louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02252315: Written Versus Verbal Education for Mild Traumatic Brain Injury
Official title: Written Versus Verbal Education for Mild Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mild traumatic brain injury (MTBI) is a common injury that involves loss of consciousness or alteration in mental status induced by an external mechanical force to the head. Education about symptoms and reassurance of a prompt recovery usually results in full recovery. However, a subgroup appears to have persistent symptoms and disability. This study will recruit MTBI patients from two Emergency Departments with the aim of identifying modifiable patient characteristics that can delay or prevent full recovery. A secondary aim is to determine if providing education in writing or in-person makes a difference.


Eligibility criteria: Inclusion Criteria:

* Confirmation of a likely concussion without hospital admission
* Participants live locally with a fixed address
* Participants experience at least one new symptom

Exclusion Criteria:

* Participants who cannot understand/read English

Primary outcomes:
measure: Presence of Postconcussional Syndrome
timeFrame: 3 Months
Secondary outcomes:
measure: Glasgow Outcome Scale-Extended (GOS-E)
timeFrame: 3 Months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 Months
measure: PTSD Checklist-Civilian version (PCL-C)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Noah Silverberg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00934115: Epidemiology of Infections in Pediatric Cancer Patients
Official title: Epidemiology of Infections in Pediatric Cancer Patients: A Prospective Multicenter Study in Israel
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infections
Keywords: To define the incidence, categories of infections by organ systems, etiologic agents and risk
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 200
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric cancer patients

Brief summary: Infections are common causes of morbidity and mortality in pediatric cancer patients. Today, there are limited data on the incidence, distribution of specific infections, causative agents and risk factors for severe infections in this population. Moreover, little data exist on the epidemiology of infections among pediatric patients with solid tumors.

The objectives of the present study are to define the incidence, categories of infections by organ systems, etiologic agents and risk factors for infections in different pediatric malignancies. The results of this study will help the investigators to better understand the epidemiology of infections in the different types of pediatric malignancies, enable the investigators to identify high risk patients, and design a better approach to empiric treatment of these patients.

A prospective, multi-center study, conducted in 5 pediatric hematology-oncology units across Israel (Rambam Medical Center, Haemek Medical Center, Schneider Children's Medical Center, Hadassah Medical Center, Soroka Medical Center). All children aged 0-18 years of age, newly diagnosed with cancer and admitted to day care or inpatient departments with fever of \>38.0 C will be included in the study. Demographic, clinical and microbiological figures will be collected in each center by a research assistant supervised by the infectious disease specialist. Data will be collected according to a pre-defined Patient Data Form and entered into an electronic data base that will be analyzed accordingly. In each event of febrile episode during chemotherapy, the following data will be collected by a research assistant using a patient data form and computerized software:

* Demographic data: age, gender, ethnicity.
* Clinical data: Underlying disease, immunizations, prophylactic antibiotics, presence of central venous catheter, intensity of chemotherapy, duration of fever, duration and severity of neutropenia, diagnosis of present event.
* Imaging data
* Microbiological data
* Outcome

The statistical analysis will be performed by an epidemiologist and statistician using the SPSS 12.0 software.


Eligibility criteria: Inclusion Criteria:

* Pediatric cancer patients admitted to hospital with fever

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04034615: The Long-term Effect of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
Official title: A Phase II, Randomized, Placebo-Controlled Study of the Long-term Efficacy of Perinatal Tissue Mesenchyme Stem Cells in the Treatment for Caesarean Section Scars
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Cicatrix
Keywords: Mesenchyme Stem Cells
Cesarean Section
Scars
Lead sponsor: Maternal and Child Health Hospital of Foshan
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to investigate the long-term efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar.

Detailed description: This trial is a continuation of the investigators' previous clinical trial (NCT02772289). In the previous three-arm randomized clinical trial involving women with primiparous singleton pregnancies, the investigators found umbilical cord mesenchymal stem cells was not significantly different from placebo for the reduction of cesarean section skin scar and did not increase recognition of participants'satisfaction at the sixth month follow-up. Although there was no statistical difference, the trial study found that the total vancouver scar scale rating was lower with the dose increased.

Some studies have suggested that it usually took 18-24 months for a typical scar matures. In this trial, the investigators want to continue to investigate the efficacy of perinatal tissue mesenchyme stem cells treatment on the appearance of a caesarean scar as compared to a similar untreated scar at the three years follow-up.

Eligibility criteria: Inclusion Criteria:

* Primiparous women receiving cesarean delivery
* Ages between 21-35 years
* Gestation ages ≥ 37 weeks and \< 42 weeks
* Willing to give and sign an informed consent form and a photographic release form
* Willing to comply with study dosing and complete the entire course of the study

Exclusion Criteria:

* Any systemic uncontrolled disease
* Recent or current cancer
* History or presenting with a keloid formation
* Wounds or local disease in treatment area
* Planning any other cosmetic procedure to the study area during the study period
* Smoking

Primary outcomes:
measure: Vancouver Scar Scale score
timeFrame: Three years post treatment
Secondary outcomes:
measure: Erythema
timeFrame: Three years post treatment
measure: Pigmentation
timeFrame: Three years post treatment
measure: Scar Thickness and Uniformity
timeFrame: Three years post treatment
measure: Subject's satisfaction
timeFrame: Three years post treatment
Other outcomes:
Locations:
city: Foshan
country: China
facility: Maternal and Child Health Hospital of Foshan
state: Guangdong
Study officials:
affiliation: Maternal and Child Health Hospital of Foshan
name: Zhengping Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05689515: Feasibility of Positive Links for Youth Care Engagement Intervention
Official title: PL4Y: A Pilot Randomized Control Trial to Study the Feasibility of Positive Links for Youth Care Engagement Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Antibody Positivity
Keywords: Positive Links
Youth
Emerging Adults
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized in a 2:1 ratio to intervention (PL4Y use) or standard of care
Primary purpose: OTHER

Brief summary: A small pilot study to assess feasibility and acceptability of the PL4Y intervention.

Detailed description: After completing enrollment and informed consent, participants will be randomly assigned to PL4Y in a 2:1 fashion (intervention:control) with a target enrollment of 40 receiving the intervention and 20 in the control arm for a total of 60 participants. There is no blinding in this study protocol.

Eligibility criteria: Inclusion Criteria:

* Confirmed HIV infection
* Recent diagnosis of HIV (within the past 6 months) OR be virologically unsuppressed (\>1000 copies/ml) OR disengaged from HIV care (\< 2 visits/last 12 months \> 90 days apart)

Exclusion Criteria:

* Cannot consent
* Unwilling to come to visits
* Unwilling to be in San Antonio for a year

Primary outcomes:
measure: Completion of Feasibility Survey
timeFrame: 12 months
measure: Viral plasma load measurement
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University Health Center Downtown
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Barbara Taylor, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04697615: Reliability of Algometry in Swimming Athletes
Official title: Reliability of Algometry as a Clinical Value in Swimming Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Athletes
Lead sponsor: São Paulo State University
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young swimming athletes who regularly train and are members of the swimming teams of the 4th region of the state of São Paulo, of the São Paulo Aquatic Federation (FAP), of the cities of Presidente Prudente, Votuporanga and São José do Rio Preto.

Brief summary: In the competitive swimming scenario, there is a significant incidence of pain, which can be justified by the high levels of training that exposes athletes to constant stress. In this way, the quantification of pain and its monitoring becomes extremely important for clinical practice. A commonly used tool with easy access and clinical applicability, capable of measuring the pain threshold (PT) in a standardized manner is the pressure algometer. However, there is a shortage in the literature of studies that evaluate the reliability of this instrument in healthy swimming athletes. Objectives: Evaluate the intra and inter-examiner reliability and to describe the profile of the PT measurements measured by the algometer in swimming athletes. Methods: It is a reliability study, and will be composed of fifty young athletes members of swimming teams, of both genders, aged between 12 and 20 years. The evaluation will be carried out on the same day and in 2 steps: (1) Test and (2) Retest. In the first step, through a third examiner, the participants will be subjected to marking of points in pre-determined muscles and in points of referred pain. Next, they will perform the PT assessment through the algometer by two other distinct and trained examiners. The interval between each examiner will be five minutes with the participant at rest. After five minutes the test was performed, the step retest will begin, which will have the same procedures as in the previous step. The statistical package SPSS Statistics 23.0 will be used to conduct the analyzes.


Eligibility criteria: Inclusion Criteria:

* Healthy swimming athletes

Exclusion Criteria:

* Being an alcoholic and/or consuming drugs and/or smoking;
* Anti-inflammatory and / or analgesic drugs less than 24 hours before the test;
* Presenting anemia, inflammatory process, diabetes, cardiovascular disease;
* Episodes of muscle-tendon or osteoarticular injury in the lower, upper and / or lower limbs spine in the last three months;
* In addition to swimming for less than two years.

Primary outcomes:
measure: Pain threshold
timeFrame: two hours
Secondary outcomes:
Other outcomes:
Locations:
city: Presidente Prudente
country: Brazil
facility: University of Sao Paulo State
state: São Paulo
Study officials:
References:
Clinical trial NCT02083315: Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Explore the Pharmacokinetics and Pharmacodynamics of TRV130, Morphine, and Placebo in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain, Acute
Keywords: acute pain, analgesia, respiratory drive, ventilator response to hypercapnia, pupillometry
Lead sponsor: Trevena Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-11
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is designed to compare TRV130 to placebo and morphine to learn about its effects on pain relief and side effects.

Detailed description: This study will explore the pharmacokinetics, pharmacodynamics (PD), safety and tolerability of TRV130.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Healthy adult males age 18 - 50 years, BMI 19-32 kg/m2
* Acceptable duration of cold pain test results at screening

Exclusion Criteria:

* Clinically significant medical illness or physical exam findings
* Active dermatological conditions or skin trauma on the non-dominant hand, or peripheral vascular disease
* Partial blindness, keratoconus, nystagmus or any other ophthalmic condition which could interfere with pupillometry
* Use of tobacco or nicotine within 6 months prior to screening
* History of recent (within 6 months) drug or alcohol abuse, as defined in DSM-IV-TR

Primary outcomes:
measure: Cold Pain Test
timeFrame: 8 hours postdose
Secondary outcomes:
measure: Ventilatory Response to Hypercapnia
timeFrame: 4 hours postdose
measure: Pupillometry
timeFrame: 8 hours postdose
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: CRI Lifetree
state: Utah
Study officials:
affiliation: Trevena Inc.
name: David G Soergel, MD
role: STUDY_CHAIR
References:
citation: Soergel DG, Subach RA, Burnham N, Lark MW, James IE, Sadler BM, Skobieranda F, Violin JD, Webster LR. Biased agonism of the mu-opioid receptor by TRV130 increases analgesia and reduces on-target adverse effects versus morphine: A randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Pain. 2014 Sep;155(9):1829-1835. doi: 10.1016/j.pain.2014.06.011. Epub 2014 Jun 19.
Clinical trial NCT06028815: Group Music Therapy Intervention With Informal Carers of Elderly Dependents
Official title: Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Care Burden
Anxiety
Depression
Coping Strategies
Quality of Life
Keywords: Group music therapy
Informal caregivers
Health-related quality of life (HRQOL)
Anxiety
Depression
Lead sponsor: University of Deusto
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of a group music therapy intervention with informal caregivers of elderly people on clinical psychological symptoms, taking into account variables such as caregiver burden, anxiety and depression.


Eligibility criteria: Inclusion Criteria:

* to be the main informal caregiver of an elderly dependant
* the dependant person has to be over 60 years of age
* to be over 18 years of age
* having signed the informed consent form accepting the assessment and intervention

Exclusion Criteria:

* not residing in Spain
* being under 18 years
* having uncompensated sensory deficits that prevented the administration of the assessment protocol;
* illiteracy.

Primary outcomes:
measure: Health-related quality of life
timeFrame: 3 months
measure: Anxiety Stay and Trait
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Burden
timeFrame: 3 months
Secondary outcomes:
measure: Coping strategies
timeFrame: 3 months
measure: Spirituality
timeFrame: 3 months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: University of Deusto
state: Bizkaia
Study officials:
References:
Clinical trial NCT01445015: Stress Management Intervention in Inner City Adolescents With Asthma
Official title: Pilot Study: Stress Management Intervention as a Tool for Managing Persistent Asthma in Inner City Adolescent Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Asthma
Psychosocial Stress
Keywords: adolescents
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2011-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will utilize a stress management program delivered over 10 sessions that is hypothesized to result in decreased stress levels and improved coping strategies in an inner city adolescent asthma population. Participants will include adolescents ages 10-15 years with physician diagnosed asthma. The outcome measures will be obtained via psychosocial questionnaires and spirometry.


Eligibility criteria: Inclusion Criteria:

* Ages 8-15 years of age
* Physician diagnosed asthma based on NHBLI guidelines
* English speaking
* Child assent/parental consent

Exclusion Criteria:

* Refusal of child assent/parental consent
* Non-English speaking
* History of psychiatric illness, autoimmune disease, HIV/AIDs, smoking history.

Primary outcomes:
measure: Scope of change in perceived stress from enrollment to completion of study using the Perceived stress scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Secondary outcomes within scope of change from enrollment to completion of study in coping as assessed by Kidcope
timeFrame: 5 weeks
measure: Secondary outcomes within scope of change from enrollment to completion of study in anxiety as measured by State Trait Inventory
timeFrame: 5 weeks
measure: Secondary outcomes within scope of change from enrollment to completion of study in quality of life as assessed by PAQLQ
timeFrame: 5 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Cornell Weill Pulmonary/Allergy pediatric clinics
state: New York
Study officials:
References:
Clinical trial NCT04624815: Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children
Official title: Factors Issued From Functional Exploration Associated to SAHOS in Asthmatic Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Asthma
Obstructive Sleep Apnea Syndrome
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 6
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: asthmatic children

Brief summary: There is an increase in the prevalence of obstructive apnea-hypopnea syndrome (OSA) in children for which the pathophysiological explanation is unknown. The main objective is to compare pharyngeal collapsibility in asthmatic children with SHS score \> 2.75 or ≤ 2.75 (OSA prediction score validated in French). Secondary objectives: Compare pharyngeal size, tracheal size, loop gain and its components (controller, plant), lung volumes and expired and nasal NO in asthmatic children with SHS score \> 2.75 or ≤ 2.75. The bias due to the possible existence of an alveolar hyperventilation syndrome associated with asthma will be taken into account.

Detailed description: Detailed measurements and questionnaires: Measurement of pharyngeal volume by acoustic pharyngometry in sitting and lying position with calculation of pharyngeal compliance. Measurement of ventilation (15 minutes) and transcutaneous PCO2 measurement, three apnea tests at the end of the test, hyperventilation test. PFT with spirometry and static volume measurement. Multiple flow measurement of exhaled NO with calculation of bronchial flow and alveolar fraction of NO. Nasal NO measurement. Questionnaires for OSA: the Pediatric Sleep Questionnaire (PSQ) and the SCR (Sleep Clinical Record). Questionnaires for functional respiratory disorder: French hyperventilation questionnaire SHAPE and the Nijmegen score

Eligibility criteria: Inclusion Criteria:

* Confirmed asthma established on the notion of typical respiratory functional signs and the notion of reversibility of a bronchial obstruction on previous PFT and/or asthma exacerbation diagnosed by the physician in an emergency room. Ongoing asthma treatment (including SABA on demand)

Exclusion Criteria:

* not asthmatic children

Primary outcomes:
measure: pharyngeal collapsibility pharyngeal collapsibility pharyngeal collapsibility
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Robert Debre Hospital
Study officials:
affiliation: Assistance Public Hôpitaux de Paris
name: Christophe DELCLAUX, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References: