louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06960356: Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome
Official title: Development of Follow-up Nursing Consultations for Children at Risk of Post-resuscitation Syndrome
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress Disorder, Post Traumatic
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2025-05-07
Enrollment: 115
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigator hypothesize that, during an IPDE consultation 3 months after discharge from critical care, the investigator will identify PTSD in approximately one-third of children, and show an association between this syndrome and quality of life in children admitted to pediatric intensive care.


Eligibility criteria: Inclusion Criteria:

* Patients aged between 1 and 17.5 years at inclusion
* Having stayed in a paediatric intensive care unit in one of the 2 participating centers: Lyon or Grenoble
* Requiring mechanical ventilation (invasive or non-invasive) for more than 24 hours

Exclusion Criteria:

* Patients already under the care of a psychologist or psychiatrist
* patients who died during their stay in intensive care
* Patients who died between discharge and 3 months
* Patients suspected of abuse
* Patient and/or parent refusal to participate
* No social security affiliation
* Patients / parents who do not speak French

Primary outcomes:
measure: post-traumatic stress disorder
timeFrame: 3 months
Secondary outcomes:
measure: Pediatric Quality of Life Inventory TM (PEDSQL scale)
timeFrame: 3 months
measure: correlation between the PTSD score and the child's quality of life
timeFrame: 3 months
measure: Measurement of the association between the characteristics of children and their stay in critical care, and the presence of PTSD
timeFrame: 3 months
measure: number of children with significant somatic symptoms
timeFrame: 3 months
measure: Screening parents for PTSD
timeFrame: 3 months
measure: factors associated with the occurrence of PTSD in parents
timeFrame: 3 months
measure: Evaluate the feasibility of having the follow-up critical care consultation carried out by a nursery nurse
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03521856: Trial for Shoulder Pathology and Pain in Chronic SCI
Official title: Trial for Shoulder Pathology and Pain in Chronic SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: spinal cord injuries
SCI
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: U.S. Department of Education
First posted: 2018-05-11
Enrollment: 35
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: This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.


Eligibility criteria: Inclusion Criteria:

1. Candidates will be men or women, 18 years of age or older.
2. Candidates must have an SCI and be at least 1 year post-diagnosis
3. Candidates must use a wheelchair (manual or electric) for at least the majority of the time.
4. Candidates must be able to transfer themselves without the help of others.
5. The presence of at least moderate shoulder pain (rating of \>= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.

Exclusion Criteria:

1. Patients younger than 18 years of age.
2. Patients who have a history of pre-injury rotator cuff tears or shoulder injury.
3. Patients who do not use a wheelchair (manual or electric) at least 50% of the time.

Primary outcomes:
measure: Change in shoulder pathology
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Change in shoulder pain using the numerical rating scale
timeFrame: Baseline to week 12
measure: Change in shoulder pain using the numerical rating scale
timeFrame: Baseline to week 16
measure: Change in shoulder pain using the WUSPI
timeFrame: Baseline to week 12
measure: Change in shoulder pain using the WUSPI
timeFrame: Baseline to week 16
measure: Change in shoulder pathology
timeFrame: Baseline to week 16
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Elizabeth R Felix, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mulroy SJ, Thompson L, Kemp B, Hatchett PP, Newsam CJ, Lupold DG, Haubert LL, Eberly V, Ge TT, Azen SP, Winstein CJ, Gordon J; Physical Therapy Clinical Research Network (PTClinResNet). Strengthening and optimal movements for painful shoulders (STOMPS) in chronic spinal cord injury: a randomized controlled trial. Phys Ther. 2011 Mar;91(3):305-24. doi: 10.2522/ptj.20100182. Epub 2011 Feb 3.
citation: Cardenas DD, Felix ER, Cowan R, Orell MF, Irwin R. Effects of Home Exercises on Shoulder Pain and Pathology in Chronic Spinal Cord Injury: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2020 Jun;99(6):504-513. doi: 10.1097/PHM.0000000000001362.
Clinical trial NCT05730556: A Study of Remote Electrical Neuromodulation for Acute Procedural Pain
Official title: Remote Electrical Neuromodulation for Acute Procedural Pain in Chronic Migraine Patients Receiving onabotulinumtoxinA
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Migraine
Keywords: OnabotulinumtoxinA (Botox) injections
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of using remote electrical neuromodulation, using the Nerivio ® device, to relieve pain associated with receiving onabotulinumtoxinA (Botox) injections for chronic migraine prevention.


Eligibility criteria: Inclusion Criteria:

* Meet the criteria for 1.3 chronic migraine based on ICHD3 criteria.
* Currently receiving onabotulinumtoxinA per PREEMPT protocol for the treatment of chronic migraine.
* Have remained stable on their current headache medication for a minimum of 8 weeks.
* Patient is willing and able to comply with the protocol to the satisfaction of the investigator.
* Patient has the capacity to provide written, informed consent for themselves.

Exclusion Criteria:

* Participants with an active implanted electrical and/or neurostimulator device (e.g., cardiac pacemaker, cochlear implant).
* Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
* Participants with uncontrolled epilepsy.
* Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study.
* Pregnant, trying to get pregnant or breastfeeding female participants.
* Subjects participating in any other interventional clinical study.
* Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
* Participants who have previous experience with the device.
* Patients with cranial deformities, prior cranial surgeries with violation of the calvarium, or shunt placement.

Primary outcomes:
measure: Change in pain intensity measured by Visual Analog Scale (VAS)
timeFrame: Baseline, 12 weeks, 24 weeks
Secondary outcomes:
measure: Presence of post-procedural headache
timeFrame: 1 day following procedure
measure: Adverse Events
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Amaal Starling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06830356: Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.
Official title: Somatostatin Receptor PET Imaging to Guide Radiotherapy Dose Escalation in High Risk Meningiomas.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meningioma
Lead sponsor: Centro di Riferimento Oncologico - Aviano
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 53
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: High-risk meningiomas always require postsurgical radiation treatment. Recent evidence has shown that increased radiation therapy dose may be associated with increased intracranial control of disease. In order to better define the volume of radiation treatment, the addition of PET imaging with somatostatin receptor tracers adds additional information compared to encephalon MRI with MoC alone.The present study aims to investigate whether radiation treatment with higher doses than the standard and defined using PET imaging can be safe and at the same time effective in order to increase progression-free survival in high-risk meningiomas.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 16 years;
* Ability to express appropriate informed consent to treatment;
* Diagnosis of grade III meningioma (regardless of presence of residual) or diagnosis of recurrence of grade II meningioma (regardless of presence of residual) or first diagnosis of grade II meningioma with presence of residual;
* In case of recurrence, confirmation can be either histological or radiological;
* Not previous brain-level radiotherapy;
* Performance status: ECOG=0-2.

Exclusion Criteria:

* Refusal to radiation treatment (i.e., absence of signed informed consent);
* Other concomitant oncologic therapies
* Current pregnancy;
* Grade I meningiomas or Grade II meningiomas if operated on at first diagnosis with radical resection;
* Inability to perform MRI with MoC or PET.

Primary outcomes:
measure: Incidence of brain radionecrosis
timeFrame: up to 13 years
measure: Assess progression free survival (progression free survival = PFS) at 3 years
timeFrame: up to 13 years
Secondary outcomes:
measure: Overall survival (Overall survival = OS)
timeFrame: up to 13 years
measure: Incidence of other toxicities
timeFrame: up to 13 years
measure: Concordance between GTV-RM and GTV-PET
timeFrame: up to 13 years
Other outcomes:
Locations:
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico di Aviano (CRO)
state: Pordenone
Study officials:
affiliation: Centro di Riferimento Oncologico di Aviano (CRO)
name: Lorenzo Vinante
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05515809: Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery
Official title: Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Cardiac Surgery
Ultrasound-guided Parasternal Block
Postoperative Pulmonary Complications
Pulmonary Function Testing
Keywords: Cardiac surgery
Ultrasound-guided Parasternal Block
Postoperative pulmonary complications
Pulmonary function testing
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-08-25
Enrollment: 84
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: Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years of age
* Elective cardiac surgery under CEC with sternotomy
* Written informed consent from the patient.
* Women of childbearing age must have a negative urine HCG pregnancy test.

Exclusion Criteria:

* Thoracotomy approach
* Mini-sternotomy approach
* Opioid drug dependence or chronic opioid drug use
* Chronic benzodiazepine use (respiratory depressant treatment or treatment that may affect postoperative respiratory function)
* Contraindication or allergy to local anesthetics
* Emergency surgery
* Acute infective endocarditis
* Immunosuppressive or steroid treatment (prednisone \> 0.5mg/kg/day or equivalent)
* AIDS with CD4 count \<200/mm3
* Autoimmune disorder
* Transplant recipient
* Inclusion in another study within the last 30 days.
* Pregnancy

Primary outcomes:
measure: Change in postoperative forced vital capacity (FVC)
timeFrame: 1 day
Secondary outcomes:
measure: Variation of FCV between both groups
timeFrame: at day 2
measure: Variation of FCV between both groups
timeFrame: at 1 month
measure: Variation of FCV between both groups
timeFrame: at 3 months
measure: Variation of forced expiratory volume in 1 second (FEV1)
timeFrame: at day 2
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT04326309: Audio Data Collection for Identification and Classification of Coughing
Official title: Audio Data Collection for Identification and Classification of Coughing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Coronavirus Infections
Hay Fever
Asthma
Chronic Obstructive Pulmonary Disease
Influenza
Common Cold
Respiratory Tract Infections
Healthy
Lead sponsor: HealthMode Inc.
Sponsor class: INDUSTRY
First posted: 2020-03-30
Enrollment: 336
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: US resident participants downloading the HealthMode Stool application from the Apple AppStore (Cohort 1) and persons in the vicinity of a HealthMode Cough Monitoring Device (Cohort 2)

Brief summary: An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.


Eligibility criteria: Inclusion Criteria:

Cohort 1, 3, 4 and 5:

* Females and males over 18 years old
* Willing to share demographic data with the sponsor of the study
* Willing to follow app use instructions during the course of the study
* Willing to complete survey instruments as described in study procedures
* Willing to provide electronic informed consent
* Able to read and understand the English language well enough to complete electronic informed consent

Cohort 2:

Any person present in the vicinity of a HealthMode Cough Monitoring Device

Exclusion Criteria:

No exclusion criteria

-

Primary outcomes:
measure: Dataset size
timeFrame: 14 days
Secondary outcomes:
measure: Cough sound identification
timeFrame: 14 days
measure: Improvement of the existing model
timeFrame: 14 days
measure: Evaluate the usability of the application
timeFrame: 14 days
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Virtual Facility
state: New York
Study officials:
References:
Clinical trial NCT02583009: A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Rosacea
Official title: Multicenter, Randomized, Double-blind, Placebo-controlled Parallel-group, Dose Finding Phase II Clinical Trial to Evaluate Anti Rosacea Effect and Safety of PAC-14028 Cream (0.1%, 0.3%, 1.0%) in Rosacea Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rosacea
Lead sponsor: Amorepacific Corporation
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 216
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is to determine the optimum dose of PAC-14028 cream in a therapeutic confirmatory clinical study by evaluating the safety and therapeutic equivalence of PAC-14028 cream 0.1%, 0.3% and 1.0% in patients with rosacea.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 19 - 70 years old
* Among the patients diagnosed with erythematotelangiectatic and papulopustular rosacea in accordance with the diagnostic criteria of the National Rosacea Society Expert Committee
* Subjects with rosacea scored 2 or more according to the Investigator Global Assessment (IGA) at screening

Exclusion Criteria:

* Those who can't be diagnosed or assessed for rosacea due to the presence of trauma, tattoo, scar, excessive hairs on the facial region
* Those who have received a facial laser treatment within 6 weeks
* Those who have been administered with oral retinoid or therapeutic vitamin A within 6 months
* Those who have received a hormonal treatment such as estrogen within 3 months
* Those who have been administered with systemic antibiotics or systemic steroid formulation within 4 weeks
* Those who have been administered with local retinoid, local steroid and local antibiotics and local medication for the treatment of rosacea on face within 4 weeks
* Those who have a history of blood disorder that can have a serious effect on the clinical study
* Women who are pregnant, lactating or who plan to be pregnant during the clinical study period or women of childbearing potential who do not use available contraceptive methods

Primary outcomes:
measure: Change in Investigator Global Assessment (IGA)
timeFrame: Week 4 from the baseline
Secondary outcomes:
measure: Improvement rate in Investigator Global Assessment (IGA)
timeFrame: Week 4 from the baseline
measure: Change in the erythema severity score
timeFrame: Week 4 from the baseline
measure: Rate of change in inflammatory lesion counts
timeFrame: Week 4 from the baseline
measure: Change in erythema index
timeFrame: Week 4 from the baseline
measure: Change in the telangiectasia severity score
timeFrame: Week 4 from the baseline
Other outcomes:
Locations:
city: Ansan si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
Study officials:
affiliation: Amorepacific R&D Center
name: Miyoung Park, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05465109: Traumatic Brain Injury and Alzheimer's Disease/Related Dementias Caregiver Support Intervention
Official title: Designing and Evaluating a Comprehensive Support Program for Families Caring for Relatives Living With TBI-AD/ADRD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Caregiver Stress Syndrome
Caregiver Burnout
Keywords: Caregiver
Traumatic brain injury
Alzheimer's
Dementia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
name: Minneapolis Veterans Affairs Medical Center
name: Mayo Clinic
First posted: 2022-07-19
Enrollment: 95
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The TBI-AD/ADRD Caregiver Support Intervention (TACSI) incorporates psychosocial and psychoeducational approaches with the objective of: a) identifying stressors associated with caregiving for family members who have the dual diagnosis of traumatic brain injury and dementia; and b) supporting caregivers in developing more effective coping and communication strategies as well as enhanced caregiving self-efficacy.


Eligibility criteria: Inclusion Criteria:

* the care recipient has a physician diagnosis of TBI and AD/ADRD (i.e., those with a diagnosis of both TBI and progressive cognitive decline)
* the caregiver self-identifies as someone who provides the most help/is most responsible for the person with TBI-AD/ADRD because of their cognitive impairments (or shares the role equally with another caregiver)
* the caregiver indicates a willingness to participate in the TACSI evaluation
* the caregiver is English speaking
* the caregiver is 21 years of age or older
* the caregiver is not currently participating in any other type of service that provides one-to-one psychosocial consultation or caregiver coaching (peer mentorship/support group participation/general counseling not specific to caregiving is not a deterrent to enrollment) at the discretion of the UMN research team
* the caregiver resides in the US.

Exclusion Criteria:

* caregivers who have a new or worsening mental health condition and are not receiving ongoing treatment. When applicable, if caregivers have not remained on a stable psychotropic medications dosage, such as antidepressants, anxiolytics or anti-psychotics, for the prior three months they will be excluded.

Primary outcomes:
measure: Caregiver primary subjective stress- Phase 1
timeFrame: change in score from baseline to 3 months
measure: Caregiver primary subjective stress- Phase 2, 3mo
timeFrame: change in score from baseline to 3 months
measure: Caregiver primary subjective stress- Phase 2, 6mo
timeFrame: change in score from baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT01238809: Gastroprotective Agent Utilization and Compliance in Patients > 60 Years Taking Low-dose Aspirin in France
Official title: Gastroprotective Agent Utilization and Compliance in Patients > 60 Years Taking Low-dose Aspirin in France
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Self-administered Questionnaire to Patients
Keywords: Compliance
France
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 7300
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of this study is to assess in general population low-dose aspirin and gastroprotective agent compliance and reasons for bad compliance


Eligibility criteria: Inclusion Criteria:

* French people \> 60 years old, part of Kantar Health Access Sant� panel

Exclusion Criteria: -

Primary outcomes:
measure: low-dose aspirin and gastroprotective treatment compliance (Girerd questionnaire: a 6-item self-administered and validated questionnaire to evaluate adherence to treatments)
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KantarHealth - France
name: Mrs Genevieve BONNELYE
role: PRINCIPAL_INVESTIGATOR
References: