treatment
Official title: Clinical and Electrographic Changes in RNS System Patients with Acupuncture Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Keywords: acupuncture
RNS
seizure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 10
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine effects of Acupuncture on a Patient's mood and cognition,evaluate changes in clinically-reported seizure frequency and severity and analyze effects of Acupuncture on electrographic epileptiform activity stored by the RNS System


Eligibility criteria: Inclusion Criteria:

* Patient implanted with the RNS system
* Patient can undergo 12 weeks of acupuncture
* Patient is able remain on stable medications for 12 weeks
* Patient is able to remain on stable Detection and Stimulation settings for 12 weeks
* Patient or/and caregiver is able to understand and sign informed consent and HIPAA authorization
* Patient or caregiver able to maintain a seizure diary for duration of study

Exclusion Criteria:

* Patient and /or caregiver is unable to sign informed consent to study
* Patient has a bleeding disorder, pacemaker, or pregnant

Primary outcomes:
measure: Percent change in number of disabling clinical seizures
timeFrame: Baseline,12 weeks post treatment
measure: Changes in seizure severity
timeFrame: Baseline,12 weeks post treatment
Secondary outcomes:
measure: Change in cognition and mood as assessed by the Quality Of Life In Epilepsy (QOLIE-10) questionnaire
timeFrame: Baseline,12 weeks post treatment
measure: Change in cognition and mood as assessed by the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline,12 weeks post treatment
measure: Change in cognition and mood as assessed by the Generalized Anxiety Disorder 7-item (GAD-7) scale
timeFrame: Baseline,12 weeks post treatment
measure: Average number of detections of seizures per-day (as stored by the RNS System)
timeFrame: Baseline
measure: Average number of detections of seizures per-day (as stored by the RNS System)
timeFrame: end of 1 month
measure: Average number of detections of seizures per-day (as stored by the RNS System)
timeFrame: end of 2 months
measure: Average number of detections of seizures per-day (as stored by the RNS System)
timeFrame: end of 3 months
measure: Average number of detections of seizures per-day (as stored by the RNS System)
timeFrame: 1 month after last treatment
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Olga Rodziyevska, MS,PA-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05271851: Tailoring Mindfulness Interventions for Families Managing Chronic Health Conditions
Official title: PEP (Parent and Child-Informed, Environmentally-Responsive Pediatric Asthma) Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mindfulness
Chronic Disease
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: University of Wisconsin, Madison
name: University of Maryland, Baltimore
name: University of Memphis
First posted: 2022-03-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member

Brief summary: This is not an intervention or treatment study. It is an observational qualitative data study about tailoring a mindfulness intervention to assist families managing chronic health conditions.

Detailed description: This is not an intervention or treatment study. It is an observational qualitative data study. Collecting information from virtual audio only interviews from between 30 and 40 US adults about whether a mindfulness intervention would assist families managing chronic health conditions; and if so, how should it be tailored to meet their needs.

Eligibility criteria: Inclusion Criteria:

* English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member

Exclusion Criteria:

* unable to complete an audio interview in English lasting 30-60 minutes

Primary outcomes:
measure: what families managing chronic illness want in a mindfulness intervention
timeFrame: 30 to 60 minute interview
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: UMD
state: Maryland
Study officials:
affiliation: UMD
name: Robin Puett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03992651: Optical Transcutaneous Sensors of Capnia and Oxygenation
Official title: Validation of Optical Transcutaneous Sensors to Measure Capnia and Tissue Oxygenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Gas Monitoring, Transcutaneous
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One single group will have simultaneous measurements of capnia and tissue oxygenation by the new sensors and by the standard laboratory sensors
Primary purpose: DIAGNOSTIC

Brief summary: This study aims at validating new optical transcutaneous sensors to evaluate tissue capnia (CO2 partial pressure) and oxygenation (blood oxygen saturation) by comparing them to standard laboratory measurements (end tidal CO2 measurements and oxygen saturation by near-infrared spectroscopy).


Eligibility criteria: Inclusion Criteria:

* Males or females between 18 and 50 year old
* Individual having health insurance
* Individual able to provided informed consent
* Subjects with no known pathology and not taking any medical treatment a priori capable of interfering with controlled hypoxia at levels required in the protocol

Exclusion Criteria:

* Body mass index \>27 kg/m²
* History of acute mountain sickness
* Chronic diseases know to be associated with high methemoglobinemia
* Known allergy to one of the materials used in the devices (lycra, polyamide...), or to the adhesive plaster.
* Active smoker (\>3 cigarets/day)
* Alcohol consumption (\>10g/day)
* Individual with high skin sensitivity due to skin diseases
* Mental disorders
* Persons who refuse to sign the information sheet and participation agreement
* Persons under guardianship or not subject to a social security system
* Pregnant woman, parturient, breastfeeding mother
* Person deprived of liberty by judicial or administrative decision
* A person who is subject to a legal protection measure that cannot be included in clinical trials.

Primary outcomes:
measure: Comparison of capnia values
timeFrame: Continuous measurement during the only experimental session (1 hour)
Secondary outcomes:
measure: Comparison of tissue oxygenation values
timeFrame: Continuous measurement during the only experimental session (1 hour)
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alpes University Hospital
state: Rhône-Alpes
Study officials:
affiliation: Grenoble Alpes Hospital
name: Stéphane Doutreleau, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: